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Document of The World Bank FOR OFFICIAL USE ONLY MICROFICHE COPY Report No. 10513-EGT Type: (SAR) Report No. 10513-EGT GOLLADAY, / X32850 / H8 050/ MN2PH STAFF APPRAISAL REPORT ARAB REPUBLIC OF EGYPT NATIONAL SCHISTOSOMIASIS CONTROL PROJECT JUNE 2, 1992 Population and Human Resources Division Country Department II Middle East and North Africa Region This document has a restricteddistribution and may be used by recipientsonly in the performance of their offical duties. Its contents may not otherwise be disclosed without World Bank authorization. Public Disclosure Authorized Public Disclosure Authorized Public Disclosure Authorized Public Disclosure Authorized Public Disclosure Authorized Public Disclosure Authorized Public Disclosure Authorized Public Disclosure Authorized

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Page 1: World Bank Documentdocuments.worldbank.org/curated/en/528481468234881261/pdf/mul… · NSCP National Schistosomiasis Control Programme SDR Special Drawing Rights SRP Schistosomiasis

Document of

The World Bank

FOR OFFICIAL USE ONLY

MICROFICHE COPY

Report No. 10513-EGT Type: (SAR) Report No. 10513-EGTGOLLADAY, / X32850 / H8 050/ MN2PH

STAFF APPRAISAL REPORT

ARAB REPUBLIC OF EGYPT

NATIONAL SCHISTOSOMIASIS CONTROL PROJECT

JUNE 2, 1992

Population and Human Resources DivisionCountry Department IIMiddle East and North Africa Region

This document has a restricted distribution and may be used by recipients only in the performance oftheir offical duties. Its contents may not otherwise be disclosed without World Bank authorization.

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CURkENCY EQUIVALENCES

Currency Unit = Egyptian Pounds (LE)US$1.00 = LE 3.30& (As of February 15, 1992)

LE 1.00 = US$ 0.30SDR1 = US$1.372 (As of May 15, 1992)

US$1 = SDRO.729

ABBREVIATIONS AND ACRONYMS

ADB African Development Bank

EDCD Endemic Diseases Control Department

epg eggs per gram

IDA International Development Association

LE Egyptian Pound

NSCP National Schistosomiasis Control Programme

SDR Special Drawing Rights

SRP Schistosomiasis Research Project

USAID United States Agency for.international Development

US$ United States Dollar

Fiscal Year: July 1 - June 30

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FOR OMFICIL USE ONLY

ARAB REPUBLIC OF EGYPrNATION4AL SCHISTOSOMIASIS CONTROL PROJECT

STAFF APPRAISAL REPORT

Table of ContentsPage no.

BASIC DATA SHEEr .................. iCREDr AND PROJECT SU'AMARY . . . iiI. INTRODUCTION ........................................... 1H. BACKGROUND ........................................... 2

The Health Situation in Egypt .. 2Life Expectancy and Mortality ............................. 2Morbidity ......................................... 2National Health Policies .. 3Overall Perfornance of the Health Sector .................... 3

Schistosomiasis .......................................... 4Control Strategies ................................... 5The Egyptian National Schistosomiasis Control Programme ............ 6The Egyptian Schistosomiasis Control Strategy . . 7

Role of IDA ............................................ 8Lessonsfrom Earlier Operations .. 9Aims of the Present Project ....................... 9

II. DESCRIPTON OF THE PROPOSED OPERATION ... 10EXpansion of the Program into the Nile Delta .. 11Consolidation of Existing Control Activities .. 11Strategic Planning and Modernization of the Program ................. 11Operational Plan ..................... 12

Screening Methods ..................... 12The Intervention Strategy ..................... 1. lSnail Control ........... .......... 14Innovative Interventions. .............................. 15Institutionai Strengthening .. 16Strategic Planning and Decentralizati .. 16

This report is based on the findings of an appraisal nission which visited Egypt in Febuaqy, 1992. The mission was staffed by Mr.Fredrick L. Golladay (Principal Human Resources Economist and Mission Leader), Dr. Bruno M.AJ. Oryseels (Parsitologif.k), andMr. Subhendu Sengupta (Management Consultant,. This report was edited and processed by Stephanie A. Soutouras (EditorialAssstant). The Peer Reviewer was Dr. 8etnhard H. Liese, Director, Health Services Department. The tesponsible Regional VicePresident was Mr. Caio Koch-Weser, the responsible Director was Mr. Ram K. Chopra, MENA Country Depalment H, and theresponsible Division Chief was Mr. Douglas H. Keare, Population and Human Resounes Operations Division. Tbe Memotmndumof the President was produced by Patricia Maughan-Color. (Operations Assisant).

This document has a restricted distribution and may be used by ecipients only in the performanceof their official duties. Its contents may not otherwise be disclosed without World Bank authorization.

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Table of Contents (cont'd)

Page no.

IV. PROJECT COSTS, FINANCING, MANAGEMENT ANDIMPLEMENTATION ......................... 17cost of the Project ....................... 17

Swmmary of Project Costs ........................ 17Basis of Cost Estimates ......................... isContingency Allowances ................... 18Foreign Exchange Component ......................... 19Recurrent Costs ......................... 19

Project Financing ....................... 20Management and Implementation ................... 20

Management Structure .................... 20Organization and Management of the Project .. 21Maintenance ................. ..................... 21Procurement .. 21Status of Preparation ............... .................. 23Disbursements .. 24Accounts and Audits .. 25Program Affordability .. 25

V. ECONOMIC ANALYSIS, RISK ASSESSMENT AND SOCIAL IMPACT ... ... 25Control of Schistosomiasis in the Delta Region .. 26The Modernization and Strengthening of Ongoing Control Activities .... ..... 27Strengthening the Capacity of the Ministry of Health to Carty

out Strategic Planning and Program Management ............... 27Risks . .............................................. 27Social Impact of the Project ................................. 29

VI. AGREEMENTS REACHED AND RECOMMENDATIONS ............... 30ANNEX 1 COMPARISON OF HEALTH INDICATORS FOR LOWER-MIDDLE

INCOMECOUNTRIES ............................... 31ANNEX 2 A BRIEF DESCRIPTION OF SCHISTOSOMIASIS ............... 32ANNEX 3 THE PROJECT AREA .. 39ANNEX 4 PROTOCOLS FOR OPERATIONAL RESEARCH ................ 41ANNEX 5 DETAILED COST TABLES .............................. 55ANNEX 6 ECONOMIC ANALYSIS ................................ 61ANNEX 7 PROJECT ORGANOGRAMS ............................. 63ANNEX 8 PROJECT MONITORING INDICATORS ..................... 65ANNEX 9 DISBURSEMENT SCHEDULE ........... .. ............... 66ANNEX 10 IMPLEMENTATION SCHEDULE .. . .67ANNEX 11 USE OF THE PESTICIDE, NICLOSAMIDE, TO CONTMROL

SCHISTOSOMIASIS ................................ 68ANNEX 12 SUPERVISION SCHEDULE .. 70MAP NO. IBRD 22206

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ARAB REPUBLIC OF EGYPrNATIONAL SCHISTOSONMASIS CONTROL PROJECT

STAFF APPRAISAL REPORT

BASIC DATA SHEET

Indicator Data Years

Per capita income US$600 1988-90Average annual growth of population (percent) 1.8 (1989-2000)

Population (millions) 51 198962 200086 2025

Hypothetical size of stationary population (millions) 120

Age structure of the population (percent):0 - 14 years 39.2 1939

24.4 202515 - 64 years 56.5 1989

67.6 2025

Crude birth rate (per 1,000 population) 32 1989Crude death rate (per 1,000 population) 10 1989Women of childbearing age as a percentage of all women 48 1989

Total fertility rate 4.2 19893.1 2000

Assumed year of reaching a net reproduction rate of 1 2015

Married women of childbearing age using contraception 38 1987(percent)

Population per physician 770 1984Births attended by health staff (percent) 24 1985Babies with low birth weights (percent) 7 1985Infant mortality rate (per 1,000 live births) 68 1989Daily calorie supply (per capita) 3213 1988Percentage of age group enrolled in primary education 90 1988Percentage of females enrolled in primary education 79 1988

Percentage of age group enrolled in secondary education 69 1988Percentage of females enrolled in secondary education 58 1988

Source: Tables 1, 26, 27, 28 and 29, 'World Development Indicators", World Development Report, 1991, NewYork: Oxford University Press, 1991.

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ARAB REPUBLIC OF ECJYPTNATIONAL SCHISTOSOMIASIS CONTROL PROJECT

STAFF APPRAISAL REPORT

CREDIT AND PROJECT SUMMARY

BORROWER: Arab Republic of EgyptBENEFICIARY: Ministry of Health, Endemic Diseases Control DepartmentAMOUNT: SDR 19.60 Million (US$26.84 million equivalent)TERMS: Standard, with 35 years maturity

PROJECT DESCRIPI'ON: The proposed project would support the development of asustainable national program to control schistosomiasis,Egypt's most important parasitic disease. The proposed projecthas three specific objectives: (i) to extend the NationalSchistosomiasis Control Programme (NSCP) to fivegovernorates in the Eastern and Westem regions of the NileDelta; (ii) to modernmze and rehabilitate the existing programin Middle and Upper Egypt, and the Suez Canal area in orderto increase its efficiency ai.d effectiveness; and (iii) to supportoperational research and ztrengthen management of theMinistry of Health's Ende - Diseases Control Department(EDCD) in order to further i- rease operating efficiency andto control operating costs. The credit would finance threecategories of expenditure: (i) laboratory equipment, vehicles,drugs, molluscicides, consulting services and training for thegovernorates being added to the national program; (ii)replacement of obsolete and depreciated laboratory equipmentand vehicles; retraining of staff; and purchase of drugs andpesticides for governorates included earlier in the nationalprogram; and (iii) consultancy services, computers, vehiclesand research funds to strengthen the central agency chargedwith planning and executing the program.

BENEFITS AND RISKS: The project would enable the NSCP to increase its coverage by17 million people and thereby to reduce the burden imposed bythe disease. It would permit the EDCD to introducemodifications to the program which would ensure r,resensitive and less costly screening, more efficient treatnr.;ni,and more cost-effective control of transmission throughtargeted (or "focal") snail control and environmentalintervention. Capturing the full benefits from improvementsin program design and technical change would require re-training and re-deployment of staff, particularly in the snail

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control program which currently employs about 6,700 people.The project would strengthen the capacity of the EDCD toanalyze policy options, prepare strategic plans, carry outoperational research, and operate information and managementsystems for the national program. The project is designed tobe implemented over a six-year period; this period has beenchosen to allow the EDCD both to develop initiatives toimiprove the program and to introduce them into routineoperations.

This project presents no significant technical ris' Theeffectiveness of diagnostic procedures and diug therapy is wt. -established; molluscicides have been used widely since 1969without adverse consequences. The long-term success of theprogram will require sustained financial support from theGovernment of Egypt. The political urgency of controlling thedisease may decline as the project lowers morbidity andmortality rates. However, a national health educationcampaign has mobilized popular support for the program. Theproject would require foreign exchange for the purchase of thedrug, praziquantel. The annual expenditure for the drugduring the maintenance phase is estimated to be about $3.3million (1991 prices). The patent for praziquantel will expirebefore the close of the credit, allowing greater competition andperhaps local drug production, either of which would lead tofurther price reductions and cost savings.

PROJECT COST ESTIMATES: (In US$ million)

Component Local Foreign Total

Expanding the coverage of the National Schistosomiasis 2.87 20.86 23.73Control Programme into the Nile Delta

ModerniizLng and rehabilitating the National Schistosomiasis 2.12 13.44 15.56Control Programme

Strengthening the management capacity of the Department of 0.61 0.14 0.75Endemic Disease Control

Total base costs 5.60 34.44 40.04

Price contingencies 0.39 2.R2 3.21

Total project costs .99 37.26 425

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FINANCING PLAN: (In US$ millions)

Local Foreign Total

Government 5.99 -- 5.99

Co-financier -- 10.42 10.42

IDA -- 26.84 26.84

Total Financing 5.99 37.26 43.25Note: Price contirgencies between negotiations (May 15, 1992) and the end of projectimplementation are estimated at US$3.21 million equivalent, or 8.0 percent of base costs.

ESTIMATED DISBURSEMENTS: (In US$ millions)

1993 1994 1995 1996 1997 1998 1999

Annual 4.75 3.95 4.10 4.00 3.90 3.23 2.91

Cumulative 4.75 8.70 12.80 16.80 20.70 23.93 26.84-| iS )etails may not add to totals due to rounding.

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ARAB REPUBLIC OF EGYPTNATIONAL SCHISTOSOMIASIS CONTROL PROJFCT

STAFF APPRAISAL REPORT

I. INTRODUCTION

1. The Govemment of Egypt has applied to the International Development Association(IDA) for a credit of Special Drawing Rights (SDR) 19.6 million to be used to expand thecoverage and improve the efficiency of its National Schistosomiasis Control Programme (NSCP).Schistosomiasis is Egypt's most widespread and most burdensome parasitic disease.Y Theinfection is transmitted by fresh water snails that are oftei: found in the irrigation canals anddrains of rural Egypt. The population of the species of snail responsible for the transmissionof the most severe form of the disease has increased significantly in the Nile Delta since thecompletion of the High Dam at Aswan.

2. The proposed project aims to develop a nation-wide program to control schistosomiasisthat can be financed and operated independently by the Government of Egypt. Egypt has reliedon foreign assistance to finance the five schistosomiasis control projects it has undertaken overthe past 25 years. The first of these projects was launched in 1969 with the assistance of theGovernment of Germany and covered the Fayoum govemorate. Four subsequent operationsextended control activities to governorates in Upper and Middle Egypt and the Suez Canal area.A sixth project was approved recently by the African Development Dank (ABD) and is expectedto become effective in July 1992.

3. The proposed credit would finance three initiatives. First, it would assist in the extensionof the NSCP to the five governorates tlat remain uncovared. These governorates lie in theEastern and Western regions of the Nile Delta and are inhabited by about 17 million people; atleast 5 million of these people currently are infected by the parasite. Second, the credit wouldhelp the Govemment of Egypt to improve operations of the NSCP in areas supported by earlierprojects. These older control programs currently serve about 15 million people. The projectwould permit the NSCP to introduce modem diagnostic and treatment technologies, and tostrengthen operational management. Third, the credit would support a program of operationalresearch and management strengthening aimed at increasing efficiency and reducing operatingcosts over the longer term. This component is expected to lead to the development of bettersurveillance, more sensitive diagnosis, and more effective treatment; these advances would inturn enable the NSCP to control morbidity at a cost that is affordable to the Government ofEgypt.

Annex 2 briefly describes the disease, its transmission and the options for its control.

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U. BACKGROUND

The Health Situation in Egypt

4. ltfe Expectancy and Montality. The life expectancy at birth for Egyptians in 1990 wasabout 61 years, which represents a gain of about 15 years since 1960.2Y The infant mortalityrate was about 68 deaths per thousand live births in 1990 compared with more than 150 thirtyyears earlier. E-gypt's life expectancy ranked thirtieth among thirty-seven lower-middle incomecountries at the close of the 1980s. At the same time, its infant mortality rate ranked twenty-seventh among this same group of cour'ries. (Annex 1 provides comparative health indicatorsfor Egypt and other lower-middle income countries.)

5. Although Egypt has achieved significant improvements in the health of its citizens overthe past three decades, the life expectancy of its people remains nearly a dozen years less thanthat of persons born in economically advanced countries. The diminished health prospects ofthe Egyptian people result primarily from high death rates among infants and small children: ifthe mortality rate for children under the age of five years were brought down to that prevailingin the advanced economies, life expectancy would be nearly seven years greater. High deathrates among children can be traced primarily to the frequt;ncy of diarrheal disease and acuterespiratory infections. The Demographic and Hea'th Survey (1988)2' found that mothersrecalled that one child in six had experienced an episode of acute diarrhea during the previousweek, and that more than 40 percent of all children under the age of five had suffered from atleast one episode of acute diarrhea in the previous six months. The same study discovered thata quarter of children under five and nearly a fifth of adults had suffered from a severerespiratory infection during the preceding month. National programs have been implementedto encourage the use of oral rehydration salts to treat acute diarrhea and a program has also beenlaunched to improve the diagnosis and treatment of bacterial pneumonia. The vaccine-preventable diseases of childhood have not contributed significantly to mortality in recent years,primarily because of the success of the national immunization program, which has now reachedover 90 percent of children with at least one immunization and about a quarter with all of therecommended immunizations.

6. Morbidity. Very little effort has been devoted to the study of morbidity in Egypt,especially among adults. The principal sources of information are the reports of the activitiesof health care institutions vhich are submitied periodically to the Ministry of Health. However,these reports refer on' tc those persons who have sought medical care, not to the entirepopulation. Moreov' ;e diagnoses reported by health facilities often are based on superficialclinical assessmentz iealth problems, m.. 'ng accuracy of the diagnoses uncertain. The

3' All statistics cited in this section are drawn from various issues of 7he World Development Report, unless notedotherwise.

F Egypfian National Population Council and the Institution for Resource Development. Demographic and HealthSurvey 1988. Cairo, October 1989.

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statistics assembled by the Ministry of Health suggest that the leading causes of morbidity areaccidents (for males) and complications of childbirth (for females). Diseases of the digestivesystem rank sccond for males and females, and infections of the respiratory system.rank thirdfor males and fourth for females. The chronic and degenerative diseases of late adulthoodimpose relatively modest demands on the health care system, in large measure because olderadults form a small fraction of the total population in a co:intry with a very high rate ofpopulation growth. Table 1.1 summarize; the activities of government health facilities bycomplaint.

7. National HeaLth Policies. Egypt has assigned high priority to health since the formationof the republic in 1962. National health policies initially sought to ensure everyone access tocurative care provided by physicians. The Government, therefore, invested heavily in theeducation of physicians and the construction of health c- - fa "-ties. However, beginning in themid-1980s the Government began to reallocate healtn . )urcrs to programs of preventivemedicine and rural health care, and to seek to reduce relia!.q3e on physicians and hospitals.Bilateral donors supported this redirection of health policy with substantial financial and technicalassistance to programs to promote child survival and maternal health. ' 1991, 47 percent ofthe national investment budget for health was assigned to preventive health care activities suchas immunization, maternal health care, fanily planning, school health, and health education.Policy documents were published in 1973, 1980 and 1986 that declared the Government'scommitment to lowering the rate of population growth to less than 2.1 percent a year by theclose of the century. A National Population Council was established in 1984 in order to promotefamily planning.

8. The Government's health priorities have been reflected in its investments in the sector.Between 1960 and 1990 Egypt increased the number of rural health units from 733 to more than5,300. Over the same period it expanded the number of physician, by a factor of nine--from11,500 to 103,400. As a result of this unusually aggressive program of investments, noEgyptian lives more than 5 kilometers from a government health facility and more than 80percent of the population lives within 1.5 kilometers of one. By 1990, a physician had beentrained for every 550 persons. This ratio contrasts with an average of about 2,300 for the entiregroup of lower-middle income countries.

9. OveraU Pt 4ormance of the Health Sector. While the health of Egyptians nas improvedsignificantly over the past thirty years, the gains have not been commensurate with thecommitment of national resources to the sector, and are not impressive when contrasted with theaccomplishments ot other lower-middle income countries. These achievements appear even lessdramatic when one :<cognizes that many of the other services that are expected to contribute toimprovements in health have been widely accessible. For example, more than 90 percent ofvillages have already been provided with a safe source of drinking water. All Egyptian villageshave been supplied with electricity. A substantial majority of householls have a private latrine.

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Table 1.1: Leading Causes of Morbidity

Disease Category Percentage

Males

1 Accidents 29.0

2 Digestive system diseases 24.6

3 Respiratory system diseases 11.4

4 Cardio-vascular diseases 8.6

5 Urogenital system diseases 8.1

6 Other causes 18.3

Total 100.00

Females

1 Pre-natal, natal, puerperium 31.0

2 Digestive system diseases 16.9

3 Accidents 13.3

4 Respiratory system diseases 9.6

5 Urogenital system diseases 9.3

6 Other Causes 19.8

Total 100.00Source: Statistical Services, Ministry of Health, 1991

10. The disappointing performance of the health care system is due primarily to problems ofstaff morale and productivity; shortages of specific items of equipment; scarcities of essential.drugs; and, most importantly, defects in the design of programs. A lack of facilities for the safedisposal of sullage water in densely populated rural areas also contributes to ill health, both bycreating ponds of insanitary wastes and by prompti;.g people to rely on more convenient canalsand drains to bathe themselves, wash kitchen utensils and launder clothes. In addition, the mostcommon occupations in rural Egypt--farming and fishing--require close contact with surfacewater that often is polluted and/or infested with the vectors that transmit disease.

Schistosomiasis

11. Schistosomiasis (known also as "bilharzia") is Egypt's leading parasitic infection. It iscaused by fluke worms about 1 centimeter long, called schistosomes. Two species of theparasite are found in Egypt. Schistosoma haematobium lives in the blood vessels around the

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bladder and causes urinary schistosomiasis. Schistosomiasis mansoni lives in the venula aroundthe intestines and produces intestinal and hepatosplenic schistosomiasis.

12. The life cycle of the parasite includes a stage during which it must invade species offreshwater snails commonly found in Egypt. Adult schistosomes typically survive for three tofive years, but some live more than twenty years. The adult schistosomes mate and the pairsthen produce three to five hundred eggs each day, most of which penetrate into the intestinesor the bladder of their hutr an host and are excreted with the feces or the urine. If the eggs aredeposited in fresh water, ewch hatches into a larva (known as a miracidium). The larva, if itsucceeds in penetrating a suitable snail, divides each day into about one thousand mobile secondstage larvae (cercariae); this p-ocess can continue for up to one hundred days. The maturecercariae emerge from the snaii into the surrounding water where they seek out and infecthumans who come in contact with the water.

13. Schistosomiasis is typically found in rural areas, but urban foci are becoming increasinglycommon in many countries. In affected communities, at least 20 percent of the population isinfected and often everyone is parasitized. The highest infection rates generally are observedamong chiidren and adolescents, because these groups often play and work in surface water andhave not acquired immunity to the parasite.

14. Infection with the parasite does not necessarily lead to disease and light infections oftengo unnoticed. The penet.'ation of the skin by cercariae often produces a slight rash (commonlydescribed as "swimmer's itch"). Urinary schistosomiasis causes blood in the urine, and frequentand painful micturition; in advanced stages, serious kidney damage can develop. Intestinalschistosomiasis initially produces (bloody) diarrhea, abdominal pain and fatigue. However,persons with intense infections over many years often develop serious liver disease. Theseverity of the disease increases with the number of worms that have infected the individual andthe duration of infection, but genetic and other factors are probably also important. Thepathology of schistosomiasis is due mainly to inflammatory reactions to eggs that have beentrapped in the bladder wall, the intestines or the liver. In advanced stages, fibrotic liver lesionsmay occlude the blood vessels of the portal system that drains the intestines and the spleen, andthus lead to spleen enlargement and (bleeding) oesophageal varices. The resulting vomiting ofblood usually leads to death. Severe schistosomiasis also leads to increased rates of cancer,particularly of the bladder.

15. The diagnosis of schistosomiasis is generally based on the microscopic detection of eggsin the excreta. For quick screening of urinary schistosomiasis, simple dip-sticks may be usedto detect blood in the urine. However, this finding may be due to other diseases and thus furtherinvestigation of those who test positive is required to establish the diagnosis.

16. Control Strategies. The transmission of schistosomiasis could be halted if either humansor human excreta could be kept ou' of snail infested water. Farming, fishing, recreationalactivities and domestic chores ensure that most Egyptians living in rural areas come in contactwith potential snail habitats daily. Attempts to design and implement programs to eliminate the

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poilution of surface water have met with little success thus far. A durable solution to theproblem of contact with polluted water clearly will depend on general socio-economic progressas well as on improvements in domestic water supply and waste management. Alternatively,transmission might be stopped by ridding the local environment of snails. Chemical pesticides(molluscicides) have been widely used to kill snails, but logistical and financial constraints havedefeated efforts to treat all the infected canals, drains and ponds simultaneously. Therefore,water courses rapidly become re-infested with snails that are transported by water currents,birds, agricultural workers and the like from untreated areas. The snail reproduces very rapidly,and thus snail colonies typically re-establish themselves in a few months. Because the snailcannot be completely eradicated, mollusciciding must be repeated frequently. Molluscicidingis very expensive and requires a highly organized and skilled staff. Only one molluscicide,niclosamide, is still commercially available. It is highly toxic to snails, their eggs, and toschistosome cercariae. It is not toxic to man and has limited biocidal effects. It is reasonablypersistent but degrades into harmless organic chemicals when exposed to sunlight. Niclosamideis also biodegradable; several microorganisms, including bacteria, metabolize it. It is lethal tofish if applied in high concentrations but not at those concentrations required to kill snailsYCopper sulfate is also sometimes used but it is not very effective in killing snails because itdegrades very rapidly in alkaline waters.

17. An alternative strategy for controlling the disease is to administer schistosomidal drugsto persons who are infected. This intervention reduces the intensity and duration of parasiticinfection and thereby lowers the probability that disease will develop. "Morbidity control" canbe achieved through the identification and treatment of infected individuals, or through thepresumptive treatment of all members of the community. Over the past decade, several drugshave become available for the practical treatment of schistosomiasis in humans; praziquantel isnow the most widely used of these drugs. A single dose of praziquantel is able to rid at least80 percent of patients of all parasites. The drug is effective against all species of schistosomesand is virtually free of objectionable side-effects. However, people who have been successfullytreated often become reinfected because of continued exposure associated with either economic,domestic or recreational activities. Therefore, in order to control disease, treatment must berepeated.

18. The Egyptian National Schistosomiasis Control Programme. Egypt launched a nationalattack on schistosomiasis in 1922--soon after the discovery of the role of snails in thetransmission of the disease. For most of the program's history it has relied on molluscicides inan attempt to control the snail. In addition the program has treated heavily infected individualswith drugs. The compounds available before 1970 produced very serious side-effects, includingdeath. Because of these side-effects, drugs had to be administered in small quantities over alengthy period under strict medical supervision. Severe nausea and headaches occurred eventhen, discouraging most people from completing the full course of treatment and thus beingcured. During the 1930s, the Government of Egypt undertook a national health education

Annex 10 provides a more extensive discussion of the pesticide and of procedures for its safe use.

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campaign in an attempt to halt the contamination of surface water with human excreta and toreduce human contact with surface water. This effort failed, principally because most peopleliving in rural areas could not survive without frequent use of surface water for domestic,agricultural or recreational purposes. A much improved molluscicide appeared on the marketin the 1960s, which made it possible to achieve higher kill rates than in the past. The intensiveuse of modem molluscicides formed the backbone of control activities from about 1960 throughthe early years of the 1970s, when two new drugs appeared on the market that both achieveda higher cure rate and produced fewer side-effects than older compounds. However, these drugsstill had to be administered over a period of weeks and thus continued to present problems oftreatment compliance. In addition, the least objectionable of these drugs was effective only inthe control of S. haematobium.

19. Near the end of the 1970s, a third "modern" drug--praziquantel--was introduced. Asreported earlier, this drug can be administered in a single dose, produces only very minor side-effects and is highly effective. Initially, praziquantel was far more expensive than earliercompounds. The Government of Egypt, in an effort to halt transmission of the disease ataffordable cost, experimented during the 1980s, with combinations of the treatment cf infectedpersons with the new drug and the application of molluscicides to snail infested water courses.As the cost of the drug decreased over the decade, suppressing the infection in the humanpopulation became an economically feasible alternative to destruction of the parasite. Drugtreatment became an even more attractive alternative as evidence accumulated suggesting thatlight infections rarely produce disease. Thus the goal of schistosomiasis control activities shiftedgradually over the past fifteen years from halting transmission through destruction of the snailand reduction of the numbers of eggs deposited in the water by human victims, to simplyreducing the intensity of infection among humans and thus lowering morbidity and mortality dueto the disease.

20. The Egyptian Schistosomiasis Control Strategy. The NSCP currently pursues a four-phase attack on schistosomiasis. During the first phase (known as the "preparation phase"),potential transmission sites and groups of people at risk are identified and carefully mapped.Staff are trained to identify infected snails, apply molluscicides, diagnose the infection, and treatinfected persons. During the second phase (the "attack phase"), an aggressive campaign ismounted in order to reduce the prevalence of infection to 10 percent or less.5' The attack isdirected at both the human and the snail populations. During the third phase (tie "consolidationphase"), both the presence of snails and the prevalence of the disease in humans are closelymonitored. Molluscicides are applied to snail habitats, and treatment is initiated wherever theparasite is identified in humans. In the fourth phase (the "maintenance phase") the rate of

if This target has been chosen because pathological consequences of the infection have rarely been observed incommunities in which the prevalence rate has been at this level for several years. This association reflects the fact that aperson can be infected with a small number of schistosomes for a long time (or a fairly large number for a brief period)without any pathological effects. The validity of this target will be kept under surveillance by the Endemic Diseases ControlDepartment.

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infection among humans is to be held to less than ten percent; persons at high risk of acquiringthe parasite are to be screened periodically and treated, if found to be infected.

21. The sharp distinctions betwe^- phases of the official strategy are in reality difficult toidentify. Instead, efforts to control sw.Aistosomiasis in Egypt combine in varying proportions fourelements of the "attack" and "consolidation" phases of the official strategy. First, childrenenrolled in primary school are supposed to be examined for the disease twice annually, andtreated with praziquantel if found to be infected, but in many areas only one screening is beingcarried out. Second, all outpatients at rural health facilities with symptoms of infection areexamined, and treated if ova are found. Third, ten percent of households in the service area ofselected facilities are supposed to be examined each month and treated if infected. (Thisprocedure was devised to provide a basis for monitoring infection rates in the community, butproble is in implementing the sampling method have undermined the survey's statisticalvalidity.) The monthly screening of ten percent of the community is not being carried out inmost communities. Finally, snail surveillance teams search for snails using specially designedscoops to obtain a "dip" from all canals and drains, at intervals of twenty meters, four times ayear. Mollusciciding is initiated in communities in which the prevalence of infection is greaterthan 20 per cent or in which snail surveillance demonstrates that infected snails are present. Thesnail control program has a staff of about 6,700 persons assigned to search for snails.Additional part time staff is hired during the season of peak activity to assist in the applicationof the molluscicide. Formal reporting procedures for this effort are weak, so it is difficult toassess the coverage of this part of the program. Moreover, the dipping technique has a smallprobability of identifying snails. Shortages of molluscicides have prevented full implementationof the strategy in recent years.

22. The five governorates located in the Eastern and Western areas of the Nile Delta havenot yet been included in the NSCP. However, primary health care facilities in the area doprovide some care for victims of schistosomiasis. In most villages, school children in gradesone and six are screened each year and outpatients are examined if the attending physician findsevidence that they are infected. Snail control activities are very limited: major canals and drainsare checked routinely for snails, and copper sulfate is sometimes applied in an effort to kill anysnails that are found, but modem molluscicides are generally not available. These interventionshave not significantly reduced the prevalence of the infection in these areas.

Role of IDA

23. IDA attaches high priority to improving the quality of Egypt's human resources andincreasing the quality of life of its people. The World Bank Group has pursued a policydialogue with Egyptian officials on family planning, education and health for more than twodecades. IDA has assisted the Government's efforts to control schistosomiasis in Middle andUpper Egypt through components of drainage and irrigation projects. It has financed twopopulation projects (1973 and 1978) but has not participated directly in projects aimed primarilyat strengthening health activities. Disease continues to undermine the productivity and well-being of the Egyptian people. The country has developed an impressive infrastructure for

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addressing the threats to health that are responsible for these problems, but has not yet achievedthe results that might be expected from these investments. The proposed project is a modestintervention aimed at attacking the weaknesses in program design and management that areresponsible for unsatisfactory performance.

Lessons from Earlier Operations

24. The two population projects were judged at completion not to have achieved theirobjectives. Evaluation of the first project was frustrated by the failure of project documents todefine objectives in quantitative terms. The project was credited with having contributed to thedevelopment of health infrastructure, the creation of awareness of maintenance issues, thepromotion of home-visiting, and the strengthening of the Ministry of Health's capacity toformulate and implement projects. Serious cost over-runs were traced to implementation delaysthat ultimately led to reduction of the scale of the project. Four lessons were learned: (a) theBorrower and IDA should reach a clear agreement on the objectives of a project and the meansrequired to achieve them; (b) a time-phased implementation plan should be prepared; (c) areconciliation of Bank Group and Government procedures should be sought very early to avoiddelays in implementation and disbursements; and, (d) details of innovative activities (in this casehome-visiting) should be worked out in advance.

25. The Second Population Project was cancelled due to limited progress after 7 years ofimplementation. This project was plagued by a lack of commitment to project objectives amongstaff of the health service, managerial difficulties, and doubts among health officials about theimportance of famrily planning interventions to population objectives. The principal lessons fromthis operation were that (a) IDA has limited leverage with which to redefine the priorities of theGovernment of Egypt; (b) projects should start small and establish a solid base for reforms; (c)implementing agencies should be involved in planning and designing major innovations; (d) theimplementation capacity of the Ministry of Health should be realistically appraised; and (e) theBank should not expect intensive supervision to substitute for good planning and clearunderstandings with implementing authorities.

26. IDA has not formally evaluated its assistance to the schistosomiasis control program.However, an intemational team of experts has reported that the program is being operatedeffectively and that control of resources is satisfactory. The report of the evaluation teampraised the management of the program.0'

Aims of the Present Project

27. This project has two broad aims. First, it is designed to expand the coverage andimprove the operations of the NSCP. Second, it is intended to initiate a systematic attack onproblems of program design, staff motivation and management in the health sector--a process

Y/ "Report of an Independent Evaluation Mission on the National Bilharzia Control Program in Egypt, 1985",Transactions of the Royal Society of Tropical Medicine and Hygiene, 81 (Supplemcnt 1987): 1-57.

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which the Bank Group might further support through assistance to future operations. Thecontrol of schistosomiasis is recognized as a high priority by political leaders, the general publicand health woivnrs. The need to expand the coverage of the NSCP to the Delta has long beenrecognized, but efforts to address this need have been thwarted by the absence of a cost-effectiveintervention strategy. The discovery of a safe and effective single dose drug has allowedschistosomiasis control programs to abandon the long-standing operational goal of eradicatingthe disease by interrupting its transmission, and to focus instead on the control of disease inhumans through treatment of those who are likely to suffer serious effects from it. This advancein control technology has not yet been fully absorbed into the operational strategy and activitiesof the NSCP. Therefore the project seeks not only to increase the coverage of the nationalcontrol program but also to assist the EDCD in institutionalizing improvements in its program.This approach addresses directly the problems encountered by earlier IDA operations in thepopulation and health sectors: it attacks a problem that is recognized as important byGovernment as well as IDA; it relies on a detailed, jointly prepared strategy for the long-termdevelopment of the program to control the disease; and it provides for financing of a smallnumber of clearly defined goods and services.

28. The second broad aim of this project is to initiate a program of cooperation that focuseson strengthening the design and management of health programs. The NSCP models on a smallscale the use of program evaluation techniques and operations research tools to identifyopportunities to improve the cost-effectiveness of health programs. The project has beendesigned to allow rapid implementation of the findings of analyses of the program and itsperformance. The project is deliberateiy modest in scale and is directed at one of the morefocused programs being carried out by the Ministry of Health. The project emphasizesstrengthening of the capacity of the EDCD to define its mission, evaluate its activities, designinterventions, assess constraints on the program and devolve respoasibility to authorities at thegovernorate and district levels. The operation is expected to lead to fui.her Bank Groupparticipation in the health sector in Egypt; these future operations would also stress thestrengthening of programs through strategic planning and improved management.

III. DESCRIPTION OF THE PROPOSED OPERATION

29. The proposed credit would support three sets of activities. First, it would help to financethe procurement of laboratory equipment, vehicles, drugs, molluscicides, consulting services andtraining to enable the NSCP to expand into the Eastern and Western areas of the Nile Delta.Second, the credit would finance training and the purchase of laboratory equipment and vehiclesfor use in Middle and Upper Egypt, and the Suez Canal area. These investments would not onlyallow the NSCP to rehabilitate older facilities but also enable it to adopt more cost-effectivemethods of diagnosis and treatment. Third, the credit would finance the strengthening of theEDCD in order to increase its capacity to evaluate (and modify as appropriate) the nationalcontrol strategy, to provide tne staff of the NSCP with the skills required for improvement ofthe program, and to oversee more effectively the overall program.

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Expansion of the Program into the Nile Delta

30. The project wouldTeh w enable the Government of Egypt to launch an attack onschistosomiasis in five governorates of the Eastern and Westem areas of the Nile Delta. Theseareas are inhabited by about 17 million people. Thus the operation would increase thepopulation served by the NSCP from 15 million to 32 million. The goal of the intensified attackon the disease would be to reduce the prevalence and intensity of infection with schistosomiasisto a level that is unlikely to result in disease. Hence, the project would seek to reduce theprevalence of infection from its current rate of more than 35 percent of the population to lessthan 10 percent, at which point the intensity of infection would be low and the likelihood thatdisease would develop would be very small. In order to achieve this goal the 871 primary healthcare facilities in the five governorates initially would: (a) screen all school children twice a year;(b) evaluate all outpatients who present themselves to health facilities and are suspected of beinginfected; and (c) examine ten percent of the population of the catchment area of each healthfacility each month. The credit would help to finance microscopes, laboratory glassware andminor items of equipment costing US$1.9 million and would provide up to US$18.1 million toobtain laboratory supplies, drugs and molluscicides over the life of the credit. In addition, theoperation would provide approximately US$1 million to retrain 1,800 laboratory technicians touse modern, cost-effective, diagnostic techniques, and to orient physicians employed by theprogram.

Consolidaton of Existing Control Activities

31. Second, the project would provide the resources needed to rehabilitate the facilities andmodernize the activities of five projects implemented earlier in Middle and Upper Egypt, andthe Suez Canal region. The credit would assist the Government in purchasing the equipment,vehicles, and supplies required to adopt modern diagnostic technologies and to maintain controlof the prevalence of schistosomiasis in these 21 governorates. The cost of refurbishing andupgrading existing facilities is being assessed by the EDCD; the preliminary analyses suggestthat US$0.7 million is needed to be spent to replace defective microscopes and upgradelaboratory equipment. In addition, US$14.1 would be required in order to finance the purchaseof diagnostic materials and drugs. Approximately US$0.3 million would be reserved for theretraining of laboratory technicians in modern diagnostic methods and orientation of physicians.

Strategic Planning and Modernization of the Program

32. Finally, the project would provide training for staff of the EDCD in modern methods ofpolicy analysis and managemernt, and would secure consultancy services to assist it instrengthening its accounting and budgeting functions and in developing studies of operationalefficiency and program effectiveness. The project would also assist in the development ofcapacity for strategic planning at both central and governorate levels as steps toward the furtherdecentralization of planning and control of the program. (Because intense transmission of thedisease tends to occur at highly specific sites, a more focal approach to surveillance and controlis expected to emerge in the maintenance phase of the program.) These activities are expected

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to lead to major efficiency gains, primarily through the development and implementation of amore refined disease control strategy.

33. The project would also provide management consultants to assist the EDCD in developinga management-oriented accounting system to supplement its existing systems which stress thecontrol of physical inputs. These consultants would advise on the development of a chart ofaccounts, the implementation of a system for accounting for capital assets and the preparationof cost analyses on a cost center basis. These consultants are to be recruited locally and to workon a part-time basis. The consultants are also expected to assist the EDCD in working with thegovernorates to prepare annual strategic plans for the control program.

Operational Plan

34. As noted above, the long-term goal of this project is to assist the Ministry of Health inimproving its policy making, planning and management in order to enable the NSCP to controlschistosomiasis using only national resources. This is a feasible prospect because of recentdevelopments in the technology for diagnosing and treating the disease and correspondingchanges in the operational objectives of control activities. If these new opportunities are fullyexploited, the operating costs and management demands of the program can be significantlyreduced. A set of rough calculations based upon the judgements of international experts suggestthat optimization of the control strategy might reduce costs by about 15 percent. The operationwould help the EDCD evaluate these new options under Egyptian field conditions andincorporate them as appropriate into the national control program. The Egyptian authorities arebeing asked to study these options following agreed research strategies and to modify the controlstrategy in accordance with the findings of the studies. The protocols are outlined in Annex 4.At Negotiations, the Ministry of Health provided assurances that the EDCD would carry out theresearch protocols presented in Annex 4 and nnodify the control strategy in accordance with thefindings of the studies (para. 89.a). The following paragraphs very briefly describe the purposesand approaches of these protocols.

35. Screening Methods. Developments in screening technology offer the possibility both ofmajor improvements in sensitivity and of savings in costs. The principal advantage of thosealternatives is greater manageability: they require less processing and are more readilysupervised. The EDCD currently relies on sedimentation of stool and urine samples todetermine whether individuals are infected. This technique relies on the fact that the ova of theparasites are heavier than water and therefore, if left in a conical flask for a period of 30-45minutes, accumulate at the bottom. (Stool specimens must be dissolved in a saline solution andsieved before sedimentation.) The residue in the bottom of the flask must be carefully drawnfrom the flask using a glass pipette and then examined under a microscope to identify ova. Thistechnique is capable of identifying a high proportion of infections if properly carried out.However, it requires well-maintained glassware and scrupulous adherence to the procedures thathave been devised to ensure that the ova are allowed to settle to the bottom of the flask.Carefully controlled surveys undertaken by UNICEF and Egyptian academic researchers suggest

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that up to two-thirds of all infected persons are undiagnosed because of defects in the executionof the sedimentation technique.2'

36. The glass slide prepared with the sediment must be examined promptly and cannot bestored for later review by supervisors. In addition, sedimentation techniques do not produce astandardized specimen that can be used to assess the intensity of infection. Finally, thesediagnostic methods are especially likely to miss light infections and hence are least useful inmonitoring conditions during the maintenance phase of the program when small numbers of lightinfections are expected.

37. Under the project, the EDCD would evaluate the feasibility of using simple dip sticks totest for the presence of blood in the urine. Dip sticks are available commercially, but aredesigned to test for a large number of abnormalities and thus are more complex and moreexpensive than is necessary. Researchers at a non-profit institution in the U.S., funded by theEdna McConnell Clark Foundation, are developing a simplified dip stick, which could bemaiiufactured locally; the market for such a device would be about 40 million items a year inEgypt alone. The economic feasibility of using dip sticks would depend as well on theprevalence of urinary schistosomiasis, since all specimens containing blood would have to bereexamined using conventional methods in order to determine whether S. haematobiwn isresponsible for the hematuria. The study would establish the cut-off value for use of thetechnique. The ability of dip sticks to detect blood deteriorates rapidly if they are stored underhumid conditions. The study would determine the optimal packaging and maximum shelf lifefor the dip sticks to be used under Egyptian field conditions.

38. The feasibility of using paper or nitrocellulose filters to remove ova from a standardizedvolume of urine would also be evaluated under Egyptian conditions. These filters may beexamined under a microscope to determine the intensity of infection for urinary schistosomiasis.The used filters can be stored for long periods and can be reexamined by supervisors or fellowworkers in order to determine if the procedure is being carried out properly. This technique isunlikely to be appropriate for use in programs to screen large numbers of asymptomatic persons,but it would be useful as a method for confirming the diagnosis obtained with a dip-stick andfor assessing the intensity of an infection.

39. The Kato technique for diagnosis of intestinal schistosomiasis would also be evaluatedfor possible introduction as the field technique for screening large groups. The Kato techniquerelies on the direct examination of a thin smear of stool prepared with a cellophane slip. Itprovides a standardized procedure for quantifying the number of eggs in a gram of stool and thusis useful in assessing the intensity of infection and the likelihood that disease will develop. Inaddition, the Kato technique produces a slide which can be stored for later reexamination bysupervisors. The EDCD has also agreed to explore the feasibility of replacing disposable,

21 Spencer, H.C, E. Ruiz-Tiben, N.S. Mansour, and B.L. Cline. 1990. 'Evaluation of UNICEF/Arab Republic ofEgypt/WHO Schistosomiasis Control Project in Beheira Govemorate", Anerican Journal of Tropical Medicine and Hygiene,(42)5:441-48.

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plastic laboratory equipment commonly used in carrying out the Kato technique, with locallymanufactured, reusable stainless steel items in order to reduce the costs and increase therobustness of the program. The new methods would first be evaluated on a pilot scale. Adecision would be taken about the frequency with which egg counts would be obtained from theKato slides and urine filters. These pilot studies would lead to operational decisions within oneyear.

40. The Interv'ention Strategy. The treatment of infected persons with praziquantel(chemotherapy) is recognized as an effective tool for controlling morbidity due toschistosomiasis. This conclusion replaces the earlier hypothesis that transmission could be haltedusing a combination of drug treatment (to reduce the discharge of ova into the environment) andsnail control (to interrupt the life cycle of the parasite). It has been demonstrated conclusivelythat under field conditions, chemotherapy does not reduce the release of eggs into theenvironment sufficiently to have a significant impact on the infection of snails and hence ontransmission. Incomplete population coverage, errors in diagnosis, incomplete cures, andmobility among infected individuals invariab'ly result in reinfectioii of the snail habitats.

41. In the Eastern and Western Delta regions. chemotherapy initially would be applied inaccordance with the existing strategy, but with: ree years a study would be completed toestablish whether, and at what stage of control, Ic- frequent screening and treatment could beimplemented. This analysis would focus on tradeoffs between more sensitive, as contrasted withmore frequent, screening (see paras. 34-38) and on the frequency of treatment necessary toeliminate intense infections.

42. The analysis would also explore the relationships between reinfection and thecharacteristics of individuals and communities in order to allow more efficient targeting ofinterventions. Past experience suggests that some villages will emerge as foci of intense initialinfection and high rates of reinfection, presumably because of local ecological conditions orbehavioral patterns. The frequency, and perhaps even the method of screening, might betailored to local realities in order to obtain greater benefits from the expenditure of availableresources; among outpatients, symptomatic cases might continue to receive priority. The yieldthat could be expected from screening visitors to rural health care facilities who do not displaysymptoms of schistosomiasis would be assessed and compared with that from other options forusing resources committed to the program.

43. The current practice of screening and treating a rotating sample of community memberswould be carefully evaluated as a basis for assessing program performance and for establishingoperational priorities. The statistical design of the sample also would be examined to ensure thatthe procedure provides a sound basis for making statements about the population. Finally, theEDCD would evaluate the possibility of following up the treatment of patients after one year,rather than the present period of three months.

44. Snail Control. The five governorates of the Eastern and Western Delta regions include168,700 kilometers of canals and drains that may harbor infected snails. To control the snail

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through the application of molluscicides is neither technically feasible nor affordable under thesecircumstances. Therefore a focused strategy of malacological surveillance and interventionshould be developed. This strategy would ensure that resources are concentrated on high-trans-mission villages and hamlets as indicated by local infection and reinfection rates in humansrather than on the existence of snails. The strategy would provide for mapping pLttems ofinfection and reinfection within those villages or hamlets identified as problems. Cut-off valuesfor snail control would be defined on the basis of epidemiological and operational studies.Tentatively, it is proposed to designate as "problem villages" or "problem hamlets" thosecommunities with an initial prevalence rate among school children of more than fifty percent,or a prevalence rate after ibree years of screening and treatment greater than fifteen percent.

45. Local epidemiological data would be used as the primary source of information inidentifying transmission sites. Malacological and sociological information would be used tocomplement maps of transmission. Reliance on area-wide snail surveys would be reduced ordiscontinued. More intensive and sensitive snail sampling methods would be considered foridentification of snails in areas where intense transmission is occurring. Rapid assessmentprocedures for the identification of water contact sites, based on questionnaires and/or directobservation, would be developed. Environmental measures designed to eliminate snail breedingat high-transmission sites would be adopted wherever practical. Otherwise, appropriatetreatment with the molluscicide, niclosamide, would be carried out. At the end of the first threeyears of this operation, the feasibility, effectiveness and cost of focal mollusciciding would bere-evaluated, concentrating e n the reduction of incidence and reinfection rates in treated villagesand research results from the Egyptian Schistosomiasis Research Project (SRP).Y'

46. Innovative Interventions. The project would include US$350,000 for the design andevaluation of innovative intervention activities. These funds would be used to explore optionsfor improving sanitation and domestic water supplies in communities with high rates oftransmission. Possible interventions might include construction of public laundries and showers,and community facilities for the disposal of waste water and excreta. Opportunities forstrengthening health education would also be explored. Activities might include developmentof appropriate teaching materials and methods for use in schools and communities. A multi-disciplinary task force would be created within a year of approval of the credit to prepare a planof action for the sanitation and health education components. At Negotiations, assurances werereceived that the EDCD would report annually on the findings of its program of operationalresearch. At the end of t ' third year, a review of the project would be held to assess theprogress of the agreed studies, evaluate the overall performance of the control program and

I' The SRP is jointly sponsored by the Government of Egypt and the United States Agency for InternationalDevelopment (USAID). It is financed by a grant from USAID and in-kind contributions from the Government of Egypt.The SRP is expected to spend approximately US$50 million over the ten years between 1988 and 1997. The researchagenda is being established by an advisory group composed of internationally reputed Egyptian and American scientists.The SRP has six main goals: the development of a vaccine for schistosomiasis, the improvement of diagnostic techniques,the strengthening of field epidemiology, the conduct of operational research, the study of social and economic consequencesof the disease and investigations on the biology of the snail. The SRP is managed by a team of Egyptians, headed by thedirector general of the EDCD.

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identify any further investigations and or modifications to be pursued in the final three years ofthe project (para. 89.b). A schedule of monitoring and evaluation indicators is provided inAnnex 8.

47. Institutional Strengthening. The monitoring, evaluation, planning and policy makingfunctions would be strengthened at all levels. Control over the quality of statistical repoitsobtained from the primary health care system would be strengthened; these efforts would focuson both the integrity of reporting and the accuracy of diagnostic information. For example, theywould include implement"ation of computerized procedures for the detection and verification ofinconsistencies in monthly reports, checks on the execution and quality of the screening andtreatment campaigns and re-examination of a random sample of urine filters and Kato slides bythe primary health care physician and/or district chief laboratory technician.

48. Rates of reinfection among treated and re-examined patients and conversion rates forchildren previously not found to be infected would be included in the reports. To this end,forms would be introduced which would allow a record to be kept for each child for severalyears.. The returns from the various target groups would be tabulated each year for eachprimary health care facility, and at six-monthly intervals for each school. Analyses of thesereports would lead to the targeting of chemotherapy on high-risk groups and the initiation ofenvironmental interventions in communities that are most likely to benefit from them. Thereturns would be compiled at the district, govemorate and nadional level. Analyses would becarried out at the lowest possible level in order to inform as fully as possible decisions about theoperation of the program. At Negotiations, assurances were received that the EDCD wouldintroduce new forns for reporting on the incidence of schistosomiasis that would allow a singlerecord to be maintained for each child for the duration of his or her schooling, and wouldimplement data editing and data management procedures to control the quality of statisticalinfomaion (para. 89.c).

49. Finally, the criteria for shifts between phases of the program would be clearly establishedand the contents of the progralm during each phase would be outlined. Changes in programcontent might include a shift to less frequent screening and treatment of school children, or adecision to broaden coverage of programs to actively screen members of the community. Cut-off values for intensive focal intervention would be defined and documented.

50. Strategic Planning and Decentralization. Each year, a strategic operational plan andbudget would be developed which reflect the resources likely to become available and theproblems and results experienced by the program. To this end, two planning seminars wouldbe organized each year. The first would bring together project managers and their deputies fromthe governorates of the Delta region (concerned mainly with S. mansoni, attack phase), Ministryof Health staff, facilitators and exteirnal consultants. A second seminar would be held for Upperand Middle Egypt (concerned mainly with S. haematobium, maintenance phase). AtNegotiations, assurances were rece.ved that the EDCD each year would prepare a strategicoperational plan and a budget that recognize the resources to be allocated to the program, andthe problems and ,esults being experienced by it (para. 89.d).

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IV. PROJECT COSTS, FINANCING, MANAGEMENTAND IMPLEMENTATION

Cost of the Project

51. Summary of Project Costs. Total project costs are estimated to be LE142.73 million orUS$43.25 million equivalent. This estimate reflects the conservative assumption that noimprovements in program efficiency will be made and the prices of laboratory supplies, drugsand pesticides will increase in line with the wholesale prices of traded manufactured goods.(The base case economic analyses also reflect these assumptions.) These costs includeexpenditures for staff training and for purchase of laboratory equipment, diagnostic laboratorysupplies, drugs, pesticides, motor vehicles, motorcycles, bicycles, consultancy services, andexternal training. Table 4.1 summarizes these costs by purpose of expenditure; Annex 5provides further details. Spending by the NSCP for employment of staff, and fcr maintenanceof buildings, furnishings, equipment and vehicles, as a part of continued support to projects inMiddle and Upper Egypt and the Suez Canal area are not included in the estimates of projectcosts. These expenditures have averaged approximately US$4.00 million annually in recentyears. If these costs were allocated to the project in accordance with standard accountingpractice, the total expenditures over the six year period from January 1, 1993 through December31, 1998 for the control of schistosomiasis would be LE250.80 million or LE1.32 per year ofprotection per person.

Table 4.1 SUMMARY OF PROJECT COSTS BY COMPONENT

LE millions US$ Millions

Local Foreign Total Local Foreign Total

Expanding the coverage of the 9.47 68.84 7831 2.87 20.86 23.73National Schistosomiasis ControlProgramme into the Nile Delta

Modernizing and rehabilitating the 7.00 44.35 51.35 2.12 13.44 15.56National Schistosomiasis ControlProgramme

Strengthening the management 2.01 0.46 2.47 0.61 0.14 0.75capacity of the Department ofEndemic Disease Control

Total base costs 18.48 113.65 132.13 5.60 34.44 40.04

Price contingencies 1.29 931 10.60 0.39 2.82 321

Total project costs 19.77 122.96 142 .7

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52. Project costs are summarized by category of expenditure in Table 4.2.

Table 4.2: PROJECT COSTS BY CATEGORY OF EXPENDITURE

ComponeatLE milions USS millions Foreign to ba

~~~~~~~~~~~~~~~~~~-~ - … ~ ~ ~ ~~~~~~ ~-~~ - …… Exchadge colsLacul Foreign Total lacal Fomeign Total (percent) (percent)

Izboitoiyequipmentand 8.02 8.02 2.43 2.43 t00 6COMPutom

Lbontm ouppll 12.28 12.28 -- 3.72 3.72 100 9

Vehicles 9.37 9.37 2.84 2.84 100 7

Dngs and pesicies A4.26 80.98 95.24 4.32 24.54 28.86 85 72

Conslingsvlce andtraining 3.33 0.17 3.50 1.01 0.05 I.N 5 3

Ic- tal operatin expeforvebhcle 0.89 2.87 3.76 0.27 0.87 1.14 76 3

........................................................ ...................................... .................. . ........................................ ...................-.......................................... .....

Total bae csos 18.48 113.69 132.17 5.60 34.45 40.05 86 100

Price contingci 1.32 9.27 10.59 0.40 2.81 3.21........................................................ .......................................................................................

Total pojectos 142 .a M 76 6Q0 37.26 26Note: .ela W .y MAt DOtNd to tDtas due to ondUng.

53. Basds of Cost Estimntes. Estimates of the costs of laboratory equipment, laboratorysupplies, drugs, pesticides and motor vehicles have been based upon recent transauions of theSRP. Estimates of the cost of training are based on recent experiences under a project for theCentral Delta area, financed by the ADB. The quantities of equipment needed to rehabilitateexisting facilities in Middle and Upper Egypt have been obtained from a survey of district-levelmanagers of h-ie control activities conducted by the EDCD. The quantities of laboratorysupplies, drugs and pesticides needed to carry out the present strategy for disease control havebeen estimated by the appraisal mission on the basis of records of current operations. Rates forlocal consultancy services and external training were obtained from the SRP. Base costestimates reflect prices as projected for the time of negotiations (May 15, 1992). About 60percent of the recurrent costs for schistosomiasis control are for the purchase of the drugpraziquantel. The patent for praziquantel will expire during project implementation, which islikely to lead to greater competition among manufacturers and a significant decline in price.Govemment agencies are not required to pay customs duties or taxes on goods procured withthe proceeds of loans or credits obtained from the World Bank Group.

54. Contingency Allowances. Because the operational research activities to be undertakenby the project are expected to lead to substantial reductions in program operating costs, physicalcontingencies have not been included in the estimates of project costs. Annual rates of priceincrease have been applied to all categories of foreign and local costs on the basis of projectedinflation rates.

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55. Foreign Exchange Compunent. The foreign exchange component was estimated asfollows: (a) laboratory equipment, computers, pesticides and laboratory supplies at 100 percent;(b) drugs at 80 percent; (c) vehicles, motorcycles, and bicycles at 100 percent; and (d) externaltraining at 95 percent. These percentages have been determined by assuming that (a) allequipment would be imported; (b) drugs would be manufactured locally from imported, bulktechnical materials; (c) vehicles would be imported; and (d) EDCD staff would be trained inmanagement and policy analysis at foreign institutions. Including contingencies, the resultingforeign exchange component is estimated at US$37.26 million, or about 86 percent of total costs.

56. Recurrent Costs. In 1991, the Govemment of Egypt budgeted about LE14 million topurchase drugs and pesticides in order to control schistosomiasis. The studies to be undertakenas part of the project are expected to lead to a sharp reduction in the prevalence of infection andhence to a decrease in annual treatment costs. Past experiences suggest that during the firstthree years of the program, prevalence of infection can be expected to decline by two-thirds;drug costs are projected to fall correspondingly. The delivery of diagnostic and treatmentservices will continue to be carried out by the primary health care system in rural health posts,centers and hospitals and no additional expenditures for staff or facilities will be required. Thus,the direct cost of the national program at the conclusion of the project is expected to be aboutUS$4.0 million (LE13.0 million) a year if no further modifications are made to the controlstrategy.

57. The studies to be undertaken as a part of the project are expected to produce majorsavings through reduced reliance on molluscicides, more sensitive diagnosis of infected persons,and less frequent treatment of infected persons. The high rate of infection found six monthsafter all persons diagnosed positive have been treated is believed to be due largely to failure toidentify many light infections. The introduction of more sensitive techniques is expected to leadto the identification and treatment of more infected persons initially, but to result in much lowerrates of apparent reinfection in subsequent periods. This hypothesis, if borne out byexperimental data, would allow the program to screen and treat at greater intervals, therebyreducing the cost of both laboratory supplies and drugs. The appraisal mission expects thesedevelopments to reduce recurrent expenditures for laboratory supplies and drugs by more thanhalf. This implies that the total recurrent direct cost of the national program would be about halfthe initial level of expenditure at the conclusion of the project.

58. To summarize, because the NSCP is operated as part of the primary health care program,no additional costs for staff, facilities or administration are anticipated. The cost of diagnosticmaterials and drugs would increase by about US$1.4 million a year during the maintenancephase, if no improvements in operational efficiency were achieved. However, the operationalresearch and management strengthening components of the project are expected to lead atminimum to (a) a reduction in the frequency of screening for infection among school childrenfrom twice a year to no more than once a year; (b) introduction of less costly methods of massscreening for urinary schistosomiasis; and (c) better targeting of snail control activities. Thesethree changes are expected to reduce incremental recurrent expenditures for the entire nationalprogram by about US$1.2 million a year; the net effect would then be to permit coverage of 32

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million persons with the budget previously allocated to the provision of services to the 15 millionpeople living in Middle and Upper Egypt and the Suez Canal areas.

Project Ffnancing

59. The proposed IDA credit of SDR19.60 million would finance 72 percent of the foreignexchange component of the project. A co-financier has expressed interest in providing co-financing for the project in the form of a grant in the amount of US$6.00 million; a second co-financier is also interested in assisting the project but has not specified the amount it mightprovide. The Government would finan. the local costs, which are estimated to be US$5.99million. If co-financing arrangements have not been finalized by December 31, 1993, theduration of the project would be reduced from six to four years. IDA would finance foreignexpenditures for equipment, vehicles, supplies, training, and drugs and pesticides. Four yearswould be sufficient to complete the capital investments to be undertaken as part of the project,but would not permit IDA to be fully involved in the institutionalization of expected changes inthe disease control strategy, and further decentralization of program administration.

Table 4.3: FINANCING PLAN(Total costs of project inputs, including contingencies in US$ millions)

Local Foreign Total

Government 5.99 -- 5.99

Co-financier -- 10.42 10.42

IDA -- 26.84 26.84

Total Financing 5.99 37.26 43.25Note: Price contingencies between negotiations(May 15, 1992) and the end of projectimplementation are estimated at US$3.21 millionequivalent, or 8.0 percent of base costs.

Management and Implementation

60. Management Structure. The proposed project would be implemented by the EDCD,Ministry of Health. The Director of Project Administration, EDCD, is responsible for thecoordination of externally financed activities; he is supported by an accountant and a staff of dataanalysts charged with project monitoring. The directorate has implemented six projectsbenefitting 15 million people. These projects have been financed by the Government ofGermany, the ADB and IDA. The directorate has managed procurement and reported on itsfinancial operations satisfactorily under the guidelines of both the ADB and the World Bank.At Negotiations, assurances were received that the Government would designate the Director ofProject Administration, EDCD, with staffing and terms of reference acceptable to IDA, to

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coordinate the work of implementing governorates, monitor progress, keep project accounts andliaise with IDA (para. 89.e).

61. Organiaion and Management of the Project. The EDCD sets policy, prepares plans,trains staff, procures and distributes drugs anc molluscicides, and evaluates field activities. TheDepartment has a staff of 65 people including seven medical doctors, twelve agriculturalengineers (responsible for surveillance and control of snails), and forty support staff includingsecretaries, clerks, drivers and peons. The health departments of the governorates and districtsimplement the program through the primary health care system. The 26 governorates eachappoint an executive director of endemic disease control who reports to an under secretary ora director general of health assigned to each govemorate. The executive director of endemicdiseases control is responsible for the day-to-day administration of the schistosomiasis controlprogram and in particular for overseeing efforts to control the snail population.

62. The management of the primary health care system is entrusted to 170 districts. Thedistricts operate rural health units, rural health centers, rural hospitals, endemic diseaseshospitals, district hospitals and a few referral hospitals. The district medical officer administersfacilities on a day-to-day basis. University hospitals provide most referral care.

63. The procurement of drugs, pesticides, and laboratory equipment and supplies is carriedout by the Central Purchasing agency of the Ministry of Health. This institution purchasesgoods and services worth about US$150 million a year. Its procedures comply with therequirements of donors including IDA and the ADB.

64. Maintenance. The performance of the Ministry of Health in carrying out schistosomiasiscontrol activities was evaluated by an panel of international experts in 1986.2' The panel foundthat the program was making "excellent progress" and went on to attribute this success to "thediligent work of the staff of the Egyp,ian Bilharzia Control Program who have undertaken thetedious work in a most professional and committed way". Its evaluation included not only anassessment of the technical aspects of the program, but also an examination of the control ofresources and the upkeep of vehicles and equipment. The NSCP and the EDCD are competentlystaffed, motivated and eifective organizations, capable of implementing and maintaining theproject.

65. Procurement. Procurement of vehicles, laboratory equipment, supplies, drugs andpesticides have been grouped into four packages, the contents of which could typically besupplied by one supplier. These purchases, which are suitable for International Compe:itiveBidding (ICB), would be procured in accordance with the Bank's "Guidelines for ProcurementUnder IBRD Loans and IDA Credits" (May, 1985). Contracts would be awarded as shown inTable 4.4.

2' The findings of the Evaluation Panel were published in a special issue of the Transactions of the Royal Society ofTropical Medicine and hygiene, 81(Supplement 1987): 1-57.

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Table 4.4: PROCUREMENT ARRANGEMENTS(Total costs of proposed project components including contingencies, in US$ millions)

Procurement method

Project element ICB Other Total

Laboratory equipment, computers, operation 9.37 0.00 9.37vehicles and laboratory supplies

(9.37)' (0.00) (9.37)

Drugs 23.52 0.00 23.52

(12.87) (0.00) (12.87)

Pesticides 8.02 0.00 8.02

(3.51) (0.00) (3.51)

Consultant servicesb 0.00 1.09 1.09

(0.00) (1.09) (1.09)

Incremental vehicle overating costs and 0.00 1.25 1.25communications

(0.00) (0.00) (0-00)Total 40.91 2.34 43.25

(26.84) (0.00) (26.84)

a. Figures in parentheses are the respective amounts financed by the IDA credit.b. Services would be procured in accordance with World Bank "Guidelines: Useof Consultants by World Bank Borrowers and by the World Bank as ExecutingAgency" (Washington, D.C., August 1981).

66. Status of Preparation. This project is at a state of preparation that would permit timelyimplementation. Equipment lists have been completed and bid specifications have beenprepared. The technical assistance package has been fully defined, terms of reference have beendrafted, and draft tender documents have been prepared. Project completion would beDecember 31, 1998 and the Closing Date would be June 30, 1999.

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67. Disbursements. The proposed project would be disbursed over a period of about sevenyears. Disbursements would be made against:

Category Percent of expenditures tobe financed

(1) Equipment (including 100% of foreignoperation vehicles) and expenditures, 100% of localmaterials expenditures (ex-factory

cost) and 85% of localexpenditures for other itemsprocured locally

(2) Drugs 100% of foreignexpenditures, 100% of localexpenditures (ex-factorycost) and 85% of localexpenditures for other itemsprocured locally

(3) Pesticides 100% of foreignexpenditures

(4) Consultants' services 100%(including services forpreparation of environmentalcontrol measures) andtraining

Disbursements from the proposed credit are expected to take place on an average of about sixmonths after incurring the expenditure. A disbursement schedule and profile, reflecting this andmaking a comparison with profile, are shown in Annex 9. Disbursements are expected to becompleted by June 30, 1999.

68. Disbursements against contracts for goods and services exceeding US$100,000 equivalentwould be made against normal documentation. Disbursements against contracts below that levelwould be made on the basis of Statements of Expenditures (SOEs), available for examination byIDA missions. To facilitate timely project implementation, the Government would establish,maintain and operate, under terms and conditions satisfactory to IDA, a Special Account in acommercial bank, to which IDA would make an initial deposit, equivalent to about US$500,000.The Special Account would be replenished as appropriate when the undisbursed balance of theaccount falls below an amount equal to 50 percent or less of the amount of the Special Account.Withdrawal applications would be supported by appropriate documentation.

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69. Project Supervision. A project launch seminar is planned for the first quarter of calendaryear 1993. At that time the details of operational research studies and initial steps towardproject implementation will be agreed. Thereafter two supervision missions will be requiredannually to monitor the progress of the project, review procurement, and participate in strategicplanning exercises. At the conclusion of the third year of operation a mid-term review will becarried out in order to evaluate overall progress and to redefine, if necessary, the operationalplan for the project. All supervision missions will include a tropical parasitologist, whoseresponsibilities will include evaluation of the quality of the technical work being carried out inthe field and at the level of the EDCD. Each year, one of the missions will be scheduled tooverlap with the annual meeting of the expert committee that oversees the work of the SRP sothat information can be exchanged and any criticisms of the project by international expertsbrought to the attention of the EDCD. One mission a year will usually include a managementconsultant whose tasks will be to review the accounting and budgeting systems and to assist inthe preparation of strategic plans. An implementation specialist will also be includedapproximately once a year to review and evaluate procurement, compliance with covenants andinstitutional development. A total of 76 staff weeks of supervision or US$462,000 (based onan average cost of US$6,000 per staff week) is estimated to be required for all supervision,including preparation of the completion report.

70. Accounts and Audits. At Negotiations, assurances were received from the Governmentthat the EDCD would maintain separate accounts for the project (para. 89.f). Project accountswould be audited in accordance with the March 1982 Bank "Guidelines for Financial Reportingand Auditing of Projects Financed by the World Bank". At Negotiations, assurances were alsoreceived that the Government, within six months of the end of each fiscal year, would provideIDA with an audit report of such scope and detail as IDA may reasonably request, including aseparate opinion by the auditor on disbursements against a certified statement of expenditures(para. 89.g).

71. Program Affordability. The project would enable the Government of Egypt to operatethe NSCP with a smaller total recurrent budget than has been spent in recent years. (See paras.55-57 for a more detailed discussion of the likely recurrent costs associated with this project.)

V. ECONOMIC ANALYSIS, RISK ASSESSMENT AND SOCIAL IMPACT

72. This project competes for resources with investment opportunities in other sectors. Inorder to inform the decision to undertake the project, IDA and the Ministry of Health haveexamined as fully as possible the economic returns to the investment. This section summarizesthe findings of that investigation and Annex 6 provides further details of the analysis.

73. The project is composed of three components. The first would reduce the prevalence andintensity of infection with schistosomiasis in the five governorates of Dakahlia, Sharkia,Qualubia, Beheira and Rural Alexandria, in the Eastern and Western Delta regions of thecountry. The second component would help to devise and implement a cost-efficient

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maintenance strategy for the national control program. The third would assist the governmentin developing a more efficient and sustainable strategy for the long-term control ofschistosomiasis throughout the country.

Control of Schistosomiasis in the Delta Region

74. This component is expected by the conclusion of the project to have reduced the numberof persons infected with schistosomes by about two-thirds. Because infection causes disease onlyif it is intense or of long duration, disease is then expected to become extremely rare. Thebenefits of the component have been translated into monetary units by estimating the willingnessof beneficiaries to pay for the improvements in their welfare that result from the project. Theseimprovements take many forms and derive primarily from the increase in life expectancy andreduced risk of death that the project produces. Increased life expectancy will not only enablepersons to earn more and to exploit more fully the potential returns from prior investments inhuman capital, but also will increase individual and community welfare directly by increasingaggregate job satisfaction, improving the lives of family members (including the directbeneficiary) and expanding opportunities for participation in the wider community. While theprimary beneficiary is the person whose life is saved, other persons including family members,friends, business associates, and community members often also have an interest in saving aperson's life.

75. Quantification of these benefits is difficult both because markets do not exist for manyof these goods, and because a comprehensive list of the beneficiaries cannot be easilyconstructed. In some instances evidence can be assembled from other settings that suggests howmuch people have valued similar improvements in their own lives or the lives of other people.For purposes of the present analysis, assumptions about the willingness of all affected personsto pay for improvements in someone's health and the numbers of persons directly affected havebeen assembled. These assumptions appear very consevative. Sensitivity analyses have beenperformed to further clarify the possible effects of a significantly over- or under-estimate of thetrue benefits. During the 1980s, about 2.5 percent of the population died from schistosomiasisbetween the ages of 35 and 45 years. Thus, during the mid-1990s, this component of the projectis expected to reduce the number of premature deaths attributable to schistosomiasis by about4,600 a year; the overwhelming majority of persons likely to die from the disease would bemales. If one assumes that society would be willing to pay US$600 in order to increase thelength of the average victim's life by a year, that the average age at death due to schistosomiasisis 40 years, and that the project will yield returns for 25 years, the internal rate of return for thiscomponent would be 40 percent. US$600 represents about a third of the average income of afully employed Egyptian worker. A number significantly smaller than total earnings was chosento reflect the fact that a significant fraction of earnings are consumed in maintaining theproductivity of the individual as a worker and do not contribute to welfare. If the reduction inthe number of deaths were only half the estimated number, the rate of return would be 17percent. If the willingness to pay to increase life expectancy by a year were only two thirds thebase estimate, the rate of return would instead be 18 percent. Annex 6 presents the assumptionsused in analyzing the economics of this component and additional sensitivity analyses. Under

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any plausible set of assumptions about the costs and benefits of this component, the rate ofreturn is much higher than that expected from conventional investments.

The Modernization and Strengthening of 1)ngoing C.rtmol Activities

76. Projects financed by the Government of Germany, the ADB and IDA have benefitted thearea bordering the Suez canal and the area lying along the Nile between Cairo and the Sudaneseborder. These projects target a rural population estimated to be about 15 million persons in1991. A credit approved by the ADB which is expected to become effective July 1, 1992, willprovide services to about 4 million people living in the Middle Delta. These projects wereintended to interrupt the transmission of the disease through the application of molluscicides andtreatment of infected persons. As reported earlier, the development of a safe, effective drugwhich can be administered in a single dose has revolutionized schistosomiasis control. Thecontrol programs in Middle and Upper Egypt have not been modified to exploit fully the newtechnology. The proposed project would provide training and equipment to enable these areasto adopt a sustainable strategy of disease control. The benefits of this investment includeimproved control and greater cost-effectiveness of the control program. Estimates of thesebenefits cannot readily be disentangled from the gains attributable to the strengthening ofstrategic planning and program management discussed in the next section. Therefore thecombined benefits of modernization and improved management are presented at the conclusionof the next subsection.

Strengthening .ae Capacity of the Ministry of Health to Carry out Strategic Planning andProgram Management

77. This component of the project aims at strengthening the capacity of the EDCD to evaluateand learn from its operational experiences and to profit from research sponsored by the SRP.These investigations are aimed at selection of the most cost-effective methods of identifying andtreating infected persons, and of reducing transmission. (Annex 4 and paras. 32 through 42describe the studies).

78. The benefits to be derived from this component are impossible to predict accurately. Ifthe findings of the studies confirm the consensus of professional judgement, a reduction inoperating costs of about LE6.00 million (US$2.00 million) a year could be achieved. (See para.56 for a discussion of likely sources of improvements in operational efficiency.)

Risks

79. The procedures for diagnosing the disease and the effectiveness of the drug have beenestablished through both rigorous controlled trials and practical experience. There is fear thatthe parasite might develop resistance to the drug over the long term, but no evidence ofresistance has been documented thus far, despite considerable research effort. The effectivenessof the commercially available molluscicide has also been convincingly established.

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80. The pesticide is not lethal to fish and other marine animals if applied at the minimumconcentrations required to kill snails. However, in practice, control programs have rarely beenable to regulate the use of molluscicides precisely and thus fish kills have sometimes occurred.The pesticide is not toxic to humans or other warm-blooded animals. Any fish that might bekilled would be fit for human consumption. The project aims at further reducing the risk to fishby minimizing reliance on snail control activities. Studies to be carried out under the projectwill assess the need to employ molluscicides in order to control disease (as opposed to haltingtransmission of the parasite through treatment of infected persons).

81. In the past, the NSCP has used 120 to 140 metric tons of pesticide per year; the proposedproject would finance a maximum of 40 metric tons per year. Moreover, snail control wouldbe attempted only in areas that suffer from exceptionally high transmission due to environmentalconditions that cannot be managed otherwise. These transmission sites are expected to be slowflowing, minor water courses near villages rather than the larger canals that are being developedas fish farms. Criteria for the use of molluscicides will be established that focus on the intensityof transmission among humans, rather than on the discovery of infected snails. At Negotiations,assurances were received that the Government of Egypt would adopt these criteria by J 'ne 30,1993, and thereafter conduct all snail control activities in compliance with these criteria,regardless of the source of financing (para. 89.h). The project would develop a rigorousjustification for the use of the pesticide and thereby sharply reduce the quantity being applied.

82. The long-term success of the program will require sustained financial support from theGovernment. The political urgency of controlling the disease may decrease as morbidity andmortality rates fall. In order to strengthen the NSCP's ability to defend its claims on the publicbudget, strategic planning and management functions are being strengthened. Popular supportfor the program is also being developed by broadcasting a series of brief messages on televisionand radio that remind the public of the consequences of the disease and the options for diagnosisand treatment. These "spots" have been highly successful thus far in building awareness andpromoting demand for screening. By adopting as its aim the reduction of morbidity rather thanthe interruption of transmission, the program avoids the risk that interruptions in the operationof elements of the control strategy would result in major setbacks to the program.

83. The project requires substantial amounts of foreign exchange in order to purchasepraziquantel. Drug costs during the maintenance phase are estimated to be about US$2.2 milliona year at the close of the credit in 1998. Egypt already has a private manufacturer of the drug,but the manufacturer only converts bulk technical ingredients into tablets. The patent forpraziquantel will expire before the close of the credit, allowing greater competition and perhapseven local production of the technical material. These developments are expected to lead tofurther reductions in the price of the drug.

84. Capturing the full economic benefits from improvements in program design and technicalchange may require some re-deployment of staff. The greatest numbers of redundancies arelikely to arise in the snail control program where nearly 6,700 persons are presently employedin searching for infected snails and applying molluscicides. The cost of snail control activities

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has represented approximately 60 percent of the total direct costs of program operations in recentyears.

85. The project has been designed to allow two years of assistance to the program followingpurchase of capital equipment and completion of studies aimed at establishing the need formodifications to the program. These two years would be used to imbed these reforms in thepractices of the EDCD and NSCP. If co-financing were not to materialize as expected, thescope of the project would be reduced from six to four years, thereby eliminating the two yearsof assistance to the reformed program. This increases the risk that reforms might not be fullyimplemented. To reduce this risk, IDA would continue to seek co-financiers and would involveothers in the review of program studies. This would strengthen the Government's resolve inpursuing greater cost-effectiveness. An informal link has already been established with the SRPand that link will be strengthened.

86. The success of efforts to strengthen the capacity of the Ministrv of Health to analyzepolicy options, prepare strategic plans, carry out operational research, and strengtheninformation systems and management systems would depend on the commitment of seniorofficials to these aims. The NSCP is complemented by the SRP, which is managed by thedirector general of the EDCD. The SRP has greatly improved the climate for research andanalysis, and has facilitated efforts to introduce the findings of serious research into operations.The environment for change is therefore exceptionally good.

Social Impact of the Project

87. Schistosomiasis affects men more than women because men typically spend significantlymore time in contact with water containing infected snails. Boys often swim in the canals anddrains, while girls rarely do, and men frequently work in irrigation canals and drains. Whilewomen often rely on canals and drains for laundering clothes and washing cooking utensils, thedischarge of soapy watei at these sites discourages the growth of snails and thus reduces the riskof transmission of the parasite. As laundry facilities and domestic water supplies improve, theeffect of schistosomiasis on women is likely to decline further. Women play a major role ineducating children not to urinate or defecate in waterways. In the long-term, schistosomiasisis expected to become an occupational disease, primarily affecting farmers and fishermen.

88. The project will support studies of methods for promoting improvements in excretadisposal and domestic hygiene. In particular, it will experiment with the construction ofcommunity laundry and waste disposal facilities. The project will also reinforce efforts toimprove hygiene through health education. These efforts are expected to benefit women directlyby reducing the time required to carry out domestic tasks and indirectly by reducing theirincidence rate for water-related diseases.

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VI. AGREEMENTS REACHED AND RECOMMENDATIONS

89. During Negotiations, the following assurances were received:

a. the EDCD would carry out the studies outlined in Annex 4 and modify thecontrol strategy in accordance with the findings of the studies (para. 34);

b. the EDCD would report annually on the findings of its programs of operationalresearch and strategic planning. At the end of the third year, a review of theproject would be held to assess the progress of the agreed studies, evaluate theoverall performance of the control program and identify any further investigationsand or modifications to be pursued in the final three years of the project (para.46)

c. the EDCD would introduce new forms for reporting on the incidence ofschistosomiasis that would allow a single record to be maintained for each childfor the duration of his or her schooling, and would implement data editing anddata management procedures to control the quality of statistical information(paras. 47-47);

d. the EDCD each year would prepare a strategic operational plan and a budget thatrecognize the resources to be allocated to the program, and the problems andresults being experienced by it. To this end, two planning seminars would beorganized each year, the first for the Delta and second for Middle and UpperEgypt and the Suez Canal areas (para. 50);

e. the Government would designate the Director of Project Administration, EDCD,with staffing and terms of reference acceptable to IDA, to coordinate the workof implementing governorates, monitor progress, keep project accounts and liaisewith IDA (para. 60);

f. the EDCD would maintain separate accounts for the project (para. 70);

g. the Government, within six months of the end of each fiscal year, would provideIDA with an audit report of such scope and detail as IDA may reasonablyrequest, including a separate opinion by the auditor on disbursements against acertified statement of expenditures (para. 70); and

h. the Government would conduct all snail control activities, regardless of the sourceof financing, in compliance with criteria agreed with the Association (para. 81);

90. Subject to these conditions, the project provides a suitable basis for an IDA credit ofSDR19.60 million equivalent to the Government of the Arab Republic of Egypt.

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ANNEX 1

COMPARISON OF HEALTH INDICATORSFOR LOWER-MIDDLE INCOME COUNTRIES

Average Infant Physicians Nurseslife mortality per 1,000 per 1,000 GNP perexpectancy rate population population *apita

Countty (1909) (1989) (1984) (1984) (1988-90)

ANGOLA 46 132 17,790 1,020 n.a.

YEMEN, REP 48 125 n.a. 1,970 n.a.

COTE D'IVOIRE 53 92 n.a. n.a. 730

PAPUA NEW GUINEA 54 59 6,070 880 860

CAMEROON 57 90 n.a. n.a. 940

EGYPr 60 68 770 n.a. 600. ...................... .......... ............................................. ..................... ........................................... ......................................... ...... ..........

MOROCCO 61 69 4,760 1,050 950

LEBANON 62 n.a. n.a. n.a. n.a.

GUATEMAIA 63 55 2,180 850 900

NICARAGUA 64 57 1,500 530 n.a.

HONDURAS 65 66 1,510 670 590

ECUADOR 66 61 820 610 960

SYRIAN ARAB REP. 66 44 1,260 890 1,010

TUNISIA 66 46 2,150 370 1,420

JORDAN 67 53 1,120 1,270 1,240

DOMINICAN REP. 67 61 1,760 1,210 820

MAURMTlUS 69 21 1,900 n.a. 2,200

POLAND 70 16 490 190 1,590

_OSTA RICA 71 17 960 450 1,910

ALGERIA 72 69 2,340 300 2,080

JAMAICA 73 16 2,050 490 1,510

PANAMA 73 22 1,000 390 1,830

CHILE 75 19 1,230 370 1,930Sowre: World Development Report, 1991, World Bank

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AN7 EX 2

A BRIEF DESCRIPTION OF SCHISTOSOMIASIS

The Parasite

Schistosomiasis is a parasitic disease caure by infection with fluke worms belonging tothe genus Schistosoma (trematoda, platyhelminthes). Five species are able to infect man: S.haematobium, S. intercalatum, S. mansoni, S. japonicum, S. mekongi. Other schistosomespecies are parasites of animals only; some of these may occasionally infect man or hybridizewith human schistosomes.

Adult schistosomes are white-grey worms, 1 to 1.5 centimeters long and 0.2 millimetersthick, with a cephalic and a ventral sucker; the sexes are separated. They live in the perivesical(S. haematobiwn) or mesenteric (other human species) veins, where they feed on blood particles.The female worm is slender and cylindrical, the male has a stouter body with flattened lateralextensions which hold the female in a "gynaecophoric canal" (figure 1). The female produceseggs with a characteristic terminal or lateral spine. Schistosomes have an average life span ofthree to five years, but may live for up to thirty years.

Transmission Cycle

Schistosomes are transmitted by specific freshwater snails. The transmission cycle isillustrated in figure 2. The eggs, produced at a rate of 300 to 3,000 per day, excrete proteolyticenzymes which enable them to penetrate through the interstitial tissue into the intestinal orvesical lumen. This migration takes several days to weeks; on their way, about half of the eggsare carried away with the blood stream or trapped in the tissues. The eggs that reach the luminaare excreted with the feces or the urine, and hatch only if they come into contact with water.In this case, they release a ciliated mobile larva called miracidium, which remains viable for upto 48 hours and is attracted by light and by chemical substances excreted by snails. Afterpenetrating a suitable vector snail, the miracidium migrates to its hepatopancreas, and developsand divides into sporocysts. After four to six weeks of development, the sporocysts divide intocercariae--mobile larvae with typical bifurcated tails which leave the snail at a rate of hundredsto thousands per day. This shedding process, which can go on for months, is stimulated by light

Adaptedfrom an article by Dr. Bruno M.A.J. Gryseels entitled "Morbidity and Mortality Controlof Schistosomiasis Mansoni in Sub Saharan Africa ', (CIP Gegevens Koninkijke Bibliotheek, DenHaag, 1990).

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and warmth. The cercariae swim freely in the water and remain viable for up to 72 hours,though their infectivity diminishes rapidly. Infection of the definitive host occurs during watercontact; the cercariae pierce the human skin in a few seconds, shed their tail and penetrate intothe subcutaneous capillaries. Thus transformed into schistosomula, they migrate with thebloodstream to the portal system, where they mature into adult worms in about one month.After mating, these migrate to the perivesical or mesenteric plexus, where egg production starts.

Figure 1: Schistosornes

____________ Male

S.

W . ____________ Female~

Figure 2: The Transmission Cycle of Schistosoma

a" wa

5o~~~~ff AIA Y |~~~Crcri,~~~~~~~~~~~~~~~~~... ... (

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Pathology

The penetration of cercariae through the skin can provoke a rash, known as "swimmer'sitch", which can also be caused by cercariae of animal schistosomes. In the stage ofdevelopment into adult worms, a feverish syndrome ("Katayama fever") can develop. Suchacute schistosomiasis is mainly seen in individuals coming into contact with the parasite for thefirst time.

The most important pathological consequences are caused by the eggs which are trappedin the tissues. These give rise to a typical granulomatous reaction and in later stages to fibrosis.The pathophysiological processed are complex and largely immune-regulated. Severe chronicdisease generally develops only after several years of (heavy) infection.

Urinary schistosomiasis is caused by S. haematobium. The eggs passing through andtrapped in the bladder wall give rise to inflammation, hemorrhages and pseudopolyposis.Inflammation around the ureteral valves and the ureters cause stenosis, stasis, hydroureter. Inlater stages calcification of the bladder wall, bladder stones, hydronephrosis, and kidney failuremay develop. Secondary 'ifection may complicate the clinical picture. There is epidemiologicalevidence that urinary schistosomiasis can predispose to bladder carcinoma. The clinicalsymptoms of urinary schistosomiasis include (terminal) hematuria, frequent and urgentmicturition, dysuria, and, in later stages, symptoms of bacterial infection, hydronephrosis orother complications.

Intestinal and hepatosplenic schistosomiasis is caused by S. mansoni or S. japonicum.Inflammation and formation of pseudopolyps around trapped eggs in the intestinal wall give riseto (bloody) diarrhoea, abdominal discomfort, colicky pains. Many eggs are transported to theliver, where they are trapped in the small ramifications of the portal system. Around the eggs,granulomatous and later fibrous reactions develop. In early stages, reactive hepatomegaly andsplenomegaly are often observed. In advanced chronic cases, the fibrotic lesions around theportal venules (a pathological pattern known as "Symmers' pipestem fibrosis") increasinglyocclude the portal system. The ensuing portal hypertension leads to splenomegaly, ascites,intestinal and oesophageal varices; the latter may cause fatal hemorrhages. The hepatocellularfunction remains in principle preserved. The severity of disease depends on the intensity andduration of the infection, and also of still largely unknown immunological and genetic factors.

Th& Intennediate Host

S. mansoni is transmitted by gastropod snails of the genus Biomphalaria, S. haematobiumand S. intercalatum by the genius Bulinus. S. japonicum and S. mekongi are transmitted byamphibious snails of the species Oncomelania and Tricula. The taxonomy is largely based onmorphological characteristics of the shell and soft parts and has undergone considerablesimplification over the last few decades. Biochemical and genetic techniques play anincreasingly important role in snail taxonomy, and tend to lead to further simplification. Firmidentification of snail species can be difficult, but is not always of crucial operational

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importance. The susceptibility to infection with Schistosoma varies between species, strains andeven individual snails.

The ecology of the snails is variable; most species can adapt to a wide range of ecologicalconditions. Biomphalaria and Bulinms tend to prefer still or slow-running waters with atemperature between 25 and 30 degrees Celsius, which are well-oxygenated, rich in organicmaterial, slightly acid, moderately conductive, and with sufficient levels of calcium andmagnesium. Snail populations often show marked seasonal variations, related to rainfall,temperature and irrigation cycles. The pattern of these seasonal variations can vary accordingto local conditions.

Snails produce large quaitities of eggs, generally after cross-fertilization, buthermaphroditic reproduction is possible. Under favorable conditions, snail populations doublein a few weeks; one snail is sufficient to colonize a water body in a few months.

Transmission Dynamics

The theoretical reproduction potential of schistosomes is enormous. In a stable endemicsituation, this potential is diluted to an average reproduction rate of one. The maintenance ofparasite populations depends thus on a complex set of relations, determined by many factors atvarious levels of the transmission cycle. So far, a satisfactory epidemiological model has notbeen forwarded. Transmission factors as well as host-related factors have been considered askey factors to the process, but biological data measuring the dynamics of each step in thetransmission cycle are scarce.

The proportion of eggs reaching water is probably very low. Based on the age-relateddistribution of egg counts, it can be estimated that children and adolescents are responsible for60 to 80 percent of the potential contamination.

Infection rates in snails are generally less than 5 percent, with considerable variations intime and space. Infected snails show increased mortality and infertility. The production ofcercariae is influenced by snail susceptibility, temperature and light.

Human water contact patterns vary according to the ecological situation and social,economic and cultural factors. Generally, children have the most intense water contact. In mostareas, domestic and recreational activities are responsible for at least half of the contacts. Thecontribution of occupational contacts depends on local conditions.

The importance of protective immunity in humans has been the subject of long debate.Recent studies indicate that an effective but complex cellular immunity, regulated by various(sub)classes of antibodies, develops after several years of (re)exposure.

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Morbidity

The importance of schistosomiasis as a public health probi2m varies from one countryand focus to another. The heterogeneity of the morbidity patterns can partly be explained byvarying intensities of infection, but probably other host and parasite-related factors are ofimportance as well.

In communities affected by urinary schistosomiasis, generally over 60 percent of theinfected individuals show microscopic hematuria; depending on the intensity of infections, grosshematuria may be seen in up to 20 percent or more of the children, and lesions of the lower andupper urinary tract can be radiologically or sonographically demonstrated in 10 to 50 percentor more of the population. Still, most infections remair. largely asymptomatic; many lesionsdiminish or disappear spontaneously over the years. Mortality is low, though some autopsystudies and longitudinal community surveys indicate that urinary schistosomiasis may be anindirect cause of death, particularly in young adults.

The morbidity due to S. manson, is more difficult to visualize and measure. Increasedfrequencies of diarrhoea and particularly dysenteric syndromes, which can sometimes be fatal,have clearly been attributed to the infection. Increased rates of hepatomegaly and splenomegalycan generally be associated with the presence and intensity of infection, particularly in children.Decompensated portal hypertension, leading to ascites, cachexia, oesophageal bleeding, is or wasa major health problem in Brazil, Egypt, Sudan and some other African foci.

Control

Without profound modification of the ecological factors determining the populationdynamics of the parasite, transmission levels cannot be durably affected. Eradication can onlybe achieved through significant socio-economic progress, which is not in view for most endemicareas.

A more realistic objective in schistosomiasis control is the reduction of the prevalencesand intensities of infection to levels at which morbidity becomes rare. This can be pursued byreducing transmission, or more directly by the large-scale treatment of infected individuals.

Chemothea. Morbidity control through large-scale, community-based chemotherapyhas become in recent years the most widely advocated strategy, due to the development of safe,effective single dose drugs and of adapted screening techniques. Different strategies can beapplied. In selective treatment the members of the target community are screened (with director indirect techniques); positive individuals are treated. In targetted treatment, the screening isfollowed by the treatment of individuals with high egg counts only. In mass treatment, allindividuals of the target community are treated indiscriminately. Each of these strategies canbe applied in selected target groups (for example, school children), or in combined or phasedapproaches (for example, first mass, later selective treatment).

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Community-based chemotherapy generally gives impressive results on the short term.However, as control is required mainly in areas with high levels of transmission, rapidreinfection is the rule rather than the exception; the impact of chemotherapy on transmissionappears to be limited, even if indiscriminate treatment is applied. In the absence of effective,sustained transmission control, treatment has to be repeated at intervals of a few years or lessfor a still undetermined period. Furthermore, the need for continuity requires integration inregular health structures. Vertical approaches based on mobile teams may have attractiveadvantages on the short term, but are expensive and difficult to sustain.

Snail control. Snai' control with chemical molluscicides was the main strategy untilmodern drugs became available. The complexity of transmission patterns, the technical andlogistical requirements, the high costs of mollusciciding and ecological considerations are someof the problems contributing to the decreasing popularity of this control method.

The only compound still on the market is Bayluscide, a wettable powder with 70 percentactive matter (niclosamide). It is highly effective in concentrations of I to 3 ppm maintainedfor 6 to 8 hours, and is non-toxic for warm-blooded animals. The potential for regeneration andreinvasion of snail populations is impressive, however, and generally they re-establish in aperiod of months. Mollusciciding has thus to be frequently repeated to be effective, thoughstudies of the local dynamics of snail populations and transmission patterns may help to developmore limited and still efficient mollusciciding programs. Molluscicides are expensive and theircorrect application requires specialized mobile teams. Large-scale snail control is therefore outof reach of most endemic countries. "Focal" mollusciciding in selected transmission sites is analternative, but the identification of the microfoci and periods of transmission can be surprisinglydifficult.

Various plants with mollusciciding properties (for example, Ambrosia Maritima,Phytolacca dodecandra) have been identified. Due to toxicity problems, low efficacy, andlogistical constraints, their application has so far been limited to experimental situations.

Biological snail control is in principle possible through the introduction of predators (fish,ducks, other snails) or competitor snails (for example, Marisa comuarietis), however,operational experiences are limited. Even if snail populations are reduced, an ecologicalequilibrium in which transmission continues can be expected to set in. The introduction of newspecies in an environment is moreover not without ecologic or even economic dangers.

Physical snail control can be pursued by proper engineering of hydraulic infrastructures:concrete lining of canals, ensuring high water velocity, strong slopes, adequate watermanagement, weed control, periodical flushing and emptying of canals. Such interventions aregenerally expensive or difficult to implement and maintain.

Sanitary and health education. Sanitation and health education are clearly the pillars ofdurable control and deserve priority, in view of the broadness of their impact. Faecal or urinarycontamination can be reduced by the construction of latrines. A significant impact on

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transmission can, however, not be expected as long as they are not consistently used by a largemajority of the population. Reduction of water contact has a more direct effect on transmission.Safe water supplits, foot bridges, public laundries, showers, etc. can considerably reduce humanexposure. Adequate designs adapted to the needs and attitudes of the population are essential,and proper maintenance must be assured. Any action should obviously be reinforced by healtheducation, in which not only the health services but also educational, socio-cultural, agriculturalstructures and the mass media can be involved. Realistic messages, consideration of culturalattitudes, targetted approaches, and adapted didactic material and methods are key factors tosuccess. However, only a gradual and partial modification of human behavior should beexpected.

In the present socio-economic conditions of most endemic countries, the results ofsanitation and health education can be expected only on the long-term. Given the limitedcapacities of most health services, intersectorial cooperation and financing are indispensable.Proper planning and implication of health ministries in development programs should be the rulefor governments and funding agencies.

Vaccination

Immunogenic antigens have been defined and some cloned, fueling the hope for avaccine. Trials in animals have produced mixed results, and the application in humans is notfor the forseeable future.

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ANNEX 3

THE PROJECT AREA

Table 1: DescriptIon (Characterlstucs) of Governorates In Eastern and Western Delta

Number Number LengthGovernorate Estimated Average of rural of rural Number Number Cultivated water

population prevalence health health of of area coursesunits clinics hospitals villages (Feddans) (km)

Dakahlia 3,802,765 23.8 206 56 6 435 608,000 46,500

Sharkia 3,715,528 21.4 18S 45 3 473 650,000 48,000

Qalubia 2,731,409 10.0 82 23 8 190 205,000 12,000

Alexandria, 3,169,308 10.9 19 2 0 0 800,000 59,000Rural

El Behema 3,538,502 30.5 190 43 3 425 100,000 2,300............ .................. ..................... ............................................................................ ....................... .............. ....................

Total 16,957,512 96.6 682 169 20 1,523 2,363,000 167,800

Source: Ministry of Health, Govemment of Egypt

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Tabk 2: Prtvaknc f Infectdon In Middle and Upper Egypt and the Suez Canal Area(Numbers of Distriats by provalenco rte for selected years, 1977-1990)

Pievalenco ratc 1977 1981 1985 1986 1987 1988 1989 1990

Mfddk EgyptBeni Suef 0-10 5 77 87 88 92 84 100

10-20 30 .. 34 27 28 22 30 1620+ 81 .. 5 2 0 2 2 0

Mania 0-10 9 .. 104 120 148 148 112 14610-20 22 80 76 48 48 84 5520+ 17 18 6 6 6 6 1

Asuit Nozth 0-10 2 27 34 17 18 33 4210-20 20 30 25 35 38 27 2120+ 42 7 5 1 2 8 4 1

,,,,,4,,,.,,,,,.,,,,,,........,5 ...................................................... . ............ ........ .Total 0-10 16 208 241 253 258 229 288

10-20 72 144 128 III 108 141 9220+ 294 .. 30 13 18 16 12 2

Upper EgyptAssuit South 0-10 .. 7 24 21 17 27 43 58

10-20 36 32 43 45 33 29 1920+ .. 37 24 16 18 20 8 3

Sohaq 0-10 .. 24 55 51 51 57 88 1110-20 59 90 92 83 80 72 S020+ 97 35 37 46 43 20 11

Quena 0-10 5 34 39 36 9 12 3110-20 48 69 70 68 83 78 7620+ 110 60 54 59 71 73 56

Auwan 0-10 42 78 80 73 76 79 8010-20 20 2 0 6 4 1 020+ 18 0 0 1 ,, 0 0

Total 0-10 .. 78 191 191 177 169 222 2810-20 .. 163 193 205 202 200 180 1420+ .. 262 119 107 124 134 101 70

Suez Canal RegionSuez 0-10 .. 4 4 5 7 7 7

10-20 .. .. 3 2 2 0 0 020+ .. .. 0 1 0 0 0 0

Tamalyia 0-10 .. .. 8 12 5 5 6 1110-20 .. .. 12 9 15 13 15 1120+ .. 7 6 7 9 6 5

Port Said 0-10 .. .. 3 3 3 4 4 410-20 ., I I I I I I20+ .. I I I 0 0 0

Damitta 0-10 .. 5 7 5 7 7 810-20 .. .. 17 17 15 13 18 2520+ .. .. 35 33 37 37 32 24

Manzala 0-10 .. .. 0 0 0 0 0 010-20 .. .. 0 1 2 3 5 520+ .. .. 20 19 18 17 IS is

Hossenia 0-10 .. 3 4 3 6 5 310-20 .. 12 12 12 8 10 820+ .. 8 7 8 9 8 12

. ................................................................................. ................................................._ ._

Total 0-10 .. .. 23 30 21 29 29 3310-20 .. .. 45 42 47 38 49 5020+ .. .. 71 67 71 72 61 56

not available.Source: Ministy of Health, Govenment of Egypt

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ANNEX 4

PROTOCOLS FOR OPERATIONAL RESEARCH

Schistosomiasis Control Program: Operational Research

I. Introduction

The extension of the National Schistosomiasis Control Programme (NSCP) to the NileDelta, and the reinforcement of maintenance strategies in the rest of Egypt, will require theintroduction of new operational approaches. Screening methods, treatment schedules, snailcontrol strategies, procedures for data management and decision making, will have to beadapted.

A large-scale operational control program such as the Egyptian NSCP should not beoverloaded with research, however interesting. Standard methods for schistosomiasis controlare to some extent available. However, the size and importance of the NSCP justifies anoptimal adaptation of methods to its specific requirements. Furthermore, methodologicalchanges must be evaluated in order to allow comparison of past and future results.

A fortunate circumstance in this critical period of extension and adaptation of the NSCPis the presence of the USAID-funded Schistosomiasis Research Project (SRP). Besidesimmunological and biochemical work, SRP supports extensive epidemiological and operationalresearch which will answer some of the operational questions. For other practical studies, itmay be difficult to interest academic research groups. Moreover, EDCD should maintain thecapacity to perform independent operational research and quality control. It would thus beuseful to create also an operational research team at the Ministry of Health. In the followingpages, the strategies of the proposed project will be summarized. On this basis, mainoperational questions which are now apparent, and possible protocols to answer them will beoutlined. The list of questions is not exhaustive, and relates mainly to issues not specifically ornot completely addressed by SRP. The protocols and decision levels are tentative, incompleteand somtimes arbitrary; they should mainly serve as guidelines for the establishment of definitiveprotocols by the Ministry of Health and involved research groups.

II. Strategies

A. CLemotherapy

In the new project area, the existing strategies for selective population chemotherapy willbe implemented. Based on the results of operational research, the following modifications maybe considered:

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1.1. Introduction of more sensitive, reproduci'le and cost-efficient screening techniques.

* Urinary schistosomiasis could be screened with reagent strips for haematuria, andconfirmed by urine sedimentation or filtration.* For intestinal schistosomiasis, the Kato technique could be used, preferably withreusable metal equipment.* Quantification of the eggs for monitoring purposes may be done in all or a randomsample of the Kato slides and urine filters.O For all symptomatic out-patients, microscopic diagnosis is maintained.

1.2. Target groups remain schoolchildren, outpatients and community samples.

* For schoolchildren, bi-annual selective population chemotherapy is maintained.Within three years research will indicate if and when treatment can become less frequent.* Among outpatients, symptomatic cases have priority. Screening of non-symptomaticpatients will depend on capacity.* The rotating sample component will be redefined based on a careful evaluation ofpast experiences. For monitoring purposes, a statistically valid rotating 10 percent sampleshould be examined yearly by governorate or district mobile teams. Communitycoverage should be pursued pragmatically, with emphasis on specific risk areas and riskgroups.

B. Focal Snail Control and Environmental Intervention.

2. 1. A focal strategy for malacological surveillance and snail control will be applied, based onthe selection of high-transmission villages and hamlets, and mapping of (re)infection andtransmission patterns within the villages.

* Cut-off values for transmission control intervention will be defined. Tentatively,"problem" villages or hamlets with an initial prevalence in school children over 50%percent, or in which the prevalence after three years of selective populationchemotherapy has not been reduced to less than 15 percent can be targeted.* Local epidemiological data, complemented with malacological and sociologicalinformation will be used to detect main transmission sites.* Area-wide snail surveys will be reduced or discontinued. For the focal snailsurveillance, more sensitive survey methods will be applied.* Rapid assessment procedures for the identification of water contact sites, based onquestionnaires and/or direct observation, will be used.* Within 3-4 years, the feasibility and cost-efficiency of focal mollusciciding will bere-evaluated.

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2.2. Increased emphasis will be given to environmental and sanitary interventions and healtheducation.

* Where possible, high-transmission sites will be eliminated or modified byenvironmental or sanitary measures. Possible interventions are the construction of publiclaundries, showers, domestic drainage systems, identification of safe bathing sites.* Health education will be strengthened by developing didactic material and methodsfor schools and other target groups such as women, based on surveys of Knowledge-Attitudes-and-Practices (SRP), and intra-sectoral and inter-sectoral collaboration.* A multi-disciplinary task force will develop a concrete plan for research and actionfor health education and sanitation within a year.

C. Monitoring and Decisionmaking

3.1. Rural health unit data will be submitted to quality control, including:

* Re-examination of a random sample of filters and slides by superiors.* Prompt verification of inconsistencies in monthly reports.* Field and administrative checks of the quality of selective population chemotherapycampaigns.

3.2. Reinfection and incidence rates will be included in the reports.

* Forms will be introduced which keep track of each child over the years.* Treated out-patients and sample subjects are followed after 1 year.* New and reinfected cases are mapped geographically to detect micro-foci.

3.3. The returns from the target groups will be tabulated per rural health unit from year to year,for schools per semester, and compiled on the district and governorate level. Supplemented withreinfection patterns, they will orient targeted chemotherapy and snail control. Governorateand/or district mobile teams will initiate and further assist the local analysis.

3.4. The national level remains responsible for over-all supervision, coordination and strategydevelopment.

* Definition of cut-off prevalence (and/or intensity) values for eritering attack andmaintenance phases, of the geographic level at which they are declared, and the strategyshifts between phases.* Definition of cut-off values for intensive focal intervention.* Translation of results of operational research in concrete strategies.* Yearly strategic operational and budgetary plans in function of the results of controland research, and operational experience.

3.5. Besides infection rates, the program should be evaluated in terms of morbidity, based onultrasound studies (SRP) and hospital data.

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3.6. Computerization of the data ;1 be gradually introduced at the level of the Ministry ofHealth and the govemorates.

EII. Tentative Operational Research Protocols

A. Selection of Screening Methods

Rationale

In the Delta, intestinal schistosomiasis (due to S. mansoni) is predominant; in Upper andMiddle Egypt, where the NSCP has been implemented so far, urinary schistosomiasis (S.haematobium), is the main problem. Screening will have to be performed for both parasites,in millions of people per year, by a limited number of technicians. Priority will have to begiven to S. mansoni infections, the morbidity of which is graver and diagnosis more difficult.Screening the relatively rare and light cases of urinary schistosomiasis should take as little time,effort and cost as possible.

The screening methods used so far are based on the sedimentation of schistosome eggsin conical flasks or test tubes; faeces are first mixed with saline and sieved. The sediment isexamined under the microscope. If well performed, these methods are sensitive, specific, simpleand cheap. They are, however, time consuming, depend on fragile glassware, do not providequantitative data, and offer limited possibilities for standardization and quality control.

Egyptian health personnel has a long experience and tradition with these techniques, onwhich most of the available data and results are based. Clearly, changes of methodology mustbe well docu .:ented and prepared. On the other hand, it is crucial to reinforce local monitoringdata, and therefore to introduce quantitative., reproducible techniques.

Such techniques have been developed and widely tested in many countries over the pastdecade. The Kato technique for S. mansoni consists essentially of calibrating 25 to 50 mg sievedfaeces in a punched template; this thick smear of faeces is spread under a piece of glycerine-soaked cellophane, allowing the faeces to clear and be examined microscopically. Urinefiltration for S. haematobiwn consists of filtrating a certain volume (generally 10 ml) of urineover a paper, millipore or nitrocellulose filter, which after (optional) staining can be examineddirectly under the microscope. Both methods allow to quantify the schistosome eggs in acalibrated amount of excreta, and thus to assess indirectly the intensity of infection, which iscorrelated with the risk of disease. For urinary schistosomiasis, also indirect screeningtechniques based on the detection of haematuria with reagent strips have shown to be simple,sensitive and rapid.

These new methods have also some disadvantages. They require manipulation of smallequipment such as filters and templates. Though cheap, supplies (of cellophane, filters, reagentstrips) have to be assured, possibly against hard currency. Reusable equipment must be cleanedcarefully to avoid parasite eggs to contaminate other samples. Reagent strip for hematuria aresensitive to climatic conditions and deteriorate rapidly once unpacked. Various kinds ofequipment and procedures are available for each methods; full standardization has certainly notbeen reached. In a large scale program such as the Egyptian NSCP (in the Delta alone, close

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to 20 million screenings per year would be performed), a careful evaluation of the varioustechniques and equipment to be used is certainly wuarranted.

B. Evaluation of Inherent Qualities of Tests

Study populations

* Three villages are selected for each parasite, with different prevalence and/orintensity levels: e.g. prevalence <20%; 20-50%; >50%. Intensities will generally becorrelated but should be checked.In principle, six villages are thus examined but combined studies on both parasites maybe possible.* In each village 300 to 500 randomly selected people of all age groups are examined,before, two months and one year after treatment. Possibly, the study can be combinedwith cure rate studies (see 2).

Methods

The following techniques are applied for each individual, by a specialized research team(Ministry of Health or SRP):

Stool examination:

* Usual routine sedimentation technique.* Standard Kato-Katz method (disposable plastic World Health Organizatiun/GTZ 43mg-templates).* Alternative Kato method with durable metal equipment; both 25 mg and 50 mgtemplates are used.* A 10 percent sample of the Kato slides is read after 1, 3, 6, 24, 48 hoursrespectively.

Urine:* Routine sedimentation technique.* Urine filtration (10 ml) on nitrocellulose, paper, nucleopore filters.* Hematuria reagent strips of cheap brands e.g. those (to be) produced by PATH.

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Practical problems, e.g.:

* Numbering and storing slides/filters.* Clogging of urine filters, staining.* Kato slides from liquid or hard stools.* Cleaning re-usable equipment (plastic templates, urine filters).* Hygienic aspects.* Shelf-life of reagent strips, by comparing results after increasing intervals (1 day-2weeks) after opening vial.

Analysis:

* Comparison of the sensitivity and specificity of different methods over-all, per agegroup, per egg count group against a "golden standard" of combined results of egg-detection methods.* Cost in local and hard currency.* Time required for preparing and reading sl. les/filters.* Optimal clearance time for Kato slides.* Cost, performance and feasibility of re-usable versus disposable equipment.* Practical feasibility.* Shelf life of reagent strips.

C. Evaluation of Primary Health Care-applicability of Tests

Study populations

Twenty "average" rural health unit-technicians are selected, trained and equipped to perform one(one for each parasite) of the new screening techniques in their rural health unit.

Methods

* The new techniques are applied by the technicians in a routine screening campaign(e.g. ± 500 school children each). Stools and urine are collected in the schools, slidesand filters are prepared and examined in the rural health unit.* Stool and urine samples are kept for quality control.* A research team daily collects the Kato slides, urine filters, stool and urine samplesof the day.* Registers and identification of samples and slides/filters are checked.* The team records the number of slides/filters prepared and/or examined per day andthe time this has required.* Time and supplies required for cleaning reusable equipment are recorded; the qualityof cleaning and practical problems are assessed.

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* In its own laboratory, the team evaluates: (i) Quality of (a sample of) Kato slides:weight, clarity, identification; (ii) Quality of urine filters: mounting, staining, identifica-tion; (iii) Quantitative and qualitative accurateness of rural health unit-results by re-examining all slides (N.B. allow for possible further clearance of Kato slides after firstexamination); (iv) New Kato slides and filters are prepared from (a sample) of thecollected stools and urines; results are compared with rural health unit-slides.

Analysis

* Comparison of qualitative and quantitative results obtained by rural health unittechnicians and research teams.* Time needed for preparing and examining slides and filters and for cleaningequipment; possible work volume per day.* Feasibility of tests in school/rural health unit setting; maintenance of technical andhygienic standards.

Expected outcome

Within one year, the two studies should lead to a documented decision about thescreening method to be applied for both parasites. Tentatively, the following minimalrequirements could be envisaged:

Kato method:

* Sensitivity equal or higher than the sedimentation method (as applied routinely inrural health units).* Unit cost of consumables and equipment less than 0.05 LE.* Correct and hygienic handling by rural health unit-technicians.* Daily number of slides per technician minimally 30/day.* Preference to reusable metal equipment with template size 50 mg.

Reagent strip technique for screening urine:

* Sensitivity > 85% for all infections (detected by sedimentation and/or filtration) and> 95% for infections over 50 eggs/lOml.* Specificity > 90%; filtration (or sedimentation) may be used as confirmationtechnique, and/or in a sample of the urines to provide quantitative monitoring data.* Cost < 0.10 LE / unit.* Shelf life at least 1 week.* Correct handling and reading by technicians.

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Urine filtration technique (for diagnosis or confirmation):

* Sensitivity equal or higher than sedimentation technique.* Daily volume minimally 30 filtrations per day.* Proper handling by rural health unit-technicians.* Cost per unit in consumables < 0.10 LE.* Preference for paper filters (cheap, can be numbered, but clog easily); choicedepends on cost and operational aspects.

The proportion of Kato slides and filters to be read quantitatively by rural health unit-staffshould be at least 10%, e.g. every 10th slide. The study should also contribute to thedevelopment of adequate forms and quality control procedures. Recommendations for the localmanufacturing of equipment and supplies will be formulated.

D. Choice of Drug

Rationale

Since 1985, praziquantel in a single dose of 40 mg/kg body weight, with a maximum of2,400 mg (4 tablets), is the standard treatment for all forms of schistosomiasis in the SCP.Millions of doses of praziquantel have been distributed over the past years; the consumption hasfurther increased after the introduction of the health education campaign on bilharzia ontelevision. Initially, the drug was obtained in its original formulation from Bayer (BiltricideR),later from Shin Poong Company in South Korea (DistocidR). In recent years the drug isproduced under license from the latter company within Egypt. The current gross price is 0.80LE/tablet.

All batches are submitted to the quality control department of the Ministry of Health, sofar with consistently satisfactory results for the contents of active substance. A comparison offield results with various brands has so far not been performed in Egypt.

Analysis of the results of the treatment campaigns shows that, after an initial decrease,prevalences tend to stabilize in spite of repeated treatment. This phenomenon is most probablythe result of reinfection and screening failures. However, the possibility of reduced drugefficacy due to emergence of resistance (SRP) or to pharmacological (formulation, watersolubility) differences between brands, must be excluded.

Study populations

The study should take place preferably in the low transmission season.Four comnrjnities are selected (two for S. mansoni, two for S. haematobium) with prevalences> 50%. In each village, ± 500 people are raildomly selected.

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Methods

* All subjects are screened with Kato method and/or urine filtration, from at least twostool/urine sample per individual.* Positives are treated with praziquantel 40 mg/kg in three (blind) randomly selectedgroups: Biltricide, Distocid (South Korea) and Distocid (Egypt).* Treated individuals are interviewed with a standardized questionnaire for side-effects,1 hour and 24 hours after treatment.* Treated individuals are re-examined 6 weeks and 12 weeks after treatment with thesame parasitological metJods (minimally 2 samples).* This study could be associated with a reinfection study by re-examining thecommunities 12 and 24 months after treatment.

Analysis

Comparison between brands, by parasite, by age group, by egg count group, of:

* % of treated subjects becoming negative (cure rates).* % reduction of people with intense infections (> 100/400 epg, >50 eplOml).* % reduction of geometric egg counts of positive individuals (egg count reduction

rates).* Side-effects experienced with various brands.

E:xpected outcome

Within 1 year, any significant difference between brands of praziquantel should bedocumented. Preference remains to be given to Egyptian Distocid, (cheapest and least hardcurrency cost). If necessary, a pharmacological evaluation should be made (SRP), andrecommendations for the manufacturer formulated.

D. Choice of Optimal Interval for Screening and Treatment

Rationale

The strategy for morbidity control in children is based so far on six-monthly screeningand treatment. This arbitrary schedule is partly based on an objective of transmission control byreducing egg output in the community. National and international experience now shows thattransmission is probably little affected by (selective) population chemotherapy. Strategies shouldthus be primarily devised in function of morbidity control, for which less frequent treatment maybe sufficient, with an obvious effect on the cost of the program. It may furthermore be expectedthat by improving the quality of screening, fewer missed cases will be "recovered" at a nextscreening. The required frequency of treatment will probably depend on the level of endemicityand morbidity, and vary between program phases.

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Study populations

The study would concentrate on S. mansoni areas; a similar study could be performed also forS. haematobium in other areas. Six groups of 500 children each, of the age group 6-10 years,will be selected for the study, three with a prevalence >50%, three with a prevalence <50%.

Methods

* All children are submitted to parasitological (Kato, urine filtration), clinical (history,clinical examination), ultrasound examination.* In each endemicity setting, one group is submitted to six-monthly, one to yearly, oneto two-yearly Pcreening and selective treatment.* In yearly follow-ups, presence and intensity of infection and morbidity are re-

assessed, with the same methods, in the entire study groups (negatives and positives).

The study will last at least 4 years, possibly longer. Children leaving school will be followedup as much as possible.

Analysis

Comparison between strategies and between endemicity settings of:

* Evolution of infection rates and intensities.* Evolution of intestinal and hepatic (urinary) morbidity.* Costs of screening, manpower, and drugs.* Cost/efficiency of various strategies, as expressed per unit cost of prevented case ofmild/severe pathology.

E:xpected outcome

Within 3-4 years a documented decision should be taken concerning the required intervals forscreening and treatment in school children in high- and low endemicity conditions, respectively.Within 5-6 years, a documented decision should be taken on the adaptation of the treatmentfrequency according to the proeram phase. As a tentative guideline, it could e.g. be proposedthat higher frequency treatment should result in a 20% increase of morbidity reduction.

E. Development of Focal Strategies

Rationale

Until 1986, transmission control was based on area-wide mollusciciding through mainsupply canals. This strategy could not be maintained because of its high cost and ecologicalconcerns. Operational experience with population chemotherapy moreover indicates, that snailcontrol did not result everywhere in as much reduction of transmission and reinfection as mighthave been expected. Consequently, the strategy was shifted to more focal snail control;mollusciciding is concentrated in villages where (re)infection rates are high (>20%).Structures, resource allocation, procedures and methods in monitoring and intervention have not

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yet been adapted to the new strategy, which requires detailed and reliable monitoring ofepidemiological and malacological indices.

In most areas covered by the SCP, over-all prevalences and intensities have generallybeen reduced by 50 to 90%. After a strong initial decrease, they tend to stabilize, however,around 10-15%, in spite of continued intense chemotherapy and mollusciciding. On a locallevel, this threshold varies strongly from one district and village to another. The phenomenonand the relative contribution of reinfection, new cases, defects in screening, treatment andreporting remain largely unexplained. In order to improve control results further, focaltransmission control and risk-group targeted chemotherapy is probably necessary. Focaltransmission patterns and risk factors for reinfection must thus be analyzed at the local level.

Study areas

Twenty (parts of) villages with prevalences over 50% (of S. mansoni and/or S. haematobiwn)are selected, each with ± 500 inhabitants.

Methods

* In each village, houses, families and schistosomiasis cases are mapped. Data on casesare provided by local rural health unit-data.* In 10 villages, these data are checked by surveys by research teams.* During a one-year period, waterways and snail populations are carefully mapped andmonitored at monthly intervals in each village.* Besides the actual dip-technique, intensive, standardized (semi-) quantitative methodswill be applied (e.g. two snail prospectors searching intensively, for 15').* Water contact sites are mapped with rapid assessment procedures, based oninterviews and inspection. Results are compared to more laborious longitudinalobservation methods.* After one year, focal snail control is started in main transmission sites in ten of thevillages, defined on the basis of mapping of cases, water contact and snail populations.Snail control continues on a monthly basis (during the transmission season) for at leasttwo years.* In the other villages, no transmission control measures are carried out.* Population chemotherapy is implemented according to the usual strategy, by the localrural health unit-teams. Reinfection rates and patterns are mapped after each schoolsurvey; again, the data are checked and supplemented by research teams in a sample ofthe populations. Adequate forms to follow up children and patients over consecutiveyears are developed.

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Analysi

* Comparison of qualitative (detection of infested sites) and quantitative (number of[infected] snails) sensitivity of snail survey methods.* Development and evaluation of procedures for mapping cases on the basis of ruralhealth unit-data, as compared to survey data.* Development and evaluation of rapid assessment procedures for mapping watercontact sites, as compared to extensive observations.+ Comparison of evolution of snail population and snail infection rates in molluscicidedand control villages.* Comparison of incidence and reinfection rates and patterns in molluscicided villagesand control villages.* Evaluation of costs of focal snail control and snail surveillance.* Analysis of demographic, sociological, geographic, ecological characteristics ofgroups/areas at risk for rapid reinfection.* Evaluation of feasibility of detecting risk group/areas on the basis of rural healthunit-data, and feasibility and cost-efficiency of targeted chemotherapy.* Comparison of cost-efficiency of focal snail control in terms of reduced reinfectionrates and of more frequent (targeted) chemotherapy.

Expected outcome

* Within 1-2 years, methods and procedures for sensitive malacological monitoring andmapping water contact patterns are developed.* Within 2-3 years, the feasibility and cost-efficiency of detection of (micro)foci withintense transmission and (re)infection, on the basis of rural health unit-data and rapidassessment procedures are evaluated.* Within 3-4 years, a documented decision is made about the relevance and feasibilityof focal mollusciciding in different ecological and epidemiological conditions.* Within 3-4 years, a documented decision is made about the relevance and feasibilityof targeted chemotherapy in risk eroups and/or risk foci.* Within 3-4 years, documented cut-off prevalence or intensity rates, and/or ecologicalcharacteristics which determine the relevance and feasibility of focal snail control, aredefined.* The study villages should also be used for research (via SRP, Ministry of Health orother groups) on socio-cultural, technical, feasibility, and cost aspects of health educationand sanitary engineering to reduce water contact.

F. Evaluation and Reinforcement of Monitoring, Surveillance and Evaluation

Rationale

The integration of the SCP in the primary health care system is its great strength andassures its sustainability. It also inevitably implies variability of quality, whereas focalinterventions for transmission or morbidity control depend crucially on local data. Improvingthe quality, standardization, interpretation of, and response to, local data is essential.

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Study populations and methods

This undertaking cannot be captured in a single study in a few villages; it concerns manyissues at all levels of the SCP.

At the ocal level, previously mentioned studies (screening methods, focal patternanalysis), will provide part of the necessary data and experiences. Forms and procedures torecord data in a more simple way, but allowing for the follow-up of individual patients, shouldbe developed.

At tRe district and governorate level, data from some 20 villages in various areas undercontrol, some selected on the basis of inconsistent or unsatisfactory results, should beretrospectively analyzed over the past 10 years:

* Technical quality of screening: training, equipment, supervision.* Population coverage rates; quality, frequency of 10% population samples.* Records and results of quality control.* History of snail control measures.* Reliability of recording, tabulating, transmission of data, a.o. by comparing resultsat various levels.* Feed-back, correction and decision making processes.* Epidemiological, demographic, ecological evaluation: concentration of cases in someparts or hamlets; conditions favoring transmission; accessibility to health services andschools; population characteristics.

At the national level, major policy decisions over the past ten years should be reviewedand analyzed:

* On which basis have they been taken (epidemiological data, cost-efficiencyconsiderations)?* How have specific monitoring mechanisms (independent monitoring teams, 10%population samples) functioned and contributed to policy decisions?* How have they been translated in concrete operational decisions and guidelines forthe executing levels?* How have methods, structures and equipment been adapted to the new needs?* How have strategy shifts been introduced, understood and implemented at theperipheral level?* How has implementation and results been supervised and evaluated at various levels?* How have the results led to new strategic decisions?

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Expected outcome

Within 2-4 years:

Local level (see previous studies)

* Protocols and forms for quality control (of screening and quality of field activities)by district or govemorate teams are operational.* New simple forms for recording (longitudinal) results in schoolchildren and the

population samp.es are developed.* Tabulating, correction and reporting procedures are developed.* Cases of infection and reinfection are roughly mapped, and focal patterns withinvillage recognized.

District and Governorate level:

* Unsatisfactory and inconsistent results from the past are at least partly understood;if possible, problems are translated in adaptations or into operational . search.* Quality control and supervision of rural health unit-actions is operational.* In collaboration with rural health unit-teams, governorate and district staff selectproblem villages, map micro-foci and take documented decisions for focalmollusciciding, environmental intervention, and/or targeted chemotherapy.

Governorate and National level:

* The role of the independent monitoring teams is redefined.e Transparent procedures for the 10% population samples are established.* Computerized data processing facilitates detection of inconsistencies, selection of

problem villages and areas, longitudinal follow-up of local results, central reporting andfeed-back.* Strategic and operational decisions, e.g. determination of cut-off prevalence rates fortransmission control and for program phasing, have been taken on the basis of objectivedata from operational research, control results, cost-efficiency and management consider-ations.* Past and present strategic shifts are translated in reasonable adaptations of structuresand resource allocation.* Yearly strategic plans of action and budgeting are developed and evaluated each year,for each project area, in planning seminars with Ministry of Health staff, governoratestaff, facilitators and consultant(s).

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ANNEX 5

DETAILED COST TABLES

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Table 1: Expandng the Coverage of the Nadond Schistosomlasis Control Programen lnto the Mie Dela(in US$ ndmions)

1992 Prices Schedud xpenditures by Year In Current Prices Total Expeandtures

Total Local Fordgn 93 94 95 96 97 98 Tota Loeal FordgnLaboratory Eqsdpmns

Microscopcs l.50 0.00 1.50 1.20 0.31 0.00 0.00 0.00 0.00 1.51 O.C0 1.51Small Labotratory Equipment 0.45 0.00 0.45 0.36 0.09 0.00 0.00 0.00 0.00 0.45 0.00 0.45Subtota Laboratory EquIpmen 1.95 0.0 1.95 1.56 0.40 0.ao 0.00 0() 0. 00 1.96 0.00 1.96

Vhicles

Bicycles 0.25 0.00 0.25 0.13 0.09 0.04 0.00 0.00 0.00 0.26 0.00 0.26Motorcycles (Surveillance) 0.66 0.00 0.66 0.48 0.18 0.00 0.00 0.00 0.90 0.66 0.00 0.66Motorcycles (Supervision) 0.11 0.00 0.11 0.06 0.06 0.00 0.00 0.00 0.00 0.11 0.00 0.11Pickup Trucks 1.16 0.00 1.16 1.16 0.00 0.00 0.00 0.00 0.00 1.16 0.00 1.16Station Wagons (4WD) 0.29 0.00 0.29 0.29 0.00 0.00 0.00 0.00 0.00 0.29 0.00 0.29 LA

Subal Vehicles 2.47 0.00 2.47 2.12 0.33 0.04 0.0 0.00 0.00 2.48 0.00 2.48Cornaers 0.05 0.00 0.05 aos 0o. aoo 0 oo a 0.00 0.ao 0.05 o.00 aConsubl S+pIes

Urine Dipsticds 1.44 0.00 1.44 0.24 0.25 0.26 0.27 0.28 0.29 1.58 0.00 1.58Kato-KatzSupplies 0.72 0.00 0.72 0.12 0.12 0.13 0.13 0.14 0.14 0.79 0.00 0.79Praziquantel 12.60 2.52 10.08 3.6 1.87 1.94 2.01 2.08 2.16 13.65 2.73 10.92Nidosamide 3.30 0.00 3.30 0.00 0.68 0.71 0.74 0.76 0.79 3.68 0.00 3.68

Sutl Cmsmnable Supples 18.06 2.52 15.54 3.96 2.92 3.04 3.15 3.26 3.38 19.70 2.73 16.97TraInng and Srices

Traning ofLabTechnicians 0.16 0.16 a00 0.08 0.08 0.00 0.oD 0.00 0.00 0.16 0.16 0.00Incremenal Operadng Costs

Incrementaloperating 1.05 0.19 0.86 0.17 0.18 0.19 0.1g 0.20 a21 1.15 0.21 a94CostVehidles

otal coat of component 23.74 2.87 20.87 7.94 3.91 3.27 3.34 3.46 3.59 25.50 3.10 22.40

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Tabk 2: Modernizng and Rehabilitating the National Schdstosomasds Control Progranne(in US$ mlidons)

1992 Prices Schedlependtures by Year n C7rrent Prces Totd Eentes

TOtd Loa ForeIgn 93 94 95 96 97 98 Toad Local Foreign

Laboratory Eqadpnemc

Microscopes 0.30 0.00 0.30 O.1S 0.16 0.00 0.00 0.00 0.00 0.31 0.00 0.31

Small Equipment 0.11 0.00 0.11 0.09 0.02 0.00 0.00 0.00 0.00 0.11 0.00 0.11

Subtotal Laboratory Equipment 0.41 0.0 0.41 0.24 0.18 0.00 0.0 0.00 0.00 0.42 0.00 0.42

Vhiceks

Replacement Vehicles 0.31 0.00 0.31 0.16 0.11 0.06 0.00 0.00 0.00 0.32 0.00 0.32 un

Subtotd Vehicles 0.31 0.00 0.31 0.16 0.11 0.06 '.00 0.00 0.00 0.32 0.00 0.32

Consumable Supples

Utine Dipstidcs 1.20 O.OP 1.20 0.20 0.21 0.22 0.22 0.23 0.24 1.32 O.OD 1.32

Kam-Katz and Millipore Kits 0.36 O.00 0.36 0.25 0.07 0.04 0.00 0.00 o.00 0.37 0.00 0.37

Praziquantd 9.00 1.80 7.20 1.50 1.56 1.61 1.67 1.73 1.80 9.87 1.97 7.90

Niclosamide 3.96 0.00 3.96 0.66 0.68 0.71 0.74 0.76 0.79 4.34 0.00 4.34

Subtotal Consuwabk Supplies 14.52 1.80 12.72 2.61 2.52 2.58 2.63 2.73 2.83 15.90 1.97 13.93

Training and Services

Training of Lab Technicians 0.32 0.32 0.00 0.16 0.17 0.00 0.00 0.00 0.00 0.33 0.33 0.00

Total cost of component 15.15 2.12 13.03 3.17 2.97 2.63 2.63 2.73 2.83 16.96 2.30 14.66

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Table 3: Strengthentng Management Capaclty of the Department of Endemic Disease Control(In US$ nmllions)

1992 Prices ScheduledExpenditures by Year in Current Prices Total Expendlres

Total Local Foreign 93 94 95 96 97 98 Totl Local Fordgn

Vehicles

Station Wagons (4WD) 0.06 0.00 0.06 0.04 0.02 0.00 0.00 0.00 0.00 0.06 0.00 0.06

Subtotal Vehicls 0.06 0.ao 0.06 0.04 0.02 0.00 0.00 000 0.00 0.06 0.00 0.06Corpquters 0.02 0.00 0.02 0.02 0.00 0.00 0.00 0.00 0.00 0.02 0.00 0.022ninlng and Services

Managenent Training 0.05 0.00 0.05 0.03 0.01 0.01 0.01 0.00 0.00 0.05 0.00 0.05Consultant Services 0.14 0.14 0.00 0.02 0.02 0.02 0.03 0.03 0.03 0.16 0.16 0.00Contract Research 0.35 0.35 0.00 0.28 0.07 0.00 0.00 0.00 0.00 0.35 0.35 0.00Srcgic Planning Workshops 0.04 0.04 0.00 0.01 0.01 0.01 0.01 0.01 0.01 0.06 0.00 0.06

Sbtosal Training and Serwces 0.58 0.53 0.05 0.34 0.11 0.04 0.05 0.04 0.04 0.62 0.51 0.11

Communications 0.09 0.08 0.01 0.02 0.02 0.02 0.02 0.02 0.02 0.10 0.09 0.01Total Cost of Component 0.75 0.61 0.14 0.42 0. 15 0.06 0.07 0.06 0.06 0.80 0.60 0.20

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Table 4: Project Costs by Conponenh(In US$ ndllion)

1992 Prices Sdheduled Expeundisres by Year In Current Prices Totd Expen*tures

Total Local ForeI8n 93 94 95 96 97 98 Tota Local Foreign

Expanifng the Covrage ofthe 23.74 2.87 20.87 7.94 3.91 3.27 3.34 3.46 3.59 25.S0 3.10 22.40Natlond SddstosondadsControl Progran Into theANkcDdra ao

ModernIing and Rdehabiltaftlg 15.15 2.12 13.03 3.17 2.97 2.63 2.63 2.73 2.83 16.96 2.30 14.66the Naoorn ScdstosondadsCmn&rd Progrmn

Strengthening Manaegment 0.75 0.61 0.14 0.42 O.IS O.06 0.07 0.06 0.06 0.80 0.60 0.20Cawiry of the Dwrunet ofEndenIc Dsease Contro

Totl Project Coats 39.64 5.60 34.04 11.53 7.03 5.96 6.04 6.25 6.48 43.26 6.W 3726

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TabteS: Projea Cos by Item of Ezpeidkwe(US$ -UM

1992 Prices Sdwd1e of Epdinw-E Tota Eipyenuara! Of_cUire Compont *7 Tfi1 IM 70T} L;7- FoJgw

Micoses Delft 1.50 0.00 1.50 1.20 0.31 0.00 0.00 0.00 0.00 1.51 0.00 1.51Miccepes UlMEgt 0.30 0.00 0.30 0.15 0.16 0.00 0.00 0.00 0.00 0.31 0.00 0.31Sai Laboeoy Equipit Delt 0.45 0.00 0.4S 0.36 0.09 0.00 0.00 0.00 0.00 04S 0.00 0.45Smenjuip E ent UIM EFt 0.13 0.00 0.11 0.09 0.02 0.00 0.00 0.00 0.00 0.11 0.00 0.11

VeiMdesBicyl Delt 0,2S 0.00 0.25 0.13 0.09 0.04 0.00 0.00 0.00 0.26 0.00 0.26Motrcclks Delta 0.66 0.00 0.66 0.48 0.18 0.00 0.00 0.00 0.00 0.66 0.00 0.66M cles Deft 0.1l 0.00 0.11 0.06 0.06 0.00 0.00 0.00 0.00 0.11 0.00 0.11Pickup Tnc, Delt 1.16 0.00 1.16 1.16 0.00 0.00 0.00 0.00 0.00 1.16 0.00 1.16Stion Waon (4WD) Deft 0.29 0.00 0.29 0.29 0.00 0.00 0.00 0.00 0.00 0.29 0.00 0.29Stac Wagn (4WD) Center 0.06 0.00 0.06 0.04 0.02 0.00 0.00 0.00 0.00 0.06 0.00 0.06Replacement Vehics UIM Et 0.31 0.00 0.31 0.16 0.11 0.06 0.00 0.00 0.00 0.32 0.00 0.32Subtota Vddda~ ~wComPUt Delt O.05 0.00 0.05 0.05 0.00 0.00 0.00 0.00 0.00 0.05 0.00 0.05COMPOe Cal 0.02 0.00 0.02 0.02 0.00 0.00 0.00 0.00 0.00 0.02 0.00 0.02Sboa Coputr:s -65-- effl-AW 5 -CiunabtemppRaUrmeDipdeks Delt 3.44 0.00 1.44 0.24 0.25 0.26 0.27 0.28 0.29 1.S8 0.00 1.58Urine Distk. UM Egt 1.20 0.00 1.20 0.20 0.21 0.22 0.22 0.23 0.24 1.32 0.00 1.32KaoKeat Supplie Deft 0.72 0.00 0.72 0.12 0.12 0.13 0.13 0.14 0.14 0.79 0.00 0.79KatoKaM and Milo Kit U/M Egt 0.36 0.00 0.36 0.25 0.07 0.04 0.00 0.00 0.00 0.37 0.00 0.37Phocku"a Delt 12.60 2.52 10.08 3.60 1.87 1.94 2.01 2.08 2.16 13.65 2.73 10.92Paziq_unt Ulm Egt 9.00 1.80 7.20 1.SO l.SS 1.61 1.67 1.73 1.30 9.87 1.97 7.90Nikobadme Delt 3.30 0.00 3.30 0.00 0.68 0.71 0.74 0.76 0.79 3.68 0.00 3.68Niclomne UIM Egt 3.96 0.00 3.96 0.66 0.68 0.71 0.74 0.76 0.79 4.34 0.00 4.34

Subtotal bkS4 -y3(-Jyflv- -- r-: r-Tw--s1- ar-a;eri&ATrainig mdp SefmeeManaganent Trning Center O.05 0.00 0.05 0.03 0.01 0.01 0.01 0.00 0.00 0.05 0.00 0.05TrainingOf Lab Technicias Delta 0.16 0.16 0.00 0.08 0.08 0.00 0.00 0.00 0.00 0.16 0.16 0.00TMining Of lAb Technician U/M Et 0.32 0.32 0.00 0.16 0.17 0.00 0.00 0.00 0.00 0.33 0.33 0.00CouuultSeavices Ceater 0.14 0.14 0.00 0.02 0.02 0.02 0.03 0.03 0.03 0.16 0.16 0.00Cna Rerch Center 0.35 0.3S 0.00 0.28 0.07 0.00 0.00 0.00 0.00 0.3S 0.3S 0.00Stwte& Pbnning Workehp Cnter 0.04 0.04 0.00 0.01 0.01 0.01 0.01 0.01 0.01 0.04 0.00 0.04

A&AWd Trani8 Ond S&rces j7S - 7.79, Wf -Z.I'lnmunrsai operatinSg cmVehicles Deb 1.05 0.19 0.86 0.17 0.18 0.19 0.19 0.20 0.21 1.15 0.21 0.94comruniesin center 0.09 0.08 0.01 0.01 0.02 0.02 0.02 0.02 0.02 0.10 0.08 0.02Siibota1Incermmaw Opewatlg Ca 7j427* f07. 2.Ji...2

Total Piojec Came ~ -;-3 ** ~ ~ - -

~rqs -7:lr ~a.2r-_%.r- o L _ Sf-or-:l aZ-ar:~.g~wB

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ANNEX 6

ECONOMIC ANALYSIS

The economics of expanding the National Schistosomiasis Control Programme to theEastern and Western Delta areas have been analyzed employing highly conservative assumptions:

(a) that no cost savings are achieved through the operational research carried outunder the project;

(b) that vehicles must be replace after seven years and that small laboratoryequipment must be replaced after five years;

(c) that the Egyptians are willing to pay between 1.3 and 0.3 per capita shares ofannual GDP to obtain an additional year of life expectancy; these values representfrom US$2.20 to US$0.50 a day.

(d) that the rural population will grow at a rate of 2 percent a year;

(e) that because of the project at least 2,300 persons will not become disabled ordie each year; the more plausible assumption that approximately 4600 deaths willbe averted each year has also been examined; (The larger figure allows forunderreporting of deaths due to incomplete coverage by the health care system,and for other pathologies caused by schistosomiasis, including cancer and acutegastrointestinal infections.)

(f) that the life of the technology is 25 years; (The control program may bereplaced eventually if a practical vaccine is developed or significant improvementsin sanitation accompany economic and social development.)

All calculations have been based on constant 1992 prices.

The results of these analyses are summarized in table 6.1. These calculations suggestthat the returns to the project significantly exceed the opportunity cost of capital.

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Table 6.1: Summary of Economic Analysis--Estimated Rate ofReturn and Sensitivity Analysis

Willingness to Pay Number of Deaths Averted Each Yearto Increase Life -_ -

Expectancy by a 4600 2300Year

US$800 40% 17%

US$600 28% 12%

US$400 18%

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ANNEX 7

PROJECT ORGANOGRAMS

CHART 1

Organogram forMinistry of Health

Minister

F! Sector Sector C.A. Sector

BEasic and MCurative Mister's Family Planning

Preventive Care Jffice

Hearet|h Affairs |l

Source: DANIDA, 1991

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CHART 2

Organogram for GovernorateDirectorates of Health

Source: DANIMA. 1i1

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ANNEX 8

PROJECT MONITORING INDICATORS

The following indicators are to be reported annually:

Input Measures

Number of rural health units

Number of rural health units not providing schistosomiasis control services, by durationof interruption in service (less than a week, one week to cne month and more than amonth), and by reason for interruption (lack of staff, equipment or supplies)

Process Indicators

Numbers of persons screened and numbers found positive reported separately for thefollowing categories:

School children screened during springSchool children screened during fallOutpatients seen at rural health facilitiesPersons screened as part of program ten percent sample-active case finding in thecommunityNew infection or reinfection (for school children only)Parasite (S. mansoni or S. haematobium)

Outcome Measures

Intensity of infection for a representative sample of patients at each health facility, byparasiteNumber of cases of hematemesis admitted to hospitals

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ANNEX 9

DISBURSEMENT SCHEDULE

ESTIMATED DISBURSEMENTS: (In US$ millions)

1993 1994 1995 1996 1997 1998 1999

Annual 4.75 3.95 4.10 4.00 3.90 3.23 2.91

Cumulative 4.75 8.70 12.80 16.80 20.70 23.93 26.84

COMPARISONS OF DISBURSEMENT PROFILES:(Percentage Disbursed by Year from Approval Date)

Year I Year2 Year3 Year4 YearS Year6 Year7 Year8

Proposed Project 18 32 48 63 77 89 100 100

Egypt, All 3 14 30 50 70 86 94 100Sectors

All Regions, 3 10 18 34 54 74 90 100Health

Egypt Education 1 6 18 46 74 94 98 100

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3992 1993 3 1994 1995 1996 199 1998 1999Ql Q2 Q3 Q4 Qt Q2QQ4 QlQ2Q3Q4 Q QQ2 Q3 Q4 QIQ2Ql Q Ql2Q3 Q4 Ql Q2 Q3 Q4 Ql Q2 Q3 Q4

Bi Fft_

_ _ _

_

C IIi n _ _ _ __xx m xx Um XX XX KR 1 Mt Xfi xf

I r- xx xx WEx xx x lx xx x a xx WE 3a x M xx xxt 30 9Dmp tfM d rq icammoLosoppo

Blr~ggA-id Um=x m xxx mx n u U x Ux ux X3 UxX Mx

ThBwy s xil xx 3m ax xx xx _ s xx u Xsx I EM x m X xx x x xxK

Tah ol%M ax x = xx M xx xx 3m 3 vXX X X xi x xx xr Mt xx x x K ix xx xx

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ANNEX 11

USE OF THE PESTICIDE, NICLOSAMIDE, TO CONTROL SCHISTOSOMIASIS

1. The Egyptian National Schistosomiasis Control Programme uses niclosamide to controlthe vector snails of schistosomiasis. The molluscicide is applied to canals, drains and bodies ofstanding water in which infected snails have been fi)und. A previous IIA credit "New LandsDevelopment Project' (1083-EGY), provided 950 nwetric tons of niclosamide to control snailsin a 24,000 feddans settlement area in Giza Governorate.

2. The proposed project will finance a maximum of 40 metric tons of the pesticide annuallyfor use nation-wide, and in addition will support studies to improve the targeting and furtherdecrease the use of the pesticide, in order to reduce program costs and environmental affects ofthe pesticide.

3. Persistence in the Environment. Niclosamide has a fairly long half-life. However it doesdegrade when exposed to sunlight and is biodegraded by bacteria.

4. Toxicity. The compound has been approved by the U.S. Food and Drug Administrationfor use as in an anthelminthic drug, particularly for the tzeatment of tape worm in humans. Aspart of the registration process, niclosamide has been thoroughly tested for toxicity,mutagenicity, carcinogenicity. The drug has been found to produce nausea occasionally in somepeople.Y' Extensive animal studies have been undertaken as part of the registration process foruse of niclosamide as a drug. These studies have shown the drug to be toxic to experimentalanimals only if administered in very large doses--more than 4000 mg per kg of body weight(rabbits) or 5000 mg per kg of body weight (rats). Studies of chronic exposure reveal that thedrug when added to the daily diet for 45 weeks at a rate of 1000 parts per million, had noadverse affect on the health of rats. A study of long term exposure in which the drug wasadministered to dogs five times a week for a year at a rate of 10 mg per kg of body revealedthat the niclosamide did not produce abnormalities in behavior, weight, urine chemistry orfunction of internal organs.Y The recommended rate of application of the chemical when usedas a molluscicide is one to two parts per million which implies that in ordLr to ingest a mg ofthe chemical through the consumption of properly treated water one would have to consume acubic meter of water. The niclesdmide is clearly not toxic to warm blooded animals in theconcentrations used to control snails.

1 7Te Medical Leuer on Drugs and Therapeutics, Vol 34, March 1992, pages 24-25.

2' Hecht, G. and C. Gloxhuber. 1962. quoted in Baylucid: Information Technique,Bayer Pflanzenschutz, Leverkusen.

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5. Precauions. The U.S. Environmental Protection Agency requires that the packaging ofniclosamide for use as a pesticide in the United States provide the warning that the compoundmay cause eye damage and be harmful if swallowed or inhaled. Labels are also require toadvise the user not to get niclosaimide in the eyes or to breathe its dust. Users are instructed towash with soap and water after handling and to wear goggles or a face shield when handling.

6. Workers in the snail control program wear protective gloves and goggles to avoid skinand eye irritation. Niclosamide is stored in locked warehouses. Empty containers are destroyedto prevent their reuse. The World Health Organization's Expert Committee on the Control ofSchistosomiasis has prepared revised guidelines on the management of the disease which includesguideline on the use of molluscicides. These guidelines are in the final stages of review and areexpected to be published during the third quarter of 1992. The EDCD has agreed to modify itsprocedures to comply with internationally accepted standards for the handling and applicationof the pesticide.

7. Niclosamide is marketed for use as a molluscicide under the trade name Baylicide. It issupplied in either granular form or as a wetable powder. The granular form has been approvedfor use by provincial and state fish and game departments in Canada and the United States asa larvicide for the control of sea lamprey in the Great Lakes. The wetable powder formulationhas been approved by the United States for control in Puerto Rico of the snail vector ofschistosomiasis. Niclosamide is applied in concentrations of one to two parts per million foreight thours.

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ANNEX 12

SUPERVISION SCHEDULE

Bank Fiscal Year Staff/Consultant Specialty Staff Weeks

1993 Parasitologist 8Implementation Specialist 4Management Consultant 3

1994 Parasitologist 6Implementation Specialist 3Management Consultant 2

1995 Parasitologist 8Implementation Specialist 2

l ____________________ Management Consultant 4

1996 Parasitologist 6Implementation Specialist 2Management Consultant 2

1997 Parasitologist 6Implementation Specialist 2Management Consultant 2

1998 Parasitologist 6Implementation Specialist 2Management Consultant 2

1999 Parasitologist 3Managment Consultant 3

TOTAL 76

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MAP SECTION

I