Final Proposal July 2013

8/13/2019 Final Proposal July 2013

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INTRODUCTION

Tuberculosis (TB) is second killer worldwide due to a single infectious agent. In 2011, 8.7

million people fell ill with TB and 1.4 million died from TB

(1)

. Over 95% of TB deaths occurin low- and middle-income countries, and it is among the top three causes of death for

women aged 15 to 44(2). In 2010, there were about 10 million orphan children as a result of

TB deaths among parents (2). In Sub-Saharan Africa an estimated 17 million people were

infected withM. tuberculosis. , the incidence of TB has been driven upward, as reflected in

estimates derived from population-based surveys and from routine TB surveillance data(3).

Sudan shoulder 8% of TB burden in the (EMRO) region (4). Tuberculosis is a major cause of

morbidity and mortality in Eastern Sudan. According to National Tuberculosis Program

(NTP), Kassala is classified as one of the most suffering states in Sudan from the burden of

tuberculosis infection. The TB epidemic is an outgrowth of the longstanding wars

(Ethiopian/Eretria, Eastern front conflict), which has gravitated poverty, malnutrition, and

increased number of displaced populations and refugees in the state. This resulting in poor

health infrastructure with lack of microscopic services and health personnel has also

contributed to the epidemic. In Kassala State, annual risk of TB infection is 120 cases per 100

000 populations(4)

.

Successful treatment of tuberculosis (TB) involve taking anti-tuberculosis drugs for at least

six months. Several countries surpassed the global target for treatment success of 85% in

2005, and in the year 2010 the target for success has been raised to 90% (5). In Sudan the

treatment success rate remained static at a rate of 80% to 82%. The main barrier for achieving

the desired success rate is the high default rate; which has increased from 10% in the 2008 to

11.9 in 2010(4). Combined with transfer-out it equals 16.1% (1246 out of 7729 patients

registered). This figure is relatively high in comparison to the other countries in the region

(which have default rates of 1%-13% that include transfers).WHO and the Sudanese TB

treatment protocol defined defaulting as a treatment interruption of two consecutive months

or more(4). Defaulting is frequently used as part of the term adherence which is defined as

the extent to which a persons behavior taking medication, following a diet, and/or

executing lifestyle changes, corresponds with agreed recommendations from a health care

provider . While, WHO defined transfer out as apatient who has been transferred to another

recording and reporting unit and whose treatment outcome is unknown.NTP aims at


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achieving a 4% default rate from the current rate of 11.9%. Knowing that default rate in

Kassala State is 11% with adding the transfers will be 16% (4).

Causes of non-adherence to anti-TB drugs have been studied worldwide; a review of many

studies (mostly from low and middle income countries) reflected the complex nature of the

adherence to treatment, and how it is influenced by the interaction of several factors. The

factors that influence adherence were categorized into structural factors (including poverty,

especially costs , financial burden and gender discrimination ), personal factors (including

knowledge, beliefs and attitudes towards treatment, interpretation of illness and wellness),

social context (incorporating support from the family and the community and stigma), health

services factors (incorporating organization of care and treatment, disease progress and side

effects)(6)

.Few studies conducted in Sudan to investigate reasons behind high default rate, one of them

were carried out in Khartoum state and one in Sinnar State. Plock C (2008) found that, in her

study in Jabal-Awlia locality in Khartoum state, most of the default happened during the

continuation phase and the possible explanation for this was the patients feeling of

improvement(7). Also not receiving information about TB treatment was found to have a

significant association with the default; the later factor could have been influenced by a

deficient health care organization (short consultation time, lack of fixed clinic hours and lack

of privacy during consultation)(7). Ibrahim H (2009) conducted study to figure out the reasons

behind high Tuberculosis default rate in Sinnar state which was reaching up to 20% of total

reported treatment outcome. The study found that there was clear discordance between

reported defaulting to Sudan National tuberculosis program and recorded at the TBMUS

register book. Also it found that there were more than 7% were death cases and considered as

default in register book (8). The study showed that the patient awareness concerning TB

duration was topped the reasons of high default rate, and it followed by socio-economic

factors and geographical factor(9).


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Problem statement

Tuberculosis is an infectious disease that due to its severity, social stigma, as well as financial

and economic burden, is of high public health importance.

Default rate in Kassala State is 11% with adding the transfers will be 16%, while NTP aims at

achieving a 4% default rate. In addition to that, defaulter rates are increasing in Kassala state.

So far no operational research on defaulting had been carried in Kassala state, to investigate

the risk factors and reasons for abandoning TB treatment, and thus this remains unaddressed.

Justification

The aim of this study was to see what the reasons behind high default rate in Kassala state

which reached to 16% in year 2011.

The importance of this study came out because it was the first study to see the actual reasons

behind high default rate in Kassala State.


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Objectives

Research question/hypothesis:

What are the factors that associated with default from treatment among adult TB patients in

Kassala State?

General objective:

To determine factors associated with defaulting from treatment among adult TB in

Kassala State during 2012.

Specific objectives:

1\ Toidentify structural factors (including poverty, financial burden and gender

discrimination)associated with defaulting from treatment of tuberculosis

2\ To estimate personal factors (including knowledge, beliefs and attitudes towards

treatment, interpretation of illness and wellness) related to defaulting from treatment of

tuberculosis

3\ To assesssocial context (incorporating support from the family and the community and

stigma),associated with defaulting from treatment of tuberculosis

4\ To measure health services factors (incorporating organization of care and treatment,

disease progress and side effects) associated with defaulting from treatment of tuberculosis


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MATERIALS AND METHODS

Study design Case control study design

Study area/setting Kassala State- East Sudan

Kassala State is the one of the eastern Sudan states encompassing 11 locality .Kassala is

bordered by Eritrea and Ethiopia to the east . Red sea state to the north; Khartoum River Nile

states to the west and Gadarif state to south west (see the map in the Annex 1) Kassala state

land space is 42.282 km (Sq). In the northern part of the state the climate is the red sea

climate, while in the other parts the environment is a desert, semi desert and valley and

savanna climate with large fruit farms inside Kassala locality. The average rainfall is 350 to

400 ml. and the temperature 33 C. to 47C. Degrees

Population and Demographic Indicators:

Kassala State is the ninth between the States in terms of population

Population:

Population

NumberFamily SizeThe Percentage of Population TypeUrbanRuralNomads

1,881,5103.643.234.8.


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Rate of Infectious Diseases of Priority

The Disease The average in Population 2011

Malaria 52:1000 of Population

Tuberculosis 120:100,000 of PopulationSchistosomiasis 5.2 :100,000 of Population

AIDS 0.67:1000 of Population


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Study population/subjects The cases are pulmonary TB cases defaulted from treatment and the controls are cases

of pulmonary TB continuing their treatment.

Inclusion criteria for selection of cases (Defaulters ):-1- Pulmonary TB patients who default from the treatment for 2 consecutive months (

according to WHO definition)

2- Both sexes from 15 years and above

Exclusion criteria:1-TB patient less than 15 years.

2- Severely ill TB patients.

3- Other type of TB


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Sample size The total sample size will be 133cases ( all defaulter in KS during 2012) + 266

control

Total Sample = 399 participants

Sampling technique:- Total coverage sample technique for cases.

- Simple random sample technique for selection of unmatched controls

- 1 Case : 2 Control- 133 Cases : 266 Control


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Study variablesThe Dependent Variable: default from treatment

The Independent Variable:

Structural factors:- Poverty, Financial burden and gender discrimination Personal factors:- Age , Sex, Marital status- Knowledge, beliefs and attitudes towards treatment, interpretation of illness and

wellness

- Residence (rural, urban and IDPs),- Language , Educational level , Occupation, Social contest- (incorporating support from the family and the community and stigma), Health services factors- Distance from TB center,- Availability of TB drugs ,-

Availability of Health Cadre

- Waiting time in TB Center- Receiving information about TB


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Data collection

It is home-based study, where a trained data collector will contact defaulters and

controls in their homes and he/she will fill the questionnaire.

Structured questionnaire will be filled for cases and controls by trained personnel

Address of defaulters will be taken from health register (TB treatment register)

Control will be randomly selected (unmatched) for each case from health register and

their questionnaires, consent will be carried by the same health worker.

Data analysis plan

-

The data will be processed; double entered and checked using Epi Info

software.

- The results will be tabulated to display the baseline and socio-demographic

characteristics between cases and controls. Independent T-test for continuous

variables and Chi2test for categorical variables will be used to estimate the p.value

so as to test for statistical significance. Significance level will be considered at

p.value 0.05.


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ETHICAL CONSIDERATIONS

Written informed consent in Arabic and verbal translation in local languagewill be obtained before enrolment in the study. The health worker who

conducts the questionnaire will provide the consent.

Both cases and controls should have the consent. Approval from the local ethical committee or from the state ministry of health

will be considered.


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IMPLICATION OF THE STUDY

Defaulting TB treatment poses serious limitations to the success of TB control programme in

many countries in the world and is one of the contributing factors to the development of drug-

resistant forms of TB.Defaulter rates are increasing in Kassala state So far no operational

research on defaulting had been carried in Kassala state, to investigate the risk factors and

reasons for abandoning TB treatment, and thus this remains unaddressed.This study served as

the first one of its kind and thus can contribute to develop a methodology on which similar

subsequent investigations in other states of Sudan can be based. This study can provide

information about reasons of defaulting, thus will guide intervention of stakeholder and

policy makers to address these reasons.


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Time frame &budget:

Time Frame

Planned activity Time frame 2013

September October November

1st

wk

2nd

wk

3rd

wk 4th

wk 1st

wk 2nd

wk 3rd

wk 4th

wk 1st

wk 2nd

wk 3rd

wk 4th

wk

Contacting with local authorities to

get approval

Identification of the Data Collection

team,

Meeting with assessment team to

discuss assessment and share

responsibilities.

Preparation & distribution of data

collection tools

Training of the Data Collection Team

Data collection.

Data entry and analysis.

1rst report draft

Final Research report


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BUDGET

item No Item cost (SDG) Days Total (SDG)

Supervisors 2 20 14 560

Data collectors 12 10 14 1680

volunteer 5 10 40 2000

Training

&stationeries

230

Follow-up 600

Total Five thousand and one hundred and sixty SDG 5160


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REFERANCES

1. Muture B, Keraka M, Kimuu P, Kabiru E, Ombeka V and Oguya F. Factors

associated with default from treatment among tuberculosis patients in nairobi

province, Kenya: A case control study. BMJ Public Health Volume 11, retrieved from

http://www.biomedcentral.com/1471-2458/11/696

2. DodorEA, AfenyanduGY: Factors associated with tuberculosis treatment default

and completion at Effia-Nkwanta Regional Hospital in Ghana. Trans R Soc Trop Med

Hygiene2005, 99(11):827-832.

3. Demissie M, Kabede D: Defaulting from tuberculosis treatment at the Addis Ababa

TB Centre and factors associated with it. Ethiopian Medical Journal 1994, 32(2):97-

106.

4. Federal Ministry of Health -National Tuberculosis Control Program.Annual

progress report. 2011

5. Daniel OJ, Oladapo OT, Alausa OK: Default from treatment programme in Sagamu,

Nigeria. Nigeria Journal of Medicine 2006, 15(1):63-7.

6. Kaona FAD, Tuba M, Siziya S, Sikaona S: An assessment of factors contributing to

treatment adherence and Knowledge of TB transmission among patients on TB

treatment. BMC Public Health 2004, 4:68.

7.Plock C. Risk factors and reasons for defaulting TB treatment in JebelAwlia Locality,

Khartoum State, Republic of Sudan,2008.
http://www.biomedcentral.com/1471-2458/11/696http://www.biomedcentral.com/1471-2458/11/696http://www.biomedcentral.com/1471-2458/11/696


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8. Ibrahim E. The reasons behind high TB default rate in Sinnar State,Republic of

Sudan, 2009.

9. Wasonga J: Factors contributing to tuberculosis treatment defaulting among slum

dwellers in Nairobi, Kenya, International congress on drug therapy in HIV. The

Gardiner-Caldwell Group Ltd; 2006:310.

10. Comolet TM, Rakotomalala R, Rajaonarioa H: Factors determining compliance

with tuberculosis treatment in urban environment, Tamatave, Madagascar.

International Journal of Tuberculosis and Lung diseases1998, 2(11):891-897.

11. Collaborative program and integrated control of communicable

diseases.(internet communication, January 2007 athttp://who.int/)

12. SNTP.Annual statistical report 2005, Statistics and Information unit, SNTP Federal

Ministry of Health.

13. TB.Annual statistical report 2005, Statistics and Information unit, Federal

Ministry of Health.
http://who.int/http://who.int/http://who.int/http://who.int/


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Annex 1:

Kassala State Map


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Annex 2: Questionnaire

Question

1. Date of the Interview..

2. Health Area.

3. Name of Health Facility..

GENERAL INFORMATION

5. Age..

6. Sex 1/ Male 2/Female

7. Marital Status

1/ Single, 2/ married, 3/ divorced, 4/ widowed, 5/ separated

8. Nationality

1/ Sudanese 2/other (specify).

9. If Sudanese, specify tribe

01. Occupation

1/ regular employment, 2/ unemployed, 3/ daily laborer, 4/ retired, 5/ student

00. Education

1/Illiterate 2/khalwa, 3/ illiteracy programme,

4/ primary school, 5/secondary school,


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6/ college student and higher

0. Number of household member (persons that live under one roof)

1/ 1 to 3, 2/ 4 to 6, 3/ 7 to 9, 4/ 10 and more,

INFORMATION ON TREATMENT

0. Did you change TBMU since initiating treatment?

0/ no 1/ yes

. If yes, did you miss treatment during change?

0/ no 1/ yes

2. Distance to treatment centre

1/ within 30 minutes, 2/ 30 minutes to 1 hour,

3/ more than 1 hour

3. Are there any costs involved in travelling to the TBMU (both ways)?

0/ no, 1/ less than 2 SDG, 2/ 3 to 5 SDG, 3/ more than 5 SDG

4. Do you have a treatment supporter?

0/ no 1/ yes


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5. How frequently did you go to the TBMU to get your drugs after the first 2 months?

1/ weekly, 2/ every second week, 3/ monthly, 4/ irregularly, 5/ defaulted

6. If answer is different from monthly, why?

1/ no available transport, 2/centre is far from residence, 3/ high cost of

treatment, 4/ feels embarrassed to come to the centre, 5/ family is not

supportive, 6/ no drugs are available, 7/other (specify)

7.Do you feel that receiving treatment makes you feel?

1/ better, 2/ as before, no changes, 3/ feel ashamed,4/ bad, 5/ realizes that it is important

to stop the spread, 6/ other (specify)

8.How do you feel about having TB?

1/ Normal. No problem for me as I know it can be cured,

2/ I feel embarrassed and I dont want anyone to know,

3/ I am afraid I might infect others or I might die,

4/ I dont care if I can be cured or not

01.How did you perceive the treatment at the TBMU? (multiple answers possible)


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1/ normal. Not good, not bad.

2/ Good and supportive.

3/ unfriendly

4/ staff does not have time to explain things well.

5/ treatment with derision.

00.Did you receive any information on the disease and its treatment? 0/ no 1/ yes

0.What is the usual treatment period until full recovery?

1/ 1 month, 2/ 2 to 4 months, 3/ 5 to 7 months, 4/ 8 months, 5/ dont know, 6/ others

(specify)

02.For defaulters only: what was the reason for you defaulting TB treatment?

03.Do you own anything of the following?

1/ Radio, 2/ TV, 3/ daily newspaper

Data collectors name:

Supervisors name:

Remarks:


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Documents

Final Proposal July 2013