Management and Implementation of Rapid Syphilis Test Introduction: A Programme Manager’s Guide

MANAGEMENT 4

The RAPId syphilis TEsT ToolkIT

THE RAPID SYPHILIS TEST TOOLKIT 02

ContentsExecutive Summary 1 Purpose of the document 1Intended Target Audience 1 How to use this document 2 Overview of Rapid Syphilis Testing Programme 3

1. Planning 41.1StakeholderEngagement 41.2Financingtheprogramme 41.3ChoosingaTest 51.3.1Typesoftests 51.3.2OperationalandPerformanceCharacteristics 71.3.3NationalprocurementofRapidSyphilisTests 9

2. Implementation 112.1UnderstandingLocalCircumstance:Conductingabaselinesurvey 112.2OrderingandDistribution 112.3Training 112.3.1 Training Workshops 11 2.3.2 Refresher Training Courses 12 2.3.3 Certification 13 2.4TestIntroduction 132.5QualityAssuranceandQualityControl 142.6MonitoringandEvaluation 142.7Dissemination 153. Planning for Scaling Up 164. References 23

Additional ReferencesLaboratory-basedevaluationofrapidsyphilisdiagnostics:Resultsfrom8SDISiteshttp://www.who.int/std_diagnostics/publications/ manuals/syphilis_evaluation.pdf Evaluating diagnostics: STIs Evaluating Diagnostics: A guide for diagnostic evaluations Evaluating Diagnostics: Evaluation of diagnostic tests for infectious diseases: general principles Evaluating Diagnostics: Evaluation of rapid diagnostic tests: syphilis Evaluating Diagnostics: Why do we need quality-assured diagnostic tests for sexually transmitted infections?

THE RAPID SYPHILIS TEST TOOLKIT THE RAPID SYPHILIS TEST TOOLKITTHE RAPID SYPHILIS TEST TOOLKIT

Management and Implementationof Rapid Syphilis Testing Introduction: A Programme Manager’s Guide

HyperlinksPlease note that hyperlinks within this document are indicated by text underlined and emboldening.

MANAGEMENT 4 Management and Implementation of Rapid Syphilis Testing Introduction: A Programme Manager’s Guide 1

Abbreviations

ANC: AntenatalCare

ASSURed:Affordable,Sensitive,Specific,User-friendly,Robustandrapid,Equipment-free,Deliverabletothosewhoneedthem

CSW: Commercialsexworker

eIA: EnzymeImmunoAssay

FTA-ABS: FluorescentTreponemalAntibodyAbsorptionAssay

IdU:Intravenousdruguser

MCh: MaternalandChildHealth

Moh:MinistryofHealth

MSM: Menwhohavesexwithmen

NGo: Non-governmentalorganization

NPV: NegativePredictiveValue

PMTCT: Prevention-of-Mother-to-Child-Transmission

PPV:PositivePredictiveValue

QA: QualityAssurance

QC:QualityControl

RCh: Reproductiveandchildhealth

RPR: RapidPlasmaReagin

RST:RapidSyphilisTesting

STAT: Same-day-Testing-And-Treatment

TPhA: TreponemapallidumHaemagglutinationAssay

TPPA: TreponemapallidumParticleAgglutinationAssay

VdRl: VenerealDiseaseResearchLaboratory

Who:WorldHealthOrganization

The RAPId syphilis TEsT ToolkIT 2

There are many reasons to introduce rapid syphilis testing into clinical practice and within existing programmes in your country. These include increasing access to prenatal screening programmes to prevent congenital syphilis;controlling syphilis in high-risk populations; and performing an epidemiological survey to assess the syphilis burden in a population.

executive Summary

Thisguideisintendedtoassistprogrammemanagersincoordinatingallaspectsoftheintroductionandmanagementofarapidsyphilistestingprogrammeirrespectiveofthetargetpopulation.Thistoolwillguideaprogrammemanagerthrougheachcomponentofarapidsyphilistestingprogram,summarizingthekeypointsofeachandprovidingreferencestomorein-depthdocumentationtobefoundinotherchaptersofthisToolkit.

Purpose of the documentThisdocumentshouldprovideprogrammemanagerswiththeabilityto:

Documentthekeystagesandcriticalcomponentsoftheintroduction ofarapidsyphilistestingprogramme.

Detailtheprocessestobeundertakenwhenimplementingrapidsyphilis testing.

Highlighttheinteractionbetweenprocessesandtheconnectivitybetween allcomponentsoftheprogramme.

Provideatooltoassistincoordinatingtheimplementationofarapidsyphilis testingprogramme.

Intended Target AudienceThisdocumentisintendedtoprovideguidancetoprogrammemanagersworkingfornon-governmentalorganizations(NGOs),theMinistryofHealth(MOH),orotherbodies,programmemanagersresponsibleforintroducingrapidsyphilistesting,and/orprogrammemanagersmanagingtheprogrammepost-implementation.

1

How to use this documentThisdocumentisdividedinto2keysections.Section1detailsallactivitiesinvolvedinplanningtheintroductionofarapidsyphilistest(RST)andSection2detailstheactivitiesinvolvedinimplementingarapidsyphilistestprogramme.Together,thisdocumentshouldillustrateallofthemajoraspectsofrapidsyphilistestintroductionthatwillbecoordinatedandmanagedbytheProgrammeManager.

Thedocumentisdesignedtobeusedinachronologicalfashion,beginningwiththePlanningStageforintroductionofrapidsyphilisteststhroughtomonitoringandevaluatingtheeffectivenessofarapidsyphilistestingprogramme.

Section1outlinestheplanningstagesthataProgrammeManagerneedstoconsiderbeforeintroducingarapidsyphilistest.

Section2outlinestheactivitiesnecessarytorollouttherapidsyphilistests.

AllrelatedguidancetoolsthatareincludedintheRapidSyphilisTestingIntroductionToolkitarereferencedthroughoutthedocumentandthereadershouldrefertotheseToolsforadditionalinformation.

PrimaryhealthcentreinWesternProvince,Zambia

MANAGEMENT 4 Management and Implementation of Rapid Syphilis Testing Introduction: A Programme Manager’s Guide 2

Overview of Rapid Syphilis Testing ProgramThegoalsandobjectivesofrapidsyphilistestintroductionwillhavebeendeterminedintheearlierstagesofplanning(refertoPlanning 1 - Advocacy and Communications Strategy.

Asanexample,theoverarchinggoalofarapidsyphilistestingprogrammemightbe:

Thereductionoftheprevalenceofactivesyphilisinfection,therebyleading toreductionsinthetransmissionandincidenceofdisease

Theperformanceofaserologicalsurveytodeterminetheprevalence ofsyphilisinadefinedgeographicareaand/oramongadefinedpopulation.

Theobjectivesofsuchaprogrammewillvarydependingonthetargetpopulation.Thismightbepregnantwomen;menwhohavesexwithmen(MSM),intravenousdrugusers(IDUs);commercialsexworkers(CSWs);oramobileortransientworkforce.

Oneobjectiveofapotentiallysuccessfulrapidsyphilistestingprogrammeshouldbetheprovisionofsame-day-testing-and-treatment(STAT).Atestresultturnaroundtimeofbetween20and30minutes(dependingonmanufacturer’sinstructions)isoneofthegreatestbenefitsofrapidtesting.Itshouldbecapitalizeduponwiththeofferofimmediatetreatmentservicesforallindividualsidentifiedaspositive.

Same-day-testing-and-treatmentisalsoapplicabletoprogrammeswhosegoalistodeterminetheprevalenceandriskfactorsofsyphilisinaregionorinapopulation;itwouldbeunethicaltodiagnosepatientsbutnottoofferappropriatetreatment.

SamedaytestingandtreatmentinremotecommunitiesintheAmazonasstate,Brazil

The RAPId syphilis TEsT ToolkIT43

MANAGEMENT 4 Management and Implementation of Rapid Syphilis Testing Introduction: A Programme Manager’s Guide 4

1. Planning

1.1 Stakeholder EngagementInteractionwithstakeholdersshouldbeanongoing,continuousprocess.Whethercommunicationtakestheformofwrittenreports,informalconversationsorannualmeetings,stakeholderswillbemoreinterestedandmoreinvestedinaprogrammeiftheyareconsistentlyremindedofitsprogressanditssuccesses.Engagingwithlocalstakeholdersmaybecomepartofyourroutineactivitiesandwilllikelybemorein-depth,withdiscussionsfocusingonthedailychallengesofprogrammeimplementation.Engagementwithnationalandinternationalstakeholdersmaytaketheformofdisseminationofinterimreportsandinteractionatlarge-scaleconferences.Bothinstancesshouldbebrieflydocumentedandshouldincludetheparticipants,topicsandoutcomesandprogrammetimelines.SeePlanning 1 - Advocacy and Communications Strategyformoreinformationonstakeholderengagement.

RefertoPlanning 1for guidance on engaging stakeholdersandPlanning 2 for guidance on mobilizing and maintaining stakeholder interest.

1.2 Financing the programmeYoushouldprepareabudgetestimatingthecostofintroducingarapidsyphilistestintocurrentservices.Thisshouldincludeallinputsrequiredfortheprogramme,includinghumanresourcerequirements,operationsandtransportationrequirements,andkeysupplyrequirements.

Implementation 1 - The Costing Guidelines for Syphilis Screening StrategiesofthisToolkitprovidesadetailedsetofguidelinesoncostingarapidsyphilistestingprogramme,includingdetailedquestionnairesandcalculationsforestimatingcosts.Theseguidelineswillallowyouto:

Estimatethetotalandaverageincrementalcostofaddingrapidsyphilis testingtoexistingservices

Estimatetheunitcost(e.g.costperpersontreated)tounderstandthe incrementalcostofincreasingaccesstotreatment.

Approximatethecost-effectivenessofthemodel

“ To ensure sustained delivery of syphilis sreening, interventionsmustprovetheyarecost-effectiverelativetothealternativesyphilisscreeningstrategiesandorcompetinghealthinterventionsatthelocal/nationallevel.

”

The RAPId syphilis TEsT ToolkIT6

1.3 Choosing a Testevaluation of test methods: Beforeanybulkprocurementofrapidsyphilistestsismadebyyourgovernmentorthedonoragencythatisfundingtherapidsyphilistestprogramme,alab-orfield-basedevaluationofrapidsyphilistestkitsshouldbeperformedbythenationalreferencelaboratoryorappropriatebody,inaccordancewithnationalregulations.Inordertoassureavailabilityofkitsfortesting,itwillbenecessaryforeachcountrytohavecheckedthevalidityofandapprovedseveralrapidtestkitsforuseinthecountry.

TheMinistryofHealthshouldestablishanationalpolicyregardingtheappropriateteststouseandanapprovedalgorithmfortesting.Refertohttp://RefertoLaboratory based evaluation of Rapid Syphilis Tests (Manual of Operations)forguidanceonperforminganevaluationofrapidsyphilistests.Thismethodologycanbeadoptedforotherdiagnostictests.RefertoRapidSyphilisTestingAlgorithmsManagement 3forguidanceondevelopingtestingandtreatmentalgorithmsforsyphilisscreeningandtreatment.

1.3.1 Types of tests ThereisarangeofdiagnostictestsavailabletodetectsyphilisinfectionthatdependsoneitherdirectvisualizationofT.pallidumordetectionofspecificandnonspecificantibodyresponses.Table 1 summarisestheoperationalcharacteristicsofthevariousdiagnostictestscurrentlyavailableforthediagnosisofsyphilis.

Therequirementforadditionalequipmentandrefrigerationcreatesbarrierstoscreening.Recognitionoftheseconstraintsledtotheevaluationofseveralrapidpoint-of-care(POC)testsbasedontheacronymASSURED(Affordable,Sensitive,Specific,User-friendly,Robustandrapid,Equipment-free,Deliverabletothosewhoneedthem).

Theintroductionofrapidtestsenableshealthsystemstoexpandscreeningprogrammestoincludefacilitieswithoutrefrigerationwhiletherapidtestresultsminimizelossestofollow-up.

ASSURed criteria for point of care tests

AffordableSensitiveSpecificUser- friendlyRobust and rapidequipment-freedeliverable to those who need them

Reference:Peeling,R.W.,Mabey,D.,Herring,A.Hook,E.W.(2006).Whydoweneedquality-assureddiagnostictestsforsexuallytransmittedinfections?NatureReviewsMicrobiology4,909-921

5

Table 1. Serological tests for syphilis

MANAGEMENT 4 Management and Implementation of Rapid Syphilis Testing Introduction: A Programme Manager’s Guide 6

Serology Tests

Non-treponemal

RapidPlasmaReagin(RPR)

VenerealDiseaseResearchLaboratory(VDRL)

Rapidnon-treponemal

Target Antigen

Cardiolipin

Cardiolipin

Immobilizedcardiolipin

Utility (confirm or screening)

Screeningormarkerofactiveinfection

Screeningormarkerofactiveinfection

Screeningormarkerofactiveinfection

operational Characteristics

Cheapandsimpleagglutinationtestperformedonacardandreadbyeye.Requiresasimplerotator.Serum/plasmasample.Needtoscreen2dilutionsbecauseofprozoneeffect.Experiencenecessaryforreading.

Agglutinationtest.Requiresashakerandamicroscopetoreadthetest-asimplelaboratorytest.Serum/plasmasample.Needtoscreen2dilutionsbecauseofprozoneeffect.Experiencenecessaryforreading.

Immunochromatographicstriporfilterpaperformat.Noequipmentrequired.Serumorwholebloodsample.Resultin30mins.Basictrainingonlyneededforreading.

Treponemal

TreponemaPallidumHaemagglutinationTechnique(TPHA)andTreponemaPallidumParticleAgglutinationtest(TPPA)

Enzymeimmunoassays(EIA)

Lysedspirochaeteboundtobloodcellsormicroparticles

Recombinanttreponemalantigen

Screeningorconfirmationofsyphilisinnon-treponemalpositives.

Screeningorconfirmation

Agglutinationtestinmicroplateformat.Requiresequipmentandrefrigeration.Expensive.Technicalexpertiserequired.Referencelaboratorytest.

Antigen-antibodyreactionwiththetreponemalantigenfixedontothewellsof96-wellmicroplates.Requiresincubators,micropipettes,washerandreader.Objectivereadoutandhighthroughputcapacity.

The RAPId syphilis TEsT ToolkIT 8

Therearemanycommercialrapidsyphilistestsavailableonthemarket.Giventhehighcostoffieldtrials,atriagesteptoselectalimitednumberofthemostpromisingtestsforfieldtrialsisnecessary.Thiscanbeperformedasalaboratory-basedevaluationoftestperformanceandreliabilityusingarchivedserumspecimensfromdiversegeographiclocations.Alternatively,itcanbedonethroughfieldtrialsoftestperformance,utilityindiseasecontrolandprevention,andacceptabilitytopatientsandcareproviders.Thisdocumentisavailableherehttp://www.who.int/std_diagnostics/publications/manuals/syphilis_evaluation.pdf

TheLaboratory-basedevaluationofrapidsyphilistests(ManualofOperations)outlinesthemethodologyandoutcomeofalaboratory-basedevaluationof6commerciallyavailablerapidsyphilistests.Themethodologyoutlinedinthisreportcanbeadaptedforcountryspecificlaboratory-basedevaluationofrapidsyphilistests.Management 3providesguidanceonhowtointegraterapidsyphilistestingintoclinicalpractice.Itpresentsalgorithmsforsyphilisscreeningusingrapidsyphilistestsontheirown,orincombinationwithothertreponemalornon-treponemallaboratorytestssuchasrapidplasmareagin,TreponemapallidumParticleAgglutinationassayorTreponemapallidumHaemagglutinationassay.

1.3.2 operational and Performance Characteristics Whenperforminganevaluationofrapidsyphilistests,youshouldassessthefollowingoperationalandperformancecharacteristics:

Sensitivity:theproportionofpersonswiththedisease/condition(true positives)whoarecorrectlyidentifiedasbeingpositivebyadiagnostictest.

Specificity:theproportionofpersonswithoutthedisease/condition(true negatives)whoarecorrectlyidentifiedasbeingnegativebyadiagnostictest.

Positive-Predictive Value (PPV): theproportionofpersonswithapositivetest resultwhohavethedisease/condition.

Negative-Predictive Value (NPV): theproportionofpersonswithanegative testresultwhodonothavethedisease/condition.

Precision: Measureofthetest’sreproducibilitywhenrepeatedonthesame sample

Accuracy: Theextenttowhichavaluefromatestreflectsoragreeswiththe referencevalueoftheanalytebeingtested

Whenselectingarapidtest,youshouldalsoconsiderthe ASSURedcriteriadescribedinsection1.3.1above.

Table 2outlinestheoperationalandperformancecharacteristicsofthedifferenttypesofsyphilistests,highlightingthekeyfeaturesandbenefitsofrapidsyphilistests.Table 3summarisestheperformanceoffourrapidsyphilistestsinafieldevaluationconductedin2006.Thiswasdoneinalaboratorysettingbytrainedlaboratorytechnicians,andinhealthfacilitiesbytrainedhealthcareworkers.

7

MANAGEMENT 4 Management and Implementation of Rapid Syphilis Test Introduction: A Programme Manager’s Guide 9

Table 2. Comparison of syphilis diagnostic tests

Pee

ling

R.W

.,Ye

H.“

Dia

gnos

ticto

ols

for

prev

entin

gan

dm

anag

ing

mat

erna

land

con

geni

tals

yphi

lis:a

nov

ervi

ew”,

in

Bul

letin

oft

heW

orld

Hea

lthO

rgan

izat

ion

2004

;82:

pp.

439-

46.

Cri

teri

a

Sens

itivi

ty

Spec

ifici

ty

Ease

ofu

se

Whe

reu

sed

Equi

pmen

tne

eded

Trai

ning

ne

eded

Aver

age

cost

dar

kfie

ld

mic

rosc

opy

74-8

6%

85-9

7%

Easy

Exam

room

,on

-site

lab1

Ligh

tm

icro

scop

ew

ith

dark

field

co

nden

ser

Exte

nsiv

e

US$

1.4

0

For

patie

nts

pres

entin

gw

ith

anu

lcer

or

lesi

onFo

rsc

reen

ing

Non

-tre

pone

mal

test

sTr

epon

emal

test

s

Ant

igen

de

tect

ion

(d

FA-T

P)

73-1

00%

89-1

00%

Mod

erat

e

Inte

rmed

iate

lab,

refe

rral

la

b

Fluo

resc

ence

m

icro

scop

e

Mod

erat

e

US$

3.0

0

dN

A

dete

ctio

n

(PC

R)

91%

99%

Com

plex

Ref

erra

llab

Mic

rofu

ge

cent

rifu

ge,

ther

mal

cy

cler

,in

cuba

tor,

m

icro

wel

lpl

ate

read

er

Exte

nsiv

e

US$

14.0

0

RP

R

86-1

00%

93-9

8%

Easy

Exam

room

,on

-site

lab

Rot

ator

Min

imal

US$

0.5

0

VdR

l

78-1

00%

98%

Easy

Exam

room

,on

-site

lab

Ligh

tm

icro

scop

e

Min

imal

US$

0.5

0

Rap

id te

st

84-9

8%

94-9

8%

Easy

Exam

room

,on

-site

lab

Non

e

Min

imal

US$

0.5

5-3.

00

eIA

82-1

00%

97-1

00%

Mod

erat

e

Inte

rmed

iate

la

b,re

ferr

al

lab

Incu

bato

r,

mic

row

ell

plat

ew

ashe

ran

dre

ader

Mod

erat

e

US$

3.0

0

TPh

A-T

PPA

85-1

00%

98-1

00%

Com

plex

Ref

erra

llab

Incu

bato

r,

mic

row

ell

plat

ew

ashe

ran

dre

ader

Exte

nsiv

e

US$

3.0

0

FTA

-AB

S

70-1

00%

94-1

00%

Com

plex

Ref

erra

llab

Fluo

resc

ence

m

icro

scop

e

Exte

nsiv

e

US$

3.0

0

8

The RAPId syphilis TEsT ToolkIT 10

Table 3. Performance characteristics of Select rapid syphilis tests

an=40;bn=362;cn=83andn=40;dn=30MabeyD,PeelingRW,BallardR,BenzakenAS,GalbanE,ChangaluchaJ,EverettD,BaliraR,FitzgeraldD,JosephP,NeretteS,LiJ,ZhengH.“Prospective,multi-centreclinic-basedevaluationoffourrapiddiagnostictestsforsyphilis”,inSexuallyTransmittedInfections2006;82:v13-v16.

1.3.3 National procurement of Rapid Syphilis TestsNationallawswilldecidewhichtestscanbeusedinyourcountry.Itisimportanttounderstandwhatproductshavetodatebeenregistered/approvedforuseinyourcountry.Thequantification,qualification,productspecificationandpre-selectionofsuppliersareallimportantconsiderationswhenselectingarapidsyphilistest.ItisimportanttoachieveafairandcompetitivepriceforproductsofassuredqualitywhilstmaintainingcompliancewithNationalRegulations.

Suppliersshouldbeauditedand/ormonitoredtoensureproductquality,servicereliabilityandgooddeliverytime.Contactnationalregulatoryagenciesforguidanceonnationalregulations.

Referto“The Use of Rapid Syphilis Tests”forconsiderationsinpurchasingRapidSyphilisTests.

Rapid Syphilis Test

AbbottDetermine

OmegaVisitect

QualproSyphicheck

StandardBioline

Clinic:WholeBlood Lab:WholeBlood Lab:Serum

Sensitivity (%)

59.6-88.5

72.7-96.1

64-84.3

85.7-100d

Specificity (%)

97.9-99.4

98.5-99.8

97.8-99.7

98.1-99.4

Sensitivity (%)

77.1-100a

77.9-98.2

70.8-97.6

87.6-100d

Specificity (%)

95.7-100b

98.7-100b

98.6-99.7

96.1-99.4

Sensitivity (%)

88.5-100c

84.2-96.1

67.4-99.7

90.2-100d

Specificity (%)

95.7-98.9

98.1-99.1

98.4-99.6

95.5-99.4

9

MANAGEMENT 4 Management and Implementation of Rapid Syphilis Test Introduction: A Programme Manager’s Guide 11

The World health organization (Who) Bulk Procurement SchemeThisservicewascreatedtofacilitateaccesstohighqualitytestkitsandbasiclaboratoryconsumablesandequipmentatreducedcosts.Throughthescheme,rapidsyphilistestscanbeorderedbythefollowinginstitutions:

AllregionalofficesoftheWorldHealthOrganization AllWorldHeathOrganizationcountryoffices(ordersarecurrently

madethroughtheregionaloffices) Non-governmentalorganizationswhichhaveofficialrelationships

withtheWorldHealthOrganization Publichealthfacilities(ordersaremadeviaWorldHealthOrganization

countryoffices)

ForadiagnostictestkittobecomeeligibletotenderforWorldHealthOrganizationprocurement,itmustpasstheWorldHealthOrganizationprequalificationprocessandmeetspecificprocurementcriteriafortestperformanceandmanufacturingstandards.Tendersfromdiagnosticmanufacturersoccuronanannualbasis,byinvitationonly.

FurtherinformationontheWorldHealthOrganizationBulkProcurementGuidelinesareavailableat:

WHOContractingandProcurementServices(WHO/CPS)AvenueAppia201211Geneva27SwitzerlandTel.+41-22-7911801Fax:+41-22-7914196Email:procurement@who.inthttp://www.who.int/diagnostics_laboratory/procurement/en/

10

The RAPId syphilis TEsT ToolkIT 12

2. Implementation

2.1 Understanding Local Circumstance: Conducting a baseline surveyWhenyouwereidentifyingtheneedforanrapidsyphilistestingprogramme,youshouldhaveconductedasituationalanalysistohighlighttheneedforrapidsyphilistestingwithinachosenpopulation(refertoguidanceonperformingaSituationalAnalysisinPlanning 1 andforasamplesituationalanalysischecklistseeManagement 1).Buildingupontheinformationpresentedinthesituationalanalysis,youshouldconductabaselinesurveytocollectdataspecifictothetargetpopulationandthefacilitieswheretheinterventionwillbeintroduced.

Yourbaselinesurveyshouldbeconductedbeforeyouintroducetheinterventionphaseoftheprogrammeandafterasituationalanalysis.RefertoImplementation 4 – Monitoring and Evaluation Tool for a Rapid Syphilis Test Programmeforguidanceonperformingabaselinesurvey.

2.2 Ordering and DistributionTherearemanycomponentstobeconsideredinordertocreateasupplychainsystemthatfunctionsandiscapableofreachingmultipleremotehealthfacilitiesinatimelyfashion.Stockoutsinterrupthealthcareservicesandimpedeahealthcareworker’sabilitytoprovidepatientsandclientswithahighlevelofcare.Effectivesupplychainmanagementisthereforeavaluablepartofafunctioninghealthcaresystem.Itisimportantalsotorefertothenationalguidelinesforsupplyandstockmanagement.Eachcountry,andsometimeseachdistrict,hasitsownscheduleandpolicyforordering,whichmayvaryfrommonthlytoquarterlytoannually.

RefertoManagement 2forfurtherinformationonorderingandmaintainingstock.

2.3 TrainingTrainingisanessentialpartofarapidsyphilistestingintroductionprogramme.Itiskeytodevelopingthetechnicalexpertiseandskillsrequiredforachievingaprogramme’sobjectivesandrealizingthestatedgoals.Managersshouldestablishprogramme-levelplans,policies,procedures,andqualityassurancemethodstoensuretrainingiseffectivelyandefficientlyincorporatedintoprojectmanagementfunctions.Furthermore,programmemanagersshoulddevelopspecificplanstoestablishaqualityassurancesystemfortrainingandhumanresourcedevelopment.

2.3.1 Training WorkshopsAtrainingprogrammecanbeestablishedthroughthecreationoftwolevelsoftrainingworkshops.Thefirst,aTrainingofTrainersworkshop,willequiptrainerstotrainthehealthcarefacilitystaffwhowillbeinvolvedintheimplementationofrapidsyphilistesting.Itshouldalsoprovideinternalmonitorsandsupervisorswithknowledgeofthepurpose,objectivesandcontentofhealthcareworkertraining.Thiswillenablethemtoreinforceon-the-jobapplicationofskillsdevelopedthroughtrainingby:

11

MANAGEMENT 4 Management and Implementation of Rapid Syphilis Test Introduction: A Programme Manager’s Guide 13

Demonstratingskills Observingperformanceandassessingskilllevels Offeringconstructivefeedback Identifyingandaddressingbarrierstoeffectiveperformanceofhealthcare

workers.Theseincludemotivation,communicationandattitude.

Thesecondleveloftrainingworkshopisdirectedattheindividualswhowillberesponsibleforconductingrapidsyphilistesting.Itshouldbedesignedtoequipstaffwiththepracticalknowledgeandskillsrequiredtoperformrapidtestsaspartofroutinecare.

2.3.2 Refresher Training CoursesRefreshertrainingisanimportantaspectofprogrammeimplementation.Thefrequencyandintensityofre-trainingwilldependonstaffexperience.Itcaneitherbepredeterminedandincludedaspartoftheprogrammetimeline,orbeconductedinresponsetopoorperformanceinqualityassuranceexercises.Generalizedrefreshertrainingshouldbeheldeveryonetotwoyearsandshouldbeintegratedwithrefreshertrainingworkshopsforotherservicesofferedalongsidesyphilistesting.Forexample,integratedrefreshertrainingforrapidsyphilistestingandprevention-of-mother-to-childtransmission(PMTCT)programmeswoulddecreasethetimestaffspendawayfromclinicsandavoidinterruptionsinservicesduetostaffabsences.

Figure 1. development of training plan

AA

A

TrainingofTrainersWorkshop

TrainingofProgramMonitors/

Supervisors

HealthcareworkerTraining

Workshop

RoutineSyphilisTesting

RoutineProgram

Monitoring/Supervision

Assess staff proficiency and identify training

needs

develop, implement and deliver needed training

to address skill and knowledge deficiencies

evaluate the effectiveness of the

training on improving skills development

evaluate the effect on worker performance

12

The RAPId syphilis TEsT ToolkIT 14

2.3.3 CertificationAllparticipantswhosuccessfullycompleteatrainingworkshopshouldreceiveacertificateofparticipation(refertoImplementation 3 – Training Package for Rapid Syphilis Testingforasampletrainingcertificate.Thecertificateshoulddocument:

Thenameofthehostorganization Thenamesofallcontributingorganizationsorinstitutionsincluding

theMinistryofHealth(ifinvolved) Thedateofthetrainingworkshop Thenameoftheparticipant Thetrainers’signatures

Certificatesserveasevidencethatanindividualhasattendedatrainingworkshopandshouldthereforebecompetentintheprovisionofrapidsyphilistestingservices.Thecontentoftheworkshopshouldnotbedocumentedonthecertificatebutshouldbearchivedinatrainingfolderthatisstoredinacentrallocationandcontains:

Acopyoftheagenda Listofparticipants Listofpresentationsandworksheets Listofevaluationsconductedduringtheworkshop.

Implementation 3 – Training Package for Rapid Syphilis Testing: Training of Trainers Workshop PreparationofthisToolkitcontainsacomprehensivesetofguidelinesontraininghealthcareworkersandtrainersandincludessamplepresentationsforbothsetsoftrainingworkshops.Youshouldmakeeveryefforttointegratetrainingonnewrapiddiagnostictestingwithinnationaltrainingprograms,soastominimizehealthcareworkers’timeawayfromtheirclinics.

2.4 Test IntroductionFacilitiesshouldcommencetestingimmediatelyuponcompletionoftrainingworkshops.Qualitymeasuresmaybeintroducedinaphased-approachoralongsideintroductionoftesting.Thiswilldependontheabilityoflaboratoryandprogrammestafftodistributequalitymaterials,andonhealthcareworkers’experiencewithqualitycontrolmeasures.Theintensityoftrainingandsupervisionwillgraduallydeclineinfrequencyashealthcareworkersbecomemoreaccomplished,butitwillneedtobemaintainedinareasofhighstaffturnover.

13

MANAGEMENT 4 Management and Implementation of Rapid Syphilis Test Introduction: A Programme Manager’s Guide 15

2.5 Quality Assurance and Quality ControlAccuracyandreliabilityofdiagnostic/laboratorytestingwillbecriticaltothesuccessofadiagnostictestintroductionprogramme.Inordertoensurethisreliabilityandreduceerrorstoaminimum,aqualitysystemthataddressesallaspectsoftesting,includingpoint-of-casetests,isessential.Eveninsiteswhichconductonlyrapidsyphilistesting,itisstillessentialtosetupalltheelementsofaqualitysystem.

Qualityassuranceisanintegratedmanagementfunctionthatdealswithsettingpolicyandrunninganadministrativecontrolsystemtoensuretheusabilityoftheproduct;inthiscase,therapidsyphilistest.Itensuresthataprocessordeviceisofthequalityneededandexpectedbytheoperator.Qualitycontrolisasystemofroutinestandardtechnicalactivitiesundertakentomeasureandcontrolthequalityoftestingagainstadefinedsetofcriteriaorstandards.Itensurescorrectoperationoftherapiddiagnostictestsandcorrectdiagnosis.

Asrapidsyphilistestingisrolledoutand/orexpandedintolargenumbersoftestingsites,itwillbeveryimportanttoimplementaqualitymanagementsystemasdetailedinthisToolkittoassurethequalityandreliabilityoftestresults.

Implementation 2 – Quality Management System Guidelines for Rapid SyphilisTesting ofthisToolkitprovidesguidanceonestablishingaQualityAssurancesystemforRapidSyphilisTesting.

2.6 Monitoring and EvaluationRoutinemonitoringandscheduledevaluationsarecriticalcomponentsofanyrapidsyphilistestingprogramme.Implementation 4 – Monitoring and Evaluation Tool for a Rapid Syphilis Test ProgrammeofthisToolkitisusedtodefinethekeyindicatorsandapproachtodatacollection.YourMonitoringandEvaluationPlanshould:

Tracktheprogressofcountryimplementationplansagainst theexpectedmilestones.

Ensurecontinuousimprovementandlearningthroughanunderstanding ofthevariousfactorsthatunderlieincreasedcoverageofquality-assured rapidsyphilistesting.

Facilitatereal-time,evidence-baseddecision-making. Identifyobstaclestotheimplementationofrapidsyphilistesting

andfindsolutions.

14

The RAPId syphilis TEsT ToolkIT 16

2.7 Dissemination Planning 1and2 ofthisToolkitprovideguidanceondevelopingadvocacyandcommunicationtoolsandactivitiestodisseminatetheprogressandresultsoftherapidsyphilistestprogramme.Communicationofprogressandresultstotherelevantstakeholdersisanessentialpartoftheuptakeofrapidsyphilistestingbydonors,healthofficialsandthepublic.

Aneffectivedisseminationandcommunicationplanshould:

Sensitizeandeducatethecommunityaboutthedisease,testingforitand whattreatmentisavailable.

Promotesafesexpractice. Counseltoreduceprevalence. Promotepartnerengagementthroughamoreintegratedapproach,

e.g.usingpartnerinvitationslipsandtherebyfosteringawareness. Targethealthcareworkersaswellaspatients. UtilizeintegratedHIVandsyphilisservices. Promoteengagementofkeystakeholders(integratedHIVpartners,

non-governmentalorganizations,MinistryofHealth,laboratorypartners).

Asthepilotdataisanalyzed,youwillneedtoorganizestakeholdermeetingstodisseminatetheresults.Theseshouldoccuronmultiplelevels.Youmustpresentresultstohealthcareworkers,laboratorypersonnel,anddistrictstaffinvolveddirectlyintheimplementationoftheproject.Youmustalsomeetwithorganizationsandgovernmentalofficialsworkingatanationalleveltoeffectpolicychange.Youshouldmaintainregularcontactwithallstakeholderstoinformthemoftheprogressandsuccessoftheprojecttodate,andtheexpecteddateofdisseminationandconclusionoftheproject.Finally,youwillneedtoarrangeafinalmeetingtodisseminatetheproject’sfindings,

15

DisseminationactivitiesduringRSTlaunch,Lima,Peru

MANAGEMENT 4 Management and Implementation of Rapid Syphilis Test Introduction: A Programme Manager’s Guide 17

3. Planning for Scaling Up

Itisessentialtomaintainthemomentumoftheprogrammethroughexitfromthepilotintothescalingupphase,sothatskillsgainedduringtheinitialstagescanbesustained.Thepilotstudyshouldhavebeenintroducedthroughexistinghealthsystemstructures.Inthisway,youwillhavebuiltastrongfoundationforscaleupandexpansionoftheprogramme.Thecomponentsofthepilotsystem–training,qualityassurance,supplychainmanagement,testingandtreatment–canbeexpandedtoalargerscalebasedonyourinitialexperiences.Yourabilitytoscaleupwilldependonthesupportandcommitmentofstakeholders:theirengagementiscriticalbeforeandduringprogrammeimplementation.

Thesearesomeofthemattersthatyoushouldconsiderforscaleup:

Whowillberesponsibleforperformingand/ormanagingaparticular activity?

Howwillthetransferprocessoccur? Arethereperformancestandardstobemaintained? Howwillitbefunded? WhowillberesponsibleformaintainingtheQualitySystem? Howwilltheprogrammebemonitored? Whatwillbetheroleofthecommunityinmanagingormonitoringthe

programme? Cantheprogrammebeintegratedintoanexistingprogramme,suchasa

MaternalandChildHealth(MCH)orPreventionofMothertoChild Transmissionprogramme?

Cantrainingbeintegratedwithexistingnationalleveltrainingprogrammes?

“ The transfer of activities and knowledge shouldbedoneformally,sothatallstakeholdersconcernedareawareofthecommitmentsandresponsibilitiesnecessarytothecontinuationoftheprogrammeatnationallevel.

”

16

The RAPId syphilis TEsT ToolkIT 18

Theplanningofanexitstrategyisnotasingleeventbutaseriesofsteps.Thefollowingtableoutlinestheessentialelementsofarapiddiagnostictestintroductionprogramme.Youwillneedtoconsidertheseinordertotransferfrompilotstagetonationwideroll-out.Youshouldalsofactorintherisksoftransferandpotentialsolutionstoovercomethem.

Figure 2. The Scaling Up Process

A A

A

A A

A

A

A

establishment of partnerships

and collaboration engagements with

various private (including industry)

and public (including regulatory bodies)

stakeholders to support service delivery

exit Strategy from Pilot

Adoption of policy or guideline changes that

may result from lessons learnt from the pilot

knowledge transfer

and expansion

development of a larger team

of trainers

Reassessment of commodity needs,

the capacity of the existing supply chain to meet the demands

of rapid syphilis testing, and quality assurance/control

materials

expanding capacity

Sourcing for increased funding

Creation of demand and advocacy for

the planned service expansion

17

MANAGEMENT 4 Management and Implementation of Rapid Syphilis Test Introduction: A Programme Manager’s Guide 19

Act

ivity

Qua

lity

Sy

stem

Ris

ks a

ssoc

iate

d w

ith tr

ansf

er

from

pilo

t to

natio

nal r

oll-

out

F

easi

bilit

y,fr

eque

ncy

&fi

nanc

ing

ofa

qua

lity

co

ntro

lsys

tem

for

RST

w

ithin

the

MO

H.

In

trod

uctio

nof

an

over

am

bitio

usq

ualit

ysy

stem

th

atc

anno

tbe

sust

aine

d.

L

oss

ofs

kills

ofH

CW

and

la

bora

tory

tech

nici

ans

with

re

spec

tto

man

ufac

ture

an

dte

stin

gof

qua

lity

sam

ples

dur

ing

tran

sfer

.

In

abili

tyo

flab

orat

ory

to

obta

inh

igh

titre

spe

cim

ens

fo

rD

ried

Tub

eSp

ecim

en

man

ufac

ture

.

In

abili

tyo

fdis

tric

tto

m

aint

ain

supe

rvis

ion

of

qual

itys

yste

ma

ndfa

ilure

to

impl

emen

tcor

rect

ive

ac

tions

whe

ren

eces

sary

.

Rec

omm

ende

d so

lutio

ns a

ndA

ctio

ns fo

r P

hase

out

E

ngag

ew

ithc

entr

al

labo

rato

ries

tod

evel

opa

su

stai

nabl

equ

ality

sys

tem

an

din

tegr

ated

HIV

/syp

hilis

pa

nel.

E

ngag

ein

dis

cuss

ions

with

re

leva

nts

take

hold

ers

to

dete

rmin

ew

hata

spec

ts

ofq

ualit

ysy

stem

(DTS

P

rofic

ienc

yP

anel

test

ing

an

d/or

kit

QC

test

ing

and/

or

confi

rmat

ory

re-t

estin

gan

d/

orin

com

ing

insp

ectio

nof

ne

wlo

ts)c

ould

be

sust

aine

d.

Dis

cuss

freq

uenc

yof

QC

an

dde

term

ine

wha

tis

fe

asib

leg

iven

cos

t

rest

rict

ions

and

goa

lso

f

qual

itys

yste

m.

P

repa

rete

chni

calg

uide

-lin

esfo

rim

plem

entin

gin

tern

ala

nde

xter

nalq

ualit

yco

ntro

lfor

rap

idte

stin

gat

th

ece

ntra

llab

orat

ory

and

at

the

heal

thc

entr

e.

T

rain

MO

Hs

uper

viso

rs

onq

ualit

yco

ntro

lasp

ects

to

ens

ure

tech

nica

lpr

ofici

ency

.

D

raw

up

budg

etfo

rco

sts

ofim

plem

entin

ga

rout

ine

qual

ityp

rogr

am.

Res

pons

ibili

ty

afte

r P

ilot S

tage

Loca

lpar

tner

ship

s.

MO

H,M

OH

labo

rato

ries

,la

bora

tori

esa

lrea

dyco

llabo

ratin

gw

ithM

OH

in

qual

itya

ssur

ance

,dis

tric

tla

bora

tori

esa

ndd

istr

ict

med

ical

offi

ce,d

istr

ict

supe

rvis

ors.

Tool

s fr

om p

ilot s

tage

that

can

be u

sed

duri

ng s

cale

-up

E

QA/

DTS

man

ufac

ture

a

ndte

stin

ggu

idel

ines

and

re

cord

form

s.

Inte

rnal

QC

man

ufac

ture

an

dte

stin

ggu

idel

ines

and

re

cord

form

s.

In

com

ing

Insp

ectio

nte

stin

ggu

idel

ines

and

re

cord

form

s.

Table 4. Planning for scale-up – consider the following programme activities

18

The RAPId syphilis TEsT ToolkIT 20

Act

ivity

Trai

ning

syst

em

Ris

ks a

ssoc

iate

d w

ith tr

ansf

er

from

pilo

t to

natio

nal r

oll-

out

L

oss

ofs

kills

ofH

CW

and

la

bora

tory

tech

nici

ans

with

re

spec

tto

test

ing,

re

port

ing

and

man

ufac

ture

of

qua

lity

cont

rol

spec

imen

s.

Rec

omm

ende

d so

lutio

ns a

ndA

ctio

ns fo

r P

hase

out

Is

sue

trai

ning

cer

tifica

tes

toa

lltr

aine

dhe

alth

care

w

orke

rs.

O

ffer

re-t

rain

ing

toH

CW

th

ats

core

dlo

wer

than

the

re

quire

dsc

ore

for

EQA

DTS

pa

nelb

efor

eph

ase-

out

E

nsur

edi

stri

cts

uper

viso

r

and

labo

rato

rys

taff

are

ad

equa

tely

trai

ned

ona

ll

aspe

cts

ofq

ualit

yan

d

inte

rnal

mon

itori

ng

In

volv

edi

stri

ct/M

OH

ate

arly

st

age

ofp

hase

out

E

nsur

eca

paci

tyb

uild

ing

on

site

am

ong

HC

W

D

evel

opa

cas

cade

of

tr

aine

rss

oth

eca

paci

tyto

tr

ain

isa

tall

leve

ls,

incl

udin

glo

call

evel

N

atio

nals

take

hold

er

mee

ting

will

pro

vide

op

port

uniti

esfo

rtr

aini

ng

alll

evel

s

E

nsur

edi

stri

cts

uper

viso

rs

and

labo

rato

rys

taff

are

ad

equa

tely

trai

ned

ona

ll

aspe

cts

ofth

equ

ality

sy

stem

.

Res

pons

ibili

ty

afte

r P

ilot S

tage

MO

H/R

efer

ence

labo

rato

ry

Tool

s fr

om p

ilot s

tage

that

can

be u

sed

duri

ng s

cale

-up

T

rain

ero

ftra

iner

sgu

ide

J

obd

escr

iptio

ns(I

nter

nal

M

onito

r/S

uper

viso

r,

Labo

rato

ryp

erso

nnel

for

D

TSm

anuf

actu

re,D

ata

M

anag

er,P

rogr

amm

e

Man

ager

,HC

W)

G

uide

lines

,FAQ

,

trou

bles

hoot

ing

guid

e

C

ertifi

catio

nof

trai

ned

staf

f

P

rofic

ienc

yC

heck

listw

hen

th

ere

ish

igh

turn

over

of

staf

f

19

MANAGEMENT 4 Management and Implementation of Rapid Syphilis Test Introduction: A Programme Manager’s Guide 21

Act

ivity

Inte

rnal

mon

it-

orin

g/Su

per-

vi

sion

Ris

ks a

ssoc

iate

d w

ith tr

ansf

er

from

pilo

t to

natio

nal r

oll-

out

H

CW

may

lose

mot

ivat

ion

if

regu

lar

supe

rvis

ion

isn

ot

mai

ntai

ned

Q

ualit

yC

ontr

olm

ayn

otb

e

done

ifn

otre

view

edo

na

re

gula

rba

sis

P

robl

ems

can

esca

late

if

ther

eis

no

regu

lar

su

perv

isio

n

Rec

omm

ende

d so

lutio

ns a

ndA

ctio

ns fo

r P

hase

out

P

hase

out

freq

uenc

yof

in

tern

alm

onito

ring

vis

its

tos

hift

resp

onsi

bilit

yto

di

stri

ct/M

OH

leve

land

bui

ld

capa

city

am

ong

HC

Wa

tthe

he

alth

cen

tres

.

C

oord

inat

evi

sits

with

di

stri

cts

uper

viso

rto

w

ork

toge

ther

and

to

prov

ide

trai

ning

for

dist

rict

su

perv

isor

E

nsur

edi

stri

cts

uper

viso

rs

are

awar

eof

role

san

d

resp

onsi

bilit

ies

prio

rto

exi

t

thro

ugh

host

ing

ofa

dequ

ate

tr

aini

nga

nda

ccom

pani

ed

site

vis

its

D

raw

up

budg

eto

fcos

tso

f

impl

emen

ting

aro

utin

e

supe

rvis

ion/

mon

itori

ng

prog

ram

In

volv

edi

stri

ct/M

OH

ate

arly

st

age

ofp

hase

out

.

T

hep

ilots

tudy

team

sho

uld

do

afo

llow

up

visi

tafte

rex

it

usin

gan

Exi

tstr

ateg

y

chec

klis

t

Res

pons

ibili

ty

afte

r P

ilot S

tage

Dis

tric

t/M

CH

/RC

Hc

oord

inat

or

Dis

tric

thea

ltho

ffice

.Dis

tric

tsu

perv

isor

s.

Tool

s fr

om p

ilot s

tage

that

can

be u

sed

duri

ng s

cale

-up

M

onito

ring

SO

P&

ch

eckl

ist,

incl

udin

gre

com

men

ded

freq

uenc

yof

mon

itori

ng

M

onito

ring

Rep

ort

tem

plat

e

C

ount

ryM

&E

plan

with

de

fined

indi

cato

rsfo

r

mon

itori

ng

C

orre

ctiv

eac

tion/

tr

oubl

esho

otin

ggu

ide

for

in

tern

alm

onito

rin

eve

nt

ofu

nacc

epta

ble

test

re

sults

and

oth

er

no

n-co

nfor

man

ces

20

The RAPId syphilis TEsT ToolkIT 22A

ctiv

ity

Supp

lyCh

ain

Ris

ks a

ssoc

iate

d w

ith tr

ansf

er

from

pilo

t to

natio

nal r

oll-

out

D

elay

inin

trod

uctio

nof

te

sts

beca

use

ofd

ifficu

lties

in

pro

cure

men

t.

S

tock

out

sca

usin

g

inte

rrup

tions

tote

stin

g

Rec

omm

ende

d so

lutio

ns a

ndA

ctio

ns fo

r P

hase

out

P

ilota

nor

der

thro

ugh

loca

l

dist

ribu

tor

and

dete

rmin

e

wha

tass

ista

nce

they

can

pr

ovid

e.

E

nsur

est

affa

thea

lthc

entr

e

are

awar

eof

the

impo

rtan

ce

oftr

acki

ngs

uppl

ies

and

or

deri

ng.

S

hare

exp

erie

nces

with

M

OH

,DH

Oa

spa

rto

ffina

l

diss

emin

atio

n.

U

seH

IVr

apid

test

or

othe

r

diag

nost

icp

rocu

rem

enta

s

ane

xam

ple

ofh

owp

roce

ss

can

wor

kan

dpo

tent

ial

pr

oble

ms

that

will

nee

dto

be

avo

ided

.

E

nsur

edi

stri

cts

uper

viso

rs

are

fam

iliar

with

sup

ply

chai

npr

oble

ms

and

are

capa

ble

ofa

ddre

ssin

glo

cal

prob

lem

s.

In

trod

uce

MO

H/D

HO

toW

HO

Bul

kP

rocu

rem

ent

Sc

hem

e.

Res

pons

ibili

ty

afte

r P

ilot S

tage

MO

H/d

istr

icth

ealth

offi

cea

nddi

stri

cts

tore

s/C

entr

als

tore

s

Tool

s fr

om p

ilot s

tage

that

can

be u

sed

duri

ng s

cale

-up

L

ocal

dis

trib

utor

con

tact

de

tails

W

HO

Bul

kP

rocu

rem

ent

Sc

hem

eG

uide

D

ocum

ents

/Sto

ckc

ards

fo

rtr

acki

ngs

uppl

y

21

MANAGEMENT 4 Management and Implementation of Rapid Syphilis Test Introduction: A Programme Manager’s Guide 23

Act

ivity

Dis

sem

- in

atio

n

Ris

ks a

ssoc

iate

d w

ith tr

ansf

er

from

pilo

t to

natio

nal r

oll-

out

N

opo

licy

chan

ge

F

acili

ties

will

reve

rtto

te

stin

gus

ing

refe

renc

e

met

hod.

Rec

omm

ende

d so

lutio

ns a

ndA

ctio

ns fo

r P

hase

out

E

ngag

eal

lrel

evan

t

stak

ehol

ders

inm

eetin

gs

for

diss

emin

atio

n.

E

nsur

eal

lint

eres

ted

part

ies

ha

vea

cces

sto

pro

ject

re

sults

,cos

ting

info

rmat

ion,

fin

alre

port

(inc

ludi

ngD

HO

,

MO

H,o

ther

NG

Os

wor

king

in

ove

rlap

ping

fiel

dse

tc.)

S

ched

ule

mee

tings

with

st

akeh

olde

rsa

tall

leve

ls

from

MO

H/n

atio

nalt

ofa

cilit

yle

vel.

C

halle

nges

and

issu

es

duri

ngR

STin

trod

uctio

nca

n

beo

btai

ned

from

the

inte

rnal

mon

itors

che

cklis

ts

and

the

wee

kly/

mon

thly

m

onito

rsm

eetin

gm

inut

es

Res

pons

ibili

ty

afte

r P

ilot S

tage

Pro

gram

me

Man

ager

and

pilo

tst

udy

team

Tool

s fr

om p

ilot s

tage

that

can

be u

sed

duri

ng s

cale

-up

D

evel

opa

com

mun

icat

ion

st

rate

gy

C

omm

unic

ate

chal

leng

es

and

less

ons

lear

ned

G

uide

lines

/FAQ

/Tr

oubl

esho

otin

ggu

ide

W

ebsi

tefo

rac

cess

ing

stud

ydo

cum

enta

tion

22

THE RAPID SYPHILIS TEST TOOLKIT 24

4. References

Planning1–Advocacy&CommunicationsStrategy

Planning2–Advocacy&CommunicationsActivities

Management1–ModelforIntegrationofRapidSyphilisTestswithinMaternalandChild Healthand/orPreventionofMothertoChildTransmissionProgrammesatPrimary HealthcareSettings

Management2–SupplyandStockManagementforHealthcareWorkers andHealthCareFacilityStaff

Management3–DevelopingSyphilisTestingandTreatmentAlgorithmsUsingRapidTests

Implementation1–TheCostingGuidelinesforSyphilisScreeningStrategies

Implementation2–QualityManagementSystemGuideforRapidSyphilisTesting

Implementation3–TrainingPackageforRapidSyphilisTesting

Implementation4–MonitoringandEvaluationToolforaRapidSyphilisTestProgramme

23