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CORRESPONDENCEOpenAccessAccept(HPTN043)SebastianKevany1,2*,GertrudeKhumalo-Sakutukwa1,OliverMurima3,AlfredChingono3,PreciousModiba4,GlendaGray5,HeidiVanRooyen5,KhalifaMrumbi6,JessieMbwambo6,SurindaKawichai7,SuwatChariyalertsak7,ChonlisaChariyalertsak3,ElizabethParadza3,MartaMulawa8,KathrynCurran9,KatherineFritz10andStephenFMorin1AbstractBackground:Study-basedglobalhealthinterventions,especiallythosethatareconductedonaninternationalormulti-sitebasis,frequentlyrequiresite-specificadaptationsinorderto(1)respondtosocio-culturaldifferencesinriskdeterminants,(2)tomakeinterventionsmorerelevanttotargetpopulationneeds,and(3)inrecognitionof'globalhealthdiplomacy'issues.
Wereportontheadaptationsdevelopment,approvalandimplementationprocessfromtheProjectAcceptvoluntarycounselingandtesting,communitymobilizationandpost-testsupportservicesintervention.
Methods:Wereviewedallrelevantdocumentationcollectedduringthestudyinterventionperiod(e.
g.
monthlyprogressreports;bi-annualsteeringcommitteepresentations)andconductedaseriesofsemi-structuredinterviewswithprojectdirectorsandbetween12and23fieldstaffateachstudysiteinSouthAfrica,Zimbabwe,ThailandandTanzaniaduring2009.
Respondentswereaskedtodescribe(1)theadaptationsdevelopmentandapprovalprocessand(2)themostsuccessfulsite-specificadaptationsfromtheperspectiveoffacilitatinginterventionimplementation.
Results:Acrosssites,proposedadaptationswereidentifiedbyfieldstaffandsubmittedtoprojectdirectorsforreviewonaformallyplannedbasis.
Thecross-siteinterventionsub-committeethenensuredfidelitytothestudyprotocolbeforeapproval.
Successfully-implementedadaptationsincluded:interventiondeliveryadaptations(e.
g.
developmentoftailoredcounselingmessagesforimmigrantlabourgroupsinSouthAfrica)political,environmentalandinfrastructuraladaptations(e.
g.
useoflocalcommunitycentersasVCTvenuesinZimbabwe);religiousadaptations(e.
g.
dividingclientsbygenderinMuslimareasofTanzania);economicadaptations(e.
g.
co-provisionofincomegeneratingskillsclassesinZimbabwe);epidemiologicaladaptations(e.
g.
provisionof'youth-friendly'servicesinSouthAfrica,ZimbabweandTanzania),andsocialadaptations(e.
g.
modificationofterminologytolocaldialectsinThailand:andadjustmentofservicedeliveryschedulestosuitseasonalanddailyworkschedulesacrosssites).
(Continuedonnextpage)*Correspondence:sebastian.
kevany@ucsf.
edu1InstituteforHealthPolicyStudies,UniversityofCalifornia,SanFrancisco,50BealeStreet,Suite1300,SanFrancisco,CA94105,USA2CenterforAIDSPreventionStudies,UniversityofCalifornia,SanFrancisco,USAFulllistofauthorinformationisavailableattheendofthearticle2012Kevanyetal.
;licenseeBioMedCentralLtd.
ThisisanOpenAccessarticledistributedunderthetermsoftheCreativeCommonsAttributionLicense(http://creativecommons.
org/licenses/by/2.
0),whichpermitsunrestricteduse,distribution,andreproductioninanymedium,providedtheoriginalworkisproperlycited.
Kevanyetal.
BMCPublicHealth2012,12:459http://www.
biomedcentral.
com/1471-2458/12/459andThailand:evaluatingfindingsfromProjectinterventionstolocalneedsinsub-SaharanAfricahealthHealthdiplomacyand``theadaptationofglobal(Continuedfrompreviouspage)Conclusions:Adaptationselection,developmentandapprovalduringmulti-siteglobalhealthresearchstudiesshouldbeaplannedprocessthatmaintainsfidelitytothestudyprotocol.
Thesuccessfulimplementationofappropriatesite-specificadaptationsmayhaveimportantimplicationsforinterventionimplementation,frombothaserviceuptakeandaglobalhealthdiplomacyperspective.
Keywords:Adaptations,Voluntarycounselingandtesting,Globalhealthdiplomacy,HIV,Sub-SaharanAfricaBackgroundTheHIVepidemicFromapublichealthperspective,thereisnomorecom-pellingcrisisintheworldtodaythantheHIVepidemicinsub-SaharanAfrica.
Sincetheepidemicbegan,morethan60millionpeoplehavebeeninfectedwithHIV[1],andin2009,AIDSkilled1.
4millionpeopleinAfricaalone.
Inadditiontothedeathanddiseaseburden,theepidemichashadanenormousimpactoneconomies,lifeexpectan-cies,andsociety.
Globally,aboutone-thirdofthosecur-rentlylivingwithHIVareaged15–24,andyoungadultsaccountfor40%ofallnewinfections[1].
Fromtheper-spectiveofnationalAIDScontrolplannersandpolicy-makersinthesecountries,evidence-basedstrategiesthathavemaximumepidemicimpactontargetregionsandpopulationsarecriticallyimportant.
Forthistooccur,bothplannersandimplementersneedinterventionsthatarebothsustainable,andadaptable,tothelocalepidemiological,cultural,economicandinfrastructuralcontext[2,3].
Randomizedcontrolledtrialsthattestsuchinterventionsshouldbecorrespondinglyflexibleandsen-sitivetolocalneedsthroughouttheirdevelopmentandimplementation.
AdaptingglobalhealthinterventionsAdaptationstohealthprogramsaredefinedasthedegreetowhichtheyarechangedormodifiedbyauserintheprocessoftheiradoptionandimplementation[4].
HIV-relatedinterventionsthathavebeenprovenforefficacyfrequentlyneedtobeadaptedtodifferentenvironmentsandsettingswhenimplementedaspublichealthprograms[5,6].
Similarly,HIV-relatedtrials,especiallythosethatareconductedinmultiplecountriesoratmultiplesiteswithinacountry,frequentlyrequiresite-specificadaptationstotheinterventioninorder(1)torespondtosocio-culturaldifferences[7](2),tomakeinterventionsmorerelevantandsensitivetotargetpopulations(includingdifferentriskdeterminantsandriskbehaviors)[2,3,8],(3)toimproveinterventionutilizationandeffectiveness[9],and(4)toensurethatinterventionsmeetminimumdiplomatic[10]andforeignpolicy[11]standards.
Forthelatter,aninabil-itytoalignbroaderpolicygoalswithglobalhealthinitia-tives,hasthepotentialtocreate'atenseandconfusingduality'[12].
Inallcases,adaptationdevelopmentandimplementationshouldbeaplannedprocessthatmain-tainsfidelitytocoreelementsofthestudyprotocol[13].
ProjectAcceptTheProjectAcceptinterventionhasbeendescribedelse-where[9].
Briefly,34communitiesinsub-SaharanAfrica(atstudysitesinSowetoandVulindlelainSouthAfrica,KisaraweinTanzania,andMutokoinZimbabwe)and14communitiesinThailandwererandomizedtoreceiveeitheracommunity-basedvoluntarycounselingandtest-ing(CBVCT)interventioninadditiontostandardclinic-basedVCT(SVCT)services,orSVCTservicesalone.
TheCBVCTinterventionhadthreemajorcomponentsdesignedtochangecommunitynormsandreduceriskofHIVinfectionamongallcommunitymembers,irrespect-iveofwhetherornottheyparticipateddirectlyintheintervention.
Thesewere(1)tomakecounselingandtest-ingmoreavailableincommunitysettingsthroughmobilevoluntarycounselingandtesting(MVCT),(2)toengagethecommunitythroughcommunitymobilization(CM),and(3)toprovidepost-testsupportservices(PTSS),in-cludingpsychosocialsupportgroups,copingeffectivenessandstigmareductiontraining.
Theinterventionwasof42monthsduration,withstartandend-datesvaryingbysite.
Althoughtheinterventionineachofthecountriesandstudysiteswasderivedfromthesametheoreticalmodel[14,15],containedthesamecorestrategies,andcon-formedtocommonstandardoperatingprocedures,theimplementationofinterventioncomponentswasdesignedtoberesponsiveandadaptabletoeachlocalcontext.
Tothisend,allstagesofinterventionimple-mentationweredeterminedthroughintensivecollabor-ationbetweenhost-countryinvestigatorsandinstitutions,studycommunities,fieldstaff,andtheirinternationalpartnerinstitutions(listedatendofpaper).
Inparticular,themultisitestudysteeringcommitteeworkedwithrepresentativesofnationalAIDSprogramsinhostcountriesthroughoutthedevelopmentoftheintervention,onbothadeliberativeandanad-hocbasis,both(1)tokeepnationalplannersinformedonprojectactivitiesand(2)toensurethatprojectactivitieswereimplementedinamannerthatwouldbebothappropri-ateandsustainableinresource-limitedsettings.
Kevanyetal.
BMCPublicHealth2012,12:459Page2of11http://www.
biomedcentral.
com/1471-2458/12/459Aninterventionsubcommitteewastaskedwithover-seeingallaspectsoftheinterventionandincludedmem-bersfromeachofthefiveprojectsites.
Thedutiesofthesubcommitteewere(1)tomonitorinterventionimple-mentationtoensurethatallsitesworkedtocommonstandards,(2)developandconductregularqualityassu-ranceactivities,and(3)propose,discussanddetermineacceptabilityofsite-specificadaptationstothestudyprotocol.
Inaddition,theinterventionsubcommitteeestablishedaninterventionworkinggroupateachsiteincludingsiteprincipalinvestigatorsandprojectdirec-tors.
Thesegroupsworkedviaconferencecallsandsitevisitsthroughouttheintervention.
Thisparticipatoryprocessfacilitatedtheresolutionofbothsite-specificandcross-siteissues–andhelpedindeveloping,determiningandapplyingprotocoladaptations.
TheCBVCTinterventionwasremarkablysuccessfulintermsofserviceutilization.
After42monthsoftheintervention,utilizationoftheCBVCTmodelwasmorethan10timeshigherthanutilizationofSVCTincontrolcommunities,acrisssites[9].
Thisdivergencewaspri-marilyattributabletothemobilenatureoftheinterven-tion,combinedwithextensiveCMeffortstopromoteutilizationininterventioncommunities.
Inadditiontotheseexplanations,theongoingadaptabilityoftheCBVCTinterventiontolocalconditionsmayhavehelpedtogenerateandmaintaintheseutilizationlevels.
AdaptationstotheProjectAcceptinterventionEachinterventioncomponentwasdesignedwithvaryingallowancesforadaptationstolocalconditionsthrough-outtheintervention.
ForMVCT,siteswerefreetodeter-minethemostappropriatesystemofservicedelivery(e.
g.
tents,caravans,communitybuildings,orprojectvehicles)aswellasfieldhoursoperatingschedules.
ForCM,studystaffwereasked:'Isourinnovationsensitiveto,andcom-patiblewith,thecommunity'sexistingvaluesandbeliefs,localculture,indigenouscustoms,pastexperiences,andtheneedsofpotentialadopters'Inthisway,CMstaffwereresponsiblefordiscoveringhowtheinterventioncouldbemademorecompatiblewithcommunities'exist-ingvaluesthrough(1)suggestinganddevelopingnewsystemsforworkingwithlocalsocialnetworksand(2)theongoingrefinementofinformation,educationandcommunication(IEC)messages.
ForPTSS,coordinatorscomponentswereencouragedtoworkwithcommunityrepresentativestoidentifylocalpost-testserviceneedsaswellascollaboratingwithrelatedexistingservices(ifany).
ForcertaincomponentsofPTSSwhichhadhereto-foreonlybeenprovedforeffectivenessinindustrializedcountries,staffwereencouragedtomonitortheiraccept-abilitytolocalpopulations.
Inthispaper,wereportontheadaptationsdevelopmentandapprovalprocessateachsiteandthemajoradaptationsdevelopedandimplementedateachsite,presentedaccordingto(1)interventioncomponentand(2)broaderadaptationsthemesandtypes.
Forallcomponents,whilescopeforpossibleadaptationswasprovidedinadvanceofinter-ventionimplementation,theadaptationprocessitselfwasmorepreciselydevelopedand'fine-tuned',inre-sponsetospecific(andoftenunforeseeable)issues,sub-sequenttointerventionimplementation.
EthicalreviewThestudyprocedureswereapprovedbythefollowingethicalreviewcommittees:TheJohnsHopkinsUniver-sityCommitteeonHumanResearch(Thailand);ChiangMaiUniversityResearchInstituteforHealthSciences(Thailand);theMinistryofPublicHealth(Thailand);TheMedicalUniversityofSouthCarolinaInstitutionalReviewBoard(IRB)forHumanResearch(Tanzania);MuhimbiliUniversityofHealthandAlliedSciencesIRB(Tanzania);TheNationalInstituteofMedicalResearchIRB(Tanzania);TheUniversityofCalifornia,SanFran-ciscoCommitteeonHumanResearch(Zimbabwe);andTheMedicalResearchCouncilofZimbabwe(Zim-babwe);andtheUniversityoftheWitwatersrandHealthSciencesResearchEthicsCommittee(SouthAfrica).
Pro-jectAcceptalsohadanindependentDataSafetyandMonitoringBoardwhichbiannuallyreviewedprojectbenchmarks,outcomes,andadverseevents.
Theseeth-icalreviewcommitteesremainedactivethroughouttheintervention,reviewingandadvisingthestudysteeringcommitteeonspecificproposedinterventionadaptationsaspartoftheapprovalprocess.
Inturn,theproject-specificethicscommitteewascomposedofinvestigatorsfromeachsite,andadvisedonwhenanadaptationwouldrequireaprotocolmodificationtobeapprovedbythesereviewboards.
MethodsCommunityconsultationsandadaptationimplementationMonitoringcommunitymembers'attitudestowardstudyactivitiesandpromotingcommunityinvolvementwerekeyelementsofinterventiondevelopmentandhelpedstudystafftotroubleshootimplementationproblemsandimple-mentadaptationswiththesupportofinterventioncom-munities.
Throughoutthedurationofthestudy,structuredcommunityinvolvementhelped(1)toensureongoingtwo-waycommunicationbetweenstudyteamsandstudycommunitiesand(2)torespondtotheethicalandprac-ticalissuesraisedbytrialparticipantsortheirrepresenta-tives.
Communicationwithrelevantdistrict,regionalandnationalleadership,includinglocalgovernmentrepresen-tatives,wasalsomaintainedthroughouttheinterventionasrequired.
Anumberofwaysofmaintainingcommunityinvolvementintheadaptationsprocessweredeveloped,asdescribedbelow.
Kevanyetal.
BMCPublicHealth2012,12:459Page3of11http://www.
biomedcentral.
com/1471-2458/12/459CommunityworkinggroupsCommunityWorkingGroups(CWGs)representedcom-munitymembers'interestsineachinterventioncommu-nity.
CWGsconsistedofapproximately30representativesfromacross-sectionoflocalethnic,tribalandcommunitygroupswhowerealsoleadingmembersoflocalsocialnet-works,includingfaith-basedorganizations(FBOs),sportingclubs,communityhealthservices,andlocalgovernment.
CWGmemberswereencouragedtokeepinclosecontactwiththeircommunities,andfrequentlymetintheabsenceoftheresearchteamtosolicitfeedbackonprojectactivitiesthatthecommunitymightbereluctanttoarticulateinalargerforum.
CWGsalsohelpedtodevelopandtailorin-formation,educationandcommunication(IEC)materialsrelevanttothevarioussocialnetworkswithinthecommu-nityandweresupportedthroughcontinuingtrainingandeducationthroughouttheintervention.
CWGmemberswerenotprojectstaff,butwerepaidasittingallowanceatsomesitesforattendanceinmeetings.
RepresentativesfromeachCWGalsoservedonaStudyAdvisoryCommit-tee(SAC),designed(1)toallowprimarystakeholderstoexerciseleadershipatahigherlevelofstudycoordinationand(2)toensurecommunityinvolvementbothwithinandacrosscommunities.
Community-basedoutreachvolunteersAspartoftheCMteam,community-basedoutreachvolunteers(CBOVs)wereresponsibleforliaisingwithlocalorganizationssuchaspeergroups,FBOsandsocialclubsonbehalfofProjectAccept.
CBOVswerecommu-nitymemberswhobecameearlyadoptersofVCTorPTSSand,wherepossible,heldstrategicpositionswithinlocalsocialnetworks.
Ascommunitymembers,CBOVswereuniquelyplacedtomonitorandreportontheon-goingacceptabilityoftheinterventiontoparticipatingcommunities.
CommunityengagementStudystaffwereconsistentlyencouragedtodevelopnewandcreativewaystokeepparticipatingcommunitiesinformedabout,andengagedin,interventiondevelop-ment,acceptabilityandadaptation.
Theseincludedregular,interactivecommunitymeetings;thecreationanduseofinformalcommunicationchannels(e.
g.
impromptugrouporindividualdiscussionswithcommunitymembers);developingrelationshipswithkeyinformantsoutsideCWGstructures(e.
g.
localbusinessowners);andfacilitat-inglinkagesbetweenCWGsothercommunityorganizations.
TheadaptationsprocessWhileprovisionforadaptationswasmadeintheoriginalstudyprotocol,asdescribedabove,theadaptationsprocesswasprimarilydevelopedduringtheinterventionitself,onasite-by-site,'learningbydoing'basis,asappropriatetothewiderangeofissuesandoftenunforeseenobstaclesthathadtobeaddressedthroughouttheinterventionperiod.
Theadaptationsprocessthereforeevolvedorganically,throughouttheintervention,onanexpostratherthanonanex-antebasis.
Inthisway,theuseofcommunityinvolve-mentandfeedbackmechanismswereessentialtotheadap-tationsprocessacrosssites.
Keyfeaturesofadaptationsdevelopmentandimplementationwereconsistentacrosssites,andincluded(1)identificationanddiscussionofsite-specificutilizationanduptakeissuesonbi-weeklyconfer-encecallswiththeinterventionsub-committeethroughouttheinterventionperiodinordertoensurepromptfeedbackonutilizationchallenges;(2)submissionofawrittenpro-posalforadaptationtotheinterventionsub-committee(3);reviewofproposals,recommendations,andforwardingtothesteeringcommitteeforfurtherreview;and(4)thesteer-ingcommitteemakingafinaldecisiononwhethertoap-proveorrejecttheproposedadaptations.
Asdescribedabove,theCBVCTinterventionalsomaintainedanethicssub-committeethroughouttheinterventionperiod,respon-sibleforthereviewandapprovalofanyproposedadapta-tionstoservicedeliveryfromahumansubjectsperspective,inordertodetermineifprotocolmodificationswouldneedtobeapprovedbythevariousreviewboards.
Adaptationsapprovedbytheethicsandinterventionsub-committees,andlaterbythestudysteeringcommittee,werethenintro-ducedtoprojectstaffviaperiodicalcross-siteretrainingsandinterventionsub-committeesitevisits.
Projectcoordi-natorswerethenresponsibleforpilot-testingtheadaptationand,equallyimportantlymonitoringperformanceoffieldstaffastheadaptationwasimplemented.
ZimbabweInZimbabwe,adaptationswereinitiallyproposedbyfieldstaffduringweeklydebriefingsfollowingconsultationswithandfeedbackfromCWGs,MVCT,CMandPTSSparticipants,aswellasotherstakeholdersinthestudycommunities,includingwardcouncilors,villageheads,localchiefs,andreligiousandpoliticalleaders.
Proposedadaptationswerethendiscussedatinternalprojectman-agementmeetingswiththeprincipalinvestigator,andapprovedadaptationswerediscussedwithinterventionmonitorsandthesteeringcommitteebeforeimplementa-tion.
Approvedadaptationswerethencommunicatedtothelocalchiefcommunity,whotheninstructedjuniorchiefs,villageheads,andsoondownthelocalhierarchytoassistprojectstaffwiththeirimplementation.
ThailandInThailand,fieldstaffacrosscomponentsandCWGswereresponsibleforobservinginterventionacceptabilityandperformanceonaday-to-daybasisthroughouttheintervention.
Additionalcommunity-levelconsultationsKevanyetal.
BMCPublicHealth2012,12:459Page4of11http://www.
biomedcentral.
com/1471-2458/12/459withteenagers,villagehealthpersonnel,religiousgroups,households,andotherlocalvolunteerorcharitygroupswerealsoconductedthroughouttheintervention.
Pro-jectstaffreportedfindingsandsuggestionsforadapta-tionstotheprojectdirectoratweeklyprojectmeetings,whichwereinturnconsideredatmonthlymeetingsofseniorstaff,includinglocalprincipalinvestigators,theprojectdirector,andinterventioncomponentcoordina-tors.
Implementationofadaptationswasrolled-outtothebroadercommunityafterconsultationwithCWGsandotherlocalstakeholders,includingcommunityrepresentativesfromgovernment,healthcareandcom-merce.
CWGmeetingswerefrequentlydividedintosmallerworkinggroupstodiscusstheimplementationofproposedadaptationsand,wereattendedbybothse-niorandfieldstaff.
TanzaniaInTanzaniaadaptationconceptualizationanddevelop-menttookplaceatthefieldstaffandCBOVlevel.
Basedontheirday-to-dayexperienceoffieldactivities,meetingsbetweenfieldstaffandCBOVswereheldonaregularbasistoexchangeideasoninterventionimplementation.
Proposedadaptationswerethenreferredtocomponentcoordinators,thelocalprojectdirector,theSAC,andthelocalprincipalinvestigator.
Afterpreliminaryapprovalforadaptationsfromthestudysteeringcommittee,furtherapprovalwassoughtfromlocalreligiousleadersandcom-munitygroups.
Beforeimplementation,alladaptationswerepublicizedandexplainedincommunitymeetings.
VulindlelaProjectstaffinitiatedchangestotheinterventioninVulin-dlela.
Thesiteusedanongoingdatamanagementandfieldwork'feedbackloop'tomonitorinterventionimple-mentationandadaptations,andweeklyreviewandplan-ningmeetingsbetweenfieldstaffandseniormanagementwerecentraltoensuringefficiencyandeffectivenessofadaptationdelivery.
Usingmonitoringandevaluationdata,includingutilizationandqualityassurancemeasurestotrackoperationalinnovationeffectivenesswasalsocriticaltotheadaptationsprocess.
CBOVsalsoplayedanimport-antroleattheVulindlelasite,providing(1)ausefulsourceofideasforwhatinnovationswouldorwouldnotworkinthisculturalcontext,and(2)ensuringthatadaptationsobtainedthenecessarysupportfromtraditional,politicalandcommunitystructures.
SowetoInSoweto,adaptationstotheinterventionoriginatedpri-marilywithfieldstaff.
Cross-componenteventsplanningcommitteesmadeupofMVCT,CMandPTSSrepresen-tativeswereestablishedineachinterventioncommunitytodevelopadaptationsbeforepresentationtotheprojectdirector.
Adaptationsprojectleaderswerethenidentifiedbytheprojectdirectorandcomponentcoordinatorsandwereresponsibleforprovidingorganizationalleadershipintheimplementationofadaptations.
CBOVswereessen-tialtotheimplementationofadaptationsinSowetobygeneratingsupportfromtheprimarystakeholders,includ-inglocalNGOs,inthecommunity.
ResultsCross-componentadaptationsInterventiondeliveryadaptationsAdaptationstothestructureandschedulesoffieldteamswererequiredacrosssites.
InZimbabweandVulindlela,theinitialdivisionandrotationoffieldteamsacrossinter-ventioncommunitiesbyinterventioncomponent(MVCT,CMandPTSS)wasfoundtobebothinefficientintermsofstafftransportationandconfusingtoparticipants.
InZimbabwe,separateCM,MVCTandPTSSteamswererestructuredintotwocombinedteams,eachofwhichincludedrepresentativesfromMVCT,CMandPTSS.
Eachteamwasallocatedtwointerventioncommunities,andoperatedineachcommunityforatwo-weekperiodeachmonth.
InVulindlela,fourcombinedteamswerecre-atedandassignedtoindividualcommunitiesforthere-mainderoftheintervention.
Interventiondeliveryscheduleswerealsoadaptedtolocalconditions.
InZim-babwe,projectstaffnegotiatedwithminingemployerstodelivertheinterventionatworkplacesforclientsthatwouldnototherwisehavehadaccesstoprojectservicesduringworkinghours,and,similarly,withfarmingemployersduringharvesttimes.
InThailand,itwasobservedwithinthefirst6monthsoftheinterventionthatutilizationbythe18to32year-oldtargetpopulationwashigheroneveningsandweekends,andinterventiondeliv-erywasrescheduledforthesetimes.
InVulindlela,alateafternoonandearlyeveninginterventiondeliveryschedulewasintroducedinresponsetoparticipantfeedbackandbasedonasuccessfulpilot.
Weekendservicedeliverywasalsopiloted,butabandonedafterparticipantsreportedapreferenceforattendingfamilyactivitiesinVulindlelaandasaresultoflowdemandinTanzania.
Anumberofothercross-componentadaptationswerealsointroducedthroughouttheintervention.
InVulin-dlela,aperformanceincentivesystem,includingbonusesforstaffmeetinginterventiondeliverytargetswasintro-ducedinresponsetohighlevelsofstaffturnoverintheearlystagesoftheintervention.
Theriskofcoercionwasmitigatedbytheexclusionoffieldsupervisorsfromthisincentivescheme.
AlsoinVulindlela,areluctancebypar-ticipantstoevaluateprojectactivitiesusingwrittenformsmeantthatthesewerereplacedbyfeedbackdiscussionswithCBOVs.
InThailandandZimbabwe,thefrequentat-tendanceofintoxicatedvillagersatinterventionactivitiesKevanyetal.
BMCPublicHealth2012,12:459Page5of11http://www.
biomedcentral.
com/1471-2458/12/459meantthatthesiteshadtodevelopasystemtoassesseli-gibilityforparticipationbasedontheamountofalcoholconsumed.
InTanzania,owingtothelongdistancesinvolved,projectequipmentwasstoredinsecurevillagestorageareas,includingthehousesofvillageleaders.
ReligiousadaptationsThesupportofFBOscanbecriticaltotheacceptanceofHIVinterventionsinresource-limitedsettings[16,17].
Siteswereencouragedtorespondtoobjections,sugges-tionsorconcernsfromFBOsaboutprojectactivitiesastheyarose,andtoadapttheinterventionaccordingly.
Acrosssites,interactionwithFBOsincludedprojectstafffacilitatingHIV/AIDSdiscussionsduringreligiousser-vices,provisionofMVCTonreligiouscentergrounds,andtheestablishmentofFBO-basedsupportgroups.
InZimbabwe,projectstaffproactivelyengagedwithreligiousgroupswithknownhistoriesofdiscouragingmembersfromseekingmedicalservices.
Inthosecaseswherereli-giousleadersdeclinedallinvolvementwiththeinterven-tion,theirdecisionwasrespectedbystudystaff.
InThailand,supportfromlocalmonkswasessentialtocom-munityacceptanceoftheinterventioninBuddhistcom-munities,andstaffweretrainedinthecorrectetiquetteandprotocolforworkingwithseniorreligiousfigures.
Inaddition,monksininterventioncommunitieswereinvitedtoparticipateintrainingsessionsonprojectgoalsandtheimpactofHIVontheircommunities.
Asaresultoftheseefforts,Buddhisttemplesweremadeavailableforprojectactivities,andanumberofmonksworkedcloselywithCBOVs.
InZimbabweandThailand,thediscussionofreli-giously-sensitiveissueswasdiscouragedduringprojectac-tivitiesheldin,orincloseproximityto,Catholicchurches(e.
g.
onchurchgrounds).
InSoweto,specialsessionsforlocalChristianchurchleaders(abafundisi)wereintro-ducedtopromoteawarenessofprojectactivities:asare-sult,religiousleadersbothaccessedMVCTanddisclosedtheirHIVstatusduringbafundisiforums.
InTanzania,interventionactivitiesweredividedbygenderinMuslimareas,projectactivitieswerenotprovidedinmosques,andCMmessageswereadaptedtoensuresensitivitytolocalMuslimcommunities,includingasuspensionofservicesduringRamadanwhenrequested.
EpidemiologicaladaptationsSiteswereencouragedtoadaptinterventiondeliverytore-spondtothelocalHIVepidemic,andinparticulartotar-getthosehigh-riskpopulationswithlowserviceutilization.
InZimbabwe,TanzaniaandSoweto,highlevelsofHIVprevalenceamongstyoungeragegroups[18]ledtotheintroductionof'youth-friendly'activitiesandcurricula,includinginterventionpresenceatsoccertournaments,whereinformationsessionswereprovidedbeforeanddur-ingmatches;presentationsonprojectactivitiesinschoolguidanceandcounselingclasses;inter-schoolquizcompeti-tionsonHIVandprojectactivities;andthedevelopmentofsupportgroupsforout-of-schoolyouths.
InZimbabwe,theinterventiontargetedtruckdriversandroadsidevendors(viainterventiondeliveryathaltingsites);militarypersonnel(viainformationsessionsatlocalbarracks);andcouples(viapromotionsencouragingjointMVCTandPTSSattendance).
InThailand,wheretheHIVepidemicisconcentratedinyoung,high-riskpopulations[1,19],CBOVsheldworkshopswithteenagegroupstoassesswhichaspectsoftheinterventionweremostattractivetothem.
InSoweto,specificpopulationgroupsweretargetedformobilization,includingtraditionalhealers,Zulumaleslivinginhostels,andwomen'sgroups.
Social,political&culturaladaptationsAlthougheffortshadbeenmadetoincludesite-specificsocialandculturaladaptationsduringprotocoldevelop-ment,arangeoffurtherandrelatedadaptationswereintroducedthroughouttheinterventionthroughtheidentificationofpopularlocalpracticesbyfieldstaff.
Acrossallsites,popularsocialgatheringplaces(e.
g.
pubsandcommunitycenters)andtheirtimesofpeakoperationwereidentifiedovertimeandincludedasinterventionvenues.
InZimbabwe,TanzaniaandSo-weto,adaptationsweremadetohealthandprojectter-minologybasedonfeedbackfromparticipantsandinkeepingwithlocaldialects.
InThailand,theseincludedtribalrituals(e.
g.
sworddancesandcostumedisplays)performedduringprojectevents;fieldstaffhiredbasedontheirknowledgeoflocallanguagesandcustoms;theprovisionofkaraokefacilitiestoparticipantsduringeveningsessions;andspecialliaisonstaffhiredandtrainedtoworkwithrefugeegroupsresidingininter-ventioncommunitieslocatedontheThailand-Burmaborder.
InTanzania,culturalnormsmeantthatwomenwerediscouragedfromutilizingprojectservices.
Asaresult,targetedcampaignsatfemalegatheringplaces(e.
g.
waterboreholes)toencouragewomentoaccessprojectserviceswereintroduced.
AlsoinTanzania,theinterventionwasre-namedas"ProjectAfiki"(thelocalKiswahilitermfor"Accept").
InbothThailandandTan-zania,smallgiftsarefrequentlyexchangedinsocialset-tingsasaformofetiquette.
Althoughtheprotocolprohibitedtheprovisionofmaterialincentivestoattendprojectactivities,itwasagreedthattheprovisionofsmall,valuelesspresents(e.
g.
keyrings)toparticipantswouldbepermittedasaculturalconcession.
InSoweto,fieldstaffobservedthatmanyparticipantswerereluc-tanttoaccessMVCTservicesaloneandpreferredtoparticipateingroups.
Asaresult,a'BringaFriend'strategywasintroduced.
Kevanyetal.
BMCPublicHealth2012,12:459Page6of11http://www.
biomedcentral.
com/1471-2458/12/459MobilevoluntarycounselingandtestingInterventiondeliveryadaptationsOngoingadaptationstoMVCTdeliverywererequiredacrosssites,andcounselingmessageswereupdatedtore-flectbothnewscientificevidenceandlocalneedsthrough-outtheintervention.
Acrosssites,(1)culturally-tailoredhealthservicesmessageswereintroducedintocounselingcurricula,includinginformationonlocalavailabilityandreferrals(exceptpractices);(2)treatmentreferralmessageswereregularlyupdatedtoreflecttheongoingexpansionofantiretroviraltherapy,and(3)specialcounselingcurriculaforhigh-riskpopulationgroupsweredeliveredinresponsetoemergingevidenceontheirroleasdriversoftheepi-demic.
InZimbabwe,clientsrequested,andrecievedtheadditionofabereavement-counselingmessagetoassistincopingwithHIV-relateddeaths.
MVCTadaptationsaccordingtoongoingchangesinnationalhealthpolicieswerealsorequiredacrosssites.
InTanzania,projectstaffcoordinatedMVCTdeliverywiththepresident'snationaltestingcampaign[20],whichwasrolledoutforathree-monthperiodmidwaythroughtheintervention.
InSowetoandVulindlela,theminimumageofparticipationinMVCTwasloweredfrom18to16yearsold,inkeepingwiththeSouthAfri-cannationalHIVtestingpolicy[21].
EnvironmentalandinfrastructuraladaptationsAcrosssites,MVCTvenuesandequipmentwereadaptedtolocalenvironmentandinfrastructure.
InZimbabwe,remotevillageswerefrequentlyinaccessibleduetoroadandweatherconditions,andparticipantsreportedwalk-ingdistancesofupto7kilometerstoaccessdesignatedvenues.
Inresponse,interventionteamsintroducedMVCTtoaseriesofremote'satellitevenues'identifiedincollaborationwithCBOVs.
InThailand,thecommu-nalphilosophyof'house,temple,school'wasadoptedforMVCTdelivery.
Withthepermissionoflocalcommu-nityleaders,Buddhisttemples,Christianchurches,otherreligiouscenters,privatehouses,andlocalhealthcenterswereusedasMVCTvenues,andriver-boatsandmotor-bikeswereusedtotransportMVCTstafftomoreremotevenues.
Tablesandchairswereprovidedbythecommu-naltemple(wat),andcommunitymemberswereactiveinhelpingtosetupequipment.
Asaresultofthiscom-munityassistance,thesitedidnotneedtoinvestincara-vansortentsthroughouttheintervention.
InTanzania,roadsideserviceprovisionwasintroducedalongmajortransportationroutestoincreaseMVCTutilization.
InVulindlela,SowetoandZimbabwe,andwiththeencour-agementofteachers,MVCTwasprovidedinlocalschools.
CMstafflaterreportedincreasedknowledgeandawarenessofprojectactivitiesfromstudents'par-ents.
InVulindlela,theoriginalMVCTcaravanswerereplacedwithlargermodelsinordertomeetutilizationdemandsatpeaktimes,whileinZimbabweandTanza-nia,tentswereusedinsteadofcaravansforlessaccess-iblesites.
Post-testsupportservicesInterventiondeliveryadaptationsCommunityperceptionsofPTSSwereambivalentattheintroductionoftheinterventionandPTSSparticipationwasoftenmistakenlyassociatedwithHIVinfectionbycommunitymembers.
Inthesecases,communitymem-bersassumedthatonlyHIV-positiveindividualswouldrequirePTSS.
TheresultinginitiallowuptakeofPTSSdrovearangeofadaptationstoeligibilityandparticipa-tioncriteriatoimprovebothrecruitmentandcommu-nityperceptionsofPTSS.
Acrosssites,initialuptakeofPTSSserviceswasmainlybypeoplewhohadnotyetbeentestedforHIVbyProjectAccept.
Theseindividualsweredesignatedas"guests"withinthePTSSsystemandweregrantedlimitedaccesstoservices.
Thisrestrictionwasabandonedafter'guest'participantsrequestedgreateraccesstoPTSSinordertoprepareforVCT.
Asaresult,theroleofPTSSevolvedintosupportingandadvisingbothVCTparticipantsandthoseconsideringVCT.
InZimbabwe,wherePTSSgroupswereinitiallyseparatedbetweenHIVpositiveandnegativeindividuals,combined-statusgroupswereintroduced,andpartici-pantswereinvitedbothtocontributetocurriculumde-velopmentandformtheirownadministrativestructures.
Thestructure,contentandschedulingofPTSSsessionswerealsoadaptedinresponsetoparticipantdemands.
Acrosssites,individualpsycho-socialcounselingsessionswereinitiallyonlyavailablebyadvanceappointment.
Astheinterventionprogressed,andinresponsetoclientdemand,thisservicewaswereprovidedbeforeandafterotherPTSSactivities,onanad-hocbasis.
InThailand,(1)CETsessionsweredividedbyagegrouptoaccommodateawideagerangeofparticipants,eachofwhichhaddifferentdiscussionpreferences,and(2)supportgroupprovisionwasdeliveredincollaborationwithlocalgovernmenthealthcentersafterstaffdiscoveredthatthesecentersweredeliveringanidenti-calservice.
AlsoinThailand,duetothelowincidenceofHIVininterventioncommunities,CETsessionswereadaptedtoprovideinformationtoHIV-negativepersonsoncopingwiththepotentialriskofHIVandhelpingotherstocopewithHIV.
InThailandandTanzania,theplanned8-hoursessionsforcopingeffectiveness(CET)andstigmare-ductionactivitieswerefoundtobetoolongforparticipants,andwerereducedtothree3hoursessionsoversuccessivedays.
InTanzania,moreflexibleschedulingofPTSSwasintroducedtorespondtocommunitydemands.
VariousotheradaptationsweremadetoPTSSservicedeliverythroughoutthecourseoftheintervention.
Acrosssites,PTSSinformationboothsweresetupadjacenttoMVCTtofacilitaterecruitmentofparticipantstoPTSS.
Kevanyetal.
BMCPublicHealth2012,12:459Page7of11http://www.
biomedcentral.
com/1471-2458/12/459InTanzania,sportingactivities,cardgamesandboardgameswereintroducedintoPTSSsessionsinordertoprovideasocialforumforHIVdiscussions.
InZimbabwe,atrainer-of-trainerscoursewasintroducedforPTSSparti-cipants.
InSoweto,PTSSadvocatesweretrainedinsafedisclosureprocedures,andspecialPTSSsessionsdesignedfortheeducationandtrainingoftraditionalhealersonHIV/AIDSandrelatedissueswereintroduced.
Asaresult,anumberoftraditionalhealersreferredtheirpatientstoMVCTandPTSS.
InVulindlela,PTSSstaffprovidedtele-phoneremindersofsessiontimestonewparticipants.
EnvironmentalandinfrastructuraladaptationsAcrosssites,PTSSvenueswereadaptedtothelocalenvir-onmentandinfrastructure.
InZimbabwe,VulindlelaandSoweto,PTSSwasredesignedasamobileserviceinordertoimproveaccess.
Venuesincludedschools,communityhalls,andlocalbusinesscenters.
InVulindlela,partici-pantsindicatedapreferenceforaccessingPTSSincom-munitiesotherthanthoseinwhichtheylived,inordertoreducepossiblestigmaassociatedwithPTSSparticipation.
Asaresult,ProjectAcceptoffices,whichwerelocatedoutsideinterventioncommunities,wereadoptedasPTSSvenues.
Transportwasprovidedtoparticipantsbyprojectstaff,andparticipantssubsequentlyreportedamoreenab-lingandopenlearningenvironment.
InZimbabwe,parti-cipantsreporteddifficultyaccessingPTSSreferralservicesduetotransportcosts.
Inresponse,projectstafftrans-portedserviceproviders,includingnutritionists,lawyers,andnurses,totheinterventioncommunities.
EconomicadaptationsPTSSadaptationsalsorespondedtolocaleconomiccondi-tions.
InZimbabweandTanzania,poverty,hungerandmal-nutritionwerecommonissuesininterventioncommunitiesandwerefrequentlycitedasreasonsfornon-attendanceoflongersessions.
Thefollowingadaptationsweredevelopedinresponse:(1)provisionoftea,lunchandnutritiousdrinks(mahewu)toparticipants,(2)incomegenerationandskillsdevelopmentclassesprovidedbeforeandafterPTSSactiv-ities,(3)developmentofpartnershipswithlocalorganiza-tionsandgovernmentofficialstoprovidefarminginputs,foodaid,andlegalservicestoparticipants,(4)supportgroupswereprovidedwithhorticulturalequipmentandtraininginpartnershipwithlocalgroups,and(5)laycoun-selorsweretrainedthroughtheZimbabweInstituteofSys-temicTherapy(ZIST-CONNECT).
InThailandandTanzania,income-generatingequipment,includingchickencoopsandcropseeds,wereprovidedtobothunemployedandHIV-positiveparticipants.
TheseadaptationshelpedbothtomitigatetheeconomiceffectsofHIV-relatedstigmaandtoattractHIV-positivepersonswithoutothermeansofincometoPTSS.
CommunitymobilizationInterventiondeliveryadaptationsAcrossallsites,ongoingadaptationstoCMmessageswererequiredtomitigatebothparticipantfearsofblooddrawsandintervention'staffstigma',inwhichprojectstaffweresuspectedofbeinginfectedwithHIV.
InVulindlela,theuseofpamphletsasanoutreachstrategywasfoundtobeineffectualduetopoorliteracyandwasreplacedbypublicmobilizationtalksheldincentralandpubliccommunityareas.
InSoweto,CM'roadshows',whichinvolvedvehiclesandfieldstafftouringthroughinterventioncommunities,weredevelopedandincludedacombinationofdoor-to-dooractivitiesandparticipa-tionbyprominentlocalcommunitymembers;CM'streetdialogues',whichinvolvedapproachinganden-gagingcommunitymembersinconversationabouttheintervention,combinedwiththedistributionofpromo-tionalmaterials;andskillsdevelopmentworkshops,in-cludingcareercounseling,wereprovidedtocommunitymembersaspartofCMactivities.
InbothSouthAfricansites,megaphonesandloudhailerswereusedtodeliverCMmessagesandannounceMVCTandPTSSvenuesandactivitiesafterstaffobservedcommunitymembersusingPAsystemstoannouncecommunityevents.
Inaddition,youth-specificCMactivitieswereintroducedinschools,andprojectdriversweretrainedtobecomepart-timeCMstaff.
Environmental,politicalandinfrastructuraladaptationsCMactivitieswerecontinuallyresponsivetothelocalen-vironment.
Acrossallsites,andinresponsetocommu-nityfeedback,CMactivitiesweregraduallyrelocatedclosertoMVCTandPTSSvenues,throughouttheinter-vention.
InZimbabwe,(1)CMactivitiesweresuspendedduringelectionperiodstoavoidbeingmistakenforpolit-icalactivismandensurethesafetyofstaff,participantsandprojectequipment,and(2)CMstaffprovidedtrans-portandnursingstaffwhereverpossibleduringdiseaseoutbreaks(e.
g.
cholera),whichwasbeyondtheinitialscopeoftheprotocol.
InSoweto,CMcampaignsspecif-icallyfocusedtheireffortsonZuluhostels,whichwereinitiallyopposedtomaleinvolvementinHIVtestingac-tivities,and,inbothSouthAfricansites,CMstaffpro-motedtheinterventionasapartofthe''lifeskills''curriculuminlocalschools.
InTanzania,CMactivitiesinremotecommunitieswereconcentratedinthedrysea-son,andCMteamsizewasadjustedacrosscommunitiesininverseproportiontointerventiondemand.
Community-basedoutreachvolunteersAcrosssites,theroleofcommunity-basedoutreachvolun-teers(CBOVs)evolvedinresponsetointerventionneeds.
InVulindlela,unanticipateddemandsofCMworkonfieldstaffresultedintheincreasedrecruitmentandutilizationKevanyetal.
BMCPublicHealth2012,12:459Page8of11http://www.
biomedcentral.
com/1471-2458/12/459ofCBOVs.
CBOVsweregivenindividualandgrouptar-getsforPTSSandMVCTrecruitment,andstipends,transportallowances,andotherincentiveswereprovided.
Asaresult,CBOVswererenamedCommunity-BasedOutreachMobilizersinkeepingwiththeirenhancedCMrole.
AlsoinVulindlela,astrongfamilycultureledtothedeliberaterecruitmentofCBOVsfromlargefamilies,whothenencouragedtheirsocialnetworkstoattendMVCTandPTSS.
InZimbabwe,initiallowlevelsofinvolvementbywomenpromptedthetrainingofincreasednumbersoffemaleCBOVs.
InTanzania,CBOVshelpedtoadviseonthechoiceofinterventionvenues,givingthemanun-anticipatedroleintheinterventiondeliveryprocess.
Discussion&conclusionsConsistency&flexibilityinadaptationdevelopmentBoththeadaptationsprocessandimplementationoftheadaptationsthemselveswerecriticaltotheacceptance,utilizationandsustainabilityoftheProjectAcceptinter-ventionacrossstudysites.
Theadaptationsprocess,whichhadtobalancesensitivitytothelocalcontextinordertoimproveutilizationagainstconsistencyinthecoreelementsofinterventiondeliveryinaccordancewiththemulti-sitestudyprotocol,alsoneededtoensureaminimumlevelofcomparabilityacrosssites.
Inthisway,site-specificadaptationsprocesses,whileprocedur-allyvariable,maintainedacommonsetoffeatures.
Theseincluded(1)involvementoffieldstaffinthegenerationofadaptations,(2)communityacceptancemeasures,and(3)theroleofthestudysteeringcommittee,ethicalre-viewboards,andinterventionsub-committeesintheirapprovalandimplementation.
Theadaptationsdevelopedacrosssites,whilediverse,alsomaintainedacommonsetofthemesandapproaches.
Inmanycases,thesamecross-component,orcomponent-specific,adaptationswouldbedevelopedindependentlyacrosssites.
Inothercases,successfuladaptationsinonesitewouldquicklybeadoptedbyothersites.
Intheseways,anumberofcommonthemesinadaptationtypes,suchasthoseidentifiedabove,werereadilyidentifiableacrosssites.
Measuringadaptationimpact&estimatingeffectsonuptakeWhileourexperiences,andassociatedanecdotalevidence,providecompellingsupportforthehypothesisthattheseadaptationsinfluencedtheimpactoftheCBVCTinterven-tionthroughincreasedMVCTandPTSSutilization,itis,ofcourse,notpossibletoestablishapurelycausallinkbe-tweenadaptationimplementationandsuchoutcomes.
Arangeofpotentialconfoundingfactorsexist,including,butbynomeanslimitedto,thestageofinterventionimple-mentation,increasedcommunityacceptanceovertime,andbroaderenvironmentalchangesinknowledgeof,andattitudestowards,testingforHIVininterventioncommu-nities.
Nonetheless,isitnotablethatinterventionuptakeininterventioncommunitieswasover10timeshigherthanincontrolcommunities,inwhichnoadaptationswerepermitted,bytheendoftheintervention[9].
Inaddition,serviceutilizationmonitoringandevaluationdata,whenreviewedonasite-by-sitebasis,maybechronologicallyassociatedwiththeimplementationofsig-nificantadaptations,whenallowingforappropriatetimelags.
Forexample,attheVulindlelasite,serviceuptakeforMVCTrosebyover100percent(meanuptakeforthefirsttwoquartersof2007was142participants,ascom-paredto289participantsinthesecondtwoquarters,andincreasingfurtherto369participantsinthefirsttwoquar-tersof2008),directlyaftertheserviceprovisionplanwasadaptedfromrotatingspecializedMVCT,PTSSandCMteamstocommunity-based,integrated,andmulti-skilledteams.
Giventhetemporalproximityofsuchimprove-mentsinutilizationwithadaptationimplementation,itmaybepostulatedthatsuchadaptationsmayhavehad,acrosssites,asignificantimpactonserviceutilization.
DeterminingwhentochallengesocietalnormsOneofthemostchallengingaspectsoftheCBVCTinterventionwasdeterminingwhentochallengesocietalnormsininterventiondeliveryandadaptation.
Forex-ample,asdescribedabove,genderissueswerecircum-ventedthroughtheadapteddeliveryoffemale-specificinterventions.
Ontheotherhand,religiousissueswere,ingeneral,accommodated,ratherthanchallenged,byadaptingtheintervention.
Decisionsaroundwhensoci-etalnormsshouldbechallenged,throughinterventionadaptationsareinherentlysubjectiveandenvironment-specific[15].
However,asageneralprinciple,adaptingto,ratherthanchallenging,societalnormswasfoundtobemostappropriateintheCBVCTcontext.
Diplomacy,globalhealth,andforeignpolicyThecapacitytoadaptglobalhealthinterventionstolocalconditionsalsohasconsiderablesignificancefromthefor-eignpolicyperspective,inthecontextofthedisciplinenowknownandrecognizedasglobalhealthdiplomacy[10].
Underthisaegis,theinclusionofscopeforadaptabil-ityininterventiondesignanddeliveryhasthepotentialtomakesignificantdifferencestolocalperceptionsofinter-nationaldevelopmentactivities,includingtheapprovalandacceptanceofprogramsandinterventionsbyrecipientcountries,communities,andindividuals,and,byexten-sion,theprofileandprestigeofdonororganizationsandcountries[22,23].
Overtime,suchinterventionsmayneedtobecomemoresensitizedtothesebroaderrolesandre-sponsibilities,ascurrentlyreflectedatthepolicylevelbyincreasedintegrationbetweendepartmentsofforeignpol-icyandforeignassistanceindonorcountries-helpingtoKevanyetal.
BMCPublicHealth2012,12:459Page9of11http://www.
biomedcentral.
com/1471-2458/12/459maintain,orevenincrease,levelsofdevelopmentfundingona'smartpower'basis.
Systemsofmoreformalllyconsid-eringthevalueandworthofglobalhealthinterventionsfroma'foreignpolicy'perspectivemaybedeveloped,in-cludingsuchconsiderationsascommunityacceptanceandinvolvement,sothatsuchtheycanbemonitoredandevalu-atedonthisbasis[24].
Theassociatedcapacityofinterven-tionstoadapttolocaleconomic,cultural,religious,andotherenvironmentalconditionsinrecipientcountriesmayhavethepotentialtomakeasubstantialdifferencetothesebroader'collateral'diplomatic,andforeignpolicyoutcomesofforeignassistanceprograms[25].
RecommendationsAnumberofadaptation-relatedrecommendationsforrelatedfutureinterventionsmaybegleanedfromthePro-jectAcceptexperience.
Collaborationwithlocalactors,notjustinservicedelivery,butatthehighestlevelsofinterventiondesignandplanning,is,ofcourse,asinequanonofanyenlightenedinterventioninthe21stcentury.
Perhapsmostimportantly,however,thenecessityofbuild-inginprovisionsandscopeforadaptationstothestudyinadvanceofinterventionimplementation,onanexantebasis,shouldbeborneinmindbothbyplannersandscien-tists.
Thismaybeachieved,mostdirectly,throughtheuseofappropriateterminologyinboththestudyprotocolandstandardoperatingproceduresdocuments:inavoidingtheuseofexcessivelydogmaticordidacticlanguage,interven-tionsmaybeimplicitlypermittedappropriatelevelsofflexibilityininterventiondelivery,whilstmaintainingfidel-itytotheoriginalstudyprotocol.
Similarly,relatedandfu-turestudiesshould,whereverpossible,makeallowanceforthemonitoringandevaluationofchangesinserviceutilizationconsequenttoadaptationimplementation-though,asdescribedabove,thismaybedifficulttoachieveinthepresenceofmultiplecompetingfactorseffectingser-viceuptake.
Nonetheless,whereverpossible,theeffectofadaptationimplementationonkeystudyoutcomesshouldbecarefullyreviewed,onasite-by-sitebasis,andwithreferencetoappropriateleadtimes,inordertodeterminetheireffectiveness.
Finally,asdescribedabove,thebroader'collateral'gainsofsuchadaptations,suchasimprovementsininternationalrelationsandcommunityacceptance,shouldbecarefullyconsidered,whereverpossible,throughthedevelopmentandapplicationofappropriatemetrics.
ConclusionsAdaptationsareparticularlyimportantinthedesignofHIV-relatedinterventions.
Giventheoft-contentiousna-tureofsuchinterventionsfromasocial,culturalandreli-giousperspective[26],itisessentialtoensurethat,whereverpossible,andfromboththeservicedeliveryandtheglobalhealthdiplomacyperspectives,theseinterven-tionsaredesignedwiththeexpectationsandneedsofrecipientcommunitiesinmind.
InthemorespecificcaseofVCT,forwhichutilizationbymost-at-riskpopulationsisfrequentlyakeyissue[27],adaptabilitytolocalcondi-tionsmayhelptobreakdownabothbehavioralandenvir-onmentalbarrierstothetestingprocess.
Ultimately,theneedforinterventionadaptationisbasedonchallengesthatcouldnothavebeenforeseenduringthedesignandlaunchoftheintervention.
Pre-parationswillneverbeperfect,sotime,money,capacityandflexibilitytoproduceinterventionshastobe'built-in'tothedesignofbothtrials,andinterventionsthem-selves,atallstagesoftheplanningprocess.
Withoutthisinherentadaptability,programdesignersandimplemen-tersriskachievingsub-optimalutilizationlevels.
Aslongasintegritytothekeyelementsoftheinterventionprotocolcanbemaintained,suchadaptationscanonlyenhancethevalueoftheinterventionintheeyesofpol-icymakers,communitiesandindividuals-inbothdonorandrecipientcountries.
CompetinginterestsTheauthorsdeclarethattheyhavenocompetinginterests.
AcknowledgementsThisresearchwassponsoredbytheU.
S.
NationalInstituteofMentalHealthasacooperativeagreement,throughcontractsU01MH066687(JohnsHopkinsUniversity),U01MH066688(MedicalUniversityofSouthCarolina),U01MH066701(UniversityofCalifornia,LosAngeles),andU01MH066702(UniversityofCalifornia,SanFrancisco).
Inaddition,thisworkwassupportedbytheHIVPreventionTrialsNetwork(HPTNProtocol043)oftheDivisionofAIDSoftheU.
S.
NationalInstituteofAllergyandInfectiousDiseases,andbytheOfficeofAIDSResearchoftheU.
S.
NationalInstitutesofHealth.
Viewsexpressedarethoseoftheauthors,andnotnecessarilythoseofsponsoringagencies.
Wethankthecommunitiesthatpartneredwithusinconductingthisresearch,andallstudyparticipantsfortheircontributions.
Wealsothankstudystaffandvolunteersatallparticipatinginstitutionsfortheirworkanddedication.
Authordetails1InstituteforHealthPolicyStudies,UniversityofCalifornia,SanFrancisco,50BealeStreet,Suite1300,SanFrancisco,CA94105,USA.
2CenterforAIDSPreventionStudies,UniversityofCalifornia,SanFrancisco,USA.
3UniversityofZimbabwe,Harare,Zimbabwe.
4PerinatalHealthResearchUnit,Soweto,SouthAfrica.
5HumanSciencesResearchCouncil,Durban,SouthAfrica.
6MuhimbiliUniversityofHealthandAlliedSciences,DaresSalaam,Tanzania.
7ChiangMaiUniversity,ChiangMai,Thailand.
8MedicalUniversityofSouthCarolina,Charleston,USA.
9DepartmentofEpidemiology,UniversityofWashington,Seattle,WA,USA.
10InternationalCenterforResearchonWomen,Washington,DC.
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doi:10.
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:Healthdiplomacytheadaptationofglobalhealthinterventionstolocalneedsinsub-SaharanAfricaandThailand:evaluatingfindingsfromProjectAccept(HPTN043).
BMCPublicHealth201212:459.
SubmityournextmanuscripttoBioMedCentralandtakefulladvantageof:ConvenientonlinesubmissionThoroughpeerreviewNospaceconstraintsorcolorgurechargesImmediatepublicationonacceptanceInclusioninPubMed,CAS,ScopusandGoogleScholarResearchwhichisfreelyavailableforredistributionSubmityourmanuscriptatwww.
biomedcentral.
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BMCPublicHealth2012,12:459Page11of11http://www.
biomedcentral.
com/1471-2458/12/459
Wereportontheadaptationsdevelopment,approvalandimplementationprocessfromtheProjectAcceptvoluntarycounselingandtesting,communitymobilizationandpost-testsupportservicesintervention.
Methods:Wereviewedallrelevantdocumentationcollectedduringthestudyinterventionperiod(e.
g.
monthlyprogressreports;bi-annualsteeringcommitteepresentations)andconductedaseriesofsemi-structuredinterviewswithprojectdirectorsandbetween12and23fieldstaffateachstudysiteinSouthAfrica,Zimbabwe,ThailandandTanzaniaduring2009.
Respondentswereaskedtodescribe(1)theadaptationsdevelopmentandapprovalprocessand(2)themostsuccessfulsite-specificadaptationsfromtheperspectiveoffacilitatinginterventionimplementation.
Results:Acrosssites,proposedadaptationswereidentifiedbyfieldstaffandsubmittedtoprojectdirectorsforreviewonaformallyplannedbasis.
Thecross-siteinterventionsub-committeethenensuredfidelitytothestudyprotocolbeforeapproval.
Successfully-implementedadaptationsincluded:interventiondeliveryadaptations(e.
g.
developmentoftailoredcounselingmessagesforimmigrantlabourgroupsinSouthAfrica)political,environmentalandinfrastructuraladaptations(e.
g.
useoflocalcommunitycentersasVCTvenuesinZimbabwe);religiousadaptations(e.
g.
dividingclientsbygenderinMuslimareasofTanzania);economicadaptations(e.
g.
co-provisionofincomegeneratingskillsclassesinZimbabwe);epidemiologicaladaptations(e.
g.
provisionof'youth-friendly'servicesinSouthAfrica,ZimbabweandTanzania),andsocialadaptations(e.
g.
modificationofterminologytolocaldialectsinThailand:andadjustmentofservicedeliveryschedulestosuitseasonalanddailyworkschedulesacrosssites).
(Continuedonnextpage)*Correspondence:sebastian.
kevany@ucsf.
edu1InstituteforHealthPolicyStudies,UniversityofCalifornia,SanFrancisco,50BealeStreet,Suite1300,SanFrancisco,CA94105,USA2CenterforAIDSPreventionStudies,UniversityofCalifornia,SanFrancisco,USAFulllistofauthorinformationisavailableattheendofthearticle2012Kevanyetal.
;licenseeBioMedCentralLtd.
ThisisanOpenAccessarticledistributedunderthetermsoftheCreativeCommonsAttributionLicense(http://creativecommons.
org/licenses/by/2.
0),whichpermitsunrestricteduse,distribution,andreproductioninanymedium,providedtheoriginalworkisproperlycited.
Kevanyetal.
BMCPublicHealth2012,12:459http://www.
biomedcentral.
com/1471-2458/12/459andThailand:evaluatingfindingsfromProjectinterventionstolocalneedsinsub-SaharanAfricahealthHealthdiplomacyand``theadaptationofglobal(Continuedfrompreviouspage)Conclusions:Adaptationselection,developmentandapprovalduringmulti-siteglobalhealthresearchstudiesshouldbeaplannedprocessthatmaintainsfidelitytothestudyprotocol.
Thesuccessfulimplementationofappropriatesite-specificadaptationsmayhaveimportantimplicationsforinterventionimplementation,frombothaserviceuptakeandaglobalhealthdiplomacyperspective.
Keywords:Adaptations,Voluntarycounselingandtesting,Globalhealthdiplomacy,HIV,Sub-SaharanAfricaBackgroundTheHIVepidemicFromapublichealthperspective,thereisnomorecom-pellingcrisisintheworldtodaythantheHIVepidemicinsub-SaharanAfrica.
Sincetheepidemicbegan,morethan60millionpeoplehavebeeninfectedwithHIV[1],andin2009,AIDSkilled1.
4millionpeopleinAfricaalone.
Inadditiontothedeathanddiseaseburden,theepidemichashadanenormousimpactoneconomies,lifeexpectan-cies,andsociety.
Globally,aboutone-thirdofthosecur-rentlylivingwithHIVareaged15–24,andyoungadultsaccountfor40%ofallnewinfections[1].
Fromtheper-spectiveofnationalAIDScontrolplannersandpolicy-makersinthesecountries,evidence-basedstrategiesthathavemaximumepidemicimpactontargetregionsandpopulationsarecriticallyimportant.
Forthistooccur,bothplannersandimplementersneedinterventionsthatarebothsustainable,andadaptable,tothelocalepidemiological,cultural,economicandinfrastructuralcontext[2,3].
Randomizedcontrolledtrialsthattestsuchinterventionsshouldbecorrespondinglyflexibleandsen-sitivetolocalneedsthroughouttheirdevelopmentandimplementation.
AdaptingglobalhealthinterventionsAdaptationstohealthprogramsaredefinedasthedegreetowhichtheyarechangedormodifiedbyauserintheprocessoftheiradoptionandimplementation[4].
HIV-relatedinterventionsthathavebeenprovenforefficacyfrequentlyneedtobeadaptedtodifferentenvironmentsandsettingswhenimplementedaspublichealthprograms[5,6].
Similarly,HIV-relatedtrials,especiallythosethatareconductedinmultiplecountriesoratmultiplesiteswithinacountry,frequentlyrequiresite-specificadaptationstotheinterventioninorder(1)torespondtosocio-culturaldifferences[7](2),tomakeinterventionsmorerelevantandsensitivetotargetpopulations(includingdifferentriskdeterminantsandriskbehaviors)[2,3,8],(3)toimproveinterventionutilizationandeffectiveness[9],and(4)toensurethatinterventionsmeetminimumdiplomatic[10]andforeignpolicy[11]standards.
Forthelatter,aninabil-itytoalignbroaderpolicygoalswithglobalhealthinitia-tives,hasthepotentialtocreate'atenseandconfusingduality'[12].
Inallcases,adaptationdevelopmentandimplementationshouldbeaplannedprocessthatmain-tainsfidelitytocoreelementsofthestudyprotocol[13].
ProjectAcceptTheProjectAcceptinterventionhasbeendescribedelse-where[9].
Briefly,34communitiesinsub-SaharanAfrica(atstudysitesinSowetoandVulindlelainSouthAfrica,KisaraweinTanzania,andMutokoinZimbabwe)and14communitiesinThailandwererandomizedtoreceiveeitheracommunity-basedvoluntarycounselingandtest-ing(CBVCT)interventioninadditiontostandardclinic-basedVCT(SVCT)services,orSVCTservicesalone.
TheCBVCTinterventionhadthreemajorcomponentsdesignedtochangecommunitynormsandreduceriskofHIVinfectionamongallcommunitymembers,irrespect-iveofwhetherornottheyparticipateddirectlyintheintervention.
Thesewere(1)tomakecounselingandtest-ingmoreavailableincommunitysettingsthroughmobilevoluntarycounselingandtesting(MVCT),(2)toengagethecommunitythroughcommunitymobilization(CM),and(3)toprovidepost-testsupportservices(PTSS),in-cludingpsychosocialsupportgroups,copingeffectivenessandstigmareductiontraining.
Theinterventionwasof42monthsduration,withstartandend-datesvaryingbysite.
Althoughtheinterventionineachofthecountriesandstudysiteswasderivedfromthesametheoreticalmodel[14,15],containedthesamecorestrategies,andcon-formedtocommonstandardoperatingprocedures,theimplementationofinterventioncomponentswasdesignedtoberesponsiveandadaptabletoeachlocalcontext.
Tothisend,allstagesofinterventionimple-mentationweredeterminedthroughintensivecollabor-ationbetweenhost-countryinvestigatorsandinstitutions,studycommunities,fieldstaff,andtheirinternationalpartnerinstitutions(listedatendofpaper).
Inparticular,themultisitestudysteeringcommitteeworkedwithrepresentativesofnationalAIDSprogramsinhostcountriesthroughoutthedevelopmentoftheintervention,onbothadeliberativeandanad-hocbasis,both(1)tokeepnationalplannersinformedonprojectactivitiesand(2)toensurethatprojectactivitieswereimplementedinamannerthatwouldbebothappropri-ateandsustainableinresource-limitedsettings.
Kevanyetal.
BMCPublicHealth2012,12:459Page2of11http://www.
biomedcentral.
com/1471-2458/12/459Aninterventionsubcommitteewastaskedwithover-seeingallaspectsoftheinterventionandincludedmem-bersfromeachofthefiveprojectsites.
Thedutiesofthesubcommitteewere(1)tomonitorinterventionimple-mentationtoensurethatallsitesworkedtocommonstandards,(2)developandconductregularqualityassu-ranceactivities,and(3)propose,discussanddetermineacceptabilityofsite-specificadaptationstothestudyprotocol.
Inaddition,theinterventionsubcommitteeestablishedaninterventionworkinggroupateachsiteincludingsiteprincipalinvestigatorsandprojectdirec-tors.
Thesegroupsworkedviaconferencecallsandsitevisitsthroughouttheintervention.
Thisparticipatoryprocessfacilitatedtheresolutionofbothsite-specificandcross-siteissues–andhelpedindeveloping,determiningandapplyingprotocoladaptations.
TheCBVCTinterventionwasremarkablysuccessfulintermsofserviceutilization.
After42monthsoftheintervention,utilizationoftheCBVCTmodelwasmorethan10timeshigherthanutilizationofSVCTincontrolcommunities,acrisssites[9].
Thisdivergencewaspri-marilyattributabletothemobilenatureoftheinterven-tion,combinedwithextensiveCMeffortstopromoteutilizationininterventioncommunities.
Inadditiontotheseexplanations,theongoingadaptabilityoftheCBVCTinterventiontolocalconditionsmayhavehelpedtogenerateandmaintaintheseutilizationlevels.
AdaptationstotheProjectAcceptinterventionEachinterventioncomponentwasdesignedwithvaryingallowancesforadaptationstolocalconditionsthrough-outtheintervention.
ForMVCT,siteswerefreetodeter-minethemostappropriatesystemofservicedelivery(e.
g.
tents,caravans,communitybuildings,orprojectvehicles)aswellasfieldhoursoperatingschedules.
ForCM,studystaffwereasked:'Isourinnovationsensitiveto,andcom-patiblewith,thecommunity'sexistingvaluesandbeliefs,localculture,indigenouscustoms,pastexperiences,andtheneedsofpotentialadopters'Inthisway,CMstaffwereresponsiblefordiscoveringhowtheinterventioncouldbemademorecompatiblewithcommunities'exist-ingvaluesthrough(1)suggestinganddevelopingnewsystemsforworkingwithlocalsocialnetworksand(2)theongoingrefinementofinformation,educationandcommunication(IEC)messages.
ForPTSS,coordinatorscomponentswereencouragedtoworkwithcommunityrepresentativestoidentifylocalpost-testserviceneedsaswellascollaboratingwithrelatedexistingservices(ifany).
ForcertaincomponentsofPTSSwhichhadhereto-foreonlybeenprovedforeffectivenessinindustrializedcountries,staffwereencouragedtomonitortheiraccept-abilitytolocalpopulations.
Inthispaper,wereportontheadaptationsdevelopmentandapprovalprocessateachsiteandthemajoradaptationsdevelopedandimplementedateachsite,presentedaccordingto(1)interventioncomponentand(2)broaderadaptationsthemesandtypes.
Forallcomponents,whilescopeforpossibleadaptationswasprovidedinadvanceofinter-ventionimplementation,theadaptationprocessitselfwasmorepreciselydevelopedand'fine-tuned',inre-sponsetospecific(andoftenunforeseeable)issues,sub-sequenttointerventionimplementation.
EthicalreviewThestudyprocedureswereapprovedbythefollowingethicalreviewcommittees:TheJohnsHopkinsUniver-sityCommitteeonHumanResearch(Thailand);ChiangMaiUniversityResearchInstituteforHealthSciences(Thailand);theMinistryofPublicHealth(Thailand);TheMedicalUniversityofSouthCarolinaInstitutionalReviewBoard(IRB)forHumanResearch(Tanzania);MuhimbiliUniversityofHealthandAlliedSciencesIRB(Tanzania);TheNationalInstituteofMedicalResearchIRB(Tanzania);TheUniversityofCalifornia,SanFran-ciscoCommitteeonHumanResearch(Zimbabwe);andTheMedicalResearchCouncilofZimbabwe(Zim-babwe);andtheUniversityoftheWitwatersrandHealthSciencesResearchEthicsCommittee(SouthAfrica).
Pro-jectAcceptalsohadanindependentDataSafetyandMonitoringBoardwhichbiannuallyreviewedprojectbenchmarks,outcomes,andadverseevents.
Theseeth-icalreviewcommitteesremainedactivethroughouttheintervention,reviewingandadvisingthestudysteeringcommitteeonspecificproposedinterventionadaptationsaspartoftheapprovalprocess.
Inturn,theproject-specificethicscommitteewascomposedofinvestigatorsfromeachsite,andadvisedonwhenanadaptationwouldrequireaprotocolmodificationtobeapprovedbythesereviewboards.
MethodsCommunityconsultationsandadaptationimplementationMonitoringcommunitymembers'attitudestowardstudyactivitiesandpromotingcommunityinvolvementwerekeyelementsofinterventiondevelopmentandhelpedstudystafftotroubleshootimplementationproblemsandimple-mentadaptationswiththesupportofinterventioncom-munities.
Throughoutthedurationofthestudy,structuredcommunityinvolvementhelped(1)toensureongoingtwo-waycommunicationbetweenstudyteamsandstudycommunitiesand(2)torespondtotheethicalandprac-ticalissuesraisedbytrialparticipantsortheirrepresenta-tives.
Communicationwithrelevantdistrict,regionalandnationalleadership,includinglocalgovernmentrepresen-tatives,wasalsomaintainedthroughouttheinterventionasrequired.
Anumberofwaysofmaintainingcommunityinvolvementintheadaptationsprocessweredeveloped,asdescribedbelow.
Kevanyetal.
BMCPublicHealth2012,12:459Page3of11http://www.
biomedcentral.
com/1471-2458/12/459CommunityworkinggroupsCommunityWorkingGroups(CWGs)representedcom-munitymembers'interestsineachinterventioncommu-nity.
CWGsconsistedofapproximately30representativesfromacross-sectionoflocalethnic,tribalandcommunitygroupswhowerealsoleadingmembersoflocalsocialnet-works,includingfaith-basedorganizations(FBOs),sportingclubs,communityhealthservices,andlocalgovernment.
CWGmemberswereencouragedtokeepinclosecontactwiththeircommunities,andfrequentlymetintheabsenceoftheresearchteamtosolicitfeedbackonprojectactivitiesthatthecommunitymightbereluctanttoarticulateinalargerforum.
CWGsalsohelpedtodevelopandtailorin-formation,educationandcommunication(IEC)materialsrelevanttothevarioussocialnetworkswithinthecommu-nityandweresupportedthroughcontinuingtrainingandeducationthroughouttheintervention.
CWGmemberswerenotprojectstaff,butwerepaidasittingallowanceatsomesitesforattendanceinmeetings.
RepresentativesfromeachCWGalsoservedonaStudyAdvisoryCommit-tee(SAC),designed(1)toallowprimarystakeholderstoexerciseleadershipatahigherlevelofstudycoordinationand(2)toensurecommunityinvolvementbothwithinandacrosscommunities.
Community-basedoutreachvolunteersAspartoftheCMteam,community-basedoutreachvolunteers(CBOVs)wereresponsibleforliaisingwithlocalorganizationssuchaspeergroups,FBOsandsocialclubsonbehalfofProjectAccept.
CBOVswerecommu-nitymemberswhobecameearlyadoptersofVCTorPTSSand,wherepossible,heldstrategicpositionswithinlocalsocialnetworks.
Ascommunitymembers,CBOVswereuniquelyplacedtomonitorandreportontheon-goingacceptabilityoftheinterventiontoparticipatingcommunities.
CommunityengagementStudystaffwereconsistentlyencouragedtodevelopnewandcreativewaystokeepparticipatingcommunitiesinformedabout,andengagedin,interventiondevelop-ment,acceptabilityandadaptation.
Theseincludedregular,interactivecommunitymeetings;thecreationanduseofinformalcommunicationchannels(e.
g.
impromptugrouporindividualdiscussionswithcommunitymembers);developingrelationshipswithkeyinformantsoutsideCWGstructures(e.
g.
localbusinessowners);andfacilitat-inglinkagesbetweenCWGsothercommunityorganizations.
TheadaptationsprocessWhileprovisionforadaptationswasmadeintheoriginalstudyprotocol,asdescribedabove,theadaptationsprocesswasprimarilydevelopedduringtheinterventionitself,onasite-by-site,'learningbydoing'basis,asappropriatetothewiderangeofissuesandoftenunforeseenobstaclesthathadtobeaddressedthroughouttheinterventionperiod.
Theadaptationsprocessthereforeevolvedorganically,throughouttheintervention,onanexpostratherthanonanex-antebasis.
Inthisway,theuseofcommunityinvolve-mentandfeedbackmechanismswereessentialtotheadap-tationsprocessacrosssites.
Keyfeaturesofadaptationsdevelopmentandimplementationwereconsistentacrosssites,andincluded(1)identificationanddiscussionofsite-specificutilizationanduptakeissuesonbi-weeklyconfer-encecallswiththeinterventionsub-committeethroughouttheinterventionperiodinordertoensurepromptfeedbackonutilizationchallenges;(2)submissionofawrittenpro-posalforadaptationtotheinterventionsub-committee(3);reviewofproposals,recommendations,andforwardingtothesteeringcommitteeforfurtherreview;and(4)thesteer-ingcommitteemakingafinaldecisiononwhethertoap-proveorrejecttheproposedadaptations.
Asdescribedabove,theCBVCTinterventionalsomaintainedanethicssub-committeethroughouttheinterventionperiod,respon-sibleforthereviewandapprovalofanyproposedadapta-tionstoservicedeliveryfromahumansubjectsperspective,inordertodetermineifprotocolmodificationswouldneedtobeapprovedbythevariousreviewboards.
Adaptationsapprovedbytheethicsandinterventionsub-committees,andlaterbythestudysteeringcommittee,werethenintro-ducedtoprojectstaffviaperiodicalcross-siteretrainingsandinterventionsub-committeesitevisits.
Projectcoordi-natorswerethenresponsibleforpilot-testingtheadaptationand,equallyimportantlymonitoringperformanceoffieldstaffastheadaptationwasimplemented.
ZimbabweInZimbabwe,adaptationswereinitiallyproposedbyfieldstaffduringweeklydebriefingsfollowingconsultationswithandfeedbackfromCWGs,MVCT,CMandPTSSparticipants,aswellasotherstakeholdersinthestudycommunities,includingwardcouncilors,villageheads,localchiefs,andreligiousandpoliticalleaders.
Proposedadaptationswerethendiscussedatinternalprojectman-agementmeetingswiththeprincipalinvestigator,andapprovedadaptationswerediscussedwithinterventionmonitorsandthesteeringcommitteebeforeimplementa-tion.
Approvedadaptationswerethencommunicatedtothelocalchiefcommunity,whotheninstructedjuniorchiefs,villageheads,andsoondownthelocalhierarchytoassistprojectstaffwiththeirimplementation.
ThailandInThailand,fieldstaffacrosscomponentsandCWGswereresponsibleforobservinginterventionacceptabilityandperformanceonaday-to-daybasisthroughouttheintervention.
Additionalcommunity-levelconsultationsKevanyetal.
BMCPublicHealth2012,12:459Page4of11http://www.
biomedcentral.
com/1471-2458/12/459withteenagers,villagehealthpersonnel,religiousgroups,households,andotherlocalvolunteerorcharitygroupswerealsoconductedthroughouttheintervention.
Pro-jectstaffreportedfindingsandsuggestionsforadapta-tionstotheprojectdirectoratweeklyprojectmeetings,whichwereinturnconsideredatmonthlymeetingsofseniorstaff,includinglocalprincipalinvestigators,theprojectdirector,andinterventioncomponentcoordina-tors.
Implementationofadaptationswasrolled-outtothebroadercommunityafterconsultationwithCWGsandotherlocalstakeholders,includingcommunityrepresentativesfromgovernment,healthcareandcom-merce.
CWGmeetingswerefrequentlydividedintosmallerworkinggroupstodiscusstheimplementationofproposedadaptationsand,wereattendedbybothse-niorandfieldstaff.
TanzaniaInTanzaniaadaptationconceptualizationanddevelop-menttookplaceatthefieldstaffandCBOVlevel.
Basedontheirday-to-dayexperienceoffieldactivities,meetingsbetweenfieldstaffandCBOVswereheldonaregularbasistoexchangeideasoninterventionimplementation.
Proposedadaptationswerethenreferredtocomponentcoordinators,thelocalprojectdirector,theSAC,andthelocalprincipalinvestigator.
Afterpreliminaryapprovalforadaptationsfromthestudysteeringcommittee,furtherapprovalwassoughtfromlocalreligiousleadersandcom-munitygroups.
Beforeimplementation,alladaptationswerepublicizedandexplainedincommunitymeetings.
VulindlelaProjectstaffinitiatedchangestotheinterventioninVulin-dlela.
Thesiteusedanongoingdatamanagementandfieldwork'feedbackloop'tomonitorinterventionimple-mentationandadaptations,andweeklyreviewandplan-ningmeetingsbetweenfieldstaffandseniormanagementwerecentraltoensuringefficiencyandeffectivenessofadaptationdelivery.
Usingmonitoringandevaluationdata,includingutilizationandqualityassurancemeasurestotrackoperationalinnovationeffectivenesswasalsocriticaltotheadaptationsprocess.
CBOVsalsoplayedanimport-antroleattheVulindlelasite,providing(1)ausefulsourceofideasforwhatinnovationswouldorwouldnotworkinthisculturalcontext,and(2)ensuringthatadaptationsobtainedthenecessarysupportfromtraditional,politicalandcommunitystructures.
SowetoInSoweto,adaptationstotheinterventionoriginatedpri-marilywithfieldstaff.
Cross-componenteventsplanningcommitteesmadeupofMVCT,CMandPTSSrepresen-tativeswereestablishedineachinterventioncommunitytodevelopadaptationsbeforepresentationtotheprojectdirector.
Adaptationsprojectleaderswerethenidentifiedbytheprojectdirectorandcomponentcoordinatorsandwereresponsibleforprovidingorganizationalleadershipintheimplementationofadaptations.
CBOVswereessen-tialtotheimplementationofadaptationsinSowetobygeneratingsupportfromtheprimarystakeholders,includ-inglocalNGOs,inthecommunity.
ResultsCross-componentadaptationsInterventiondeliveryadaptationsAdaptationstothestructureandschedulesoffieldteamswererequiredacrosssites.
InZimbabweandVulindlela,theinitialdivisionandrotationoffieldteamsacrossinter-ventioncommunitiesbyinterventioncomponent(MVCT,CMandPTSS)wasfoundtobebothinefficientintermsofstafftransportationandconfusingtoparticipants.
InZimbabwe,separateCM,MVCTandPTSSteamswererestructuredintotwocombinedteams,eachofwhichincludedrepresentativesfromMVCT,CMandPTSS.
Eachteamwasallocatedtwointerventioncommunities,andoperatedineachcommunityforatwo-weekperiodeachmonth.
InVulindlela,fourcombinedteamswerecre-atedandassignedtoindividualcommunitiesforthere-mainderoftheintervention.
Interventiondeliveryscheduleswerealsoadaptedtolocalconditions.
InZim-babwe,projectstaffnegotiatedwithminingemployerstodelivertheinterventionatworkplacesforclientsthatwouldnototherwisehavehadaccesstoprojectservicesduringworkinghours,and,similarly,withfarmingemployersduringharvesttimes.
InThailand,itwasobservedwithinthefirst6monthsoftheinterventionthatutilizationbythe18to32year-oldtargetpopulationwashigheroneveningsandweekends,andinterventiondeliv-erywasrescheduledforthesetimes.
InVulindlela,alateafternoonandearlyeveninginterventiondeliveryschedulewasintroducedinresponsetoparticipantfeedbackandbasedonasuccessfulpilot.
Weekendservicedeliverywasalsopiloted,butabandonedafterparticipantsreportedapreferenceforattendingfamilyactivitiesinVulindlelaandasaresultoflowdemandinTanzania.
Anumberofothercross-componentadaptationswerealsointroducedthroughouttheintervention.
InVulin-dlela,aperformanceincentivesystem,includingbonusesforstaffmeetinginterventiondeliverytargetswasintro-ducedinresponsetohighlevelsofstaffturnoverintheearlystagesoftheintervention.
Theriskofcoercionwasmitigatedbytheexclusionoffieldsupervisorsfromthisincentivescheme.
AlsoinVulindlela,areluctancebypar-ticipantstoevaluateprojectactivitiesusingwrittenformsmeantthatthesewerereplacedbyfeedbackdiscussionswithCBOVs.
InThailandandZimbabwe,thefrequentat-tendanceofintoxicatedvillagersatinterventionactivitiesKevanyetal.
BMCPublicHealth2012,12:459Page5of11http://www.
biomedcentral.
com/1471-2458/12/459meantthatthesiteshadtodevelopasystemtoassesseli-gibilityforparticipationbasedontheamountofalcoholconsumed.
InTanzania,owingtothelongdistancesinvolved,projectequipmentwasstoredinsecurevillagestorageareas,includingthehousesofvillageleaders.
ReligiousadaptationsThesupportofFBOscanbecriticaltotheacceptanceofHIVinterventionsinresource-limitedsettings[16,17].
Siteswereencouragedtorespondtoobjections,sugges-tionsorconcernsfromFBOsaboutprojectactivitiesastheyarose,andtoadapttheinterventionaccordingly.
Acrosssites,interactionwithFBOsincludedprojectstafffacilitatingHIV/AIDSdiscussionsduringreligiousser-vices,provisionofMVCTonreligiouscentergrounds,andtheestablishmentofFBO-basedsupportgroups.
InZimbabwe,projectstaffproactivelyengagedwithreligiousgroupswithknownhistoriesofdiscouragingmembersfromseekingmedicalservices.
Inthosecaseswherereli-giousleadersdeclinedallinvolvementwiththeinterven-tion,theirdecisionwasrespectedbystudystaff.
InThailand,supportfromlocalmonkswasessentialtocom-munityacceptanceoftheinterventioninBuddhistcom-munities,andstaffweretrainedinthecorrectetiquetteandprotocolforworkingwithseniorreligiousfigures.
Inaddition,monksininterventioncommunitieswereinvitedtoparticipateintrainingsessionsonprojectgoalsandtheimpactofHIVontheircommunities.
Asaresultoftheseefforts,Buddhisttemplesweremadeavailableforprojectactivities,andanumberofmonksworkedcloselywithCBOVs.
InZimbabweandThailand,thediscussionofreli-giously-sensitiveissueswasdiscouragedduringprojectac-tivitiesheldin,orincloseproximityto,Catholicchurches(e.
g.
onchurchgrounds).
InSoweto,specialsessionsforlocalChristianchurchleaders(abafundisi)wereintro-ducedtopromoteawarenessofprojectactivities:asare-sult,religiousleadersbothaccessedMVCTanddisclosedtheirHIVstatusduringbafundisiforums.
InTanzania,interventionactivitiesweredividedbygenderinMuslimareas,projectactivitieswerenotprovidedinmosques,andCMmessageswereadaptedtoensuresensitivitytolocalMuslimcommunities,includingasuspensionofservicesduringRamadanwhenrequested.
EpidemiologicaladaptationsSiteswereencouragedtoadaptinterventiondeliverytore-spondtothelocalHIVepidemic,andinparticulartotar-getthosehigh-riskpopulationswithlowserviceutilization.
InZimbabwe,TanzaniaandSoweto,highlevelsofHIVprevalenceamongstyoungeragegroups[18]ledtotheintroductionof'youth-friendly'activitiesandcurricula,includinginterventionpresenceatsoccertournaments,whereinformationsessionswereprovidedbeforeanddur-ingmatches;presentationsonprojectactivitiesinschoolguidanceandcounselingclasses;inter-schoolquizcompeti-tionsonHIVandprojectactivities;andthedevelopmentofsupportgroupsforout-of-schoolyouths.
InZimbabwe,theinterventiontargetedtruckdriversandroadsidevendors(viainterventiondeliveryathaltingsites);militarypersonnel(viainformationsessionsatlocalbarracks);andcouples(viapromotionsencouragingjointMVCTandPTSSattendance).
InThailand,wheretheHIVepidemicisconcentratedinyoung,high-riskpopulations[1,19],CBOVsheldworkshopswithteenagegroupstoassesswhichaspectsoftheinterventionweremostattractivetothem.
InSoweto,specificpopulationgroupsweretargetedformobilization,includingtraditionalhealers,Zulumaleslivinginhostels,andwomen'sgroups.
Social,political&culturaladaptationsAlthougheffortshadbeenmadetoincludesite-specificsocialandculturaladaptationsduringprotocoldevelop-ment,arangeoffurtherandrelatedadaptationswereintroducedthroughouttheinterventionthroughtheidentificationofpopularlocalpracticesbyfieldstaff.
Acrossallsites,popularsocialgatheringplaces(e.
g.
pubsandcommunitycenters)andtheirtimesofpeakoperationwereidentifiedovertimeandincludedasinterventionvenues.
InZimbabwe,TanzaniaandSo-weto,adaptationsweremadetohealthandprojectter-minologybasedonfeedbackfromparticipantsandinkeepingwithlocaldialects.
InThailand,theseincludedtribalrituals(e.
g.
sworddancesandcostumedisplays)performedduringprojectevents;fieldstaffhiredbasedontheirknowledgeoflocallanguagesandcustoms;theprovisionofkaraokefacilitiestoparticipantsduringeveningsessions;andspecialliaisonstaffhiredandtrainedtoworkwithrefugeegroupsresidingininter-ventioncommunitieslocatedontheThailand-Burmaborder.
InTanzania,culturalnormsmeantthatwomenwerediscouragedfromutilizingprojectservices.
Asaresult,targetedcampaignsatfemalegatheringplaces(e.
g.
waterboreholes)toencouragewomentoaccessprojectserviceswereintroduced.
AlsoinTanzania,theinterventionwasre-namedas"ProjectAfiki"(thelocalKiswahilitermfor"Accept").
InbothThailandandTan-zania,smallgiftsarefrequentlyexchangedinsocialset-tingsasaformofetiquette.
Althoughtheprotocolprohibitedtheprovisionofmaterialincentivestoattendprojectactivities,itwasagreedthattheprovisionofsmall,valuelesspresents(e.
g.
keyrings)toparticipantswouldbepermittedasaculturalconcession.
InSoweto,fieldstaffobservedthatmanyparticipantswerereluc-tanttoaccessMVCTservicesaloneandpreferredtoparticipateingroups.
Asaresult,a'BringaFriend'strategywasintroduced.
Kevanyetal.
BMCPublicHealth2012,12:459Page6of11http://www.
biomedcentral.
com/1471-2458/12/459MobilevoluntarycounselingandtestingInterventiondeliveryadaptationsOngoingadaptationstoMVCTdeliverywererequiredacrosssites,andcounselingmessageswereupdatedtore-flectbothnewscientificevidenceandlocalneedsthrough-outtheintervention.
Acrosssites,(1)culturally-tailoredhealthservicesmessageswereintroducedintocounselingcurricula,includinginformationonlocalavailabilityandreferrals(exceptpractices);(2)treatmentreferralmessageswereregularlyupdatedtoreflecttheongoingexpansionofantiretroviraltherapy,and(3)specialcounselingcurriculaforhigh-riskpopulationgroupsweredeliveredinresponsetoemergingevidenceontheirroleasdriversoftheepi-demic.
InZimbabwe,clientsrequested,andrecievedtheadditionofabereavement-counselingmessagetoassistincopingwithHIV-relateddeaths.
MVCTadaptationsaccordingtoongoingchangesinnationalhealthpolicieswerealsorequiredacrosssites.
InTanzania,projectstaffcoordinatedMVCTdeliverywiththepresident'snationaltestingcampaign[20],whichwasrolledoutforathree-monthperiodmidwaythroughtheintervention.
InSowetoandVulindlela,theminimumageofparticipationinMVCTwasloweredfrom18to16yearsold,inkeepingwiththeSouthAfri-cannationalHIVtestingpolicy[21].
EnvironmentalandinfrastructuraladaptationsAcrosssites,MVCTvenuesandequipmentwereadaptedtolocalenvironmentandinfrastructure.
InZimbabwe,remotevillageswerefrequentlyinaccessibleduetoroadandweatherconditions,andparticipantsreportedwalk-ingdistancesofupto7kilometerstoaccessdesignatedvenues.
Inresponse,interventionteamsintroducedMVCTtoaseriesofremote'satellitevenues'identifiedincollaborationwithCBOVs.
InThailand,thecommu-nalphilosophyof'house,temple,school'wasadoptedforMVCTdelivery.
Withthepermissionoflocalcommu-nityleaders,Buddhisttemples,Christianchurches,otherreligiouscenters,privatehouses,andlocalhealthcenterswereusedasMVCTvenues,andriver-boatsandmotor-bikeswereusedtotransportMVCTstafftomoreremotevenues.
Tablesandchairswereprovidedbythecommu-naltemple(wat),andcommunitymemberswereactiveinhelpingtosetupequipment.
Asaresultofthiscom-munityassistance,thesitedidnotneedtoinvestincara-vansortentsthroughouttheintervention.
InTanzania,roadsideserviceprovisionwasintroducedalongmajortransportationroutestoincreaseMVCTutilization.
InVulindlela,SowetoandZimbabwe,andwiththeencour-agementofteachers,MVCTwasprovidedinlocalschools.
CMstafflaterreportedincreasedknowledgeandawarenessofprojectactivitiesfromstudents'par-ents.
InVulindlela,theoriginalMVCTcaravanswerereplacedwithlargermodelsinordertomeetutilizationdemandsatpeaktimes,whileinZimbabweandTanza-nia,tentswereusedinsteadofcaravansforlessaccess-iblesites.
Post-testsupportservicesInterventiondeliveryadaptationsCommunityperceptionsofPTSSwereambivalentattheintroductionoftheinterventionandPTSSparticipationwasoftenmistakenlyassociatedwithHIVinfectionbycommunitymembers.
Inthesecases,communitymem-bersassumedthatonlyHIV-positiveindividualswouldrequirePTSS.
TheresultinginitiallowuptakeofPTSSdrovearangeofadaptationstoeligibilityandparticipa-tioncriteriatoimprovebothrecruitmentandcommu-nityperceptionsofPTSS.
Acrosssites,initialuptakeofPTSSserviceswasmainlybypeoplewhohadnotyetbeentestedforHIVbyProjectAccept.
Theseindividualsweredesignatedas"guests"withinthePTSSsystemandweregrantedlimitedaccesstoservices.
Thisrestrictionwasabandonedafter'guest'participantsrequestedgreateraccesstoPTSSinordertoprepareforVCT.
Asaresult,theroleofPTSSevolvedintosupportingandadvisingbothVCTparticipantsandthoseconsideringVCT.
InZimbabwe,wherePTSSgroupswereinitiallyseparatedbetweenHIVpositiveandnegativeindividuals,combined-statusgroupswereintroduced,andpartici-pantswereinvitedbothtocontributetocurriculumde-velopmentandformtheirownadministrativestructures.
Thestructure,contentandschedulingofPTSSsessionswerealsoadaptedinresponsetoparticipantdemands.
Acrosssites,individualpsycho-socialcounselingsessionswereinitiallyonlyavailablebyadvanceappointment.
Astheinterventionprogressed,andinresponsetoclientdemand,thisservicewaswereprovidedbeforeandafterotherPTSSactivities,onanad-hocbasis.
InThailand,(1)CETsessionsweredividedbyagegrouptoaccommodateawideagerangeofparticipants,eachofwhichhaddifferentdiscussionpreferences,and(2)supportgroupprovisionwasdeliveredincollaborationwithlocalgovernmenthealthcentersafterstaffdiscoveredthatthesecentersweredeliveringanidenti-calservice.
AlsoinThailand,duetothelowincidenceofHIVininterventioncommunities,CETsessionswereadaptedtoprovideinformationtoHIV-negativepersonsoncopingwiththepotentialriskofHIVandhelpingotherstocopewithHIV.
InThailandandTanzania,theplanned8-hoursessionsforcopingeffectiveness(CET)andstigmare-ductionactivitieswerefoundtobetoolongforparticipants,andwerereducedtothree3hoursessionsoversuccessivedays.
InTanzania,moreflexibleschedulingofPTSSwasintroducedtorespondtocommunitydemands.
VariousotheradaptationsweremadetoPTSSservicedeliverythroughoutthecourseoftheintervention.
Acrosssites,PTSSinformationboothsweresetupadjacenttoMVCTtofacilitaterecruitmentofparticipantstoPTSS.
Kevanyetal.
BMCPublicHealth2012,12:459Page7of11http://www.
biomedcentral.
com/1471-2458/12/459InTanzania,sportingactivities,cardgamesandboardgameswereintroducedintoPTSSsessionsinordertoprovideasocialforumforHIVdiscussions.
InZimbabwe,atrainer-of-trainerscoursewasintroducedforPTSSparti-cipants.
InSoweto,PTSSadvocatesweretrainedinsafedisclosureprocedures,andspecialPTSSsessionsdesignedfortheeducationandtrainingoftraditionalhealersonHIV/AIDSandrelatedissueswereintroduced.
Asaresult,anumberoftraditionalhealersreferredtheirpatientstoMVCTandPTSS.
InVulindlela,PTSSstaffprovidedtele-phoneremindersofsessiontimestonewparticipants.
EnvironmentalandinfrastructuraladaptationsAcrosssites,PTSSvenueswereadaptedtothelocalenvir-onmentandinfrastructure.
InZimbabwe,VulindlelaandSoweto,PTSSwasredesignedasamobileserviceinordertoimproveaccess.
Venuesincludedschools,communityhalls,andlocalbusinesscenters.
InVulindlela,partici-pantsindicatedapreferenceforaccessingPTSSincom-munitiesotherthanthoseinwhichtheylived,inordertoreducepossiblestigmaassociatedwithPTSSparticipation.
Asaresult,ProjectAcceptoffices,whichwerelocatedoutsideinterventioncommunities,wereadoptedasPTSSvenues.
Transportwasprovidedtoparticipantsbyprojectstaff,andparticipantssubsequentlyreportedamoreenab-lingandopenlearningenvironment.
InZimbabwe,parti-cipantsreporteddifficultyaccessingPTSSreferralservicesduetotransportcosts.
Inresponse,projectstafftrans-portedserviceproviders,includingnutritionists,lawyers,andnurses,totheinterventioncommunities.
EconomicadaptationsPTSSadaptationsalsorespondedtolocaleconomiccondi-tions.
InZimbabweandTanzania,poverty,hungerandmal-nutritionwerecommonissuesininterventioncommunitiesandwerefrequentlycitedasreasonsfornon-attendanceoflongersessions.
Thefollowingadaptationsweredevelopedinresponse:(1)provisionoftea,lunchandnutritiousdrinks(mahewu)toparticipants,(2)incomegenerationandskillsdevelopmentclassesprovidedbeforeandafterPTSSactiv-ities,(3)developmentofpartnershipswithlocalorganiza-tionsandgovernmentofficialstoprovidefarminginputs,foodaid,andlegalservicestoparticipants,(4)supportgroupswereprovidedwithhorticulturalequipmentandtraininginpartnershipwithlocalgroups,and(5)laycoun-selorsweretrainedthroughtheZimbabweInstituteofSys-temicTherapy(ZIST-CONNECT).
InThailandandTanzania,income-generatingequipment,includingchickencoopsandcropseeds,wereprovidedtobothunemployedandHIV-positiveparticipants.
TheseadaptationshelpedbothtomitigatetheeconomiceffectsofHIV-relatedstigmaandtoattractHIV-positivepersonswithoutothermeansofincometoPTSS.
CommunitymobilizationInterventiondeliveryadaptationsAcrossallsites,ongoingadaptationstoCMmessageswererequiredtomitigatebothparticipantfearsofblooddrawsandintervention'staffstigma',inwhichprojectstaffweresuspectedofbeinginfectedwithHIV.
InVulindlela,theuseofpamphletsasanoutreachstrategywasfoundtobeineffectualduetopoorliteracyandwasreplacedbypublicmobilizationtalksheldincentralandpubliccommunityareas.
InSoweto,CM'roadshows',whichinvolvedvehiclesandfieldstafftouringthroughinterventioncommunities,weredevelopedandincludedacombinationofdoor-to-dooractivitiesandparticipa-tionbyprominentlocalcommunitymembers;CM'streetdialogues',whichinvolvedapproachinganden-gagingcommunitymembersinconversationabouttheintervention,combinedwiththedistributionofpromo-tionalmaterials;andskillsdevelopmentworkshops,in-cludingcareercounseling,wereprovidedtocommunitymembersaspartofCMactivities.
InbothSouthAfricansites,megaphonesandloudhailerswereusedtodeliverCMmessagesandannounceMVCTandPTSSvenuesandactivitiesafterstaffobservedcommunitymembersusingPAsystemstoannouncecommunityevents.
Inaddition,youth-specificCMactivitieswereintroducedinschools,andprojectdriversweretrainedtobecomepart-timeCMstaff.
Environmental,politicalandinfrastructuraladaptationsCMactivitieswerecontinuallyresponsivetothelocalen-vironment.
Acrossallsites,andinresponsetocommu-nityfeedback,CMactivitiesweregraduallyrelocatedclosertoMVCTandPTSSvenues,throughouttheinter-vention.
InZimbabwe,(1)CMactivitiesweresuspendedduringelectionperiodstoavoidbeingmistakenforpolit-icalactivismandensurethesafetyofstaff,participantsandprojectequipment,and(2)CMstaffprovidedtrans-portandnursingstaffwhereverpossibleduringdiseaseoutbreaks(e.
g.
cholera),whichwasbeyondtheinitialscopeoftheprotocol.
InSoweto,CMcampaignsspecif-icallyfocusedtheireffortsonZuluhostels,whichwereinitiallyopposedtomaleinvolvementinHIVtestingac-tivities,and,inbothSouthAfricansites,CMstaffpro-motedtheinterventionasapartofthe''lifeskills''curriculuminlocalschools.
InTanzania,CMactivitiesinremotecommunitieswereconcentratedinthedrysea-son,andCMteamsizewasadjustedacrosscommunitiesininverseproportiontointerventiondemand.
Community-basedoutreachvolunteersAcrosssites,theroleofcommunity-basedoutreachvolun-teers(CBOVs)evolvedinresponsetointerventionneeds.
InVulindlela,unanticipateddemandsofCMworkonfieldstaffresultedintheincreasedrecruitmentandutilizationKevanyetal.
BMCPublicHealth2012,12:459Page8of11http://www.
biomedcentral.
com/1471-2458/12/459ofCBOVs.
CBOVsweregivenindividualandgrouptar-getsforPTSSandMVCTrecruitment,andstipends,transportallowances,andotherincentiveswereprovided.
Asaresult,CBOVswererenamedCommunity-BasedOutreachMobilizersinkeepingwiththeirenhancedCMrole.
AlsoinVulindlela,astrongfamilycultureledtothedeliberaterecruitmentofCBOVsfromlargefamilies,whothenencouragedtheirsocialnetworkstoattendMVCTandPTSS.
InZimbabwe,initiallowlevelsofinvolvementbywomenpromptedthetrainingofincreasednumbersoffemaleCBOVs.
InTanzania,CBOVshelpedtoadviseonthechoiceofinterventionvenues,givingthemanun-anticipatedroleintheinterventiondeliveryprocess.
Discussion&conclusionsConsistency&flexibilityinadaptationdevelopmentBoththeadaptationsprocessandimplementationoftheadaptationsthemselveswerecriticaltotheacceptance,utilizationandsustainabilityoftheProjectAcceptinter-ventionacrossstudysites.
Theadaptationsprocess,whichhadtobalancesensitivitytothelocalcontextinordertoimproveutilizationagainstconsistencyinthecoreelementsofinterventiondeliveryinaccordancewiththemulti-sitestudyprotocol,alsoneededtoensureaminimumlevelofcomparabilityacrosssites.
Inthisway,site-specificadaptationsprocesses,whileprocedur-allyvariable,maintainedacommonsetoffeatures.
Theseincluded(1)involvementoffieldstaffinthegenerationofadaptations,(2)communityacceptancemeasures,and(3)theroleofthestudysteeringcommittee,ethicalre-viewboards,andinterventionsub-committeesintheirapprovalandimplementation.
Theadaptationsdevelopedacrosssites,whilediverse,alsomaintainedacommonsetofthemesandapproaches.
Inmanycases,thesamecross-component,orcomponent-specific,adaptationswouldbedevelopedindependentlyacrosssites.
Inothercases,successfuladaptationsinonesitewouldquicklybeadoptedbyothersites.
Intheseways,anumberofcommonthemesinadaptationtypes,suchasthoseidentifiedabove,werereadilyidentifiableacrosssites.
Measuringadaptationimpact&estimatingeffectsonuptakeWhileourexperiences,andassociatedanecdotalevidence,providecompellingsupportforthehypothesisthattheseadaptationsinfluencedtheimpactoftheCBVCTinterven-tionthroughincreasedMVCTandPTSSutilization,itis,ofcourse,notpossibletoestablishapurelycausallinkbe-tweenadaptationimplementationandsuchoutcomes.
Arangeofpotentialconfoundingfactorsexist,including,butbynomeanslimitedto,thestageofinterventionimple-mentation,increasedcommunityacceptanceovertime,andbroaderenvironmentalchangesinknowledgeof,andattitudestowards,testingforHIVininterventioncommu-nities.
Nonetheless,isitnotablethatinterventionuptakeininterventioncommunitieswasover10timeshigherthanincontrolcommunities,inwhichnoadaptationswerepermitted,bytheendoftheintervention[9].
Inaddition,serviceutilizationmonitoringandevaluationdata,whenreviewedonasite-by-sitebasis,maybechronologicallyassociatedwiththeimplementationofsig-nificantadaptations,whenallowingforappropriatetimelags.
Forexample,attheVulindlelasite,serviceuptakeforMVCTrosebyover100percent(meanuptakeforthefirsttwoquartersof2007was142participants,ascom-paredto289participantsinthesecondtwoquarters,andincreasingfurtherto369participantsinthefirsttwoquar-tersof2008),directlyaftertheserviceprovisionplanwasadaptedfromrotatingspecializedMVCT,PTSSandCMteamstocommunity-based,integrated,andmulti-skilledteams.
Giventhetemporalproximityofsuchimprove-mentsinutilizationwithadaptationimplementation,itmaybepostulatedthatsuchadaptationsmayhavehad,acrosssites,asignificantimpactonserviceutilization.
DeterminingwhentochallengesocietalnormsOneofthemostchallengingaspectsoftheCBVCTinterventionwasdeterminingwhentochallengesocietalnormsininterventiondeliveryandadaptation.
Forex-ample,asdescribedabove,genderissueswerecircum-ventedthroughtheadapteddeliveryoffemale-specificinterventions.
Ontheotherhand,religiousissueswere,ingeneral,accommodated,ratherthanchallenged,byadaptingtheintervention.
Decisionsaroundwhensoci-etalnormsshouldbechallenged,throughinterventionadaptationsareinherentlysubjectiveandenvironment-specific[15].
However,asageneralprinciple,adaptingto,ratherthanchallenging,societalnormswasfoundtobemostappropriateintheCBVCTcontext.
Diplomacy,globalhealth,andforeignpolicyThecapacitytoadaptglobalhealthinterventionstolocalconditionsalsohasconsiderablesignificancefromthefor-eignpolicyperspective,inthecontextofthedisciplinenowknownandrecognizedasglobalhealthdiplomacy[10].
Underthisaegis,theinclusionofscopeforadaptabil-ityininterventiondesignanddeliveryhasthepotentialtomakesignificantdifferencestolocalperceptionsofinter-nationaldevelopmentactivities,includingtheapprovalandacceptanceofprogramsandinterventionsbyrecipientcountries,communities,andindividuals,and,byexten-sion,theprofileandprestigeofdonororganizationsandcountries[22,23].
Overtime,suchinterventionsmayneedtobecomemoresensitizedtothesebroaderrolesandre-sponsibilities,ascurrentlyreflectedatthepolicylevelbyincreasedintegrationbetweendepartmentsofforeignpol-icyandforeignassistanceindonorcountries-helpingtoKevanyetal.
BMCPublicHealth2012,12:459Page9of11http://www.
biomedcentral.
com/1471-2458/12/459maintain,orevenincrease,levelsofdevelopmentfundingona'smartpower'basis.
Systemsofmoreformalllyconsid-eringthevalueandworthofglobalhealthinterventionsfroma'foreignpolicy'perspectivemaybedeveloped,in-cludingsuchconsiderationsascommunityacceptanceandinvolvement,sothatsuchtheycanbemonitoredandevalu-atedonthisbasis[24].
Theassociatedcapacityofinterven-tionstoadapttolocaleconomic,cultural,religious,andotherenvironmentalconditionsinrecipientcountriesmayhavethepotentialtomakeasubstantialdifferencetothesebroader'collateral'diplomatic,andforeignpolicyoutcomesofforeignassistanceprograms[25].
RecommendationsAnumberofadaptation-relatedrecommendationsforrelatedfutureinterventionsmaybegleanedfromthePro-jectAcceptexperience.
Collaborationwithlocalactors,notjustinservicedelivery,butatthehighestlevelsofinterventiondesignandplanning,is,ofcourse,asinequanonofanyenlightenedinterventioninthe21stcentury.
Perhapsmostimportantly,however,thenecessityofbuild-inginprovisionsandscopeforadaptationstothestudyinadvanceofinterventionimplementation,onanexantebasis,shouldbeborneinmindbothbyplannersandscien-tists.
Thismaybeachieved,mostdirectly,throughtheuseofappropriateterminologyinboththestudyprotocolandstandardoperatingproceduresdocuments:inavoidingtheuseofexcessivelydogmaticordidacticlanguage,interven-tionsmaybeimplicitlypermittedappropriatelevelsofflexibilityininterventiondelivery,whilstmaintainingfidel-itytotheoriginalstudyprotocol.
Similarly,relatedandfu-turestudiesshould,whereverpossible,makeallowanceforthemonitoringandevaluationofchangesinserviceutilizationconsequenttoadaptationimplementation-though,asdescribedabove,thismaybedifficulttoachieveinthepresenceofmultiplecompetingfactorseffectingser-viceuptake.
Nonetheless,whereverpossible,theeffectofadaptationimplementationonkeystudyoutcomesshouldbecarefullyreviewed,onasite-by-sitebasis,andwithreferencetoappropriateleadtimes,inordertodeterminetheireffectiveness.
Finally,asdescribedabove,thebroader'collateral'gainsofsuchadaptations,suchasimprovementsininternationalrelationsandcommunityacceptance,shouldbecarefullyconsidered,whereverpossible,throughthedevelopmentandapplicationofappropriatemetrics.
ConclusionsAdaptationsareparticularlyimportantinthedesignofHIV-relatedinterventions.
Giventheoft-contentiousna-tureofsuchinterventionsfromasocial,culturalandreli-giousperspective[26],itisessentialtoensurethat,whereverpossible,andfromboththeservicedeliveryandtheglobalhealthdiplomacyperspectives,theseinterven-tionsaredesignedwiththeexpectationsandneedsofrecipientcommunitiesinmind.
InthemorespecificcaseofVCT,forwhichutilizationbymost-at-riskpopulationsisfrequentlyakeyissue[27],adaptabilitytolocalcondi-tionsmayhelptobreakdownabothbehavioralandenvir-onmentalbarrierstothetestingprocess.
Ultimately,theneedforinterventionadaptationisbasedonchallengesthatcouldnothavebeenforeseenduringthedesignandlaunchoftheintervention.
Pre-parationswillneverbeperfect,sotime,money,capacityandflexibilitytoproduceinterventionshastobe'built-in'tothedesignofbothtrials,andinterventionsthem-selves,atallstagesoftheplanningprocess.
Withoutthisinherentadaptability,programdesignersandimplemen-tersriskachievingsub-optimalutilizationlevels.
Aslongasintegritytothekeyelementsoftheinterventionprotocolcanbemaintained,suchadaptationscanonlyenhancethevalueoftheinterventionintheeyesofpol-icymakers,communitiesandindividuals-inbothdonorandrecipientcountries.
CompetinginterestsTheauthorsdeclarethattheyhavenocompetinginterests.
AcknowledgementsThisresearchwassponsoredbytheU.
S.
NationalInstituteofMentalHealthasacooperativeagreement,throughcontractsU01MH066687(JohnsHopkinsUniversity),U01MH066688(MedicalUniversityofSouthCarolina),U01MH066701(UniversityofCalifornia,LosAngeles),andU01MH066702(UniversityofCalifornia,SanFrancisco).
Inaddition,thisworkwassupportedbytheHIVPreventionTrialsNetwork(HPTNProtocol043)oftheDivisionofAIDSoftheU.
S.
NationalInstituteofAllergyandInfectiousDiseases,andbytheOfficeofAIDSResearchoftheU.
S.
NationalInstitutesofHealth.
Viewsexpressedarethoseoftheauthors,andnotnecessarilythoseofsponsoringagencies.
Wethankthecommunitiesthatpartneredwithusinconductingthisresearch,andallstudyparticipantsfortheircontributions.
Wealsothankstudystaffandvolunteersatallparticipatinginstitutionsfortheirworkanddedication.
Authordetails1InstituteforHealthPolicyStudies,UniversityofCalifornia,SanFrancisco,50BealeStreet,Suite1300,SanFrancisco,CA94105,USA.
2CenterforAIDSPreventionStudies,UniversityofCalifornia,SanFrancisco,USA.
3UniversityofZimbabwe,Harare,Zimbabwe.
4PerinatalHealthResearchUnit,Soweto,SouthAfrica.
5HumanSciencesResearchCouncil,Durban,SouthAfrica.
6MuhimbiliUniversityofHealthandAlliedSciences,DaresSalaam,Tanzania.
7ChiangMaiUniversity,ChiangMai,Thailand.
8MedicalUniversityofSouthCarolina,Charleston,USA.
9DepartmentofEpidemiology,UniversityofWashington,Seattle,WA,USA.
10InternationalCenterforResearchonWomen,Washington,DC.
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