The
Brazilian
Journal
of
INFECTIOUS
DISEASES
w w w . e l s e v i e r . c o m / l o c a t e / b j i d
Original
article
Over-the-counter
human
immunodeficiency
virus
self-test
kits:
time
to
explore
their
use
for
men
who
have
sex
with
men
in
Brazil
Sheri
A.
Lippman
a,
Valdiléa
G.
Veloso
b,
Susan
Buchbinder
c,
Nilo
Martinez
Fernandes
b,
Veriano
Terto
d,
Patrick
S.
Sullivan
e,
Beatriz
Grinsztejn
b,∗aUniversityofCalifornia,SanFrancisco,CenterforAidsPreventionStudies,DepartmentofMedicine,SanFrancisco,CA,USA bInstitutodePesquisaClínicaEvandroChagas,Fundac¸ãoOswaldoCruz,RiodeJaneiro,RJ,Brazil
cBridgeHIV,SanFranciscoDepartmentofPublicHealth,SanFrancisco,CA,USA
dInstitutodeEstudosemSaúdeColetivadaUniversidadeFederaldoRiodeJaneiro(IESC/UFRJ),RiodeJaneiro,RJ,Brazil eEmoryUniversity,RollinsSchoolofPublicHealth,Atlanta,GA,USA
a
r
t
i
c
l
e
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n
f
o
Articlehistory:
Received20February2014 Accepted24February2014 Availableonline3April2014
Keywords: Brazil HIVtesting MSM Self-testing Home-basedtesting
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Increasing accessand frequencyofhuman immunodeficiencyvirustestingare critical tostemmingtheepidemic.InBrazil’sconcentratedepidemic,humanimmunodeficiency virusprevalenceinthemenwhohavesexwithmen/transgenderpopulationfarexceeds thatinthegeneralpopulation,buttestingratesfallbelowwhatisneededtoensureearly detectionandtreatment.Over-the-counterhumanimmunodeficiencyvirusself-testingkits, nowavailable instoresintheU.S.,have enormouspotentialtoincrease testingaccess andfrequencyandtofacilitateearlydetectionandtreatment.Withtheadventofhuman immunodeficiencyvirusself-testinguponus,itistimelytoengagethescientificcommunity, government,andcivilsocietyinadialogaroundhowtobestutilizethistechnologyinBrazil. Wesummarizerecentresearchonover-the-countertestingamongmenwhohavesexwith men,raisepotentialquestionsandchallengestousingself-tests,suggestimplementation strategies,andoutlinearesearchagendamovingforward.
©2014ElsevierEditoraLtda.Allrightsreserved.
Introduction
Humanimmunodeficiencyvirus(HIV)testingistheprimary gateway into HIV/AIDS prevention and treatment, making increased access and frequency of HIV testing critical to
∗ Correspondingauthor.
E-mailaddress:gbeatriz@ipec.fiocruz.br(B.Grinsztejn).
stemmingthespreadoftheepidemic.PeoplewithHIVwho areawareoftheirstatuscanbeginlifesavingtreatment,which in turn decreases HIV infectiousness1,2 and may decrease
riskbehaviorsfollowingdiagnosis.3–7Furthermore,modeling
studies inthe U.S.suggest thata substantialproportionof newinfectionsare spreadbypersonsunawareoftheirHIV
http://dx.doi.org/10.1016/j.bjid.2014.02.002
infection,8,9andthatincreasedtestingalonecouldoptimally
reducenewinfectionsbyasmuchas1/3inoneyear.10Testing
remainsahighpriorityandmustbemadeaswidely acces-sibleaspossible,particularlytopopulationsmostatriskof infection.
Brazil’s HIV epidemic is concentrated among men who havesexwithmen(MSM)andtranssexual/transgender popu-lations,withelevated prevalencealsooccurringamongsex workersandinjectiondrugusers.11Ascomparedtothe
gen-eralpopulation,whoseprevalenceisstableataround0.4–0.6%, HIV prevalence among MSM in Brazil is estimated to be between 13.6% and 14.4%.11–13 Nevertheless, studies have
demonstratedthat onlyabouthalfofBrazilianMSM report anyhistoryoftesting,13–15 and thatonly30%reporttesting
inthepastyear.16CurrentlytheUSCentersforDisease
Con-trolandPreventionrecommendthattestingformost-at-risk MSM beconductedevery 3–6 months.14 In arecently
con-ducted national respondent driven sampling study, nearly 50%ofMSMwho testedseropositivewereunawareoftheir infection.13LatediagnosiscontinuestobepervasiveinBrazil,
particularlyformen.17 Strategiestoincreasetestinguptake
andfrequencyamongMSMareneeded.
OnJuly32012,theUnitedStatesFoodandDrug Administra-tion(USFDA)approvedOver-the-Counter(OTC)licensingfor thesaliva-basedOraQuickIn-HomeHIVtestTM(OraSure
Tech-nologies,Inc.,Bethlehem,PA).18Thesetestsarenowavailable inUSpharmacies,andanumberofEuropeannationsarenot farbehind.Inlate2013theFrenchHealthMinistryannounced thatself-testingkits forHIVwillbecommerciallyavailable in 2014;19 the United Kingdom recently lifted the ban on
HIVhometestkits,whichshouldbecomeavailablethrough commercialchannelsbyApril2014.20ThehopeofOTCHIV
self-testing kits is that they will both facilitatetesting for communitiesathigh risk ofHIV transmission,particularly thosecommunitieswhicharereticent totest,andincrease testing frequency and thus early detection and treatment. ThistechnologyisparticularlypromisingforMSMand trans-genderpopulations, forwhom negativeexperiences inthe public healthsystem, including long queues and discrimi-nation (related to sexual orientation, gender identity, or a positiveHIVtest),mayreducetheirlikelihoodofclinic atten-dance.
AsOTCHIVtestingexpands,thetimetoengagethe sci-entificcommunity,government,andcivilsocietyinadialog aroundhowtobestutilizethistechnologyinBrazilhascome. Weprovide abriefreviewofrecent researchon utilization andacceptabilityofHIVself-testingforMSM,raisepotential implicationsoftheOTCtests,andsuggestpotentialstrategies forimplementationofself-testingandalsoaresearchagenda movingforward.
How
to
target
OTC
testing?
SincetheideaofOTCHIVtestingemergedinthe nineties, muchoftheearlydebatecenteredontheissueofthequality (sensitivityandspecificity)ofthekitsandtheriskprofileof populationstargetedfortestuse.Thereisboththepotential forfalse-negativeresultsshortlyafterinfection(thewindow period) and anincreasedburdenoffalse-positiveresultsif
self-testingisadoptedbylowprevalencepopulations,such as the “worried well” of repeat testers.21,22 However,
self-conductedHIVtestshavegenerallyperformedquitewell:a recentlypublishedsystematicreviewofbothoralfluidand finger stick self-conducted rapid HIV tests documented a veryhighspecificityinsupervised(withahealthcareworker present)andunsupervised(withaphonelineforquestions) settings.Thefindingsonsensitivityvariedfrom93%to100% inunsupervisedenvironments.23
Targeting hometesting toparticularly high-risk popula-tions can mitigatepoor predictive values. If the OTC tests currentlyapprovedintheU.S.weretargetedtoMSMinBrazil, boththe positiveandnegativepredictivevaluesofthetest wouldbeapproximately99%(assumingHIVprevalenceof10% andOraSuresensitivityat92%andspecificityat99.98%inthe homeenvironment).18Theextended‘windowperiod’for
anti-bodydetectionofuptothreemonthsremainsanunfortunate reality.Thereishopethattheperformancecharacteristicsof the rapidtests willimprove incomingyears;however, the antibodytestswillalwayshaveawindowperiodandthis lim-itationwillalwaysrequirecarefulorientation,particularlyfor thosewithrecentinfections.Ofcourse,theissueofthe win-dowperiodexistsforclinic-conductedrapidtestsaswellas self-conductedtests;communityeducationaroundthe test-ingwindowremainsaprioritywhethertestsareconducted aloneorinclinics.Italsomustbemadecleartoconsumers thatself-testscannotbeusedasaconfirmatorytesting mech-anism;thetestisnotlicensedforthispurpose.Tothisend, successfulintroductionofOTCtestingwillhingeon increas-ingawarenessaroundthetestingwindowandthelimitations of the current rapid tests, particularly among health care professionalsandthenon-governmentalorganizations(NGO) communitywhomayactasgatekeepers.
Will
MSM
use
OTC
testing?
Todate,publisheddataindicatethatMSMarepoisedtouse self-tests. Utilization data on self-testing among MSM are stillsomewhatscarce,thoughanumber ofstudiesare cur-rentlyunderway,includingoneinRiodeJaneiro,Brazil.One landmarkstudyinNewYorkprovidedhomeHIVteststo27 non-condomusingHIV-negativeMSMwithmultiplepartners touseforpartnerscreening.Uptakeoftestingwashigh:101 partnerswereself-testedoverthreemonths,andthe major-ity ofparticipantswantedtocontinueusinghometestkits followingthe studyperiod.24 Other U.S.-basedstudieshave
demonstratedthatMSMwoulduseself-testswhengiventhe opportunity andthat theyusedthem accurately.25,26 There
isalsoampledataonspeculativeacceptabilityofself-testing (notbasedonactualexperience).InBrazil,90%ofrespondents onanationalInternetsurveywithMSMreportedthatthey woulduseHIVself-testsifprovidedtheopportunity;overhalf reportedapreferenceforself-testingascomparedto clinic-basedtesting;and60%ofrespondentssaidtheywould use self-teststomakechoicesaboutunprotectedsexwithsexual partners.27Similarly,acceptabilitystudiesconductedinthe
USamongMSMdemonstratesubstantialinterestinusingHIV hometests.25,28
Whilethedataonacceptabilitytodateare encouraging, thereisstill muchthat isunknownabout uptakeofthese testsoutsideoftheresearchenvironmentandabout accept-abilitywithinthe diverse population thatis oftengrouped as‘MSM’.Forexample,thereislittleinformationregarding acceptabilityamongtransgenderpopulations.Littleisknown aboutacceptabilityamonghealthcareproviderswhomaybe distributingtestkitsorattendingpopulationspresentingwith self-testingresults.Infact,whetherBrazilianMSMandother at-riskpopulationsusetheOTCtestswhentheybecome avail-ablemaydependtoalargeextentonthesupportofhealth careprovidersandencouragementfromtheNGOcommunity; asupportiveenvironmentcanenableMSMtoaccesstesting accordingtotheirneeds.Self-testingmayofferanopportunity tobolsternotonlytestingratesbutalsoasenseofautonomy orempowermentintheMSMcommunityastheytakecontrol oftheirhealth.23
What
about
counseling
and
linkage
to
care?
Voluntarytesting andcounseling (VCT) hasbeen a corner-stoneoftheBrazilianprogramsincethefirstHIVtestsbecame availableinthepublicsystemin1985.Inacountrywhere qual-itycounselinghasbeenemphasized,OTCtestsraiseanumber ofquestions.Howwillcounselingbeofferedinconjunction withthesetests?Whatcounselingisneededbeforeandafter thetestkitisacquiredandconducted?Whatsystemcan guar-anteeaccesstocounselingandpsychologicalcareifneeded? Whowillbebestpositionedtoprovidethecounselingneeded? Healthcareprofessionals,NGOstaff,peereducators?Thereis noquestionthatavailabilityofOTCtestscouldmeanamore limitedcounselingexperienceandlessdirectcontactwiththe healthsystem.
Therehasbeenrecentdebate globallyastothevalueof putting diminishing resources into the pre-test counseling andconsentprocessesthatwereestablishedintheeighties. Whiledatafromthosewhotestpositivehaveindicatedthat apre-andpost-testcounselingexperienceiscriticalbothfor supportandtocreatethatfirstcriticallinkwiththe health system,29thereislittleevidencethattypicalpre-test
counsel-ingimpactsbehaviorsforthosewhoarenegative.30Infact,
oneclinicaltrialfoundthattherewasnodecreaseinSTI/HIV incidenceamongSTDclinicpatientsreceivingrapidHIVtests withpatient-centeredpre-testcounselingcomparedtothose receivingarapidtestwithinformationonly.31Required
coun-selingmayevenrepresentanobstacletotesting–bothdue toexperiencedstigmainthehealthestablishmentanddue totheinaccessibility(distance,waittimes)ofclinics.Inlight ofthisfact,somehaveadvocatedforeliminatingmandated pre-testcounseling,whichisoftenofvariablequality,32toput
moreresourcesintoeffectivepost-testcounselingand facil-itating linkagetocareforHIV positives.33,34 Analternative
viewisthatnoteverytestrequiresthesamelevelof counsel-ing.Instead,MSMcouldbeencouragedtotestfrequently(two tofourtimesayear),butencouragedtoundergocounseling onlyonceayearorondemand.Thehometestingdebatemay beinstrumentalinadvancingdiscussionsaboutthecurrent, traditionalcounselingmodel.
There is also a broad debate about how linkage to care would be managed in the self-testing environment. If users of OTC tests understand the need for confirm-atory testing, and recent evidence would suggest that many do,then the confirmatory testcan serveas the first ‘link’ into the care system.35 Research on mechanisms to
facilitatelinkageinthe contextofself-testing willbe criti-cal.
What
are
the
potential
social
harms?
The potential social harms and unintended consequences of using home test kits and approaches to mitigate these potential negative effectsrequire attention.Concerns with self-testing includeadverseemotionalreactions topositive tests, riskcompensationfollowinganegativetest,coercion touse tests, andpotential partnerviolencewhentestsare utilized inrelationships.Inthe recentstudyofOTCtesting conductedinMSM inNew YorkCity,use ofapproximately 100kitswithcasualpartnerspriortoinitiatingsexresulted in 10 positive results and no sexual intercourse nor vio-lent reactions followinga positive result.24 There were no cases of physicalviolence when the use ofa test kit was proposedanddeclined.Harmtoself,thoughoftenthe cen-terpiece oftheargument againstself-testing,has notbeen documentedintheageofARTs.36Becausecounseling
oppor-tunitieswillnecessarilybereducedwithself-testing,support mechanisms(includinghotlinesor0–800numbers, informa-tionalbrochures,web-support[videoorchat],andelectronic ormobiletestresultassistance)willneedtobedevelopedto accompanytestkits.
WhetheranHIVnegativeself-testmightencourageunsafe sex (discourage condom use) is an important question to pose,againdrivinghometheimportanceofeducationaround the window period. Todate, the worriesaround risk com-pensationhavenotbeensubstantiatedforotherprevention technologiesineitherPrEPtrials37,38orcircumcisiontrials.39
Thereareotherrisksposedbytakingtestkitshome:family membersorfriendscouldfindtheclearlymarkedHIV test-ing kits,threatening privacy.Thismay necessitate creative packaging and disposal materials. Further,pressure totest fromfriendsorpartnersisarealconcern.Forsexworkersany forcedutilizationbyclients,pimps,orbrothelownerscould havesevere consequences(ascould usebysexworkerson theirclients).Finally,thereisthepotentialthatdistributionof hometestkitswouldencouragefurtherwithdrawalor alien-ationfromthepublichealthsystem,particularlyforMSMand transgenderpeoplealreadyuncomfortableinthepublic sec-tor.
In order tomitigate potential socialharms, partnership with NGOs and other representative institutionsrelated to MSMpopulationsshouldbesoughtinfleshingoutplansfor research and implementation.Community based organiza-tionshavelongbeenrecognizedasanimportantresourcefor theimplementationandreinforcementofHIV/AIDS preven-tionandcontrolpoliciesandprograms.40InBrazil,aswellas
inotherdevelopingcountries,NGOshavealsobuiltan effec-tivenetworkforsocialandpsychologicalsupportforthose mostaffectedbyHIV.41
A
proposed
research
agenda
Overall,thenetpreventionpotentialforOTCtestingforMSM andotherpopulationsisstillpoorlyunderstood.Aboveall,it remainslargelyuncertainwhethertheavailabilityofOTCtest kitswillbringabouttheanticipatedincreaseinHIVtesting rates.AtleastonerandomizedstudyoftheimpactofOraQuick testkitdistributionontestingfrequencyamongMSMwillbe launchedintheUSin2014.Itisalsounclearwhetherthe bene-fitsofincreasesintestingrateswouldbeoffsetbyfewerpeople testinginclinics,lesslinkagetocare,andthereducedaccuracy ofOTCtests.42Itisalsounknownwhetherpeoplewillseek
confirmatorytestingandlinktocarefollowinguseofa self-test.Theselargerquestionswillneedtobestudiedregionally –aswillaspectsofdemandandsupplyofOTCtests, includ-ingappropriatedistributionchannelsfortestkitsthatensure accessiblecostsordistributioninthepublicsector,soasnot toexcludethepopulationsmostinneedoftesting alterna-tives.
SpecifictoBrazil,wherethereisbutonefeasibilitystudy (thatweare awareof)underway,weproposethe following researchquestionstosupportsafeandaccurateuseofOTC testinginpopulationswiththegreatestneed:
- Whataretheoptimalmechanismstoensureeffective link-agetopost-testcounseling,confirmatorytesting,care,and treatment?Whatreferralresourcescanbeincludedintest kitsandcanfeasiblybeusedtoensurefollow-upforpositive tests?
- Whataretheoptimalsupportmechanismstoensuresafe and accurate use of test kits, minimizing social harms, including in-kitresources, webresources, hotlines, peer-networks,andNGOs?
- WhatistheoptimaldistributionsysteminBraziltoensure accesstotestkitsforthosewhomostrequiretestingand arelessapttoaccesspublicservices?
- Howdoesavailabilityofself-testkitsaffecttestingdecisions (including when, where,and withwhom totest),testing frequency,andsexualbehavior?
- WhataretheHIVtestingneedsofdifferentsectorsofthe diverse‘MSM’populationandhowcantheybemetusing OTCtests?
Therearecurrentlyplanstoevaluatetheimplementation ofinnovativeHIV testingmodalities, including self-testing, targetingMSMinCuritiba,inSouthernBrazil,incollaboration withtheCDCandthePEPFARKeyPopulationImplementation ScienceFund.
Implications
for
policy
and
practice
Pendingresearchresults,webelievethatOTCtestingmightbe madeavailableinahybridstrategyinBrazil.First,self-testing kitscouldbeintroducedasanalternativetestingoptionfor thoseidentifiedathealthservicesashighrisk(i.e.MSM, trans-genderpopulations,thoseseekingPost-ExposureProphylaxis (PEP),sexworkers,andpartnersinsero-discordantcouples). Theseindividualscouldbeofferedhometestingkitswithin
theSUSasanalternativetocomingintotheclinicforrepeat testsortotakehometocoverthewindowperiod(testing2–3 monthslaterfollowinganegativetestatahealthservice).This strategycanbothdecreasetheburdenonexistingtesting ser-vices andempowerindividualstoutilizetestingthatmeets theirindividualneeds.
Thesecondstrategywouldbetoofferkitsforsalein phar-macies,whichmayimproveaccessforthosewhoprefernotto attendclinics.Mentendtoutilizeserviceslessfrequentlythan womeninBrazil,sothispharmacy-basedstrategymayappeal toMSM.Theconcernwithpharmacysalesis,ofcourse,cost. HIVvulnerabilityisthehighestinresourcepoorpopulations whomaynotbeabletopurchasetests,whichhighlightsthe importanceofmakingOTCtestsavailablethroughthepublic systemand/orviaNGOsandotheralternativetestingsettings, suchasmobileunits.Thesubsidizedpharmacysystemmay proveafeasibleoptionforthose comingwithprescriptions fromSUS.
Moving
ahead
Mounting the suggestedresearch program will necessitate politicaldiscussions,includingthepotentialrevisionof cur-rentpre-testcounselingpractices.Indeed,self-conductedHIV testingwillchallengelong-heldbeliefsaboutthedeliveryof HIV/AIDSpreventionandcareandrequiresadialogbetween thepublicsector,healthcareprovidersandcivilsociety.The Brazilian Ministry ofHealth is currently taking largesteps toadvancethecountry’spreventionandtreatmentagenda. InDecember 2013,theadoptionofthe testandtreat strat-egy wasincorporated into thenewnational HIVtreatment guidelines.AllindividualsdiagnosedwithHIVinfectionwillbe offeredARVtreatmentregardlessofCD4count.Itisexpected thatthis willleadtoatleast100,000newindividualsliving withHIVgainingaccesstocombined antiretroviraltherapy. Inaddition, Brazilistakingadvantageofthelocalcapacity tomanufactureHIVrapidtestkits,includingoralfluidkits, whichshouldmakeHIVtestingavailabletohigh-risk popu-lationsoutsideofhealthservicesinsettingssuchusmobile unitsandNGOs.
AstheHIVpreventionandcareleaderinLatinAmerica, Brazilisinthepositiontoexploreresearchandpartnerships thatwillpreparethecountryandtheregionforOTCHIV test-ing.ThetimehascometoexplorethepotentialofOTCtesting asanadditionaltoolinthebattleagainstHIV.
Conflicts
of
interest
Theauthorsdeclarenoconflictsofinterest.
Acknowledgements
Theauthors thankHeidiJonesand MariaAmeliaVerasfor theircommentsondraftsofthismanuscript.
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