“Evaluating SMS to promote retention and adherence to ART ......• Group 2 will receive SMS texts...

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“EvaluatingSMStopromoteretentionandadherencetoARTprograms”

–3ie-GDNfinancedimpactevaluationprojectinBurkinaFaso–

NataschaWagner,PhDAssistantProfessor

wagner@iss.nl

Kortenaerkade12TheHague

March2016

Summary

Therapiduptakeofmobilephonesacrossthedevelopingworldinrecentyearshasinspireda host of innovative concepts for how these devices can be harnessed to promote publichealth.Inthesecontexts,thepotentialofmobiledevicestopromotehealthybehaviorsandfacilitate health service delivery looms large. Yet, to date, few rigorous evaluations havebeenconducteddemonstratingtheimpactof“mobilehealth”(mHealth)interventions.

Inthisstudy,wewillevaluatewhetherashortmessageservice(SMS)remindersystemcanbeharnessedtosupportHIV/AIDSpatients inBurkinaFaso. In themidstof thecountry’spush to escalate access to antiretroviral therapy (ART), high rates of attrition fromtreatmentprogramshavebeen identified as a concern. Plans for a two-yearpilot projectthatemploysSMStofollow-uponpatientsandencouragethemtoremainincarehavebeenputinmotion.Wehavedesignedanimpactevaluationtobebuiltintothisintervention.

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Patients starting an antiretroviral regimen will be enrolled in the study and randomlyassigned to an SMS intervention or control group. For those participants enrolled in theintervention,SMSwillbesentonaweeklybasis,remindingthemtotaketheirantiretroviralmedications. The evaluation will determine whether this form of consistent follow-upservesasahelpfultoolforpatientsinitiatingART.Specifically,theevaluationwill identifywhether patients who receive SMS are more likely to remain in care, adhere to theirantiretroviralregimens,andexperiencethehealthbenefitsassociatedwithtreatment.

To this end, the impact of message type and frequency will be considered. That is, wesuspectthatduetolowliteracyratesASCIIimagesmightbeanalternativetotextmessagesinremindingpeopletotaketheirmedication.Moreover,weexpectthatparticipantsinitiallymotivatedbythetextmessagesmayexperiencemessagefatigueoverthecourseofthetwoyears. This study aims to detect the critical point up to which text messages can beefficientlyemployed.Tothatend,threefollow-upsurveyswillbeconductedoverthetwo-yearperiod.

Inthiscurrenteraofantiretroviralscale-up,thisevaluationprovidesatimelyinvestigationofthefundamentalbehavioralcomponentsofeffectivetreatment.Byexaminingthevariousfactors underlying decisions to discontinue treatment, it strives to identify the mostsignificantbarrierstolong–termsuccesswithART.

Intervention

Inrecentyears, ithasbeenobservedthatmanypatientswhobeginantiretroviraltherapydonot continuebeyond the first twoyears.This isdespite the fact thatART is a lifelongtreatment course and that stoppagesorbreaks in treatmentwill likely to lead to a rapiddeterioration in health. In Sub-Saharan Africa, rates of attrition from ART programs areparticularlyhigh.Onesystematicreviewfoundthat40%ofpatientsarelostfromaftertwoyears,21%oftheseinjustthefirstsixmonthsoftreatment(RosenandFox,2007).

The intervention to be evaluated takes aim at these high rates of patient attrition andemploys an everyday technology, the mobile phone, to promote healthy behaviors.Specifically,theinterventionisanSMSsupportsystemforpatientsbeginningorintheearlyyearsoftreatment.RandomlyselectedparticipantsrecruitedfromhealthcentersacrossthecountrywillreceiveweeklySMSreminders.TheseSMSwillencouragepatientstotaketheirpillsandremindthemoftheimportanceofARTfortheirhealth.Theintentistoserveasanimmediateandconsistentmeansofpatientfollow-up.Inregionswherecontactwithhealthpersonnelislimitedanddistancestohealthcentersmaybeconsiderable,thisfollow-uphashighimpactpotential.

Theimmediateintendedoutcomesareenhancedretentionandadherence(i.e.pill-taking)toantiretroviraltherapy.Ultimately, improvementsinpatienthealtharealsodesired.Theinterventionwillrunforaninitialperiodoftwoyears.

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Thisevaluationwilladdressthefollowingquestions:

1) DoSMSreminderspromoteretentioninHIVtreatmentprogramsandencourage

adherencetoantiretroviralregimens?2) ArehealthoutcomesimprovedaspatientsreceiveSMSreminders?3) AresubjectivehealthoutcomesimprovedaspatientsreceiveSMSreminders?4) Canmessagefatiguebeobservedinthemediumtolong-term?5) Dothetype(textversuspicture)andthefrequency(onceaweekversustwicea

week)oftheSMShaveadifferentialimpact?6) ArepatientsreceivingtheSMSmessagesmorelikelytowork?7) Havepatientsreceivingthemessagesabetternutritionalstatus?

The primary outcomes of the study will thus be retention in care (measured as theproportion of patients who remain in treatment programs), adherence to treatment(measuredastheproportionofpillstakenofthoseprescribed),andpatienthealth.Patienthealth will be monitored by two biomarkers—CD4 counts and the BMI—as well as byincidenceofco-infection,mortality,andsubjectivehealthratings.

Theexperimentitself

Treatmentarmswillvarybymessagecontent.Formalversusinformalmessagesandremindersframedintermsofhealthgainsversushealthriskswillbeevaluated.Participantswillthusberandomlyassignedtooneoffivegroups:

• Group0willserveasthecontrolandwillnotreceiveanySMSreminders• Group1willreceiveSMStextswithvaryingcontent,lowfrequency,onemessageper

week• Group2willreceiveSMStextswithvaryingcontent,highfrequency,twomessages

perweek• Group3willreceiveSMStextswithvaryingcontentandASCIIimage,twomessages

perweek• Group4willreceiveASCIIimages,lowfrequency,onemessageperweek

All groups receive the standard of care. Along with periodic clinical check-ups andtreatmentcounseling,thisincludesroutinemonitoringofpatientCD4cellsandviralloadasmeasures of disease progression. Adherence support and/or additional treatmentcounselingmayalsobeprovidedatthecommunitylevel.Thisisassessedduringthefollow-upsurveysincollaborationwiththelocalassociationsthatsupportpeoplelivingwithHIV(PLHIV)inBurkinaFaso.

For groups 1-4, messages will be sent on a weekly basis. A total of 4-8 monthly textmessageswill thus be sent to each participant assigned to groups 1-4.Messageswill bemonitoredthelocaltelecommunicationcompanyEVOLVE.EVOLVEenablesustosendtext

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messagesinbulkandkeeparecordofallcommunicationsent.Thisallowsustoverifythatthe text messages are sent and that the intervention is properly implemented. Themessagesareone-way(i.e.recipientsarenotpromptedtorespond).

The study started with the baseline survey in February 2015. Patients on antiretroviralregimenhavebeenenrolledinfromFebruarytoMarch2015.Morethan3,800peoplelivingwith HIV across Burkina Faso participate in the study. The participants were randomlyassignedtovariousSMSinterventionsoracontrolgroup.

The study is officially registered as trail with ISRCTN. The trial reference N° isISRCTN16558614.