ABAS, MELANIE AMNA
Background. HIV care has been rapidly decentralized in high-prevalence countries like Zimbabwe, in thedrive to expand access to antiretroviral therapy (ART) and to achieve viral suppression in people living withHIV/AIDS (PLWH).1,2 Optimising adherence to simple affordable regimens is especially critical in settingswhere third-line ART is barely available. Depression in Zimbabwe, like elsewhere, is common in PLWH3and a key barrier to ART adherence.4 There is a dearth of interventions for depression and poor ARTadherence which are feasible for non-specialists to deliver. These facts underscore the public healthsignificance of focusing on those with depression and a detectable viral load receiving ART regimens.Preliminary work. We have conducted extensive preliminary work to evaluate the cultural appropriatenessand feasibility of a stepped care, task-shifted intervention for treating depression and non-adherence inZimbabwe. Using available lay adherence counselors, this intervention links with the existing ZimbabweanHIV care pathway. We 1) culturally adapted the Life-Steps adherence intervention through qualitativestudies and tested it in 100 PLWH,5 2) developed a combined depression-adherence intervention calledTENDAI (meaning ?thankful? in the Shona language) through integrating the adapted adherenceintervention with Problem-Solving Therapy for depression (a simple culturally-acceptable treatment fordepression used in Zimbabwe)6 and 3) successfully completed an open trial and then a pilot randomizedtrial of TENDAI.7 Together, these studies show feasibility, acceptability and potential beneficial effects ondepression, adherence, and HIV viral suppression. Our combined US, UK and Zimbabwean consortiumbring together a history of successful trials in HIV and depression.8-10 Our proposal is strongly endorsed bythe Ministry of Health AIDS and TB Unit. Design: we propose a two-arm effectiveness RCT of the TENDAIintervention in HIV clinics in rural Zimbabwe in 290 people on ART (first, second or third line treatment) witha detectable viral load (=> 1000 viral RNA copies) and clinically significant depression. The TENDAIintervention will be compared to Enhanced Usual Care (EUC). Primary outcomes at 12 months (Aim 1)include proportion of HIV viral suppression in each condition, adherence to ART (assessed electronicallyand by ART detection in Dried Blood Spot), and depression (assessed via a locally validated questionnaireby an independent evaluator). We will also test (Aim 2) moderators (sex, depression severity) of thetreatment effect, and examine changes in adherence and depression as mediators of the effect on viralsuppression. Through collecting resource utilization and cost data we will examine the cost-effectiveness ofour novel treatment compared to EUC on reduced depression and, potentially, on better HIV outcomes(Aim 3). If successful, the RCT results will enable us to recommend a strategy for adherence counselingand depression care locally and in the east and southern African region.