GH16-005, Zimbabwe, Implementing a sustainable adherence intervention, monitoring virologic suppression and drug resistance among HIV-infected adolescents receiving Antiretroviral treatment

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Program Director/Principal Investigator (Last, First, Middle): Makadzange, Azure Tariro In 2014 UNAIDS set ambitious goals to achieve 90% virologic suppression rates among individuals on ART. In Zimbabwe this is an ambitious target particularly among adolescents; <5% of HIV infected individuals received HIV viral load (VL) testing in 2015 and treatment failure rates among adolescents range between 35-42%. Adolescents failing ART also have high rates of drug resistance. Scalable strategies to facilitate improved VL monitoring, adherence support and genotyping for those with persistent viremia are urgently needed. We have shown that dried blood spot (DBS) samples can be used for routine VL monitoring on existing technologies. We have also adapted an evidence based, widely used, cognitive behavioral therapy (CBT) adherence intervention (Life-Steps) for use in Zimbabwe and have identified a low-cost genotyping strategy that can facilitate detection of drug resistance mutations using already existing RT-PCR technology. We hypothesize that our proposed package of care will result in a decrease in virologic failure rates among adolescents. Our primary study objective is to determine if implementation of a package of care that includes DBS based viral load monitoring, coupled with an evidence-based intervention to improve ART adherence using cognitive- behavioral principles and genotyping for those with persistent viremia decreases 12-month virologic failure rates among HIV-infected adolescents compared with standard of care. We will also adapt and integrate Nzira Itsva for Adolescents (NI), a cultural adaptation of Life-Steps into routine care as an adherence support intervention for HIV infected adolescents, and implement a novel low-cost genotyping assay using Pan Degenerate Amplification and Adaptation (PANDAA) of viral RNA as a point mutation assay for the detection of drug resistance. Process and cost data will be collected for subsequent cost-analysis. The proposed intervention will be a two-arm cluster-randomized trial in Mashonaland West and Matabeleland North provinces of Zimbabwe. The units of randomization will be public and largely rural clinics within the provinces, with sites randomized to the intervention or to the standard of care. The study is anticipated to show that the use of DBS in routine monitoring of adolescents is feasible, to show that CBT if incorporated into routine counseling activities can complement viral load monitoring and genotyping to reduce treatment failure rates and preserve therapeutic options for infected adolescents. The results of this study will have important implications in Zimbabwe and other low-income countries in sub-Saharan Africa with a large proportion of HIV infected adolescents. The study will include young adolescents 10-14 years, as well as older adolescents 14-19 years and therefore provide data that will guide implementation of strategies for virologic success in the growing number of children who are surviving on ART into adolescents, as well as for behaviorally infected adolescents. OMB No. 0925-0001/0002 (Rev. 08/12 Approved Through 8/31/2015) Page Continuation Format Page