Program Director/Principal Investigator (Last, First, Middle): Makadzange, Azure TariroIn 2014 UNAIDS set ambitious goals to achieve 90% virologic suppression rates among individuals on ART. InZimbabwe this is an ambitious target particularly among adolescents; <5% of HIV infected individuals receivedHIV 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 VLmonitoring, adherence support and genotyping for those with persistent viremia are urgently needed. We haveshown 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) adherenceintervention (Life-Steps) for use in Zimbabwe and have identified a low-cost genotyping strategy that canfacilitate detection of drug resistance mutations using already existing RT-PCR technology. We hypothesizethat our proposed package of care will result in a decrease in virologic failure rates among adolescents. Ourprimary study objective is to determine if implementation of a package of care that includes DBS based viralload 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 failurerates among HIV-infected adolescents compared with standard of care. We will also adapt and integrate NziraItsva for Adolescents (NI), a cultural adaptation of Life-Steps into routine care as an adherence supportintervention for HIV infected adolescents, and implement a novel low-cost genotyping assay using PanDegenerate Amplification and Adaptation (PANDAA) of viral RNA as a point mutation assay for the detection ofdrug resistance. Process and cost data will be collected for subsequent cost-analysis. The proposedintervention will be a two-arm cluster-randomized trial in Mashonaland West and Matabeleland North provincesof Zimbabwe. The units of randomization will be public and largely rural clinics within the provinces, with sitesrandomized to the intervention or to the standard of care. The study is anticipated to show that the use of DBSin routine monitoring of adolescents is feasible, to show that CBT if incorporated into routine counselingactivities can complement viral load monitoring and genotyping to reduce treatment failure rates and preservetherapeutic options for infected adolescents. The results of this study will have important implications inZimbabwe and other low-income countries in sub-Saharan Africa with a large proportion of HIV infectedadolescents. The study will include young adolescents 10-14 years, as well as older adolescents 14-19 yearsand therefore provide data that will guide implementation of strategies for virologic success in the growingnumber of children who are surviving on ART into adolescents, as well as for behaviorally infectedadolescents.OMB No. 0925-0001/0002 (Rev. 08/12 Approved Through 8/31/2015) Page Continuation Format Page
; First; Middle): Makadzange; Azure TariroAdolescents with HIV in sub-Saharan Africa have high treatment failure rates and increasing drug resistance.Novel; scalable approaches for HIV viral load (VL) monitoring; genotying to detect resistance and evidencebased adherence interventions are desperately required. We propose through a cluster-randomized study todetermine the efficacy of a package of care that includes VL monitoring; genotyping and a cognitive behavioralapproach to adherence in reducing adolescent treatment failure rates in sub-Saharan Africa; and hypothesizethat this low-cost and scalable approach will lead to a decrease in treatment failure rates among adolescents.OMB No. 0925-0001/0002 (Rev. 08/12 Approved Through 8/31/2015) Page Continuation Format Page
