? DESCRIPTION (provided by applicant): Data showing treatment-mediated, HIV-1 RNA suppression reduces transmission risk by 96%, has created a global aspiration for an AIDS-free generation. These findings, combined with the health advantages of Antiretroviral Therapy (ART), have led the World Health Organization to recommend initiating ART earlier in the disease course. South Africa (SA), the country with the largest HIV-epidemic, will be adopting these guidelines in 2015. Treatment-refusal, a phenomenon our team identified among newly diagnosed, ART- eligible adults in SA in 2011, may undermine the potential gains that could be made with earlier treatment. The research proposed here seeks to capitalize on our understanding of ART refusal by designing a feasible and acceptable intervention to improve ART initiation. This multi-component intervention, titled the Treatment Ambassador Program (TAP), will target HIV+ people who do not initiate treatment within six months of learning they are eligible. It will be aimed at addressing barriers to ART initiation identified through our prio qualitative research, as framed through the Theory of Triadic Influence. Our intervention will last 16 weeks, and will aim to address the three streams of influences on decision-making through a system of patient navigation and support with an assigned HIV+ partner trained in motivational interviewing. To develop our intervention, we have formed an interdisciplinary collaboration with expertise in socio-behavioral and biomedical research. In Aim 1 we will use qualitative research methods to explore barriers and facilitators to implementation of the proposed TAP intervention by performing semi-structured interviews with 20 ART eligible adults and 10 healthcare providers, to develop and refine the draft intervention content and procedures. In Aim 2 we will develop the different components of the intervention and conduct an iterative phased-approach of our intervention. As part of this aim, we will develop intervention manuals based on feedback from our qualitative aim, train Treatment Ambassadors, and conduct an initial assessment with 10 participants, to maximize acceptability and retention. In Aim 3 we will conduct a pilot randomized controlled trial of the four-month TAP intervention to determine the acceptability, feasibility and preliminary impact of the intervention on ART refusal. Eighty participants will be enrolled and followed for a total of 10 months (four months of intervention plus six months of follow-up). Participants will be randomized to either standard of care (referral for ART) (n=40), o the TAP intervention (n=40) RNA suppression at six months post-intervention. We will conduct a mixed-methods process evaluation of the . The primary outcome will be ART initiation; the secondary outcome will be HIV-1 different intervention components and their implementation using quantitative, qualitative, and observational methods. We intend to use our findings to inform development a refined intervention to be formally tested in a R01 grant submission. The ultimate goal of this work is to contribute to sustainable solutions to tackle ART refusal and promote early and enduring uptake of treatment in SA.

R34MH108393

2015-08-18

2018-04-30