CHWs, mHealth, and Combination HIV Prevention in a Hotspot: A Randomized Trial

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 DESCRIPTION (provided by applicant): Kasensero, Uganda, a fishing community on Lake Victoria, is a representative HIV "hotspot" with extremely high HIV prevalence (44.3%) and incidence (~3.9/100py), yet low HIV service utilization. Hotspots such as Kasensero may seed and sustain HIV in general populations, compromising national and regional HIV control efforts. PEPFAR, UNAIDS, and WHO have recognized the urgent need to target hotspots with enhanced HIV treatment and prevention efforts. However, evidence on low-cost, comprehensive, and effective HIV control strategies for hotspots is limited and is thus a priority need for the field. We propose a household-randomized, controlled trial in Kasensero to evaluate the impact on HIV service uptake and HIV incidence of CHWs promoting combination HIV prevention (CHP) services supported by mobile health technologies (mHealth). Combination HIV Prevention (CHP) is the implementation of multiple HIV prevention services (HIV testing and counseling, antiretroviral therapy, medical male circumcision, and behavior change) to maximize population- level impact on HIV incidence. For CHP to substantively decrease HIV incidence, most community members must be assessed for risk factors and current CHP utilization, then triaged, motivated, linked, and, if HIV- infected, retained in care. The proposed intervention will use low-cost CHWs leveraging mHealth decision support, counseling, and text messaging tools to promote CHP along this entire continuum of service utilization. Intervention feasibility has been supported by pilot work, and we now propose a randomized evaluation. The hypotheses are that household residents receiving the intervention will have improved CHP service uptake and decreased HIV incidence compared to controls. In Aim 1, the intervention will be evaluated through a pragmatic, household-randomized trial (n~1200 households, n~1800 participants). Intervention arm participants will be visited by CHWs trained to evaluate and triage household into risk categories, provide tailored CHP health counseling, linkage, and adherence support, and send targeted text messages, all supported by a mHealth decision support tool. The conceptual framework is based on a situated Information, Motivation, and Behavioral Skills (sIMB) model. The primary outcomes will be CHP service coverage and HIV incidence at 36 months. Other outcomes will be community viral load, sIMB and implementation measures, retention, virologic suppression, and sexual behaviors. In Aim 2, mixed methods evaluations of the trial will be conducted to evaluate implementation processes, facilitators, and barriers to inform study results and future program uptake. Focus groups and in-depth interviews will be conducted during and after the follow-up period and synthesized with quantitative data. Intervention costs will also be prospectively measured to provide information on program affordability. Through these Aims, a novel, low-cost, and scalable intervention to improve CHP uptake will be evaluated in an HIV "hotspot" critical to controlling the HIV epidemic. The study design ensures rigorous evidence of immediate relevance to many stakeholders.