Phase II RCT of Comprehensive Triaged HIV Prevention: Tanzania

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DESCRIPTION (provided by applicant): Despite 20 years of considerable HIV prevention efforts in Sub Saharan Africa the epidemic continues to have devastating impacts. The advent of expansion of treatment and care for AIDS in the region has provided important and lifesaving services, but has also added complexity to coordination and service delivery across prevention and care efforts. How to best combine intervention strategies (prevention, treatment, care, behavioral, biomedical) is a pressing question in the field. We believe that the best way to combine interventions is based on synergy, with intervention components directly reinforcing one another, not just whether programs occur simultaneously. In addition, needs are great and services limited. To achieve the maximum population-level reduction in HIV incidence it is important that those at greatest risk of transmitting and acquiring HIV receive more intensive interventions. Yet most programs target only at the population level, by groups, and do not have mechanisms to triage services individually. The other major impediment to successful interventions is the lack of attention to the structural barriers that at-risk populations face in accessing services. We propose to conduct a rigorous 3-year Phase II trial of a promising HIV prevention strategy designed to significantly reduce population-level HIV incidence in rural developing country settings with severe generalized HIV epidemics. The study design is a two-arm community randomized controlled trial of Comprehensive Triaged HIV Prevention (CTHP) in two rural communities matched on demographics and HIV risks in Kisarawe District, Tanzania. The primary endpoint is HIV and STI incidence. The intervention was designed from lessons learned from our extensive work in the area over the past 8 years. The intervention links community-based testing and counseling to treatment and care, triages intervention intensity to risk of clients, and addresses key structural barriers to utilization. Components include: community mobilization, community-based VCT, enhanced counseling for high risk and HIV-infected clients, incentives for uptake of VCT by sex partners of high risk and HIV-infected clients. For clients who test positive for HIV there is posttest psychosocial support, income generation activities, assisted and active referral to treatment, and adherence support for treatment. The intervention was designed to be comprehensive, but also inexpensive and replicable. We will also carefully assess the safety and acceptability of the intervention in this Phase II trial. Detailed mediation analyses will be also conducted to identify which components of the intervention were most effective. The study will position the project to advance to an appropriately powered Phase III trial should compelling efficacy be found, and safety and acceptance be established.