Unified Approach to Address PrEP Cascade for BMSM

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Biomedical HIV prevention tools are very promising, but are not sufficiently reaching those in greatest need. This R34 application requests support to develop a novel, unified model to address PrEP interest, uptake, and adherence among Black men who have sex with men (BMSM). BMSM have experienced elevated rates of HIV incidence and prevalence since the beginning of the US epidemic, and the CDC estimates that half of BMSM will be diagnosed with HIV in their lifetime. In our current (non-overlapping) work, we have documented an exceedingly high 5.1% annual HIV incidence rate and 35% HIV prevalence rate among BMSM (R01MH094230, N=549). Although Pre-Exposure Prophylaxis (PrEP) is highly effective for preventing HIV, there is urgent need to improve efforts to deliver PrEP, in particular, for BMSM at-risk for HIV. Current strategies to increase PrEP interest, uptake, and adherence are not adequate and there are formidable barriers (e.g., stigma surrounding PrEP use, and adherence and retention concerns) to sufficient coverage of PrEP that must be addressed. Without considerable and targeted change to our current approach to PrEP delivery, we will fail to adequately provide PrEP to those in greatest need. In our PrEP focused preliminary studies with BMSM, we have identified two primary areas in need of critical focus and intervention – (1) stigma related to PrEP use, and (2) medication cognitions such as the perceived costs and benefits of taking PrEP, both of which can impede PrEP interest, uptake, and adherence. To address these areas we are proposing to develop an intervention model grounded in two novel cognitive/behavioral theories: the HIV Stigma Framework and the Medication Necessity-Concerns Framework. Our proposed study includes: Specific Aim 1: Conduct elicitation research with BMSM, community advisers, and expert consultants to design an empirically-based PrEP enhancement intervention for use in targeted service delivery settings. Specific Aim 2: PrEP messaging and intervention content will be assessed by a community advisory panel, and intervention feasibility and acceptability will be completed by conducting a pre-pilot test of the intervention procedures. Specific Aim 3: Conduct a pilot test that compares the PrEP enhancement intervention (N=100), including on-demand interactive text messaging, to a contact matched PrEP information only and sexual risk counseling control intervention (N=50) at 2, 4, and 6 month follow-ups on PrEP uptake, adherence, and persistence in order to establish preliminary intervention efficacy. Advances in biomedical HIV prevention, such as the availability of PrEP, will only impact the HIV epidemic if concurrent efforts are made to address the social and behavioral challenges that are associated with achieving sufficient coverage of PrEP among individuals at elevated risk for HIV. Low-resource burden, easily implemented, and effective social/behavioral interventions are urgently needed if the full benefits of PrEP are to be realized. If effective and disseminated, this intervention would meet current prevention needs and its potential impact on HIV infections averted could be substantial.