Female sex workers (FSW) are at significantly heightened risk for HIV infection globally. Pre-exposure prophylaxis (PrEP) offers significant promise for addressing FSW?s high HIV risk. However, to date uptake in this key population has been limited. Additionally, the efficacy of PrEP is directly related to the level of adherence, and significantly lower adherence to anti- retroviral therapy (ART) has been observed among FSW compared to non-FSW counterparts. Socio-structural factors such as sex work stigma, discrimination and violence have been linked to lower PrEP uptake and ART adherence in FSW. Community empowerment approaches to HIV prevention that address these socio-structural factors have been found to be associated with significant reductions in the odds of HIV infection in FSW. In turn, integrating PrEP delivery into a community empowerment response to HIV among FSW may maximize its effectiveness. We recently completed a two-community randomized trial of a community empowerment model of combination HIV prevention (Project Shikamana) among FSW in Iringa, Tanzania. HIV incidence was significantly lower in the intervention community vs. the control community at 18- month follow-up. However, the overall HIV incidence rate across arms was 7.4% at 18 months, underscoring the need to integrate biomedical preventions tools such as PrEP into the model. Building on our existing research infrastructure, local partnerships and established FSW cohort, we propose to assess the feasibility, initial effects and process of integrating PrEP into the Shikamana model in the intervention community compared to standard-of-care HIV services in a matched comparison community. Elements of the Shikamana model that will be tailored to PrEP service delivery include: (1) a community-led drop-in-center which will offer monthly PrEP refills, adherence counseling and community mobilization activities that foster social cohesion and collective action to address structural constraints to HIV prevention and PrEP uptake and adherence; (2) ongoing peer education and navigation to promote PrEP awareness and facilitate access to PrEP services; (2) sensitivity training for clinical providers delivering PrEP; and (4) SMS messages to promote intervention engagement and support adherence to PrEP. We will assess the feasibility and initial effects of integrating PrEP into the Shikamana model by examining differences in PrEP uptake and adherence using a biomarker of ARV adherence and incident HIV infections across two study communities. We will examine the role of socio-structural pathways, such as stigma and cohesion, on PrEP and HIV outcomes among 200 FSW and explore implementation facilitators and barriers using a mixed methods approach.
The proposed study will assess the feasibility, initial effects and process of integrating PrEP into an evidence-based community-driven model of HIV prevention for FSW in sub-Saharan Africa. Study findings will inform the global roll-out of PrEP for FSW and other key populations.
