Closing a Critical HIV Prevention Gap: Demonstrating Safety and Effective Delivery of Daily Oral Pre-exposure Prophylaxis (PrEP) as Part of an HIV Combination Preventive Intervention for Sex Workers in Kolkata and Mysore-Mandya, India

This PrEP demonstration study is designed to assess the feasibility and impact of delivering PrEP in addition to the existing package of HIV prevention interventions available to female sex workers in India. The study aims to: 1) identify female sex workers in need of HIV prevention and willing to take PrEP; 2) evaluate sustained uptake and adherence to oral PrEP; 3) assess safe delivery of PrEP; and 4) demonstrate effective delivery of PrEP within the context of the National Program of Targeted Interventions. The study will be implemented in two regions and among two typologies of female sex workers in India: brothel-based FSWs in Kolkata and FSWs operating from different settings in Mysore and Mandya.

Outcome 1: Identification of female sex workers in need of HIV prevention and willing to take oral PrEP For optimal delivery with limited resources, it is critical to provide HIV prevention strategies such as PrEP to populations at greatest risk of infection. Female sex workers are an important population for HIV prevention in India, prioritized as a "core high risk group" for targeted interventions by the India National AIDS Control Organization (NACO) (NACO 2013 annual report). In particular, some FSWs report inconsistent condom use and have unmet needs for HIV prevention (Ramesh, 2010; Reza-Paul, 2008). For example, these women may be less empowered or able to consistently demand condom use by their clients or may wish to become pregnant. PrEP has the potential to be an additional, more acceptable and effective HIV prevention method for female sex workers who have difficulty using condoms consistently.

This study proposes the development and use of a risk screening tool to identify female sex workers who are most vulnerable to HIV. This tool will guide recruitment into the demonstration study and could later assist health providers in deciding who will benefit most from PrEP for HIV prevention. In addition, this study will assess the proportion of FSWs identified by the risk screening tool who are willing to take PrEP. Quantitative and qualitative evaluations will identify factors related to the decision to initiate PrEP as well as reasons why FSWs decline PrEP.

Outcome 2: Sustained uptake and adherence to oral PrEP among female sex workers Similar to all medications, sustained uptake and adherence to PrEP is fundamental for efficacy in preventing HIV acquisition. In the four clinical trials of oral PrEP that demonstrated efficacy, study participants with high adherence had the greatest protection from HIV (Baeten 2012, Choopanya 2013, Grant 2010, Thigpen 2012). Likewise, across PrEP trials, there was a clear relationship between higher efficacy and a greater proportion of participants with study drug detectable in their blood. Two randomized clinical trials of daily oral PrEP among heterosexual women in Africa found no efficacy for HIV prevention; poor adherence to PrEP most likely explains these results (Marrazzo 2013, Van Damme 2012). For example, drug level testing in the FEM-PrEP Study found that less than 40% of a random sample of HIV negative women in the PrEP arm of the study had detectable levels of PrEP in their blood (Van Damme 2012). Analyses of high-risk subgroups of study participants in the Partners PrEP Study found PrEP efficacy estimates ranged from 64 to 84%, showing consistently high efficacy of PrEP in preventing HIV across various higher risk groups, including women (Murnane 2013).

Preliminary community awareness campaigns for PrEP among female sex workers in Kolkata found high interest in PrEP - approximately 80% reported willingness to take daily, oral PrEP. Sex workers in Mysore-Mandya are engaged in series of consultations where information related to PrEP as a tool for combination prevention is being discussed and questions or concerns related to PrEP addressed. In both places, initial observations show that there are some sex workers (e.g. those who are on long time contracts, those with overnight clients where sometimes the number of clients are not disclosed, those who want to be pregnant, and those who do not use condoms with their regular partners) expressed interest in being part of the demonstration project.