Abstract
We assessed the impact of pre-exposure prophylaxis (PrEP) in the context of a community-based HIV program among female sex workers (FSWs) in Kolkata, India. This was an open-label, uncontrolled demonstration trial. HIV seronegative FSWs over 18 years were eligible. Participants were administered daily tenofovir/emtricitabine (TDF-FTC) with follow-up visits at months 1, 3, 6, 9, 12, and 15. Drug adherence was monitored by self-report, and a random subset of participants underwent plasma TDF testing. 843 women were screened and 678 enrolled and started on PrEP. Seventy-nine women (11%) did not complete all scheduled visits: four women died of reasons unrelated to PrEP and 75 withdrew, for a 15-month retention rate of 89%. Self-reported daily adherence was over 70%. Among those tested for TDF, the percentage of women whose level reached ≥40 ng/mL was 65% by their final visit. There were no HIV seroconversions, and no evidence of significant changes in sexual behavior. This study demonstrated the feasibility and effectiveness of PrEP for FSWs in Kolkata, with very high levels of adherence to PrEP and no HIV seroconversions. The integration of PrEP into an existing community-based HIV prevention program ensured community support and facilitated adherence.
Highlights
We present the results of a demonstration trial in Kolkata, India, designed to assess the feasibility and impact of delivering pre-exposure prophylaxis (PrEP), integrated within an existing community-based HIV prevention program for female sex workers (FSWs) in Kolkata, the capital of West Bengal, and one of the largest cities in India
Kolkata has a concentrated HIVepidemic, with an estimated HIV prevalence of 2.2% among FSWs in 201514, as compared to an HIV prevalence in the general adult population of 0.21%.14. This PrEP demonstration trial was conducted by the Durbar Mahila Samanwaya Committee (DMSC), a large community-owned sex work program comprising over 60,000 FSW members, who are largely brothel based
Whereas PrEP has consistently been shown to be effective at preventing HIV infection in Randomized clinical trials (RCTs) of men who have sex with men (MSM),6,24,25 results among women have been less encouraging: two major clinical trials (VOICE26 and FEMPrEP27) conducted in South Africa found no evidence of reduced risk among heterosexual women
Summary
India has the third largest HIV epidemic in the world, with the highest rates of HIV infection concentrated among key affected populations, including female sex workers (FSWs). In India, FSWs are at high risk of HIV through unprotected sex from both sex work partners and intimate partners. Condom use prevents HIV and other sexually transmitted infections (STIs), but not all FSWs are able to use condoms consistently and correctly, with regular partners. In India, it is estimated that at least 20% of FSWs remain at high risk of acquiring HIV infection for this reason, despite the best efforts of HIV prevention programs. Other approaches are needed to close this significant prevention gap.Randomized clinical trials (RCTs) have demonstrated the efficacy of daily, oral tenofovir/emtricitabine (TDF-FTC) in preventing HIV infections among high-risk populations, including FSWs, in a wide range of settings. In 2012, the U.S Food and Drug Administration approved the use of coformulated TDF-FTC for HIV pre-exposure prophylaxis (PrEP) among adults at high risk of HIV infection. India has the third largest HIV epidemic in the world, with the highest rates of HIV infection concentrated among key affected populations, including female sex workers (FSWs).. Condom use prevents HIV and other sexually transmitted infections (STIs), but not all FSWs are able to use condoms consistently and correctly, with regular partners.. In India, it is estimated that at least 20% of FSWs remain at high risk of acquiring HIV infection for this reason, despite the best efforts of HIV prevention programs.. Randomized clinical trials (RCTs) have demonstrated the efficacy of daily, oral tenofovir/emtricitabine (TDF-FTC) in preventing HIV infections among high-risk populations, including FSWs, in a wide range of settings.. In 2012, the U.S Food and Drug Administration approved the use of coformulated TDF-FTC for HIV pre-exposure prophylaxis (PrEP) among adults at high risk of HIV infection.
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