The Ashodaya PrEP project: Lessons and implications for scaling up PrEP from a community-led demonstration project among female sex workers in Mysore, India

Abstract

To inform PrEP roll out, Ashodaya Samithi, a sex workers' collective, conducted a community-led prospective demonstration project among female sex workers in Mysore and Mandya, India. Following a community preparedness phase and pre-screening, participants were recruited for clinical screening and enrolment, provided PrEP as part of combination HIV prevention, and followed for 16 months. Adherence was measured by self-reported pill intake and by tenofovir blood level testing among a subset of participants. Of the 647 participants enrolled, 640 completed follow-up. Condom use remained stable and no HIV seroconversions occurred. Self-reported daily PrEP intake over the last month was 97.97% at the end of the study. Tenofovir blood levels >40 ng/mL (consistent with steady state dosing) were detected among 80% (n = 68/85) and 90.48% (n = 76/84) of participants at month 3 and 6, respectively. Our study holds important insights for rolling out PrEP in community settings as part of targeted HIV prevention interventions.

Successful integration of HIV pre-exposure prophylaxis into a community-based HIV prevention program for female sex workers in Kolkata, India

“…33 A similar study to ours was conducted in South India, led by a long standing community-owned HIV prevention organization, and it also demonstrated both high levels of adherence as well as retention. 13 There was no evidence of significant changes in selfreported sexual behavior or other measured risk factors, such as alcohol and drug abuse. While these reports could have been distorted by lack of blinding or social desirability bias, the proportion of women treated for STIs, a more objective marker for sexual risk behavior, declined significantly over time, supporting the notion that PrEP use was not associated with increased risk in sexual behavior.…”

“…However, only one study to date has evaluated the use of oral PrEP by FSWs or other high-risk populations in India. 13 In this study, we present the results of a demonstration trial in Kolkata, India, designed to assess the feasibility and impact of delivering PrEP, integrated within an existing community-based HIV prevention program for FSWs in Kolkata, the capital of West Bengal, and one of the largest cities in India (population 15 million). We assessed whether daily oral PrEP could be added in a safe and effective manner to a package of HIV preventive interventions for FSWs.…”

The demographic features and outcome indicators of the Barbados HIV Pre-exposure Prophylaxis Program, 2018-2019

“…Approximately half of the clients in this study reported side effects which they linked to the ARV use. The predominance of gastrointestinal issues is common across the literature, but this rate is higher than that reported in trials and in Australian and Indian demonstration projects, where side effects occurred in around one third of persons ( 22 , 29 , 31 ). The discrepancy may be explained by reported side-effects being actually unrelated to ARV use and recall bias given the length of time between initiation and follow up (3 months).…”

“…The efficacy of PrEP has been conclusively shown in clinical trials, such as the iPrEx, IPERGAY and Partners PrEP, but reports from real-world implementation have only been available for around five years and largely focused on demonstration projects which are smaller scale research endeavours designed to assess acceptability, cost and program design for scale-up ( 21 , 22 ). This study is the first of its kind in the English-speaking Caribbean and while the uptake rate is narrowly defined as those who initiated PrEP from among those formally assessed for eligibility (as opposed to anyone who had enquired about PrEP or been told about the intervention, which was impossible to ascertain), the excellent rate of uptake demonstrates the widescale acceptability of PrEP in Barbados, which has a largely Black population of African descent, and in both men and women.…”

“…Especially low continuation rates among men who have sex with women, many of whom were in sero-discordant relationships, may be due to better viral suppression in the HIV positive partners or discontinuation of the sero-discordant partnership, which improved clinical follow-up would be better able to ascertain. Initial trials showed disappointing retention and adherence rates in women, but subsequent demonstration projects have revealed a reversal of these findings, although most of these projects were conducted among female sex workers ( 22 , 27 ). This study enrolled a very small number of women, but the good uptake and continuation rates hold promise for future engagements with women who could benefit from PrEP and the necessary expansion of the national program.…”