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

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.