Pre-exposure prophylaxis (PrEP) for men who have sex with men and transgender women in a clinic and a community-based setting: results from the first demonstration project in India.

BACKGROUND: Understanding the 'real-world' challenges of delivery of pre-exposure prophylaxis (PrEP) among men who have sex with men (MSM) and transgender women (TGW) provides critical insights to guide and optimise future roll-out of the PrEP in India. METHODS: Between 18 December 2019 and 31 July 2023, self-identified MSM and TGW, ≥18 years, at substantial risk for HIV were followed for 12 months for PrEP acceptability, adherence, adverse events and condom use at community-based and clinic-based settings in Jalandhar (Punjab) and Pune (Maharashtra), respectively. Data were analysed for correlates of retention and adherence. Exit interviews were conducted. RESULTS: The median (IQR) age of the 650 participants was 26 (22, 30) years; the majority were literate and unmarried. The overall 1-year retention was 63.2%, with 84% and 41.7% in the community-based and clinic-based settings respectively. Overall, 64.8% participants had ≥80% adherence. Being from a community-based setting, having received secondary/higher secondary/graduate level education and living with family were significantly associated with ≥80% adherence. Overall, 9.7% showed grade-2 decline in creatinine clearance. Among 411 retained, condomless anal sex (CAS) with any partner, anytime in the last 6 months was 84.4% and 78.1% at baseline and 12 months respectively. Overall, seven seroconversions occurred. CONCLUSION: Daily oral PrEP was acceptable and safe among MSM and TGW. Inclusion of PrEP as an additional prevention option would be critical for controlling HIV. Baseline risk assessment is important before initiating PrEP. Recurrent condom and risk reduction counselling during oral PrEP uptake is crucial for preventing CAS. Self-risk assessment and planned usage/stoppage of PrEP observed in the study indicates a need for counselling and assessment for potential interruptions of daily oral PrEP. Additionally, adherence would be affected, with implications for evaluating the programme's success.