Demonstration project of oral TDF-containing PrEP, administered, once-daily orally to men having sex with men (MSM) and transgender women (TGW) in India: Study protocol

BackgroundIndia has successfully reduced Human Immuno-deficiency Virus (HIV) incidence, with a 66% decline since the year 2000 has been seen; however, control among Men having sex with Men (MSM) and transgender women (TGW) remains a critical challenge. Oral Pre-Exposure Prophylaxis (PrEP) may help close a critical HIV prevention gap for MSM and TGW in India; however, no studies to date have evaluated the feasibility of oral PrEP among MSM and TGW in India. MethodsThe proposed study aims at understanding the implementation of the provision of daily oral-Tenofovir (TDF) containing PrEP among MSM and TGW through the clinic and community-based delivery models in Pune, Maharashtra, and Jalandhar, Punjab respectively in India. The study aims at estimating PrEP adherence, facilitators, and barriers to PrEP use, retention, acceptability, and willingness to pay for PrEP. After the screening, eligible participants (n = 600) will receive PrEP medicines and will be monitored quarterly for HIV, STIs, and renal and liver toxicity for 12 months as per the schedule of events. The primary outcomes of interest are PrEP acceptability, PrEP adherence, retention rate, adverse medical events, and sexual behavioural changes with PrEP use and breakthrough infections while on PrEP. The study will assess the feasibility of two service delivery models; however, the data from the two service delivery models will be analyzed independently and will not be compared for feasibility and other outcome indicators. The study has been initiated after obtaining appropriate regulatory approvals. DiscussionPrEP is efficacious in preventing HIV among high-risk population however there are scarce data on providing PrEP to MSM and TGW. The study will provide critical evidence to programs and policymakers on the implementation of PrEP in a real world setting, among MSM and TGW in India including identifying populations that can benefit most from this additional HIV prevention intervention along with acceptable delivery strategies and means of support for adherence.

Automated summary

This study aims to evaluate the feasibility and effectiveness of providing daily oral PrEP to MSM and TGW in Pune and Jalandhar, India. Through screening 600 eligible participants and providing PrEP medication for 12 months, the study will assess PrEP acceptability, adherence, retention rate, and associated side effects and behavioral changes. The findings will provide crucial evidence for policymakers on implementing PrEP among MSM and TGW in India and identifying the target population and delivery strategies to enhance its effectiveness.