Demonstrating Safety and Effective Delivery of Daily Oral Pre-exposure Prophylaxis (PrEP) for Sex Workers in India

• Status: Completed
• Trial end date: 2018-06-30
• Target enrollment: 0
• Participant gender: Female

Summary

Female sex workers (FSWs) in India are at high risk of HIV infection, and while correct and consistent condom use is an effective means of preventing HIV transmission, many FSWs have difficulty insisting on their use. Alternative HIV prevention options are needed for FSWs who are unable to correctly and consistently use condoms with their clients or regular partners. Oral pre-exposure prophylaxis (PrEP) may be an important tool to fill this critical prevention gap, and a demonstration project is required to assess the impact and feasibility of the use of PrEP as an HIV prevention intervention among most at risk FSWs in India.

The proposed project will take place at two sites in India and will assess the use of a risk assessment tool to identify FSWs who would most benefit from PrEP, collect information about the reasons why FSWs choose to accept or decline PrEP, evaluate two different PrEP delivery strategies (weekly clinic pick-up or home delivery by peer educators every second day), monitor adherence to and discontinuation of PrEP, and evaluate unintended consequences of the use of PrEP in these communities (e.g. reduction of condom use, drug side effects or adverse events, social harms or resistance). To ensure the safety of study participants, a community advisory board will be set up and will meet regularly to inform study staff of any concerns that the community may have related to the study, so that the study staff can respond in a timely manner. A data safety and monitoring board will also be established to monitor participant safety.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Manitoba
• Collaborators: Ashodaya Samithi; DMSC; World Health Organization
• Treatments: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir

Criteria

Inclusion Criteria:

• Self-identification as a current FSW

• Age 18 and older

• Self-reported interest in and willingness to take PrEP

• Score cutoff on risk screening tool / PrEP indication tool

• HIV-negative test at time of enrollment (per testing algorithm)

• No clinical signs of acute HIV infection

• Hepatitis-B virus antigen negative (upon screening)

• Creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula) (upon screening)

• Not currently taking PrEP or enrolled in another PrEP demonstration project

• Negative urine pregnancy test at time of enrollment

• Lives within the catchment area of the project site and no plans to move away from the project area in the next 16 months

Exclusion Criteria:

• Under 18

• Does not meet inclusion criteria