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