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

Status:Completed
Phase:Open Label
Principal Investigator(s):ushena Reza-Paul, MBBS, Smarajit Jana, MBBS
Objective: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.
Prevention Option(s):PrEP
Study Design:Open label
Arms and Assigned Interventions
DescriptionParticipants will be initiated on PrEP and asked to select one of two PrEP delivery options. Participants will return to the study site every three months for an additional follow-up visit. At follow-up visits, participants will receive HIV testing and counselling, pregnancy testing, syndromic screening for STIs, and clinical diagnosis of adverse events. Those who test HIV-positive will be discontinued on PrEP, exited from the study and referred for HIV care and treatment. Those who have an adverse event will be clinically evaluated to determine whether they should suspend PrEP use and will be provided with the appropriate management for the adverse event. Participants who test HIV-negative will receive patient-centred counselling around PrEP.
Mode of Delivery
ARMsExperimental
Official Code: NCT02148094
Trial Sponsors: DMSC Ashodaya Samithi, University of Manitoba, WHO
Start Date
End Date
April 19, 2016
June 19, 2018
Enrollment:2,000
Age range: 18 Years ↔ 49 Years
Population:Cisgender Women