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

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.

Conditions

• HIV Infection

Interventions

DRUG

Truvada

The demonstration project will use a prospective cohort design, enrolling individuals and following them up at multiple intervals over the course of 16 months. Study participants will be asked to take one tablet of Truvada daily, as HIV Pre-Exposure Prophylaxis, over this period. They will be asked to attend 7 regular visits at the project sites over the course of the project. In between visits, they will receive peer educator home visits every other day, as part of regular DMSC (Kolkata) and Ashodaya (Mysore/Mandya) outreach prevention activities. We plan to enroll 2000 female sex workers equally split between the two sites.

Sponsors & Collaborators

• World Health Organization

  collaborator OTHER

• DMSC

  collaborator UNKNOWN

• Ashodaya Samithi

  collaborator UNKNOWN

• University of Manitoba

  lead OTHER

Principal Investigators

• Sushena Reza-Paul, MBBS · University of Manitoba, Ashodaya Samithi

• Smarajit Jana, MBBS · DMSC

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

49 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-01-31

Primary Completion

2018-04-30

Completion

2018-06-30

Countries

• India

Study Locations