Early Antiretroviral Therapy and Pre-exposure Prophylaxis for HIV Prevention Among Female Sex Workers in Cotonou, Benin

Summary

In the last few years, early treatment of HIV-infected individuals, or "treatment as prevention (TasP), and pre-exposure prophylaxis with antiretroviral drugs among HIV-negative people at very high-risk of acquiring the infection (PrEP) have emerged as highly promising biological preventive interventions to tackle the HIV pandemic within the framework of combination prevention, a multi-component strategy that has been promoted for the last five years. In West Africa, the evidence strongly suggests that female sex workers (FSWs) contribute very disproportionally to the HIV spread. This is why the investigators propose this TasP and PrEP demonstration project in Benin, where our group has been involved in HIV prevention research in the sex work milieu for the last two decades.

After a run-in phase for community preparedness and the development of a specific education program on adherence, the investigators plan to recruit 100 HIV-infected FSWs in the TasP component of the project (these women will receive a first-line antiretroviral treatment (ART) regimen as per the Benin guidelines) and 250 HIV-negative FSWs in the PrEP component (these women will receive Truvada®). The recruitment period will last for one year, followed by an additional one year of follow-up, for a total follow-up period varying between 12 and 24 months, depending on when a given woman is recruited in the study. During follow-up visits every three months, the investigators will closely monitor treatment adherence and changes in sexual behaviour, including the use of viral load testing among TasP participants and Truvada® plasma level testing for PrEP participants, as well as detection of prostate-specific antigen (PSA) and Y-chromosome DNA in vaginal fluids in all participants.

The investigators will evaluate the feasibility of TasP and PrEP through a set of indicators, including uptake, coverage, adherence, condom migration, occurrence of side effects and development of drug resistance, whereas mathematical modeling will be used to predict the potential impact of both interventions in the sex work milieu and the general population, based on the actual set of indicators observed. The study will be completed by an economic evaluation of the interventions and a cost-effectiveness analysis.

Finally, the investigators will disseminate the results to the study population and to the Beninese health authorities and ensure the broad implementation of these interventions in Benin if the demonstration project shows that they are feasible and relevant.

Conditions

• Adherence to Medication Regime

Interventions

BIOLOGICAL

TasP using ART regimen as per Benin guidelines

Administration of ART to HIV positive female sew workers in order to prevent HIV transmission.

BIOLOGICAL

PrEP using Truvada

Administration of Truvada to HIV negative female sex workers in order to prevent HIV acquisition.

Sponsors & Collaborators

• Bill and Melinda Gates Foundation

  collaborator OTHER

• Gilead Sciences

  collaborator INDUSTRY

• Imperial College London

  collaborator OTHER

• University of Bristol

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• Centre Muraz

  collaborator OTHER

• Université de Montréal

  collaborator OTHER

• Institut National en Santé Publique du Québec

  collaborator OTHER

• Université d'Abomey-Calavi

  collaborator OTHER

• National AIDS Control Organisation

  collaborator OTHER

• CHU de Quebec-Universite Laval

  lead OTHER

Principal Investigators

• Michel Alary, MD, PhD · CHU de Quebec-Universite Laval

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-10-31

Primary Completion

2016-12-31

Completion

2016-12-31

Countries

• Benin

Study Locations