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

NCT02237027 | Completed Phase 4

• 1 other identifier: OPP1098973
• Study Type: interventional
• Target: 361
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

HIV; Early treatment as prevention (TasP); Pre-exposure prophylaxis (PrEP); antiretroviral treatment; prevention; feasibility; female sex workers; Benin; West Africa

Outcome Measures

Primary Outcomes (3)

• Percentage of participants adherent to treatment (self-report and pill count)

  To evaluate adherence to treatment in TasP and PrEP groups.

  Change from day 14 to months 3, 6, 9, 12, 15, 18, 21 and 24

• Percentage of participants adherent to treatment (drug dosage in plasma)

  Quantification of tenofovir and emtricitabine in plasma to evaluate adherence to treatment in PrEP group.

  Change from day 14 to months 6, 12, and 24

• Percentage of participants adherent to treatment (treatment failure)

  Quantification of viral loads in TasP group to detect treatment failure, a very good marker of treatment adherence.

  Change from baseline to months 6, 12, 18, and 24

Secondary Outcomes (8)

• Percentage of HIV seroconversion among participants from PrEP group

  Change from baseline to months 3, 6, 9, 12, 15, 18, 21 and 24

• Occurence of side effects

  Change from baseline to months 6, 12, 18, and 24

• Change in condom use (self-report)

  Change from baseline to months 3, 6, 9, 12, 15, 18, 21 and 24

• Change in condom use (biomarkers)

  Change from baseline to months 6, 12, and 24

• Development of drug resistance

  Change from baseline to 24th month

Study Arms (2)

TasP group

EXPERIMENTAL

HIV positive female sex workers receiving TasP using ART regimen as per Benin guidelines

Biological: TasP using ART regimen as per Benin guidelines

PrEP group

EXPERIMENTAL

HIV negative female sex workers receiving PrEP using Truvada

Biological: PrEP using Truvada

Interventions

TasP using ART regimen as per Benin guidelines BIOLOGICAL

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

TasP group

PrEP using Truvada BIOLOGICAL

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

Also known as: Combination of Tenofovir disoproxyl fumarate 300mg and Emtricitabine 200 mg

PrEP group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being aged 18 years or more
• Being HIV-positive at screening and re-confirmed on a second sample
• Being HIV treatment naïve

You may not qualify if:

• Women showing a compromised renal or liver function at clinical follow-up could be excluded anytime during the course of the study.
• PrEP
• Being aged 18 years or more
• Being HIV-negative at screening and re-confirmed at the recruitment visit
• Being pregnant of breastfeeding
• Women showing a compromised renal or liver function at clinical follow-up could be excluded anytime during the course of the study.

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead
• Bill and Melinda Gates Foundation: collaborator
• Gilead Sciences: collaborator
• Imperial College London: collaborator
• University of Bristol: collaborator
• Johns Hopkins University: collaborator
• Centre Muraz: collaborator
• Université de Montréal: collaborator
• Institut National en Santé Publique du Québec: collaborator
• Université d'Abomey-Calavi: collaborator
• National AIDS Control Organisation: collaborator

Study Sites (1)

Dispensaire IST (DIST)

Cotonou, Benin

Location

Related Publications (1)

• Geidelberg L, Mitchell KM, Alary M, Mboup A, Behanzin L, Guedou F, Geraldo N, Goma-Matsetse E, Giguere K, Aza-Gnandji M, Kessou L, Diallo M, Keke RK, Bachabi M, Dramane K, Lafrance C, Affolabi D, Diabate S, Gagnon MP, Zannou DM, Gangbo F, Silhol R, Cianci F, Vickerman P, Boily MC. Mathematical Model Impact Analysis of a Real-Life Pre-exposure Prophylaxis and Treatment-As-Prevention Study Among Female Sex Workers in Cotonou, Benin. J Acquir Immune Defic Syndr. 2021 Feb 1;86(2):e28-e42. doi: 10.1097/QAI.0000000000002535.

  PMID: 33105397 DERIVED

MeSH Terms

Conditions

Medication Adherence

Interventions

Emtricitabine

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Michel Alary, MD, PhD

  CHU de Quebec-Universite Laval

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: August 20, 2014
• First Posted: September 11, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 19, 2017

Record last verified: 2016-01

Locations

BE (1)