Access to PrEP for MSM: Acceptability and Feasibility in Community-based Clinics in West Africa (CohMSM-PrEP) (CohMSM-PrEP)

January 31, 2024 updated by: ANRS, Emerging Infectious Diseases

Access to Pre-exposure Prophylaxis for Men Who Have Sex With Men: Acceptability and Feasibility in Community-based Clinics in West Africa (CohMSM-PrEP)

This demonstration project will assess the acceptability and feasibility of pre-exposure prophylaxis (PrEP) for men who have sex with men (MSM) as part of a comprehensive HIV prevention package in community-based clinics in West Africa.

An interventional, open label, multidisciplinary and multicentre cohort study will be performed in Burkina Faso, Côte d'Ivoire, Mali, and Togo.

All MSM enrolled will benefit from a comprehensive HIV prevention package including quarterly clinical examinations, screening and treatment of STIs, screening of HIV, PrEP (daily or on-demand, according the participant's choice), immunisation against hepatitis B, individualised peer-led support (for adherence and prevention), group discussions, condoms, and lubricants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This demonstration project will assess the acceptability and feasibility of pre-exposure prophylaxis (PrEP) for men who have sex with men (MSM) as part of a comprehensive HIV prevention package in community-based clinics in West Africa.

The specific objectives are to assess the acceptability of PrEP, the adherence to PrEP and to quarterly HIV testing, the safety of daily and on-demand use of TDF/FTC, the impact of PrEP on the other prevention strategies, the incidence of sexually transmitted infections (STIs) on PrEP, the "real life" effectiveness of PrEP use and treatment-related resistance, and the cost and cost-effectiveness of PrEP.

This interventional, open label, multidisciplinary and multicentre cohort study will be performed in Burkina Faso, Côte d'Ivoire, Mali, and Togo.

All MSM enrolled will benefit from a comprehensive HIV prevention package including quarterly clinical examinations, screening and treatment of STIs, screening of HIV, PrEP (daily or on-demand, according the participant's choice), immunisation against hepatitis B, individualised peer-led support (for adherence and prevention), group discussions, condoms, and lubricants.

These activities will be performed by community-based organisations which are pioneer in the fight against HIV, especially in MSM. The study will have a total duration of 3 years.

Study Type

Interventional

Enrollment (Actual)

649

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Burkina Faso
      • Ouagadougou, Burkina Faso
        • Centre Oasis, Association African Solidarité
  • Côte D'Ivoire
      • Abidjan, Côte D'Ivoire
        • Clinique de Confiance, Espace Confiance
  • Mali
      • Bamako, Mali
        • Clinique des Halles, ARCAD-SIDA
  • Togo
      • Lomé, Togo
        • Centre Lucia, Espoir Vie Togo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male (or transgender male person at birth)
  • At least 18 years old
  • HIV-seronegative
  • Having had at least one anal sex episode with another man within the previous 6 months

  • Having at least one of the following criteria:

    • Have a sexual partner (male or female) infected with HIV without evidence of virological suppression
    • Have had anal or vaginal sex episodes without condoms with more than one partner within the previous 6 months
    • Have had a sexually-transmitted infection (STI) within the previous 6 months (syndromic or biological approach, or mentioned by the participant)
    • Have received post-exposure prophylaxis for HIV within the previous 6 months
    • Wishing to reinforce its means of prevention through the use of PrEP
  • Accepting to participate in the study and signing the informed consent form

Exclusion Criteria:

  • Clinical manifestations suggesting a primary HIV infection
  • Recent probable HIV exposure
  • Creatinine clearance <60 mL/min calculated according to the Cockroft & Gault formula
  • Positive or undetermined HBsAg
  • Allergy or contraindication to any of the components of PrEP
  • Participation in another biomedical and/or behavioral study on HIV or STIs (excluding CohMSM)
  • Disability of the person making it difficult, if not impossible, to participate in the study or understanding of the information given to him
  • Predictable non-compliance with the protocol (geographical distance, non-compliance with monitoring or other reasons)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: HIV prevention package including PrEP
Drug: HIV prevention package including PrEP
All MSM enrolled will benefit from a comprehensive HIV prevention package including quarterly clinical examinations, screening and treatment of STIs, screening of HIV, PrEP (TDF 300 mg + FTC 200 mg), daily or on-demand, according the participant's choice, immunisation against hepatitis B, individualised peer-led support (for adherence and prevention), group discussions, condoms, and lubricants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of MSM under PrEP among eligible HIV-seronegative participants
Time Frame: 3 years
To assess the acceptability of PrEP
3 years
Percentage of MSM using daily and/ord on-demand PrEP
Time Frame: 3 years
To assess the acceptability of PrEP
3 years
Number of MSM followed after 3 years compared to the number of MSM included (retention in the program)
Time Frame: 3 years
To assess the acceptability of PrEP
3 years
Percentage of adherence reported by MSM
Time Frame: 3 years
To assess the adherence to PrEP
3 years
Counting of TDF/FTC tablets
Time Frame: 3 years
To assess the adherence to PrEP
3 years
Plasma concentrations of TDF and FTC
Time Frame: 3 years
To assess the adherence to PrEP
3 years
Percentage of HIV tests performed
Time Frame: 3 years
To assess the adherence to quarterly HIV testing
3 years
Clinical and biological adverse events related to TDF and FTC
Time Frame: 3 years
To assess the safety of daily and on-demand use of TDF/FTC
3 years
Frequency of condomless anal intercourse
Time Frame: 3 years
To assess the evolution of the other prevention strategies on PrEP
3 years
Frequency of sexual intercourse associated with alcohol and/or drug use
Time Frame: 3 years
To assess the evolution of the other prevention strategies on PrEP
3 years
Incidence rate of STIs
Time Frame: 3 years
To assess the incidence of STIs on PrEP
3 years
Incidence rate of HIV infection
Time Frame: 3 years
To assess the "real life" effectiveness of PrEP use and the emergence of treatment-related resistance
3 years
Percentage of TDF/FTC resistance among MSM newly infected by HIV
Time Frame: 3 years
To assess the "real life" effectiveness of PrEP use and the emergence of treatment-related resistance
3 years
Total cost of the intervention over the study period and in the long term
Time Frame: 3 years
To assess the cost and cost-effectiveness of PrEP
3 years
Incremental cost-effectiveness ratio of the intervention (versus no intervention) over the study period and in the long term
Time Frame: 3 years
To assess the cost and cost-effectiveness of PrEP
3 years
Conditions of TDF/FTC price and of effectiveness for the intervention to be cost-effective in the study countries
Time Frame: 3 years
To assess the cost and cost-effectiveness of PrEP
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ANRS, Emerging Infectious Diseases

Collaborators

Université Montpellier
Expertise France
ARCAD-SIDA MALI
Coalition Internationale Sida
Espace Confiance, Côte d'Ivoire
Association African Solidarité
Espoir Vie-Togo - ONG
SESSTIM (IRD, Inserm, Université Aix-Marseille)
Institut de Médecine Tropicale, Anvers, Belgique
Centre de Recherche Internationale pour la Santé, Université de Ouagadougou
Laboratoire BIOLIM, Université de Lomé

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2017

Primary Completion (Actual)

December 23, 2020

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

March 2, 2018

First Submitted That Met QC Criteria

March 2, 2018

First Posted (Actual)

March 8, 2018

Study Record Updates

Last Update Posted (Actual)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANRS 12369 CohMSM-PrEP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV/AIDS

Clinical Trials on HIV prevention package including PrEP

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe