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CompletedNCT03459157CohMSM-PrEPUpdated Apr 23, 2026

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

An interventional study of HIV prevention package including PrEP in HIV/AIDS, sponsored by ANRS, Emerging Infectious Diseases. Completed at 4 sites in 4 countries. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-23.

Sponsored by ANRS, Emerging Infectious Diseases · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
649
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study summary

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.

Read the 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.

02

Conditions studied

  • HIV/AIDS

Keywords

  • HIV infection
  • Men who have sex with men
  • Pre-exposure prophylaxis
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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)
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
649 participants (actual)

Study arms

  • Other
    HIV prevention package including PrEP

    Drug: HIV prevention package including PrEP

Interventions

  • DrugHIV 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.

05

What researchers measure

Primary outcomes

  1. Percentage of MSM under PrEP among eligible HIV-seronegative participants

    To assess the acceptability of PrEP

    Time frame: 3 years

  2. Percentage of MSM using daily and/ord on-demand PrEP

    To assess the acceptability of PrEP

    Time frame: 3 years

  3. Number of MSM followed after 3 years compared to the number of MSM included (retention in the program)

    To assess the acceptability of PrEP

    Time frame: 3 years

  4. Percentage of adherence reported by MSM

    To assess the adherence to PrEP

    Time frame: 3 years

  5. Counting of TDF/FTC tablets

    To assess the adherence to PrEP

    Time frame: 3 years

  6. Plasma concentrations of TDF and FTC

    To assess the adherence to PrEP

    Time frame: 3 years

  7. Percentage of HIV tests performed

    To assess the adherence to quarterly HIV testing

    Time frame: 3 years

  8. Clinical and biological adverse events related to TDF and FTC

    To assess the safety of daily and on-demand use of TDF/FTC

    Time frame: 3 years

  9. Frequency of condomless anal intercourse

    To assess the evolution of the other prevention strategies on PrEP

    Time frame: 3 years

  10. Frequency of sexual intercourse associated with alcohol and/or drug use

    To assess the evolution of the other prevention strategies on PrEP

    Time frame: 3 years

  11. Incidence rate of STIs

    To assess the incidence of STIs on PrEP

    Time frame: 3 years

  12. Incidence rate of HIV infection

    To assess the "real life" effectiveness of PrEP use and the emergence of treatment-related resistance

    Time frame: 3 years

  13. Percentage of TDF/FTC resistance among MSM newly infected by HIV

    To assess the "real life" effectiveness of PrEP use and the emergence of treatment-related resistance

    Time frame: 3 years

  14. Total cost of the intervention over the study period and in the long term

    To assess the cost and cost-effectiveness of PrEP

    Time frame: 3 years

  15. Incremental cost-effectiveness ratio of the intervention (versus no intervention) over the study period and in the long term

    To assess the cost and cost-effectiveness of PrEP

    Time frame: 3 years

  16. Conditions of TDF/FTC price and of effectiveness for the intervention to be cost-effective in the study countries

    To assess the cost and cost-effectiveness of PrEP

    Time frame: 3 years

06

Study locations

4 sites
  • Centre Oasis, Association African Solidarité
    Ouagadougou, Burkina Faso
  • Clinique de Confiance, Espace Confiance
    Abidjan, Côte d’Ivoire
  • Clinique des Halles, ARCAD-SIDA
    Bamako, Mali
  • Centre Lucia, Espoir Vie Togo
    Lomé, Togo
07

References and documents

Publications

  • Eubanks A, Coulibaly B, Dembele Keita B, Anoma C, Dah TTE, Mensah E, Maradan G, Bourrelly M, Mora M, Riegel L, Rojas Castro D, Yaya I, Spire B, Laurent C, Sagaon-Teyssier L; and the COHMSM-PrEP Study Group. Rate and Predictors of Ineffective HIV Protection in African Men Who Have Sex with Men Taking Pre-Exposure Prophylaxis. AIDS Behav. 2022 Nov;26(11):3524-3537. doi: 10.1007/s10461-022-03692-8. Epub 2022 Apr 25. PubMed 35469111 ↗
  • Eubanks A, Dembele Keita B, Anoma C, Dah TTE, Mensah E, Maradan G, Bourrelly M, Mora M, Riegel L, Rojas Castro D, Yaya I, Spire B, Laurent C, Sagaon-Teyssier L; CohMSM-PrEP Study Group. Reaching a Different Population of MSM in West Africa With the Integration of PrEP Into a Comprehensive Prevention Package (CohMSM-PrEP ANRS 12369-Expertise France). J Acquir Immune Defic Syndr. 2020 Nov 1;85(3):292-301. doi: 10.1097/QAI.0000000000002453. PubMed 32732768 ↗
  • Laurent C, Dembele Keita B, Yaya I, Le Guicher G, Sagaon-Teyssier L, Agboyibor MK, Coulibaly A, Traore I, Malan JB, De Baetselier I, Eubanks A, Riegel L, Rojas Castro D, Faye-Kette H, Kone A, Diande S, Dagnra CA, Serrano L, Diallo F, Mensah E, Dah TTE, Anoma C, Vuylsteke B, Spire B; CohMSM-PrEP Study Group. HIV pre-exposure prophylaxis for men who have sex with men in west Africa: a multicountry demonstration study. Lancet HIV. 2021 Jul;8(7):e420-e428. doi: 10.1016/S2352-3018(21)00005-9. Epub 2021 May 25. PubMed 34048794 ↗
08

Registry details

Key details

Study ID
NCT03459157
Lead sponsor
ANRS, Emerging Infectious Diseases
Collaborators
Expertise France, Université Montpellier, SESSTIM (IRD, Inserm, Université Aix-Marseille), Coalition Internationale Sida, Institut de Médecine Tropicale, Anvers, Belgique, ARCAD-SIDA MALI, Association African Solidarité, Centre de Recherche Internationale pour la Santé, Université de Ouagadougou, Espace Confiance, Côte d'Ivoire, Espoir Vie-Togo - ONG, Laboratoire BIOLIM, Université de Lomé
Responsible party
Sponsor
First posted
Mar 8, 2018
Start date
Nov 20, 2017
Primary completion
Dec 23, 2020
Completion
Jun 30, 2021
Last update
Apr 23, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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