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HIV/AIDSCohMSM-PrEPNCT03459157

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

A study testing HIV prevention package including PrEP in people with HIV/AIDS, run by ANRS, Emerging Infectious Diseases at 4 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
HIV/AIDS
What is being tested?
HIV prevention package including PrEP
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
649 participants
Where
4 sitesin 4 countries
Study dates
20 Nov 2017to 30 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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)

Trial locations and contacts

4 sites in 4 countries.

4 sites in 4 countries

Burkina Faso1 site

  • Centre Oasis, Association African Solidarité

    Ouagadougou

Other trials in Burkina Faso

Côte d’Ivoire1 site

  • Clinique de Confiance, Espace Confiance

    Abidjan

Other trials in Côte d’Ivoire

Mali1 site

  • Clinique des Halles, ARCAD-SIDA

    Bamako

Other trials in Mali

Togo1 site

  • Centre Lucia, Espoir Vie Togo

    Lomé

About this study

Official title: 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.

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.

Conditions
HIV/AIDS
Being tested
HIV prevention package including PrEP
Keywords
HIV infection, Men who have sex with men, Pre-exposure prophylaxis
Medical subject headings
Acquired Immunodeficiency Syndrome, HIV Infections, Homosexuality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HIV prevention package including PrEPDrug

    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.

Study groups in NCT03459157
Study groupRoleWhat they receive
HIV prevention package including PrEPOtherNot described
Receives: Drug: HIV prevention package including PrEP

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    To assess the acceptability of PrEP

    Measured: 3 years

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

    To assess the acceptability of PrEP

    Measured: 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

    Measured: 3 years

  4. Percentage of adherence reported by MSM

    To assess the adherence to PrEP

    Measured: 3 years

  5. Counting of TDF/FTC tablets

    To assess the adherence to PrEP

    Measured: 3 years

  6. Plasma concentrations of TDF and FTC

    To assess the adherence to PrEP

    Measured: 3 years

  7. Percentage of HIV tests performed

    To assess the adherence to quarterly HIV testing

    Measured: 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

    Measured: 3 years

  9. Frequency of condomless anal intercourse

    To assess the evolution of the other prevention strategies on PrEP

    Measured: 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

    Measured: 3 years

  11. Incidence rate of STIs

    To assess the incidence of STIs on PrEP

    Measured: 3 years

  12. Incidence rate of HIV infection

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2018
  2. Study start20 Nov 2017
  3. Primary completion23 Dec 2020
  4. Study completion30 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
649 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03459157
Sponsor's protocol ID
ANRS 12369 CohMSM-PrEP
Acronym
CohMSM-PrEP
Status last verified
Apr 2026
First submitted
2 Mar 2018
Last updated
23 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A study testing HIV prevention package including PrEP in people with HIV/AIDS, run by ANRS, Emerging Infectious Diseases at 4 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Burkina Faso, Côte d’Ivoire, Mali, Togo. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of MSM under PrEP among eligible HIV-seronegative participants (time frame: 3 years). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03459157, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.

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