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Completed

NCT Number: NCT03459157

Access to PrEP for MSM: 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.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Behavior Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Homosexuality Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexual Behavior Sexuality Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Centre Oasis, Association African Solidarité, Ouagadougou, Burkina Faso

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

HIV prevention package including PrEP

Drug

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.

Primary outcomes

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

    Time frame: 3 years

    To assess the acceptability of PrEP

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

    Time frame: 3 years

    To assess the acceptability of PrEP

  3. 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

  4. Percentage of adherence reported by MSM

    Time frame: 3 years

    To assess the adherence to PrEP

  5. Counting of TDF/FTC tablets

    Time frame: 3 years

    To assess the adherence to PrEP

  6. Plasma concentrations of TDF and FTC

    Time frame: 3 years

    To assess the adherence to PrEP

  7. Percentage of HIV tests performed

    Time frame: 3 years

    To assess the adherence to quarterly HIV testing

  8. 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

  9. Frequency of condomless anal intercourse

    Time frame: 3 years

    To assess the evolution of the other prevention strategies on PrEP

  10. 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

  11. Incidence rate of STIs

    Time frame: 3 years

    To assess the incidence of STIs on PrEP

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Collaborators

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

Registry information

Official study 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)

Acronym: CohMSM-PrEP

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Mar 8, 2018
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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