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

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ClinicalTrials.gov Identifier: NCT03459157
Recruitment Status : Recruiting
First Posted : March 8, 2018
Last Update Posted : March 8, 2018
Sponsor:
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, Abidjan, Côte d'Ivoire
Espoir Vie Togo, Lomé, Togo
Laboratoire BIOLIM, Université de Lomé
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Brief 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.


Condition or disease Intervention/treatment Phase
HIV/AIDS Drug: HIV prevention package including PrEP Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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)
Actual Study Start Date : November 20, 2017
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03459157


Contacts
Contact: Christian Laurent, PhD +33 4 67 41 61 50 christian.laurent@ird.fr
Contact: Bintou Dembélé Keita, MD +223 20 23 72 59 bdembele@arcadsida.org

Locations
Burkina Faso
Centre Oasis, Association African Solidarité Recruiting
Ouagadougou, Burkina Faso
Contact: Ter Tiero Elias Dah, MD    + 226 71 35 86 35    tertiero81@yahoo.fr   
Côte D'Ivoire
Clinique de Confiance, Espace Confiance Not yet recruiting
Abidjan, Côte D'Ivoire
Contact: Camille Anoma, MD    +225 21 35 28 61    anomacamille@yahoo.fr   
Mali
Clinique des Halles, ARCAD-SIDA Not yet recruiting
Bamako, Mali
Contact: Bintou Dembélé Keita, MD    +223 20 23 72 59    bdembele@arcadsida.org   
Togo
Centre Lucia, Espoir Vie Togo Recruiting
Lomé, Togo
Contact: Ephrem Mensah, MD    +228 90 01 64 11    ephremensah@hotmail.fr   
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
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, Abidjan, Côte d'Ivoire
Espoir Vie Togo, Lomé, Togo
Laboratoire BIOLIM, Université de Lomé

Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT03459157     History of Changes
Other Study ID Numbers: ANRS 12369 CohMSM-PrEP
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
HIV infection
Men who have sex with men
Pre-exposure prophylaxis