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

Primary Purpose

HIV/AIDS

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
HIV prevention package including PrEP
Sponsored by
ANRS, Emerging Infectious Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV/AIDS focused on measuring HIV infection, Men who have sex with men, Pre-exposure prophylaxis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Centre Oasis, Association African Solidarité
  • Clinique de Confiance, Espace Confiance
  • Clinique des Halles, ARCAD-SIDA
  • Centre Lucia, Espoir Vie Togo

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

HIV prevention package including PrEP

Arm Description

Outcomes

Primary Outcome Measures

Percentage of MSM under PrEP among eligible HIV-seronegative participants
To assess the acceptability of PrEP
Percentage of MSM using daily and/ord on-demand PrEP
To assess the acceptability of PrEP
Number of MSM followed after 3 years compared to the number of MSM included (retention in the program)
To assess the acceptability of PrEP
Percentage of adherence reported by MSM
To assess the adherence to PrEP
Counting of TDF/FTC tablets
To assess the adherence to PrEP
Plasma concentrations of TDF and FTC
To assess the adherence to PrEP
Percentage of HIV tests performed
To assess the adherence to quarterly HIV testing
Clinical and biological adverse events related to TDF and FTC
To assess the safety of daily and on-demand use of TDF/FTC
Frequency of condomless anal intercourse
To assess the evolution of the other prevention strategies on PrEP
Frequency of sexual intercourse associated with alcohol and/or drug use
To assess the evolution of the other prevention strategies on PrEP
Incidence rate of STIs
To assess the incidence of STIs on PrEP
Incidence rate of HIV infection
To assess the "real life" effectiveness of PrEP use and the emergence of treatment-related resistance
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
Total cost of the intervention over the study period and in the long term
To assess the cost and cost-effectiveness of PrEP
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
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

Secondary Outcome Measures

Full Information

First Posted
March 2, 2018
Last Updated
January 21, 2021
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
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1. Study Identification

Unique Protocol Identification Number
NCT03459157
Brief Title
Access to PrEP for MSM: Acceptability and Feasibility in Community-based Clinics in West Africa (CohMSM-PrEP)
Acronym
CohMSM-PrEP
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 20, 2017 (Actual)
Primary Completion Date
April 14, 2020 (Actual)
Study Completion Date
June 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
HIV infection, Men who have sex with men, Pre-exposure prophylaxis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
649 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Facility Information:
Facility Name
Centre Oasis, Association African Solidarité
City
Ouagadougou
Country
Burkina Faso
Facility Name
Clinique de Confiance, Espace Confiance
City
Abidjan
Country
Côte D'Ivoire
Facility Name
Clinique des Halles, ARCAD-SIDA
City
Bamako
Country
Mali
Facility Name
Centre Lucia, Espoir Vie Togo
City
Lomé
Country
Togo

12. IPD Sharing Statement

Citations:
PubMed Identifier
34048794
Citation
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.
Results Reference
derived

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

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