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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 February 2024
• Main ID: NCT03459157
• Date of registration: 02/03/2018
• Prospective Registration: No
• Primary sponsor: ANRS, Emerging Infectious Diseases
• Public title: Access to PrEP for MSM: Acceptability and Feasibility in Community-based Clinics in West Africa (CohMSM-PrEP) CohMSM-PrEP
• Scientific 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)
• Date of first enrolment: November 20, 2017
• Target sample size: 649
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03459157
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Burkina Faso, Côte D'Ivoire, Mali, Togo

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

HIV/AIDS

Intervention(s)

Drug: HIV prevention package including PrEP

Primary Outcome(s)

Incidence rate of STIs [Time Frame: 3 years]

Percentage of adherence reported by MSM [Time Frame: 3 years]

Percentage of MSM using daily and/ord on-demand PrEP [Time Frame: 3 years]

Counting of TDF/FTC tablets [Time Frame: 3 years]

Incremental cost-effectiveness ratio of the intervention (versus no intervention) over the study period and in the long term [Time Frame: 3 years]

Frequency of sexual intercourse associated with alcohol and/or drug use [Time Frame: 3 years]

Incidence rate of HIV infection [Time Frame: 3 years]

Number of MSM followed after 3 years compared to the number of MSM included (retention in the program) [Time Frame: 3 years]

Frequency of condomless anal intercourse [Time Frame: 3 years]

Percentage of TDF/FTC resistance among MSM newly infected by HIV [Time Frame: 3 years]

Clinical and biological adverse events related to TDF and FTC [Time Frame: 3 years]

Conditions of TDF/FTC price and of effectiveness for the intervention to be cost-effective in the study countries [Time Frame: 3 years]

Total cost of the intervention over the study period and in the long term [Time Frame: 3 years]

Percentage of HIV tests performed [Time Frame: 3 years]

Percentage of MSM under PrEP among eligible HIV-seronegative participants [Time Frame: 3 years]

Plasma concentrations of TDF and FTC [Time Frame: 3 years]

Secondary ID(s)

ANRS 12369 CohMSM-PrEP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Expertise France

Institut de Médecine Tropicale, Anvers, Belgique

Centre de Recherche Internationale pour la Santé, Université de Ouagadougou

Coalition Internationale Sida

Association African Solidarité

Laboratoire BIOLIM, Université de Lomé

Université Montpellier

ARCAD-SIDA MALI

Espace Confiance, Côte d'Ivoire

Espoir Vie-Togo - ONG

SESSTIM (IRD, Inserm, Université Aix-Marseille)