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

• Status: Active, not recruiting
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: ANRS, Emerging Infectious Diseases; French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Collaborators: ARCAD-SIDA MALI; ARCAD-SIDA, Bamako, Mali; Association African Solidarité; Association African Solidarité, Ouagadougou, Burkina Faso; Centre de Recherche Internationale pour la Santé, Université de Ouagadougou; Coalition Internationale Sida; Coalition Internationale Sida, Pantin, France; Espace Confiance, Abidjan, Côte d'Ivoire; Espace Confiance, Côte d'Ivoire; Espoir Vie Togo, Lomé, Togo; 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

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)