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

ANRS, Emerging Infectious Diseases

Status: Completed

Conditions: HIV/AIDS

Treatments: Drug: HIV prevention package including PrEP

Study type: Interventional

Funder types: Other

Identifiers

NCT03459157

ANRS 12369 CohMSM-PrEP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 649 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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649 participants in 1 patient group

HIV prevention package including PrEP

Other group

Treatment:

Drug: HIV prevention package including PrEP