Clinical trial

Access to Pre-exposure Prophylaxis for Men Who Have Sex With Men: Acceptability and Feasibility in Community-based Clinics in West Africa (CohMSM-PrEP)

Name

ANRS 12369 CohMSM-PrEP

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. 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.

Trial arms

Trial start

2017-11-20

Estimated PCD

2020-12-23

Trial end

2021-06-30

Status

Completed

Treatment

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.

Arms:

HIV prevention package including PrEP

Size

649

Primary endpoint

Percentage of MSM under PrEP among eligible HIV-seronegative participants

3 years

Percentage of MSM using daily and/ord on-demand PrEP

3 years

Number of MSM followed after 3 years compared to the number of MSM included (retention in the program)

3 years

Percentage of adherence reported by MSM

3 years

Counting of TDF/FTC tablets

3 years

Plasma concentrations of TDF and FTC

3 years

Percentage of HIV tests performed

3 years

Clinical and biological adverse events related to TDF and FTC

3 years

Frequency of condomless anal intercourse

3 years

Frequency of sexual intercourse associated with alcohol and/or drug use

3 years

Incidence rate of STIs

3 years

Incidence rate of HIV infection

3 years

Percentage of TDF/FTC resistance among MSM newly infected by HIV

3 years

Total cost of the intervention over the study period and in the long term

3 years

Incremental cost-effectiveness ratio of the intervention (versus no intervention) over the study period and in the long term

3 years

Conditions of TDF/FTC price and of effectiveness for the intervention to be cost-effective in the study countries

3 years

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)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 649, 'type': 'ACTUAL'}}

Updated at

2024-02-01

1 organization

Organization

ANRS, Emerging Infectious Diseases