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Access to PrEP for MSM: Acceptability and Feasibility in Community-based Clinics in West Africa (CohMSM-PrEP) | Clinical Trials | Clareo Health

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

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

NCT03459157•ANRS, Emerging Infectious Diseases

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Yes

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
+1 more criteria

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)

Locations (4)

Centre Oasis, Association African Solidarité

Ouagadougou, Burkina Faso

Clinique de Confiance, Espace Confiance

Abidjan, Côte d’Ivoire

Clinique des Halles, ARCAD-SIDA

Bamako, Mali

Centre Lucia, Espoir Vie Togo

Lomé, Togo

Key Dates

Start Date

November 20, 2017

Primary Completion Date

December 23, 2020

Completion Date

June 30, 2021

Last Updated

February 1, 2024

Enrollment

649

ACTUAL participants

Conditions

HIV/AIDS

Interventions

HIV prevention package including PrEP

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 1, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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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