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

Not Applicable

Completed

• Conditions: HIV/AIDS
• Interventions: Drug: HIV prevention package including PrEP

• Registration Number: NCT03459157
• Lead Sponsor: ANRS, Emerging Infectious Diseases

Brief 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.

Study Timeline

• Study Start: 2017-11-20
• Study First Submitted: 2018-03-02
• Study First Submitted QC: 2018-03-02
• Study First Posted: 2018-03-08
• Primary Completion: 2020-12-23
• Study Completion: 2021-06-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 649

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HIV prevention package including PrEP	HIV prevention package including PrEP	-

Primary Outcome Measures

Name	Time	Method
Percentage of HIV tests performed	3 years	To assess the adherence to quarterly HIV testing
Clinical and biological adverse events related to TDF and FTC	3 years	To assess the safety of daily and on-demand use of TDF/FTC
Counting of TDF/FTC tablets	3 years	To assess the adherence to PrEP
Number of MSM followed after 3 years compared to the number of MSM included (retention in the program)	3 years	To assess the acceptability of PrEP
Percentage of adherence reported by MSM	3 years	To assess the adherence to PrEP
Plasma concentrations of TDF and FTC	3 years	To assess the adherence to PrEP
Total cost of the intervention over the study period and in the long term	3 years	To assess the cost and cost-effectiveness of PrEP
Percentage of MSM under PrEP among eligible HIV-seronegative participants	3 years	To assess the acceptability of PrEP
Incidence rate of HIV infection	3 years	To assess the "real life" effectiveness of PrEP use and the emergence of treatment-related resistance
Percentage of MSM using daily and/ord on-demand PrEP	3 years	To assess the acceptability of PrEP
Frequency of sexual intercourse associated with alcohol and/or drug use	3 years	To assess the evolution of the other prevention strategies on PrEP
Frequency of condomless anal intercourse	3 years	To assess the evolution of the other prevention strategies on PrEP
Percentage of TDF/FTC resistance among MSM newly infected by HIV	3 years	To assess the "real life" effectiveness of PrEP use and the emergence of treatment-related resistance
Conditions of TDF/FTC price and of effectiveness for the intervention to be cost-effective in the study countries	3 years	To assess the cost and cost-effectiveness of PrEP
Incidence rate of STIs	3 years	To assess the incidence of STIs on PrEP
Incremental cost-effectiveness ratio of the intervention (versus no intervention) over the study period and in the long term	3 years	To assess the cost and cost-effectiveness of PrEP

Trial Locations

Locations (4)

Clinique des Halles, ARCAD-SIDA; 🇲🇱 Bamako, Mali

Centre Lucia, Espoir Vie Togo; 🇹🇬 Lomé, Togo

Centre Oasis, Association African Solidarité; 🇧🇫 Ouagadougou, Burkina Faso

Clinique de Confiance, Espace Confiance; 🇨🇮 Abidjan, Côte D'Ivoire