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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV/AIDS

Intervention / Treatment
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* Drug: HIV prevention package including PrEP


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: HIV prevention package including PrEP<br> | Drug: HIV prevention package including PrEP<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV infection, Men who have sex with men, Pre-exposure prophylaxis