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

HIV/AIDS Clinical Trial

— CohMSM-PrEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03459157
• Other study ID #: ANRS 12369 CohMSM-PrEP
• Status: Completed
• Phase: N/A
• Start date: November 20, 2017
• Est. completion date: June 30, 2021

Study information

• Verified date: January 2024
• Source: ANRS, Emerging Infectious Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 649
• Est. completion date: June 30, 2021
• Est. primary completion date: December 23, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Burkina Faso	Centre Oasis, Association African Solidarité	Ouagadougou
Côte D'Ivoire	Clinique de Confiance, Espace Confiance	Abidjan
Mali	Clinique des Halles, ARCAD-SIDA	Bamako
Togo	Centre Lucia, Espoir Vie Togo	Lomé

Sponsors (12)

Lead Sponsor	Collaborator
ANRS, Emerging Infectious Diseases	ARCAD-SIDA MALI, Association African Solidarité, Centre de Recherche Internationale pour la Santé, Université de Ouagadougou, Coalition Internationale Sida, Espace Confiance, Côte d'Ivoire, Espoir Vie-Togo - ONG, Expertise France, Institut de Médecine Tropicale, Anvers, Belgique, Laboratoire BIOLIM, Université de Lomé, SESSTIM (IRD, Inserm, Université Aix-Marseille), Université Montpellier

Countries where clinical trial is conducted

Burkina Faso,  Côte D'Ivoire,  Mali,  Togo, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of MSM under PrEP among eligible HIV-seronegative participants	To assess the acceptability of PrEP	3 years
Primary	Percentage of MSM using daily and/ord on-demand PrEP	To assess the acceptability of PrEP	3 years
Primary	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
Primary	Percentage of adherence reported by MSM	To assess the adherence to PrEP	3 years
Primary	Counting of TDF/FTC tablets	To assess the adherence to PrEP	3 years
Primary	Plasma concentrations of TDF and FTC	To assess the adherence to PrEP	3 years
Primary	Percentage of HIV tests performed	To assess the adherence to quarterly HIV testing	3 years
Primary	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
Primary	Frequency of condomless anal intercourse	To assess the evolution of the other prevention strategies on PrEP	3 years
Primary	Frequency of sexual intercourse associated with alcohol and/or drug use	To assess the evolution of the other prevention strategies on PrEP	3 years
Primary	Incidence rate of STIs	To assess the incidence of STIs on PrEP	3 years
Primary	Incidence rate of HIV infection	To assess the "real life" effectiveness of PrEP use and the emergence of treatment-related resistance	3 years
Primary	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
Primary	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
Primary	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
Primary	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