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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03459157
Other study ID # ANRS 12369 CohMSM-PrEP
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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