Clinical trial NCT03459157: Access to PrEP for MSM: Acceptability and Feasibility in Community-based Clinics in West Africa (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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: HIV infection
Men who have sex with men
Pre-exposure prophylaxis
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Expertise France
name: Université Montpellier
name: SESSTIM (IRD, Inserm, Université Aix-Marseille)
name: Coalition Internationale Sida
name: Institut de Médecine Tropicale, Anvers, Belgique
name: ARCAD-SIDA MALI
name: Association African Solidarité
name: Centre de Recherche Internationale pour la Santé, Université de Ouagadougou
name: Espace Confiance, Côte d'Ivoire
name: Espoir Vie-Togo - ONG
name: Laboratoire BIOLIM, Université de Lomé
First posted: 2018-03-08
Enrollment: 649
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of MSM under PrEP among eligible HIV-seronegative participants
timeFrame: 3 years
measure: Percentage of MSM using daily and/ord on-demand PrEP
timeFrame: 3 years
measure: Number of MSM followed after 3 years compared to the number of MSM included (retention in the program)
timeFrame: 3 years
measure: Percentage of adherence reported by MSM
timeFrame: 3 years
measure: Counting of TDF/FTC tablets
timeFrame: 3 years
measure: Plasma concentrations of TDF and FTC
timeFrame: 3 years
measure: Percentage of HIV tests performed
timeFrame: 3 years
measure: Clinical and biological adverse events related to TDF and FTC
timeFrame: 3 years
measure: Frequency of condomless anal intercourse
timeFrame: 3 years
measure: Frequency of sexual intercourse associated with alcohol and/or drug use
timeFrame: 3 years
measure: Incidence rate of STIs
timeFrame: 3 years
measure: Incidence rate of HIV infection
timeFrame: 3 years
measure: Percentage of TDF/FTC resistance among MSM newly infected by HIV
timeFrame: 3 years
measure: Total cost of the intervention over the study period and in the long term
timeFrame: 3 years
measure: Incremental cost-effectiveness ratio of the intervention (versus no intervention) over the study period and in the long term
timeFrame: 3 years
measure: Conditions of TDF/FTC price and of effectiveness for the intervention to be cost-effective in the study countries
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ouagadougou
country: Burkina Faso
facility: Centre Oasis, Association African Solidarité
city: Abidjan
country: Côte D'Ivoire
facility: Clinique de Confiance, Espace Confiance
city: Bamako
country: Mali
facility: Clinique des Halles, ARCAD-SIDA
city: Lomé
country: Togo
facility: Centre Lucia, Espoir Vie Togo
Study officials:
References:
citation: Laurent C, Dembele Keita B, Yaya I, Le Guicher G, Sagaon-Teyssier L, Agboyibor MK, Coulibaly A, Traore I, Malan JB, De Baetselier I, Eubanks A, Riegel L, Rojas Castro D, Faye-Kette H, Kone A, Diande S, Dagnra CA, Serrano L, Diallo F, Mensah E, Dah TTE, Anoma C, Vuylsteke B, Spire B; CohMSM-PrEP Study Group. HIV pre-exposure prophylaxis for men who have sex with men in west Africa: a multicountry demonstration study. Lancet HIV. 2021 Jul;8(7):e420-e428. doi: 10.1016/S2352-3018(21)00005-9. Epub 2021 May 25.