NCT03459157

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
649

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 8, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

3.1 years

First QC Date

March 2, 2018

Last Update Submit

April 21, 2026

Conditions

HIV/AIDS

Keywords

HIV infectionMen who have sex with menPre-exposure prophylaxis

Outcome Measures

Primary Outcomes (16)

  • 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

Study Arms (1)

HIV prevention package including PrEP

OTHER
Drug: HIV prevention package including PrEP

Interventions

HIV prevention package including PrEPDRUG

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.

HIV prevention package including PrEP

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Centre Oasis, Association African Solidarité

Ouagadougou, Burkina Faso

Location

Clinique de Confiance, Espace Confiance

Abidjan, Côte d’Ivoire

Location

Clinique des Halles, ARCAD-SIDA

Bamako, Mali

Location

Centre Lucia, Espoir Vie Togo

Lomé, Togo

Location

Related Publications (3)

  • Eubanks A, Coulibaly B, Dembele Keita B, Anoma C, Dah TTE, Mensah E, Maradan G, Bourrelly M, Mora M, Riegel L, Rojas Castro D, Yaya I, Spire B, Laurent C, Sagaon-Teyssier L; and the COHMSM-PrEP Study Group. Rate and Predictors of Ineffective HIV Protection in African Men Who Have Sex with Men Taking Pre-Exposure Prophylaxis. AIDS Behav. 2022 Nov;26(11):3524-3537. doi: 10.1007/s10461-022-03692-8. Epub 2022 Apr 25.

    PMID: 35469111BACKGROUND

  • Eubanks A, Dembele Keita B, Anoma C, Dah TTE, Mensah E, Maradan G, Bourrelly M, Mora M, Riegel L, Rojas Castro D, Yaya I, Spire B, Laurent C, Sagaon-Teyssier L; CohMSM-PrEP Study Group. Reaching a Different Population of MSM in West Africa With the Integration of PrEP Into a Comprehensive Prevention Package (CohMSM-PrEP ANRS 12369-Expertise France). J Acquir Immune Defic Syndr. 2020 Nov 1;85(3):292-301. doi: 10.1097/QAI.0000000000002453.

    PMID: 32732768RESULT

  • 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.

    PMID: 34048794DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeHIV InfectionsHomosexuality

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSexualitySexual BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2018

First Posted

March 8, 2018

Study Start

November 20, 2017

Primary Completion

December 23, 2020

Study Completion

June 30, 2021

Last Updated

April 23, 2026

Record last verified: 2026-04

Locations

BU(1)MA(1)TO(1)CÔ(1)