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| Name | Class |
|---|---|
| Expertise France | OTHER |
| Université Montpellier | OTHER |
| SESSTIM (IRD, Inserm, Université Aix-Marseille) | UNKNOWN |
| Coalition Internationale Sida |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV prevention package including PrEP | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIV prevention package including PrEP | Drug | 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. |
| 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 |
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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:
Accepting to participate in the study and signing the informed consent form
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Oasis, Association African Solidarité | Ouagadougou | Burkina Faso | ||||
| Clinique de Confiance, Espace Confiance |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35469111 | Background | 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. | |
| 32732768 |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D015658 | HIV Infections |
| D006716 | Homosexuality |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| OTHER |
| Institut de Médecine Tropicale, Anvers, Belgique | UNKNOWN |
| ARCAD-SIDA MALI | OTHER |
| Association African Solidarité | OTHER |
| Centre de Recherche Internationale pour la Santé, Université de Ouagadougou | UNKNOWN |
| Espace Confiance, Côte d'Ivoire | OTHER |
| Espoir Vie-Togo - ONG | OTHER |
| Laboratoire BIOLIM, Université de Lomé | UNKNOWN |
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|
| 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 |
| Abidjan |
| Côte d’Ivoire |
| Clinique des Halles, ARCAD-SIDA | Bamako | Mali |
| Centre Lucia, Espoir Vie Togo | Lomé | Togo |
| Result |
| 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. |
| 34048794 | Derived | 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. |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D019529 | Sexuality |
| D012725 | Sexual Behavior |
| D001519 | Behavior |