Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-28 @ 7:09 AM
Study NCT ID:
NCT03459157
Status:
COMPLETED
Last Update Posted:
2024-02-01
First Post:
2018-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Access to PrEP for MSM: Acceptability and Feasibility in Community-based Clinics in West Africa (CohMSM-PrEP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D006716', 'term': 'Homosexuality'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D019529', 'term': 'Sexuality'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 649}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-31', 'studyFirstSubmitDate': '2018-03-02', 'studyFirstSubmitQcDate': '2018-03-02', 'lastUpdatePostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of MSM under PrEP among eligible HIV-seronegative participants', 'timeFrame': '3 years', 'description': 'To assess the acceptability of PrEP'}, {'measure': 'Percentage of MSM using daily and/ord on-demand PrEP', 'timeFrame': '3 years', 'description': 'To assess the acceptability of PrEP'}, {'measure': 'Number of MSM followed after 3 years compared to the number of MSM included (retention in the program)', 'timeFrame': '3 years', 'description': 'To assess the acceptability of PrEP'}, {'measure': 'Percentage of adherence reported by MSM', 'timeFrame': '3 years', 'description': 'To assess the adherence to PrEP'}, {'measure': 'Counting of TDF/FTC tablets', 'timeFrame': '3 years', 'description': 'To assess the adherence to PrEP'}, {'measure': 'Plasma concentrations of TDF and FTC', 'timeFrame': '3 years', 'description': 'To assess the adherence to PrEP'}, {'measure': 'Percentage of HIV tests performed', 'timeFrame': '3 years', 'description': 'To assess the adherence to quarterly HIV testing'}, {'measure': 'Clinical and biological adverse events related to TDF and FTC', 'timeFrame': '3 years', 'description': 'To assess the safety of daily and on-demand use of TDF/FTC'}, {'measure': 'Frequency of condomless anal intercourse', 'timeFrame': '3 years', 'description': 'To assess the evolution of the other prevention strategies on PrEP'}, {'measure': 'Frequency of sexual intercourse associated with alcohol and/or drug use', 'timeFrame': '3 years', 'description': 'To assess the evolution of the other prevention strategies on PrEP'}, {'measure': 'Incidence rate of STIs', 'timeFrame': '3 years', 'description': 'To assess the incidence of STIs on PrEP'}, {'measure': 'Incidence rate of HIV infection', 'timeFrame': '3 years', 'description': 'To assess the "real life" effectiveness of PrEP use and the emergence of treatment-related resistance'}, {'measure': 'Percentage of TDF/FTC resistance among MSM newly infected by HIV', 'timeFrame': '3 years', 'description': 'To assess the "real life" effectiveness of PrEP use and the emergence of treatment-related resistance'}, {'measure': 'Total cost of the intervention over the study period and in the long term', 'timeFrame': '3 years', 'description': 'To assess the cost and cost-effectiveness of PrEP'}, {'measure': 'Incremental cost-effectiveness ratio of the intervention (versus no intervention) over the study period and in the long term', 'timeFrame': '3 years', 'description': 'To assess the cost and cost-effectiveness of PrEP'}, {'measure': 'Conditions of TDF/FTC price and of effectiveness for the intervention to be cost-effective in the study countries', 'timeFrame': '3 years', 'description': 'To assess the cost and cost-effectiveness of PrEP'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV infection', 'Men who have sex with men', 'Pre-exposure prophylaxis'], 'conditions': ['HIV/AIDS']}, 'referencesModule': {'references': [{'pmid': '34048794', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nAn interventional, open label, multidisciplinary and multicentre cohort study will be performed in Burkina Faso, Côte d'Ivoire, Mali, and Togo.\n\nAll 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.", 'detailedDescription': '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.\n\nThe 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.\n\nThis interventional, open label, multidisciplinary and multicentre cohort study will be performed in Burkina Faso, Côte d\'Ivoire, Mali, and Togo.\n\nAll 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.\n\nThese 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male (or transgender male person at birth)\n* At least 18 years old\n* HIV-seronegative\n* Having had at least one anal sex episode with another man within the previous 6 months\n* Having at least one of the following criteria:\n\n * Have a sexual partner (male or female) infected with HIV without evidence of virological suppression\n * Have had anal or vaginal sex episodes without condoms with more than one partner within the previous 6 months\n * Have had a sexually-transmitted infection (STI) within the previous 6 months (syndromic or biological approach, or mentioned by the participant)\n * Have received post-exposure prophylaxis for HIV within the previous 6 months\n * Wishing to reinforce its means of prevention through the use of PrEP\n* Accepting to participate in the study and signing the informed consent form\n\nExclusion Criteria:\n\n* Clinical manifestations suggesting a primary HIV infection\n* Recent probable HIV exposure\n* Creatinine clearance \\<60 mL/min calculated according to the Cockroft \\& Gault formula\n* Positive or undetermined HBsAg\n* Allergy or contraindication to any of the components of PrEP\n* Participation in another biomedical and/or behavioral study on HIV or STIs (excluding CohMSM)\n* Disability of the person making it difficult, if not impossible, to participate in the study or understanding of the information given to him\n* Predictable non-compliance with the protocol (geographical distance, non-compliance with monitoring or other reasons)'}, 'identificationModule': {'nctId': 'NCT03459157', 'acronym': 'CohMSM-PrEP', 'briefTitle': 'Access to PrEP for MSM: Acceptability and Feasibility in Community-based Clinics in West Africa (CohMSM-PrEP)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'ANRS, Emerging Infectious Diseases'}, 'officialTitle': 'Access to Pre-exposure Prophylaxis for Men Who Have Sex With Men: Acceptability and Feasibility in Community-based Clinics in West Africa (CohMSM-PrEP)', 'orgStudyIdInfo': {'id': 'ANRS 12369 CohMSM-PrEP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'HIV prevention package including PrEP', 'interventionNames': ['Drug: HIV prevention package including PrEP']}], 'interventions': [{'name': 'HIV prevention package including PrEP', 'type': 'DRUG', 'description': "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.", 'armGroupLabels': ['HIV prevention package including PrEP']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ouagadougou', 'country': 'Burkina Faso', 'facility': 'Centre Oasis, Association African Solidarité', 'geoPoint': {'lat': 12.36566, 'lon': -1.53388}}, {'city': 'Abidjan', 'country': 'Côte d’Ivoire', 'facility': 'Clinique de Confiance, Espace Confiance', 'geoPoint': {'lat': 5.35444, 'lon': -4.00167}}, {'city': 'Bamako', 'country': 'Mali', 'facility': 'Clinique des Halles, ARCAD-SIDA', 'geoPoint': {'lat': 12.60915, 'lon': -7.97522}}, {'city': 'Lomé', 'country': 'Togo', 'facility': 'Centre Lucia, Espoir Vie Togo', 'geoPoint': {'lat': 6.12874, 'lon': 1.22154}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ANRS, Emerging Infectious Diseases', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Expertise France', 'class': 'OTHER'}, {'name': 'Université Montpellier', 'class': 'OTHER'}, {'name': 'SESSTIM (IRD, Inserm, Université Aix-Marseille)', 'class': 'UNKNOWN'}, {'name': 'Coalition Internationale Sida', 'class': 'OTHER'}, {'name': 'Institut de Médecine Tropicale, Anvers, Belgique', 'class': 'UNKNOWN'}, {'name': 'ARCAD-SIDA MALI', 'class': 'OTHER'}, {'name': 'Association African Solidarité', 'class': 'OTHER'}, {'name': 'Centre de Recherche Internationale pour la Santé, Université de Ouagadougou', 'class': 'UNKNOWN'}, {'name': "Espace Confiance, Côte d'Ivoire", 'class': 'OTHER'}, {'name': 'Espoir Vie-Togo - ONG', 'class': 'OTHER'}, {'name': 'Laboratoire BIOLIM, Université de Lomé', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}