Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-01-05 @ 5:35 PM
Study NCT ID:
NCT05472051
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2021-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Health and Migration Trajectories of Housekeepers in Bamako
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D012725', 'term': 'Sexual Behavior'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': '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': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 644}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-11', 'studyFirstSubmitDate': '2021-09-13', 'studyFirstSubmitQcDate': '2022-07-21', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability of the community-based offer of healthcare services', 'timeFrame': '18 month after the start of the study', 'description': "Percentage of housekeepers attending the community-based healthcare services during the ADDAD's activities (among the total number of housekeepers attending the ADDAD's activities)"}, {'measure': 'Prevalence of infectious diseases among housekeepers attending the community-based healthcare services and accepting screening', 'timeFrame': '18 month after the start of the study', 'description': 'Prevalence of infectious diseases among housekeepers attending the community-based healthcare services and accepting screening:\n\nPercentage of HIV positive Percentage of HBV positive Percentage of HCV positive Percentage of TB POSITIVE Percentage of genital infectious diseases'}, {'measure': 'Pregnancy', 'timeFrame': '18 month after the start of the study', 'description': 'Number of positive pregnancy tests among housekeepers accepting screening'}, {'measure': 'HBV Vaccin', 'timeFrame': '18 month after the start of the study', 'description': 'Number of housekeepers accepting HBV vaccine among those negative to both HBV and HCV'}, {'measure': 'Mental health', 'timeFrame': '18 month after the start of the study', 'description': 'Prevalence of mental disorders such as depression, anxiety, insomnia, post-traumatic stress'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Housekeepers', 'Young girls', 'Mali', 'Accès to healthcare', 'Community-based services'], 'conditions': ['HIV Infections', 'Hepatitis B', 'Hepatitis C', 'Tuberculosis', 'STIs', 'Sex Behavior']}, 'descriptionModule': {'briefSummary': "In Mali, migration from rural zones is a cultural phenomenon existing since 1970. During the dry season (9 months), an important number of young women leave their villages and migrate towards urban zones to seek for a job. In Bamako, the estimated number of housekeepers is 100 000 coming from rural regions and aged between 11 and 19 years. The current healthcare offer seems to be non-adapted to their particularities.\n\nThis is a community-based research constructed on the basis of the activities of two NGOs in Mali: ADDAD (association for the defense of the rights of Housekeepers and domestic helpers ) and ARCAD Santé PLUS (the main NGO for healthcare access for HIV, hepatitis, and sexual health services). The research is conducted by the SanteRCom team in the UMR1252 SESSTIM research unit.\n\nThe main objective of this observational study is to study the knowledge, beliefs, behaviors and practices in terms of health in general, and sexual health in particular; and to assess the acceptability of an offer of community-based prevention and health services provided by ARCAD Santé PLUS integrated in the activities of ADDAD. The integrating of community-based healthcare offer in a familiar and reassuring framework, such as that of ADDAD, should promote access to health services among housekeepers.\n\nThe research is organized in 3 stages:\n\n1. Preliminary qualitative survey based on focus group discussions. Allowing the identification of the housekeepers' needs in terms of prevention and healthcare services; and the behavioral particularities of the housekeepers community. It is planned to conduct 7 focus groups including between 42 and 56 housekeepers.\n2. Communication and awareness campaigns in the regions of origin of housekeepers. Campaigns will be constructed on the basis of the results obtained from the preliminary qualitative survey.\n3. Communication and awareness campaigns in Bamako; community-based activities for housekeepers will be organized 3 times per week during 5 months by the NGO ADDAD. Activities will include the community-based offer of prevention and healthcare services provided by the NGO ARCAD Santé PLUS, i.e. the novelty in the ADDAD's activities. A quantitative and qualitative surveys will be conducted over 5 months with participants recruited during the community-based activities. It is expected to enroll at least 1134 housekeepers, and to conduct a maximum of 25 individual interviews with selected housekeepers."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Young girls working in Bamako as Housekeepers being aged at least 12 years.', 'genderDescription': 'Young girls working in Bamako as housekeepers (not self-representation)', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Being a young girl and working in Bamako as housekeeper\n* Speak one of the most current languages : Bambara, Dogon, French\n* Being aged at least 12 years,\n* To provide written consent. For minors (12 to 17 years old) the consent of a member of the ADDAD NGO as the legal responsible.\n\nExclusion Criteria:\n\n* Minor housekeepers refusing the presence and signature of the ADDAD's member\n* Housekeepers whose mental health would be judged (by the doctor) not appropriate to participate\n* Housekeepers not able to understand and/or to sign the written consent"}, 'identificationModule': {'nctId': 'NCT05472051', 'acronym': '2DM2K', 'briefTitle': 'Health and Migration Trajectories of Housekeepers in Bamako', 'organization': {'class': 'OTHER_GOV', 'fullName': 'ANRS, Emerging Infectious Diseases'}, 'officialTitle': 'Health and Migration Trajectories of Housekeepers in Bamako: Situation and Acceptability of a Community-based Offer of Sexual Health Services', 'orgStudyIdInfo': {'id': 'ANRS 0005s'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Young girls housekeepers', 'description': 'Malian young girls migrating from rural areas towards Bamako to seek for a job as housekeepers. Include young girls aged at least 12 years.', 'interventionNames': ['Other: Community-based healthcare offer provided by an the ARCAD Santé PLUS NGO and integrated into the activities of the ADDAD NGO']}], 'interventions': [{'name': 'Community-based healthcare offer provided by an the ARCAD Santé PLUS NGO and integrated into the activities of the ADDAD NGO', 'type': 'OTHER', 'description': 'In the framework of the current activities of the ARCAD Santé PLUS a team formed by a doctor, a nurse and laboratory assistant will provide prevention and medical activities during the community-based activities organized by the housekeepers ADDAD NGO. The medical consultation will propose:\n\n* HIV screening, including pre- and post- counseling\n* Hepatitis B and hepatitis C screening, including pré- and post- counseling. The HBV vaccine will be proposed to housekeepers with negative results to both HBV and HCV testing\n* Tuberculosis screening will be proposed to housekeepers with symptoms suggesting the possibility of TB\n* For housekeepers sexually active, the medical team will propose a gynecological test in order to screen for genital infections. Furthermore, a pregnancy test will be proposed.\n\nMedicines for current diseases (headache, diarrhea, etc. will be provided by the medical staff).', 'armGroupLabels': ['Young girls housekeepers']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'Commune VI', 'city': 'Bamako', 'state': 'Niamakoro, Sièbougouni, Rue 173, Porte 146', 'country': 'Mali', 'facility': 'ADDAD', 'geoPoint': {'lat': 12.60915, 'lon': -7.97522}}], 'overallOfficials': [{'name': 'Luis Sagaon Teyssier, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMR 1252 SESSTIM'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ANRS, Emerging Infectious Diseases', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}