Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT06554418
Status:
RECRUITING
Last Update Posted:
2025-08-19
First Post:
2024-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
What Works to Prevent Violence Against Women and Girls in Somalia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized at the districts level in two regions of Somalia'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2029-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-14', 'studyFirstSubmitDate': '2024-08-12', 'studyFirstSubmitQcDate': '2024-08-12', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cyber-Sexual Harassment survey score', 'timeFrame': '9 and 12 months', 'description': 'Adolescent report of experience of peer-to-peer or adult on-line and in-person harassment, Mean scale score ranges from 1 to 5 with higher scores being worse outcome'}, {'measure': 'Peer-to-peer physical and sexual violence in school and community survey score', 'timeFrame': '9 and 12 months', 'description': 'Adolescent report of experience of peer to peer violence in schools, Mean scale score ranges from 1 to 5 with higher scores being worse outcome'}, {'measure': 'Harsh punishment in school as assessed by the Parent-Child Conflict Scale adapted for teachers', 'timeFrame': '9 and 12 months', 'description': 'Adolescent report of witness or experience harsh punishment in school using the Parent-Child Conflict Tactics Scale adapted for teachers, Mean scale score 1-5, with higher score being worse outcome'}, {'measure': 'Witnessing intimate partner violence (IPV) survey score', 'timeFrame': '9 and 12 months', 'description': 'Adolescent report of witnessing IPV in the household, mean scale score ranges from 1 to 5 with higher scores being worse outcome'}, {'measure': 'Harsh Punishment in Household as assessed by the Parent-Child Conflict Scale', 'timeFrame': '9 and 12 months', 'description': 'Adolescent report of witness and experience harsh punishment in household using Parent-Child Conflict Tactics Scale, mean scale score ranges from 1 to 5 with higher scores being worse outcome'}, {'measure': 'IPV victimization and/or perpetration as assessed by Somalia National Survey', 'timeFrame': '9 and 12 months', 'description': 'Adult report of experience and/or perpetration of IPV, mean scale score ranges from 1 to 5 with higher scores being worse outcome'}, {'measure': 'Use of Harsh Punishment in Household as assessed by the Parent-Child Conflict Tactics Scale', 'timeFrame': '9 and 12 months', 'description': 'Adult report of use of harsh punishment, mean scale score ranges from 1 to 5 with higher scores being worse outcome'}, {'measure': 'Non-partner harassment as assessed by the National Somalia Survey', 'timeFrame': '9 and 12 months', 'description': 'Adult report of non-partner harassment, mean scale score ranges from 1 to 5 with higher scores being worse outcome'}, {'measure': 'Non-partner physical and/or sexual violence victimization as assessed by the National Somalia Survey', 'timeFrame': '9 and 12 months', 'description': 'Adult report of physical and/or sexual violence victimization by non-partner, mean scale score ranges from 1 to 5 with higher scores being worse outcome'}], 'secondaryOutcomes': [{'measure': 'Personal Beliefs and Social Norms about Gender Based Violence as assessed by the Social Norms and Beliefs about Gender Based Violence Scale', 'timeFrame': '9 and 12 months', 'description': 'Adolescent and adult personal beliefs and social norms about gender based violence, mean scale scores range from 1-5, higher scores being worse outcome'}, {'measure': 'Gender equality survey score', 'timeFrame': '9 and 12 months', 'description': 'Adult and adolescent report of equality in access to education, resources and decision making between women/girls and men/boys, mean scale score range from 1-5, higher score is worse outcome'}, {'measure': 'IPV acceptability survey score', 'timeFrame': '9 and 12 months', 'description': 'Adult and adolescent report on acceptability of intimate partner violence (IPV), for example, It is justifiable for a husband to hit his wife because she argues with him, it is acceptable for a husband to force his wife to have sex when she does not want to. mean subscale score range from 1-5, higher score is worse outcome'}, {'measure': 'Sexual and reproductive health knowledge and empowerment score', 'timeFrame': '9 and 12 months', 'description': 'Adolescent knowledge in the domains of puberty, female genital mutilation (FGM), child marriage, and sexually transmitted infection (STI) and empowerment measured for puberty, child marriage, FGM, PV, and contraception use, mean scale score range from 1-5, higher score is better outcomes'}, {'measure': 'Confidence in service providers (adolescents and adults) score', 'timeFrame': '9 and 12 months', 'description': 'Adolescent and adult report on confidence in service providers in responding to gender based violence across several sectors (health care, justice system, elders, psychosocial services and community health workers). Mean scale score range from 1-5, higher score is better outcome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Violence Prevention']}, 'descriptionModule': {'briefSummary': 'The Communities Care (CC) program has demonstrated promise in changing harmful social norms associated with Gender-based violence (GBV) and increasing confidence in services for women and girls. Therefore, the study will adapt the existing CC program based on previous learnings with adults and expand programming to include adolescent boys and girls, creating the CC adult and CC adolescent program. The CC program intervention implementation will be led by Comitato Internazionale per lo Sviluppo dei Popoli (CISP) non-Governmental Organization (NGO) in partnership with Somalia Ministry of Education and local Women led Organizations (WLO), public schools and mapped GBV and child protection (CP) service providers in Banadir and Galmudug regions of Somalia.\n\nJohns Hopkins will collaborate with local research colleagues to evaluate the CC adult and CC adolescent program. The study will use a hybrid type 2 effectiveness-implementation design guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Quantitative methods will be used to measure outcomes at baseline and endline (24 months post baseline) with adults and adolescents (10 and older) participants in the CC programs in intervention compared to control districts in the two regions (Banadir and Galmudug) in South Central Somalia. Quantitative methods will also be used to measure outcomes with adults and adolescents (10 years and older) community members (members that do not participate in the CC program) in intervention and control districts in the 2 regions at baseline, midline (12-months), endline (24-months) and maintenance (36 months). In addition, quantitative and qualitative methods at midline and endline will be used to measure the CC adult and CC adolescent intervention reach, adoption, implementation and maintenance in intervention districts in the two regions.', 'detailedDescription': 'What Works to Prevent Violence Against Women and Children (FCDO funded) has funded a collaboration between Johns Hopkins and Comitato Internazionale per lo Sviluppo dei Popoli (CISP) NGO in partnership with Somalia Ministry of Education and local researchers and Women led Organizations (WLO) to evaluate the Communities Care (CC) violence prevention intervention with both adults and adolescent in community and school-based settings in two regions of Somalia. The study will use a hybrid type 2 effectiveness-implementation design guided by the RE-AIM framework (e.g., reach, effectiveness, adoption, implementation and maintenance). Quantitative methods will be used to measure violence, health and social norms outcomes with adults (18 and older) and adolescents (10 and older) with participants in CC intervention districts and control districts in the two regions (Banadir and Galmudug) in South Central Somalia. Quantitative methods will also be used to measure outcomes with adults and adolescents (10 years and older) community members (members that do not participate in the CC program) in intervention and control districts in the 2 regions at baseline, midline (12-months), endline (24-months) and maintenance (36 months). In addition, quantitative and qualitative methods at midline and endline will be used to measure the CC adult and CC adolescent intervention reach, adoption, implementation and maintenance in intervention districts in the two regions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '10 Years', 'genderBased': True, 'genderDescription': 'self-identified as male and female adolescents and adults', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Age 10 years or older\n* Participant in CC adult or CC adolescent program in collaboration with 9 public schools in districts randomized to intervention or control in two regions of Somalia\n* Living/resident of target districts (including internally displaced persons (IDPs) and does not have plans to move/leave the district or surrounding area in the next 12 months (this is critical for the longitudinal data collection with CC program participants)\n\nExclusion Criteria:\n\n* Less than 10 years old\n* Not a participant in CC adult or CC adolescent\n* Not a resident of target districts-'}, 'identificationModule': {'nctId': 'NCT06554418', 'briefTitle': 'What Works to Prevent Violence Against Women and Girls in Somalia', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'What Works to Prevent Violence Against Women and Girls: Evaluation of the Communities Care Program in Somalia', 'orgStudyIdInfo': {'id': 'IRB00418976'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Communities Care', 'description': 'Districts in two regions of Somalia randomized to Communities Care violence prevention program with adults and adolescents', 'interventionNames': ['Behavioral: Communities Care']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Districts in two regions of Somalia randomized to control - usual programming related to prevention of violence'}], 'interventions': [{'name': 'Communities Care', 'type': 'BEHAVIORAL', 'description': 'Communities Care is a violence prevention program targeting social norms and behavioral change', 'armGroupLabels': ['Communities Care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mogadishu', 'state': 'Wadajir District', 'status': 'RECRUITING', 'country': 'Somalia', 'contacts': [{'name': 'Michele Stella', 'role': 'CONTACT', 'email': 'michele.stella@cisp-ngo.org'}], 'facility': 'CISP Somalia', 'geoPoint': {'lat': 2.03711, 'lon': 45.34375}}], 'centralContacts': [{'name': 'Nancy Glass, PhD', 'role': 'CONTACT', 'email': 'nglass1@jhu.edu', 'phone': '4432579947'}], 'overallOfficials': [{'name': 'Nancy Glass, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Comitato Internazionale per los Sviluppo dei Popoli (CISP)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}