Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-03-28 @ 12:13 PM
Study NCT ID:
NCT02771132
Status:
COMPLETED
Last Update Posted:
2020-03-18
First Post:
2016-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Cluster-randomized Trial to Assess a Sexual Assault Prevention Intervention in Adolescents in Nairobi, Kenya
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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-16', 'studyFirstSubmitDate': '2016-05-11', 'studyFirstSubmitQcDate': '2016-05-11', 'lastUpdatePostDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sexual Assault Incidence (WHO-Violence Against Women Survey)', 'timeFrame': '12 months', 'description': 'self-reports of sexual assault within past 12 months, compared between control and intervention groups'}], 'secondaryOutcomes': [{'measure': 'Physical Violence Incidence (WHO-Violence Against Women Survey)', 'timeFrame': '8-20 months post-intervention', 'description': 'Self-reports of physical violence, compared between control and intervention groups'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sexual Assault and Rape', 'Violence, Non-accidental']}, 'referencesModule': {'references': [{'pmid': '35579915', 'type': 'DERIVED', 'citation': 'Mphamba D, Solomon FR, Nyairo G, Kim CJ, Krishnamoorthi M, Edem B, Amuyunzu-Nyamongo M, Kang J, Baiocchi M, Sarnquist CC. Youth voices from an informal settlement of Nairobi, Kenya: Engaging adolescent perspectives on violence to inform prevention. Glob Public Health. 2022 Dec;17(12):3686-3699. doi: 10.1080/17441692.2022.2076895. Epub 2022 May 17.'}, {'pmid': '31248392', 'type': 'DERIVED', 'citation': 'Sarnquist C, Kang JL, Amuyunzu-Nyamongo M, Oguda G, Otieno D, Mboya B, Omondi N, Kipkirui D, Baiocchi M. A protocol for a cluster-randomized controlled trial testing an empowerment intervention to prevent sexual assault in upper primary school adolescents in the informal settlements of Nairobi, Kenya. BMC Public Health. 2019 Jun 27;19(1):834. doi: 10.1186/s12889-019-7154-x.'}], 'seeAlsoLinks': [{'url': 'http://www.whatworks.co.za/', 'label': 'This protocol is part of the What Works to Prevent Violence Initiative, a global program to prevent violence against women and girls'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to compare the effectiveness of classroom-based behavioral interventions (12-hour girls program and 12-hour boys program), to a standard-of care intervention, on reducing the incidence of self-reported sexual assault among girls from baseline.\n\nSecondary objectives of this study is to determine the impact of the interventions on related physical and mental health status/outcomes, STI-risk behaviors, self-efficacy, and self-esteem.', 'detailedDescription': 'In Kenya, up to 46% of women report childhood sexual assault. In an implementation research project, a team at Stanford University will be pairing with three Kenyan NGO\'s to research the effectiveness of an intervention to prevent sexual assault among adolescent girls in the informal settlements around Nairobi, Kenya. The study design will be a cluster-randomized controlled trial with two arms comparing the intervention to a standard of care group. The intervention consists of two side-by-side behavioral and skills-based interventions, one for girls and one for boys, taught in schools. The interventions include identifying and avoiding risky situations, verbal techniques to diffuse situations, as well as bystander intervention techniques for boys and self-defense techniques for girls. Settlements with schools participating in the project include Kibera, Dandora, Huruma, and Mukuru.\n\nThis grant is part of the larger "What Works to Prevent Violence: A global program to prevent violence against women and girls" initiative, which is a large international initiative aimed at the prevention of gender-based violence. The initiative includes 18 projects from around the globe, and is supported by the Medical Research Council of South Africa, the London School of Hygiene and Tropical Medicine, and the UK Department for International Development (DFID). The primary contact people at Stanford University for this project are Clea Sarnquist, DrPH, MPH (cleas@stanford.edu) and Michael Baiocchi, PhD (baiocchi@stanford.edu).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adolescents aged 11-15 years\n* Enrolled in the target schools\n* Able to communicate in the study languages: English or Kiswahili\n\nExclusion Criteria:\n\n* significant mental condition (learning difficulty, mental illness or substance abuse) which would impair their ability to consent to participation in the trial.'}, 'identificationModule': {'nctId': 'NCT02771132', 'briefTitle': 'A Cluster-randomized Trial to Assess a Sexual Assault Prevention Intervention in Adolescents in Nairobi, Kenya', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'A Cluster-randomized Trial to Assess a Sexual Assault Prevention Intervention in Upper Primary School Adolescents in Nairobi, Kenya', 'orgStudyIdInfo': {'id': '34706'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': '12-hour intervention "IMPower" empowerment self defense course for girls and 12-hour Source of Strength for boys+ 2 refresher sessions (at 2 hrs. per session)', 'interventionNames': ['Behavioral: 12-hr "IMPower" empowerment self defense course', 'Behavioral: 12-hr Source of Strength for boys']}, {'type': 'OTHER', 'label': 'Standard of Care', 'description': '1-2 hour course based on Ministry of Education life skills course (no refresher sessions)', 'interventionNames': ['Behavioral: Life-skills course']}], 'interventions': [{'name': '12-hr "IMPower" empowerment self defense course', 'type': 'BEHAVIORAL', 'description': 'The purpose of the 12-hr "IMPower" empowerment self defense course intervention for girls is to empower then to avoid risky situations, advocate for themselves, and, if needed, defend themselves against an attack.', 'armGroupLabels': ['Intervention']}, {'name': '12-hr Source of Strength for boys', 'type': 'BEHAVIORAL', 'description': 'The 12-hr Source of Strength for boys curriculum is specifically designed for 10-13 year-old boys and focused on promoting gender equality, developing positive masculinity, and teaching safe and effective bystander intervention techniques.', 'armGroupLabels': ['Intervention']}, {'name': 'Life-skills course', 'type': 'BEHAVIORAL', 'description': 'A 1.5-2 hour life skills class that is based on the Kenyan Ministry of Education life skills course and includes a wide range of topics, including sexual assault but also sanitation, food safety, and personal rights. All school-aged children who attend school typically receive this type of curriculum.', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nairobi', 'country': 'Kenya', 'facility': 'African Institute for Health and Development', 'geoPoint': {'lat': -1.28333, 'lon': 36.81667}}], 'overallOfficials': [{'name': 'Michael Baiocchi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'To protect the privacy of the participants (who are minors), parties interested in the data should contact the investigators and provide evidence of IRB approval and data security safeguards at their institution(s). The sponsoring agency, DFID, anticipates making some of the data publicly available in the future.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'African Institute for Health and Development, Kenya', 'class': 'UNKNOWN'}, {'name': 'Medical Research Council, South Africa', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mike Baiocchi', 'investigatorAffiliation': 'Stanford University'}}}}