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Trial record 1 of 1 for:    NCT02771132
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A Cluster-randomized Trial to Assess a Sexual Assault Prevention Intervention in Adolescents in Nairobi, Kenya

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ClinicalTrials.gov Identifier: NCT02771132
Recruitment Status : Completed
First Posted : May 12, 2016
Last Update Posted : March 18, 2020
Sponsor:
Collaborators:
African Institute for Health and Development, Kenya
Medical Research Council, South Africa
Information provided by (Responsible Party):
Mike Baiocchi, Stanford University

Brief Summary:

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.

Secondary 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.


Condition or disease Intervention/treatment Phase
Sexual Assault and Rape Violence, Non-accidental Behavioral: 12-hr "IMPower" empowerment self defense course Behavioral: 12-hr Source of Strength for boys Behavioral: Life-skills course Not Applicable

Detailed Description:

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.

This 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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Cluster-randomized Trial to Assess a Sexual Assault Prevention Intervention in Upper Primary School Adolescents in Nairobi, Kenya
Study Start Date : September 2015
Actual Primary Completion Date : September 2018
Actual Study Completion Date : April 2019

Arm Intervention/treatment
Experimental: Intervention
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)
Behavioral: 12-hr "IMPower" empowerment self defense course
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.

Behavioral: 12-hr Source of Strength for boys
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.

Standard of Care
1-2 hour course based on Ministry of Education life skills course (no refresher sessions)
Behavioral: Life-skills course
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.




Primary Outcome Measures :
  1. Sexual Assault Incidence (WHO-Violence Against Women Survey) [ Time Frame: 12 months ]
    self-reports of sexual assault within past 12 months, compared between control and intervention groups


Secondary Outcome Measures :
  1. Physical Violence Incidence (WHO-Violence Against Women Survey) [ Time Frame: 8-20 months post-intervention ]
    Self-reports of physical violence, compared between control and intervention groups



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Ages Eligible for Study:   11 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adolescents aged 11-15 years
  • Enrolled in the target schools
  • Able to communicate in the study languages: English or Kiswahili

Exclusion Criteria:

  • significant mental condition (learning difficulty, mental illness or substance abuse) which would impair their ability to consent to participation in the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02771132


Locations
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Kenya
African Institute for Health and Development
Nairobi, Kenya
Sponsors and Collaborators
Stanford University
African Institute for Health and Development, Kenya
Medical Research Council, South Africa
Investigators
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Principal Investigator: Michael Baiocchi, PhD Stanford University
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mike Baiocchi, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT02771132    
Other Study ID Numbers: 34706
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan 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.