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Clinical Trials/NCT02771132
NCT02771132
Completed
Not Applicable

A Cluster-randomized Trial to Assess a Sexual Assault Prevention Intervention in Upper Primary School Adolescents in Nairobi, Kenya

Stanford University1 site in 1 country4,121 target enrollmentSeptember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sexual Assault and Rape
Sponsor
Stanford University
Enrollment
4121
Locations
1
Primary Endpoint
Sexual Assault Incidence (WHO-Violence Against Women Survey)
Status
Completed
Last Updated
6 years ago

Overview

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.

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).

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
April 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mike Baiocchi

Principal Investigator

Stanford University

Eligibility 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.

Outcomes

Primary Outcomes

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 Outcomes

  • Physical Violence Incidence (WHO-Violence Against Women Survey)(8-20 months post-intervention)

Study Sites (1)

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