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Completed

NCT Number: NCT02771132

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

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.

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Key information

Age range

11 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

African Institute for Health and Development

Nairobi, Kenya

About this study

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 ([email protected]) and Michael Baiocchi, PhD ([email protected]).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

12-hr "IMPower" empowerment self defense course

Behavioral

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.

12-hr Source of Strength for boys

Behavioral

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.

Life-skills course

Behavioral

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • African Institute for Health and Development, Kenya
  • Medical Research Council, South Africa

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
May 12, 2016
Registry last updated
Mar 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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