Clinical trial NCT02771132: A Cluster-randomized Trial to Assess a Sexual Assault Prevention Intervention in Adolescents in Nairobi, Kenya
Official title: A Cluster-randomized Trial to Assess a Sexual Assault Prevention Intervention in Upper Primary School Adolescents in Nairobi, Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Assault and Rape
Violence, Non-accidental
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: African Institute for Health and Development, Kenya
name: Medical Research Council, South Africa
First posted: 2016-05-12
Enrollment: 4121
Sex: ALL
Minimum age (years): 11
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: Sexual Assault Incidence (WHO-Violence Against Women Survey)
timeFrame: 12 months
Secondary outcomes:
measure: Physical Violence Incidence (WHO-Violence Against Women Survey)
timeFrame: 8-20 months post-intervention
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: African Institute for Health and Development
Study officials:
affiliation: Stanford University
name: Michael Baiocchi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.