School Support as Structural HIV Prevention for Adolescent Orphans in Kenya

Phase 2

Completed

• Conditions: HIV
• Interventions: Behavioral: School Support Intervention

• Registration Number: NCT01501864
• Lead Sponsor: Pacific Institute for Research and Evaluation

Brief Summary

The purpose of this study is to test whether school support can keep adolescent Kenyan orphans in school, reduce sexual risk behaviors, and prevent HIV /HSV-2 infection.

Detailed Description

This study examines the impact of school support as a structural intervention, tested among adolescent orphans in Siaya District, Nyanza Province, Kenya.

Aims for the proposed study are: 1) To experimentally test whether providing comprehensive school support to Kenyan orphaned boys and girls will reduce school dropout, reduce sexual risk behaviors, and prevent HIV/HSV-2 infection; 2) To conduct a process evaluation of the implementation of the program; and 3) To conduct comparative cost effectiveness analyses, specifying the intervention's cost and return on investment as evidenced by cost per unit improvement in the primary outcomes of school enrollment, delay of sexual debut and prevention of risk behaviors and HIV/HSV-2 infection, as well as by gains in health-related quality of life.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-11-03
• Study First Submitted QC: 2011-12-29
• Study First Posted: 2011-12-30
• Primary Completion: 2016-09
• Study Completion: 2017-03-31
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-22
• Last Update Posted: 2017-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 835

Inclusion Criteria

• Orphan (one or both parents deceased)
• In Grade 7 or 8 in a primary school participating in the study

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
School Support Group	School Support Intervention	School Support Intervention

Primary Outcome Measures

Name	Time	Method
Change from baseline in ever had sexual intercourse at 2 years	Baseline and 2 years
Change from baseline in ever had sexual intercourse at 3 years	Baseline and 3 years
HIV Incidence	3 years
Dropped out of school	From date of randomization until drop out from school, up to 3 years
HSV-2 Incidence	3 years
Change from baseline in ever had sexual intercourse at 1 year	Baseline and 1 year

Secondary Outcome Measures

Name	Time	Method
Ever married or ever pregnant	From date of randomization until marriage or preganancy, up to 3 years
Health-related quality of life	Baseline and 3 years

Trial Locations

Locations (2)

Moi University, Department of Nursing Sciences; 🇰🇪 Eldoret, Kenya

Pacific Institute for Research and Evaluation; 🇺🇸 Chapel Hill, North Carolina, United States