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School Support as Structural HIV Prevention for Adolescent Orphans in Kenya

School Support as Structural HIV Prevention for Adolescent Orphans in Kenya

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01501864
Enrollment
835
Registered
2011-12-30
Start date
2011-07-31
Completion date
2017-03-31
Last updated
2017-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

HIV prevention, HSV-2, Schooling, Kenya, Orphans, School support

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.

Interventions

BEHAVIORALSchool Support Intervention

Comprehensive school support is provided that includes payment of school fees, school uniform, and a nurse researcher who monitors attendance and addresses problems that may lead to school absence and dropout.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Moi University
CollaboratorOTHER
University of North Carolina, Chapel Hill
CollaboratorOTHER
Pacific Institute for Research and Evaluation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
HSV-2 Incidence3 years
Change from baseline in ever had sexual intercourse at 3 yearsBaseline and 3 years
HIV Incidence3 years
Dropped out of schoolFrom date of randomization until drop out from school, up to 3 years
Change from baseline in ever had sexual intercourse at 1 yearBaseline and 1 year
Change from baseline in ever had sexual intercourse at 2 yearsBaseline and 2 years

Secondary

MeasureTime frame
Health-related quality of lifeBaseline and 1 year
Ever married or ever pregnantFrom date of randomization until marriage or preganancy, up to 3 years

Countries

Kenya, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026