School Support as Structural HIV Prevention for Adolescent Orphans in Kenya

HIV Clinical Trial

Official title:

School Support as Structural HIV Prevention for Adolescent Orphans in Kenya

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01501864
• Other study ID #: PIRE-0580
• Secondary ID: R01MH092215
• Status: Completed
• Phase: Phase 2
• First received: November 3, 2011
• Last updated: September 22, 2017
• Start date: July 2011
• Est. completion date: March 31, 2017

Study information

• Verified date: September 2017
• Source: Pacific Institute for Research and Evaluation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 835
• Est. completion date: March 31, 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Orphan (one or both parents deceased)

• In Grade 7 or 8 in a primary school participating in the study

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• School 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.

Locations

Country	Name	City	State
Kenya	Moi University, Department of Nursing Sciences	Eldoret
United States	Pacific Institute for Research and Evaluation	Chapel Hill	North Carolina

Sponsors (4)

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

Countries where clinical trial is conducted

United States,  Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dropped out of school		From date of randomization until drop out from school, up to 3 years
Primary	Change from baseline in ever had sexual intercourse at 1 year		Baseline and 1 year
Primary	Change from baseline in ever had sexual intercourse at 2 years		Baseline and 2 years
Primary	Change from baseline in ever had sexual intercourse at 3 years		Baseline and 3 years
Primary	HIV Incidence		3 years
Primary	HSV-2 Incidence		3 years
Secondary	Ever married or ever pregnant		From date of randomization until marriage or preganancy, up to 3 years
Secondary	Health-related quality of life		Baseline and 1 year
Secondary	Health-related quality of life		Baseline and 2 years
Secondary	Health-related quality of life		Baseline and 3 years