School Support as Structural HIV Prevention for Adolescent Orphans in Kenya

September 22, 2017 updated by: Pacific Institute for Research and Evaluation
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

835

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Eldoret, Kenya
        • Moi University, Department of Nursing Sciences
  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Pacific Institute for Research and Evaluation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: School Support Group
School Support 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.
No Intervention: Control
No school support

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Ever married or ever pregnant
Time Frame: From date of randomization until marriage or preganancy, up to 3 years
From date of randomization until marriage or preganancy, up to 3 years
Health-related quality of life
Time Frame: Baseline and 1 year
Baseline and 1 year
Health-related quality of life
Time Frame: Baseline and 2 years
Baseline and 2 years
Health-related quality of life
Time Frame: Baseline and 3 years
Baseline and 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pacific Institute for Research and Evaluation

Collaborators

National Institute of Mental Health (NIMH)
University of North Carolina, Chapel Hill
Moi University

Investigators

  • Principal Investigator: Hyunsan Cho, Ph.D., Pacific Institute for Research and Evaluation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2011

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

March 31, 2017

Study Registration Dates

First Submitted

November 3, 2011

First Submitted That Met QC Criteria

December 29, 2011

First Posted (Estimate)

December 30, 2011

Study Record Updates

Last Update Posted (Actual)

September 26, 2017

Last Update Submitted That Met QC Criteria

September 22, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PIRE-0580
  • R01MH092215 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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