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Completed

NCT Number: NCT01501864

School Support as Structural HIV Prevention for Adolescent Orphans in Kenya

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.

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Key information

Conditions

HIV

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Moi University, Department of Nursing Sciences, Eldoret, Kenya

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

School Support Intervention

Behavioral

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.

Primary outcomes

  1. Dropped out of school

    Time frame: From date of randomization until drop out from school, up to 3 years

  2. Change from baseline in ever had sexual intercourse at 1 year

    Time frame: Baseline and 1 year

  3. Change from baseline in ever had sexual intercourse at 2 years

    Time frame: Baseline and 2 years

  4. Change from baseline in ever had sexual intercourse at 3 years

    Time frame: Baseline and 3 years

  5. HIV Incidence

    Time frame: 3 years

  6. HSV-2 Incidence

    Time frame: 3 years

Secondary outcomes

  1. Ever married or ever pregnant

    Time frame: From date of randomization until marriage or preganancy, up to 3 years

  2. Health-related quality of life

    Time frame: Baseline and 1 year

  3. Health-related quality of life

    Time frame: Baseline and 2 years

  4. Health-related quality of life

    Time frame: Baseline and 3 years

Sponsors and collaborators

Lead sponsor

Pacific Institute for Research and Evaluation

Other

Collaborators

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

Registry information

Important dates

Study start
2011
Primary completion
2016
Study completion
2017
First posted
Dec 30, 2011
Registry last updated
Sep 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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