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School Support as Structural HIV Prevention for Adolescent Orphans in Kenya

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01501864
First Posted: December 30, 2011
Last Update Posted: September 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Mental Health (NIMH)
Moi University
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Pacific Institute for Research and Evaluation
  Purpose
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.

Condition Intervention Phase
HIV Behavioral: School Support Intervention Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: School Support as Structural HIV Prevention for Adolescent Orphans in Kenya

Resource links provided by NLM:


Further study details as provided by Pacific Institute for Research and Evaluation:

Primary Outcome Measures:
  • Dropped out of school [ Time Frame: 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 ]
  • Change from baseline in ever had sexual intercourse at 2 years [ Time Frame: Baseline and 2 years ]
  • Change from baseline in ever had sexual intercourse at 3 years [ Time Frame: Baseline and 3 years ]
  • HIV Incidence [ Time Frame: 3 years ]
  • HSV-2 Incidence [ Time Frame: 3 years ]

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

Enrollment: 835
Actual Study Start Date: July 2011
Study Completion Date: March 31, 2017
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Orphan (one or both parents deceased)
  • In Grade 7 or 8 in a primary school participating in the study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01501864


Locations
United States, North Carolina
Pacific Institute for Research and Evaluation
Chapel Hill, North Carolina, United States, 27514
Kenya
Moi University, Department of Nursing Sciences
Eldoret, Kenya
Sponsors and Collaborators
Pacific Institute for Research and Evaluation
National Institute of Mental Health (NIMH)
Moi University
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Hyunsan Cho, Ph.D. Pacific Institute for Research and Evaluation
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pacific Institute for Research and Evaluation
ClinicalTrials.gov Identifier: NCT01501864     History of Changes
Other Study ID Numbers: PIRE-0580
R01MH092215 ( U.S. NIH Grant/Contract )
First Submitted: November 3, 2011
First Posted: December 30, 2011
Last Update Posted: September 26, 2017
Last Verified: September 2017

Keywords provided by Pacific Institute for Research and Evaluation:
HIV prevention
HSV-2
Schooling
Kenya
Orphans
School support