School Support as Structural HIV Prevention for Adolescent Orphans in Kenya

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Moi University
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Pacific Institute for Research and Evaluation
ClinicalTrials.gov Identifier:
NCT01501864
First received: November 3, 2011
Last updated: June 5, 2013
Last verified: June 2013

November 3, 2011
June 5, 2013
July 2011
October 2014   (final data collection date for primary outcome measure)
  • Dropped out of school [ Time Frame: From date of randomization until drop out from school, up to 3 years ] [ Designated as safety issue: No ]
  • Change from baseline in ever had sexual intercourse at 1 year [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
  • Change from baseline in ever had sexual intercourse at 2 years [ Time Frame: Baseline and 2 years ] [ Designated as safety issue: No ]
  • Change from baseline in ever had sexual intercourse at 3 years [ Time Frame: Baseline and 3 years ] [ Designated as safety issue: No ]
  • HIV Incidence [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • HSV-2 Incidence [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01501864 on ClinicalTrials.gov Archive Site
  • Ever married or ever pregnant [ Time Frame: From date of randomization until marriage or preganancy, up to 3 years ] [ Designated as safety issue: No ]
  • Health-related quality of life [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
  • Health-related quality of life [ Time Frame: Baseline and 2 years ] [ Designated as safety issue: No ]
  • Health-related quality of life [ Time Frame: Baseline and 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
School Support as Structural HIV Prevention for Adolescent Orphans in Kenya
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV
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.
  • Experimental: School Support Group
    School Support Intervention
    Intervention: Behavioral: School Support Intervention
  • No Intervention: Control
    No school support
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
837
March 2015
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Orphan (one or both parents deceased)
  • In Grade 7 or 8 in a primary school participating in the study
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Kenya
 
NCT01501864
PIRE-0580, R01MH092215
No
Pacific Institute for Research and Evaluation
Pacific Institute for Research and Evaluation
  • National Institute of Mental Health (NIMH)
  • Moi University
  • University of North Carolina, Chapel Hill
Principal Investigator: Hyunsan Cho, Ph.D. Pacific Institute for Research and Evaluation
Pacific Institute for Research and Evaluation
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP