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: October 6, 2014
Last verified: August 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 835
Study Start Date: July 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: October 2014 (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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Moi University
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Hyunsan Cho, Ph.D. Pacific Institute for Research and Evaluation
  More Information

No publications provided

Responsible Party: Pacific Institute for Research and Evaluation
ClinicalTrials.gov Identifier: NCT01501864     History of Changes
Other Study ID Numbers: PIRE-0580, R01MH092215
Study First Received: November 3, 2011
Last Updated: October 6, 2014
Health Authority: United States: Institutional Review Board
Kenya: Institutional Review Board
United States: Federal Government

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

ClinicalTrials.gov processed this record on October 23, 2014