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School Support as Structural HIV Prevention for Adolescent Orphans in Kenya

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.
 
ClinicalTrials.gov Identifier: NCT01501864
Recruitment Status : Completed
First Posted : December 30, 2011
Last Update Posted : September 26, 2017
Sponsor:
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

Tracking Information
First Submitted Date  ICMJE November 3, 2011
First Posted Date  ICMJE December 30, 2011
Last Update Posted Date September 26, 2017
Actual Study Start Date  ICMJE July 2011
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 29, 2011)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 29, 2011)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE School Support as Structural HIV Prevention for Adolescent Orphans in Kenya
Official Title  ICMJE School Support as Structural HIV Prevention for Adolescent Orphans in Kenya
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE HIV
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: School Support Group
    School Support Intervention
    Intervention: Behavioral: School Support Intervention
  • No Intervention: Control
    No school support
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 6, 2014)
835
Original Actual Enrollment  ICMJE
 (submitted: December 29, 2011)
836
Actual Study Completion Date  ICMJE March 31, 2017
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Orphan (one or both parents deceased)
  • In Grade 7 or 8 in a primary school participating in the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Kenya,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01501864
Other Study ID Numbers  ICMJE PIRE-0580
R01MH092215 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pacific Institute for Research and Evaluation
Study Sponsor  ICMJE Pacific Institute for Research and Evaluation
Collaborators  ICMJE
  • National Institute of Mental Health (NIMH)
  • Moi University
  • University of North Carolina, Chapel Hill
Investigators  ICMJE
Principal Investigator: Hyunsan Cho, Ph.D. Pacific Institute for Research and Evaluation
PRS Account Pacific Institute for Research and Evaluation
Verification Date September 2017

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