School Support as Structural HIV Prevention for Adolescent Orphans in Kenya
This study is ongoing, but not recruiting participants.
Sponsor:
Pacific Institute for Research and Evaluation
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
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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: | 837 |
| 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
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: | June 5, 2013 |
| 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 June 18, 2013