- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01501864
School Support as Structural HIV Prevention for Adolescent Orphans in Kenya
Study Overview
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Eldoret, Kenya
- Moi University, Department of Nursing Sciences
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North Carolina
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Chapel Hill, North Carolina, United States, 27514
- Pacific Institute for Research and Evaluation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Orphan (one or both parents deceased)
- In Grade 7 or 8 in a primary school participating in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: School Support Group
School Support Intervention
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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.
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No Intervention: Control
No school support
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dropped out of school
Time Frame: From date of randomization until drop out from school, up to 3 years
|
From date of randomization until drop out from school, up to 3 years
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Change from baseline in ever had sexual intercourse at 1 year
Time Frame: Baseline and 1 year
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Baseline and 1 year
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Change from baseline in ever had sexual intercourse at 2 years
Time Frame: Baseline and 2 years
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Baseline and 2 years
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Change from baseline in ever had sexual intercourse at 3 years
Time Frame: Baseline and 3 years
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Baseline and 3 years
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HIV Incidence
Time Frame: 3 years
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3 years
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HSV-2 Incidence
Time Frame: 3 years
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3 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Ever married or ever pregnant
Time Frame: From date of randomization until marriage or preganancy, up to 3 years
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From date of randomization until marriage or preganancy, up to 3 years
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Health-related quality of life
Time Frame: Baseline and 1 year
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Baseline and 1 year
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Health-related quality of life
Time Frame: Baseline and 2 years
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Baseline and 2 years
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Health-related quality of life
Time Frame: Baseline and 3 years
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Baseline and 3 years
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Hyunsan Cho, Ph.D., Pacific Institute for Research and Evaluation
Publications and helpful links
General Publications
- Cho H, Mbai I, Luseno WK, Hobbs M, Halpern C, Hallfors DD. School Support as Structural HIV Prevention for Adolescent Orphans in Western Kenya. J Adolesc Health. 2018 Jan;62(1):44-51. doi: 10.1016/j.jadohealth.2017.07.015. Epub 2017 Nov 6.
- Hallfors DD, Cho H, Mbai II, Millimo BW, Atieno C, Okumu D, Luseno WK, Hartman S, Halpern CT, Hobbs MM. Disclosure of HSV-2 serological test results in the context of an adolescent HIV prevention trial in Kenya. Sex Transm Infect. 2015 Sep;91(6):395-400. doi: 10.1136/sextrans-2015-052025. Epub 2015 Jul 2.
- Cho H, Luseno W, Halpern C, Zhang L, Mbai I, Milimo B, Hallfors DD. Discordance of HIV and HSV-2 biomarkers and self-reported sexual behaviour among orphan adolescents in Western Kenya. Sex Transm Infect. 2015 Jun;91(4):260-5. doi: 10.1136/sextrans-2014-051720. Epub 2014 Nov 6.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PIRE-0580
- R01MH092215 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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