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School Support as Structural HIV Prevention for Adolescent Orphans in Kenya

P

Pacific Institute for Research and Evaluation (PIRE)

Status and phase

Completed
Phase 2

Conditions

HIV

Treatments

Behavioral: School Support Intervention

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01501864
PIRE-0580
R01MH092215 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

835 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Orphan (one or both parents deceased)
  • In Grade 7 or 8 in a primary school participating in the study

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

835 participants in 2 patient groups

School Support Group
Experimental group
Description:
School Support Intervention
Treatment:
Behavioral: School Support Intervention
Control
No Intervention group
Description:
No school support

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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