School Support as Structural HIV Prevention for Adolescent Orphans in Kenya

Study Overview
=================
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.

Official Title
-----------------
School Support as Structural HIV Prevention for Adolescent Orphans in Kenya

Conditions
-----------------
HIV

Intervention / Treatment
-----------------
* Behavioral: School Support Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Orphan (one or both parents deceased) In Grade 7 or 8 in a primary school participating in the study
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: School Support Group<br>School Support Intervention | Behavioral: School Support Intervention<br>* 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.<br>|
| No Intervention: Control<br>No school support | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dropped out of school |  | From date of randomization until drop out from school, up to 3 years | 
| Change from baseline in ever had sexual intercourse at 1 year |  | Baseline and 1 year | 
| Change from baseline in ever had sexual intercourse at 2 years |  | Baseline and 2 years | 
| Change from baseline in ever had sexual intercourse at 3 years |  | Baseline and 3 years | 
| HIV Incidence |  | 3 years | 
| HSV-2 Incidence |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ever married or ever pregnant |  | From date of randomization until marriage or preganancy, up to 3 years | 
| Health-related quality of life |  | Baseline and 1 year | 
| Health-related quality of life |  | Baseline and 2 years | 
| Health-related quality of life |  | Baseline and 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV prevention, HSV-2, Schooling, Kenya, Orphans, School support