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临床试验/NCT01501864
NCT01501864已完成2 期

School Support as Structural HIV Prevention for Adolescent Orphans in Kenya

Pacific Institute for Research and Evaluation3 个研究点 分布在 2 个国家目标入组 835 人开始时间: 2011年7月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
835
试验地点
3
主要终点
Dropped out of school

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

  • 未提供

研究组 & 干预措施

School Support Group

Experimental

School Support Intervention

干预措施: School Support Intervention (Behavioral)

Control

No Intervention

No school support

结局指标

主要结局

Dropped out of school

时间窗: From date of randomization until drop out from school, up to 3 years

Change from baseline in ever had sexual intercourse at 2 years

时间窗: Baseline and 2 years

HSV-2 Incidence

时间窗: 3 years

Change from baseline in ever had sexual intercourse at 1 year

时间窗: Baseline and 1 year

Change from baseline in ever had sexual intercourse at 3 years

时间窗: Baseline and 3 years

HIV Incidence

时间窗: 3 years

次要结局

  • Ever married or ever pregnant(From date of randomization until marriage or preganancy, up to 3 years)
  • Health-related quality of life(Baseline and 3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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