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临床试验/NCT00336180
NCT00336180已完成2 期

Adolescent Drug and HIV Prevention in South Africa

Penn State University2 个研究点 分布在 1 个国家目标入组 7,695 人开始时间: 2003年9月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
7,695
试验地点
2
主要终点
incidence of ATOD use

研究概览

简要总结

The purpose of this trial is to test the effectiveness of a classroom-based prevention program (HealthWise: Learning Life Skills for Young Adults) to reduce the risk of HIV/AIDS and STIs, as well as substance use, among adolescents in one area of South Africa.

详细描述

Recent estimates of the incidence of HIV among South African youth reveal rates to be among the highest in the world. Research shows that the sexual behaviors that put youth at increased risk for HIV often occur in the context of substance use. Consequently, effective prevention programs will most likely target both types of risk behavior. Research and theory also suggest that a positive youth development approach may be an useful way to reduce risk behavior. Therefore, our study involves the implementation of a classroom-based leisure, life-skill, and sexuality education curriculum, HealthWise: Learning Life Skills for Young Adults. This program is designed to reduce substance use and sexual risk behavior and to increase healthy leisure behavior and intra- and interpersonal skills.

Students from 4 high schools are currently receiving the HealthWise lessons in the 8th and 9th grades; students from 5 other schools serve as controls. Participants complete survey assessments on PalmPilots twice per year, until they leave school. Three cohorts of students are participating in this trial.

Our hypothesis is that HealthWise participants will engage in less risk behavior than controls. This will be tested using various statistical methodologies, including multiple regression, structural equation modeling, and growth modeling.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • attending one of nine secondary schools involved in the HealthWise South Africa research trial

排除标准

  • 未提供

结局指标

主要结局

incidence of ATOD use

时间窗: 2 years

incidence of lifetime sexual intercourse

时间窗: 2 years

rates of condom use

时间窗: 2 years

number of sexual partners

时间窗: 2 years

次要结局

  • knowledge and attitudes about substances and sex(2 years)
  • healthy leisure attitudes/behaviors(2 years)
  • levels of inter- and intrapersonal skills(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Edward A. Smith

Interim Director

Penn State University

研究点 (2)

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