Adolescent Drug and HIV Prevention in South Africa

Phase 2

Completed

• Conditions: Substance-Related Disorders; Sexually Transmitted Diseases
• Interventions: Behavioral: HealthWise South Africa curriculum

• Registration Number: NCT00336180
• Lead Sponsor: Penn State University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2006-06-09
• Study First Submitted QC: 2006-06-09
• Study First Posted: 2006-06-13
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-19
• Last Update Posted: 2013-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7695

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HW	HealthWise South Africa curriculum	The experimental group (HW) receives 18 classroom-based lessons on leisure motivation, life skills, and skills to avoid substance use and sexual risk.

Primary Outcome Measures

Name	Time	Method
incidence of ATOD use	2 years
incidence of lifetime sexual intercourse	2 years
rates of condom use	2 years
number of sexual partners	2 years

Secondary Outcome Measures

Name	Time	Method
healthy leisure attitudes/behaviors	2 years
levels of inter- and intrapersonal skills	2 years
knowledge and attitudes about substances and sex	2 years

Trial Locations

Locations (1)

University of the Western Cape; 🇿🇦 Bellville, South Africa