Adolescent Drug and HIV Prevention in South Africa

NCT ID: NCT00336180

Last Updated: 2013-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 7695 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2008-04-30

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.

Conditions

Substance-Related Disorders; Sexually Transmitted Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

HW

The experimental group (HW) receives 18 classroom-based lessons on leisure motivation, life skills, and skills to avoid substance use and sexual risk.

Group Type: EXPERIMENTAL

HealthWise South Africa curriculum

Intervention Type: BEHAVIORAL

18 classroom lessons

Interventions

HealthWise South Africa curriculum

18 classroom lessons

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Penn State University

OTHER

Sponsor Role: lead

Responsible Party

Edward A. Smith

Interim Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edward A Smith, DrPH

Role: PRINCIPAL_INVESTIGATOR

The Pennsylvania State University

Linda L Caldwell, PhD

Role: PRINCIPAL_INVESTIGATOR

The Pennsylvania State University

Locations

University of the Western Cape

Bellville, , South Africa

Countries

South Africa

References

Caldwell L, Smith E, Wegner L, Vergnani T, Mpofu E, Flisher AJ, Mathews, C. HealthWise South Africa: Development of a life skills curriculum for young adults. World Leisure 3: 4-17, 2004.

Reference Type: BACKGROUND

Other Identifiers

R01DA017491

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01DA017491

Identifier Type: NIH

Identifier Source: org_study_id

View Link