Adolescent Drug and HIV Prevention in South Africa

March 19, 2013 updated by: Edward A. Smith, Penn State University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

7695

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
      • Bellville, South Africa, 7535
        • University of the Western Cape

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence of ATOD use
Time Frame: 2 years
2 years
incidence of lifetime sexual intercourse
Time Frame: 2 years
2 years
rates of condom use
Time Frame: 2 years
2 years
number of sexual partners
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
knowledge and attitudes about substances and sex
Time Frame: 2 years
2 years
healthy leisure attitudes/behaviors
Time Frame: 2 years
2 years
levels of inter- and intrapersonal skills
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Penn State University

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Edward A Smith, DrPH, The Pennsylvania State University
  • Principal Investigator: Linda L Caldwell, PhD, The Pennsylvania State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

June 9, 2006

First Submitted That Met QC Criteria

June 9, 2006

First Posted (Estimate)

June 13, 2006

Study Record Updates

Last Update Posted (Estimate)

March 21, 2013

Last Update Submitted That Met QC Criteria

March 19, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01DA017491 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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