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OpenTrials
Completed

NCT Number: NCT00336180

Adolescent Drug and HIV Prevention in South Africa

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

HealthWise South Africa curriculum

Behavioral

18 classroom lessons

Primary outcomes

  1. incidence of ATOD use

    Time frame: 2 years

  2. incidence of lifetime sexual intercourse

    Time frame: 2 years

  3. rates of condom use

    Time frame: 2 years

  4. number of sexual partners

    Time frame: 2 years

Secondary outcomes

  1. knowledge and attitudes about substances and sex

    Time frame: 2 years

  2. healthy leisure attitudes/behaviors

    Time frame: 2 years

  3. levels of inter- and intrapersonal skills

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Jun 13, 2006
Registry last updated
Mar 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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