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Clinical Trials/NCT00336180
NCT00336180CompletedPhase 2

Adolescent Drug and HIV Prevention in South Africa

Penn State University2 sites in 1 country7,695 target enrollmentStarted: September 2003Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
7,695
Locations
2
Primary Endpoint
incidence of ATOD use

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

incidence of ATOD use

Time Frame: 2 years

incidence of lifetime sexual intercourse

Time Frame: 2 years

rates of condom use

Time Frame: 2 years

number of sexual partners

Time Frame: 2 years

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Edward A. Smith

Interim Director

Penn State University

Study Sites (2)

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