Adolescent Drug and HIV Prevention in South Africa - Tabular View

Tracking Information

First Received Date ^ICMJE

June 9, 2006

Last Updated Date

December 8, 2008

Start Date ^ICMJE

September 2003

Estimated Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

incidence of ATOD use [ Time Frame: 2 years ] [ Designated as safety issue: No ]
incidence of lifetime sexual intercourse [ Time Frame: 2 years ] [ Designated as safety issue: No ]
rates of condom use [ Time Frame: 2 years ] [ Designated as safety issue: No ]
number of sexual partners [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

incidence of ATOD use at 6, 12 & 18 months
incidence of lifetime sexual intercourse at 6, 12 & 18 months
rates of condom use at 6, 12 & 18 months
number of sexual partners at 6, 12 & 18 months

Change History

Complete list of historical versions of study NCT00336180 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

knowledge and attitudes about substances and sex [ Time Frame: 2 years ] [ Designated as safety issue: No ]
healthy leisure attitudes/behaviors [ Time Frame: 2 years ] [ Designated as safety issue: No ]
levels of inter- and intrapersonal skills [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

knowledge and attitudes about substances and sex at 6, 12 & 18 months
healthy leisure attitudes/behaviors at 6, 12 & 18 months
levels of inter- and intrapersonal skills at 6, 12 & 18 months

Descriptive Information

Brief Title ^ICMJE

Adolescent Drug and HIV Prevention in South Africa

Official Title ^ICMJE

Adolescent Drug and HIV Prevention in South Africa

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 Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Substance-Related Disorders
Sexually Transmitted Diseases

Intervention ^ICMJE

Behavioral: HealthWise South Africa curriculum

Study Arms / Comparison Groups

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

7695

Estimated Completion Date

April 2008

Estimated Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

None

Gender

Both

Ages

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

South Africa

Administrative Information

NCT ID ^ICMJE

NCT00336180

Responsible Party

Edward Smith, Penn State University

Study ID Numbers ^ICMJE

R01-DA017491

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

February 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP