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| Sponsored by: |
National Institute on Drug Abuse (NIDA) |
|---|---|
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00336180 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Substance-Related Disorders Sexually Transmitted Diseases |
Behavioral: HealthWise South Africa curriculum |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Adolescent Drug and HIV Prevention in South Africa |
| Estimated Enrollment: | 7695 |
| Study Start Date: | September 2003 |
| Estimated Study Completion Date: | April 2008 |
| Estimated Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
HW: Experimental
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
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| South Africa | |
| University of the Western Cape | |
| Bellville, South Africa, 7535 | |
| Principal Investigator: | Edward A Smith, DrPH | The Pennsylvania State University |
| Principal Investigator: | Linda L Caldwell, PhD | The Pennsylvania State University |
More Information
| Responsible Party: | Penn State University ( Edward Smith ) |
| Study ID Numbers: | R01-DA017491 |
| Study First Received: | June 9, 2006 |
| Last Updated: | December 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00336180 History of Changes |
| Health Authority: | United States: Institutional Review Board; United States: Federal Government |
|
Adolescent Adolescent behavior Adolescent development Drinking behavior |
Health behavior Reproductive Behavior Sexual Behavior South Africa |
|
Genital Diseases, Female Virus Diseases Mental Disorders HIV Infections Acquired Immunodeficiency Syndrome |
Sexually Transmitted Diseases Drinking Behavior Substance-Related Disorders Disorders of Environmental Origin Genital Diseases, Male |
|
Genital Diseases, Female Virus Diseases Mental Disorders Sexually Transmitted Diseases |
Substance-Related Disorders Disorders of Environmental Origin Genital Diseases, Male Infection |