Adolescent Drug and HIV Prevention in South Africa
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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 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | Adolescent Drug and HIV Prevention in South Africa |
- 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 ]
- 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 ]
| Enrollment: | 7695 |
| Study Start Date: | September 2003 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- attending one of nine secondary schools involved in the HealthWise South Africa research trial
Exclusion Criteria:
- None
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00336180
| 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
Additional Information:
Publications:
| Responsible Party: | Edward A. Smith, Interim Director, Penn State University |
| ClinicalTrials.gov Identifier: | NCT00336180 History of Changes |
| Other Study ID Numbers: | R01-DA017491, R01DA017491 |
| Study First Received: | June 9, 2006 |
| Last Updated: | March 19, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by Penn State University:
|
Adolescent Adolescent behavior Adolescent development Drinking behavior |
Health behavior Reproductive Behavior Sexual Behavior South Africa |
Additional relevant MeSH terms:
|
Sexually Transmitted Diseases Substance-Related Disorders Chemically-Induced Disorders Genital Diseases, Female |
Genital Diseases, Male Infection Mental Disorders Virus Diseases |
ClinicalTrials.gov processed this record on March 03, 2015