Adolescent Drug and HIV Prevention in South Africa
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|ClinicalTrials.gov Identifier: NCT00336180|
Recruitment Status : Completed
First Posted : June 13, 2006
Last Update Posted : March 21, 2013
|Condition or disease||Intervention/treatment||Phase|
|Substance-Related Disorders Sexually Transmitted Diseases||Behavioral: HealthWise South Africa curriculum||Phase 2 Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7695 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adolescent Drug and HIV Prevention in South Africa|
|Study Start Date :||September 2003|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||April 2008|
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
- 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 ]
- knowledge and attitudes about substances and sex [ Time Frame: 2 years ]
- healthy leisure attitudes/behaviors [ Time Frame: 2 years ]
- levels of inter- and intrapersonal skills [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00336180
|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|