Adolescent Drug and HIV Prevention in South Africa
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| First Received Date ICMJE | June 9, 2006 | ||||||||
| Last Updated Date | March 19, 2013 | ||||||||
| Start Date ICMJE | September 2003 | ||||||||
| Primary Completion Date | April 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00336180 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: HealthWise South Africa curriculum
18 classroom lessons |
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| Study Arm (s) | 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.
Intervention: Behavioral: HealthWise South Africa curriculum |
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| Publications * | Caldwell L, Smith E, Wegner L, Vergnani T, Mpofu E, Flisher AJ, Mathews, C. HealthWise South Africa: Development of a life skills curriculum for young adults. World Leisure 3: 4-17, 2004. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 7695 | ||||||||
| Completion Date | April 2008 | ||||||||
| Primary Completion Date | April 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | Not Provided | ||||||||
| 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 Number ICMJE | NCT00336180 | ||||||||
| Other Study ID Numbers ICMJE | R01-DA017491, R01DA017491 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Edward A. Smith, Penn State University | ||||||||
| Study Sponsor ICMJE | Penn State University | ||||||||
| Collaborators ICMJE | National Institute on Drug Abuse (NIDA) | ||||||||
| Investigators ICMJE |
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| Information Provided By | Penn State University | ||||||||
| Verification Date | March 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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