This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Adolescent Drug and HIV Prevention in South Africa

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Edward A. Smith, Penn State University
ClinicalTrials.gov Identifier:
NCT00336180
First received: June 9, 2006
Last updated: March 19, 2013
Last verified: March 2013
  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
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Adolescent Drug and HIV Prevention in South Africa

Resource links provided by NLM:


Further study details as provided by Edward A. Smith, Penn State University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00336180

Locations
South Africa
University of the Western Cape
Bellville, South Africa, 7535
Sponsors and Collaborators
Penn State University
National Institute on Drug Abuse (NIDA)
Investigators
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:
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.

Responsible Party: Edward A. Smith, Interim Director, Penn State University
ClinicalTrials.gov Identifier: NCT00336180     History of Changes
Other Study ID Numbers: R01DA017491 ( US NIH Grant/Contract Award Number )
Study First Received: June 9, 2006
Last Updated: March 19, 2013

Keywords provided by Edward A. Smith, Penn State University:
Adolescent
Adolescent behavior
Adolescent development
Drinking behavior
Health behavior
Reproductive Behavior
Sexual Behavior
South Africa

Additional relevant MeSH terms:
Substance-Related Disorders
Sexually Transmitted Diseases
Chemically-Induced Disorders
Mental Disorders
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on June 28, 2017