Adolescent Drug and HIV Prevention in South Africa

This study has been completed.
Sponsor:
Collaborator:
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

June 9, 2006
March 19, 2013
September 2003
April 2008   (final data collection date for primary outcome measure)
  • 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 ]
  • incidence of ATOD use at 6, 12 & 18 months
  • incidence of lifetime sexual intercourse at 6, 12 & 18 months
  • rates of condom use at 6, 12 & 18 months
  • number of sexual partners at 6, 12 & 18 months
Complete list of historical versions of study NCT00336180 on ClinicalTrials.gov Archive Site
  • 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 ]
  • knowledge and attitudes about substances and sex at 6, 12 & 18 months
  • healthy leisure attitudes/behaviors at 6, 12 & 18 months
  • levels of inter- and intrapersonal skills at 6, 12 & 18 months
Not Provided
Not Provided
 
Adolescent Drug and HIV Prevention in South Africa
Adolescent Drug and HIV Prevention in South Africa

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • Substance-Related Disorders
  • Sexually Transmitted Diseases
Behavioral: HealthWise South Africa curriculum
18 classroom lessons
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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7695
April 2008
April 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT00336180
R01-DA017491, R01DA017491
Yes
Edward A. Smith, Penn State University
Penn State University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Edward A Smith, DrPH The Pennsylvania State University
Principal Investigator: Linda L Caldwell, PhD The Pennsylvania State University
Penn State University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP