Adolescent Drug and HIV Prevention in South Africa

Substance-Related Disorders Clinical Trial

Official title:

Adolescent Drug and HIV Prevention in South Africa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00336180
• Other study ID #: R01DA017491
• Secondary ID: R01DA017491
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 9, 2006
• Last updated: March 19, 2013
• Start date: September 2003
• Est. completion date: April 2008

Study information

• Verified date: March 2013
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7695
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Sexually Transmitted Diseases
• Substance-Related Disorders

Intervention

Behavioral:
• HealthWise South Africa curriculum
18 classroom lessons

Locations

Country	Name	City	State
South Africa	University of the Western Cape	Bellville

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

South Africa, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of ATOD use		2 years	No
Primary	incidence of lifetime sexual intercourse		2 years	No
Primary	rates of condom use		2 years	No
Primary	number of sexual partners		2 years	No
Secondary	knowledge and attitudes about substances and sex		2 years	No
Secondary	healthy leisure attitudes/behaviors		2 years	No
Secondary	levels of inter- and intrapersonal skills		2 years	No

External Links

•   Link