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

History of Changes

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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label
Official Title:	Adolescent Drug and HIV Prevention in South Africa

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Penn State University:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]


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
Genders Eligible for Study:	Both
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:

Related Info This link exits the ClinicalTrials.gov site

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
Study First Received:	June 9, 2006
Last Updated:	March 19, 2013
Health Authority:	United States: Institutional Review Board United States: Federal Government

Keywords provided by Penn State University:


Adolescent Adolescent behavior Adolescent development Drinking behavior	Health behavior Reproductive Behavior Sexual Behavior South Africa

Additional relevant MeSH terms:


Sexually Transmitted Diseases Substance-Related Disorders Infection Virus Diseases	Genital Diseases, Male Genital Diseases, Female Chemically-Induced Disorders Mental Disorders

ClinicalTrials.gov processed this record on September 28, 2016

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