Adolescent Drug and HIV Prevention in South Africa - Full Text View

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 II Phase III

MedlinePlus related topics:

AIDS Sexually Transmitted Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Other, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title:	Adolescent Drug and HIV Prevention in South Africa

Further study details as provided by National Institute on Drug Abuse (NIDA):

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 ]

Estimated Enrollment:	7695
Study Start Date:	September 2003
Estimated Study Completion Date:	April 2008
Estimated Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
HW: Experimental 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

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:

None

Contacts and Locations

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

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

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:	Penn State University ( Edward Smith )
Study ID Numbers:	R01-DA017491
First Received:	June 9, 2006
Last Updated:	February 14, 2008
ClinicalTrials.gov Identifier:	NCT00336180
Health Authority:	United States: Institutional Review Board; United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):

Adolescent

Adolescent behavior

Adolescent development

Drinking behavior

Health behavior

Reproductive Behavior

Sexual Behavior

South Africa

Study placed in the following topic categories:

Genital Diseases, Female

Virus Diseases

Mental Disorders

HIV Infections

Acquired Immunodeficiency Syndrome

Sexually Transmitted Diseases

Drinking Behavior

Substance-Related Disorders

Disorders of Environmental Origin

Genital Diseases, Male

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00336180