Clinical trial NCT00336180: Adolescent Drug and HIV Prevention in South Africa
Official title: Adolescent Drug and HIV Prevention in South Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Substance-Related Disorders
Sexually Transmitted Diseases
Keywords: Adolescent
Adolescent behavior
Adolescent development
Drinking behavior
Health behavior
Reproductive Behavior
Sexual Behavior
South Africa
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2006-06-13
Enrollment: 7695
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.

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 criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: incidence of ATOD use
timeFrame: 2 years
measure: incidence of lifetime sexual intercourse
timeFrame: 2 years
measure: rates of condom use
timeFrame: 2 years
measure: number of sexual partners
timeFrame: 2 years
Secondary outcomes:
measure: knowledge and attitudes about substances and sex
timeFrame: 2 years
measure: healthy leisure attitudes/behaviors
timeFrame: 2 years
measure: levels of inter- and intrapersonal skills
timeFrame: 2 years
Other outcomes:
Locations:
city: Bellville
country: South Africa
facility: University of the Western Cape
Study officials:
affiliation: The Pennsylvania State University
name: Edward A Smith, DrPH
role: PRINCIPAL_INVESTIGATOR
affiliation: The Pennsylvania State University
name: Linda L Caldwell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.