NCT00336180

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,695

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2003

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 13, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

March 21, 2013

Status Verified

March 1, 2013

Enrollment Period

4.6 years

First QC Date

June 9, 2006

Last Update Submit

March 19, 2013

Conditions

Substance-Related DisordersSexually Transmitted Diseases

Keywords

AdolescentAdolescent behaviorAdolescent developmentDrinking behaviorHealth behaviorReproductive BehaviorSexual BehaviorSouth Africa

Outcome Measures

Primary Outcomes (4)

  • incidence of ATOD use

    2 years

  • incidence of lifetime sexual intercourse

    2 years

  • rates of condom use

    2 years

  • number of sexual partners

    2 years

Secondary Outcomes (3)

  • knowledge and attitudes about substances and sex

    2 years

  • healthy leisure attitudes/behaviors

    2 years

  • levels of inter- and intrapersonal skills

    2 years

Study Arms (1)

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

Interventions

HealthWise South Africa curriculumBEHAVIORAL

18 classroom lessons

HW

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of the Western Cape

Bellville, 7535, South Africa

Location

Related 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.

    BACKGROUND

MeSH Terms

Conditions

Substance-Related DisordersSexually Transmitted DiseasesAdolescent BehaviorDrinking BehaviorHealth BehaviorReproductive BehaviorSexual Behavior

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersCommunicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Edward A Smith, DrPH

    The Pennsylvania State University

    PRINCIPAL INVESTIGATOR

  • Linda L Caldwell, PhD

    The Pennsylvania State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Interim Director

Study Record Dates

First Submitted

June 9, 2006

First Posted

June 13, 2006

Study Start

September 1, 2003

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

March 21, 2013

Record last verified: 2013-03

Locations

ZA(1)