CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,057 enrolled
Drug / intervention
HIV/STD Risk-Reduction +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00559403
NCT00559403Phase 3Completed

South African Adolescent Health Promotion Project

University of Pennsylvania·interventional·Posted Nov 16, 2007·Updated Sep 25, 2015

In Brief

A Phase 3 clinical trial evaluating HIV/STD Risk-Reduction and Health Promotion for HIV Infections and Sexually Transmitted Disease. Completed, enrolled 1,057 participants.

Detailed Summary

This study will evaluate the effect of an HIV/STD risk-reduction program on the sexual behavior of South African adolescents.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 16, 2007
Enrollment StartOct 1, 2004
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 18.6 years ago

Interventions

HIV/STD Risk-Reductionbehavioral

Let Us Protect Our Future consists of twelve 1-hour sessions to increase knowledge, motivation, and skills in practicing abstinence and condom use. It is highly structured, and Xhosa-speaking male and female co-facilitators implement the program using standardized manuals. Treatment sessions include mixed-gender and single-gender activities, games, brainstorming, and role-playing. Comic workbooks are used to address abstinence, condom use, and how risky behavior affects goals and dreams. The Xhosa culture is taken into account, including cultural transformations in urban township settings. Take-home assignments enlist parents' help to empower their children to reduce their STD risk and ensure that parents are aware of the nature of the treatment program.

Health Promotionbehavioral

The health promotion treatment is structurally similar to the HIV/STD treatment: each has the same number of sessions and sessions led by Xhosa-speaking male and female co-facilitators. It focuses on behaviors linked with risk of heart disease, diabetes, high blood pressure, certain cancers, and alcohol and drug abuse, which are all leading causes of morbidity and mortality among South Africans. Participants are taught that healthful behaviors, including eating habits, physical activity, dental hygiene, and avoidance of cigarette smoking and substance use, can prevent these health problems. Comic workbook story lines are used to increase risk perception and awareness of health risks. Take-home assignments are used to foster communication with parents about healthful lifestyle.