Effect of HIV/STD Risk Reduction Program on South African Adolescents

Phase 2

Completed

• Conditions: HIV Infections; Sexually Transmitted Disease
• Interventions: Behavioral: HIV/STD Risk-Reduction; Behavioral: Health Promotion

• Registration Number: NCT00559403
• Lead Sponsor: University of Pennsylvania

Brief Summary

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

Detailed Description

HIV is a virus that can lead to acquired immunodeficiency syndrome (AIDS), a disease that breaks down the immune system and allows for entry of life-threatening secondary infections. HIV is transmitted through the exchange of bodily fluids, primarily through sexual intercourse. South Africa has been one of the countries in which the AIDS pandemic has had an especially devastating effect. New cases of HIV infection in South Africa have been occurring at a high rate in people 15 to 24 years of age. There is no vaccine or cure for HIV yet, making disease prevention methods imperative. An important part of the prevention process is early education on HIV to reduce sexual-risk behavior and to promote safe sexual practices. This study will evaluate the effect of an HIV/STD risk-reduction program on the sexual behavior of South African adolescents.

In this single-blind study, participants will include sixth grade students from 18 South African schools that meet study criteria. The participants will be randomly divided into 2 structurally similar treatment groups. One group will take part in HIV/STD risk-reduction sessions, while the other group will take part in health promotion sessions. There will be 12 total sessions, each lasting 1 hour. The participants in the HIV/STD risk-reduction group will be taught to practice abstinence and condom use through interactive activities, comic workbooks, and take-home assignments. Through similar methods, the participants in the health promotion group will be taught about general health problems, such as heart disease, diabetes, alcohol and drug abuse, and certain cancers. Participants will also be taught healthful behaviors to help prevent these health problems. All participants will provide self-reports of sexual behavior and precautionary methods used in sexual intercourse immediately before the first and after the last treatment sessions. Follow-up evaluations will occur at Months 3, 6, 12, 42, and 54 months post-treatment. STDs will be assessed 42 and 54 months post-treatment

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2007-11-14
• Study First Submitted QC: 2007-11-15
• Study First Posted: 2007-11-16
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-23
• Last Update Posted: 2015-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1057

Inclusion Criteria

• Schools, with Grade 6 learners, that served the general population of learners, not just those with learning disabilities
• Grade 6 learners at participating schools with signed parent/guardian consent forms

Exclusion Criteria

• Schools exclusively serving children with learning disabilities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIV/STD Sessions	HIV/STD Risk-Reduction	The HIV/STD Risk-Reduction Intervention arm focuses on reducing the risk of STDs, including HIV.
Health Promotion Control Sessions	Health Promotion	The Health Promotion Intervention arm focuses on physical activity, diet, and other behaviors linked to risk of heart disease, high blood pressure, stroke, diabetes, and certain cancers, which are all leading causes of morbidity and mortality among South Africans.

Primary Outcome Measures

Name	Time	Method
Protection use in sexual intercourse	Measured at Month 12

Secondary Outcome Measures

Name	Time	Method
Sexual intercourse considerations: number of sexual partners, sexual debut, anal intercourse, consistency of condom use	Measured at Month 12
Theoretical mediators of abstinence (e.g., self-efficacy to avoid having sexual intercourse)	Measured at Month 12
Theoretical mediators of condom use (e.g., self-efficacy to use condoms)	Measured at Month 12
HIV/STD risk-reduction knowledge	Measured at Month 12
Condom-use knowledge	Measured at Month 12
Biologically confirmed STDs	Measured at Month 42	Positive test for chlamydial infection, gonorrhea, and trichomoniasis