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South African Adolescent Health Promotion Project


Phase 2/Phase 3
N/A
N/A
Not Enrolling
Both
HIV Infections, Sexually Transmitted Disease

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Trial Information

South African Adolescent Health Promotion Project


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, and 12 post-treatment.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Protection use in sexual intercourse

Outcome Time Frame:

Measured at Month 12

Safety Issue:

No

Principal Investigator

John B. Jemmott III, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pennsylvania

Authority:

United States: Federal Government

Study ID:

R01 MH065867

NCT ID:

NCT00559403

Start Date:

October 2004

Completion Date:

December 2006

Related Keywords:

  • HIV Infections
  • Sexually Transmitted Disease
  • Human immunodeficiency virus
  • South Africa
  • Intervention Studies
  • Sexual Behavior
  • Adolescents
  • STD
  • HIV Seronegativity
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Sexually Transmitted Diseases

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