South African Adolescent Health Promotion Project
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,057
- 主要终点
- Protection use in sexual intercourse
研究概览
简要总结
This study will evaluate the effect of an HIV/STD risk-reduction program on the sexual behavior of South African adolescents.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Schools exclusively serving children with learning disabilities
结局指标
主要结局
Protection use in sexual intercourse
时间窗: Measured at Month 12
次要结局
- 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)
研究者
John Jemmott
Kenneth B. Clark Professor of Communication and Psychiatry
University of Pennsylvania