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临床试验/NCT00332878
NCT00332878已完成3 期

RCT of Stepping Stones Behavioural Intervention for HIV

Medical Research Council, South Africa1 个研究点 分布在 1 个国家目标入组 2,801 人开始时间: 2003年3月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
2,801
试验地点
1
主要终点
HIV sero-incidence

研究概览

简要总结

This study will evaluate the effectiveness of Stepping Stones, an HIV-prevention education program, versus a brief HIV-focused intervention, in improving sexual health and preventing HIV infection in young residents of rural South African communities.

详细描述

HIV is arguably the most important problem currently facing the South African population. It is possible that biotechnology will eventually be able to lessen the disease's threat by introducing a vaccine or vaginal microbicide, but these are not expected to be available within the next 5 to 10 years. It is therefore extremely important to prevent HIV infection by modifying sexual behaviors. Voluntary counseling and testing have been shown to have an important impact on sexual behavior, but it is essential that other approaches to HIV prevention are developed and evaluated. Little research, however, has been done on behavioral interventions, relative to the amount of research that has been devoted to biotechnology development. Stepping Stones is an approach to HIV prevention that aims to improve sexual health through building stronger, more gender-equitable relationships with better communication between partners. This study will evaluate the effectiveness of the Stepping Stones program versus a brief HIV-focused intervention in improving sexual health and preventing HIV infection in young residents of rural South African communities.

Participants in this open-label study will be randomly assigned to take part in either the Stepping Stones program or the brief HIV-focused intervention (control). All participants will first attend a baseline study visit, which will include an interview and HIV testing. The control intervention will entail a single 2- to 3-hour meeting among same-sex peer groups, and will include exercises about HIV and safer sex practices that will be drawn from the Stepping Stones program. Stepping Stones will entail 17 sessions with same-sex peer groups, and will be implemented over a period of 3 to 12 weeks. Sessions will involve discussions on a variety of sexual health issues, including the following topics: reflections on love; sexual health joys and problems; body mapping; menstruation; contraception and conception, including infertility; sexual problems; unwanted pregnancy; HIV; STDs; safer sex; gender-based violence; motivations for sexual behavior; and dealing with grief and loss. Peer groups will come together for 3 of the 17 meetings to build assertive communication skills by leading presentations on exercises from the Stepping Stones program. HIV testing will be performed again after 12 and 24 months to assess program effectiveness. Face-to-face interviews will be held at Months 6, 12, and 24 to assess the impact of the intervention on behavior, attitude, and beliefs.

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
None

入排标准

年龄范围
16 Years 至 23 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Resident of the village in which individual is studying (i.e., not a migrant scholar)
  • Mature enough to understand the study and the consent process

排除标准

  • 未提供

结局指标

主要结局

HIV sero-incidence

时间窗: 24 months post-baseline

次要结局

  • HSV-2 sero-incidence(24 months post-baseline)
  • correct condom use at last sex, number of partners, transactional sex, intimate partner violence, any casual partner,(12 months and 24 months post-baseline)

研究者

发起方
Medical Research Council, South Africa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tasnim Mohsam

Administrator

Medical Research Council, South Africa

研究点 (1)

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