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临床试验/NCT00947271
NCT00947271已完成3 期

HIV Prevention for STD Clinic Patients

The Miriam Hospital2 个研究点 分布在 1 个国家目标入组 1,010 人开始时间: 2009年10月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
1,010
试验地点
2
主要终点
Number of Sexual Partners, 6 Months Post Intervention

研究概览

简要总结

This study will determine whether showing an educational DVD to people at sexually transmitted infection clinics can reduce incidence of new infections and risky sexual behaviors and improve overall health.

详细描述

Sexually transmitted infections (STIs) can produce long-term health problems. They are often linked to HIV, which can also be sexually transmitted, because both occur in the same populations and because STIs and HIV interact biologically. Having an STI other than HIV can increase the risk of HIV acquisition and transmission as well as negatively impact HIV progression. The population of people who go to clinics specializing in STIs are particularly at risk of engaging in risky sexual behaviors and having poor health outcomes-like infection with an STI. This study will test the effectiveness of using an educational DVD to reduce incidence of risky sexual behaviors and STI acquisition, including risk of HIV, and to improve overall health.

Participation in this study will involve two phases. In Phase 1, participants will complete both computerized and paper surveys and watch an educational DVD. The educational DVD may include information on diet, physical activity, sleep, smoking, STIs, and stress. Participants will be recruited from among people who are already going to the clinic, and participation will add approximately 1.5 hours to their visits. In Phase 2, participants will be asked to complete four follow-up visits occurring 3, 6, 9, and 12 months after Phase 1. During these follow-up visits, participants will complete a 45-minute computerized survey similar to that in Phase 1 and provide urine and throat samples for STI testing. All surveys will assess health-related thoughts, feelings, and behaviors, including sexual behaviors. Participants will be compensated for completing Phase 1 and each visit in Phase 2.

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
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Evidence of sexual risk behavior, defined as either signs, symptoms, or diagnosis indicative of an STD during the past 3 months; or unprotected vaginal or anal intercourse with two or more sexual partners, a partner with two or more partners, an anonymous partner, an injection drug using partner, or a partner with an STD

排除标准

  • Impaired mental status that would prevent participant from providing informed consent or participating meaningfully
  • Inability to understand English

结局指标

主要结局

Number of Sexual Partners, 6 Months Post Intervention

时间窗: 6 months post intervention

number of sexual partners reported in the past 3 months, assessed 6 months post intervention.

Number of Sexual Partners, 12 Months Post Intervention

时间窗: 12 months post intervention

number of sexual partners in the past 3 months, assessed 12 months post intervention

Number of Sexual Partners, 3 Months Post Intervention

时间窗: Measured after 3 months

number of sexual partners in the past 3 months, assessed 3 months post intervention

Number of Sexual Partners, 9 Months Post Intervention

时间窗: 9 months post intervention

number of sexual partners in the past 3 months, assessed 9 months post intervention

次要结局

  • Sexually Transmitted Infection Incidence(Measured throughout the 12 months post intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael P. Carey

Director, Centers for Behavioral and Preventive Medicine

The Miriam Hospital

研究点 (2)

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