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临床试验/NCT00183573
NCT00183573已完成2 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 1,554 人开始时间: 2004年3月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
1,554
试验地点
2
主要终点
Sexual behavior

研究概览

简要总结

This study will determine the effectiveness of a two-step HIV prevention program in reducing risky sexual practices and decreasing the incidence of sexually transmitted diseases (STDs).

详细描述

Numerous factors influence one's sexual choices, including social support and pressure, internal feelings and beliefs, and knowledge about the subject. Data indicate that people who are well-informed about the risks associated with certain sexual behaviors are more likely to protect themselves than those who are less informed. This study will determine whether an intervention comprising information, motivation, and behavioral skills components is more effective than an information-only workshop in changing sexual behavior for HIV prevention.

At study entry, participants will undergo a physical exam, various STD tests, and a rapid HIV test, which can provide test results within several hours. While waiting for their test results at the study clinic, participants will complete a computerized questionnaire assessing their thoughts, feelings, and behaviors regarding sexual activities. Participants will also be exposed to one of two brief health promotion interventions: a motivational, one-on-one counseling session or a DVD on safer sex. After receiving their test results, participants will be asked to complete a brief postassessment questionnaire about their attitudes toward their test results and the intervention.

Two-thirds of the participants will then be invited to attend an intensive, 4-hour safer sex workshop. These participants will be randomly assigned to one of two workshops: an information-only workshop or a workshop that includes information, motivation, and behavioral skills components. Participants who choose not to participate in the workshop will complete the study after receiving their STD and HIV test results. Participants who participate in the workshop will return to the clinic at 3, 6, and 12 months after the workshop to complete another questionnaire about sexual behaviors and give a urine sample for STD testing.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis or symptoms of an STD within 3 months prior to study entry OR have had unprotected vaginal or anal intercourse with one or more of the following: 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
  • Able to understand English

排除标准

  • Psychosis or impaired mental status that would prevent participant from providing informed consent
  • Have been tested for HIV within 3 months prior to study entry
  • HIV infected

结局指标

主要结局

Sexual behavior

时间窗: 12 months

次要结局

  • STD incidence(12 months)

研究者

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

Michael P. Carey

Director, CBPM

The Miriam Hospital

研究点 (2)

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