跳至主要内容
临床试验/NCT02116049
NCT02116049已完成不适用

Intervention to Assist MSM Disclose HIV Status to Casual Sex Partners

University of South Florida2 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2009年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
340
试验地点
2
主要终点
Change from baseline to 52 Weeks in the number/proportion of sex partners disclosed to

研究概览

简要总结

Men who have sex with men (MSM) remain disproportionately represented in the national HIV/AIDS statistics. Little progress has been made in understanding the nuances of MSM sexual behavior or communication that may be perpetuating the spread of HIV. Non-disclosure of an HIV-positive status may be a key factor responsible for male-male HIV transmission. There are no known intervention programs whose primary focus is to help MSM develop requisite skills to disclose their status to casual sexual partners. The development of such interventions is essential because of the numerous repercussions for not disclosing when one is HIV-positive such as legal prosecution and the transmission of HIV. In a previous intervention development study (R21MH067494) the research team created and tested a 4 session intervention found to be promising for increasing disclosure to casual sexual partners. The purpose of the proposed research is to further refine and enhance our HIV disclosure intervention (DI) designed to increase disclosure to casual sexual partners and reduce sexual risk taking behaviors among HIV-positive MSM; assess the relative effectiveness of a disclosure intervention to an attention control case management group (ACCM) for HIV-positive MSM; examine the effects of the intervention over time; explore differential treatment responses to the disclosure intervention and ACCM on the basis of ethnicity, age, and education level as well as examine the mediating effect of baseline frequency of sexual activity, severity of substance abuse at baseline, and stigmatized fear on the relationship between intervention type and the outcome. Finally, the investigators will test how treatment engagement, retention and expectations predict subsequent disclosure and risky sexual outcomes.

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
Male
接受健康志愿者

入选标准

  • HIV-positive
  • Have sex with other men
  • Over the age of 18
  • Sexually active in the past 90 days
  • 2 or more partners in last 12 months
  • Indicate an interest in learning more about disclosing serostatus to casual sex partners
  • Speak and understand English
  • Plan on living in Tampa area for at least 1 year

排除标准

  • HIV-negative
  • Children under the age of 18
  • Men who exclusively have sex with women
  • Those who cannot speak and understand English
  • Those who have not been sexually active or are behaviorally monogamous

结局指标

主要结局

Change from baseline to 52 Weeks in the number/proportion of sex partners disclosed to

时间窗: Baseline, Week 7, Week 12, Week 24, Week 52

Disclosure to sexual partners is measured at the encounter level (last 5 sexual encounters during the prior 30 day period), and as an aggregate (number of partners disclosed to during the prior 30 day period.

次要结局

  • Change from baseline to 52 Weeks in HIV Transmission Risk(Baseline, Week 7, Week 12, Week 24, Week 52)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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