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临床试验/NCT00836290
NCT00836290已完成不适用

Positive Lifestyles Using Safety

Yale University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2008年1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
90
试验地点
2
主要终点
Changes in reported drug use episodes across different partners categorized by perceived HIV-status of each partner

研究概览

简要总结

Project PLUS tests an HIV risk reduction/adherence behavioral intervention with HIV-infected individuals in Connecticut prisons. Participants are randomly assigned to one of three groups: prior to release from incarceration (Group 1), after release from incarceration (Group 2), and treatment-as-usual (Group 3). We hypothesize that the intervention groups (Groups 1 & 2) will demonstrate significantly greater knowledge regarding drug- and sex- related HIV risk behavior and HIV medication adherence, greater motivation to reduce HIV risk behavior and improve HIV medication adherence, and enhanced skills for engaging in HIV risk reduction behavior and HIV medication adherence vs. the treatment-as-usual group. We will also compare these outcomes between Groups 1 and 2.

详细描述

Project PLUS is an HIV risk reduction/Highly Active Antiretroviral Therapy (HAART) adherence behavioral intervention for persons being released from prisons in Connecticut. The intervention is delivered one-on-one to HIV-infected individuals prior to release from incarceration (Group 1) vs. after release from incarceration (Group 2) vs. treatment as usual (Group 3). The primary hypothesis is that the intervention groups (Groups 1 & 2) will demonstrate significantly greater reduction in rates of HIV sexual and drug risk behaviors and a significantly greater increase in HAART adherence compared to Group 3 participants at 4 months following release from prison. (However, those in Group 3 may come back to participate in the educational sessions, as non-study participants, after their participation has been completed). Based on the IMB model of health behavior change, the primary outcomes of interest are HIV risk reduction knowledge, motivation, behavioral skills (Fisher & Fisher, 1992) and specific event-level partner-by-partner drug and sex risk outcomes including the frequency of unprotected sex episodes across different partners categorized by perceived HIV-status of each partner, numbers of different sexual partners, changes in the frequency of condom use, changes in reported adherence to HIV medication, and changes in reported drug use episodes across different partners categorized by perceived HIV-status of each partner. Additional outcomes of interest include greater knowledge regarding drug- and sex- related HIV risk behaviors and HAART adherence, greater motivation to reduce HIV risk behaviors and improve HAART adherence, enhanced skills for engaging in HIV risk reduction behaviors and HAART adherence. A comparison between Groups 1 & 2 has never been examined, so an important part of this study is to explore this comparison.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
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

  • Are 18 years of age or older
  • Meet DSM-IV criteria for opioid-dependence
  • Are scheduled to be released from prison within the next 30 days
  • Are confirmed to be HIV-infected
  • Report drug- or sex-related HIV risk behavior prior to incarceration
  • Are willing to provide locator information
  • Able to read and understand the questionnaires and consent form
  • No minimum duration of incarceration
  • Available for the full duration of the study with no anticipated circumstances impeding participation (e.g., pending court case or warrant).

排除标准

  • Have an untreated bipolar or psychotic disorder
  • Suicidal or homicidal ideation

结局指标

主要结局

Changes in reported drug use episodes across different partners categorized by perceived HIV-status of each partner

时间窗: Pre-release, Day of Release, 1-mo ff-up, 3-mo ff-up

Frequency of unprotected sex episodes across different partners categorized by perceived HIV-status of each partner

时间窗: Pre-release, Day of Release, 1-mo ff-up, 3-mo ff-up

Changes in reported HIV medication adherence

时间窗: Pre-release, Day of Release, 1-mo ff-up, 3-mo ff-up

Numbers of different sexual partners

时间窗: Pre-release, Day of Release, 1-mo ff-up, 3-mo ff-up

Changes in the frequency of condom use reported

时间窗: Pre-release, Day of Release, 1-mo ff-up, 3-mo ff-up

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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