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临床试验/NCT00447798
NCT00447798已完成不适用

Project Hope: Hospital Visit is an Opportunity for Prevention and Engagement With HIV-positive Crack Users

Columbia University4 个研究点 分布在 1 个国家目标入组 413 人开始时间: 2005年6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
413
试验地点
4
主要终点
To evaluate the efficacy of a brief, theoretically-based intervention in reducing unprotected sexual intercourse by HIV-positive crack users recruited from the inpatient/hospital setting.

研究概览

简要总结

The proposed study uses a two-arm randomized experimental design to evaluate the efficacy of a brief, theoretically-guided, "Prevention Care Advocate" intervention with HIV-positive crack users. Study participants will be recruited from the HIV inpatient hospital wards of two inner-city hospitals that serve a similar population of HIV-positive patients: Jackson Memorial Hospital (JMH) in Miami, Florida and Grady Memorial Hospital (GMH) in Atlanta, Georgia.

详细描述

The proposed study uses a two-arm randomized experimental design to evaluate the efficacy of a brief, theoretically-guided, "Prevention Care Advocate" intervention with HIV-positive crack users. Study participants will be recruited from the HIV inpatient hospital wards of two inner-city hospitals that serve a similar population of HIV-positive patients: Jackson Memorial Hospital (JMH) in Miami, Florida and Grady Memorial Hospital (GMH) in Atlanta, Georgia.

This 8-session, multi-component, skills-building intervention adapted from strategies used in prior studies encourages participants to advocate prevention and receipt of primary care services for themselves and their peers. We will employ a randomized experimental design to compare the intervention's efficacy with an attention-control group.

SPECIFIC AIMS Aim 1: To evaluate the efficacy of a brief, theoretically-based intervention in reducing unprotected sexual intercourse by HIV-positive crack users recruited from the inpatient/hospital setting. The impact of the intervention on secondary outcomes including the increased use of HIV primary outpatient care and readiness for and entry to drug treatment, will also be evaluated.

Aim 2: To examine whether knowledge, motivation and perceived self-efficacy are impacted by the intervention, and if changes in these variables explain change in the behavioral outcomes of interest.

Aim 3: To determine the extent to which behavioral outcomes are maintained over time.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
盲法
Double (Participant, Outcomes Assessor)

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

  • HIV positive
  • Sexually active
  • Recruited from inpatient/hospital setting
  • Crack user

排除标准

  • HIV negative
  • Not sexually active
  • Not recruited from inpatient/hospital setting
  • Non crack user

结局指标

主要结局

To evaluate the efficacy of a brief, theoretically-based intervention in reducing unprotected sexual intercourse by HIV-positive crack users recruited from the inpatient/hospital setting.

时间窗: 1 year

次要结局

  • The impact of the intervention on secondary outcomes including the increased use of HIV primary outpatient care and readiness for and entry to drug treatment, will also be evaluated.(1 year)

研究者

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

Lisa Metsch

Stephen Smith Professor of Sociomedical Sciences and Chair, Department of Sociomedical Sciences

Columbia University

研究点 (4)

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