Contextualizing & Responding to HIV Risk Behaviors
2017年9月29日 更新者：Tawandra Rowell-Cunsolo、Columbia University
Contextualizing & Responding to HIV Risk Behaviors Among Black Drug Offenders
The purpose of this study was to pilot test the potential for improvement in antiretroviral medication adherence of a an adapted group-based, multi-session, community-based Antiretroviral Therapy (ART) adherence and risk reduction intervention, Project ADHerence Education and Risk Evaluation (ADHERE). Project ADHERE was compared to a single-session group-based medication adherence intervention, Medication Adherence and Care Engagement (MACE).
A secondary aim was to examine the impact of Project ADHERE on HIV risk behaviors (i.e., illicit drug use and unprotected sexual behavior).
This study was designed to inform, design, and pilot test the two antiretroviral medication adherence interventions for HIV-infected formerly incarcerated individuals.
研究概览
详细说明
Formerly incarcerated Black drug offenders are at an elevated risk for HIV infection.
Despite substantial research expressing the need for HIV prevention services for ex-offenders postrelease, this population has limited access to quality programming and services related to HIV risk reduction.
This K01 application seeks to inform and adapt an HIV risk reduction intervention to address the needs of formerly incarcerated Black drug offenders who are being released from prisons in the New York City metropolitan area.The study will utilize qualitative and quantitative methods to inform and adapt an HIV prevention intervention for this study population.
研究类型
介入性
注册 (实际的)
32
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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New York
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New York、New York、美国、10032
- Columbia University Medical Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- ≥18 years of age
- HIV seropositive with "detectable" viral load (VL)(defined as >50 copies/mL)
- history of drug use (used illicit drugs within the past year)
- experienced incarceration in prison or jail within the past five years
Exclusion Criteria:
- living in a healthcare or assisted living facility
- experienced incarceration longer than five years ago
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Project ADHERE
Participants will receive a 3-session antiretroviral medication adherence and risk reduction intervention called Project ADHERE.
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This is a 3-session ART medication adherence and risk reduction intervention.
Participants are educated about the importance of staying healthy and taking their medication as prescribed; to discuss importance of improved immune functioning and what their "viral load" means; reminded that they can still infect others with HIV, and that there currently is no cure for HIV; expected to generate strategies to overcome adherence barriers; educated about sexually transmitted infections (STI)/HIV transmission modes; assisted in devising an appropriate medication adherence and risk reduction plan.
Participants will report their progress and discuss challenges experienced when implementing their medication adherence and risk reduction plans while establishing short- and long-term goals.
其他名称：
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有源比较器：Control MACE
Participants will receive a one-session antiretroviral medication adherence intervention called MACE.
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This one-session medication adherence intervention covers the following content: 1) a discussion on what viral load represents and what HIV does to the body; 2) referral to a provider for participants without a provider; 3) the importance of maintaining regular contact with a health care provider; and 4) benefits of being retained in care.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of participants who reached at least 85% medication adherence rate.
大体时间：Over a 3-month period
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Self-report data and viral loads to test for medication adherence will be collected and analyzed to yield the rate (%).
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Over a 3-month period
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of participants with HIV risk behaviors
大体时间：Over a 3-month period
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Information on illicit drug use and unprotected sexual behavior wil be collected and analyzed.
We sought to reduce the frequency of illicit drug use, and instance of unprotected sexual behavior as calculated in the percentage of participants.
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Over a 3-month period
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Tawandra Rowell-Cunsolo, MD、Assistant Professor of Social Welfare Science (in Nursing), Nursing Scholarship & Research
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年7月5日
初级完成 (实际的)
2016年12月21日
研究完成 (实际的)
2016年12月21日
研究注册日期
首次提交
2017年9月29日
首先提交符合 QC 标准的
2017年9月29日
首次发布 (实际的)
2017年10月4日
研究记录更新
最后更新发布 (实际的)
2017年10月4日
上次提交的符合 QC 标准的更新
2017年9月29日
最后验证
2017年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Project ADHERE的临床试验
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London School of Hygiene and Tropical MedicineChildren's Investment Fund Foundation; Splash完全的
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University of North Carolina, Chapel HillCenters for Disease Control and Prevention完全的
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Johns Hopkins UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA)完全的