使用远程医疗解决 HIV 护理中的酒精滥用问题 (ReACH3)
This project will test the effects of a telehealth counseling program on reducing alcohol use and improving HIV viral control among people with HIV who drink heavily. In total, 600 heavy drinkers with HIV will be assigned to either (a) a single session of brief counseling on alcohol use or (b) brief counseling plus referral to a telehealth counseling program that includes multiple sessions of counseling by videoconferencing and text messaging support. To understand the effects of the program, participants' alcohol use, HIV outcomes, and health will be assessed over a 2-year period.
研究概览
详细说明
The purpose of the proposed study is to test the real-world effectiveness of the ReACH (Reducing Alcohol use and related Comorbidities in HIV care) telehealth counseling protocol in a pragmatic Hybrid Type 1 effectiveness-implementation randomized trial. The study will recruit 600 heavy-drinking PLWH from four federally-qualified health centers in geographically distinct regions across the U.S, which provide services to over 14,000 PLWH. Upon completing enrollment, participants will be randomized to receive either single-session brief intervention (BI) by phone with referral to local treatment when appropriate or BI plus referral to ReACH telehealth counseling (TC). Participants will complete follow-ups through 24 months after baseline to assess longer-term changes in drinking and health outcomes. The study will test the hypothesis that TC compared to BI will result in (a) reduced number of drinks consumed per week and frequency of heavy drinking and (b) increased odds of having an undetectable viral load at 12- and 24-month follow-ups. Secondary outcomes include self-reported ART adherence, engagement in condomless sex with non-exclusive partners, frequency of other substance use, phosphatidylethanol levels (a biomarker of recent alcohol use), and Veterans Aging Cohort Study index scores. The study also will examine potential moderators of TC effectiveness. As a secondary aim, implementation measures corresponding to aspects of the Dynamic Sustainability Framework will be assessed including implementation outcomes of acceptability, appropriateness, and feasibility guided by Proctor's Implementation Outcomes Framework. Thus, this pragmatic Hybrid Type 1 trial will help establish the real-world effectiveness of the ReACH TC intervention while also providing key implementation-related measures and outcomes that will inform future ReACH TC scale up and sustainability.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Rhode Island
-
Providence、Rhode Island、美国、02912
- Brown University
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- In care for HIV at one of 4 participating federally qualified health centers, report at least one heavy drinking day (4+ drinks) or average more than 7 drinks per week in the past 30 days
Exclusion Criteria:
- need for supervised alcohol detoxification, as indicated by having a history of severe withdrawal symptoms such as seizures and delirium tremens.
学习计划
研究是如何设计的？
设计细节
- 主要用途：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 |
|---|---|
|
有源比较器：Brief intervention
A brief alcohol intervention lasting about 10 minutes, delivered after the baseline assessments. |
Brief alcohol intervention delivered by telephone or videoconferencing focusing on advising participants to reduce drinking |
|
实验性的：Brief Intervention plus Telehealth Counseling
A brief alcohol intervention followed by referral to a telehealth counseling protocol including 5 sessions of counseling based on Motivational Interviewing and delivered by videoconferencing. Telehealth counseling extends for up to two years and also includes a text messaging intervention to encourage reductions in drinking. |
Brief alcohol intervention delivered by telephone or videoconferencing focusing on advising participants to reduce drinking 5 sessions of counseling on alcohol use based on Motivational Interviewing. A daily and then monthly text messaging program designed to help participants monitor drinking, set goals, and reinforce successful reduction or abstinence. |
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 |
|---|---|---|
|
Alcoholics drinks consumed per week
大体时间：12 months
|
Average number of alcoholic drinks consumed per week over the past 30 days |
12 months
|
|
Alcoholics drinks consumed per week
大体时间：24 months
|
Average number of alcoholic drinks consumed per week over the past 30 days |
24 months
|
|
Number of heavy drinking days
大体时间：12 months
|
Number of days consuming 4 or more drinks in a day over the past 30 days |
12 months
|
|
Number of heavy drinking days
大体时间：24 months
|
Number of days consuming 4 or more drinks in a day over the past 30 days |
24 months
|
|
Proportion of participants with a detectable HIV viral load
大体时间：12 months
|
Viral load test result that indicates HIV virus is detectable in the blood |
12 months
|
|
Proportion of participants with a detectable HIV viral load
大体时间：24 months
|
Viral load test result that indicates HIV virus is detectable in the blood |
24 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of the past 30 days adherent to antiretroviral therapy
大体时间：12 months
|
Antiretroviral therapy adherence as assessed by self-report |
12 months
|
|
Proportion of the past 30 days adherent to antiretroviral therapy
大体时间：24 months
|
Antiretroviral therapy adherence as assessed by self-report |
24 months
|
|
Condomless sex with non-steady partners
大体时间：12 months
|
Number of days in the past 30 having condomless sex with a non-steady partner |
12 months
|
|
Condomless sex with non-steady partners
大体时间：24 months
|
Number of days in the past 30 having condomless sex with a non-steady partner |
24 months
|
|
Veterans Aging Cohort Study (VACS) index total score
大体时间：12 months
|
Index of physiologic health calculated using HIV viral load, CD4 cell counts, liver function, creatinine, hemoglobin, platelets, white blood cell count, and height/weight (for body mass index). Higher scores indicate greater physiologic injury and risk for mortality. |
12 months
|
|
Veterans Aging Cohort Study (VACS) index total score
大体时间：24 months
|
Index of physiologic health calculated using HIV viral load, CD4 cell counts, liver function, creatinine, hemoglobin, platelets, white blood cell count, and height/weight (for body mass index). Higher scores indicate greater physiologic injury and risk for mortality. |
24 months
|
合作者和调查者
调查人员
- 首席研究员：Christopher Kahler, PhD、Brown University School of Public Health
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Data will be shared through the National Data Archive. We also will post de-identified data used in the primary analyses of trial outcomes after those have been published.
IPD 共享时间框架
Data in the NDA will be available 6 months after the first participants are recruited and will remain in there.
IPD 共享访问标准
Investigators can access date in the NDA using the available portal. We will allow access to the outcomes data to all through Brown's data archive once the outcome paper is published.
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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