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临床试验/NCT04546971
NCT04546971进行中(未招募)不适用

Using Telehealth to Address Alcohol Misuse in HIV Care

Brown University2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2021年6月22日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
600
试验地点
2
主要终点
Proportion of participants with a detectable HIV viral load

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (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

  • 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

排除标准

  • need for supervised alcohol detoxification, as indicated by having a history of severe withdrawal symptoms such as seizures and delirium tremens.

结局指标

主要结局

Proportion of participants with a detectable HIV viral load

时间窗: 24 months

Viral load test result that indicates HIV virus is detectable in the blood

Alcoholics drinks consumed per week

时间窗: 24 months

Average number of alcoholic drinks consumed per week over the past 30 days

Number of heavy drinking days

时间窗: 24 months

Number of days consuming 4 or more drinks in a day over the past 30 days

次要结局

  • Condomless sex with non-steady partners(24 months)
  • Proportion of the past 30 days adherent to antiretroviral therapy(24 months)
  • Veterans Aging Cohort Study (VACS) index total score(24 months)

研究者

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

Christopher W. Kahler

Professor

Brown University

研究点 (2)

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