Suspended

ReACH3Using Telehealth to Address Alcohol Misuse in HIV Care

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What is being tested

Brief Intervention

+ Telehealth Counseling

+ Text messaging

Behavioral
Who is being recruted

Alcohol Drinking

+ Behavior

+ Drinking Behavior

Over 18 Years
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: June 2021
See protocol details

Summary

Principal SponsorBrown University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 22, 2021

Actual date on which the first participant was enrolled.

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.

Official TitleUsing Telehealth to Address Alcohol Misuse in HIV Care
Principal SponsorBrown University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

600 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Alcohol DrinkingBehaviorDrinking Behavior

Criteria

1 inclusion criteria required to participate
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

1 exclusion criteria prevent from participating
need for supervised alcohol detoxification, as indicated by having a history of severe withdrawal symptoms such as seizures and delirium tremens.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Group II

Active Comparator
A brief alcohol intervention lasting about 10 minutes, delivered after the baseline assessments.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Brown University

Providence, United StatesOpen Brown University in Google Maps
SuspendedOne Study Center