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Active, Not Recruiting

NCT Number: NCT04546971

Using Telehealth to Address Alcohol Misuse in HIV Care

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Alcohol Drinking Behavior Drinking Behavior HIV Viremia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brown University

Providence, Rhode Island, 02912, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brief intervention

Behavioral

Brief alcohol intervention delivered by telephone or videoconferencing focusing on advising participants to reduce drinking

Telehealth Counseling

Behavioral

5 sessions of counseling on alcohol use based on Motivational Interviewing.

Text messaging

Behavioral

A daily and then monthly text messaging program designed to help participants monitor drinking, set goals, and reinforce successful reduction or abstinence.

Primary outcomes

  1. Alcoholics drinks consumed per week

    Time frame: 12 months

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

  2. Alcoholics drinks consumed per week

    Time frame: 24 months

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

  3. Number of heavy drinking days

    Time frame: 12 months

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

  4. Number of heavy drinking days

    Time frame: 24 months

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

  5. Proportion of participants with a detectable HIV viral load

    Time frame: 12 months

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

  6. Proportion of participants with a detectable HIV viral load

    Time frame: 24 months

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

Secondary outcomes

  1. Proportion of the past 30 days adherent to antiretroviral therapy

    Time frame: 12 months

    Antiretroviral therapy adherence as assessed by self-report

  2. Proportion of the past 30 days adherent to antiretroviral therapy

    Time frame: 24 months

    Antiretroviral therapy adherence as assessed by self-report

  3. Condomless sex with non-steady partners

    Time frame: 12 months

    Number of days in the past 30 having condomless sex with a non-steady partner

  4. Condomless sex with non-steady partners

    Time frame: 24 months

    Number of days in the past 30 having condomless sex with a non-steady partner

  5. Veterans Aging Cohort Study (VACS) index total score

    Time frame: 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.

  6. Veterans Aging Cohort Study (VACS) index total score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Brown University

Other

Registry information

Acronym: ReACH3

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Sep 14, 2020
Registry last updated
Aug 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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