Using Telehealth to Address Alcohol Misuse in HIV Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-22

Study Completion Date

2026-05-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Reducing Unsafe Alcohol Use in HIV-Positive Individuals

NCT00371969

Alcohol Abuse

COMPLETED NA

Brief Therapy Intervention for Heavy/Hazardous Drinking in HIV-Positive Women

NCT00127231

HIV Infections Alcoholism

COMPLETED NA

Behavioral Interventions to Reduce Heavy Drinking Among MSM in HIV Primary Care

NCT02709759

Alcohol Drinking HIV

COMPLETED NA

Brief Electronic Intervention for Heavy Drinking and Sex Risk Among MSM Seeking HIV Testing

NCT03435783

HIV Infections Alcohol Abuse

COMPLETED NA

Reducing Alcohol Dependence Among HIV-Positive Individuals

NCT02501057

Alcohol Dependence

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alcohol Drinking HIV Viremia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Brief intervention

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

Group Type ACTIVE_COMPARATOR

Brief Intervention

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Brief Intervention

Intervention Type BEHAVIORAL

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

Telehealth Counseling

Intervention Type BEHAVIORAL

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

Text messaging

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Brief Intervention

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

Intervention Type BEHAVIORAL

Telehealth Counseling

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

Intervention Type BEHAVIORAL

Text messaging

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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