Using Telehealth to Address Alcohol Misuse in HIV Care

Alcohol Drinking Clinical Trial

— ReACH3  

Official title:

Using Telehealth to Address Alcohol Misuse in HIV Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04546971
• Other study ID #: 2P01AA019072
• Status: Recruiting
• Phase: N/A
• Start date: June 22, 2021
• Est. completion date: April 15, 2026

Study information

• Verified date: April 2024
• Source: Brown University
• Contact: Christopher Kahler, PhD
• Phone: 401 863-6651
• Email: christopher_kahler[@]brown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: April 15, 2026
• Est. primary completion date: April 15, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• HIV Viremia
• Viremia

Intervention

Behavioral:
• Brief Intervention
Brief alcohol intervention delivered by telephone or videoconferencing focusing on advising participants to reduce drinking
• Telehealth Counseling
5 sessions of counseling on alcohol use based on Motivational Interviewing.
• Text messaging
A daily and then monthly text messaging program designed to help participants monitor drinking, set goals, and reinforce successful reduction or abstinence.

Locations

Country	Name	City	State
United States	Brown University	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcoholics drinks consumed per week	Average number of alcoholic drinks consumed per week over the past 30 days	12 months
Primary	Alcoholics drinks consumed per week	Average number of alcoholic drinks consumed per week over the past 30 days	24 months
Primary	Number of heavy drinking days	Number of days consuming 4 or more drinks in a day over the past 30 days	12 months
Primary	Number of heavy drinking days	Number of days consuming 4 or more drinks in a day over the past 30 days	24 months
Primary	Proportion of participants with a detectable HIV viral load	Viral load test result that indicates HIV virus is detectable in the blood	12 months
Primary	Proportion of participants with a detectable HIV viral load	Viral load test result that indicates HIV virus is detectable in the blood	24 months
Secondary	Proportion of the past 30 days adherent to antiretroviral therapy	Antiretroviral therapy adherence as assessed by self-report	12 months
Secondary	Proportion of the past 30 days adherent to antiretroviral therapy	Antiretroviral therapy adherence as assessed by self-report	24 months
Secondary	Condomless sex with non-steady partners	Number of days in the past 30 having condomless sex with a non-steady partner	12 months
Secondary	Condomless sex with non-steady partners	Number of days in the past 30 having condomless sex with a non-steady partner	24 months
Secondary	Veterans Aging Cohort Study (VACS) index total score	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
Secondary	Veterans Aging Cohort Study (VACS) index total score	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