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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04546971
Other study ID # 2P01AA019072
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 22, 2021
Est. completion date April 15, 2025

Study information

Verified date June 2023
Source Brown University
Contact Christopher Kahler, PhD
Phone 401 863-6651
Email christopher_kahler@brown.edu
Is FDA regulated No
Health authority
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, 2025
Est. primary completion date April 15, 2025
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.

Study Design


Related Conditions & MeSH terms


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
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