- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04546971
Using Telehealth to Address Alcohol Misuse in HIV Care (ReACH3)
June 1, 2023 updated by: Christopher W. Kahler, Brown University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Estimated)
600
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Christopher Kahler, PhD
- Phone Number: 401 863-6651
- Email: christopher_kahler@brown.edu
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02912
- Recruiting
- Brown University
-
Contact:
- Christopher Kahler, Ph.D.
- Phone Number: 401-863-6651
- Email: Christopher_Kahler@brown.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Brief intervention
A brief alcohol intervention lasting about 10 minutes, delivered after the baseline assessments.
|
Brief alcohol intervention delivered by telephone or videoconferencing focusing on advising participants to reduce drinking
|
Experimental: 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.
|
Brief alcohol intervention delivered by telephone or videoconferencing focusing on advising participants to reduce drinking
5 sessions of counseling on alcohol use based on Motivational Interviewing.
A daily and then monthly text messaging program designed to help participants monitor drinking, set goals, and reinforce successful reduction or abstinence.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alcoholics drinks consumed per week
Time Frame: 12 months
|
Average number of alcoholic drinks consumed per week over the past 30 days
|
12 months
|
Alcoholics drinks consumed per week
Time Frame: 24 months
|
Average number of alcoholic drinks consumed per week over the past 30 days
|
24 months
|
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
|
12 months
|
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
|
24 months
|
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
|
12 months
|
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
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of the past 30 days adherent to antiretroviral therapy
Time Frame: 12 months
|
Antiretroviral therapy adherence as assessed by self-report
|
12 months
|
Proportion of the past 30 days adherent to antiretroviral therapy
Time Frame: 24 months
|
Antiretroviral therapy adherence as assessed by self-report
|
24 months
|
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
|
12 months
|
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
|
24 months
|
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.
|
12 months
|
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.
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christopher Kahler, PhD, Brown University School of Public Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 22, 2021
Primary Completion (Estimated)
April 15, 2025
Study Completion (Estimated)
April 15, 2025
Study Registration Dates
First Submitted
September 2, 2020
First Submitted That Met QC Criteria
September 8, 2020
First Posted (Actual)
September 14, 2020
Study Record Updates
Last Update Posted (Estimated)
June 2, 2023
Last Update Submitted That Met QC Criteria
June 1, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2P01AA019072 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data will be shared through the National Data Archive.
We also will post de-identified data used in the primary analyses of trial outcomes after those have been published.
IPD Sharing Time Frame
Data in the NDA will be available 6 months after the first participants are recruited and will remain in there.
IPD Sharing Access Criteria
Investigators can access date in the NDA using the available portal.
We will allow access to the outcomes data to all through Brown's data archive once the outcome paper is published.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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