Using Telehealth to Address Alcohol Misuse in HIV Care
ReACH3
1 other identifier
interventional
600
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2020
CompletedFirst Posted
Study publicly available on registry
September 14, 2020
CompletedStudy Start
First participant enrolled
June 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2026
ExpectedAugust 18, 2025
August 1, 2025
4.8 years
September 2, 2020
August 14, 2025
Conditions
Outcome Measures
Primary Outcomes (6)
Alcoholics drinks consumed per week
Average number of alcoholic drinks consumed per week over the past 30 days
12 months
Alcoholics drinks consumed per week
Average number of alcoholic drinks consumed per week over the past 30 days
24 months
Number of heavy drinking days
Number of days consuming 4 or more drinks in a day over the past 30 days
12 months
Number of heavy drinking days
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
Viral load test result that indicates HIV virus is detectable in the blood
12 months
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 Outcomes (6)
Proportion of the past 30 days adherent to antiretroviral therapy
12 months
Proportion of the past 30 days adherent to antiretroviral therapy
24 months
Condomless sex with non-steady partners
12 months
Condomless sex with non-steady partners
24 months
Veterans Aging Cohort Study (VACS) index total score
12 months
- +1 more secondary outcomes
Study Arms (2)
Brief intervention
ACTIVE COMPARATORA brief alcohol intervention lasting about 10 minutes, delivered after the baseline assessments.
Brief Intervention plus Telehealth Counseling
EXPERIMENTALA 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- need for supervised alcohol detoxification, as indicated by having a history of severe withdrawal symptoms such as seizures and delirium tremens.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brown Universitylead
Study Sites (1)
Brown University
Providence, Rhode Island, 02912, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher Kahler, PhD
Brown University School of Public Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 2, 2020
First Posted
September 14, 2020
Study Start
June 22, 2021
Primary Completion
April 15, 2026
Study Completion (Estimated)
May 15, 2026
Last Updated
August 18, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Data in the NDA will be available 6 months after the first participants are recruited and will remain in there.
- 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.
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.