Clinical Trials Logo

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

NCT number NCT04546971
Study type Interventional
Source Brown University
Contact Christopher Kahler, PhD
Phone 401 863-6651
Status Recruiting
Phase N/A
Start date June 22, 2021
Completion date April 15, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT05414344 - A Brief Intervention for Alcohol Users With Interpersonal Trauma N/A
Active, not recruiting NCT05521906 - Evaluation of PRYSHM for LGBTQIA2S+ Youth N/A
Not yet recruiting NCT04786587 - Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
Withdrawn NCT04659278 - Endourage Complete Spectrum Oral Mucosal Drops (OMD) in Adults Desiring a Reduction in Ethanol Use N/A
Not yet recruiting NCT03632408 - Hangover and Residual Zopiclone Effect on Spatial Perception Phase 1
Completed NCT02718508 - An e-Parenting Skills Intervention to Decrease Injured Adolescents' Alcohol Use N/A
Active, not recruiting NCT02629679 - Sports, Education and Consumption of Substances in Adolescents N/A
Completed NCT02945371 - Tailored Inhibitory Control Training to Reverse EA-linked Deficits in Mid-life N/A
Completed NCT01553136 - Varenicline Treatment of Alcohol Dependence in Smokers Phase 2
Completed NCT01442753 - Family-Skills Training to Prevent Tobacco and Other Substance Use in Latino Youth N/A
Completed NCT01081119 - Brief Voluntary Alcohol and Drug Intervention for Middle School Youth Phase 2
Completed NCT00289965 - Substance Use Risk Education (SURE) Project Phase 2
Completed NCT04510116 - Adults In The Making Prevention Trial N/A
Completed NCT00506753 - Motivation and Skills for Delta-9-tetrahydrocannabinol/Ethanol (THC/ETOH+) Teens in Jail N/A
Recruiting NCT05288790 - Microbiome Metabolites and Alcohol in HIV to Reduce CVD RCT Phase 2
Recruiting NCT05620849 - Young Adult Education on Alcohol & Health N/A
Recruiting NCT04054466 - Nursing Counseling to the Change of Behavior of Alcohol Consumption in Patients in HAART N/A
Recruiting NCT03588754 - Does Propranolol, a Beta Blocker, Attenuate Stress-Induced Drinking? Phase 2
Recruiting NCT06074341 - TeleHealth Resources for IndiVidualizEd Goals (THRIVE) in Alcohol Recovery Study N/A
Terminated NCT04596267 - Pitolisant Effects on Alcohol Self-Administration in Heavy Drinkers Phase 1