Clinical trial NCT04546971: Using Telehealth to Address Alcohol Misuse in HIV Care
Official title: Using Telehealth to Address Alcohol Misuse in HIV Care
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alcohol Drinking
HIV Viremia
Lead sponsor: Brown University
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Alcoholics drinks consumed per week
timeFrame: 12 months
measure: Alcoholics drinks consumed per week
timeFrame: 24 months
measure: Number of heavy drinking days
timeFrame: 12 months
measure: Number of heavy drinking days
timeFrame: 24 months
measure: Proportion of participants with a detectable HIV viral load
timeFrame: 12 months
measure: Proportion of participants with a detectable HIV viral load
timeFrame: 24 months
Secondary outcomes:
measure: Proportion of the past 30 days adherent to antiretroviral therapy
timeFrame: 12 months
measure: Proportion of the past 30 days adherent to antiretroviral therapy
timeFrame: 24 months
measure: Condomless sex with non-steady partners
timeFrame: 12 months
measure: Condomless sex with non-steady partners
timeFrame: 24 months
measure: Veterans Aging Cohort Study (VACS) index total score
timeFrame: 12 months
measure: Veterans Aging Cohort Study (VACS) index total score
timeFrame: 24 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
affiliation: Brown University School of Public Health
name: Christopher Kahler, PhD
role: PRINCIPAL_INVESTIGATOR
References: