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.
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
Allocation
RANDOMIZED
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.
Brown University
Providence, Rhode Island, United States
Alcoholics drinks consumed per week
Average number of alcoholic drinks consumed per week over the past 30 days
Time frame: 12 months
Alcoholics drinks consumed per week
Average number of alcoholic drinks consumed per week over the past 30 days
Time frame: 24 months
Number of heavy drinking days
Number of days consuming 4 or more drinks in a day over the past 30 days
Time frame: 12 months
Number of heavy drinking days
Number of days consuming 4 or more drinks in a day over the past 30 days
Time frame: 24 months
Proportion of participants with a detectable HIV viral load
Viral load test result that indicates HIV virus is detectable in the blood
Time frame: 12 months
Proportion of participants with a detectable HIV viral load
Viral load test result that indicates HIV virus is detectable in the blood
Time frame: 24 months
Proportion of the past 30 days adherent to antiretroviral therapy
Antiretroviral therapy adherence as assessed by self-report
Time frame: 12 months
Proportion of the past 30 days adherent to antiretroviral therapy
Antiretroviral therapy adherence as assessed by self-report
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Purpose
TREATMENT
Masking
SINGLE
Enrollment
226
Time frame: 24 months
Condomless sex with non-steady partners
Number of days in the past 30 having condomless sex with a non-steady partner
Time frame: 12 months
Condomless sex with non-steady partners
Number of days in the past 30 having condomless sex with a non-steady partner
Time frame: 24 months
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.
Time frame: 12 months
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.
Time frame: 24 months