Targeting Non-virally Suppressed Adults With Alcohol Use Disorder in HIV Primary Care

HealthCall-S: Targeting Non-virally Suppressed Adults With Alcohol Use Disorder in HIV Primary Care

The proposed pilot study is a randomized feasibility trial of technology-enhanced brief intervention for drinking reduction and antiretroviral therapy (ART) adherence in 60 non-virally suppressed HIV participants who meet criteria for DSM-5 Alcohol Use Disorder (AUD) in a Primary Care clinic.

Study sample will be recruited from a large urban HIV primary care clinic at Montefiore Hospital where the investigators previously successfully enrolled, randomized and treated study participants

The interventions consist of brief meetings to discuss drinking and ART adherence enhanced with daily self-monitoring through the use of a smartphone application that tracks drinking and other aspects of health. These meetings will be based on the Clinician's Guide, a brief intervention for heavy drinking in primary care settings advocated by the National Institute on Alcohol Abuse and Alcoholism. Participants will be assessed at baseline, 30, 60, 90 days, and 6 months after baseline. By the end of treatment (60 days) and throughout the follow-up period, alcohol use is expected to highest among participants who receive the Clinician's Guide alone, and lowest among participants who receive the Clinician's Guide plus the smartphone application.

Study Overview

• Status: Terminated
• Conditions: Alcohol Dependence; HIV/AIDS
• Intervention / Treatment: Behavioral: Clinician Guide (CG); Behavioral: Clinician Guide plus HealthCall

Detailed Description

HIV infection is a widespread health problem in the U.S. Antiretroviral (ART) therapy has increased longevity and changed the nature of risk factors for morbidity and mortality. Alcohol consumption has become an increasingly serious health issue among HIV primary care patients. Drinking is a key factor in progression to severe liver damage (especially those co-infected with hepatitis), and liver disease is now one of the most common causes of death among those with HIV. Excess drinking is also associated with medication noncompliance, reduces the effect of antiretroviral treatment, and is linked to other health problems. Therefore, helping HIV patients reduce unsafe drinking is crucial to their long-term health. This study aims to evaluate an evidence-based approach, the Clinician Guide, when combined with an innovative smartphone application designed to help users track drinking and ART adherence and other aspects of health. An effective, easily implemented alcohol-reduction intervention could be incorporated into standard care in HIV clinics to help prevent or slow the progress of some medical problems in HIV-infected individuals, improve ART medication compliance, prolong lifespan and decrease risk behavior associated with alcohol use.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Hospital Infectious Disease clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 and older
• Patient had 4 or more drinks on any day in prior 30 days
• Patient meets criteria for DSM5 current alcohol dependence
• HIV+
• Non-virally suppressed (HIV RNA > 200 last check)
• Able to give informed consent

Exclusion Criteria:

• Multi-drug resistant HIV and no fully suppressive treatment regimen is available
• Unwilling to take ART medications
• Patient is psychotic, suicidal, or homicidal
• Patient has gross cognitive impairment
• Patient does not speak English or Spanish
• Patient has definite plans to leave the greater New York metropolitan area within the study period
• Patient has vision/hearing impairment that would preclude participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Clinician Guide; Clinician Guide is an evidence-based, NIAAA-advocated approach to brief intervention for heavy drinking in primary care settings.	Behavioral: Clinician Guide (CG); An evidence-based, intervention approach to reduce heavy drinking in primary care settings.
Active Comparator: Clinician Guide plus HealthCall; Clinician Guide plus the use of HealthCall, a smartphone application to monitor daily alcohol use, ART adherence and other health behaviors.	Behavioral: Clinician Guide (CG); An evidence-based, intervention approach to reduce heavy drinking in primary care settings.; Behavioral: Clinician Guide plus HealthCall; HealthCall is a smartphone application designed to help participants keep track of their daily alcohol use, medication adherence and a few other health behaviors through brief daily use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Alcohol Consumption	Assessing change over time in the total number of drinks in the past 30 days from baseline to each time point.	Baseline, 30, 60 days (end-of-treatment), 3, and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HIV Viral Load	Assessing change in viral load count between two time points.	Baseline and 6 months
Change in ART medication adherence	Assessing change in ART medication usage between baseline and each time point.	Baseline, 30, 60 days (end-of-treatment), 3, 5 and 6 months

Collaborators and Investigators

• Sponsor: Research Foundation for Mental Hygiene, Inc.
• Collaborators: Montefiore Medical Center
• Investigators: Principal Investigator: Deborah S Hasin, PhD, New York State Psychiatric Institute & Columbia University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2020
• Primary Completion (Actual): March 27, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: February 17, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (Actual): February 21, 2020

Study Record Updates

• Last Update Posted (Actual): October 9, 2020
• Last Update Submitted That Met QC Criteria: October 7, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Human Immunodeficiency Virus; Unsafe Drinking; Antiretroviral Therapy (ART); Clinician Guide (CG)
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism
• Other Study ID Numbers: AA023163-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to make IPD available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No