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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04280068
Recruitment Status : Terminated (Due to COVID-19 recruitment and enrollment of participants was halted)
First Posted : February 21, 2020
Last Update Posted : October 9, 2020
Sponsor:
Collaborator:
Montefiore Medical Center
Information provided by (Responsible Party):
Deborah Hasin, Research Foundation for Mental Hygiene, Inc.

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Alcohol Dependence HIV/AIDS Behavioral: Clinician Guide (CG) Behavioral: Clinician Guide plus HealthCall Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to an evidenced-based brief behavioral intervention.
Masking: Single (Outcomes Assessor)
Masking Description: Outcomes assessor will be blinded to arms assignments.
Primary Purpose: Treatment
Official Title: HealthCall-S: Targeting Non-virally Suppressed Adults With Alcohol Use Disorder in HIV Primary Care
Actual Study Start Date : March 2, 2020
Actual Primary Completion Date : March 27, 2020
Actual Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol HIV/AIDS

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.




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


Secondary Outcome Measures :
  1. Change in HIV Viral Load [ Time Frame: Baseline and 6 months ]
    Assessing change in viral load count between two time points.

  2. Change in ART medication adherence [ Time Frame: Baseline, 30, 60 days (end-of-treatment), 3, 5 and 6 months ]
    Assessing change in ART medication usage between baseline and each time point.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04280068


Locations
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United States, New York
Montefiore Hospital Infectious Disease clinic
Bronx, New York, United States, 10467
Sponsors and Collaborators
Research Foundation for Mental Hygiene, Inc.
Montefiore Medical Center
Investigators
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Principal Investigator: Deborah S Hasin, PhD New York State Psychiatric Institute & Columbia University Medical Center
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Responsible Party: Deborah Hasin, Professor of Epidemiology (in Psychiatry) Columbia University, Research Foundation for Mental Hygiene, Inc.
ClinicalTrials.gov Identifier: NCT04280068    
Other Study ID Numbers: AA023163-05
First Posted: February 21, 2020    Key Record Dates
Last Update Posted: October 9, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make IPD available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Deborah Hasin, Research Foundation for Mental Hygiene, Inc.:
Human Immunodeficiency Virus
Unsafe Drinking
Antiretroviral Therapy (ART)
Clinician Guide (CG)
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders