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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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04280068
Enrollment
3
Registered
2020-02-21
Start date
2020-03-02
Completion date
2020-06-30
Last updated
2020-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Dependence, HIV/AIDS

Keywords

Human Immunodeficiency Virus, Unsafe Drinking, Antiretroviral Therapy (ART), Clinician Guide (CG)

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.

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.

Interventions

BEHAVIORALClinician 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.

BEHAVIORALClinician Guide (CG)

An evidence-based, intervention approach to reduce heavy drinking in primary care settings.

Sponsors

Research Foundation for Mental Hygiene, Inc.
Lead SponsorOTHER
Montefiore Medical Center
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Outcomes assessor will be blinded to arms assignments.

Intervention model description

Participants will be randomized to an evidenced-based brief behavioral intervention.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Alcohol ConsumptionBaseline, 30, 60 days (end-of-treatment), 3, and 6 monthsAssessing change over time in the total number of drinks in the past 30 days from baseline to each time point.

Secondary

MeasureTime frameDescription
Change in HIV Viral LoadBaseline and 6 monthsAssessing change in viral load count between two time points.
Change in ART medication adherenceBaseline, 30, 60 days (end-of-treatment), 3, 5 and 6 monthsAssessing change in ART medication usage between baseline and each time point.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026