Clinical trial NCT04280068: Targeting Non-virally Suppressed Adults With Alcohol Use Disorder in HIV Primary Care
Official title: HealthCall-S: Targeting Non-virally Suppressed Adults With Alcohol Use Disorder in HIV Primary Care
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Alcohol Dependence
HIV/AIDS
Keywords: Human Immunodeficiency Virus
Unsafe Drinking
Antiretroviral Therapy (ART)
Clinician Guide (CG)
Lead sponsor: Research Foundation for Mental Hygiene, Inc.
Sponsor class: OTHER
Collaborators: name: Montefiore Medical Center
First posted: 2020-02-21
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to an evidenced-based brief behavioral intervention.
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in Alcohol Consumption
timeFrame: Baseline, 30, 60 days (end-of-treatment), 3, and 6 months
Secondary outcomes:
measure: Change in HIV Viral Load
timeFrame: Baseline and 6 months
measure: Change in ART medication adherence
timeFrame: Baseline, 30, 60 days (end-of-treatment), 3, 5 and 6 months
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Hospital Infectious Disease clinic
state: New York
Study officials:
affiliation: New York State Psychiatric Institute & Columbia University Medical Center
name: Deborah S Hasin, PhD
role: PRINCIPAL_INVESTIGATOR
References: