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

HIV/AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04280068
• Other study ID #: AA023163-05
• Status: Terminated
• Phase: N/A
• Start date: March 2, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: October 2020
• Source: Research Foundation for Mental Hygiene, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: June 30, 2020
• Est. primary completion date: March 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism
• HIV/AIDS

Intervention

Behavioral:
• Clinician Guide (CG)
An evidence-based, intervention approach to reduce heavy drinking in primary care settings.
• 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.

Locations

Country	Name	City	State
United States	Montefiore Hospital Infectious Disease clinic	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Research Foundation for Mental Hygiene, Inc.	Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in HIV Viral Load	Assessing change in viral load count between two time points.	Baseline and 6 months
Secondary	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