Understanding and Intervening With Heavy Drinking Among Patients With HIV and HCV

NCT03652675 | Completed Results

• 2 other identifiers: 7649K23AA023753
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Among patients with HIV, especially those also infected with HCV, heavy drinking is associated with significant risks to health. However, little is known about how to best intervene with co-infected heavy drinkers, a particularly high risk group for whom targeted intervention has not been developed. Therefore, this study proposes to test a newly developed drinking-reduction intervention for patients with both HIV and HCV, which combines components of successful interventions developed for HIV and for liver disease patients. 60 HIV/HCV co-infected drinkers from HIV primary care will be recruited in order to ensure an adequate final sample size of 45 participants completing the study. A clinic recruiter will identify and refer potential participants based on their medical record, who will then be screened for eligibility by the research coordinator. Potential participants from outside of this clinic will also be recruited through self-referrals via flyers and through RecruitMe, an online based recruitment tool. Participants will be randomly assigned to an intervention or control condition, while ensuring that equal numbers of individuals with alcohol use disorder are assigned to each condition. The intervention condition will receive brief in-person sessions with a counselor and will be asked to use a smartphone app daily to keep track of drinking and other health behaviors for two months. The intervention sessions will include information about HIV, HCV and alcohol, and the counselor will give the participant information about their liver function and alcohol use to try to motivate them to drink less. The control condition will simply be asked to drink less and will be given pamphlets with general information on HIV, Hepatitis C, and drinking from educational websites on HIV/HCV co-infection. The intervention condition will then be evaluated to see if it was more effective at reducing drinking than the control condition.

Conditions

Alcohol Use Disorder; HIV/AIDS; Hepatitis C; Binge Drinking

Keywords

Heavy Drinking; HIV; Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Mean Drinks Per Drinking Day Measured Using Timeline Follow Back (TLFB) at 60 Days.

  Mean drinks per drinking day in the last 30 days, assessed at baseline and repeatedly during follow-up so that change can be analyzed. Abstention is coded as zero.

  60 days (end of treatment)

Secondary Outcomes (4)

• Change in Number of Days Drank as Assessed by Item From the Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS)

  60 days (end of treatment)

• Change in Largest Number of Drinks Assessed by Item From the Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS)

  60 days (end of treatment)

• Change in Number of Days Binge Drinking as Assessed by Item From the Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS)

  60 days (end of treatment)

• Change in Number of Days Intoxicated as Assessed by Item From the Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS)

  60 days (end of treatment)

Other Outcomes (3)

• Self-efficacy to Change Drinking as Measured by Brief Version of Situational Confidence Questionnaire (SCQ)

  60 days (end of treatment)

• Readiness to Change Drinking Measured by University of Rhode Island Change Assessment Scale (URICA)

  60 days (end of treatment)

• Readiness to Change Drinking Measured by The Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)

  60 days (end of treatment)

Study Arms (2)

Intervention: (Clinician's Guide + HealthCall for HIV/HCV)

EXPERIMENTAL

Behavioral: Intervention: (Clinician's Guide + HealthCall for HIV/HCV)

Educational control condition

NO INTERVENTION

Participant will spend 20 minutes at the clinic, observed by the counselor, reviewing an educational pamphlet on drinking, HIV, and HCV.

Interventions

Intervention: (Clinician's Guide + HealthCall for HIV/HCV) BEHAVIORAL

This intervention consists of an adaptation of the National Institutes of Health (NIH) Clinician's Guide (CG; NIAAA, 2007) in conjunction with the previously tested HealthCall smartphone app program (Hasin et al., 2013; Hasin et al., 2014). Participants will complete a brief baseline meeting (\~20 minutes) with a counselor to discuss alcohol use, liver function, and HIV medication adherence. They will track their drinking using HealthCall for 60 days, with brief follow-up meetings with their counselor to check in about their drinking 30 and 60 days later.

Intervention: (Clinician's Guide + HealthCall for HIV/HCV)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 through 99 (inclusive)
• HIV infection
• Ever been diagnosed with HCV infection (regardless of treatment status; including active or remitted infection)
• Recent (last 3 month) liver panel results available
• During prior 30 days, ≥4 drinks in one day at least once
• Can speak and read English
• Current and regular HIV care in NYC metro area

You may not qualify if:

• Participation in ongoing HealthCall study at Montefiore Hospital
• Potential participant has definite plans to leave the greater New York metropolitan area during study period
• Potential participant is psychotic, suicidal, or homicidal
• Potential participant is at-risk for developing alcohol withdrawal symptoms

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

NewYork-Presbyterian / Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (2)

• Hasin DS, Aharonovich E, Greenstein E. HealthCall for the smartphone: technology enhancement of brief intervention in HIV alcohol dependent patients. Addict Sci Clin Pract. 2014 Feb 17;9(1):5. doi: 10.1186/1940-0640-9-5.

  PMID: 24533631 BACKGROUND

• Hasin DS, Aharonovich E, O'Leary A, Greenstein E, Pavlicova M, Arunajadai S, Waxman R, Wainberg M, Helzer J, Johnston B. Reducing heavy drinking in HIV primary care: a randomized trial of brief intervention, with and without technological enhancement. Addiction. 2013 Jul;108(7):1230-40. doi: 10.1111/add.12127. Epub 2013 Apr 17.

  PMID: 23432593 BACKGROUND

Related Links

• National Institute on Alcohol Abuse and Alcoholism - Helping Patients Who Drink Too Much: A Clinician's Guide

MeSH Terms

Conditions

Alcoholism; Acquired Immunodeficiency Syndrome; Hepatitis C; Binge Drinking

Interventions

Methods

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hepatitis, Viral, Human; Flaviviridae Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Alcohol Drinking; Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Limitations and Caveats

As recruitment started later and moved more slowly than intended, a smaller sample size than intended was obtained.

Results Point of Contact

• Title: Jennifer C Elliott, PhD
• Organization: Columbia University / New York State Psychiatric Institute

jce2130@cumc.columbia.edu

646 774 7953

Study Officials

• Jennifer C Elliott, Ph.D

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: After participants complete the screening assessment, the research coordinator will be able to determine alcohol use disorder status from the responses. The research coordinator will provide the counselor or PI with subject identification number (ID; assigned consecutively) and alcohol use disorder status. The counselor or PI will then randomize participants using pre-determined blocked lists created by a biostatistician, in order to balance treatment groups across alcohol use disorder status (the research coordinator will not randomize in order to remain blind to condition).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: August 24, 2018
• First Posted: August 29, 2018
• Study Start: November 1, 2018
• Primary Completion: June 8, 2020
• Study Completion: June 8, 2020
• Last Updated: July 23, 2021
• Results First Posted: July 20, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)