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

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ClinicalTrials.gov Identifier: NCT03652675
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : July 12, 2019
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Jennifer C Elliott, New York State Psychiatric Institute

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.


Condition or disease Intervention/treatment Phase
Alcohol Use Disorder HIV/AIDS Hepatitis C Binge Drinking Behavioral: Intervention: (Clinician's Guide + HealthCall for HIV/HCV) Not Applicable

Detailed Description:

Patients with HIV have high rates of heavy drinking and alcohol problems, and face serious medical consequences from this use. Some research suggests that alcohol can increase viral load and decrease CD4 (cluster of differentiation 4; e.g., T helper cells) count, although this literature is conflicting. It also increases risk for liver damage, as does hepatitis co-infection, making liver disease a leading cause of death for patients with HIV. Patients with alcohol problems are also less adherent to antiretroviral therapy (ART), and some intentionally skip ART to try to avoid hepatotoxic effects of combining ART with alcohol. Some studies also show alcohol's interference with other aspects of engagement in HIV care.

Approximately 25% of HIV-infected patients are co-infected with HCV. Although HCV alone can lead to liver damage, HIV accelerates this progression, as does heavy drinking. Further, individuals with HCV who drink heavily may be less likely to access HCV medication. Despite serious health risks associated with alcohol use, some research suggests that HIV/HCV patients drink more than HIV mono-infected patients.

Growing recognition of alcohol-related harm in HIV patients has stimulated the development of drinking reduction interventions for HIV infected heavy drinkers, some of which have been successful. Some interventions for HCV mono-infected drinkers and liver disease patients have also shown promise. Yet there are no known successful interventions that target HIV/HCV co-infected patients, a group with elevated drinking and particularly high consequences of drinking. Interventions for HIV patients address HIV health, but do not address liver fibrosis, which is an urgent threat to survival for co-infected patients. Interventions for liver disease patients discuss fibrosis to motivate drinking reduction, but neglect HIV and important topics such as ART adherence. Given that the drinking interventions for HIV and liver disease patients both effectively target drinking in medical patients, albeit through attention to different medical issues, such approaches can and should be integrated to provide an intervention that best meets the needs of patients with both HIV and HCV, a particularly high-risk group. In order to meet this need, an intervention will be tested for HIV/HCV co-infected drinkers. A total of 60 patients will be recruited and randomized to receive either the newly developed intervention or an educational control.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: 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).
Primary Purpose: Treatment
Official Title: Understanding and Intervening With Heavy Drinking Among Patients With HIV and HCV: Clinical Trial
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol HIV/AIDS

Arm Intervention/treatment
Experimental: Intervention: (Clinician's Guide + HealthCall for HIV/HCV) Behavioral: Intervention: (Clinician's Guide + HealthCall for HIV/HCV)
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.

No Intervention: Educational control condition
Participant will spend 20 minutes at the clinic, observed by the counselor, reviewing an educational pamphlet on drinking, HIV, and HCV.



Primary Outcome Measures :
  1. Change in mean drinks per drinking day measured using Timeline Follow Back (TLFB) [ Time Frame: Baseline, 30 days, 60 days (end of treatment), 90 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.


Secondary Outcome Measures :
  1. Change in measures of alcohol use assessed by items from the Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS) [ Time Frame: Baseline, 30 days, 60 days (end of treatment), 90 days ]
    Other measures of alcohol use (drinking frequency, maximum quantity of drinks per day, frequency of binge drinking and intoxication) for the last 30 days, assessed at baseline and repeatedly during follow-up so that change can be analyzed.


Other Outcome Measures:
  1. Change in readiness to change drinking measured by University of Rhode Island Change Assessment Scale (URICA) [ Time Frame: Baseline, 30 days, 60 days (end of treatment), 90 days ]
    Readiness to change drinking in the last 30 days, assessed at baseline and repeatedly during follow-up so that change can be analyzed.

  2. Change in readiness to change drinking measured by The Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) [ Time Frame: Baseline, 30 days, 60 days (end of treatment), 90 days ]
    Readiness to change drinking in the last 30 days,assessed at baseline and repeatedly during follow-up so that change can be analyzed.

  3. Change in self-efficacy to change drinking measured by brief version of Situational Confidence Questionnaire (SCQ) [ Time Frame: Baseline, 30 days, 60 days (end of treatment), 90 days ]
    Change in self-efficacy to change drinking in the last 30 days, assessed at baseline and repeatedly during follow-up so that change can be analyzed.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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): NCT03652675


Contacts
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Contact: Jennifer C Elliott, Ph.D 646-774-7953 jennifer.elliott@nyspi.columbia.edu

Locations
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United States, New York
NewYork-Presbyterian / Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Jennifer C Elliott, Ph.D New York State Psychiatric Institute
  Study Documents (Full-Text)

Documents provided by Jennifer C Elliott, New York State Psychiatric Institute:
Informed Consent Form  [PDF] July 9, 2019


Additional Information:
Publications:
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Responsible Party: Jennifer C Elliott, Research Scientist, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT03652675     History of Changes
Other Study ID Numbers: 7649
K23AA023753 ( U.S. NIH Grant/Contract )
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Jennifer C Elliott, New York State Psychiatric Institute:
Heavy Drinking
HIV
Hepatitis C
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
Hepatitis C
Hepatitis
Alcoholism
Binge Drinking
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Flaviviridae Infections
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders