Clinical trial NCT03652675: Understanding and Intervening With Heavy Drinking Among Patients With HIV and HCV
Official title: Understanding and Intervening With Heavy Drinking Among Patients With HIV and HCV: Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
HIV/AIDS
Hepatitis C
Binge Drinking
Keywords: Heavy Drinking
HIV
Hepatitis C
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2018-08-29
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Mean Drinks Per Drinking Day Measured Using Timeline Follow Back (TLFB) at 60 Days.
timeFrame: 60 days (end of treatment)
Secondary outcomes:
measure: Change in Number of Days Drank as Assessed by Item From the Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS)
timeFrame: 60 days (end of treatment)
measure: Change in Largest Number of Drinks Assessed by Item From the Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS)
timeFrame: 60 days (end of treatment)
measure: Change in Number of Days Binge Drinking as Assessed by Item From the Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS)
timeFrame: 60 days (end of treatment)
measure: Change in Number of Days Intoxicated as Assessed by Item From the Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS)
timeFrame: 60 days (end of treatment)
Other outcomes:
measure: Self-efficacy to Change Drinking as Measured by Brief Version of Situational Confidence Questionnaire (SCQ)
timeFrame: 60 days (end of treatment)
measure: Readiness to Change Drinking Measured by University of Rhode Island Change Assessment Scale (URICA)
timeFrame: 60 days (end of treatment)
measure: Readiness to Change Drinking Measured by The Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)
timeFrame: 60 days (end of treatment)
Locations:
city: New York
country: United States
facility: NewYork-Presbyterian / Columbia University Medical Center
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Jennifer C Elliott, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.