Understanding and Intervening With Heavy Drinking Among Patients With HIV and HCV
Completed · Not applicable
Conditions studied: Alcohol Use Disorder, HIV/AIDS, Hepatitis C, Binge Drinking
In brief
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.
Key facts
- Study ID
- NCT03652675
- Run by
- New York State Psychiatric Institute
- People needed
- 31
- Starts
- 2018-11-01
- Expected to finish
- 2020-06-08
- Last updated by the study team
- 2021-07-23
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- NewYork-Presbyterian / Columbia University Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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