N/A
N=31
Understanding and Intervening With Heavy Drinking Among Patients With HIV and HCV
Alcohol Use Disorder · HIV/AIDS · Hepatitis C · Binge Drinking
Bottom Line
View on ClinicalTrials.gov: NCT03652675 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Mean Drinks Per Drinking Day Measured Using Timeline Follow Back (TLFB) at 60 Days. — 2.61; 5.49 Drinks per drinking day
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intervention: (Clinician's Guide + HealthCall for HIV/HCV) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Drinks Per Drinking Day Measured Using Timeline Follow Back (TLFB) at 60 Days. |
2.61; 5.49 | — |
| SECONDARY Change in Number of Days Drank as Assessed by Item From the Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS) |
-6.08; -3.09 | — |
| SECONDARY Change in Largest Number of Drinks Assessed by Item From the Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS) |
-4; -5.36 | — |
| SECONDARY Change in Number of Days Binge Drinking as Assessed by Item From the Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS) |
-7.92; -6.27 | — |
| SECONDARY Change in Number of Days Intoxicated as Assessed by Item From the Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS) |
-1.83; -0.64 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03652675). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.