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

Understanding and Intervening With Heavy Drinking Among Patients With HIV and HCV: Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03652675
Enrollment
31
Registered
2018-08-29
Start date
2018-11-01
Completion date
2020-06-08
Last updated
2021-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Heavy Drinking, HIV, Hepatitis C

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.

Interventions

BEHAVIORALIntervention: (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.

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
New York State Psychiatric Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
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).

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mean Drinks Per Drinking Day Measured Using Timeline Follow Back (TLFB) at 60 Days.60 days (end of treatment)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.

Secondary

MeasureTime frameDescription
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)The largest number of drinks consumed within one day in the last 30 days (RANGE 0-30) was assessed at baseline and repeatedly during follow-up so that change can be analyzed. A change value is calculated here such that a negative value indicates a decrease in drinking.
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)Number of days drank in the last 30 days (RANGE 0-30) was assessed at baseline and repeatedly during follow-up so that change can be analyzed. A change value is calculated here such that a negative value indicates a decrease in drinking.
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)Number of days engaging in binge drinking (4+ drinks) in the last 30 days (RANGE 0-30) was assessed at baseline and repeatedly during follow-up so that change can be analyzed. A change value is calculated here such that a negative value indicates a decrease in drinking.
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)Number of days intoxicated in the last 30 days (RANGE 0-30) was assessed at baseline and repeatedly during follow-up so that change can be analyzed. A change value is calculated here such that a negative value indicates a decrease in drinking.

Other

MeasureTime frameDescription
Readiness to Change Drinking Measured by The Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)60 days (end of treatment)Readiness to change drinking in the last 30 days,assessed at baseline and repeatedly during follow-up so that change can be analyzed. Higher scores indicate more recognition, ambivalence, and taking steps toward change, respectively. For full range and interpretation, see individual outcomes below. Recognition scale - Range 7 (very low recognition) to 35 (high recognition) Ambivalence scale - Range 4 (very low ambivalence) to 20 (very high ambivalence) Taking Steps scale - Range 8 (very low on taking steps to change drinking) to 40 (very high score)
Readiness to Change Drinking Measured by University of Rhode Island Change Assessment Scale (URICA)60 days (end of treatment)Readiness to change drinking in the last 30 days, assessed at baseline and repeatedly during follow-up so that change can be analyzed. Higher scores indicate more readiness to change. Range from -2 to +14. The scale is scored when points are averaged for all four (precontemplation, contemplation, action, maintenance) scales. Add Contemplation + Action + Maintenance averages, then subtract Precontemplation average.
Self-efficacy to Change Drinking as Measured by Brief Version of Situational Confidence Questionnaire (SCQ)60 days (end of treatment)Self-efficacy to change drinking in the last 30 days, assessed at baseline and repeatedly during follow-up so that change can be analyzed. Participants rate eight situations regarding their confidence in their ability to resist drinking (0% - Not at all confident to 100% - Totally confident). The final score is an average that can range from 0 (lowest) to 100 (highest) self-efficacy.

Countries

United States

Participant flow

Participants by arm

ArmCount
Intervention: (Clinician's Guide + HealthCall for HIV/HCV)
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.
16
Educational Control Condition
Participant will spend 20 minutes at the clinic, observed by the counselor, reviewing an educational pamphlet on drinking, HIV, and HCV.
15
Total31

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up44

Baseline characteristics

CharacteristicIntervention: (Clinician's Guide + HealthCall for HIV/HCV)Educational Control ConditionTotal
Age, Continuous56.7 years
STANDARD_DEVIATION 11.2
56.1 years
STANDARD_DEVIATION 9.7
56.4 years
STANDARD_DEVIATION 10.4
Baseline Drinks per Drinking Day5.24 Drinks
STANDARD_DEVIATION 3.8
6.09 Drinks
STANDARD_DEVIATION 2.17
5.65 Drinks
STANDARD_DEVIATION 3.1
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants2 Participants3 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
15 Participants12 Participants27 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
14 Participants11 Participants25 Participants
Race (NIH/OMB)
More than one race
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants2 Participants
Race (NIH/OMB)
White
1 Participants1 Participants2 Participants
Region of Enrollment
United States
16 Participants15 Participants31 Participants
Sex/Gender, Customized
Female
4 Participants4 Participants8 Participants
Sex/Gender, Customized
Male
12 Participants9 Participants21 Participants
Sex/Gender, Customized
Other
0 Participants1 Participants1 Participants
Sex/Gender, Customized
Transgender
0 Participants1 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 160 / 15
other
Total, other adverse events
0 / 160 / 15
serious
Total, serious adverse events
0 / 160 / 15

Outcome results

Primary

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.

Time frame: 60 days (end of treatment)

Population: Of the 31 participants enrolled at baseline, 23 completed the 60-day follow-up and are reported here.~Drinks per drinking day (primary outcome), with abstention coded as zero, at 60 days (end-of-treatment)

ArmMeasureValue (MEAN)Dispersion
Intervention: (Clinician's Guide + HealthCall for HIV/HCV)Mean Drinks Per Drinking Day Measured Using Timeline Follow Back (TLFB) at 60 Days.2.61 Drinks per drinking dayStandard Deviation 3.35
Educational Control ConditionMean Drinks Per Drinking Day Measured Using Timeline Follow Back (TLFB) at 60 Days.5.49 Drinks per drinking dayStandard Deviation 4.24
Secondary

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

The largest number of drinks consumed within one day in the last 30 days (RANGE 0-30) was assessed at baseline and repeatedly during follow-up so that change can be analyzed. A change value is calculated here such that a negative value indicates a decrease in drinking.

Time frame: 60 days (end of treatment)

Population: Of the 31 participants enrolled at baseline, 23 completed the 60-day follow-up and are reported here.~Change scores from baseline - AUDADIS drinking variables at 60 days

ArmMeasureValue (MEAN)Dispersion
Intervention: (Clinician's Guide + HealthCall for HIV/HCV)Change in Largest Number of Drinks Assessed by Item From the Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS)-4 drinksStandard Deviation 5.15
Educational Control ConditionChange in Largest Number of Drinks Assessed by Item From the Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS)-5.36 drinksStandard Deviation 9.51
Secondary

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

Number of days engaging in binge drinking (4+ drinks) in the last 30 days (RANGE 0-30) was assessed at baseline and repeatedly during follow-up so that change can be analyzed. A change value is calculated here such that a negative value indicates a decrease in drinking.

Time frame: 60 days (end of treatment)

Population: Of the 31 participants enrolled at baseline, 23 completed the 60-day follow-up and are reported here.~Change scores from baseline - AUDADIS drinking variables at 60 days

ArmMeasureValue (MEAN)Dispersion
Intervention: (Clinician's Guide + HealthCall for HIV/HCV)Change in Number of Days Binge Drinking as Assessed by Item From the Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS)-7.92 daysStandard Deviation 8.24
Educational Control ConditionChange in Number of Days Binge Drinking as Assessed by Item From the Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS)-6.27 daysStandard Deviation 11.66
Secondary

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

Number of days drank in the last 30 days (RANGE 0-30) was assessed at baseline and repeatedly during follow-up so that change can be analyzed. A change value is calculated here such that a negative value indicates a decrease in drinking.

Time frame: 60 days (end of treatment)

Population: Of the 31 participants enrolled at baseline, 23 completed the 60-day follow-up and are reported here.~Change scores from baseline - AUDADIS drinking variables at 60 days

ArmMeasureValue (MEAN)Dispersion
Intervention: (Clinician's Guide + HealthCall for HIV/HCV)Change in Number of Days Drank as Assessed by Item From the Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS)-6.08 DaysStandard Deviation 10.75
Educational Control ConditionChange in Number of Days Drank as Assessed by Item From the Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS)-3.09 DaysStandard Deviation 10.4
Secondary

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

Number of days intoxicated in the last 30 days (RANGE 0-30) was assessed at baseline and repeatedly during follow-up so that change can be analyzed. A change value is calculated here such that a negative value indicates a decrease in drinking.

Time frame: 60 days (end of treatment)

Population: Of the 31 participants enrolled at baseline, 23 completed the 60-day follow-up and are reported here.~Change scores from baseline - AUDADIS drinking variables at 60 days

ArmMeasureValue (MEAN)Dispersion
Intervention: (Clinician's Guide + HealthCall for HIV/HCV)Change in Number of Days Intoxicated as Assessed by Item From the Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS)-1.83 daysStandard Deviation 4.13
Educational Control ConditionChange in Number of Days Intoxicated as Assessed by Item From the Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS)-0.64 daysStandard Deviation 6.67
Other Pre-specified

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

Readiness to change drinking in the last 30 days,assessed at baseline and repeatedly during follow-up so that change can be analyzed. Higher scores indicate more recognition, ambivalence, and taking steps toward change, respectively. For full range and interpretation, see individual outcomes below. Recognition scale - Range 7 (very low recognition) to 35 (high recognition) Ambivalence scale - Range 4 (very low ambivalence) to 20 (very high ambivalence) Taking Steps scale - Range 8 (very low on taking steps to change drinking) to 40 (very high score)

Time frame: 60 days (end of treatment)

Population: Of the 31 participants enrolled at baseline, 23 completed the 60-day follow-up and are reported here.~SOCRATES subscales - Recognition, Ambivalence, Taking Steps

ArmMeasureGroupValue (MEAN)Dispersion
Intervention: (Clinician's Guide + HealthCall for HIV/HCV)Readiness to Change Drinking Measured by The Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)Recognition scale26.08 Points on the SOCRATES subscalesStandard Deviation 6.4
Intervention: (Clinician's Guide + HealthCall for HIV/HCV)Readiness to Change Drinking Measured by The Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)Ambivalence scale12.25 Points on the SOCRATES subscalesStandard Deviation 2.99
Intervention: (Clinician's Guide + HealthCall for HIV/HCV)Readiness to Change Drinking Measured by The Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)Taking Steps scale34.33 Points on the SOCRATES subscalesStandard Deviation 4.79
Educational Control ConditionReadiness to Change Drinking Measured by The Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)Recognition scale26.55 Points on the SOCRATES subscalesStandard Deviation 3.93
Educational Control ConditionReadiness to Change Drinking Measured by The Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)Ambivalence scale13.36 Points on the SOCRATES subscalesStandard Deviation 2.98
Educational Control ConditionReadiness to Change Drinking Measured by The Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)Taking Steps scale28.73 Points on the SOCRATES subscalesStandard Deviation 6.42
Other Pre-specified

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

Readiness to change drinking in the last 30 days, assessed at baseline and repeatedly during follow-up so that change can be analyzed. Higher scores indicate more readiness to change. Range from -2 to +14. The scale is scored when points are averaged for all four (precontemplation, contemplation, action, maintenance) scales. Add Contemplation + Action + Maintenance averages, then subtract Precontemplation average.

Time frame: 60 days (end of treatment)

Population: Of the 31 participants enrolled at baseline, 23 completed the 60-day follow-up and are reported here.~Readiness to change, as measured by the URICA

ArmMeasureValue (MEAN)Dispersion
Intervention: (Clinician's Guide + HealthCall for HIV/HCV)Readiness to Change Drinking Measured by University of Rhode Island Change Assessment Scale (URICA)9.82 Points on the URICAStandard Deviation 2.16
Educational Control ConditionReadiness to Change Drinking Measured by University of Rhode Island Change Assessment Scale (URICA)8.98 Points on the URICAStandard Deviation 1.67
Other Pre-specified

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

Self-efficacy to change drinking in the last 30 days, assessed at baseline and repeatedly during follow-up so that change can be analyzed. Participants rate eight situations regarding their confidence in their ability to resist drinking (0% - Not at all confident to 100% - Totally confident). The final score is an average that can range from 0 (lowest) to 100 (highest) self-efficacy.

Time frame: 60 days (end of treatment)

Population: Of the 31 participants enrolled at baseline, 23 completed the 60-day follow-up.Two participants were missing SCQ data at 60 days, so results are reported for 21 participants.~Self-efficacy at 60 days (end-of-treatment), as measured by brief version of Situational Confidence Questionnaire (SCQ)

ArmMeasureValue (MEAN)Dispersion
Intervention: (Clinician's Guide + HealthCall for HIV/HCV)Self-efficacy to Change Drinking as Measured by Brief Version of Situational Confidence Questionnaire (SCQ)74.86 Points on the SCQStandard Deviation 17.99
Educational Control ConditionSelf-efficacy to Change Drinking as Measured by Brief Version of Situational Confidence Questionnaire (SCQ)66.3 Points on the SCQStandard Deviation 17.52

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026