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

Sponsor
New York State Psychiatric Institute (Other)
Overall Status
Completed
CT.gov ID
NCT03652675
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
31
Enrollment
1
Location
2
Arms
19.2
Actual Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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
  • Behavioral: Intervention: (Clinician's Guide + HealthCall for HIV/HCV)
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
31 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 :
Nov 1, 2018
Actual Primary Completion Date :
Jun 8, 2020
Actual Study Completion Date :
Jun 8, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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 Outcome Measures

  1. 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.

  2. 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.

  3. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 NewYork-Presbyterian / Columbia University Medical Center New York New York United States 10032

Sponsors and Collaborators

  • New York State Psychiatric Institute
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Jennifer C Elliott, Ph.D, New York State Psychiatric Institute

Study Documents (Full-Text)

More Information

Additional Information:

Publications

Responsible Party:
Jennifer C Elliott, Research Scientist, New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT03652675
Other Study ID Numbers:
  • 7649
  • K23AA023753
First Posted:
Aug 29, 2018
Last Update Posted:
Jul 23, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jennifer C Elliott, Research Scientist, New York State Psychiatric Institute
Heavy Drinking
HIV
Hepatitis C
Additional relevant MeSH terms:
Hepatitis C
Hepatitis
Alcoholism
Binge Drinking

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Intervention: (Clinician's Guide + HealthCall for HIV/HCV) Educational Control Condition
Arm/Group Description 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. Participant will spend 20 minutes at the clinic, observed by the counselor, reviewing an educational pamphlet on drinking, HIV, and HCV.
Period Title: Overall Study
STARTED 16 15
COMPLETED 12 11
NOT COMPLETED 4 4

Baseline Characteristics

Arm/Group Title Intervention: (Clinician's Guide + HealthCall for HIV/HCV) Educational Control Condition Total
Arm/Group Description 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. Participant will spend 20 minutes at the clinic, observed by the counselor, reviewing an educational pamphlet on drinking, HIV, and HCV. Total of all reporting groups
Overall Participants 16 15 31
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
56.7
(11.2)
56.1
(9.7)
56.4
(10.4)
Sex/Gender, Customized (Count of Participants)
Male
12
75%
9
60%
21
67.7%
Female
4
25%
4
26.7%
8
25.8%
Transgender
0
0%
1
6.7%
1
3.2%
Other
0
0%
1
6.7%
1
3.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
1
6.3%
2
13.3%
3
9.7%
Not Hispanic or Latino
15
93.8%
12
80%
27
87.1%
Unknown or Not Reported
0
0%
1
6.7%
1
3.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
1
6.7%
1
3.2%
Asian
0
0%
0
0%
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
14
87.5%
11
73.3%
25
80.6%
White
1
6.3%
1
6.7%
2
6.5%
More than one race
0
0%
1
6.7%
1
3.2%
Unknown or Not Reported
1
6.3%
1
6.7%
2
6.5%
Region of Enrollment (Count of Participants)
United States
16
100%
15
100%
31
100%
Baseline Drinks per Drinking Day (Drinks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Drinks]
5.24
(3.8)
6.09
(2.17)
5.65
(3.10)

Outcome Measures

1. Primary Outcome
Title Mean Drinks Per Drinking Day Measured Using Timeline Follow Back (TLFB) at 60 Days.
Description 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)

Outcome Measure Data

Analysis Population Description
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)
Arm/Group Title Intervention: (Clinician's Guide + HealthCall for HIV/HCV) Educational Control Condition
Arm/Group Description 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. Participant will spend 20 minutes at the clinic, observed by the counselor, reviewing an educational pamphlet on drinking, HIV, and HCV.
Measure Participants 12 11
Mean (Standard Deviation) [Drinks per drinking day]
2.61
(3.35)
5.49
(4.24)
2. Secondary Outcome
Title Change in Number of Days Drank as Assessed by Item From the Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS)
Description 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)

Outcome Measure Data

Analysis Population Description
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
Arm/Group Title Intervention: (Clinician's Guide + HealthCall for HIV/HCV) Educational Control Condition
Arm/Group Description 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. Participant will spend 20 minutes at the clinic, observed by the counselor, reviewing an educational pamphlet on drinking, HIV, and HCV.
Measure Participants 12 11
Mean (Standard Deviation) [Days]
-6.08
(10.75)
-3.09
(10.4)
3. Other Pre-specified Outcome
Title Self-efficacy to Change Drinking as Measured by Brief Version of Situational Confidence Questionnaire (SCQ)
Description 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)

Outcome Measure Data

Analysis Population Description
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)
Arm/Group Title Intervention: (Clinician's Guide + HealthCall for HIV/HCV) Educational Control Condition
Arm/Group Description 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. Participant will spend 20 minutes at the clinic, observed by the counselor, reviewing an educational pamphlet on drinking, HIV, and HCV.
Measure Participants 12 9
Mean (Standard Deviation) [Points on the SCQ]
74.86
(17.99)
66.3
(17.52)
4. Other Pre-specified Outcome
Title Readiness to Change Drinking Measured by University of Rhode Island Change Assessment Scale (URICA)
Description 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)

Outcome Measure Data

Analysis Population Description
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
Arm/Group Title Intervention: (Clinician's Guide + HealthCall for HIV/HCV) Educational Control Condition
Arm/Group Description 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. Participant will spend 20 minutes at the clinic, observed by the counselor, reviewing an educational pamphlet on drinking, HIV, and HCV.
Measure Participants 12 11
Mean (Standard Deviation) [Points on the URICA]
9.82
(2.16)
8.98
(1.67)
5. Other Pre-specified Outcome
Title Readiness to Change Drinking Measured by The Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)
Description 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)

Outcome Measure Data

Analysis Population Description
Of the 31 participants enrolled at baseline, 23 completed the 60-day follow-up and are reported here. SOCRATES subscales - Recognition, Ambivalence, Taking Steps
Arm/Group Title Intervention: (Clinician's Guide + HealthCall for HIV/HCV) Educational Control Condition
Arm/Group Description 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. Participant will spend 20 minutes at the clinic, observed by the counselor, reviewing an educational pamphlet on drinking, HIV, and HCV.
Measure Participants 12 11
Recognition scale
26.08
(6.4)
26.55
(3.93)
Ambivalence scale
12.25
(2.99)
13.36
(2.98)
Taking Steps scale
34.33
(4.79)
28.73
(6.42)
6. Secondary Outcome
Title Change in Largest Number of Drinks Assessed by Item From the Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS)
Description 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)

Outcome Measure Data

Analysis Population Description
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
Arm/Group Title Intervention: (Clinician's Guide + HealthCall for HIV/HCV) Educational Control Condition
Arm/Group Description 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. Participant will spend 20 minutes at the clinic, observed by the counselor, reviewing an educational pamphlet on drinking, HIV, and HCV.
Measure Participants 12 11
Mean (Standard Deviation) [drinks]
-4
(5.15)
-5.36
(9.51)
7. Secondary Outcome
Title Change in Number of Days Binge Drinking as Assessed by Item From the Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS)
Description 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)

Outcome Measure Data

Analysis Population Description
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
Arm/Group Title Intervention: (Clinician's Guide + HealthCall for HIV/HCV) Educational Control Condition
Arm/Group Description 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. Participant will spend 20 minutes at the clinic, observed by the counselor, reviewing an educational pamphlet on drinking, HIV, and HCV.
Measure Participants 12 11
Mean (Standard Deviation) [days]
-7.92
(8.24)
-6.27
(11.66)
8. Secondary Outcome
Title Change in Number of Days Intoxicated as Assessed by Item From the Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS)
Description 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)

Outcome Measure Data

Analysis Population Description
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
Arm/Group Title Intervention: (Clinician's Guide + HealthCall for HIV/HCV) Educational Control Condition
Arm/Group Description 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. Participant will spend 20 minutes at the clinic, observed by the counselor, reviewing an educational pamphlet on drinking, HIV, and HCV.
Measure Participants 12 11
Mean (Standard Deviation) [days]
-1.83
(4.13)
-0.64
(6.67)

Adverse Events

Time Frame Every 30 days for 90 days.
Adverse Event Reporting Description Consistent with ClinicalTrials.gov definition.
Arm/Group Title Intervention: (Clinician's Guide + HealthCall for HIV/HCV) Educational Control Condition
Arm/Group Description 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. Participant will spend 20 minutes at the clinic, observed by the counselor, reviewing an educational pamphlet on drinking, HIV, and HCV.
All Cause Mortality
Intervention: (Clinician's Guide + HealthCall for HIV/HCV) Educational Control Condition
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/16 (0%) 0/15 (0%)
Serious Adverse Events
Intervention: (Clinician's Guide + HealthCall for HIV/HCV) Educational Control Condition
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/16 (0%) 0/15 (0%)
Other (Not Including Serious) Adverse Events
Intervention: (Clinician's Guide + HealthCall for HIV/HCV) Educational Control Condition
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/16 (0%) 0/15 (0%)

Limitations/Caveats

As recruitment started later and moved more slowly than intended, a smaller sample size than intended was obtained.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Jennifer C Elliott, PhD
Organization Columbia University / New York State Psychiatric Institute
Phone 646 774 7953
Email jce2130@cumc.columbia.edu
Responsible Party:
Jennifer C Elliott, Research Scientist, New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT03652675
Other Study ID Numbers:
  • 7649
  • K23AA023753
First Posted:
Aug 29, 2018
Last Update Posted:
Jul 23, 2021
Last Verified:
Jul 1, 2021