Trial Outcomes & Findings for Understanding and Intervening With Heavy Drinking Among Patients With HIV and HCV (NCT NCT03652675)
NCT ID: NCT03652675
Last Updated: 2021-07-23
Results Overview
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.
COMPLETED
NA
31 participants
60 days (end of treatment)
2021-07-23
Participant Flow
Participant milestones
| Measure |
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.
|
Educational Control Condition
Participant will spend 20 minutes at the clinic, observed by the counselor, reviewing an educational pamphlet on drinking, HIV, and HCV.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
|
Overall Study
COMPLETED
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
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.
|
Educational Control Condition
Participant will spend 20 minutes at the clinic, observed by the counselor, reviewing an educational pamphlet on drinking, HIV, and HCV.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
Baseline Characteristics
Understanding and Intervening With Heavy Drinking Among Patients With HIV and HCV
Baseline characteristics by cohort
| Measure |
Intervention: (Clinician's Guide + HealthCall for HIV/HCV)
n=16 Participants
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.
|
Educational Control Condition
n=15 Participants
Participant will spend 20 minutes at the clinic, observed by the counselor, reviewing an educational pamphlet on drinking, HIV, and HCV.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.7 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
56.1 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
56.4 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Transgender
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Baseline Drinks per Drinking Day
|
5.24 Drinks
STANDARD_DEVIATION 3.8 • n=5 Participants
|
6.09 Drinks
STANDARD_DEVIATION 2.17 • n=7 Participants
|
5.65 Drinks
STANDARD_DEVIATION 3.10 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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)
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.
Outcome measures
| Measure |
Intervention: (Clinician's Guide + HealthCall for HIV/HCV)
n=12 Participants
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.
|
Educational Control Condition
n=11 Participants
Participant will spend 20 minutes at the clinic, observed by the counselor, reviewing an educational pamphlet on drinking, HIV, and HCV.
|
|---|---|---|
|
Mean Drinks Per Drinking Day Measured Using Timeline Follow Back (TLFB) at 60 Days.
|
2.61 Drinks per drinking day
Standard Deviation 3.35
|
5.49 Drinks per drinking day
Standard Deviation 4.24
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Intervention: (Clinician's Guide + HealthCall for HIV/HCV)
n=12 Participants
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.
|
Educational Control Condition
n=11 Participants
Participant will spend 20 minutes at the clinic, observed by the counselor, reviewing an educational pamphlet on drinking, HIV, and HCV.
|
|---|---|---|
|
Change in Number of Days Drank as Assessed by Item From the Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS)
|
-6.08 Days
Standard Deviation 10.75
|
-3.09 Days
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Intervention: (Clinician's Guide + HealthCall for HIV/HCV)
n=12 Participants
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.
|
Educational Control Condition
n=11 Participants
Participant will spend 20 minutes at the clinic, observed by the counselor, reviewing an educational pamphlet on drinking, HIV, and HCV.
|
|---|---|---|
|
Change in Largest Number of Drinks Assessed by Item From the Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS)
|
-4 drinks
Standard Deviation 5.15
|
-5.36 drinks
Standard Deviation 9.51
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Intervention: (Clinician's Guide + HealthCall for HIV/HCV)
n=12 Participants
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.
|
Educational Control Condition
n=11 Participants
Participant will spend 20 minutes at the clinic, observed by the counselor, reviewing an educational pamphlet on drinking, HIV, and 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 days
Standard Deviation 8.24
|
-6.27 days
Standard Deviation 11.66
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Intervention: (Clinician's Guide + HealthCall for HIV/HCV)
n=12 Participants
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.
|
Educational Control Condition
n=11 Participants
Participant will spend 20 minutes at the clinic, observed by the counselor, reviewing an educational pamphlet on drinking, HIV, and HCV.
|
|---|---|---|
|
Change in Number of Days Intoxicated as Assessed by Item From the Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS)
|
-1.83 days
Standard Deviation 4.13
|
-0.64 days
Standard Deviation 6.67
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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)
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.
Outcome measures
| Measure |
Intervention: (Clinician's Guide + HealthCall for HIV/HCV)
n=12 Participants
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.
|
Educational Control Condition
n=9 Participants
Participant will spend 20 minutes at the clinic, observed by the counselor, reviewing an educational pamphlet on drinking, HIV, and HCV.
|
|---|---|---|
|
Self-efficacy to Change Drinking as Measured by Brief Version of Situational Confidence Questionnaire (SCQ)
|
74.86 Points on the SCQ
Standard Deviation 17.99
|
66.3 Points on the SCQ
Standard Deviation 17.52
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Intervention: (Clinician's Guide + HealthCall for HIV/HCV)
n=12 Participants
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.
|
Educational Control Condition
n=11 Participants
Participant will spend 20 minutes at the clinic, observed by the counselor, reviewing an educational pamphlet on drinking, HIV, and HCV.
|
|---|---|---|
|
Readiness to Change Drinking Measured by University of Rhode Island Change Assessment Scale (URICA)
|
9.82 Points on the URICA
Standard Deviation 2.16
|
8.98 Points on the URICA
Standard Deviation 1.67
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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
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)
Outcome measures
| Measure |
Intervention: (Clinician's Guide + HealthCall for HIV/HCV)
n=12 Participants
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.
|
Educational Control Condition
n=11 Participants
Participant will spend 20 minutes at the clinic, observed by the counselor, reviewing an educational pamphlet on drinking, HIV, and HCV.
|
|---|---|---|
|
Readiness to Change Drinking Measured by The Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)
Recognition scale
|
26.08 Points on the SOCRATES subscales
Standard Deviation 6.4
|
26.55 Points on the SOCRATES subscales
Standard Deviation 3.93
|
|
Readiness to Change Drinking Measured by The Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)
Ambivalence scale
|
12.25 Points on the SOCRATES subscales
Standard Deviation 2.99
|
13.36 Points on the SOCRATES subscales
Standard Deviation 2.98
|
|
Readiness to Change Drinking Measured by The Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)
Taking Steps scale
|
34.33 Points on the SOCRATES subscales
Standard Deviation 4.79
|
28.73 Points on the SOCRATES subscales
Standard Deviation 6.42
|
Adverse Events
Intervention: (Clinician's Guide + HealthCall for HIV/HCV)
Educational Control Condition
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jennifer C Elliott, PhD
Columbia University / New York State Psychiatric Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place