An interventional study of Intervention: (Clinician's Guide + HealthCall for HIV/HCV) in Alcohol Use Disorder, HIV/AIDS and Hepatitis C, sponsored by New York State Psychiatric Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2021-07-23.
Sponsored by New York State Psychiatric Institute · Not applicable, Interventional, and Treatment
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.
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.
1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
This study's enrollment of 31 is below the median of 88 across 1,428 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →New York State Psychiatric Institute is the lead sponsor of 435 studies on the registry; 27 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 45 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Intervention: (Clinician's Guide + HealthCall for HIV/HCV)
Participant will spend 20 minutes at the clinic, observed by the counselor, reviewing an educational pamphlet on drinking, HIV, and 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.
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)
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)
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)
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)
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)
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)
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)
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)
| Milestone | Intervention: (Clinician's Guide + HealthCall for HIV/HCV) | Educational Control Condition |
|---|---|---|
| Started | 16 | 15 |
| Completed | 12 | 11 |
| Not completed | 4 | 4 |
| Withdrew: Lost to follow-up | 4 | 4 |
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.
| Drinks per drinking day | Intervention: (Clinician's Guide + HealthCall for HIV/HCV) | Educational Control Condition |
|---|---|---|
| Mean Drinks Per Drinking Day Measured Using Timeline Follow Back (TLFB) at 60 Days. | 2.61 ± 3.35 | 5.49 ± 4.24 |
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.
| Days | Intervention: (Clinician's Guide + HealthCall for HIV/HCV) | Educational Control Condition |
|---|---|---|
| Change in Number of Days Drank as Assessed by Item From the Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS) | -6.08 ± 10.75 | -3.09 ± 10.4 |
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.
| Points on the SCQ | Intervention: (Clinician's Guide + HealthCall for HIV/HCV) | Educational Control Condition |
|---|---|---|
| Self-efficacy to Change Drinking as Measured by Brief Version of Situational Confidence Questionnaire (SCQ) | 74.86 ± 17.99 | 66.3 ± 17.52 |
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.
| Points on the URICA | Intervention: (Clinician's Guide + HealthCall for HIV/HCV) | Educational Control Condition |
|---|---|---|
| Readiness to Change Drinking Measured by University of Rhode Island Change Assessment Scale (URICA) | 9.82 ± 2.16 | 8.98 ± 1.67 |
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)
| Points on the SOCRATES subscales | Intervention: (Clinician's Guide + HealthCall for HIV/HCV) | Educational Control Condition |
|---|---|---|
| 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 |
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.
| drinks | Intervention: (Clinician's Guide + HealthCall for HIV/HCV) | Educational Control Condition |
|---|---|---|
| Change in Largest Number of Drinks Assessed by Item From the Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS) | -4 ± 5.15 | -5.36 ± 9.51 |
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.
| days | Intervention: (Clinician's Guide + HealthCall for HIV/HCV) | Educational Control Condition |
|---|---|---|
| Change in Number of Days Binge Drinking as Assessed by Item From the Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS) | -7.92 ± 8.24 | -6.27 ± 11.66 |
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.
| days | Intervention: (Clinician's Guide + HealthCall for HIV/HCV) | Educational Control Condition |
|---|---|---|
| Change in Number of Days Intoxicated as Assessed by Item From the Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS) | -1.83 ± 4.13 | -0.64 ± 6.67 |
Collected over Every 30 days for 90 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention: (Clinician's Guide + HealthCall for HIV/HCV) | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Educational Control Condition | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Age, Continuous(years) | Intervention: (Clinician's Guide + HealthCall for HIV/HCV) | Educational Control Condition | Total |
|---|---|---|---|
| Mean | 56.7 ± 11.2 | 56.1 ± 9.7 | 56.4 ± 10.4 |
| Sex/Gender, Customized(Participants) | Intervention: (Clinician's Guide + HealthCall for HIV/HCV) | Educational Control Condition | Total |
|---|---|---|---|
| Male | 12 | 9 | 21 |
| Female | 4 | 4 | 8 |
| Transgender | 0 | 1 | 1 |
| Other | 0 | 1 | 1 |
| Ethnicity (NIH/OMB)(Participants) | Intervention: (Clinician's Guide + HealthCall for HIV/HCV) | Educational Control Condition | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 2 | 3 |
| Not Hispanic or Latino | 15 | 12 | 27 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Intervention: (Clinician's Guide + HealthCall for HIV/HCV) | Educational Control Condition | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 14 | 11 | 25 |
| White | 1 | 1 | 2 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Region of Enrollment(Participants) | Intervention: (Clinician's Guide + HealthCall for HIV/HCV) | Educational Control Condition | Total |
|---|---|---|---|
| United States | 16 | 15 | 31 |
| Baseline Drinks per Drinking Day(Drinks) | Intervention: (Clinician's Guide + HealthCall for HIV/HCV) | Educational Control Condition | Total |
|---|---|---|---|
| Mean | 5.24 ± 3.8 | 6.09 ± 2.17 | 5.65 ± 3.10 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2018 to primary completion in Jun 2020, 19 months.
Results were first posted in Jul 2021, 1 year 1 month after primary completion.
Of 470 non-industry interventional studies with no phase under Alcoholism, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 55. This study's 19 months is below that.
Counting every sponsor, half of 493 studies reached it within 33 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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