Alcohol Use DisorderNCT03652675
Understanding and Intervening With Heavy Drinking Among Patients With HIV and HCV
A study testing Intervention: (Clinician's Guide + HealthCall for HIV/HCV) in people with Alcohol Use Disorder and HIV/AIDS, run by New York State Psychiatric Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Alcohol Use Disorder, HIV/AIDS, Hepatitis C
- What is being tested?
- Intervention: (Clinician's Guide + HealthCall for HIV/HCV)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 8 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
NewYork-Presbyterian / Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Understanding and Intervening With Heavy Drinking Among Patients With HIV and HCV: Clinical Trial
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.
Read the 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.
- Conditions
- Alcohol Use Disorder, HIV/AIDS, Hepatitis C, Binge Drinking
- Being tested
- Intervention: (Clinician's Guide + HealthCall for HIV/HCV)
- Keywords
- Heavy Drinking, HIV, Hepatitis C
- Medical subject headings
- Alcoholism, Acquired Immunodeficiency Syndrome, Hepatitis C, Binge Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention: (Clinician's Guide + HealthCall for HIV/HCV)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: (Clinician's Guide + HealthCall for HIV/HCV) | Experimental | Not described Receives: Behavioral: Intervention: (Clinician's Guide + HealthCall for HIV/HCV) |
| Educational control condition | No intervention | Participant will spend 20 minutes at the clinic, observed by the counselor, reviewing an educational pamphlet on drinking, HIV, and HCV. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 days (end of treatment)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 60 days (end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start1 Nov 2018
- Primary completion8 Jun 2020
- Study completion8 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Jennifer C Elliott, New York State Psychiatric Institute
- Investigators
- Jennifer C Elliott, Ph.D, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03652675
- Sponsor's protocol ID
- 7649
- Other IDs
- K23AA023753
- Status last verified
- Jul 2021
- First submitted
- 24 Aug 2018
- Last updated
- 23 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hasin DS, Aharonovich E, Greenstein E. HealthCall for the smartphone: technology enhancement of brief intervention in HIV alcohol dependent patients. Addict Sci Clin Pract. 2014 Feb 17;9(1):5. doi: 10.1186/1940-0640-9-5.
PubMed 24533631Hasin DS, Aharonovich E, O'Leary A, Greenstein E, Pavlicova M, Arunajadai S, Waxman R, Wainberg M, Helzer J, Johnston B. Reducing heavy drinking in HIV primary care: a randomized trial of brief intervention, with and without technological enhancement. Addiction. 2013 Jul;108(7):1230-40. doi: 10.1111/add.12127. Epub 2013 Apr 17.
PubMed 23432593Elliott JC, Ali M, Radecka O, Lerias D, Shalev N, Stohl M, Aharonovich E, Hasin DS. An Intervention to Reduce Drinking Among Individuals With HIV and Hepatitis C: A Pilot Randomized Controlled Trial. J Stud Alcohol Drugs. 2024 Mar;85(2):227-233. doi: 10.15288/jsad.23-00010. Epub 2023 Nov 2.
PubMed 37947429
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding and Intervening With Heavy Drinking Among Patients With HIV and HCV: Clinical Trial
- ClinicalTrials.gov ID
- NCT03652675
- Acronym / sponsor ID
- 7649
- Conditions
- Alcohol Use Disorder, HIV/AIDS, Hepatitis C, Binge Drinking
- Keywords
- Heavy Drinking, HIV, Hepatitis C
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 8 Jun 2020 (actual)
- Study completion
- 8 Jun 2020 (actual)
- First posted
- 29 Aug 2018 (actual)
- Results
- Posted 20 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: (Clinician's Guide + HealthCall for HIV/HCV) | Experimental | Behavioral: Intervention: (Clinician's Guide + HealthCall for HIV/HCV) |
| Educational control condition | No intervention | –Participant will spend 20 minutes at the clinic, observed by the counselor, reviewing an educational pamphlet on drinking, HIV, and HCV. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention: (Clinician's Guide + HealthCall for HIV/HCV) |
Primary outcome
Mean Drinks Per Drinking Day Measured Using Timeline Follow Back (TLFB) at 60 Days.
Time frame: 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.
4 secondary outcomes
Change in Number of Days Drank as Assessed by Item From the Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS)
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)
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)
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)
Time frame: 60 days (end of treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24533631Hasin DS, Aharonovich E, Greenstein E. HealthCall for the smartphone: technology enhancement of brief intervention in HIV alcohol dependent patients. Addict Sci Clin Pract. 2014 Feb 17;9(1):5. doi: 10.1186/1940-0640-9-5.
- Background: PubMed 23432593Hasin DS, Aharonovich E, O'Leary A, Greenstein E, Pavlicova M, Arunajadai S, Waxman R, Wainberg M, Helzer J, Johnston B. Reducing heavy drinking in HIV primary care: a randomized trial of brief intervention, with and without technological enhancement. Addiction. 2013 Jul;108(7):1230-40. doi: 10.1111/add.12127. Epub 2013 Apr 17.
- Derived from this study: PubMed 37947429Elliott JC, Ali M, Radecka O, Lerias D, Shalev N, Stohl M, Aharonovich E, Hasin DS. An Intervention to Reduce Drinking Among Individuals With HIV and Hepatitis C: A Pilot Randomized Controlled Trial. J Stud Alcohol Drugs. 2024 Mar;85(2):227-233. doi: 10.15288/jsad.23-00010. Epub 2023 Nov 2.
- National Institute on Alcohol Abuse and Alcoholism - Helping Patients Who Drink Too Much: A Clinician's GuideLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Alcohol Use Disorder
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer C Elliott, Ph.D principal investigator
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention: (Clinician's Guide + HealthCall for HIV/HCV) in people with Alcohol Use Disorder and HIV/AIDS, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Drinks Per Drinking Day Measured Using Timeline Follow Back (TLFB) at 60 Days. (time frame: 60 days (end of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03652675, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.