Hepatitis CNCT01707030
Web-based Intervention to Reduce Alcohol Use in Veterans With Hepatitis C
A study testing Web-Based Brief Alcohol Intervention in people with Hepatitis C and Alcohol Abuse, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
Many people who are infected with Hepatitis C misuse alcohol, which is even more dangerous for them than it is for a non-infected person. In this VA study, such individuals will be screened and given feedback on their drinking using an Internet-based program which has been shown to reduce drinking in other… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Alcohol Abuse
- What is being tested?
- Web-Based Brief Alcohol Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2015to 29 Jun 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be a US military veteran.
- Over the age of 17 with liver disease.
- Must be receiving care at a VA liver clinic.
Who cannot join
- Those with no current or historical use of alcohol.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1290
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121
About this study
Many people who are infected with Hepatitis C misuse alcohol, which is even more dangerous for them than it is for a non-infected person. In this VA study, such individuals will be screened and given feedback on their drinking using an Internet-based program which has been shown to reduce drinking in other populations. The research team will evaluate whether the program helps Veterans drink less over time and thereby improve their health.
Read the detailed description
As many as 80% of Veterans with the hepatitis C virus (HCV) engage in harmful drinking. This is a major health challenge given that even light and moderate alcohol consumption can worsen the course and consequences of HCV and can be a barrier to receiving antiviral therapy. In response, the VA Uniform Mental Health Services Package has made it a priority that HCV and other ambulatory clinics provide evidence-based mental health services to all Veterans engaging in harmful drinking within two week (but preferably the same day as the clinic visit). The investigators' CREATE partners, the VA Office of Mental Health Services, VA Operations (10N), and the VA Office of Public Health, are strongly committed to achieving this standard throughout the Veterans Health Administration (VHA). However, the cost and organizational challenges to meeting this mandate in HCV clinics are enormous, but may be surmountable through the use of self-directed technology that minimizes demands on scarce staff time.
The primary objective of this study is to implement and evaluate a web-based brief alcohol intervention (BAI) for treating Veterans with HCV and seeking care at two VA HCV clinics - Veterans Affairs Palo Alto Health Care System (VAPAHCS) and San Francisco Veterans Affairs Medical Center (SFVAMC). This study will have three aims: First (Aim 1), the investigators plan to assess patient, provider, and system factors that may impact the initial adoption of this intervention in two VA HCV clinics. These data will result in the development of a protocol for the initial implementation of the web-based BAI at the investigators' two study sites. A secondary aim will involve obtaining patient and provider feedback on an existing web-based BAI (see www.bmi-aft.org, VA Intranet Only) to help inform its redesign for use with this population. Second (Aim 2), the investigators will implement and examine the effectiveness of a web-based BAI in two HCV clinics to reduce alcohol consumption in Veterans with HCV at three- and six-months post-treatment. Third (Aim 3), the investigators will conduct a budget impact analysis to estimate the short-term costs (1-3 years) of adoption and diffusion of the web-based BAI and the trajectory of health care spending for study participants.
This mixed-methods study will utilize qualitative and quantitative methods to achieve its three primary aims. To address aim 1, qualitative interviews will be used to collect data that will inform the initial implementation and re-versioning of a web-based BAI for use in two HCV clinics located at the Palo Alto and San Francisco. To address aim 2, the investigators will use a randomized, hybrid (type 1) design with patient level clinical outcome data and formative evaluation data collected to examine the effectiveness of the web-based BAI. "Hybrid" designs also integrate formative evaluation into experimental designs to identify factors that impact the effectiveness of implementation efforts. Formative evaluation (e.g., site visits, clinic observation, and interviews with staff and patients) will be used to improve the adoption of the web-based BAI at both sites and to provide evidence-based guidance to the investigators' CREATE operational partners for nationwide implementation. To address aim 3, the investigators will conduct a budget impact analysis to estimate the short-term costs (1-3 years) of adoption and diffusion of the web-based BAI and the trajectory of health care spending for study participants. The investigators plan to collect several types of utilization data, including outpatient, inpatient, and pharmacy utilization, and calculate total dollars.
- Conditions
- Hepatitis C, Alcohol Abuse
- Being tested
- Web-Based Brief Alcohol Intervention, Usual Care
- Keywords
- clinical trial, veteran, substance use disorder
- Medical subject headings
- Hepatitis C, Alcoholism, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-Based Brief Alcohol InterventionOther
Participants report their alcohol use and problems on line and receive feedback comparing them to national norms.
Usual CareOther
All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems.
| Study group | Role | What they receive |
|---|---|---|
| BAI Arm | Experimental | Receiving a web-based brief intervention for alcohol problems Receives: Other: Web-Based Brief Alcohol Intervention; Other: Usual Care |
| Usual Care | Active comparator | In usual care, Hepatitis C clinic staff will sometimes discuss alcohol use with patients, and this will be the experience of some of the controls Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Days of Unhealthy Alcohol Consumption
The number of days on which alcohol was consumed beyond recommended levels in the last 30 days.
Measured: Baseline, 3 months, and 6 months
Change in Drinking Days
The number of days on which alcohol was consumed at any level in the last 30 days.
Measured: Baseline, 3 months, and 6 months
Secondary outcomes (4)
Change in Drinks Per Drinking Day
The number of standard drinks (0.5 ounce ethanol equivalent) consumed on those days that an individual drank in the last 30 days.
Measured: Baseline, 3 months, and 6 months
Change in Symptoms of Psychological Distress (PHQ-9)
Symptoms of psychological distress will be measured using the Patient Health Questionnaire (PHQ-9). The PHQ-9 provides an assessment of depression severity. The minimum value is 0 and the maximum value is 27. Lower scores are better. The reliability, validity, and clinical utility of the PHQ-9 instrument are well-established.
Measured: Baseline, 3 months, and 6 months
Change in SF-12 Physical Health Composite
The Short Form-12 (SF-12) is a 12-item health survey based on the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) designed to assess two component health status summary scales (physical and mental component summaries) in the general U.S. population . The SF-12 has demonstrated good internal consistency reliability and construct validity. This reflects the physical health component of the SF-12. Scores range from 0-100 and higher scores are better.
Measured: Baseline, 3 months, and 6 months
Change in Additional Care
Total costs in dollars of all VA and non-VA inpatient, outpatient and pharmacy costs.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study start1 Mar 2015
- Primary completion29 Jun 2018
- Study completion29 Jun 2018
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 (6)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Keith N. Humphreys, PhD MA, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CAMichael A Cucciare, PhD, Principal investigator, Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01707030
- Sponsor's protocol ID
- CRE 12-009
- Status last verified
- Mar 2025
- First submitted
- 3 Oct 2012
- Last updated
- 21 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Timko C, Schultz NR, Cucciare MA, Vittorio L, Garrison-Diehn C. Retention in medication-assisted treatment for opiate dependence: A systematic review. J Addict Dis. 2016;35(1):22-35. doi: 10.1080/10550887.2016.1100960. Epub 2015 Oct 14.
PubMed 26467975Cucciare MA, Timko C. Bridging the gap between medical settings and specialty addiction treatment. Addiction. 2015 Sep;110(9):1417-9. doi: 10.1111/add.12977. No abstract available.
PubMed 26223170Cucciare MA, Cheung RC, Rongey C. Treating substance use disorders in patients with hepatitis C. Addiction. 2015 Jul;110(7):1057-9. doi: 10.1111/add.12893. Epub 2015 Mar 27. No abstract available.
PubMed 25816843Timko C, Kong C, Vittorio L, Cucciare MA. Screening and brief intervention for unhealthy substance use in patients with chronic medical conditions: a systematic review. J Clin Nurs. 2016 Nov;25(21-22):3131-3143. doi: 10.1111/jocn.13244. Epub 2016 May 3.
PubMed 27140392Cucciare MA, Jamison AL, Combs AS, Joshi G, Cheung RC, Rongey C, Huggins J, Humphreys K. Adapting a computer-delivered brief alcohol intervention for veterans with Hepatitis C. Inform Health Soc Care. 2017 Dec;42(4):378-392. doi: 10.1080/17538157.2016.1255628. Epub 2017 Jan 9.
PubMed 28068154Cucciare MA, Combs AS, Joshi G, Han X, Humphreys K. Computer-delivered brief alcohol intervention for patients with liver disease: a randomized controlled trial. Addiction. 2021 May;116(5):1076-1087. doi: 10.1111/add.15263. Epub 2020 Oct 6.
PubMed 32924207
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based Intervention to Reduce Alcohol Use in Veterans With Hepatitis C
- ClinicalTrials.gov ID
- NCT01707030
- Acronym / sponsor ID
- CRE 12-009
- Conditions
- Hepatitis C, Alcohol Abuse
- Keywords
- clinical trial, veteran, substance use disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 29 Jun 2018 (actual)
- Study completion
- 29 Jun 2018 (actual)
- First posted
- 15 Oct 2012 (estimated)
- Results
- Posted 25 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many people who are infected with Hepatitis C misuse alcohol, which is even more dangerous for them than it is for a non-infected person. In this VA study, such individuals will be screened and given feedback on their drinking using an Internet-based program which has been shown to reduce drinking in other populations. The research team will evaluate whether the program helps Veterans drink less over time and thereby improve their health.
Detailed description
As many as 80% of Veterans with the hepatitis C virus (HCV) engage in harmful drinking. This is a major health challenge given that even light and moderate alcohol consumption can worsen the course and consequences of HCV and can be a barrier to receiving antiviral therapy. In response, the VA Uniform Mental Health Services Package has made it a priority that HCV and other ambulatory clinics provide evidence-based mental health services to all Veterans engaging in harmful drinking within two week (but preferably the same day as the clinic visit). The investigators' CREATE partners, the VA Office of Mental Health Services, VA Operations (10N), and the VA Office of Public Health, are strongly committed to achieving this standard throughout the Veterans Health Administration (VHA). However, the cost and organizational challenges to meeting this mandate in HCV clinics are enormous, but may be surmountable through the use of self-directed technology that minimizes demands on scarce staff time.
The primary objective of this study is to implement and evaluate a web-based brief alcohol intervention (BAI) for treating Veterans with HCV and seeking care at two VA HCV clinics - Veterans Affairs Palo Alto Health Care System (VAPAHCS) and San Francisco Veterans Affairs Medical Center (SFVAMC). This study will have three aims: First (Aim 1), the investigators plan to assess patient, provider, and system factors that may impact the initial adoption of this intervention in two VA HCV clinics. These data will result in the development of a protocol for the initial implementation of the web-based BAI at the investigators' two study sites. A secondary aim will involve obtaining patient and provider feedback on an existing web-based BAI (see www.bmi-aft.org, VA Intranet Only) to help inform its redesign for use with this population. Second (Aim 2), the investigators will implement and examine the effectiveness of a web-based BAI in two HCV clinics to reduce alcohol consumption in Veterans with HCV at three- and six-months post-treatment. Third (Aim 3), the investigators will conduct a budget impact analysis to estimate the short-term costs (1-3 years) of adoption and diffusion of the web-based BAI and the trajectory of health care spending for study participants.
This mixed-methods study will utilize qualitative and quantitative methods to achieve its three primary aims. To address aim 1, qualitative interviews will be used to collect data that will inform the initial implementation and re-versioning of a web-based BAI for use in two HCV clinics located at the Palo Alto and San Francisco. To address aim 2, the investigators will use a randomized, hybrid (type 1) design with patient level clinical outcome data and formative evaluation data collected to examine the effectiveness of the web-based BAI. "Hybrid" designs also integrate formative evaluation into experimental designs to identify factors that impact the effectiveness of implementation efforts. Formative evaluation (e.g., site visits, clinic observation, and interviews with staff and patients) will be used to improve the adoption of the web-based BAI at both sites and to provide evidence-based guidance to the investigators' CREATE operational partners for nationwide implementation. To address aim 3, the investigators will conduct a budget impact analysis to estimate the short-term costs (1-3 years) of adoption and diffusion of the web-based BAI and the trajectory of health care spending for study participants. The investigators plan to collect several types of utilization data, including outpatient, inpatient, and pharmacy utilization, and calculate total dollars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAI Arm | Experimental | Other: Web-Based Brief Alcohol Intervention, Other: Usual CareReceiving a web-based brief intervention for alcohol problems |
| Usual Care | Active comparator | Other: Usual CareIn usual care, Hepatitis C clinic staff will sometimes discuss alcohol use with patients, and this will be the experience of some of the controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must be a US military veteran.
- Over the age of 17 with liver disease.
- Must be receiving care at a VA liver clinic.
Key exclusion criteria (1 listed)
- Those with no current or historical use of alcohol.
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 |
|---|---|---|
| Web-Based Brief Alcohol InterventionParticipants report their alcohol use and problems on line and receive feedback comparing them to national norms. | Other | BAI Arm |
| Usual CareAll patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems. | Other | BAI Arm, Usual Care |
Primary outcome
Change in Days of Unhealthy Alcohol Consumption
Time frame: Baseline, 3 months, and 6 months
The number of days on which alcohol was consumed beyond recommended levels in the last 30 days.
Change in Drinking Days
Time frame: Baseline, 3 months, and 6 months
The number of days on which alcohol was consumed at any level in the last 30 days.
4 secondary outcomes
Change in Drinks Per Drinking Day
Time frame: Baseline, 3 months, and 6 months
Change in Symptoms of Psychological Distress (PHQ-9)
Time frame: Baseline, 3 months, and 6 months
Change in SF-12 Physical Health Composite
Time frame: Baseline, 3 months, and 6 months
Change in Additional Care
Time frame: Baseline and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26467975Timko C, Schultz NR, Cucciare MA, Vittorio L, Garrison-Diehn C. Retention in medication-assisted treatment for opiate dependence: A systematic review. J Addict Dis. 2016;35(1):22-35. doi: 10.1080/10550887.2016.1100960. Epub 2015 Oct 14.
- Results publication: PubMed 26223170Cucciare MA, Timko C. Bridging the gap between medical settings and specialty addiction treatment. Addiction. 2015 Sep;110(9):1417-9. doi: 10.1111/add.12977. No abstract available.
- Results publication: PubMed 25816843Cucciare MA, Cheung RC, Rongey C. Treating substance use disorders in patients with hepatitis C. Addiction. 2015 Jul;110(7):1057-9. doi: 10.1111/add.12893. Epub 2015 Mar 27. No abstract available.
- Results publication: PubMed 27140392Timko C, Kong C, Vittorio L, Cucciare MA. Screening and brief intervention for unhealthy substance use in patients with chronic medical conditions: a systematic review. J Clin Nurs. 2016 Nov;25(21-22):3131-3143. doi: 10.1111/jocn.13244. Epub 2016 May 3.
- Results publication: PubMed 28068154Cucciare MA, Jamison AL, Combs AS, Joshi G, Cheung RC, Rongey C, Huggins J, Humphreys K. Adapting a computer-delivered brief alcohol intervention for veterans with Hepatitis C. Inform Health Soc Care. 2017 Dec;42(4):378-392. doi: 10.1080/17538157.2016.1255628. Epub 2017 Jan 9.
- Results publication: PubMed 32924207Cucciare MA, Combs AS, Joshi G, Han X, Humphreys K. Computer-delivered brief alcohol intervention for patients with liver disease: a randomized controlled trial. Addiction. 2021 May;116(5):1076-1087. doi: 10.1111/add.15263. Epub 2020 Oct 6.
- Individual participant dataSharing planned: No
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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.
Keith N. Humphreys, PhD MA principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
Michael A Cucciare, PhD principal investigator
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-Based Brief Alcohol Intervention in people with Hepatitis C and Alcohol Abuse, run by VA Office of Research and Development at 2 sites 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 3 inclusion and 1 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 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 25 Sep 2019). 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?
Change in Days of Unhealthy Alcohol Consumption (time frame: Baseline, 3 months, and 6 months). The study lists 2 primary outcomes in all. 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 NCT01707030, which also lists 6 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 21 Mar 2025.