Liver Diseases, AlcoholicNCT01410123
Integrated Stepped Care for Unhealthy Alcohol Use in HIV
A study testing Integrated Stepped Care (ISC) and Treatment as Usual in people with Liver Diseases, Alcoholic and Alcoholism, run by Yale University at 5 sites in United States.
Trial summary
The study is a series of 3 linked randomized clinical trials of 6 month duration, with a total of 12 month follow-up, to evaluate the effect of Integrated Stepped Care on drinking outcomes and HIV biologic markers (including VACS index) in HIV-infected patients with unhealthy alcohol use. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Liver Diseases, Alcoholic, Alcoholism, HIV
- What is being tested?
- Integrated Stepped Care (ISC) and Treatment as Usual
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 319 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2013to 31 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be HIV-infected and receiving HIV care at one of the participating medical centers.
- Meet one of the following criteria for unhealthy alcohol use:
- At-risk Drinking Study- greater than 14 drinks per week or greater than 4 drinks per occasion in men and greater than 7 drinks per week or greater than 3 drinks per occasion in women and those over 65.
- Alcohol Abuse or Dependence Study - Meet DSM-IV TR criteria for alcohol abuse or dependence, not in remission.
- Moderate Alcohol + Liver Disease Study - Report alcohol consumption in the past month, are HCV co-infected, confirmed by HCV viral load or have liver fibrosis - Fib-4 (>1.45). Do not meet criteria for at-risk drinking, alcohol abuse or dependence.
- Be able to understand English and provide informed consent.
Who cannot join
- Be acutely suicidal, or with a psychiatric condition that affects the ability to provide informed consent or participate in counseling interventions (e.g. psychotic, dementia, delusional).
- Be currently enrolled in formal treatment for alcohol (excluding self-help, e.g. Alcoholics Anonymous)
- Have medical conditions that would preclude completing or be of harm during the course of the study.
- Pregnant or nursing women or women who do not agree to use a reliable form of birth control.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
VAMC Atlanta
Atlanta, Georgia, 30033
Dallas VA Medical Center
Dallas, Texas, 75216
VAMC Houston
Houston, Texas, 77030
New York VAMC - New York Harbor Healthcare System
New York, New York, 10010
Washington DC VAMC
Washington D.C., District of Columbia, 20422
About this study
The study is a series of 3 linked randomized clinical trials of 6 month duration, with a total of 12 month follow-up, to evaluate the effect of Integrated Stepped Care on drinking outcomes and HIV biologic markers (including VACS index) in HIV-infected patients with unhealthy alcohol use.
Read the detailed description
Unhealthy alcohol use threatens the health benefits seen with antiretroviral therapy (ART) for HIV-infected (HIV+) patients. Although research has demonstrated the efficacy of brief interventions, motivational counseling, and medications to treat unhealthy alcohol use in HIV uninfected patients, there is limited research or use of these treatments in HIV+ patients. We have demonstrated that integrated treatment of addiction in HIV clinics is feasible. Stepped care algorithms can facilitate the evaluation of varying intensities of treatments for unhealthy alcohol use. The proposed study will compare onsite Integrated Stepped Care treatment (ISC) to treatment as usual (TAU) in three, linked, 6-month randomized clinical trials in 642 HIV+ patients with unhealthy alcohol use. Screened patients are randomized to ISC or TAU after determining that they meet criteria for either 1) at-risk drinking, 2) alcohol abuse or dependence or 3) moderate alcohol consumption in the presence of liver disease. ISC and TAU are tailored to the drinking category. ISC for at-risk drinkers and those with Moderate Alcohol use and Liver Disease begins with a brief intervention and is stepped up to Motivational Enhancement Therapy (MET) in those who meet predefined failure criteria. ISC for abuse or dependence begins with addiction physician management (APM) including alcohol pharmacotherapy if not contraindicated. APM is stepped up to include MET if predefined failure criteria are met. The study will test the hypothesis that ISC leads to decreased alcohol consumption and improved HIV biomarkers. Data analyses will be conducted on the intention to treat sample.
- Conditions
- Liver Diseases, Alcoholic, Alcoholism, HIV, Hepatitis C
- Being tested
- Integrated Stepped Care (ISC), Treatment as Usual
- Medical subject headings
- Liver Diseases, Alcoholic, Alcoholism, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Stepped Care (ISC)Other
- At risk drinking: Step 1: Brief negotiated interview (BNI) + booster; Step 2: Motivational Enhancement Therapy; Step 3: Addiction Physician Management + Alcohol pharmacotherapy
- Alcohol abuse/dependence: Step 1: Addiction Physician Management + Alcohol Pharmacotherapy; Step 2: Motivational Enhancement Therapy; Step 3: Detoxification and aftercare
- Moderate Alcohol + Liver Disease:
Step 1: Brief Negotiated Interview (BNI)+ booster; Step 2: Motivational Enhancement Therapy; Step 3: Addiction physician management + alcohol pharmacotherapy.
Treatment as UsualOther
The TAU arm will receive a handout with alcohol information embedded within general health-related information (exercise, smoking cessation, and flu vaccination) and standard care as provided by their treating physician. All patients will have access to a NIAAA informational website.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual (TAU) | Other | Not described Receives: Other: Treatment as Usual |
| Integrated Stepped Care (ISC) | Other | Not described Receives: Other: Integrated Stepped Care (ISC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
At risk drinking: Drinks per week
Measured: 6 months
Alcohol abuse or dependence: Drinks per week
Measured: 6 months
Moderate Alcohol + Liver Disease group: Abstinence.
Measured: 6 months
Secondary outcomes (2)
Alcohol consumption by phosphatidylethanol (PEth), an alcohol biomarker
Measured: 6 months
Change in biological markers as measured by the VACS index.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2011 (estimated)
- Study startJan 2013
- Primary completion31 Jul 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Liver Diseases, AlcoholicStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), US Department of Veterans Affairs
- Responsible party
- Sponsor
- Investigators
- David Fiellin, MD, Principal investigator, Yale UniversityJennifer Edelman, M.D., MHS, Study director, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410123
- Sponsor's protocol ID
- 1105008544
- Other IDs
- U01AA020795
- Status last verified
- Dec 2022
- First submitted
- 28 Jul 2011
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Edelman EJ, Hansen NB, Cutter CJ, Danton C, Fiellin LE, O'Connor PG, Williams EC, Maisto SA, Bryant KJ, Fiellin DA. Implementation of integrated stepped care for unhealthy alcohol use in HIV clinics. Addict Sci Clin Pract. 2016 Jan 13;11(1):1. doi: 10.1186/s13722-015-0048-z.
PubMed 26763048Edelman EJ, Maisto SA, Hansen NB, Cutter CJ, Dziura J, Fiellin LE, O'Connor PG, Bedimo R, Gibert C, Marconi VC, Rimland D, Rodriguez-Barradas MC, Simberkoff MS, Justice AC, Bryant KJ, Fiellin DA. The Starting Treatment for Ethanol in Primary care Trials (STEP Trials): Protocol for Three Parallel Multi-Site Stepped Care Effectiveness Studies for Unhealthy Alcohol Use in HIV-Positive Patients. Contemp Clin Trials. 2017 Jan;52:80-90. doi: 10.1016/j.cct.2016.11.008. Epub 2016 Nov 20.
PubMed 27876616Edelman EJ, Maisto SA, Hansen NB, Cutter CJ, Dziura J, Deng Y, Fiellin LE, O'Connor PG, Bedimo R, Gibert CL, Marconi VC, Rimland D, Rodriguez-Barradas MC, Simberkoff MS, Tate JP, Justice AC, Bryant KJ, Fiellin DA. Integrated stepped alcohol treatment for patients with HIV and liver disease: A randomized trial. J Subst Abuse Treat. 2019 Nov;106:97-106. doi: 10.1016/j.jsat.2019.08.007. Epub 2019 Aug 17.
PubMed 31540617Edelman EJ, Maisto SA, Hansen NB, Cutter CJ, Dziura J, Deng Y, Fiellin LE, O'Connor PG, Bedimo R, Gibert CL, Marconi VC, Rimland D, Rodriguez-Barradas MC, Simberkoff MS, Tate JP, Justice AC, Bryant KJ, Fiellin DA. Integrated stepped alcohol treatment for patients with HIV and alcohol use disorder: a randomised controlled trial. Lancet HIV. 2019 Aug;6(8):e509-e517. doi: 10.1016/S2352-3018(19)30076-1. Epub 2019 May 17.
PubMed 31109915Edelman EJ, Maisto SA, Hansen NB, Cutter CJ, Dziura J, Deng Y, Fiellin LE, O'Connor PG, Bedimo R, Gibert CL, Marconi VC, Rimland D, Rodriguez-Barradas MC, Simberkoff MS, Tate JP, Justice AC, Bryant KJ, Fiellin DA. Integrated stepped alcohol treatment for patients with HIV and at-risk alcohol use: a randomized trial. Addict Sci Clin Pract. 2020 Jul 29;15(1):28. doi: 10.1186/s13722-020-00200-y.
PubMed 32727618Eyawo O, Deng Y, Dziura J, Justice AC, McGinnis K, Tate JP, Rodriguez-Barradas MC, Hansen NB, Maisto SA, Marconi VC, O'Connor PG, Bryant K, Fiellin DA, Edelman EJ. Validating Self-Reported Unhealthy Alcohol Use With Phosphatidylethanol (PEth) Among Patients With HIV. Alcohol Clin Exp Res. 2020 Oct;44(10):2053-2063. doi: 10.1111/acer.14435. Epub 2020 Sep 19.
PubMed 33460225McGinnis KA, Tate JP, Bryant KJ, Justice AC, O'Connor PG, Rodriguez-Barradas MC, Crystal S, Cutter CJ, Hansen NB, Maisto SA, Marconi VC, Williams EC, Cook RL, Gordon AJ, Gordon KS, Eyawo O, Edelman EJ, Fiellin DA. Change in Alcohol Use Based on Self-Report and a Quantitative Biomarker, Phosphatidylethanol, in People With HIV. AIDS Behav. 2022 Mar;26(3):786-794. doi: 10.1007/s10461-021-03438-y. Epub 2021 Sep 20.
PubMed 34542779
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Stepped Care for Unhealthy Alcohol Use in HIV
- ClinicalTrials.gov ID
- NCT01410123
- Acronym / sponsor ID
- 1105008544
- Conditions
- Liver Diseases, Alcoholic, Alcoholism, HIV, Hepatitis C
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), US Department of Veterans Affairs
- Study start
- Jan 2013
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 4 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a series of 3 linked randomized clinical trials of 6 month duration, with a total of 12 month follow-up, to evaluate the effect of Integrated Stepped Care on drinking outcomes and HIV biologic markers (including VACS index) in HIV-infected patients with unhealthy alcohol use.
Detailed description
Unhealthy alcohol use threatens the health benefits seen with antiretroviral therapy (ART) for HIV-infected (HIV+) patients. Although research has demonstrated the efficacy of brief interventions, motivational counseling, and medications to treat unhealthy alcohol use in HIV uninfected patients, there is limited research or use of these treatments in HIV+ patients. We have demonstrated that integrated treatment of addiction in HIV clinics is feasible. Stepped care algorithms can facilitate the evaluation of varying intensities of treatments for unhealthy alcohol use. The proposed study will compare onsite Integrated Stepped Care treatment (ISC) to treatment as usual (TAU) in three, linked, 6-month randomized clinical trials in 642 HIV+ patients with unhealthy alcohol use. Screened patients are randomized to ISC or TAU after determining that they meet criteria for either 1) at-risk drinking, 2) alcohol abuse or dependence or 3) moderate alcohol consumption in the presence of liver disease. ISC and TAU are tailored to the drinking category. ISC for at-risk drinkers and those with Moderate Alcohol use and Liver Disease begins with a brief intervention and is stepped up to Motivational Enhancement Therapy (MET) in those who meet predefined failure criteria. ISC for abuse or dependence begins with addiction physician management (APM) including alcohol pharmacotherapy if not contraindicated. APM is stepped up to include MET if predefined failure criteria are met. The study will test the hypothesis that ISC leads to decreased alcohol consumption and improved HIV biomarkers. Data analyses will be conducted on the intention to treat sample.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual (TAU) | Other | Other: Treatment as Usual |
| Integrated Stepped Care (ISC) | Other | Other: Integrated Stepped Care (ISC) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be HIV-infected and receiving HIV care at one of the participating medical centers.
- Meet one of the following criteria for unhealthy alcohol use:
- Be able to understand English and provide informed consent.
Key exclusion criteria (4 listed)
- Be acutely suicidal, or with a psychiatric condition that affects the ability to provide informed consent or participate in counseling interventions (e.g. psychotic, dementia, delusional).
- Be currently enrolled in formal treatment for alcohol (excluding self-help, e.g. Alcoholics Anonymous)
- Have medical conditions that would preclude completing or be of harm during the course of the study.
- Pregnant or nursing women or women who do not agree to use a reliable form of birth control.
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 |
|---|---|---|
| Integrated Stepped Care (ISC)1. At risk drinking: Step 1: Brief negotiated interview (BNI) + booster; Step 2: Motivational Enhancement Therapy; Step 3: Addiction Physician Management + Alcohol pharmacotherapy 2. Alcohol abuse/dependence: Step 1: Addiction Physician Management + Alcohol Pharmacotherapy; Step 2: Motivational Enhancement Therapy; Step 3: Detoxification and aftercare 3. Moderate Alcohol + Liver Disease: Step 1: Brief Negotiated Interview (BNI)+ booster; Step 2: Motivational Enhancement Therapy; Step 3: Addiction physician management + alcohol pharmacotherapy. | Other | Integrated Stepped Care (ISC) |
| Treatment as UsualThe TAU arm will receive a handout with alcohol information embedded within general health-related information (exercise, smoking cessation, and flu vaccination) and standard care as provided by their treating physician. All patients will have access to a NIAAA informational website. | Other | Treatment as Usual (TAU) |
Primary outcome
At risk drinking: Drinks per week
Time frame: 6 months
Alcohol abuse or dependence: Drinks per week
Time frame: 6 months
Moderate Alcohol + Liver Disease group: Abstinence.
Time frame: 6 months
2 secondary outcomes
Alcohol consumption by phosphatidylethanol (PEth), an alcohol biomarker
Time frame: 6 months
Change in biological markers as measured by the VACS index.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Background: PubMed 26763048Edelman EJ, Hansen NB, Cutter CJ, Danton C, Fiellin LE, O'Connor PG, Williams EC, Maisto SA, Bryant KJ, Fiellin DA. Implementation of integrated stepped care for unhealthy alcohol use in HIV clinics. Addict Sci Clin Pract. 2016 Jan 13;11(1):1. doi: 10.1186/s13722-015-0048-z.
- Background: PubMed 27876616Edelman EJ, Maisto SA, Hansen NB, Cutter CJ, Dziura J, Fiellin LE, O'Connor PG, Bedimo R, Gibert C, Marconi VC, Rimland D, Rodriguez-Barradas MC, Simberkoff MS, Justice AC, Bryant KJ, Fiellin DA. The Starting Treatment for Ethanol in Primary care Trials (STEP Trials): Protocol for Three Parallel Multi-Site Stepped Care Effectiveness Studies for Unhealthy Alcohol Use in HIV-Positive Patients. Contemp Clin Trials. 2017 Jan;52:80-90. doi: 10.1016/j.cct.2016.11.008. Epub 2016 Nov 20.
- Results publication: PubMed 31540617Edelman EJ, Maisto SA, Hansen NB, Cutter CJ, Dziura J, Deng Y, Fiellin LE, O'Connor PG, Bedimo R, Gibert CL, Marconi VC, Rimland D, Rodriguez-Barradas MC, Simberkoff MS, Tate JP, Justice AC, Bryant KJ, Fiellin DA. Integrated stepped alcohol treatment for patients with HIV and liver disease: A randomized trial. J Subst Abuse Treat. 2019 Nov;106:97-106. doi: 10.1016/j.jsat.2019.08.007. Epub 2019 Aug 17.
- Results publication: PubMed 31109915Edelman EJ, Maisto SA, Hansen NB, Cutter CJ, Dziura J, Deng Y, Fiellin LE, O'Connor PG, Bedimo R, Gibert CL, Marconi VC, Rimland D, Rodriguez-Barradas MC, Simberkoff MS, Tate JP, Justice AC, Bryant KJ, Fiellin DA. Integrated stepped alcohol treatment for patients with HIV and alcohol use disorder: a randomised controlled trial. Lancet HIV. 2019 Aug;6(8):e509-e517. doi: 10.1016/S2352-3018(19)30076-1. Epub 2019 May 17.
- Results publication: PubMed 32727618Edelman EJ, Maisto SA, Hansen NB, Cutter CJ, Dziura J, Deng Y, Fiellin LE, O'Connor PG, Bedimo R, Gibert CL, Marconi VC, Rimland D, Rodriguez-Barradas MC, Simberkoff MS, Tate JP, Justice AC, Bryant KJ, Fiellin DA. Integrated stepped alcohol treatment for patients with HIV and at-risk alcohol use: a randomized trial. Addict Sci Clin Pract. 2020 Jul 29;15(1):28. doi: 10.1186/s13722-020-00200-y.
- Results publication: PubMed 33460225Eyawo O, Deng Y, Dziura J, Justice AC, McGinnis K, Tate JP, Rodriguez-Barradas MC, Hansen NB, Maisto SA, Marconi VC, O'Connor PG, Bryant K, Fiellin DA, Edelman EJ. Validating Self-Reported Unhealthy Alcohol Use With Phosphatidylethanol (PEth) Among Patients With HIV. Alcohol Clin Exp Res. 2020 Oct;44(10):2053-2063. doi: 10.1111/acer.14435. Epub 2020 Sep 19.
- Results publication: PubMed 34542779McGinnis KA, Tate JP, Bryant KJ, Justice AC, O'Connor PG, Rodriguez-Barradas MC, Crystal S, Cutter CJ, Hansen NB, Maisto SA, Marconi VC, Williams EC, Cook RL, Gordon AJ, Gordon KS, Eyawo O, Edelman EJ, Fiellin DA. Change in Alcohol Use Based on Self-Report and a Quantitative Biomarker, Phosphatidylethanol, in People With HIV. AIDS Behav. 2022 Mar;26(3):786-794. doi: 10.1007/s10461-021-03438-y. Epub 2021 Sep 20.
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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.
David Fiellin, MD principal investigator
Yale University
Jennifer Edelman, M.D., MHS study director
Yale University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Stepped Care (ISC) and Treatment as Usual in people with Liver Diseases, Alcoholic and Alcoholism, run by Yale University at 5 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 6 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 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
At risk drinking: Drinks per week (time frame: 6 months). The study lists 3 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 NCT01410123, which also lists 7 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 Dec 2022.