Clinical trial NCT01410123: Integrated Stepped Care for Unhealthy Alcohol Use in HIV
Official title: Integrated Stepped Care for Unhealthy Alcohol Use in HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Diseases, Alcoholic
Alcoholism
HIV
Hepatitis C
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: US Department of Veterans Affairs
First posted: 2011-08-04
Enrollment: 319
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Be HIV-infected and receiving HIV care at one of the participating medical centers.
2. 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.
3. Be able to understand English and provide informed consent.

Exclusion Criteria:

1. 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).
2. Be currently enrolled in formal treatment for alcohol (excluding self-help, e.g. Alcoholics Anonymous)
3. Have medical conditions that would preclude completing or be of harm during the course of the study.
4. Pregnant or nursing women or women who do not agree to use a reliable form of birth control.

Primary outcomes:
measure: At risk drinking: Drinks per week
timeFrame: 6 months
measure: Alcohol abuse or dependence: Drinks per week
timeFrame: 6 months
measure: Moderate Alcohol + Liver Disease group: Abstinence.
timeFrame: 6 months
Secondary outcomes:
measure: Alcohol consumption by phosphatidylethanol (PEth), an alcohol biomarker
timeFrame: 6 months
measure: Change in biological markers as measured by the VACS index.
timeFrame: 6 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington DC VAMC
state: District of Columbia
city: Atlanta
country: United States
facility: VAMC Atlanta
state: Georgia
city: New York
country: United States
facility: New York VAMC - New York Harbor Healthcare System
state: New York
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
city: Houston
country: United States
facility: VAMC Houston
state: Texas
Study officials:
affiliation: Yale University
name: David Fiellin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Jennifer Edelman, M.D., MHS
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Edelman 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.
citation: Edelman 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.
citation: Edelman 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.
citation: Edelman 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.
citation: Eyawo 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.
citation: McGinnis 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.