Integrated Stepped Care for Unhealthy Alcohol Use in HIV

Tracking Information
First Submitted Date ICMJE	July 28, 2011
First Posted Date ICMJE	August 4, 2011
Last Update Posted Date	January 10, 2018
Study Start Date ICMJE	January 2013
Estimated Primary Completion Date	July 2018 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: August 2, 2011)	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 ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01410123 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: January 8, 2018)	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 ]
Original Secondary Outcome Measures ICMJE; (submitted: August 2, 2011)	Change in biological markers as measured by the VACS index. [ Time Frame: 6 months ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Integrated Stepped Care for Unhealthy Alcohol Use in HIV
Official Title ICMJE	Integrated Stepped Care for Unhealthy Alcohol Use in HIV
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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Liver Diseases, Alcoholic; Alcoholism; HIV; Hepatitis C
Intervention ICMJE	Other: Integrated Stepped Care (ISC) 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.; Other: Treatment as Usual 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 Arms	Treatment as Usual (TAU) Intervention: Other: Treatment as Usual; Integrated Stepped Care (ISC) Intervention: Other: Integrated Stepped Care (ISC)
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.; 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. Erratum in: Contemp Clin Trials. 2017 Sep;60:125.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Active, not recruiting
Actual Enrollment ICMJE; (submitted: January 8, 2018)	319
Original Estimated Enrollment ICMJE; (submitted: August 2, 2011)	642
Estimated Study Completion Date	July 2018
Estimated Primary Completion Date	July 2018 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: 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. Exclusion Criteria: 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.
Sex/Gender	Sexes Eligible for Study: All
Ages	21 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01410123
Other Study ID Numbers ICMJE	1105008544; U01AA020795 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Yale University
Study Sponsor ICMJE	Yale University
Collaborators ICMJE	National Institute on Alcohol Abuse and Alcoholism (NIAAA); VA Office of Research and Development
Investigators ICMJE	Principal Investigator: David Fiellin, MD Yale University Study Director: Jennifer Edelman, M.D., MHS Yale University
PRS Account	Yale University
Verification Date	January 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP