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Financial Incentives, Randomization With Stepped Treatment Trial (FIRST)

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ClinicalTrials.gov Identifier: NCT03089320
Recruitment Status : Recruiting
First Posted : March 24, 2017
Last Update Posted : August 14, 2018
Sponsor:
Collaborators:
VA Connecticut Healthcare System
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Yale University

Brief Summary:
The investigators plan to determine the effectiveness of contingency management (CM) plus stepped care for unhealthy alcohol use in HIV-positive patients.

Condition or disease Intervention/treatment Phase
Unhealthy Alcohol Use Behavioral: Contingency Management Counseling Behavioral: Addiction Physician Management Behavioral: Motivational Enhancement Therapy Not Applicable

Detailed Description:
HIV-positive patients with unhealthy alcohol use are not often motivated to decrease their alcohol consumption and rarely receive treatment for their drinking. To address these challenges, we plan to provide treatment in HIV clinics, highlight to patients the impact alcohol can have on their medical conditions, and use Contingency Management (CM) with a stepped care design to adjust treatment to patient response. CM is an evidence based therapy that promotes abstinence from substance use, including alcohol. Since CM has not been studied for unhealthy alcohol use in HIV-infected patients we will include a stepped care strategy that provides Addiction Psychiatrist Management (APM) (with alcohol pharmacotherapies as indicated) and Motivational Enhancement Therapy (MET) for patients who do not achieve abstinence with CM. Phosphatidylethanol (PEth), is a validated biomarker that can confirm alcohol abstinence over three weeks. To capture the range of adverse effects of alcohol on health, we will include patients with at-risk drinking, alcohol use disorder, and medical conditions that can be adversely impacted by alcohol including those with a detectable HIV viral load, tobacco use disorder, liver fibrosis, untreated hepatitis C, depression and those taking psychoactive medications that interact with alcohol. The goal of the Financial Incentives, Randomization with Stepped Treatment (FIRST) Trial is to compare onsite CM plus stepped care versus treatment as usual (TAU) in a randomized clinical trial of HIV-positive patients with unhealthy alcohol use at seven HIV clinics. CM patients will receive onsite CM counseling sessions with financial rewards contingent on abstinence demonstrated by breathalyzer and PEth. Rewards can also be awarded for addressing medical conditions impacted by alcohol and achieving alcohol treatment goals. After three months, patients will be stepped up to APM and MET if PEth results indicate they have not attained abstinence. This randomized clinical trial will test the hypothesis that CM plus stepped care leads to greater abstinence, decreased alcohol consumption and improved HIV biomarkers as measured by the VACS Index.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 348 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Financial Incentives, Randomization With Stepped Treatment Trial
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol HIV/AIDS

Arm Intervention/treatment
No Intervention: Treatment As Usual (TAU)
We have elected to compare the CM plus stepped care condition to TAU to test its efficacy against a "real world" control and because CM plus stepped care is a comprehensive stand alone intervention that would substitute for TAU. While annual AUDIT-C screening is mandatory at the 7 sites, providing interventions for patients with unhealthy alcohol use is a matter of physician judgment and individual clinical practice with wide practice variation. HIV clinicians will not receive knowledge of the results of follow-up research assessments. We will conduct a Treatment Services Review at each follow-up to assess for receipt of addiction treatment services received since the last assessment and assess for contamination.
Experimental: Contingency Management plus Stepped Care (Step 2)

Step 1: Contingency management; Step 2: Addiction physician management and motivational enhancement therapy

Consistent with tenets of stepped care designs we provide a priori intervals and criteria (drinking targets) that dictate increasing the intensity of treatment (stepping up) based on research and standards in the field. All CM plus stepped care subjects will undergo PEth testing at 3 months to determine the efficacy of Step 1. Patients with a PEth > 8 ng/ml will continue on to Step 2.

Behavioral: Contingency Management Counseling
Contingency management (CM) is an efficacious treatment for individuals with substance use disorders. In line with operant conditioning, CM typically provides reinforcers (rewards) contingent upon attaining specified goals such as decreased substance use and/or abstinence.

Behavioral: Addiction Physician Management
Patients in the CM plus stepped care arm who have PEth > 8 ng/ml at 3 months will progress to Step 2 and receive onsite treatment from an Addiction Psychiatrist (APM) in the HIV clinic. APM will provide care that is typically provided by physicians in specialty referral programs.

Behavioral: Motivational Enhancement Therapy

Patients in the CM plus stepped care arm who have PEth > 8 ng/ml at 3 months will progress to Step 2 and receive onsite Motivational Enhancement Therapy (MET) from the Social Worker in the HIV clinic.

MET is grounded in research on processes of natural recovery during which patients move through stages of change - precontemplation, contemplation, determination, action, and maintenance. The Social Worker's role is to assist the patient in moving through the stages of change. MET uses motivational interviewing and reflective listening to help patients identify internal sources of motivation to support reductions in alcohol.





Primary Outcome Measures :
  1. Proportion of participants of participants with Phosphatidylethanol (PeTH) documented abstinence by the alcohol biomarker, phosphatidylethanol (PEth) [ Time Frame: 6 month ]
    Phosphatidylethanol (PEth) accumulates in human red blood cells when the body is exposed to ethanol. Alcohol biomarkers are physiological indicators of alcohol exposure or ingestion and may reflect the presence of chronic and/or high level of use of alcohol. This will be evaluated as a binary variable to determine the proportion with abstinence (defined as % with PEth value <8ng/mL).


Secondary Outcome Measures :
  1. Change in biological markers as measured by the VACS index [ Time Frame: 6 months ]
    The Veterans Aging Cohort Study Index (VACS Index) creates a score by summing pre-assigned points for age, routinely monitored indicators of HIV disease (CD4 count and HIV-1 RNA), and general indicators of organ system injury including hemoglobin, platelets, aspartate and alanine transaminase (AST and ALT), creatinine, and viral hepatitis C infection (HCV). This score is weighted to indicate increasing risk of all-cause mortality with increasing score. The score can be used to estimate risk of all-cause mortality using a conversion factor. The VACS Index will be evaluated based on most recent values at the time of data extraction. VACS Index score will be treated as a continuous variable.

  2. Self-reported abstinence from alcohol [ Time Frame: 6 months ]
    Recorded via web based time-line followback


Other Outcome Measures:
  1. Undetectable HIV Viral load [ Time Frame: 6 months ]
    Viral load will be analyzed as a continuous measure (log10 copies/ml).

  2. Smoking cessation by exhaled carbon monoxide [ Time Frame: 6 months ]
    It is measured by CO monitor

  3. Liver fibrosis based on Fibrosis-4 (FIB-4) score [ Time Frame: 6 months ]
    The Fibrosis-4 score helps to estimate the amount of scarring in the liver. Using a lower cutoff value of 1.45, a FIB-4 score <1.45 had a negative predictive value of 90% for advanced fibrosis (Ishak fibrosis score 4-6 which includes early bridging fibrosis to cirrhosis). In contrast, a FIB-4 >3.25 would have a 97% specificity and a positive predictive value of 65% for advanced fibrosis. In the patient cohort in which this formula was first validated, at least 70% patients had values <1.45 or >3.25.

  4. Undetectable Hepatitis C viral load [ Time Frame: 6 months ]
    An HCV antibody test is used to screen for past exposure and current infection. It detects the presence of antibodies to the virus, indicating exposure to HCV.

  5. Depressive symptoms via PHQ-9 [ Time Frame: 6 months ]
    Patient Health Questionnaire (PHQ-9) ranges from 0 to 27. A higher score indicates worse depression. 5-9 are minimal symptoms, 10-14 is considered minor depression, 15-19 is major depression that is moderately severe, and >20 is severe, major depression.

  6. Recent receipt of a psychoactive medication that may interact with alcohol [ Time Frame: 6 months ]
    number of patients with use of psychoactive medications that interact with alcohol



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be HIV-infected.
  • Recent significant alcohol consumption as determined by a PEth greater than 20 ng/ml.
  • Able to provide informed consent.
  • Meet any of the following criteria for unhealthy alcohol use:
  • At-risk Drinking - 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 65.161
  • Medical condition impacted by alcohol as evidenced by one of the following: 1) detectable HIV viral load (>200 copies/ml),) tobacco use disorder and smoking more than 5 cigarettes per day, 3) detectable HCV virus, 4) liver fibrosis with a FIB-4 >1.45) Patient Health Questionnaire (PHQ-9, validated measure for depression) score greater than 9, or 6) current (at least 30 day supply in the past 60 days) prescription for a psychoactive medication that interacts with alcohol-including benzodiazepines, opioids, antipsychotics, antidepressants, sleeping medications and muscle relaxants.
  • Alcohol Use Disorder - Meet DSM-5 criteria for alcohol use disorder, not in remission

Exclusion Criteria:

No subject may:

  • Be acutely suicidal, or with a psychiatric condition that affects his/her ability to provide informed consent or participate in counseling interventions (e.g. psychotic, dementia, delusional).
  • Be currently enrolled in formal treatment for alcohol (excluding mutual-help, e.g. Alcoholics Anonymous)
  • Have medical conditions that would preclude completing or be of harm during the course of the study.
  • Be a pregnant or nursing woman or women who do not agree to use a reliable form of birth control.
  • Have a current diagnosis of or be in remission for a gambling disorder given the gaming nature of CM.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03089320


Contacts
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Contact: Elizabeth A Porter, MBA +1 (203) 737-3347 elizabeth.porter@yale.edu

Locations
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United States, California
Greater Los Angeles VA Healthcare Center Infectious Disease Section Not yet recruiting
Los Angeles, California, United States, 90073
Contact: Matthew Goetz, MD    310-478-3711 ext 43818    Matthew.goetz@va.gov   
United States, District of Columbia
Washington DC Veterans Affairs Not yet recruiting
Washington, District of Columbia, United States, 20422
Contact: Cynthia Gilbert, MD    202-745-7560    Cynthia.gibert@med.va.gov   
United States, Georgia
VA Medical Center Recruiting
Atlanta, Georgia, United States, 30033
Contact: Vincent Marconi, MD    404-321-6111 ext 7592    vcmarco@emory.edu   
United States, New York
James J. Peters VA Medical Center Recruiting
Bronx, New York, United States, 10468
Contact: Sheldon Brown, MD    718-584-9000 ext 5842    Sheldon.brown@va.gov   
VA NY Harbor Healthcare System Recruiting
New York, New York, United States, 10010
Contact: Michael Simberkoff, MD    212-951-3417    Mike.SimberkoffMD@va.gov   
United States, Texas
VA North Texas Healthcare System Not yet recruiting
Dallas, Texas, United States, 75216
Contact: Roger Berdino, MD    214-857-1410    Roger.Bedimo@va.gov   
VAMC Houston Recruiting
Houston, Texas, United States, 77030
Contact: Maria Rodriguez-Barradas, MD    713-794-8856    maria.rodriguez-barradas@va.gov   
Sponsors and Collaborators
Yale University
VA Connecticut Healthcare System
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: David Fiellin, MD Yale University
Study Director: E. Jennifer Edelman, MD Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03089320     History of Changes
Other Study ID Numbers: 2000020383
U01AA020795 ( U.S. NIH Grant/Contract )
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yale University:
HIV, Heavy drinking, Alcohol Abuse, AIDS
Additional relevant MeSH terms:
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Alcohol Drinking
Drinking Behavior