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
|Condition or disease||Intervention/treatment||Phase|
|Unhealthy Alcohol Use||Behavioral: Contingency Management Counseling Behavioral: Addiction Physician Management Behavioral: Motivational Enhancement Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||348 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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).
- 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.
- Self-reported abstinence from alcohol [ Time Frame: 6 months ]Recorded via web based time-line followback
- Undetectable HIV Viral load [ Time Frame: 6 months ]Viral load will be analyzed as a continuous measure (log10 copies/ml).
- Smoking cessation by exhaled carbon monoxide [ Time Frame: 6 months ]It is measured by CO monitor
- 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.
- 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.
- 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.
- 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
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
|Contact: Elizabeth A Porter, MBA||+1 (203) firstname.lastname@example.org|
|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.email@example.com|
|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.firstname.lastname@example.org|
|United States, Georgia|
|VA Medical Center||Recruiting|
|Atlanta, Georgia, United States, 30033|
|Contact: Vincent Marconi, MD 404-321-6111 ext 7592 email@example.com|
|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.firstname.lastname@example.org|
|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|
|Houston, Texas, United States, 77030|
|Contact: Maria Rodriguez-Barradas, MD 713-794-8856 email@example.com|
|Principal Investigator:||David Fiellin, MD||Yale University|
|Study Director:||E. Jennifer Edelman, MD||Yale University|