Financial Incentives, Randomization With Stepped Treatment Trial

Unhealthy Alcohol Use Clinical Trial

— FIRST  

Official title:

Financial Incentives, Randomization With Stepped Treatment Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03089320
• Other study ID #: 2000020383
• Secondary ID: U01AA020795
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: April 1, 2023

Study information

• Verified date: March 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

In addition to the randomized control trial, the FIRST Trial Implementation sub-study will be launched in the final year of the study. The goals of this sub-study are to explore barriers and facilitators to implementation of contingency management to address unhealthy alcohol in HIV treatment settings as it relates to: a) adoption, b) feasibility, c) acceptability, and d) tools and training needs to promote high fidelity implementation. In the context of the FIRST trial, we seek to recruit patient participants and the staff (i.e., research coordinators and Social Workers) involved with delivering CM across participating sites. Patient participants will be enrolled from the three highest-enrolling sites to complete an in-depth telephone interview. Staff participants from all sites involved in implementing study protocols will be invited to participate in a brief online survey and a focus group. Qualitative data will be analyzed by a multidisciplinary team using content analysis to identify themes and ideas regarding barrier and facilitators to CM implementation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Unhealthy Alcohol Use

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	VA Medical Center	Atlanta	Georgia
United States	James J. Peters VA Medical Center	Bronx	New York
United States	VAMC Houston	Houston	Texas
United States	Greater Los Angeles VA Healthcare Center Infectious Disease Section	Los Angeles	California
United States	Louisiana Health Sciences Center	New Orleans	Louisiana
United States	VA NY Harbor Healthcare System	New York	New York
United States	Washington DC Veterans Affairs	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	National Institute on Alcohol Abuse and Alcoholism (NIAAA), VA Connecticut Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Undetectable HIV Viral Load	Viral load will be analyzed as a continuous measure (log10 copies/ml).	6 months
Other	Smoking Cessation by Exhaled Carbon Monoxide	It is measured by CO monitor	6 months
Other	Liver Fibrosis Based on Fibrosis-4 (FIB-4) Score	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.	6 months
Other	Undetectable Hepatitis C Viral Load	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.	6 months
Other	Depressive Symptoms Via PHQ-9	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 months
Other	Recent Receipt of a Psychoactive Medication That May Interact With Alcohol	number of patients with use of psychoactive medications that interact with alcohol	6 months
Primary	Self-reported Abstinence From Alcohol	Recorded via web based time-line followback	6 months
Secondary	Proportion of Participants of Participants With Phosphatidylethanol (PeTH) Documented Abstinence by the Alcohol Biomarker, Phosphatidylethanol (PEth)	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).	6 month
Secondary	Change in Biological Markers as Measured by the VACS Index	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. Possible scores range from 0 to 164. A higher score indicates greater burden of disease.	6 months