Financial Incentives, Randomization With Stepped Treatment Trial

Not Applicable

Completed

• Conditions: Unhealthy Alcohol Use
• Interventions: Behavioral: Contingency Management Counseling; Behavioral: Addiction Physician Management; Behavioral: Motivational Enhancement Therapy

• Registration Number: NCT03089320
• Lead Sponsor: 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.

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.

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.

Study Timeline

• Study First Submitted: 2017-03-17
• Study First Submitted QC: 2017-03-17
• Study First Posted: 2017-03-24
• Study Start: 2018-05-01
• Primary Completion: 2023-04-01
• Study Completion: 2023-04-01
• Status Verified: 2024-03
• Results First Submitted: 2024-03-15
• Results First Submitted QC: 2024-03-15
• Last Update Submitted: 2024-03-15
• Results First Posted: 2024-04-15
• Last Update Posted: 2024-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Contingency Management plus Stepped Care (Step 2)	Contingency Management Counseling	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.
Contingency Management plus Stepped Care (Step 2)	Addiction Physician Management	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.
Contingency Management plus Stepped Care (Step 2)	Motivational Enhancement Therapy	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.

Primary Outcome Measures

Name	Time	Method
Self-reported Abstinence From Alcohol	6 months	Recorded via web based time-line followback

Secondary Outcome Measures

Name	Time	Method
Change in Biological Markers as Measured by the VACS Index	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. Possible scores range from 0 to 164. A higher score indicates greater burden of disease.
Proportion of Participants of Participants With Phosphatidylethanol (PeTH) Documented Abstinence by the Alcohol Biomarker, Phosphatidylethanol (PEth)	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).

Trial Locations

Locations (7)

Greater Los Angeles VA Healthcare Center Infectious Disease Section; 🇺🇸 Los Angeles, California, United States

James J. Peters VA Medical Center; 🇺🇸 Bronx, New York, United States

VA Medical Center; 🇺🇸 Atlanta, Georgia, United States

VA NY Harbor Healthcare System; 🇺🇸 New York, New York, United States

Washington DC Veterans Affairs; 🇺🇸 Washington, District of Columbia, United States

Louisiana Health Sciences Center; 🇺🇸 New Orleans, Louisiana, United States

VAMC Houston; 🇺🇸 Houston, Texas, United States