Financial Incentives, Randomization With Stepped Treatment Trial

NCT ID: NCT03089320

Last Updated: 2024-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2023-04-01

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.

Conditions

Unhealthy Alcohol Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Contingency Management Counseling

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Connecticut Healthcare System

FED

Sponsor Role: collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Fiellin, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

E. Jennifer Edelman, MD

Role: STUDY_DIRECTOR

Yale University

Locations

Greater Los Angeles VA Healthcare Center Infectious Disease Section

Los Angeles, California, United States

Washington DC Veterans Affairs

Washington D.C., District of Columbia, United States

VA Medical Center

Atlanta, Georgia, United States

Louisiana Health Sciences Center

New Orleans, Louisiana, United States

VA NY Harbor Healthcare System

New York, New York, United States

James J. Peters VA Medical Center

The Bronx, New York, United States

VAMC Houston

Houston, Texas, United States

Countries

United States

References

Edelman EJ, Dziura J, Deng Y, DePhilippis D, Ferguson T, Brown S, Marconi VC, Goetz MB, Rodriguez-Barradas MC, Simberkoff MS, Molina PE, Weintrob AC, Maisto SA, Paris M, Justice AC, Bryant KJ, Fiellin DA. Integrated Stepped Alcohol Treatment With Contingency Management for Unhealthy Alcohol Use Among People With HIV: A Randomized Controlled Trial. J Acquir Immune Defic Syndr. 2025 Jan 1;98(1):72-81. doi: 10.1097/QAI.0000000000003534.

Reference Type: DERIVED

PMID: 39321757 (View on PubMed)

Edelman EJ, Dziura J, Deng Y, DePhilippis D, Fucito LM, Ferguson T, Bedimo R, Brown S, Marconi VC, Goetz MB, Rodriguez-Barradas MC, Simberkoff MS, Molina PE, Weintrob AC, Maisto SA, Paris M, Justice AC, Bryant KJ, Fiellin DA. Contingency management with stepped care for unhealthy alcohol use among individuals with HIV: Protocol for a randomized controlled trial. Contemp Clin Trials. 2023 Aug;131:107242. doi: 10.1016/j.cct.2023.107242. Epub 2023 May 23.

Reference Type: DERIVED

PMID: 37230168 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

U01AA020795

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000020383

Identifier Type: -

Identifier Source: org_study_id