Financial Incentives, Randomization With Stepped Treatment Trial

NCT03089320 | Completed Results DMC

• 2 other identifiers: 2000020383U01AA020795
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Unhealthy Alcohol Use

Keywords

HIV, Heavy drinking, Alcohol Abuse, AIDS

Outcome Measures

Primary Outcomes (1)

• Self-reported Abstinence From Alcohol

  Recorded via web based time-line followback

  6 months

Secondary Outcomes (2)

• Proportion of Participants of Participants With Phosphatidylethanol (PeTH) Documented Abstinence by the Alcohol Biomarker, Phosphatidylethanol (PEth)

  6 month

• Change in Biological Markers as Measured by the VACS Index

  6 months

Other Outcomes (6)

• Undetectable HIV Viral Load

  6 months

• Smoking Cessation by Exhaled Carbon Monoxide

  6 months

• Liver Fibrosis Based on Fibrosis-4 (FIB-4) Score

  6 months

Study Arms (2)

Treatment As Usual (TAU)

NO INTERVENTION

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.

Contingency Management plus Stepped Care (Step 2)

EXPERIMENTAL

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; Behavioral: Addiction Physician Management; Behavioral: Motivational Enhancement Therapy

Interventions

Contingency Management Counseling 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.

Contingency Management plus Stepped Care (Step 2)

Addiction Physician Management 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.

Contingency Management plus Stepped Care (Step 2)

Motivational Enhancement Therapy 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.

Contingency Management plus Stepped Care (Step 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• VA Connecticut Healthcare System: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (7)

Greater Los Angeles VA Healthcare Center Infectious Disease Section

Los Angeles, California, 90073, United States

Location

Washington DC Veterans Affairs

Washington D.C., District of Columbia, 20422, United States

Location

VA Medical Center

Atlanta, Georgia, 30033, United States

Location

Louisiana Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

VA NY Harbor Healthcare System

New York, New York, 10010, United States

Location

James J. Peters VA Medical Center

The Bronx, New York, 10468, United States

Location

VAMC Houston

Houston, Texas, 77030, United States

Location

Related Publications (2)

• 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.

  PMID: 39321757 DERIVED

• 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.

  PMID: 37230168 DERIVED

MeSH Terms

Conditions

Alcoholism; Acquired Immunodeficiency Syndrome

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. David Fiellin
• Organization: Yale University

david.fiellin@yale.edu

203-737-3347

Study Officials

• David Fiellin, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• E. Jennifer Edelman, MD

  Yale University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2017
• First Posted: March 24, 2017
• Study Start: May 1, 2018
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: April 15, 2024
• Results First Posted: April 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)