Clinical trial NCT03089320: Financial Incentives, Randomization With Stepped Treatment Trial
Official title: Financial Incentives, Randomization With Stepped Treatment Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unhealthy Alcohol Use
Keywords: HIV, Heavy drinking, Alcohol Abuse, AIDS
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: VA Connecticut Healthcare System
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2017-03-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Self-reported Abstinence From Alcohol
timeFrame: 6 months
Secondary outcomes:
measure: Proportion of Participants of Participants With Phosphatidylethanol (PeTH) Documented Abstinence by the Alcohol Biomarker, Phosphatidylethanol (PEth)
timeFrame: 6 month
measure: Change in Biological Markers as Measured by the VACS Index
timeFrame: 6 months
Other outcomes:
measure: Undetectable HIV Viral Load
timeFrame: 6 months
measure: Smoking Cessation by Exhaled Carbon Monoxide
timeFrame: 6 months
measure: Liver Fibrosis Based on Fibrosis-4 (FIB-4) Score
timeFrame: 6 months
measure: Undetectable Hepatitis C Viral Load
timeFrame: 6 months
measure: Depressive Symptoms Via PHQ-9
timeFrame: 6 months
measure: Recent Receipt of a Psychoactive Medication That May Interact With Alcohol
timeFrame: 6 months
Locations:
city: Los Angeles
country: United States
facility: Greater Los Angeles VA Healthcare Center Infectious Disease Section
state: California
city: Washington
country: United States
facility: Washington DC Veterans Affairs
state: District of Columbia
city: Atlanta
country: United States
facility: VA Medical Center
state: Georgia
city: New Orleans
country: United States
facility: Louisiana Health Sciences Center
state: Louisiana
city: Bronx
country: United States
facility: James J. Peters VA Medical Center
state: New York
city: New York
country: United States
facility: VA NY Harbor Healthcare System
state: New York
city: Houston
country: United States
facility: VAMC Houston
state: Texas
Study officials:
affiliation: Yale University
name: David Fiellin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: E. Jennifer Edelman, MD
role: STUDY_DIRECTOR
References: