Financial Incentives, Randomization With Stepped Treatment Trial

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.

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.