3/6 COMpAAAS U01: Intervention Study

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HIV-infected 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 348 HIV-infected patients with unhealthy alcohol use at seven HIV clinics. CM patients will receive onsite CM counseling sessions adminstered by a Social Worker 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. Data analyses will be conducted on the intention to treat sample of patients. The primary outcome is the proportion of individuals with PEth documented abstinence at six months. Secondary outcomes include alcohol consumption assessed using Timeline Followback, and change in the VACS Index. Novel aspects of this proposal include: 1) The first evaluation of CM for unhealthy alcohol use in HIV clinics, 2) An assessment of onsite CM plus stepped care including APM and MET, 3) Use of PEth to guide CM rewards and as a trial outcome, 4) Addressing patient motivation with CM and a focus on medical conditions impacted by alcohol, 5) Use of the VACS Index, a validated biomarker that reflects overall health and abstinence among HIV-infected patients receiving addiction treatment. This study, conducted by experienced HIV and addiction researchers, will determine the efficacy of CM plus stepped care in HIV-infected patients with unhealthy alcohol use.