The ARCH comprises 3 primary research components (RC) and a pilot studies component. The three major projects are described below.
Research Component 1 (RC1) is entitled Alcohol and HIV-Associated Brain Dysfunction [Ron Cohen, component PI]. This is a longitudinal study that compares HIV-infected and seronegative control subjects with and without heavy alcohol use in a between-group design with repeated measures. Participants will be assessed at three time points: baseline, 12 months, and 36 months. Measures of neurocognitive function, and plasma measures of liver function and immunological and virologic status with respect to both HIV and hepatitis C will be obtained. Brain MRI will be also be performed at each assessment, including diffusion tensor imaging (DTI) to assess the structural integrity of the brain white matter, volumetric and cortical thickness measures from structural T1 image, and magnetic resonance spectroscopy (MRS) to determine metabolic abnormalities in key brain regions of interest. The neuroimaging and neurocognitive measures serve as the primary dependent measures.
Research Component 2 (RC2) is entitled Brief Intervention for HIV-Infected MSM in Primary Care [Christopher Kahler, component PI]. This study is a randomized clinical trial in which 224 heavy drinking men who have sex with men (MSM), who receive their HIV primary care at Fenway Health in Boston, are randomly assigned to treatment as usual (TAU) or TAU plus a brief intervention to reduce alcohol use (TAU-BI). TAU-BI is based on MI and includes personalized feedback tailored to an HIV-infected MSM population. TAU-BI includes a single 60-minute session at baseline and booster sessions in-person at 3 and 6 months. Follow-up assessments extend 12 months past baseline. The first primary aim of the study is to test the hypothesis that TAU-BI, compared to TAU, will result in reduced alcohol consumption over a 12-month follow-up period. Reductions in high-risk sexual behavior and increased adherence to HAART are secondary outcomes along with change in CD4 lymphocyte counts and HIV RNA.
Brown University Emergency Department Study (5R01AA009892-17; Monti, PI): This study (N=302) tests whether a single-session multiple risk Motivational Interview (MI) can more effectively decrease and maintain reduction in alcohol use, alcohol related problems, and sexual risk taking following discharge from the ED than Brief Advice (BA). Baseline, MI, and BA are administered in the ED. Follow-ups will be conducted at 3, 6 and 9 months. In addition, this study addresses potential mediators (motivation to change risk taking, self-efficacy) of MI effects and whether reductions in sexual risk associated with MI compared to BA are accounted for by reduced drinking. The cost-effectiveness of the interventions will also be addressed.
C.1. Description of Pilots 1-4. Four initial Pilot Projects have been selected for funding by the PPC.
Pilot 1: PI: Tara White, Ph.D.
Title “Imaging Functional Alcohol Effects in HIV”
Dr. White is an Assistant Professor of Behavioral and Social Sciences (Research) at Brown University’s CAAS. Pilot 1 analyzes the impact of alcohol and HIV on functional brain responses to an acute dose of alcohol over the biphasic time course of its effects. The study aims to provide new information about the functional impact of alcohol in response to a moderate acute dose of alcohol (0.6) which is routinely consumed by HIV+ heavy drinkers in the real-world that can have direct application in dissemination efforts to reduce alcohol use in this population.
Pilot 2: PI: Barry Lester, Ph.D.
Title: “Prenatal Exposure to Antiretroviral Therapy and Alcohol: Newborn Neurobehavior”.
Dr. Lester is a senior researcher whose work has focused on the effects of prenatal drug exposure on newborn neurobehavior. He is a Professor of Psychiatry and Human Behavior and Pediatrics and is Director of the Brown Center for the Study of Children at Risk based at Women and Infants Hospital where this pilot study will be conducted. Pilot 2 will examine the relationship between prenatal exposure to varying levels of alcohol and neurobehavioral deficits in infants also prenatally exposed to antiretroviral therapy.
Pilot 3: PI: Jack Wands, MD
Title: “Molecular Characteristics of Occult HBV Strains from HIV+ Women with Alcohol Abuse”
Dr. Wands is a senior investigator and Professor of Medicine and Director of the Liver Research Center at Rhode Island Hospital. His Pilot Project aims to provide molecular virologic information on the impact of occult hepatitis B infection and alcohol on the process of progressive severe liver disease in women with chronic HIV infection.
Pilot 4 PI: Susan Kiene, Ph.D.
Title: “Alcohol and HIV Risk-taking among Fishermen and Commercial Sex Workers in Uganda”.
Dr. Kiene is Adjunct Assistant Professor (Research) of Behavioral and Social Sciences currently funded by a K01 from NIMH that focuses on adapting an efficacious intervention for reducing risky sexual behavior to a primary prevention setting in Uganda. Her Pilot Project will enable her to initiate research in a new population and region in Uganda.