ARCH II Study (Alcohol Research Center on HIV Study II)
Condition: Alcohol Consumption; HIV; Motivation
MeSH terms: Alcohol Drinking
Study type: Interventional

Summary: 
      This study is being done to learn about the interaction of alcohol consumption and HIV on
      brain function. The proposed study will have two broad objectives. The first is to
      incorporate functional neuroimaging (FMRI) approaches, along with additional Magnetic
      Resonance Spectroscopy (MRS) methods that will enable a delineation in both functional and
      cerebral metabolic disturbances affecting specific functional brain systems that are
      associated with the interaction of ethanol (ETOH) consumption on Human Immunodeficiency Virus
      (HIV)-associated brain dysfunction. Recent data indicate that HIV infected patients with
      heavy ETOH consumption have FMRI abnormalities and exhibit alterations on other neuroimaging
      measures compared to moderate drinkers and people who do not drink at all. The second
      objective is to examine the extent to which reductions in ETOH consumption among heavy
      drinkers with HIV infection result from a motivational intervention. The findings from this
      study will provide important information on how heavy ETOH and HIV interact to affect the
      brain functional responsiveness, and the extent of improvement that might be gained by
      reducing heavy ETOH use.
    

Detailed description: 
      In this research study, participants will be randomized (much like flipping a coin) by a
      computer program to either no counseling or FMRI during the baseline visit in the second
      session for this visit.

      Each time point (baseline, 3 months and 9 months) consists of 2 participant sessions. Session
      1) at baseline is for the purposes of recruiting and determining if participants meet study
      criteria; during all visits, study criteria are reviewed to ensure that enrolled participants
      are still eligible. After determining eligibility, study information is explained by the
      research assistant and consent is then obtained. Additional psychiatric and substance use
      assessment and neurological and will be performed. Blood and urine specimens will be obtained
      and sent to lab for measurement of immunological, virologic, and hepatic status and other
      biomarkers. The remainder of the blood specimens will be frozen and banked for future
      analyses. All blood specimens banks for future analyses will be deidentified. A
      neurocognitive assessment performed by a research assistant. The duration will be
      approximately 120 minutes. Session 2) will occur within one week of visit one. It will
      consist of an MRI scan lasting approximately 50 minutes. Functional imaging will be conducted
      during this MRI time. All participants will undergo all procedures at baseline, and three and
      nine months.
    

Intervention name(s): Motivational Interviewing; Questionnaire assessment; Neurocognitive assessments; Blood specimens
Intervention type(s): Behavioral; Other; Other; Other
Intervention description(s): A type of counseling aimed at reducing consumption of alcohol.; Several different types of questionnaires will be fill out by the participants.; Several different types of neurocognitive assessment will be performed.; Blood specimens will be used to measure the immunological, virologic, and hepatic status, as well as other biomarkers.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Alcohol and brain function; HIV and brain function; Motivational Interviewing