ARCH II Study (Alcohol Research Center on HIV Study II)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Alcohol and HIV: Biobehavioral Interactions and Intervention

Conditions
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Alcohol Consumption, HIV, Motivation

Intervention / Treatment
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* Behavioral: Motivational Interviewing
* Other: Questionnaire assessment
* Other: Neurocognitive assessments
* Other: Blood specimens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV-infected; English speaking; Physically mobile; Willingness to participate in the Motivational Interviewing (MI) to reduce ETOH consumption. Exclusion Criteria: Neurological disorders; Evidence of dementia; Past opportunistic brain infection; Major psychiatric illness; Current major psychiatric disturbance; Unstable medical conditions (cancer); MRI contraindications (e.g., pregnancy, claustrophobia, metal implants); Physical impairment precluding motor response or lying still.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motivational Interviewing Group<br>This group of participants will receive the motivational interviewing. In addition to blood specimen collection, a questionnaire assessment and neurocognitive assessments will also be performed. | Behavioral: Motivational Interviewing<br>* A type of counseling aimed at reducing consumption of alcohol.<br>Other: Questionnaire assessment<br>* Several different types of questionnaires will be fill out by the participants.<br>Other: Neurocognitive assessments<br>* Several different types of neurocognitive assessment will be performed.<br>Other: Blood specimens<br>* Blood specimens will be used to measure the immunological, virologic, and hepatic status, as well as other biomarkers.<br>|
| Active Comparator: Control Group<br>This group of participants will not receive motivational interviewing. They will have blood specimen collection, questionnaire assessment, and neurocognitive assessments performed. | Other: Questionnaire assessment<br>* Several different types of questionnaires will be fill out by the participants.<br>Other: Neurocognitive assessments<br>* Several different types of neurocognitive assessment will be performed.<br>Other: Blood specimens<br>* Blood specimens will be used to measure the immunological, virologic, and hepatic status, as well as other biomarkers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FMRI images will be performed for changes in the brain between the groups | Cerebral metabolite abnormalities | Baseline and 6 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Structured Clinical Interview for Diagnostic and Statistical Manual (DSM)-IV (SCID) | A structured interview given to participants in order to assess current and past alcohol use and dependence | Baseline | 
| Lifetime Alcohol and Drug Use History | This interview will be conducted at baseline to gather information about age of onset of alcohol use, period of heaviest drinking, most drinks consumed on a single day, and number of drug classes used lifetime. | Baseline | 
| Kreek-McHugh-Schluger-Kellogg (KMSK) Scale | Developed as a research measure of drug use severity in accordance with DSM-IV criteria, the KMSK is reliable and valid, quantifying frequency, duration, and amount of individual drug use. | Baseline, 3-month, 6-month, and 12-month follow-ups. | 
| Timeline Followback (TLFB) | The TLFB interview will be used to assess recent alcohol use at baseline, as well as during the follow-up intervals. The TLFB interview is a calendar-assisted structured interview which provides a way to cue memory so that accurate recall is enhanced. The TLFB will provide data on the percentage of drinking days, drinks consumed per week, and the percentage of heavy drinking days. | Baseline, 3-month, 6-month, and 12-month follow-ups. | 
| Urine Drug Screen | Urine drug screens will be performed using Varian's TestCup Pro5, testing for benzodiazepines, amphetamines, opiates, & cocaine. | Baseline, 3-month, 6-month, and 12-month follow-ups. | 
| Short Inventory of Problems (SIP) | The SIP assesses 15 negative consequences of alcohol use over the chosen time period (in this case 3 months) and has been found to have good psychometric properties. Maximum score is 45 | Baseline, 3-month, 6-month, and 12-month follow-ups. | 
| Epworth Sleepiness Scale (ESS) | The ESS proposes eight daytime scenarios, and the participant is asked to rate how likely they are to fall asleep in each situation on a four-point scale (0-3). | Baseline, 3-month, 6-month, and 12-month follow-ups. | 
| Center for Epidemiological Studies-Depression Scale (CES-D) | A 20-item screening test for depression and depressive disorder | Baseline, 3-month, 6-month, and 12-month follow-ups. | 
| Beck Anxiety Inventory | 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety | Baseline, 3-month, 6-month, and 12-month follow-ups. | 
| Early Life Stress Questionnaire (ELSQ) | A 5-section self-report questionnaire assessment of adverse childhood events | Baseline | 
| The Frontal System Behavioral Scale (FrSBe) | A 46-item self-report questionnaire designed to measure behavior related to frontal systems damage | Baseline, 3-month, 6-month, and 12-month follow-ups. | 
| Medical Outcomes Study HIV Health Survey (MOS-HIV) | A 35-item self-report questionnaire designed in order to assess functional status and well-being among HIV-positive individuals | Baseline, 3-month, 6-month, and 12-month follow-ups. | 
| Montreal Cognitive Assessment (MoCA) | measurement used to screen for dementia and mild cognitive impairment | Baseline, 3-month, 6-month, and 12-month follow-ups. | 
| Hopkins Verelan Learning Test Revised (HVLT-R) | cognitive assessment that measures verbal learning and memory | Baseline, 3-month, 6-month, and 12-month follow-ups. | 
| Brief Visuospatial Memory Test Revised (BVMT-R) | A measure of visuospatial memory | Baseline, 3-month, 6-month, and 12-month follow-ups. | 
| Paced Auditory Serial Addition Test (PASAT-1) | A cognitive assessment which measures visuospatial memory | Baseline, 3-month, 6-month, and 12-month follow-ups. | 
| WAIS-3 Letter Number Sequencing | 7-item cognitive assessment with a total of 21 maximum points | Baseline, 3-month, 6-month, and 12-month follow-ups. | 
| WAIS-3 Digit Symbol | A timed neuropsychological test sensitive to brain damage, dementia, age and depression consisting of digit-symbol pairs followed by a list of digits | Baseline, 3-month, 6-month, and 12-month follow-ups. | 
| WAIS-3 Symbol Search | Cognitive assessment measuring processing speed with a total max score of | Baseline, 3-month, 6-month, and 12-month follow-ups. | 
| Trail Making | timed cognitive assessment looking at working memory and executive functioning | Baseline, 3-month, 6-month, and 12-month follow-ups. | 
| Grooved Pegboard | measures performance speed in a fine motor task | Baseline, 3-month, 6-month, and 12-month follow-ups. | 
| Stroop Task | timed cognitive task | Baseline, 3-month, 6-month, and 12-month follow-ups. | 
| Verbal Fluency | timed language measure | Baseline, 3-month, 6-month, and 12-month follow-ups. | 
| Animal Fluency | timed language measure | Baseline, 3-month, 6-month, and 12-month follow-ups. | 
| The Wechsler Test of Adult Reading (WTAR) | cognitive tast measuring verbal intelligence | Baseline, 3-month, 6-month, and 12-month follow-ups. | 
| Boston Naming Test |  | Baseline, 3-month, 6-month, and 12-month follow-ups. | 
| Adaptive Rate Continuous Performance Test (ARCPT) | computerized adaptive task measuring attention | Baseline, 3-month, 6-month, and 12-month follow-ups. | 
| California Computerized Assessment Package (CalCAP) | computerized task measuring reaction time | Baseline, 3-month, 6-month, and 12-month follow-ups. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol and brain function, HIV and brain function, Motivational Interviewing