Clinical trial NCT02563574: ARCH II Study (Alcohol Research Center on HIV Study II)
Official title: Alcohol and HIV: Biobehavioral Interactions and Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Consumption
HIV
Motivation
Keywords: Alcohol and brain function
HIV and brain function
Motivational Interviewing
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Brown University
First posted: 2015-09-30
Enrollment: 14
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: FMRI images will be performed for changes in the brain between the groups
timeFrame: Baseline and 6 month follow-up
Secondary outcomes:
measure: Structured Clinical Interview for Diagnostic and Statistical Manual (DSM)-IV (SCID)
timeFrame: Baseline
measure: Lifetime Alcohol and Drug Use History
timeFrame: Baseline
measure: Kreek-McHugh-Schluger-Kellogg (KMSK) Scale
timeFrame: Baseline, 3-month, 6-month, and 12-month follow-ups.
measure: Timeline Followback (TLFB)
timeFrame: Baseline, 3-month, 6-month, and 12-month follow-ups.
measure: Urine Drug Screen
timeFrame: Baseline, 3-month, 6-month, and 12-month follow-ups.
measure: Short Inventory of Problems (SIP)
timeFrame: Baseline, 3-month, 6-month, and 12-month follow-ups.
measure: Epworth Sleepiness Scale (ESS)
timeFrame: Baseline, 3-month, 6-month, and 12-month follow-ups.
measure: Center for Epidemiological Studies-Depression Scale (CES-D)
timeFrame: Baseline, 3-month, 6-month, and 12-month follow-ups.
measure: Beck Anxiety Inventory
timeFrame: Baseline, 3-month, 6-month, and 12-month follow-ups.
measure: Early Life Stress Questionnaire (ELSQ)
timeFrame: Baseline
measure: The Frontal System Behavioral Scale (FrSBe)
timeFrame: Baseline, 3-month, 6-month, and 12-month follow-ups.
measure: Medical Outcomes Study HIV Health Survey (MOS-HIV)
timeFrame: Baseline, 3-month, 6-month, and 12-month follow-ups.
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline, 3-month, 6-month, and 12-month follow-ups.
measure: Hopkins Verelan Learning Test Revised (HVLT-R)
timeFrame: Baseline, 3-month, 6-month, and 12-month follow-ups.
measure: Brief Visuospatial Memory Test Revised (BVMT-R)
timeFrame: Baseline, 3-month, 6-month, and 12-month follow-ups.
measure: Paced Auditory Serial Addition Test (PASAT-1)
timeFrame: Baseline, 3-month, 6-month, and 12-month follow-ups.
measure: WAIS-3 Letter Number Sequencing
timeFrame: Baseline, 3-month, 6-month, and 12-month follow-ups.
measure: WAIS-3 Digit Symbol
timeFrame: Baseline, 3-month, 6-month, and 12-month follow-ups.
measure: WAIS-3 Symbol Search
timeFrame: Baseline, 3-month, 6-month, and 12-month follow-ups.
measure: Trail Making
timeFrame: Baseline, 3-month, 6-month, and 12-month follow-ups.
measure: Grooved Pegboard
timeFrame: Baseline, 3-month, 6-month, and 12-month follow-ups.
measure: Stroop Task
timeFrame: Baseline, 3-month, 6-month, and 12-month follow-ups.
measure: Verbal Fluency
timeFrame: Baseline, 3-month, 6-month, and 12-month follow-ups.
measure: Animal Fluency
timeFrame: Baseline, 3-month, 6-month, and 12-month follow-ups.
measure: The Wechsler Test of Adult Reading (WTAR)
timeFrame: Baseline, 3-month, 6-month, and 12-month follow-ups.
measure: Boston Naming Test
timeFrame: Baseline, 3-month, 6-month, and 12-month follow-ups.
measure: Adaptive Rate Continuous Performance Test (ARCPT)
timeFrame: Baseline, 3-month, 6-month, and 12-month follow-ups.
measure: California Computerized Assessment Package (CalCAP)
timeFrame: Baseline, 3-month, 6-month, and 12-month follow-ups.
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami
country: United States
facility: Florida International University
state: Florida
Study officials:
affiliation: University of Florida
name: Ron Cohen, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: