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

Not Applicable

Completed

• Conditions: Motivation; Alcohol Consumption; HIV
• Interventions: Other: Questionnaire assessment; Behavioral: Motivational Interviewing; Other: Neurocognitive assessments; Other: Blood specimens

• Registration Number: NCT02563574
• Lead Sponsor: University of Florida

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.

Study Timeline

• Study First Submitted: 2015-09-28
• Study First Submitted QC: 2015-09-28
• Study First Posted: 2015-09-30
• Study Start: 2016-12
• Primary Completion: 2021-12-16
• Study Completion: 2021-12-16
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-23
• Last Update Posted: 2022-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• HIV-infected;
• English speaking;
• Physically mobile;
• Willingness to participate in the Motivational Interviewing (MI) to reduce ETOH consumption.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Questionnaire assessment	This group of participants will not receive motivational interviewing. They will have blood specimen collection, questionnaire assessment, and neurocognitive assessments performed.
Motivational Interviewing Group	Motivational Interviewing	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.
Motivational Interviewing Group	Questionnaire assessment	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.
Control Group	Neurocognitive assessments	This group of participants will not receive motivational interviewing. They will have blood specimen collection, questionnaire assessment, and neurocognitive assessments performed.
Control Group	Blood specimens	This group of participants will not receive motivational interviewing. They will have blood specimen collection, questionnaire assessment, and neurocognitive assessments performed.
Motivational Interviewing Group	Blood specimens	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.
Motivational Interviewing Group	Neurocognitive assessments	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.

Primary Outcome Measures

Name	Time	Method
FMRI images will be performed for changes in the brain between the groups	Baseline and 6 month follow-up	Cerebral metabolite abnormalities

Secondary Outcome Measures

Name	Time	Method
Boston Naming Test	Baseline, 3-month, 6-month, and 12-month follow-ups.
Adaptive Rate Continuous Performance Test (ARCPT)	Baseline, 3-month, 6-month, and 12-month follow-ups.	computerized adaptive task measuring attention
Kreek-McHugh-Schluger-Kellogg (KMSK) Scale	Baseline, 3-month, 6-month, and 12-month follow-ups.	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.
Stroop Task	Baseline, 3-month, 6-month, and 12-month follow-ups.	timed cognitive task
Structured Clinical Interview for Diagnostic and Statistical Manual (DSM)-IV (SCID)	Baseline	A structured interview given to participants in order to assess current and past alcohol use and dependence
Lifetime Alcohol and Drug Use History	Baseline	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.
Timeline Followback (TLFB)	Baseline, 3-month, 6-month, and 12-month follow-ups.	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.
Short Inventory of Problems (SIP)	Baseline, 3-month, 6-month, and 12-month follow-ups.	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
Urine Drug Screen	Baseline, 3-month, 6-month, and 12-month follow-ups.	Urine drug screens will be performed using Varian's TestCup Pro5, testing for benzodiazepines, amphetamines, opiates, \& cocaine.
Epworth Sleepiness Scale (ESS)	Baseline, 3-month, 6-month, and 12-month follow-ups.	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).
Grooved Pegboard	Baseline, 3-month, 6-month, and 12-month follow-ups.	measures performance speed in a fine motor task
Verbal Fluency	Baseline, 3-month, 6-month, and 12-month follow-ups.	timed language measure
Animal Fluency	Baseline, 3-month, 6-month, and 12-month follow-ups.	timed language measure
The Wechsler Test of Adult Reading (WTAR)	Baseline, 3-month, 6-month, and 12-month follow-ups.	cognitive tast measuring verbal intelligence
California Computerized Assessment Package (CalCAP)	Baseline, 3-month, 6-month, and 12-month follow-ups.	computerized task measuring reaction time
Center for Epidemiological Studies-Depression Scale (CES-D)	Baseline, 3-month, 6-month, and 12-month follow-ups.	A 20-item screening test for depression and depressive disorder
Beck Anxiety Inventory	Baseline, 3-month, 6-month, and 12-month follow-ups.	21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety
Early Life Stress Questionnaire (ELSQ)	Baseline	A 5-section self-report questionnaire assessment of adverse childhood events
The Frontal System Behavioral Scale (FrSBe)	Baseline, 3-month, 6-month, and 12-month follow-ups.	A 46-item self-report questionnaire designed to measure behavior related to frontal systems damage
Medical Outcomes Study HIV Health Survey (MOS-HIV)	Baseline, 3-month, 6-month, and 12-month follow-ups.	A 35-item self-report questionnaire designed in order to assess functional status and well-being among HIV-positive individuals
Montreal Cognitive Assessment (MoCA)	Baseline, 3-month, 6-month, and 12-month follow-ups.	measurement used to screen for dementia and mild cognitive impairment
Hopkins Verelan Learning Test Revised (HVLT-R)	Baseline, 3-month, 6-month, and 12-month follow-ups.	cognitive assessment that measures verbal learning and memory
Brief Visuospatial Memory Test Revised (BVMT-R)	Baseline, 3-month, 6-month, and 12-month follow-ups.	A measure of visuospatial memory
Paced Auditory Serial Addition Test (PASAT-1)	Baseline, 3-month, 6-month, and 12-month follow-ups.	A cognitive assessment which measures visuospatial memory
WAIS-3 Letter Number Sequencing	Baseline, 3-month, 6-month, and 12-month follow-ups.	7-item cognitive assessment with a total of 21 maximum points
WAIS-3 Symbol Search	Baseline, 3-month, 6-month, and 12-month follow-ups.	Cognitive assessment measuring processing speed with a total max score of
WAIS-3 Digit Symbol	Baseline, 3-month, 6-month, and 12-month follow-ups.	A timed neuropsychological test sensitive to brain damage, dementia, age and depression consisting of digit-symbol pairs followed by a list of digits
Trail Making	Baseline, 3-month, 6-month, and 12-month follow-ups.	timed cognitive assessment looking at working memory and executive functioning

Trial Locations

Locations (2)

University of Florida; 🇺🇸 Gainesville, Florida, United States

Florida International University; 🇺🇸 Miami, Florida, United States