ARCH II Study (Alcohol Research Center on HIV Study II)
Primary Purpose
Alcohol Consumption, HIV, Motivation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing
Questionnaire assessment
Neurocognitive assessments
Blood specimens
Sponsored by

About this trial
This is an interventional basic science trial for Alcohol Consumption focused on measuring Alcohol and brain function, HIV and brain function, Motivational Interviewing
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.
Sites / Locations
- University of Florida
- Florida International University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Motivational Interviewing Group
Control Group
Arm Description
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.
This group of participants will not receive motivational interviewing. They will have blood specimen collection, questionnaire assessment, and neurocognitive assessments performed.
Outcomes
Primary Outcome Measures
FMRI images will be performed for changes in the brain between the groups
Cerebral metabolite abnormalities
Secondary Outcome Measures
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
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.
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.
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.
Urine Drug Screen
Urine drug screens will be performed using Varian's TestCup Pro5, testing for benzodiazepines, amphetamines, opiates, & cocaine.
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
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).
Center for Epidemiological Studies-Depression Scale (CES-D)
A 20-item screening test for depression and depressive disorder
Beck Anxiety Inventory
21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety
Early Life Stress Questionnaire (ELSQ)
A 5-section self-report questionnaire assessment of adverse childhood events
The Frontal System Behavioral Scale (FrSBe)
A 46-item self-report questionnaire designed to measure behavior related to frontal systems damage
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
Montreal Cognitive Assessment (MoCA)
measurement used to screen for dementia and mild cognitive impairment
Hopkins Verelan Learning Test Revised (HVLT-R)
cognitive assessment that measures verbal learning and memory
Brief Visuospatial Memory Test Revised (BVMT-R)
A measure of visuospatial memory
Paced Auditory Serial Addition Test (PASAT-1)
A cognitive assessment which measures visuospatial memory
WAIS-3 Letter Number Sequencing
7-item cognitive assessment with a total of 21 maximum points
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
WAIS-3 Symbol Search
Cognitive assessment measuring processing speed with a total max score of
Trail Making
timed cognitive assessment looking at working memory and executive functioning
Grooved Pegboard
measures performance speed in a fine motor task
Stroop Task
timed cognitive task
Verbal Fluency
timed language measure
Animal Fluency
timed language measure
The Wechsler Test of Adult Reading (WTAR)
cognitive tast measuring verbal intelligence
Boston Naming Test
Adaptive Rate Continuous Performance Test (ARCPT)
computerized adaptive task measuring attention
California Computerized Assessment Package (CalCAP)
computerized task measuring reaction time
Full Information
NCT ID
NCT02563574
First Posted
September 28, 2015
Last Updated
March 23, 2022
Sponsor
University of Florida
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Brown University
1. Study Identification
Unique Protocol Identification Number
NCT02563574
Brief Title
ARCH II Study (Alcohol Research Center on HIV Study II)
Official Title
Alcohol and HIV: Biobehavioral Interactions and Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 16, 2021 (Actual)
Study Completion Date
December 16, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Brown University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Consumption, HIV, Motivation
Keywords
Alcohol and brain function, HIV and brain function, Motivational Interviewing
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Motivational Interviewing Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
This group of participants will not receive motivational interviewing. They will have blood specimen collection, questionnaire assessment, and neurocognitive assessments performed.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Intervention Description
A type of counseling aimed at reducing consumption of alcohol.
Intervention Type
Other
Intervention Name(s)
Questionnaire assessment
Intervention Description
Several different types of questionnaires will be fill out by the participants.
Intervention Type
Other
Intervention Name(s)
Neurocognitive assessments
Intervention Description
Several different types of neurocognitive assessment will be performed.
Intervention Type
Other
Intervention Name(s)
Blood specimens
Intervention Description
Blood specimens will be used to measure the immunological, virologic, and hepatic status, as well as other biomarkers.
Primary Outcome Measure Information:
Title
FMRI images will be performed for changes in the brain between the groups
Description
Cerebral metabolite abnormalities
Time Frame
Baseline and 6 month follow-up
Secondary Outcome Measure Information:
Title
Structured Clinical Interview for Diagnostic and Statistical Manual (DSM)-IV (SCID)
Description
A structured interview given to participants in order to assess current and past alcohol use and dependence
Time Frame
Baseline
Title
Lifetime Alcohol and Drug Use History
Description
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.
Time Frame
Baseline
Title
Kreek-McHugh-Schluger-Kellogg (KMSK) Scale
Description
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.
Time Frame
Baseline, 3-month, 6-month, and 12-month follow-ups.
Title
Timeline Followback (TLFB)
Description
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.
Time Frame
Baseline, 3-month, 6-month, and 12-month follow-ups.
Title
Urine Drug Screen
Description
Urine drug screens will be performed using Varian's TestCup Pro5, testing for benzodiazepines, amphetamines, opiates, & cocaine.
Time Frame
Baseline, 3-month, 6-month, and 12-month follow-ups.
Title
Short Inventory of Problems (SIP)
Description
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
Time Frame
Baseline, 3-month, 6-month, and 12-month follow-ups.
Title
Epworth Sleepiness Scale (ESS)
Description
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).
Time Frame
Baseline, 3-month, 6-month, and 12-month follow-ups.
Title
Center for Epidemiological Studies-Depression Scale (CES-D)
Description
A 20-item screening test for depression and depressive disorder
Time Frame
Baseline, 3-month, 6-month, and 12-month follow-ups.
Title
Beck Anxiety Inventory
Description
21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety
Time Frame
Baseline, 3-month, 6-month, and 12-month follow-ups.
Title
Early Life Stress Questionnaire (ELSQ)
Description
A 5-section self-report questionnaire assessment of adverse childhood events
Time Frame
Baseline
Title
The Frontal System Behavioral Scale (FrSBe)
Description
A 46-item self-report questionnaire designed to measure behavior related to frontal systems damage
Time Frame
Baseline, 3-month, 6-month, and 12-month follow-ups.
Title
Medical Outcomes Study HIV Health Survey (MOS-HIV)
Description
A 35-item self-report questionnaire designed in order to assess functional status and well-being among HIV-positive individuals
Time Frame
Baseline, 3-month, 6-month, and 12-month follow-ups.
Title
Montreal Cognitive Assessment (MoCA)
Description
measurement used to screen for dementia and mild cognitive impairment
Time Frame
Baseline, 3-month, 6-month, and 12-month follow-ups.
Title
Hopkins Verelan Learning Test Revised (HVLT-R)
Description
cognitive assessment that measures verbal learning and memory
Time Frame
Baseline, 3-month, 6-month, and 12-month follow-ups.
Title
Brief Visuospatial Memory Test Revised (BVMT-R)
Description
A measure of visuospatial memory
Time Frame
Baseline, 3-month, 6-month, and 12-month follow-ups.
Title
Paced Auditory Serial Addition Test (PASAT-1)
Description
A cognitive assessment which measures visuospatial memory
Time Frame
Baseline, 3-month, 6-month, and 12-month follow-ups.
Title
WAIS-3 Letter Number Sequencing
Description
7-item cognitive assessment with a total of 21 maximum points
Time Frame
Baseline, 3-month, 6-month, and 12-month follow-ups.
Title
WAIS-3 Digit Symbol
Description
A timed neuropsychological test sensitive to brain damage, dementia, age and depression consisting of digit-symbol pairs followed by a list of digits
Time Frame
Baseline, 3-month, 6-month, and 12-month follow-ups.
Title
WAIS-3 Symbol Search
Description
Cognitive assessment measuring processing speed with a total max score of
Time Frame
Baseline, 3-month, 6-month, and 12-month follow-ups.
Title
Trail Making
Description
timed cognitive assessment looking at working memory and executive functioning
Time Frame
Baseline, 3-month, 6-month, and 12-month follow-ups.
Title
Grooved Pegboard
Description
measures performance speed in a fine motor task
Time Frame
Baseline, 3-month, 6-month, and 12-month follow-ups.
Title
Stroop Task
Description
timed cognitive task
Time Frame
Baseline, 3-month, 6-month, and 12-month follow-ups.
Title
Verbal Fluency
Description
timed language measure
Time Frame
Baseline, 3-month, 6-month, and 12-month follow-ups.
Title
Animal Fluency
Description
timed language measure
Time Frame
Baseline, 3-month, 6-month, and 12-month follow-ups.
Title
The Wechsler Test of Adult Reading (WTAR)
Description
cognitive tast measuring verbal intelligence
Time Frame
Baseline, 3-month, 6-month, and 12-month follow-ups.
Title
Boston Naming Test
Time Frame
Baseline, 3-month, 6-month, and 12-month follow-ups.
Title
Adaptive Rate Continuous Performance Test (ARCPT)
Description
computerized adaptive task measuring attention
Time Frame
Baseline, 3-month, 6-month, and 12-month follow-ups.
Title
California Computerized Assessment Package (CalCAP)
Description
computerized task measuring reaction time
Time Frame
Baseline, 3-month, 6-month, and 12-month follow-ups.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ron Cohen, Ph.D
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Florida International University
City
Miami
State/Province
Florida
ZIP/Postal Code
33199
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ARCH II Study (Alcohol Research Center on HIV Study II)
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