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Completed

NCT Number: NCT02563574

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

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.

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Key information

Conditions

Alcohol Consumption Alcohol Drinking Behavior Drinking Behavior HIV Motivation

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida, Gainesville, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Motivational Interviewing

Behavioral

A type of counseling aimed at reducing consumption of alcohol.

Questionnaire Assessment

Other

Several different types of questionnaires will be fill out by the participants.

Neurocognitive assessments

Other

Several different types of neurocognitive assessment will be performed.

Blood specimens

Other

Blood specimens will be used to measure the immunological, virologic, and hepatic status, as well as other biomarkers.

Primary outcomes

  1. FMRI images will be performed for changes in the brain between the groups

    Time frame: Baseline and 6 month follow-up

    Cerebral metabolite abnormalities

Secondary outcomes

  1. Structured Clinical Interview for Diagnostic and Statistical Manual (DSM)-IV (SCID)

    Time frame: Baseline

    A structured interview given to participants in order to assess current and past alcohol use and dependence

  2. Lifetime Alcohol and Drug Use History

    Time frame: 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.

  3. Kreek-McHugh-Schluger-Kellogg (KMSK) Scale

    Time frame: 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.

  4. Timeline Followback (TLFB)

    Time frame: 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.

  5. Urine Drug Screen

    Time frame: 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.

  6. Short Inventory of Problems (SIP)

    Time frame: 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

  7. Epworth Sleepiness Scale (ESS)

    Time frame: 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).

  8. Center for Epidemiological Studies-Depression Scale (CES-D)

    Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.

    A 20-item screening test for depression and depressive disorder

  9. Beck Anxiety Inventory

    Time frame: 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

  10. Early Life Stress Questionnaire (ELSQ)

    Time frame: Baseline

    A 5-section self-report questionnaire assessment of adverse childhood events

  11. The Frontal System Behavioral Scale (FrSBe)

    Time frame: 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

  12. Medical Outcomes Study HIV Health Survey (MOS-HIV)

    Time frame: 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

  13. Montreal Cognitive Assessment (MoCA)

    Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.

    measurement used to screen for dementia and mild cognitive impairment

  14. Hopkins Verelan Learning Test Revised (HVLT-R)

    Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.

    cognitive assessment that measures verbal learning and memory

  15. Brief Visuospatial Memory Test Revised (BVMT-R)

    Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.

    A measure of visuospatial memory

  16. Paced Auditory Serial Addition Test (PASAT-1)

    Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.

    A cognitive assessment which measures visuospatial memory

  17. WAIS-3 Letter Number Sequencing

    Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.

    7-item cognitive assessment with a total of 21 maximum points

  18. WAIS-3 Digit Symbol

    Time frame: 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

  19. WAIS-3 Symbol Search

    Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.

    Cognitive assessment measuring processing speed with a total max score of

  20. Trail Making

    Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.

    timed cognitive assessment looking at working memory and executive functioning

  21. Grooved Pegboard

    Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.

    measures performance speed in a fine motor task

  22. Stroop Task

    Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.

    timed cognitive task

  23. Verbal Fluency

    Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.

    timed language measure

  24. Animal Fluency

    Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.

    timed language measure

  25. The Wechsler Test of Adult Reading (WTAR)

    Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.

    cognitive tast measuring verbal intelligence

  26. Boston Naming Test

    Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.

  27. Adaptive Rate Continuous Performance Test (ARCPT)

    Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.

    computerized adaptive task measuring attention

  28. California Computerized Assessment Package (CalCAP)

    Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.

    computerized task measuring reaction time

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Brown University
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Alcohol and HIV: Biobehavioral Interactions and Intervention

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Sep 30, 2015
Registry last updated
Apr 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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