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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02563574
Other study ID # IRB201500625-N
Secondary ID 2P01AA019072-06O
Status Completed
Phase N/A
First received
Last updated
Start date December 2016
Est. completion date December 16, 2021

Study information

Verified date March 2022
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date December 16, 2021
Est. primary completion date December 16, 2021
Accepts healthy volunteers No
Gender All
Age group 25 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Motivational Interviewing
A type of counseling aimed at reducing consumption of alcohol.
Other:
Questionnaire assessment
Several different types of questionnaires will be fill out by the participants.
Neurocognitive assessments
Several different types of neurocognitive assessment will be performed.
Blood specimens
Blood specimens will be used to measure the immunological, virologic, and hepatic status, as well as other biomarkers.

Locations

Country Name City State
United States University of Florida Gainesville Florida
United States Florida International University Miami Florida

Sponsors (3)

Lead Sponsor Collaborator
University of Florida Brown University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary FMRI images will be performed for changes in the brain between the groups Cerebral metabolite abnormalities Baseline and 6 month follow-up
Secondary 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
Secondary 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
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary Early Life Stress Questionnaire (ELSQ) A 5-section self-report questionnaire assessment of adverse childhood events Baseline
Secondary 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.
Secondary 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.
Secondary Montreal Cognitive Assessment (MoCA) measurement used to screen for dementia and mild cognitive impairment Baseline, 3-month, 6-month, and 12-month follow-ups.
Secondary 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.
Secondary Brief Visuospatial Memory Test Revised (BVMT-R) A measure of visuospatial memory Baseline, 3-month, 6-month, and 12-month follow-ups.
Secondary Paced Auditory Serial Addition Test (PASAT-1) A cognitive assessment which measures visuospatial memory Baseline, 3-month, 6-month, and 12-month follow-ups.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary Trail Making timed cognitive assessment looking at working memory and executive functioning Baseline, 3-month, 6-month, and 12-month follow-ups.
Secondary Grooved Pegboard measures performance speed in a fine motor task Baseline, 3-month, 6-month, and 12-month follow-ups.
Secondary Stroop Task timed cognitive task Baseline, 3-month, 6-month, and 12-month follow-ups.
Secondary Verbal Fluency timed language measure Baseline, 3-month, 6-month, and 12-month follow-ups.
Secondary Animal Fluency timed language measure Baseline, 3-month, 6-month, and 12-month follow-ups.
Secondary The Wechsler Test of Adult Reading (WTAR) cognitive tast measuring verbal intelligence Baseline, 3-month, 6-month, and 12-month follow-ups.
Secondary Boston Naming Test Baseline, 3-month, 6-month, and 12-month follow-ups.
Secondary Adaptive Rate Continuous Performance Test (ARCPT) computerized adaptive task measuring attention Baseline, 3-month, 6-month, and 12-month follow-ups.
Secondary California Computerized Assessment Package (CalCAP) computerized task measuring reaction time Baseline, 3-month, 6-month, and 12-month follow-ups.
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