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

HIV Clinical Trial

Official title:

Alcohol and HIV: Biobehavioral Interactions and Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02563574
• Other study ID #: IRB201500625-N
• Secondary ID: 2P01AA019072-06O
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Alcohol Consumption
• Alcohol Drinking
• HIV
• Motivation

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.