ARCH II Study (Alcohol Research Center on HIV Study II)
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
- 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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Motivational Interviewing Group 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. |
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.
Other: Neurocognitive assessments
Several different types of neurocognitive assessment will be performed.
Other: Blood specimens
Blood specimens will be used to measure the immunological, virologic, and hepatic status, as well as other biomarkers.
|
| Active Comparator: Control Group This group of participants will not receive motivational interviewing. They will have blood specimen collection, questionnaire assessment, and neurocognitive assessments performed. |
Other: Questionnaire assessment
Several different types of questionnaires will be fill out by the participants.
Other: Neurocognitive assessments
Several different types of neurocognitive assessment will be performed.
Other: Blood specimens
Blood specimens will be used to measure the immunological, virologic, and hepatic status, as well as other biomarkers.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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.
- 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.
- 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.
- 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
- 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).
- 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 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
- 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
- Trail Making [Baseline, 3-month, 6-month, and 12-month follow-ups.]
timed cognitive assessment looking at working memory and executive functioning
- Grooved Pegboard [Baseline, 3-month, 6-month, and 12-month follow-ups.]
measures performance speed in a fine motor task
- Stroop Task [Baseline, 3-month, 6-month, and 12-month follow-ups.]
timed cognitive 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
- 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
- California Computerized Assessment Package (CalCAP) [Baseline, 3-month, 6-month, and 12-month follow-ups.]
computerized task measuring reaction time
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Florida | Gainesville | Florida | United States | 32610 |
| 2 | Florida International University | Miami | Florida | United States | 33199 |
Sponsors and Collaborators
- University of Florida
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Brown University
Investigators
- Principal Investigator: Ron Cohen, Ph.D, University of Florida
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB201500625-N
- 2P01AA019072-06
- OCR16162