Alcohol ConsumptionNCT02563574
ARCH II Study (Alcohol Research Center on HIV Study II)
A study testing Motivational Interviewing, Questionnaire assessment and Neurocognitive assessments in people with Alcohol Consumption and HIV, run by University of Florida at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Alcohol Consumption, HIV, Motivation
- What is being tested?
- Motivational Interviewing, Questionnaire assessment and Neurocognitive assessments
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2016to 16 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-infected;
- English speaking;
- Physically mobile;
- Willingness to participate in the Motivational Interviewing (MI) to reduce ETOH consumption.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Florida
Gainesville, Florida, 32610
Florida International University
Miami, Florida, 33199
About this study
Official title: Alcohol and HIV: Biobehavioral Interactions and Intervention
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.
Read the 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.
- Conditions
- Alcohol Consumption, HIV, Motivation
- Being tested
- Motivational Interviewing, Questionnaire assessment, Neurocognitive assessments, Blood specimens
- Keywords
- Alcohol and brain function, HIV and brain function, Motivational Interviewing
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
A type of counseling aimed at reducing consumption of alcohol.
Questionnaire assessmentOther
Several different types of questionnaires will be fill out by the participants.
Neurocognitive assessmentsOther
Several different types of neurocognitive assessment will be performed.
Blood specimensOther
Blood specimens will be used to measure the immunological, virologic, and hepatic status, as well as other biomarkers.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing Group | Experimental | 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. Receives: Behavioral: Motivational Interviewing; Other: Questionnaire assessment; Other: Neurocognitive assessments; Other: Blood specimens |
| Control Group | Active comparator | This group of participants will not receive motivational interviewing. They will have blood specimen collection, questionnaire assessment, and neurocognitive assessments performed. Receives: Other: Questionnaire assessment; Other: Neurocognitive assessments; Other: Blood specimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
FMRI images will be performed for changes in the brain between the groups
Cerebral metabolite abnormalities
Measured: Baseline and 6 month follow-up
Secondary outcomes (28)
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
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline, 3-month, 6-month, and 12-month follow-ups.
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.
Measured: Baseline, 3-month, 6-month, and 12-month follow-ups.
Urine Drug Screen
Urine drug screens will be performed using Varian's TestCup Pro5, testing for benzodiazepines, amphetamines, opiates, \& cocaine.
Measured: Baseline, 3-month, 6-month, and 12-month follow-ups.
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
Measured: Baseline, 3-month, 6-month, and 12-month follow-ups.
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).
Measured: Baseline, 3-month, 6-month, and 12-month follow-ups.
Center for Epidemiological Studies-Depression Scale (CES-D)
A 20-item screening test for depression and depressive disorder
Measured: Baseline, 3-month, 6-month, and 12-month follow-ups.
Beck Anxiety Inventory
21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety
Measured: Baseline, 3-month, 6-month, and 12-month follow-ups.
Early Life Stress Questionnaire (ELSQ)
A 5-section self-report questionnaire assessment of adverse childhood events
Measured: Baseline
The Frontal System Behavioral Scale (FrSBe)
A 46-item self-report questionnaire designed to measure behavior related to frontal systems damage
Measured: Baseline, 3-month, 6-month, and 12-month follow-ups.
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
Measured: Baseline, 3-month, 6-month, and 12-month follow-ups.
Montreal Cognitive Assessment (MoCA)
measurement used to screen for dementia and mild cognitive impairment
Measured: Baseline, 3-month, 6-month, and 12-month follow-ups.
Hopkins Verelan Learning Test Revised (HVLT-R)
cognitive assessment that measures verbal learning and memory
Measured: Baseline, 3-month, 6-month, and 12-month follow-ups.
Brief Visuospatial Memory Test Revised (BVMT-R)
A measure of visuospatial memory
Measured: Baseline, 3-month, 6-month, and 12-month follow-ups.
Paced Auditory Serial Addition Test (PASAT-1)
A cognitive assessment which measures visuospatial memory
Measured: Baseline, 3-month, 6-month, and 12-month follow-ups.
WAIS-3 Letter Number Sequencing
7-item cognitive assessment with a total of 21 maximum points
Measured: Baseline, 3-month, 6-month, and 12-month follow-ups.
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
Measured: Baseline, 3-month, 6-month, and 12-month follow-ups.
WAIS-3 Symbol Search
Cognitive assessment measuring processing speed with a total max score of
Measured: Baseline, 3-month, 6-month, and 12-month follow-ups.
Trail Making
timed cognitive assessment looking at working memory and executive functioning
Measured: Baseline, 3-month, 6-month, and 12-month follow-ups.
Grooved Pegboard
measures performance speed in a fine motor task
Measured: Baseline, 3-month, 6-month, and 12-month follow-ups.
Stroop Task
timed cognitive task
Measured: Baseline, 3-month, 6-month, and 12-month follow-ups.
Verbal Fluency
timed language measure
Measured: Baseline, 3-month, 6-month, and 12-month follow-ups.
Animal Fluency
timed language measure
Measured: Baseline, 3-month, 6-month, and 12-month follow-ups.
The Wechsler Test of Adult Reading (WTAR)
cognitive tast measuring verbal intelligence
Measured: Baseline, 3-month, 6-month, and 12-month follow-ups.
Boston Naming Test
Measured: Baseline, 3-month, 6-month, and 12-month follow-ups.
Adaptive Rate Continuous Performance Test (ARCPT)
computerized adaptive task measuring attention
Measured: Baseline, 3-month, 6-month, and 12-month follow-ups.
California Computerized Assessment Package (CalCAP)
computerized task measuring reaction time
Measured: Baseline, 3-month, 6-month, and 12-month follow-ups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study startDec 2016
- Primary completion16 Dec 2021
- Study completion16 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol ConsumptionStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Brown University
- Responsible party
- Sponsor
- Investigators
- Ron Cohen, Ph.D, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02563574
- Sponsor's protocol ID
- IRB201500625-N
- Other IDs
- 2P01AA019072-06, OCR16162
- Status last verified
- Mar 2022
- First submitted
- 28 Sep 2015
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Scott K, Guy AA, Zelaya DG, Surace A, Elwy AR, Keuroghlian AS, Mayer KH, Monti PM, Kahler CW. Research and engagement considerations for alcohol use telehealth services within HIV care: a qualitative exploration in federally qualified health centers. AIDS Care. 2023 Nov;35(11):1786-1795. doi: 10.1080/09540121.2023.2197640. Epub 2023 Apr 11.
PubMed 37039068
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol and HIV: Biobehavioral Interactions and Intervention
- ClinicalTrials.gov ID
- NCT02563574
- Acronym / sponsor ID
- IRB201500625-N
- Conditions
- Alcohol Consumption, HIV, Motivation
- Keywords
- Alcohol and brain function, HIV and brain function, Motivational Interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Brown University
- Study start
- Dec 2016
- Primary completion
- 16 Dec 2021 (actual)
- Study completion
- 16 Dec 2021 (actual)
- First posted
- 30 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing Group | Experimental | Behavioral: Motivational Interviewing, Other: Questionnaire assessment, Other: Neurocognitive assessments, Other: Blood specimensThis group of participants will receive the motivational interviewing. In addition to blood specimen collection, a questionnaire assessment and neurocognitive assessments will also be performed. |
| Control Group | Active comparator | Other: Questionnaire assessment, Other: Neurocognitive assessments, Other: Blood specimensThis group of participants will not receive motivational interviewing. They will have blood specimen collection, questionnaire assessment, and neurocognitive assessments performed. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV-infected;
- English speaking;
- Physically mobile;
- Willingness to participate in the Motivational Interviewing (MI) to reduce ETOH consumption.
Key exclusion criteria (8 listed)
- Neurological disorders;
- Evidence of dementia;
- Past opportunistic brain infection;
- Major psychiatric illness;
- Current major psychiatric disturbance;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational InterviewingA type of counseling aimed at reducing consumption of alcohol. | Behavioural | Motivational Interviewing Group |
| Questionnaire assessmentSeveral different types of questionnaires will be fill out by the participants. | Other | Control Group, Motivational Interviewing Group |
| Neurocognitive assessmentsSeveral different types of neurocognitive assessment will be performed. | Other | Control Group, Motivational Interviewing Group |
| Blood specimensBlood specimens will be used to measure the immunological, virologic, and hepatic status, as well as other biomarkers. | Other | Control Group, Motivational Interviewing Group |
Primary outcome
FMRI images will be performed for changes in the brain between the groups
Time frame: Baseline and 6 month follow-up
Cerebral metabolite abnormalities
28 secondary outcomes
Structured Clinical Interview for Diagnostic and Statistical Manual (DSM)-IV (SCID)
Time frame: Baseline
Lifetime Alcohol and Drug Use History
Time frame: Baseline
Kreek-McHugh-Schluger-Kellogg (KMSK) Scale
Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.
Timeline Followback (TLFB)
Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.
Urine Drug Screen
Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.
Short Inventory of Problems (SIP)
Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.
Epworth Sleepiness Scale (ESS)
Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.
Center for Epidemiological Studies-Depression Scale (CES-D)
Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.
Beck Anxiety Inventory
Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.
Early Life Stress Questionnaire (ELSQ)
Time frame: Baseline
The Frontal System Behavioral Scale (FrSBe)
Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.
Medical Outcomes Study HIV Health Survey (MOS-HIV)
Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.
Montreal Cognitive Assessment (MoCA)
Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.
Hopkins Verelan Learning Test Revised (HVLT-R)
Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.
Brief Visuospatial Memory Test Revised (BVMT-R)
Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.
Paced Auditory Serial Addition Test (PASAT-1)
Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.
WAIS-3 Letter Number Sequencing
Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.
WAIS-3 Digit Symbol
Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.
WAIS-3 Symbol Search
Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.
Trail Making
Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.
Grooved Pegboard
Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.
Stroop Task
Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.
Verbal Fluency
Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.
Animal Fluency
Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.
The Wechsler Test of Adult Reading (WTAR)
Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.
Boston Naming Test
Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.
Adaptive Rate Continuous Performance Test (ARCPT)
Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.
California Computerized Assessment Package (CalCAP)
Time frame: Baseline, 3-month, 6-month, and 12-month follow-ups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Derived from this study: PubMed 37039068Scott K, Guy AA, Zelaya DG, Surace A, Elwy AR, Keuroghlian AS, Mayer KH, Monti PM, Kahler CW. Research and engagement considerations for alcohol use telehealth services within HIV care: a qualitative exploration in federally qualified health centers. AIDS Care. 2023 Nov;35(11):1786-1795. doi: 10.1080/09540121.2023.2197640. Epub 2023 Apr 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron Cohen, Ph.D principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing, Questionnaire assessment and Neurocognitive assessments in people with Alcohol Consumption and HIV, run by University of Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FMRI images will be performed for changes in the brain between the groups (time frame: Baseline and 6 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02563574, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.