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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2021-12-16

Brief Summary

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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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Detailed Description

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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

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Alcohol Consumption HIV Motivation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Motivational Interviewing

Intervention Type BEHAVIORAL

A type of counseling aimed at reducing consumption of alcohol.

Questionnaire assessment

Intervention Type OTHER

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

Neurocognitive assessments

Intervention Type OTHER

Several different types of neurocognitive assessment will be performed.

Blood specimens

Intervention Type OTHER

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

Control Group

This group of participants will not receive motivational interviewing. They will have blood specimen collection, questionnaire assessment, and neurocognitive assessments performed.

Group Type ACTIVE_COMPARATOR

Questionnaire assessment

Intervention Type OTHER

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

Neurocognitive assessments

Intervention Type OTHER

Several different types of neurocognitive assessment will be performed.

Blood specimens

Intervention Type OTHER

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

Interventions

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Motivational Interviewing

A type of counseling aimed at reducing consumption of alcohol.

Intervention Type BEHAVIORAL

Questionnaire assessment

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

Intervention Type OTHER

Neurocognitive assessments

Several different types of neurocognitive assessment will be performed.

Intervention Type OTHER

Blood specimens

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No