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

Status:	Recruiting
Conditions:	HIV / AIDS, Psychiatric
Therapuetic Areas:	Immunology / Infectious Diseases, Psychiatry / Psychology
Healthy:	No
Age Range:	25 - 75
Updated:	1/2/2019
Start Date:	December 2016
End Date:	December 2020
Contact:	Megan A Forbes, B.S
Email:	meganforbes@phhp.ufl.edu
Phone:	352-294-5844

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.

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.

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.

We found this trial at

sites

University of Florida

Gainesville, Florida 32610

(352) 392-3261