ARCH II Study (Alcohol Research Center on HIV Study II)
Alcohol and HIV: Biobehavioral Interactions and Intervention
3 other identifiers
interventional
14
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2016
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2015
CompletedFirst Posted
Study publicly available on registry
September 30, 2015
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 16, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 16, 2021
CompletedApril 4, 2022
March 1, 2022
5 years
September 28, 2015
March 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
FMRI images will be performed for changes in the brain between the groups
Cerebral metabolite abnormalities
Baseline and 6 month follow-up
Secondary Outcomes (28)
Structured Clinical Interview for Diagnostic and Statistical Manual (DSM)-IV (SCID)
Baseline
Lifetime Alcohol and Drug Use History
Baseline
Kreek-McHugh-Schluger-Kellogg (KMSK) Scale
Baseline, 3-month, 6-month, and 12-month follow-ups.
Timeline Followback (TLFB)
Baseline, 3-month, 6-month, and 12-month follow-ups.
Urine Drug Screen
Baseline, 3-month, 6-month, and 12-month follow-ups.
- +23 more secondary outcomes
Study Arms (2)
Motivational Interviewing Group
EXPERIMENTALThis 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 COMPARATORThis group of participants will not receive motivational interviewing. They will have blood specimen collection, questionnaire assessment, and neurocognitive assessments performed.
Interventions
A type of counseling aimed at reducing consumption of alcohol.
Several different types of questionnaires will be fill out by the participants.
Several different types of neurocognitive assessment will be performed.
Blood specimens will be used to measure the immunological, virologic, and hepatic status, as well as other biomarkers.
Eligibility Criteria
You may qualify if:
- HIV-infected;
- English speaking;
- Physically mobile;
- Willingness to participate in the Motivational Interviewing (MI) to reduce ETOH consumption.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Floridalead
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)collaborator
- Brown Universitycollaborator
Study Sites (2)
University of Florida
Gainesville, Florida, 32610, United States
Florida International University
Miami, Florida, 33199, United States
Related Publications (1)
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.
PMID: 37039068DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ron Cohen, Ph.D
University of Florida
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2015
First Posted
September 30, 2015
Study Start
December 1, 2016
Primary Completion
December 16, 2021
Study Completion
December 16, 2021
Last Updated
April 4, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share