# Cognitive and Inflammation Targeted Gut-Brain Interventions in People Living with HIV who are High-Risk Alcohol Users

> **NIH NIH P01** · UNIVERSITY OF FLORIDA · 2022 · $406,625

## Abstract

RC2 Summary
 The overarching goal of Research Component 2 (RC2) is to determine whether two non-invasive biological
interventions, transcutaneous vagal nerve stimulation (tVNS) and a probiotic supplementation intervention (PBI), will
improve cognitive and brain functioning, systemic and neuroinflammation, and gut microbiome health in people living
with HIV (PWLH) who are high risk users of alcohol. The study will also delineate mechanisms of the gut-brain axis, which
is particularly relevant, given that the factors underlying adverse cognitive and brain effects of alcohol use among PLWH
remains unresolved. There is also considerable public health significance if beneficial effects of tVNS and/or PBI can be
demonstrated, as cognitive disturbances that adversely impact health outcomes, functional abilities and quality of life
are common (~ 50% prevalence), despite marked reductions in mortality in the era of antiretroviral therapies (ART).
Among PLWH with reconstituted immune function and undetectable viral loads, comorbid conditions remain common
and can have adverse functional consequences. High risk alcohol use, prevalent among PLWH, not only contributes to
cognitive and brain dysfunction, but also further exacerbates comorbidities (e.g. liver disease, hepatitis coinfection,
obesity, and cardiovascular and gastrointestinal dysfunction), and reduces treatment adherence while increasing the
propensity for high risk sexual behaviors, worse health outcomes, and transmission of the virus. The study’s clinical
significance is strong given the need for effective interventions to improve cognition and health outcomes in PLWH.
 To test these hypotheses, we will conduct a hybrid randomized clinical trial that will enroll 80 PLWH who are high
risk drinkers from our existing research infrastructure supported by the Southern HIV Alcohol Research Consortium
(SHARC). In a 2x2 factorial design, participants will be randomly assigned to one of 4 conditions (tVNS+placebo, sham-
stimulaiton+placebo, tVNS+probiotic, sham-stimulation+probiotic). We will obtain data on alcohol consumption,
cognitive assessments, blood biomarkers, stool microbiome, and neuroimaging at three timepoints (baseline, 30-days,
90 days).

## Key facts

- **NIH application ID:** 10486018
- **Project number:** 5P01AA029543-02
- **Recipient organization:** UNIVERSITY OF FLORIDA
- **Principal Investigator:** Eric Porges
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $406,625
- **Award type:** 5
- **Project period:** 2021-09-10 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10486018

## Citation

> US National Institutes of Health, RePORTER application 10486018, Cognitive and Inflammation Targeted Gut-Brain Interventions in People Living with HIV who are High-Risk Alcohol Users (5P01AA029543-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10486018. Licensed CC0.

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