# Characterize longitudinal events of oral high-risk human papillomavirus among an at-risk population (CLEAR)

> **NIH NIH R01** · UNIVERSITY OF MARYLAND BALTIMORE · 2024 · $598,940

## Abstract

Project Summary/Abstract
Males living with HIV are estimated to be at a 2- to 5-fold higher risk of developing human papillomavirus-
related oropharyngeal cancer (HPV-OPC) compared to the general population, with up to 90% of cases
attributed to oral high-risk (oHR)-HPV16. Because precancerous lesions are a challenge to diagnose and
clinicians have no reliable means of identifying vulnerable patients, effective interventions will require a
thorough understanding of the natural history of oHR-HPV. The presence of persistent non-oral HR-HPV
precedes precancerous lesion development in other HPV-related cancers; the same may be true for oHR-HPV.
HIV and anti-retroviral therapy (ART) may alter the oral microbiome and give rise to oral lesions and
periodontal disease, creating an immune microenvironment conducive to persistent oHR-HPV that ultimately
increases the risk for HPV-OPC. Predictors of oHR-HPV infection and persistence could serve as detection
markers for HPV-OPC to prompt preventive treatment early in disease progression when treatment outcomes
are most favorable. We propose to conduct a prospective study to characterize longitudinal events of oHR-
HPV among an at-risk population (CLEAR). We will leverage our longstanding multidisciplinary and
international collaboration and the established cohort receiving care at the sexual and gender minority-friendly
TRUST clinic in Nigeria. A total of 1,200 HPV-unvaccinated Nigerian non-heterosexual males who perform oral
sex and are living with or without HIV will be screened for oHR-HPV. A subset of 500 males, including those
with a prevalent oHR-HPV will be followed every 3 months for up to 2 years. We will collect oral gargle and
blood samples to detect incident and persistent oHR-HPV infection; measure CD4, HIV viral load, and the oral
microbiome; characterize oral sex practices; and perform dental examinations to document periodontal
disease, oral lesions, and dental caries. We will determine the association between HIV clinical markers and
oral-anogenital contact and the prevalence of oHR-HPV (AIM 1). We will compare the time course of oHR-HPV
as a function of HIV status (AIM 2). We will evaluate the relationship between dental phenotypes, the oral
microbiome, HIV clinical measures, and oHR-HPV infection (AIM 3). Understanding the oHR-HPV burden, time
course of infection, and oral cavity indicators of the immune microenvironment in the context of HIV will
generate robust data needed to help inform predictive models and develop rational risk-stratified screening
algorithms to help mitigate risk of HPV-OPC in males living with HIV.

## Key facts

- **NIH application ID:** 10891791
- **Project number:** 1R01DE033862-01
- **Recipient organization:** UNIVERSITY OF MARYLAND BALTIMORE
- **Principal Investigator:** Rebecca G. Nowak
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $598,940
- **Award type:** 1
- **Project period:** 2024-09-01 → 2029-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10891791

## Citation

> US National Institutes of Health, RePORTER application 10891791, Characterize longitudinal events of oral high-risk human papillomavirus among an at-risk population (CLEAR) (1R01DE033862-01). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10891791. Licensed CC0.

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