# Genital Health of Trans-males on Testosterone

> **NIH NIH R21** · GEORGE WASHINGTON UNIVERSITY · 2021 · $207,336

## Abstract

Project Summary/Abstract:
The prevalence of cervical and anal canceris significantly higher in the transgender populationrelative to cisgender
people, yet the genital immune microenvironment that may elucidate underlying biological mechanisms of cancer
development in this population remains uncharacterized.
Transgender males (TM) are assigned female at birth but identify as male, and often are on long-term high doses
of testosterone (T). High levels of T have been linked to greater risk of invasive cervical carcinoma in cisgender
females (CF) and increased risk for detecting Human papilloma virus (HPV) 16/18 DNA in anal swabs in cisgender
males who have sex with men (MSM). However, a critical gap in our knowledge exists regarding the effects of T
on the cervical and anal immune microenvironment in TM. Potential mechanisms underlying susceptibility of
developing HPV-associated genital cancers can include the presence of high-risk genotypes and dysregulated
immune microenvironment.
This goal of this proposal is to evaluate high risk HPV prevalence and characterize the genital mucosal immune
microenvironment in cervical and anal compartments of TM on T. Data generated will provide valuable clinical
information that would allow us to evaluate if T use, and specifically the level of T elevation, impacts genital immune
dysregulation, HPV infection and HPV genotype (high vs low risk).
We have unique access to this population through Dr. Goldstein, the Director of Clinical Research at Whitman
Walker Health (WWH), Washington DC, who is actively involved in transgender health research and a co-
investigator on this proposal. We propose to recruit 50 TM who are on T for at least 2 years and a comparison
group of 50 race- and age-matched CF who are not on any hormonal therapy or contraceptives. Cervical and anal
swab samples will be collected and analyzed for HR-HPV genotypes, biomarkers of inflammation and innate
immune biomarkers of protection.
There is a growing interest in the National Institutes of Health to fund transgender research as evidenced by the
PAR-20-054 titled “Transgender People: Immunity, Prevention, and Treatment of HIV and STIs”. We are uniquely
poised to respond to this PAR by virtue of our experience in the field and access to this vulnerable population.
Assessment of data obtained fromthis study will provide us with baseline virological and immunological information
and spur further research in understanding mechanisms in HPV-associated cancers in this population.

## Key facts

- **NIH application ID:** 10163017
- **Project number:** 1R21AI157927-01
- **Recipient organization:** GEORGE WASHINGTON UNIVERSITY
- **Principal Investigator:** Mimi Ghosh
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $207,336
- **Award type:** 1
- **Project period:** 2021-03-15 → 2023-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10163017

## Citation

> US National Institutes of Health, RePORTER application 10163017, Genital Health of Trans-males on Testosterone (1R21AI157927-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10163017. Licensed CC0.

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