NCT04531943

Feminizing Hormone Therapy and the Rectal Mucosa Immune Environment in Transgender Women

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 285 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

The overarching goal of this research study is to achieve a better understanding of the rectal mucosal effects of feminizing hormones in people assigned male sex at birth and currently taking feminizing hormones who have sex with men. Better understanding the rectal mucosa in this population will allow for the optimization of current biomedical HIV prevention interventions and enhance design of future interventions, including an effective HIV vaccine. This study will recruit approximately 520 transgender women who have receptive anal intercourse with men (TGWSM) and cis-gender men into one of two cohorts. Cohort 1 is a cross-sectional study and Cohort 2 is a longitudinal study; enrollment into each cohort is based on participant characteristics.

Detailed description

Transgender women who have receptive anal intercourse with men (TGWSM; assigned male sex at birth and taking/planning to take feminizing hormone therapy) are at high risk of HIV, and many HIV infections occur due to exposure to the rectal mucosa. In this study, the researchers will examine the biologic effects of feminizing hormone therapy on the mucosal immune milieu of the rectum. A better understanding of rectal HIV transmission among TGWSM will lead to the development of improved biomedical prevention interventions. Historically, TGWSM have been grouped with men who have sex with men (MSM) in HIV prevention studies due to presumed similar risks of rectal HIV exposure despite their unique psychosocial, biologic, and prevention needs. From a biologic perspective, many TGWSM use feminizing hormone therapy with uncertain rectal mucosal effects. The effects of endogenous and exogenous hormones in the human and animal-model female genital tract has been described with estrogen generally being seen as hindering HIV transmission and progesterone facilitating transmission; however, few studies report effects on the rectal mucosa. In addition, the intestinal mucosa is known to be steroidogenic, and colonic epithelial cells express estrogen receptor β, suggesting that exogenous hormone therapy likely has an effect on the rectal mucosa that could influence HIV transmission. For this project, the researchers will build upon our successful translational mucosal immunology program with a highly successful clinical research and retention infrastructure that was designed to understand factors that may influence rectal HIV transmission and propose to examine the effects of feminizing hormone therapy on the rectal mucosal resident cellular populations, transcriptome, and microbiome in TGWSM. In the rectal mucosa, the researchers will compare HIV target cell availability, the transcriptome, and microbiome in a cross-sectional cohort of 1) TGWSM on using feminizing hormone therapy (n=300) and 2) cisgender MSM (n=150). The researchers will also examine HIV target cell availability, the transcriptome, and microbiome in a longitudinal study of TGWSM (n=70) before and after initiating feminizing hormone therapy. Two cohorts of HIV-negative TGWSM will be enrolled in this study. Cohort 1 will be a cross-sectional study where the researchers will enroll 300 TGWSM who are on feminizing hormone therapy and a control group of 150 sexually active cisgender men (assigned male sex at birth and currently identify as male) who have sex with men. Individuals in Cohort 1 will participate in study activities for up to 12 weeks. Cohort 2 is a longitudinal study where 70 TGWSM who are naïve to feminizing hormone therapy or have not taken feminizing hormone therapy for \> 6 months and plan to initiate feminizing hormone therapy will be enrolled. Individuals in Cohort 2 will participate in study activities for 18 months.

Conditions

• HIV Prevention

Interventions

Type	Name	Description
DRUG	Estrogen	Feminizing hormone therapy consisting of estrogen alone, as prescribed by the participant's healthcare provider.
DRUG	Estrogen plus Progesterone	Feminizing hormone therapy consisting of estrogen and progesterone, as prescribed by the participant's healthcare provider.

Timeline

• Start date: 2020-10-01
• Primary completion: 2024-04-04
• Completion: 2024-04-04
• First posted: 2020-08-31
• Last updated: 2025-06-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study