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

NCT04531943 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 285

Last updated 2025-06-17

No results posted yet for this study

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.

Conditions

  • HIV Prevention

Interventions

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.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Colleen Kelley, MD, MPH · Emory University

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2024-04-04
Completion
2024-04-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04531943 on ClinicalTrials.gov