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Search / Trial NCT06565663

MaPGAS Decision Making

Launched by DARTMOUTH-HITCHCOCK MEDICAL CENTER · Aug 20, 2024

Trial Information

Current as of November 11, 2025

Enrolling by invitation

Keywords

Gender Affirming Surgery Sex Reassignment Surgery Gender Reassignment Surgery Phalloplasty Metoidioplasty Transmasculine Ftm Gender Dysphoria Transgender Penile Reconstruction Female To Male Neophallus Transsexual Genital Reconstruction Reconstructive Urology

ClinConnect Summary

This study is testing a new online decision aid to help people who are transgender or non-binary and assigned female at birth decide about Metoidioplasty or Phalloplasty (MaPGAS), which are gender-affirming surgeries. It’s a randomized trial, meaning participants are assigned by chance to either use the decision aid in addition to usual care or to receive usual care only. The goal is to see if the tool makes the decision process easier, reduces uncertainty about choices, and helps people feel more prepared to talk with their doctor. The tool is web-based, includes information on options, risks and benefits, and patient stories, and it’s available for about four weeks before the surgical consultation. Researchers will measure how the tool changes people’s sense of certainty and readiness, and also how usable the tool is and whether it supports shared decision-making with clinicians.

Who can join: adults 18 and older, assigned female at birth, who identify as transgender male and/or gender non-binary, living in the United States, and able to read and understand English at roughly a sixth-grade level. They must have a consultation scheduled for metoidioplasty or phalloplasty (or be post-operative), and not have participated in prior tool refinement focus groups. The study is led by Dartmouth-Hitchcock Medical Center with a collaboration at the University of Utah. About 140 participants are planned, and enrollment is currently ongoing with results expected around 2027. Participants will complete surveys before and after using the tool, and will also provide feedback on usability and how helpful the decision aid was in preparing for discussions with their healthcare team.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Assigned female on the original birth certificate.
  • Self-identifies as transgender male and/or gender non-binary.
  • Able to speak, read, and understand English at a sixth-grade level.
  • Aged 18 or older.
  • Resides in the USA.
  • For decision aid refinement: Considering metoidioplasty or phalloplasty, or is post-operative.
  • For intervention and control arm: Has a consultation scheduled for metoidioplasty or phalloplasty.
  • Exclusion Criteria:
  • Participants involved in the initial tool refinement focus groups cannot participate in the intervention or control group to avoid contamination of the study outcomes.

About Dartmouth Hitchcock Medical Center

Dartmouth-Hitchcock Medical Center (DHMC) is a leading academic medical institution located in Lebanon, New Hampshire, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a major teaching hospital affiliated with the Geisel School of Medicine at Dartmouth, DHMC integrates cutting-edge clinical trials and translational research into its comprehensive patient care approach. The center emphasizes collaboration across disciplines, aiming to enhance patient outcomes through rigorous scientific investigation, education, and community engagement. With a focus on ethical practices and patient safety, DHMC is dedicated to contributing to the advancement of medical knowledge and improving health care delivery.

Locations

Salt Lake City, Utah, United States

Hanover, New Hampshire, United States

Patients applied

0 patients applied

Trial Officials

Rachel A. Moses, MD, MPH

Principal Investigator

Dartmouth-Hitchcock Clinic

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported