Cancer Screening, Gender Diverse Populations, Transgender
Conditions
Brief summary
This study aims to quantify the rates of cervical cancer screening and endometrial sampling prior to gender-affirming hysterectomy, assess the need for these tests in TGD individuals, and explore patient-centered options for these tests. By assessing the status of testing and correlation with hysterectomy pathology, this study will provide preliminary data on the current state of guideline-concordant care and provide initial evidence for the development of evidence-based guidelines in the future
Interventions
OTHERNo intervention
Observational study
Sponsors
University of Minnesota
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* 18 years and older * Able to provide voluntary written consent prior to the performance of any research related activity. Patients who can provide informed consent * Able to understand, speak, read, and write in English * Patients who have undergone hysterectomy, or plan to have a hysterectomy * Patients who are transgender and gender diverse"
Exclusion criteria
* Opted out of research * \<18 years old * Lacks capacity to consent/has diminished capacity to consent * Cannot provide informed consent * Those on the study's community advisory board
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of cervical cancer screening and endometrial sampling in TGD individuals | Month 36 | Describe the rates of cervical cancer screening and endometrial sampling in TGD individuals undergoing hysterectomy in the MHealth Fairview System between January 2014-June 2024. |
| Whether HPV self-testing affects the rates of cervical cancer screening in TGD individuals | Month 36 | Describe the rates of cervical and endometrial cancer and their precursor lesions on pathology after hysterectomy that was undiagnosed prior to hysterectomy in TGD individuals in the MHealth Fairview System between January 2014-June 2024. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| how introducing the option of HPV self-testing affects the rates of cervical cancer screening in TGD individuals undergoing hysterectomy. | Month 36 | Assess how introducing the option of HPV self-testing affects the rates of cervical cancer screening in TGD individuals undergoing hysterectomy. Patients planning hysterectomy who are not up to date on cervical cancer screening will be offered standard cervical cancer screening or HPV self-testing. These participants will also be recruited to complete surveys and interviews. Patients who are up to date on cervical cancer screening prior to their hysterectomy consult will have the option to complete a mock self-swab or no testing. Participants who are up to date on cervical cancer screening will be surveyed regarding their experiences with cervical cancer screening and how the self-testing option impacts cervical cancer screening. |
| how introducing the option of HPV self-testing affects patient experience | Month 36 | Understand how introducing the option of non-invasive testing affects the patient experience for TGD patients undergoing hysterectomy. Recruited participants who are undergoing hysterectomy for gender-affirmation will be asked to complete surveys (N=30) and qualitative interviews (N=15) to evaluate how the option of self-testing or non-invasive testing affects the patient experience. |
Countries
United States
Contacts
CONTACTSamantha Hoffman, MD
PRINCIPAL_INVESTIGATORSamantha Hoffman, MD
University of Minnesota
Outcome results
None listed