NCT05175170

Brief Summary

The aim of this study is to test if using a web-based medical decision-making tool on the topics of fertility and fertility-preservation increases knowledge among transgender youth and young adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 9, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 3, 2022

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

April 7, 2023

Completed
Last Updated

April 7, 2023

Status Verified

April 1, 2023

Enrollment Period

4 months

First QC Date

December 2, 2021

Results QC Date

December 8, 2022

Last Update Submit

April 6, 2023

Conditions

Transgender Adolescents & Young Adults

Keywords

fertilitydecision-making

Outcome Measures

Primary Outcomes (1)

  • Change in Fertility-related Knowledge

    The primary study outcome is change in fertility-related knowledge from same-day pre-AFFRMED to post-AFFRMED exposure. Participants will complete a fertility-related knowledge test instrument immediately prior to AFFRMED exposure. Participants will be given 1 hour to freely navigate the web-based AFFRMED prototype. Thereafter, participants will get a 5-minute break before completing a post-AFFRMED fertility knowledge test. The knowledge test consists of 41 items, and reflects a percentage correct score ranging from 0-100% correct. The Mean Difference results reflect the difference in fertility knowledge test mean scores between pre-AFFRMED and post-AFFRMED exposure.

    Pre-treatment and immediately post-treatment (same day)

Secondary Outcomes (1)

  • Change in Decisional Self-Efficacy

    Pre-treatment and immediately post-treatment (same day)

Other Outcomes (3)

  • Participant-Reported Feasibility of AFFRMED

    Immediately post-treatment (same day)

  • Participant-Reported Acceptability of AFFRMED

    Immediately post-treatment (same day)

  • Participant-Reported Appropriateness of AFFRMED

    Immediately post-treatment (same day)

Study Arms (1)

Decision-aid

EXPERIMENTAL

Participants will spend up to one hour freely navigating the web-based decision aid. They will complete pre- and post-test measures to determine if using the decision-aid website increased knowledge and impacted decision self-efficacy regarding fertility and fertility preservation.

Behavioral: Decision-aid

Interventions

Decision-aidBEHAVIORAL

The decision aid consists of domains related to human reproduction, fertility, and fertility preservation. The domains address priority learning objectives in each domain to increase knowledge on the impact of gender-affirming medical interventions on fertility and fertility preservation options.

Decision-aid

Eligibility Criteria

Age8 Years - 24 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsYouth and young adults who identify as transgender, trans, nonbinary, gender fluid, or genderqueer
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • (1) youth is between the ages of 8-14 years
  • (2) youth self-asserts a transgender identity
  • (3) youth has expressed interest in GnRHa or is currently on GnRHa treatment; or
  • (1) AYA is between the ages of 13-24 years,
  • (2) AYA self-asserts a transgender identity, and
  • (3) AYA has expressed interest in gender-affirming hormone (GAH) or is currently on GAH treatment.
  • Parents of eligible youth will be eligible to participate.

You may not qualify if:

  • (1) youth/parents are unable to read, speak or understand English
  • (2) youth/parents are unable or unwilling to provide consent/assent/parental permission for study participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60614, United States

Location

MeSH Terms

Interventions

Decision Support Techniques

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

Title
Dr. Diane Chen
Organization
Ann & Robert H. Lurie Children's Hospital of Chicago
DiChen@luriechildrens.org
312-227-2939

Study Officials

  • Diane Chen, PhD

    Ann & Robert H Lurie Children's Hospital of Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Behavioral Health Director; Associate Professor of Psychiatry and Behavioral Sciences, & Pediatrics

Study Record Dates

First Submitted

December 2, 2021

First Posted

January 3, 2022

Study Start

June 3, 2021

Primary Completion

October 9, 2021

Study Completion

October 9, 2021

Last Updated

April 7, 2023

Results First Posted

April 7, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)