Fertility Decision-Making in Youth and Young Adults

Study Overview
=================
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.

Detailed Description
-----------------
The pilot trial of Aid for Fertility-Related Medical Decisions (AFFRMED) is a single-arm, pre-/post- feasibility, acceptability, and preliminary efficacy trial. 10 transgender adolescents and young adults (AYA) and 10 parents of transgender AYA participated in a 90-120 min, virtual research visit via Zoom. During this visit they completed pre-test measures of fertility knowledge and decisional self-efficacy, followed by up to 1 hour to freely navigate AFFRMED decision aid. After using AFFRMED, participants completed post-test measures of fertility knowledge and decisional self-efficacy, as well as implementation outcomes measures (Acceptability of Intervention, Intervention Appropriateness Measure, and Feasibility of Intervention Measure).

Official Title
-----------------
Fertility Decision-Making in Youth and Young Adults

Conditions
-----------------
Transgender Adolescents & Young Adults

Intervention / Treatment
-----------------
* Behavioral: Decision-aid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (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. Exclusion Criteria: (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.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 24 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decision-aid<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Decisional Self-Efficacy | The secondary study outcome is change in decisional self-efficacy for fertility-related decision-making from same-day pre-AFFRMED to post-AFFRMED exposure using the Decision Self Efficacy Scale. Decision Self Efficacy Scale scores range from 0 [not at all confident] to 100 [very confident]. A score of 0 indicates 'extremely low self-efficacy' and a score of 100 indicates 'extremely high self-efficacy'. The Mean Difference results reflect the difference in decisional self-efficacy mean scores between pre-AFFRMED and post-AFFRMED exposure. | Pre-treatment and immediately post-treatment (same day) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fertility, decision-making