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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decision-aid | Behavioral | 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. |
| 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) |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Participant-Reported Feasibility of AFFRMED | The other study outcomes are related to participant-reported feasibility of the AFFRMED. Participants will also be asked to rate the feasibility of the AFFRMED using the validated Feasibility of Intervention Measure (FIM). Scale scores range from 4 to 20, with higher scores indicating greater feasibility. | Immediately post-treatment (same day) |
Inclusion Criteria:
Exclusion Criteria:
Youth and young adults who identify as transgender, trans, nonbinary, gender fluid, or genderqueer
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| Name | Affiliation | Role |
|---|---|---|
| Diane Chen, PhD | Ann & Robert H Lurie Children's Hospital of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60614 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Transgender Youth and Young Adults | Transgender youth and young adults will navigate the decision-aid consisting 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. |
| FG001 | Parents of Transgender Youth and Young Adults | Parents of transgender youth and young adults will navigate the decision-aid consisting 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Transgender Youth and Young Adults | Transgender youth and young adults will navigate the decision-aid consisting 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Pre-treatment and immediately post-treatment (same day) |
|
2 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Transgender Youth and Young Adults | Transgender youth and young adults will navigate the decision-aid consisting 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Diane Chen | Ann & Robert H. Lurie Children's Hospital of Chicago | 312-227-2939 | DiChen@luriechildrens.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 25, 2019 | Nov 17, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 7, 2022 | Nov 14, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003661 | Decision Support Techniques |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| Pre-treatment and immediately post-treatment (same day) |
| Participant-Reported Acceptability of AFFRMED | The other study outcomes are related to participant-reported acceptability of the AFFRMED. Participants will also be asked to rate the acceptability of the AFFRMED using the validated Acceptability of Intervention Measure (AIM). Scale scores range from 4 to 20, with higher scores indicating greater acceptability. | Immediately post-treatment (same day) |
| Participant-Reported Appropriateness of AFFRMED | The other study outcomes are related to participant-reported appropriateness of the AFFRMED. Participants will also be asked to rate the appropriateness of the AFFRMED using the validated Intervention Appropriateness Measure (IAM). Scale scores range from 4 to 20, with higher scores indicating greater appropriateness. | Immediately post-treatment (same day) |
| BG001 | Parents of Transgender Youth and Young Adults | Parents of transgender youth and young adults will navigate the decision-aid consisting 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | Parents of Transgender Youth and Young Adults | Parents of transgender youth and young adults will navigate the decision-aid consisting 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. |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Pre-treatment and immediately post-treatment (same day) |
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| Other Pre-specified | Participant-Reported Feasibility of AFFRMED | The other study outcomes are related to participant-reported feasibility of the AFFRMED. Participants will also be asked to rate the feasibility of the AFFRMED using the validated Feasibility of Intervention Measure (FIM). Scale scores range from 4 to 20, with higher scores indicating greater feasibility. | Posted | Mean | Standard Deviation | score on a scale | Immediately post-treatment (same day) |
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| Other Pre-specified | Participant-Reported Acceptability of AFFRMED | The other study outcomes are related to participant-reported acceptability of the AFFRMED. Participants will also be asked to rate the acceptability of the AFFRMED using the validated Acceptability of Intervention Measure (AIM). Scale scores range from 4 to 20, with higher scores indicating greater acceptability. | Posted | Mean | Standard Deviation | score on a scale | Immediately post-treatment (same day) |
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| Other Pre-specified | Participant-Reported Appropriateness of AFFRMED | The other study outcomes are related to participant-reported appropriateness of the AFFRMED. Participants will also be asked to rate the appropriateness of the AFFRMED using the validated Intervention Appropriateness Measure (IAM). Scale scores range from 4 to 20, with higher scores indicating greater appropriateness. | Posted | Mean | Standard Deviation | score on a scale | Immediately post-treatment (same day) |
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| 10 |
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| 10 |
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| 10 |
| EG001 | Parents of Transgender Youth and Young Adults | Parents of transgender youth and young adults will navigate the decision-aid consisting 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. | 0 | 10 | 0 | 10 | 0 | 10 |
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The hypothesis of this analysis was that using the AFFRMED would increase fertility-related decision self-efficacy. This paired-samples t-test compares participants' pre- and post-test decision self-efficacy scores.
| t-test, 1 sided |
| 0.051 |
| Mean Difference (Final Values) |
| -8.081 |
| 2-Sided |
| Other |