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Behavioural Intervention
Peer Support for Gender Confirmation Surgery (STRIVE Trial)
N/A
Waitlist Available
Led By Geolani Dy, MD
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented recommendation by surgeon for vaginoplasty
Seeking vaginoplasty
Must not have
Do not speak English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up enrollment, 6 months after enrollment, immediate pre-operative, 3 months post-operative, 6 months post-operative
Awards & highlights
No Placebo-Only Group
Summary
This trial focuses on improving health outcomes for transgender and nonbinary individuals seeking gender-affirming surgery. The study compares the effectiveness of a virtual peer support group versus usual care in preparing patients for vagin
Who is the study for?
The STRIVE study is for transgender and nonbinary adults aged 18 or older seeking vaginoplasty. It aims to improve their well-being by comparing a virtual peer support intervention with usual care. Participants must be planning to undergo surgery at one of the participating centers.
What is being tested?
This trial tests if virtual group-based peer support led by trans individuals who've had gender-affirming surgery can better prepare patients for vaginoplasty compared to standard care with educational materials. The effectiveness will be measured through coping skills, meeting surgical criteria, and other health outcomes.
What are the potential side effects?
Since this trial focuses on social support rather than medical interventions, there are no direct side effects like those associated with medications or surgeries. However, participants may experience varying levels of emotional response related to the social interactions within the peer-support groups.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My surgeon has recommended a vaginoplasty for me.
Select...
I am seeking vaginoplasty.
Select...
I have consulted with a surgeon about gender-affirming vaginoplasty.
Select...
I am 18 years old or older.
Select...
I identify as trans or non-binary.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not speak English.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ enrollment, 6 months after enrollment, 6 months post-operative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment, 6 months after enrollment, 6 months post-operative
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Patient-reported coping self-efficacy as assessed by the CSES
Secondary study objectives
Completion of preoperative criteria for scheduling GGAS
Other study objectives
Anxiety assessed by the GAD-7
Bodily appearance satisfaction assessed by the GENDER-Q "Appearance" scale
Complications and adverse effects assessed by the GENDER-Q "Adverse Effects" scale
+11 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: STRIVE Peer Support InterventionExperimental Treatment1 Intervention
A virtual group-based peer support intervention led by trans peers who have had genital gender-affirming surgery.
Group II: Enhanced Usual CareActive Control1 Intervention
Usual care enhanced with written and web-based education materials.
Find a Location
Who is running the clinical trial?
Oregon Health and Science UniversityLead Sponsor
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