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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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~enrollment, 6 months after enrollment, 6 months post-operative
This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment, 6 months after enrollment, 6 months post-operative for reporting.

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 more

Awards & 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
1,000 Previous Clinical Trials
7,388,123 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
572 Previous Clinical Trials
27,077,341 Total Patients Enrolled
Whitman-Walker InstituteOTHER_GOV
2 Previous Clinical Trials
1,229 Total Patients Enrolled
~173 spots leftby Sep 2028
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