Gender Affirmation SurgerySTRIVENCT06436560
Support for Transgender and Non-Binary Individuals Seeking Vaginoplasty Study
A study testing STRIVE Peer Support Intervention in people with Gender Affirmation Surgery and Perioperative Care, run by Oregon Health and Science University at 9 sites in United States.
Trial summary
The STRIVE study is the first national randomized trial to focus on improving well-being, access to surgical care and other health outcomes for transgender and nonbinary (referred to as trans) people seeking genital gender-affirming surgery (GGAS). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Gender Affirmation Surgery, Perioperative Care, Transgender Health
- What is being tested?
- STRIVE Peer Support Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 9 sitesUnited States
- Study dates
- 10 Dec 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-identified trans or non-binary individual
- Seeking vaginoplasty
- Completed consultation with gender-affirming surgeon for vaginoplasty
- Documented recommendation by surgeon for vaginoplasty
- Can complete survey responses online, by phone or on paper.
- Willing and able to participate in virtual peer support intervention
Show all 9Show fewer
- Aged 18 or older
- English speaking
- Able to provide independent written consent
Who cannot join
- Do not speak English
- Cannot complete survey responses online, by phone, or on paper
- Are unwilling to participate in a virtual peer support intervention
- Have co-morbidities or other conditions that exclude them from candidacy for vaginoplasty
- Are currently involved in delivery of the STRIVE Intervention
- Are unable or unwilling to participate.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites
Rush University
Chicago, Illinois, 60612
Henry Ford Health
Detroit, Michigan, 48202
University of Minnesota
Minneapolis, Minnesota, 55455
New York University Langone Health
New York, New York, 10017
Temple University
Philadelphia, Pennsylvania, 19140
Oregon Health and Science University
Portland, Oregon, 97239
University of Utah
Salt Lake City, Utah, 84132
University of California San Francisco
San Francisco, California, 94143
University of Washington
Seattle, Washington, 98195
About this study
Official title: Support for Transgender and Non-Binary Individuals Seeking Vaginoplasty (STRIVE) Study
The STRIVE study is the first national randomized trial to focus on improving well-being, access to surgical care and other health outcomes for transgender and nonbinary (referred to as trans) people seeking genital gender-affirming surgery (GGAS). Trans people have gender identities that are different from the sex they were assigned at birth. Due to discrimination based on their gender identity in settings such as schools, the workplace, housing and health care, trans people face much higher rates of distress as well as poorer health and quality of life. Trans people are often unable to access necessary surgeries and hormone therapy to help align their bodies with their gender identities due to a lack of trained medical providers and limited insurance coverage for gender-affirming care.
The most common GGAS that trans people seek is vaginoplasty, which is the surgical creation of vaginal anatomy. Because of the high demand for this surgery and limited number of medical centers that offer it, trans people face lengthy wait times and complicated health system processes, increasing stress, negative mental health effects and social isolation. Social and peer-support interventions have been shown to decrease isolation and improve health. Social support during the GGAS process was also identified by the Transgender and Non-Binary Surgery - Allied Research Collective (TRANS-ARC) as the top research priority. Due to limited information on this topic, the STRIVE study was developed to meet this need.
Read more
The research team's goals are to:
- Compare the effectiveness of two approaches to presurgical preparation for vaginoplasty: a virtual group-based peer support intervention led by trans peers who have had GGAS, or usual care delivered by gender-affirming surgical teams, enhanced with patient education materials.
- Determine if the intervention improves meeting presurgical criteria for vaginoplasty.
- Evaluate if patients, peer supporters and healthcare staff find the intervention acceptable.
The research team will conduct a pragmatic randomized controlled trial, meaning participants will be assigned by chance to one of two groups: peer-support group or usual care enhanced with written and web-based education materials. This study is pragmatic because it is happening under real-life conditions to understand if the intervention will work in practice.
The research team will work with five academic gender-affirming surgery programs across the country to recruit and enroll 290 trans adults ages 18 and older who are seeking vaginoplasty. Participants assigned to the peer support group will receive the intervention virtually over the course of three months, facilitated by peer facilitators trained in collaboration with Trans Lifeline. The usual care group will receive education from their gender-affirming surgical team, with in-depth materials that cover the same topics as the virtual course.
The primary outcome to be measures at six months is coping self-efficacy, reported by patients, using a survey which assesses perceived ability to deal with stressors. The research team will explore additional outcomes at 12 months, including meeting GGAS presurgical criteria and other outcomes deemed important to trans community partners, surgeons and other gender-affirming providers (e.g., psychological stress, social support, resilience, quality of life, presurgical knowledge, surgical delays and cancellations). Postsurgical outcomes, including surgical satisfaction and other related outcomes, will be measured at 24 months. Finally, the team will conduct in-depth interviews with participants who undergo the intervention to understand their experiences at the beginning of the study and after six months. Researchers will also interview peer supporters and clinicians to understand how to improve and implement the support intervention more broadly.
In designing this study, the research team worked closely with trans community members and patients, health services and policy researchers, gender-affirming surgeons, advocates, gender program administrators and representatives from social support organizations. Collaboration with and input from the trans community during the conduct of this study will be critical to ensure that the STRIVE study is patient centered. Results from this study will be shared in multiple forms, including clinical guideline recommendations, policy briefs, patient-centered reports, web-based information and summaries for clinicians and researchers. Trans people seeking gender-affirming surgery can use the study findings to understand options for social support to improve quality of life and health outcomes. Clinicians, gender program administrators, health insurance companies and health policy advisors can use the findings from this study to better support and prepare patients who are seeking gender-affirming surgery.
Read the detailed description
OUTLINE The STRIVE (Support for Transgender and Non-Binary Individuals Seeking Vaginoplasty) Study is a multi-site, two-arm randomized pragmatic trial to determine if an evidence-based peer support intervention improves patient-reported and patient-centered clinical outcomes for individuals seeking genital gender-affirming surgery (GGAS) compared with enhanced usual care.
PRIMARY OBJECTIVES Aim 1: To compare the effectiveness of a virtual, group-based perioperative peer support intervention with enhanced usual care on coping self-efficacy (primary outcome) among patients seeking vaginoplasty.
- Hypothesis 1: Patients in the intervention arm will have greater improvements in coping self-efficacy at 6 months post-enrollment compared to patients who receive enhanced usual care.
Aim 2: To determine whether our perioperative peer support intervention improves patient probability of meeting pre-operative GGAS criteria (secondary outcome), and other prioritized patient-centered outcomes (exploratory outcomes).
- Hypothesis 2a: More patients in the intervention arm will meet pre-operative GGAS criteria at 12 months post-enrollment compared with patients who receive enhanced usual care.
- Hypotheses 2b: Patients in the intervention arm will have decreased psychological distress (anxiety, depression, suicidal ideation) and gender minority stress, and greater social support, resilience, QOL, pre-operative surgical knowledge, and fewer surgical delays. For participants who undergo surgery during the follow-up period, those in the intervention arm will have fewer surgical complications, greater completion of vaginal dilation, greater surgical satisfaction, and fewer unplanned emergency department and clinic visits at 6 months post-operatively.
Aim 3: To evaluate the acceptability of this centralized, virtual, group-based perioperative peer support intervention among patients, peer support specialists and healthcare team members.
- Being tested
- STRIVE Peer Support Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STRIVE Peer Support InterventionOther
A virtual group-based peer support intervention led by trans peers who have had genital gender-affirming surgery.
| Study group | Role | What they receive |
|---|---|---|
| STRIVE Peer Support Intervention | Experimental | A virtual group-based peer support intervention led by trans peers who have had genital gender-affirming surgery. Receives: Other: STRIVE Peer Support Intervention |
| Enhanced Usual Care | No intervention | Usual care enhanced with written and web-based education materials. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported coping self-efficacy as assessed by the CSES
Patient-reported coping self-efficacy is measured using the Coping Self-Efficacy Scale (CSES), a survey that assesses the perceived ability to deal with stressors using a score range of 0-260. Zero is equivalent to no perceived ability to deal with stressors; 260 indicates the highest attainable level of perceived ability to deal with stressors.
Measured: Enrollment, 6 months after enrollment, 12 months after enrollment, immediate pre-operative, 3 months post-operative, 6 months post-operative
Secondary outcomes (1)
Completion of preoperative criteria for scheduling GGAS
Completion of pre-operative criteria for scheduling genital gender-affirming surgery (GGAS), a proxy for patient readiness that is assessed based on each patient's ability to meet criteria of the center at which they are seeking care. Pre-operative criteria generally follow the World Professional Association for Transgender Health (WPATH) Standards of Care (SOC), which have been adopted by most public and private insurers in making coverage decisions for GGAS. WPATH SOC criteria include: a letter of support from a mental health professional attesting to one's ability to provide informed consent stability of ones' gender identity and desire for surgery, and that any mental health and/or medical conditions are well-managed. Additional center-specific requirements may also include: meeting weight criteria; nicotine cessation; glycemic control; and attestation of adequate social support and post-operative housing stability.
Measured: Enrollment, 6 months after enrollment, 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start10 Dec 2024
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gender Affirmation SurgeryStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, NYU Langone Health, Rush University, University of Utah, University of Minnesota, Temple University, University of California, San Francisco, University of Washington, Trans Lifeline, Whitman-Walker Institute, Duke University, Henry Ford Health System
- Responsible party
- Principal investigator, Geolani Dy, Oregon Health and Science University
- Investigators
- Geolani Dy, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436560
- Sponsor's protocol ID
- STUDY00026957
- Other IDs
- 1023677
- Acronym
- STRIVE
- Status last verified
- Mar 2026
- First submitted
- 24 May 2024
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to safety concerns about the use of data expressed during patient engagement processes, the STRIVE Study does not currently plan to share individual participant data (IPD) publicly.
Publications
Sage L, Hart E, Meyer N, Hnilicka O, Penkin A, Poteat TC, Aguayo-Romero R, Comstock BA; STRIVE Publications Committee; Dy GW. Support for Transgender and Nonbinary Individuals Seeking Vaginoplasty (STRIVE) study: protocol for a national randomised pragmatic trial. BMJ Open. 2026 Feb 12;16(2):e114287. doi: 10.1136/bmjopen-2025-114287.
PubMed 41688114
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Support for Transgender and Non-Binary Individuals Seeking Vaginoplasty (STRIVE) Study
- ClinicalTrials.gov ID
- NCT06436560
- Acronym / sponsor ID
- STRIVE / STUDY00026957
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, NYU Langone Health, Rush University, University of Utah, University of Minnesota, Temple University, University of California, San Francisco, University of Washington, Trans Lifeline, Whitman-Walker Institute, Duke University, Henry Ford Health System
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The STRIVE study is the first national randomized trial to focus on improving well-being, access to surgical care and other health outcomes for transgender and nonbinary (referred to as trans) people seeking genital gender-affirming surgery (GGAS). Trans people have gender identities that are different from the sex they were assigned at birth. Due to discrimination based on their gender identity in settings such as schools, the workplace, housing and health care, trans people face much higher rates of distress as well as poorer health and quality of life. Trans people are often unable to access necessary surgeries and hormone therapy to help align their bodies with their gender identities due to a lack of trained medical providers and limited insurance coverage for gender-affirming care.
The most common GGAS that trans people seek is vaginoplasty, which is the surgical creation of vaginal anatomy. Because of the high demand for this surgery and limited number of medical centers that offer it, trans people face lengthy wait times and complicated health system processes, increasing stress, negative mental health effects and social isolation. Social and peer-support interventions have been shown to decrease isolation and improve health. Social support during the GGAS process was also identified by the Transgender and Non-Binary Surgery - Allied Research Collective (TRANS-ARC) as the top research priority. Due to limited information on this topic, the STRIVE study was developed to meet this need.
The research team's goals are to:
- Compare the effectiveness of two approaches to presurgical preparation for vaginoplasty: a virtual group-based peer support intervention led by trans peers who have had GGAS, or usual care delivered by gender-affirming surgical teams, enhanced with patient education materials.
- Determine if the intervention improves meeting presurgical criteria for vaginoplasty.
- Evaluate if patients, peer supporters and healthcare staff find the intervention acceptable.
The research team will conduct a pragmatic randomized controlled trial, meaning participants will be assigned by chance to one of two groups: peer-support group or usual care enhanced with written and web-based education materials. This study is pragmatic because it is happening under real-life conditions to understand if the intervention will work in practice.
The research team will work with five academic gender-affirming surgery programs across the country to recruit and enroll 290 trans adults ages 18 and older who are seeking vaginoplasty. Participants assigned to the peer support group will receive the intervention virtually over the course of three months, facilitated by peer facilitators trained in collaboration with Trans Lifeline. The usual care group will receive education from their gender-affirming surgical team, with in-depth materials that cover the same topics as the virtual course.
The primary outcome to be measures at six months is coping self-efficacy, reported by patients, using a survey which assesses perceived ability to deal with stressors. The research team will explore additional outcomes at 12 months, including meeting GGAS presurgical criteria and other outcomes deemed important to trans community partners, surgeons and other gender-affirming providers (e.g., psychological stress, social support, resilience, quality of life, presurgical knowledge, surgical delays and cancellations). Postsurgical outcomes, including surgical satisfaction and other related outcomes, will be measured at 24 months. Finally, the team will conduct in-depth interviews with participants who undergo the intervention to understand their experiences at the beginning of the study and after six months. Researchers will also interview peer supporters and clinicians to understand how to improve and implement the support intervention more broadly.
In designing this study, the research team worked closely with trans community members and patients, health services and policy researchers, gender-affirming surgeons, advocates, gender program administrators and representatives from social support organizations. Collaboration with and input from the trans community during the conduct of this study will be critical to ensure that the STRIVE study is patient centered. Results from this study will be shared in multiple forms, including clinical guideline recommendations, policy briefs, patient-centered reports, web-based information and summaries for clinicians and researchers. Trans people seeking gender-affirming surgery can use the study findings to understand options for social support to improve quality of life and health outcomes. Clinicians, gender program administrators, health insurance companies and health policy advisors can use the findings from this study to better support and prepare patients who are seeking gender-affirming surgery.
Detailed description
OUTLINE The STRIVE (Support for Transgender and Non-Binary Individuals Seeking Vaginoplasty) Study is a multi-site, two-arm randomized pragmatic trial to determine if an evidence-based peer support intervention improves patient-reported and patient-centered clinical outcomes for individuals seeking genital gender-affirming surgery (GGAS) compared with enhanced usual care.
PRIMARY OBJECTIVES Aim 1: To compare the effectiveness of a virtual, group-based perioperative peer support intervention with enhanced usual care on coping self-efficacy (primary outcome) among patients seeking vaginoplasty.
- Hypothesis 1: Patients in the intervention arm will have greater improvements in coping self-efficacy at 6 months post-enrollment compared to patients who receive enhanced usual care.
Aim 2: To determine whether our perioperative peer support intervention improves patient probability of meeting pre-operative GGAS criteria (secondary outcome), and other prioritized patient-centered outcomes (exploratory outcomes).
- Hypothesis 2a: More patients in the intervention arm will meet pre-operative GGAS criteria at 12 months post-enrollment compared with patients who receive enhanced usual care.
- Hypotheses 2b: Patients in the intervention arm will have decreased psychological distress (anxiety, depression, suicidal ideation) and gender minority stress, and greater social support, resilience, QOL, pre-operative surgical knowledge, and fewer surgical delays. For participants who undergo surgery during the follow-up period, those in the intervention arm will have fewer surgical complications, greater completion of vaginal dilation, greater surgical satisfaction, and fewer unplanned emergency department and clinic visits at 6 months post-operatively.
Aim 3: To evaluate the acceptability of this centralized, virtual, group-based perioperative peer support intervention among patients, peer support specialists and healthcare team members.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STRIVE Peer Support Intervention | Experimental | Other: STRIVE Peer Support InterventionA virtual group-based peer support intervention led by trans peers who have had genital gender-affirming surgery. |
| Enhanced Usual Care | No intervention | –Usual care enhanced with written and web-based education materials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Self-identified trans or non-binary individual
- Seeking vaginoplasty
- Completed consultation with gender-affirming surgeon for vaginoplasty
- Documented recommendation by surgeon for vaginoplasty
- Can complete survey responses online, by phone or on paper.
Key exclusion criteria (6 listed)
- Do not speak English
- Cannot complete survey responses online, by phone, or on paper
- Are unwilling to participate in a virtual peer support intervention
- Have co-morbidities or other conditions that exclude them from candidacy for vaginoplasty
- Are currently involved in delivery of the STRIVE Intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STRIVE Peer Support InterventionA virtual group-based peer support intervention led by trans peers who have had genital gender-affirming surgery. | Other | STRIVE Peer Support Intervention |
Primary outcome
Patient-reported coping self-efficacy as assessed by the CSES
Time frame: Enrollment, 6 months after enrollment, 12 months after enrollment, immediate pre-operative, 3 months post-operative, 6 months post-operative
Patient-reported coping self-efficacy is measured using the Coping Self-Efficacy Scale (CSES), a survey that assesses the perceived ability to deal with stressors using a score range of 0-260. Zero is equivalent to no perceived ability to deal with stressors; 260 indicates the highest attainable level of perceived ability to deal with stressors.
1 secondary outcome
Completion of preoperative criteria for scheduling GGAS
Time frame: Enrollment, 6 months after enrollment, 12 months after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Derived from this study: PubMed 41688114Sage L, Hart E, Meyer N, Hnilicka O, Penkin A, Poteat TC, Aguayo-Romero R, Comstock BA; STRIVE Publications Committee; Dy GW. Support for Transgender and Nonbinary Individuals Seeking Vaginoplasty (STRIVE) study: protocol for a national randomised pragmatic trial. BMJ Open. 2026 Feb 12;16(2):e114287. doi: 10.1136/bmjopen-2025-114287.
- Individual participant dataSharing planned: No. Due to safety concerns about the use of data expressed during patient engagement processes, the STRIVE Study does not currently plan to share individual participant data (IPD) publicly.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Geolani Dy, MD principal investigator
Oregon Health and Science University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STRIVE Peer Support Intervention in people with Gender Affirmation Surgery and Perioperative Care, run by Oregon Health and Science University at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported coping self-efficacy as assessed by the CSES (time frame: Enrollment, 6 months after enrollment, 12 months after enrollment, immediate pre-operative, 3 months post-operative, 6 months post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06436560, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.