Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06436560
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-24
Brief Title:
Support for Transgender and Non-Binary Individuals Seeking Vaginoplasty Study
Sponsor:
Oregon Health and Science University
Organization:
Oregon Health and Science University
Study Overview
Official Title:
Support for Transgender and Non-Binary Individuals Seeking Vaginoplasty STRIVE Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STRIVE
Brief 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 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 teams 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 260 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 from 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 eg 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
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 teams 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 260 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 from 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 eg 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1023677 | OTHER_GRANT | Patient-Centered Outcomes Research Institute PCORI | None |