Nctid:
NCT06615401
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000068116", "term"=>"Gender Dysphoria"}], "ancestors"=>[{"id"=>"D020018", "term"=>"Sexual Dysfunctions, Psychological"}, {"id"=>"D001523", "term"=>"Mental Disorders"}], "browseLeaves"=>[{"id"=>"M227", "name"=>"Gender Dysphoria", "asFound"=>"Gender Dysphoria", "relevance"=>"HIGH"}, {"id"=>"M21873", "name"=>"Sexual Dysfunctions, Psychological", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>700}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-10-23", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-11", "completionDateStruct"=>{"date"=>"2027-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-11-08", "studyFirstSubmitDate"=>"2024-09-23", "studyFirstSubmitQcDate"=>"2024-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-11-12", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-10-15", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Barriers and facilitators to receipt of gender-affirming treatment", "timeFrame"=>"~21 months", "description"=>"Through a national survey, the investigators will identify barriers and facilitators to receipt of gender-affirming treatment in VA and VA Community Care among transgender and gender diverse Veterans."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["transgender", "gender dysphoria", "gender-affirming treatment"], "conditions"=>["Gender Dysphoria"]}, "descriptionModule"=>{"briefSummary"=>"Transgender Veterans (trans Vets) frequently experience gender dysphoria or distress related to discord between their gender identity and birth sex. Gender-affirming treatments (GATs) are medically necessary treatments to reduce gender dysphoria. However, not much is known about the barriers and facilitators that influence GAT access and receipt in VA and VA Community Care (CC), among trans Vets who desire GATs. The goals of this mixed-methods study are to determine which GATs trans Vets receive and in which setting, identify barriers and facilitators associated with desired GAT receipt in VA and CC, how barriers and facilitators influence GAT access and desire, and how to improve GAT access in VA and CC. In partnership with the Stakeholder Advisory Group, the investigators will develop patient-centered implementation strategies to address barriers and enhance facilitators to GAT access. The proposed study will position us to deploy these strategies in a follow-up study to mitigate barriers, improve GAT access in VA and CC, and promote trans health equity.", "detailedDescription"=>"Background: Transgender people experience discord between their gender identity and birth sex, defined as gender dysphoria. Gender-affirming treatments (GATs) are medically necessary treatments to reduce gender dysphoria. However, among transgender Veterans (trans Vets) who desire GATs, not much is known about barriers and facilitators to accessing and receiving GATs in VA and VA Community Care (CC). To ensure effective and equitable GAT access for trans Vets, it is critical to understand: \\[1\\] GATs trans Vets receive and where they receive them, \\[2\\] barriers, including social determinants of health (SDOH) barriers that are highly prevalent among trans Vets, and facilitators associated with desired GAT receipt in VA and CC, \\[3\\] how barriers and facilitators influence GAT access and desire, and \\[4\\] how to improve GAT access in VA and CC.\n\nSignificance: This study addresses the 2022 HSR\\&D priority areas of Access to Care, Health Equity/SDOH, MISSION Act, and research gap of underserved LGBTQ+ Veterans. It is also a high priority for the operational partners in VA LGBTQ+ Health Program, Pharmacy Benefits Management, Office of Integrated Veteran Care, and Office of Mental Health and Suicide Prevention. Knowledge gained from this study will ensure that GAT delivery in the VA is patient-centered and is responsive to the lived realities and needs of trans Vets.\n\nInnovation and Impact: This study will be the first to characterize the GATs received in VA and/or CC to understand how VA and CC are balanced in terms of delivering GATs. This study will also provide novel data on trans Vet experiences related to GAT access in CC, which will be likely relevant to other underserved Veterans accessing CC. Further, it will be innovative in providing data on services and resources used by trans Vets to address barriers that influence GAT access. This will be key to developing patient-centered implementation strategies to improve GAT access in VA and CC.\n\nSpecific Aims: The investigators propose a sequential explanatory mixed method study whose aims are to:\n\nAim 1. Characterize the GATs received by trans Vets in VA and/or CC (VA/CC) Aim 2. Identify barriers and facilitators associated with desired GAT receipt in VA and CC Aim 3: Understand trans Vet experiences related to GAT access in VA and CC.\n\nMethodology: Database Aim 1: The investigators will expand the VA cohort of 9,608 trans Vets (IIR 17-238) from 2006-18 to the data available at the time of funding. The investigators will add CC data to determine the types of GATs received by trans Vets in VA and/or CC. Survey Aim 2: The investigators will survey a national sample of trans Vets identified from Aim 1. Among trans Vets who desire GATs, the investigators will determine SDOH barriers, other barriers, and facilitators associated with desired GAT receipt. Among trans Vets who did not desire GATs, the investigators will determine reasons for not wanting GATs. Qualitative Aim 3: From Aim 2 participants, the investigators will recruit a purposive sample of trans Vets who received all desired GAT(s), who received some desired GAT(s), and who received no desired GAT(s). The investigators will also recruit a national sample of LGBTQ+ Veteran Care Coordinators. The investigators will seek to understand experiences and perspectives on GAT access in VA and CC, how SDOH barriers, other barriers, and facilitators influence GAT access and desire, and how to improve GAT access in VA and CC. Informed by study findings and in partnership with the Stakeholder Advisory Group, the investigators will develop patient-centered implementation strategies to mitigate barriers and enhance facilitators to improve GAT access in VA and CC.\n\nNext Steps/Implementation: The investigators will conduct a follow-up hybrid implementation effectiveness study to deploy these strategies to address barriers that impede GAT access and improve GAT access in VA and CC."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "genderBased"=>true, "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Transgender and gender diverse veterans as identified by documentation of gender identity disorder diagnoses, self-identified gender identity and transgender-related health factors.", "genderDescription"=>"All transmasculine, transfeminine and non-binary Veterans identified by the inclusion criteria above.", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* All veterans with documentation of gender identity disorder diagnoses\n* Self-reported gender identity as transgender and relevant transgender-related health factor\n\nExclusion Criteria:\n\n* None"}, "identificationModule"=>{"nctId"=>"NCT06615401", "briefTitle"=>"Understanding Perceived Access and Receipt of Gender-affirming Treatments Among Transgender Veterans", "organization"=>{"class"=>"FED", "fullName"=>"VA Office of Research and Development"}, "officialTitle"=>"Understanding Perceived Access and Receipt of Gender-affirming Treatments Among Transgender Veterans", "orgStudyIdInfo"=>{"id"=>"IIR 22-201"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Transgender and Gender Diverse Veterans", "description"=>"Veterans with documentation of either a gender identity disorder diagnoses, self-identified gender identity as transgender and gender diverse or transgender-related health factor."}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"01730-1114", "city"=>"Bedford", "state"=>"Massachusetts", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Guneet K Jasuja, PhD", "role"=>"CONTACT", "email"=>"Guneet.Jasuja@va.gov", "phone"=>"781-687-2767"}, {"name"=>"Guneet K. Jasuja, PhD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"VA Bedford HealthCare System, Bedford, MA", "geoPoint"=>{"lat"=>42.49065, "lon"=>-71.27617}}], "centralContacts"=>[{"name"=>"Guneet K Jasuja, PhD", "role"=>"CONTACT", "email"=>"Guneet.Jasuja@va.gov", "phone"=>"(781) 687-2767"}, {"name"=>"Julianne E Brady, MPH", "role"=>"CONTACT", "email"=>"julianne.brady@va.gov", "phone"=>"(857) 736-5110"}], "overallOfficials"=>[{"name"=>"Guneet K. Jasuja, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"VA Bedford HealthCare System, Bedford, MA"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"VA Office of Research and Development", "class"=>"FED"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
