Thrombosis Risk in Transgender Adolescents and Young Adults Starting Gender-Affirming Hormone Therapy

开始性别肯定激素治疗的跨性别青少年和年轻人的血栓形成风险

• 批准号: 10674629
• 负责人: Tanya L. Kowalczyk Mullins
• 金额: $ 62.67万
• 依托单位: CINCINNATI CHILDRENS HOSP MED CTR
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-01 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10674629
• 关键词: Adherence; Adolescent and Young Adult; Adult; Age; Age Years; Androgens; Anticoagulation; Attitude; Behavior; Benefits and Risks; Biological; Blood Coagulation Factor; Blood coagulation; Caring; Childhood; Clinical; Coagulation Process; Contraceptive methods; Counseling; Data; Decision Making; Educational Intervention; Estradiol; Estrogens; Evaluation; Event; Exhibits; Family; Female; Fibrin fragment D; Foundations; Gender; Generations; Genetic Polymorphism; Goals; Guidelines; Health; Healthcare; Hematologist; Hemostatic Agents; Hemostatic function; Hormone replacement therapy; Hormone use; Human Biology; Individual; Influentials; Institution; Intention; Intervention; Interview; Knowledge; Learning; Measurable; Mental Depression; Mental Health; Outcome; Patients; Pediatric Hematologist; Persons; Physicians; Platelet Activation; Population; Prophylactic treatment; Public Health; Recommendation; Reporting; Research; Research Methodology; Resistance; Risk; Risk Factors; Sampling; Standardization; Suicide; Suicide attempt; Surveys; System; Telephone; Testosterone; Thrombin; Thrombophilia; Thrombosis; Time; Treatment Protocols; Variant; Visit; Work; Youth; activated Protein C; assigned female at birth; assigned male at birth; cis-female; clinical development; clinical practice; cognitive interview; cohort; design; effective intervention; experience; gender affirming hormone therapy; gender dysphoria; gender nonconforming; health care disparity; high risk; human disease; improved; inhibitor; innovation; method development; novel; physical conditioning; pilot test; prospective; reducing suicide; suicidal risk; thrombotic; tool development; transgender; transgender women

PROJECT SUMMARY Gender-affirming hormone therapy (GAHT) is one of the most effective interventions for treating gender dys- phoria in transgender and gender nonconforming (hereafter transgender) youth, thereby reducing suicide risk. GAHT, particularly estrogen, may increase the risk of thrombosis. While hematologists often evaluate patients before GAHT start who are at risk of thrombosis due to personal/family risk factors, there are no guidelines or data to inform management. This lack of data leads to significant variation in clinical practice that may com- promise care. Because this knowledge gap hinders the ability of gender care clinicians and hematologists to provide optimal care to transgender youth, the objectives of this proposal are to prospectively examine biologic changes associated with thrombotic risk in a cohort of transgender youth receiving estrogen GAHT and to ex- amine the attitudes and practices of clinicians who make decisions about thromboprophylaxis for youth on GAHT. The proposed work is relevant to the priorities of understanding human biology (defining changes in thrombotic risk associated with estrogen GAHT) and reducing human disease (defining which transgender youth may benefit from thromboprophylaxis). The proposed research is innovative in the focus on transgender youth, comprehensive examination of changes in coagulation factors in youth using estrogen GAHT, and de- termination of factors influencing the treatment recommendations of hematologists for thromboprophylaxis among transgender youth with personal/family risk factors for thrombosis. The specific aims are to: 1) prospec- tively determine changes in coagulation that would predispose to thrombosis over the first 24 months of estro- gen GAHT in a population of transgender women (up to age 22 years at GAHT start); and 2) characterize the attitudes, practices, and intentions of hematologists caring for youth toward recommending thromboprophylaxis to TG youth with personal/family risk factors for thrombosis. In Aim 1, 75 transgender women up to 22 years of age who are starting estrogen GAHT will undergo thorough and systematic evaluation of hemostatic factors at baseline prior to GAHT start, and then at 3, 6, 12, 18, and 24 months, with interim telephone study visits. Hor- mone usage and adherence, coagulation parameters, thrombophilia polymorphisms, and platelet activation will be assessed. In Aim 2, well-established qualitative and survey research methods will be used. Up to 20 adult and pediatric hematologists will complete individual interviews. Data from these interviews will be used to gen- erate items for a new survey that will undergo survey development methods (cognitive interviews, pilot testing) before being fielded to a sample of U.S. and Canadian hematologists to understand their attitudes, behaviors, and intentions to recommend thromboprophylaxis to transgender youth at risk for thrombosis and factors asso- ciated with these intentions. The results of this work provide the foundation for 1) an intervention targeting phy- sicians to improve knowledge of thrombosis risk in the setting of GAHT and 2) development of clinical guid- ance to aid in referral, evaluation, and management of transgender youth at risk for thrombosis.

项目摘要 性别肯定激素疗法（GAHT）是治疗性别障碍最有效的干预措施之一。 在变性人和性别歧视（以下简称变性人）青年隐斜视，从而降低自杀风险。 GAHT，特别是雌激素，可能会增加血栓形成的风险。虽然血液学家经常评估病人 在GAHT开始之前，由于个人/家庭风险因素而有血栓形成风险的患者，没有指南或 数据为管理层提供信息。这种数据的缺乏导致临床实践中的显著差异，可能会导致 承诺关怀因为这种知识差距阻碍了性别保健临床医生和血液学家的能力， 为跨性别青少年提供最佳护理，该提案的目标是前瞻性地检查生物 在接受雌激素GAHT的变性青年队列中与血栓形成风险相关的变化， 我认为，临床医生对青少年血栓预防的态度和做法， GAHT。拟议的工作与理解人类生物学的优先事项有关（定义 血栓形成风险与雌激素GAHT）和减少人类疾病（定义哪些跨性别 年轻人可能受益于血栓预防）。拟议的研究在关注变性人方面具有创新性 青年，全面检查凝血因子的变化，在青年使用雌激素GAHT，和去- 终止影响血液科医生血栓预防治疗建议的因素 有血栓形成个人/家庭风险因素的变性青年。具体目标是：1）展望- 明确确定凝血的变化，这将倾向于血栓形成的前24个月的雌激素， 性别GAHT在跨性别女性人群中（GAHT开始时年龄不超过22岁）;以及2）表征 关心青少年的血液科医生对推荐血栓预防的态度、实践和意图 有血栓形成个人/家庭危险因素的TG青年。在目标1中，75名22岁以下的变性妇女， 开始使用雌激素GAHT的年龄将接受彻底和系统的止血因素评估， GAHT开始前基线，然后在3、6、12、18和24个月时，进行中期电话研究访视。Hor- 激素的使用和依从性、凝血参数、血栓形成倾向多态性和血小板活化将 被评估。在目标2中，将使用完善的定性和调查研究方法。最多20名成人 和儿科血液学家将完成个别访谈。这些数据将被用于分析- 评估将采用调查开发方法（认知访谈、试点测试）的新调查项目 在被派往美国和加拿大血液学家的样本，以了解他们的态度，行为， 并打算向有血栓形成风险的跨性别青年推荐血栓预防， 与这些意图有关。这项工作的结果为1）针对物理学的干预提供了基础- 提高医生对GAHT中血栓形成风险的认识; 2）制定临床指南， 有机会帮助转介，评估和管理有血栓形成风险的变性青年。