Dominic Moog

Purpose: We aimed to describe utilization of, perspectives on, and access to gender-affirming care (GAC) in the U.S. Ballroom community, including anticipated and experienced barriers to and facilitators of receiving GAC. Methods: This cross-sectional study utilized an anonymous survey to collect information on types of GAC utilized and desired, satisfaction with GAC, barriers to and facilitators of access among U.S. Ballroom community members, and demographics including race, ethnicity, and gender identity. Responses were collected at a Ball in St. Louis and via word-of-mouth snowball sampling between September and December of 2022. Individuals who self-identified as transgender, gender-nonbinary, genderqueer, or agender were included in analysis. Cisgender-identifying individuals were excluded. Survey responses were described with number and percentage. Results: Seventy-four responses were analyzed per inclusion criteria and losses due to survey incompletion. Ninety-three percent of participants identified as Black or Black and another race/ethnicity. Forty-four participants previously or currently received GAC. Financial difficulties and insurance issues were the most reported barriers to access; insurance coverage, assistance from friends, family, and/or members of their community, and appointment/service availability were the most reported facilitators. Twenty-three of 30 GAC-naïve participants expressed interest in or uncertainty about receiving GAC. Financial difficulties, discrimination, and fear/anxiety were the most anticipated barriers to access; financial assistance and insurance coverage were the most anticipated facilitators. Many participants reported experiencing or anticipating discrimination. Conclusion: These findings, particularly differential experienced and anticipated barriers, offer insights for improving access to GAC that may promote well-being among transgender and gender-diverse people of color.

Background: Current guidelines for gender-affirming hormone therapy (GAHT) for transgender women are mostly based on clinical experience from experts in the field and treatments used on postmenopausal women. While care is currently provided with the best available evidence, there is a critical gap in knowledge about the safest and most effective estradiol routes of administration for GAHT in transgender women; this statement is supported by the World Professional Association for Transgender Health on their Standards of Care for the Health of Transgender and Gender Diverse People, version 8. Furthermore, the reported rates of cardiometabolic adverse events in transgender women highlight the importance of investigating changes in lipoproteins, glucose, and insulin sensitivity, among other markers while receiving GAHT. Objective: This study aims to evaluate the degree of testosterone suppression achieved at 1, 6, and 12 months in treatment-naive transgender women when randomized to GAHT with estradiol and spironolactone as antiandrogens. As a secondary aim, this study will assess the treatment effect on metabolic and coagulation factors from baseline to 6 and 12 months after initiating GAHT. Methods: This is a prospective pilot, open-label, randomized clinical trial conducted at an adult transgender clinic in a tertiary medical center. The 3 treatment arms include once-daily sublingual 17-β estradiol, twice-daily sublingual 17-β estradiol, and transdermal 17-β estradiol. All participants received spironolactone as an antiandrogen. Transgender women aged 18 to 45 years who are being evaluated for the initiation of GAHT with 17-β estradiol and did not have a history of coagulopathy, cigarette smoking, liver disease, dyslipidemia requiring treatment, or use of gonadotropin-releasing hormone agonist were eligible to enroll. The main outcome is the total testosterone suppression at 1 and 6 months after the initiation of GAHT, and the secondary outcome is to assess treatment effect in a lipid panel; homeostatic model assessment for insulin resistance; coagulation factors II, IX, and XI; Von Willebrand factor; activated protein C resistance; protein C; and protein S at baseline, 6 months, and 12 months after therapy is initiated. Results: This study was funded in March 2022, and enrollment concluded in August 2022. It was concluded in July 2023, and currently, the results are being analyzed for publication. Conclusions: The Transgender Estradiol Affirming Therapy (TREAT) study offers a rigorous and reproducible approach to answer important questions regarding GAHT in transgender women, specifically, the most effective 17-β estradiol regimen to suppress testosterone levels to 50 ng/dL, as currently recommended. Trial Registration: ClinicalTrials.gov NCT05010707; https://clinicaltrials.gov/study/NCT05010707 International Registered Report Identifier (IRRID): DERR1-10.2196/53092

BACKGROUND Current guidelines for gender-affirming hormone therapy (GAHT) for transgender women are mostly based on clinical experience from experts in the field and treatments used on postmenopausal women. While care is currently provided with the best available evidence, there is a critical gap in knowledge about the safest and most effective estradiol routes of administration for GAHT in transgender women; this statement is supported by the World Professional Association for Transgender Health on their Standards of Care for the Health of Transgender and Gender Diverse People, version 8. Furthermore, the reported rates of cardiometabolic adverse events in transgender women highlight the importance of investigating changes in lipoproteins, glucose, and insulin sensitivity, among other markers while receiving GAHT. OBJECTIVE This study aims to evaluate the degree of testosterone suppression achieved at 1, 6, and 12 months in treatment-naive transgender women when randomized to GAHT with estradiol and spironolactone as antiandrogens. As a secondary aim, this study will assess the treatment effect on metabolic and coagulation factors from baseline to 6 and 12 months after initiating GAHT. METHODS This is a prospective pilot, open-label, randomized clinical trial conducted at an adult transgender clinic in a tertiary medical center. The 3 treatment arms include once-daily sublingual 17-β estradiol, twice-daily sublingual 17-β estradiol, and transdermal 17-β estradiol. All participants received spironolactone as an antiandrogen. Transgender women aged 18 to 45 years who are being evaluated for the initiation of GAHT with 17-β estradiol and did not have a history of coagulopathy, cigarette smoking, liver disease, dyslipidemia requiring treatment, or use of gonadotropin-releasing hormone agonist were eligible to enroll. The main outcome is the total testosterone suppression at 1 and 6 months after the initiation of GAHT, and the secondary outcome is to assess treatment effect in a lipid panel; homeostatic model assessment for insulin resistance; coagulation factors II, IX, and XI; Von Willebrand factor; activated protein C resistance; protein C; and protein S at baseline, 6 months, and 12 months after therapy is initiated. RESULTS This study was funded in March 2022, and enrollment concluded in August 2022. It was concluded in July 2023, and currently, the results are being analyzed for publication. CONCLUSIONS The Transgender Estradiol Affirming Therapy (TREAT) study offers a rigorous and reproducible approach to answer important questions regarding GAHT in transgender women, specifically, the most effective 17-β estradiol regimen to suppress testosterone levels to 50 ng/dL, as currently recommended. CLINICALTRIAL ClinicalTrials.gov NCT05010707; https://clinicaltrials.gov/study/NCT05010707 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/53092

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INTRODUCTION: Limited research and the lack of guidelines on “withdrawal” or coitus interruptus lead to inconsistent provider-patient recommendations regarding its use. Patients consequently rely on peers or online communities to learn about this neglected contraceptive method. To better understand knowledge gaps and concerns, we examined posts about withdrawal on the popular, anonymous internet discussion forum, Reddit. METHODS: Posts containing the search terms: “coitus interruptus,” “withdrawal,” “pull out,” “pre-ejaculate,” or “pre-cum” were extracted and filtered for relevant content. Data extraction was limited to gendered forums/subreddits from 2010-2019: “TwoXChromosomes,” “Askwomen,” “Askmen,” “OneY.” We developed an initial codebook with expected themes, augmented with salient themes emerging from a random sampling of 10% of posts, and revised iteratively until adequate inter-rater agreement was reached; remaining posts were coded independently. RESULTS: Of 271 withdrawal-related queries, 19% were submitted by men; 81% referenced the contributor’s own use of withdrawal. Salient themes included: concerns about pregnancy risk (52%), using withdrawal with additional contraception (49%), impact on personal life/relationship (27%), benefits/pleasure from using withdrawal (12%), when or how to effectively use withdrawal (7%), and problems encountered (3%). Posts to female-focused forums more frequently inquired about pregnancy risk, while those on men’s forums inquired about when/how to use withdrawal (P<.01); themes were not associated with contributor gender. CONCLUSION: Withdrawal-related queries on Reddit are more frequently posted by women, the majority of whom want to better understand their risk of pregnancy with withdrawal. Research on operationalizing withdrawal and withdrawal-related pregnancy risk may help providers counsel patients and decrease their reliance on online forums.