PDF(Pubmed)
Abstract：
BACKGROUND: Transgender men (TGM) are underrepresented in genital microbiome research. Our prospective study in Birmingham, AL investigated genital microbiota changes over time in TGM initiating testosterone, including the development of incident bacterial vaginosis (iBV). Here, we present lessons learned from recruitment challenges encountered during the conduct of this study.
METHODS: Inclusion criteria were assigned female sex at birth, TGM or non-binary identity, age ≥18 years, interested in injectable testosterone but willing to wait 7 days after enrollment before starting, and engaged with a testosterone-prescribing provider. Exclusion criteria were recent antibiotic use, HIV/STI infection, current vaginal infection, pregnancy, or past 6 months testosterone use. Recruitment initiatives included community advertisements via flyers, social media posts, and referrals from local gender health clinics.
RESULTS: Between February 2022 and October 2023, 61 individuals contacted the study, 17 (27.9%) completed an in-person screening visit, and 10 (58.8%) of those screened were enrolled. The primary reasons for individuals failing study screening were having limited access to testosterone-prescribing providers, already being on testosterone, being unwilling to wait 7 days to initiate testosterone therapy, or desiring the use of topical testosterone. Engagement of non-White TGM was also minimal.
CONCLUSIONS: Despite robust study inquiry by TGM, screening and enrollment challenges were faced including engagement by TGM not yet in care and specific study eligibility criteria. Excitement among TGM for research representation should be leveraged in future work by engaging transgender community stakeholders at the inception of study development, particularly regarding feasibility of study inclusion and exclusion criteria, as well as recruitment of TGM of color. These results also highlight the need for more clinical resources for prescribing gender-affirming hormone therapy, especially in the Southeastern US.
METHODS: Inclusion criteria were assigned female sex at birth, TGM or non-binary identity, age ≥18 years, interested in injectable testosterone but willing to wait 7 days after enrollment before starting, and engaged with a testosterone-prescribing provider. Exclusion criteria were recent antibiotic use, HIV/STI infection, current vaginal infection, pregnancy, or past 6 months testosterone use. Recruitment initiatives included community advertisements via flyers, social media posts, and referrals from local gender health clinics.
RESULTS: Between February 2022 and October 2023, 61 individuals contacted the study, 17 (27.9%) completed an in-person screening visit, and 10 (58.8%) of those screened were enrolled. The primary reasons for individuals failing study screening were having limited access to testosterone-prescribing providers, already being on testosterone, being unwilling to wait 7 days to initiate testosterone therapy, or desiring the use of topical testosterone. Engagement of non-White TGM was also minimal.
CONCLUSIONS: Despite robust study inquiry by TGM, screening and enrollment challenges were faced including engagement by TGM not yet in care and specific study eligibility criteria. Excitement among TGM for research representation should be leveraged in future work by engaging transgender community stakeholders at the inception of study development, particularly regarding feasibility of study inclusion and exclusion criteria, as well as recruitment of TGM of color. These results also highlight the need for more clinical resources for prescribing gender-affirming hormone therapy, especially in the Southeastern US.
摘要：
背景：跨性别男性（TGM）在生殖器微生物组研究中代表性不足。我们在伯明翰的前瞻性研究，AL调查了TGM启动睾丸激素的生殖器微生物群随着时间的变化，包括细菌性阴道病（iBV）的发展。这里,我们介绍了在进行这项研究期间遇到的招聘挑战的经验教训。
方法：纳入标准为出生时的女性，TGM或非二进制身份，年龄≥18岁，对注射睾酮感兴趣，但愿意在入组后等待7天再开始，并与睾丸激素处方提供者合作。排除标准是最近使用抗生素，HIV/STI感染，目前的阴道感染，怀孕,或过去6个月使用睾丸激素。招募计划包括通过传单进行社区广告，社交媒体帖子，以及当地性别健康诊所的转诊。
结果：在2022年2月至2023年10月之间，有61人联系了该研究，17人(27.9%)完成了面对面的筛查访问，和10（58.8％）的筛选者被纳入。个人未能通过研究筛查的主要原因是获得睾酮处方提供者的机会有限，已经在服用睾丸激素，不愿意等待7天开始睾酮治疗，或希望使用局部睾酮。非白人TGM的参与也很少。
结论：尽管TGM进行了强有力的研究调查，我们面临的筛查和纳入挑战包括TGM尚未参与护理和特定研究资格标准.TGM对研究代表的兴奋应在未来的工作中利用，方法是在研究开发开始时让跨性别社区利益相关者参与进来，特别是关于研究纳入和排除标准的可行性，以及招聘TGM的颜色。这些结果还强调了需要更多的临床资源来处方性别确认激素疗法，尤其是在美国东南部。
方法：纳入标准为出生时的女性，TGM或非二进制身份，年龄≥18岁，对注射睾酮感兴趣，但愿意在入组后等待7天再开始，并与睾丸激素处方提供者合作。排除标准是最近使用抗生素，HIV/STI感染，目前的阴道感染，怀孕,或过去6个月使用睾丸激素。招募计划包括通过传单进行社区广告，社交媒体帖子，以及当地性别健康诊所的转诊。
结果：在2022年2月至2023年10月之间，有61人联系了该研究，17人(27.9%)完成了面对面的筛查访问，和10（58.8％）的筛选者被纳入。个人未能通过研究筛查的主要原因是获得睾酮处方提供者的机会有限，已经在服用睾丸激素，不愿意等待7天开始睾酮治疗，或希望使用局部睾酮。非白人TGM的参与也很少。
结论：尽管TGM进行了强有力的研究调查，我们面临的筛查和纳入挑战包括TGM尚未参与护理和特定研究资格标准.TGM对研究代表的兴奋应在未来的工作中利用，方法是在研究开发开始时让跨性别社区利益相关者参与进来，特别是关于研究纳入和排除标准的可行性，以及招聘TGM的颜色。这些结果还强调了需要更多的临床资源来处方性别确认激素疗法，尤其是在美国东南部。
