Sevelius Jae M, Neilands Torsten B, Reback Cathy J, Castro Danielle, Dilworth Samantha E, Kaplan Rachel L, Johnson Mallory O
Department of Medicine, Center for AIDS Prevention Studies, University of California, San Francisco, San Francisco, CA, United States.
Department of Medicine, Center of Excellence for Transgender Health, University of California, San Francisco, San Francisco, CA, United States.
Front Reprod Health. 2021 Oct 27;3:665723. doi: 10.3389/frph.2021.665723. eCollection 2021.
Transgender women (assigned "male" at birth but who do not identify as male) are disproportionately impacted by HIV and experience unique barriers and facilitators to HIV care engagement. In formative work, we identified culturally specific and modifiable barriers to HIV treatment engagement among transgender women living with HIV (TWH), including prioritizing transition-related healthcare over HIV treatment, avoiding HIV care settings due to gender-related and HIV stigma, concerns about potential drug interactions with hormones, and inadequate social support. Grounded in the investigators' Models of Gender Affirmation and Health Care Empowerment, we developed the intervention to optimize engagement in HIV care among TWH at risk for treatment failure and consequential morbidity, mortality, and onward transmission of HIV. We conducted a 2-arm randomized controlled trial (RCT) of the intervention's efficacy in Los Angeles and San Francisco to improve engagement in care among TWH ( = 278). The primary outcome was virologic control indicated by undetectable HIV-1 level (undetectability = < 20 copies/mL), at baseline and follow-up assessment for 12 months at 3-month intervals. This study was approved by University of California, San Francisco Institutional Review Board (15-17910) and Western Institutional Review Board (20181370). Participants provided informed consent before enrolment in the study. We are committed to collaboration with National Institutes of Health officials, other researchers, and health and social services communities for rapid dissemination of data and sharing of materials. The results will be published in peer-reviewed academic journals and scientific presentations. We will make our results available to researchers interested in transgender health to avoid unintentional duplication of research, as well as to others in health and social services communities, including HIV clinics, LGBT community-based organizations, and AIDS service organizations. Clinicaltrials.gov, identifier NCT03081559.
跨性别女性（出生时被指定为“男性”但自我认同并非男性）受艾滋病毒影响的比例过高，在参与艾滋病毒治疗护理方面面临独特的障碍和促进因素。在前期研究中，我们确定了感染艾滋病毒的跨性别女性（TWH）在参与艾滋病毒治疗护理方面存在特定文化背景且可改变的障碍，包括将与性别转变相关的医疗保健置于艾滋病毒治疗之上、因性别相关和艾滋病毒污名而避开艾滋病毒护理机构、担心药物与激素之间可能存在相互作用以及社会支持不足。基于研究人员的性别肯定和医疗保健赋权模型，我们开发了一种干预措施，以优化有治疗失败及后续发病、死亡和艾滋病毒进一步传播风险的TWH参与艾滋病毒护理的情况。我们在洛杉矶和旧金山进行了一项双臂随机对照试验（RCT），以评估该干预措施在改善TWH护理参与度方面的疗效（ = 278）。主要结局是在基线以及每隔3个月进行为期12个月的随访评估时，以无法检测到艾滋病毒-1水平（无法检测 = < 20拷贝/毫升）表明的病毒学控制情况。本研究获得了加利福尼亚大学旧金山分校机构审查委员会（15 - 17910）和西部机构审查委员会（20181370）的批准。参与者在纳入研究前提供了知情同意书。我们致力于与美国国立卫生研究院官员、其他研究人员以及卫生和社会服务团体合作，以便快速传播数据和共享材料。研究结果将发表在同行评审的学术期刊上，并进行科学展示。我们将把研究结果提供给对跨性别健康感兴趣的研究人员，以避免无意的重复研究，同时也提供给卫生和社会服务团体中的其他人员，包括艾滋病毒诊所、基于LGBT社区的组织以及艾滋病服务组织。Clinicaltrials.gov标识符：NCT03081559。
