Comparative- and cost-effectiveness research determining the optimal intervention for advancing transgender women living with HIV to full viral suppression

摘要 跨性别妇女（TW）通过艾滋病毒护理连续体获得次优进展，1-7包括贫穷妇女 艾滋病毒医疗保健利用率，8，9艾滋病毒医疗保健保留率，10-12和病毒抑制率。3，4，6，7，13，14这些 这些问题因共病而加剧，例如物质使用障碍（SUD），15 -22， 与生活质量降低、过量死亡增加、高成本医疗保健的利用相关 服务，参与街头经济和监禁周期。 事实证明，这是艾滋病毒护理和艾滋病毒护理连续性发展的沿着障碍。 至关重要的是，结束艾滋病毒流行病（EHE）的努力包括有效的干预措施，以将TW与艾滋病毒联系起来并保留下来 25 -27这项研究建立在我们的两个有希望的发现， 示范项目，亚历克西斯项目28和短信我，女孩！29个使用了同伴健康导航（PHN） 以及SMS（即，短信），分别用于推进TW艾滋病毒感染者完全抑制病毒。 虽然这两种干预措施的有效性已经确定，但它们的比较有效性， 所需资源/成本、成本效益和对亚组的异质影响，包括那些 SUD，尚未进行评价。鉴于许多负面的个人和公共健康后果， 艾滋病毒未经治疗/治疗不足，TW的艾滋病毒服务经常在资源有限的情况下提供， 30-33全面的经济评估对于为决策提供信息至关重要， 利益相关者，如供应商、保险公司和政策制定者。“意向治疗”RCT将随机化 将参与者（N=225）分成：单独的PHN（n=75）、单独的SMS（n=75）或PHN+SMS（n=75）。使用相同的时间 点作为HRSA项目，重复测量设计将评估基线，3-，6-，12-， 和随机分组后18个月。具体目标是：1）进行比较有效性研究 确定PHN与SMS与PHN+SMS在以下方面的相对有效性的试验：主要（a）病毒学 （B）HIV治疗依从性自我效能量表评分;（c） 艾滋病健康信念量表评分;（d）社会支持行为量表评分;和（e）尿液 药物筛查结果; 2）确定准备、实施和维持每一项所需的资源 干预措施，并估计相关成本; 3）进行全面的成本效益分析， 确定卫生保健部门、国家政策制定者和社会每项干预措施的相对价值 第二个目标是确定各种干预措施的不同干预效果 这是由于健康的社会和结构决定因素以及个人层面的特征。TW是一个高优先级 达到EHE 25 -27目标的人口和洛杉矶县（研究地点）是EHE的优先事项 34，35研究结果有可能通过产生 显著改善台湾地区的病毒抑制，并指导服务提供和公共政策。

Abstract Trans women (TW) achieve suboptimal advancement through the HIV Care Continuum,1-7 including poor HIV healthcare utilization,8,9 retention in HIV medical care,10-12 and rates of viral suppression.3,4,6,7,13,14 These issues are exacerbated by comorbid conditions, such as substance use disorder (SUD),15-22 which is also associated with reduced quality-of-life, and increased overdose deaths, utilization of high-cost healthcare services, engagement in a street economy, and cycles of incarceration.23,24 Drug use among TW has been demonstrated to be a barrier to HIV care and advancement along the HIV Care Continuum.16 Thus, it is critical that efforts to End the HIV Epidemic (EHE) include effective interventions to link and retain TW in HIV care through full viral suppression.25-27 This study builds on the promising findings from our two HRSA-funded demonstration projects, The Alexis Project28 and Text Me, Girl!,29 which utilized Peer Health Navigation (PHN) and SMS (i.e., text messaging), respectively, for advancing TW living with HIV to full viral suppression. Though the effectiveness of both interventions has been established, their comparative-effectiveness, required resources/costs, cost-effectiveness, and heterogeneous effects on subgroups, including those with SUD, have not been evaluated. Given the many negative personal- and public-health consequences of untreated/undertreated HIV, and that HIV services for TW are frequently delivered in resource-limited, community-based settings,30-33 a comprehensive economic evaluation is critical to inform decisions of stakeholders, such as providers, insurers, and policymakers. The “intent-to-treat” RCT will randomize participants (N=225) into: PHN alone (n=75), SMS alone (n=75), or PHN+SMS (n=75). Using the same time points as the HRSA projects, the repeated-measures design will assess participants at baseline, 3-, 6-, 12-, and 18-months post-randomization. The specific aims are: 1) Conduct a comparative effectiveness research trial to determine the relative effectiveness of PHN vs. SMS vs. PHN+SMS in terms of: Primary (a) virologic suppression; and Secondary outcomes (b) HIV Treatment Adherence Self-Efficacy Scale scores; (c) the AIDS Health Belief Scale scores; (d) the Inventory of Socially Supportive Behaviors scores; and (e) urine drug screen results; 2) Identify the resources required to prepare for, implement, and sustain each intervention, and estimate the associated costs; 3) Conduct a comprehensive cost-effectiveness analysis to determine the relative value of each intervention from the healthcare-sector, state-policymaker, and societal perspectives; and, a Secondary Aim to determine heterogeneous intervention effects across interventions due to social and structural determinants of health and individual-level characteristics. TW are a high-priority population for reaching EHE25-27 goals and Los Angeles County (the study location) is an EHE priority County.34,35 Findings have the potential to improve individual and population health outcomes by generating significant improvements in viral suppression among TW and guiding service provision and public policy.