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

比较和成本效益研究确定促进感染艾滋病毒的跨性别女性达到完全病毒抑制的最佳干预措施

• 批准号: 10481288
• 负责人: Sean M. Murphy
• 金额: $ 63.7万
• 依托单位: FRIENDS RESEARCH INSTITUTE, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-15 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10481288
• 关键词: Acquired Immunodeficiency Syndrome; Adoption; Age; Behavior; Caring; Characteristics; Communities; Comparative Effectiveness Research; Continuity of Patient Care; Cost Effectiveness Analysis; Cost effectiveness research; County; Development; Distal; Drug Screening; Drug usage; Education; Effectiveness; Effectiveness of Interventions; Emergency department visit; Epidemic; Equipment and supply inventories; Food; Funding; Goals; HIV; HIV Infections; HIV Seropositivity; HIV diagnosis; HIV/AIDS; Health; Health Care Costs; Health Care Sector; Housing; Imprisonment; Individual; Inpatients; Insurance; Insurance Carriers; Intervention; Legal; Link; Location; Los Angeles; Measures; Medical; Modeling; National Institute of Drug Abuse; Outcome; Participant; Policy Maker; Population; Population Intervention; Poverty; Primary Care; Productivity; Provider; Public Health; Public Policy; Quality of life; Quality-Adjusted Life Years; Race; Randomized; Research; Resources; Screening Result; Self Efficacy; Service provision; Services; Sexual and Gender Minorities; Social support; Subgroup; Substance Use Disorder; System; Text; Text Messaging; Time; United States Health Resources and Services Administration; United States National Institutes of Health; Urine; Viral; arm; comorbidity; comparative effectiveness; cost; cost effective intervention; cost effectiveness; design; economic evaluation; effective intervention; ethnic identity; experience; girls; health belief; health care service; health care service utilization; health disparity populations; improved; intervention effect; overdose death; peer; population health; relative effectiveness; response; safety net; secondary outcome; social; social cognitive theory; social determinants; structural health determinants; theories; transgender women; treatment adherence; treatment as usual; women of color

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.

摘要 跨性别妇女(TW)通过艾滋病毒护理连续体实现次优进步，1-7人，包括穷人 艾滋病毒保健利用率，8，9艾滋病毒医疗保留率，10-12和病毒抑制率。3，4，6，7，13，14 共病情况加剧了问题，如物质使用障碍(SUD)，15-22也是 与生活质量下降和过量死亡增加有关，利用高成本的医疗保健 服务，参与街头经济，以及监禁周期。23，24在TW中使用毒品 被证明是艾滋病毒护理和艾滋病毒护理持续进展的障碍。16因此，它是 至关重要的是，结束艾滋病毒流行的努力包括有效的干预措施，以联系和保留艾滋病毒中的TW 通过全面抑制病毒进行护理。25-27这项研究建立在我们两个由HRSA资助的有希望的发现的基础上 示范项目，Alexis Project28和Text Me，Girl！，29，它们利用了对等健康导航(PHN) 和短信(即，短信)，分别用于促进携带艾滋病毒的TW患者完全抑制病毒。 虽然这两种干预措施的有效性已经确定，但它们的相对有效性， 所需资源/成本、成本效益和对分组的异质性影响，包括 Sud，还没有经过评估。考虑到许多负面的个人和公共健康后果 未经治疗/未得到充分治疗的艾滋病毒，为TW提供的艾滋病毒服务往往是在资源有限、 以社区为基础的环境，30-33综合经济评估对于制定决策至关重要 利益相关者，如提供商、保险公司和政策制定者。“意向治疗”RCT将随机化 参与者(N=225)分为：单独使用PHN(n=75)、单独使用短信(n=75)或PHN+短信(n=75)。使用相同的时间 作为HRSA项目，重复测量设计将在基线、3-、6-、12-、 以及随机化后的18个月。具体目标是：1)开展效果比较研究 试验以确定PHN、SMS和PHN+SMS在以下方面的相对有效性：(A)病毒学 抑制；和次要结果(B)艾滋病毒治疗依从性自我效能量表得分； 艾滋病健康信念量表得分；(D)社会支持行为量表得分；和(E)尿液 药物筛选结果；2)确定准备、实施和维持每个结果所需的资源 干预措施，并估算相关成本；3)进行全面的成本效益分析，以 确定来自医疗保健部门、国家政策制定者和社会各界的每项干预措施的相对价值 视角；次要目标是确定各种干预措施的不同干预效果 由于健康的社会和结构决定因素以及个人层面的特点。TW是一个高度优先的 达到EHE25-27目标的人口和洛杉矶县(研究地点)是EHE的优先事项 34，35项研究结果有可能通过以下方式改善个人和人口的健康结果 TW在病毒抑制方面的重大改进，并指导服务提供和公共政策。