A Multi-Level Trauma-Informed Approach to Increase HIV Pre-exposure Prophylaxis Initiation among Black Women

一种多层次的创伤知情方法，以增加黑人女性中艾滋病毒暴露前预防的启动

• 批准号: 10817423
• 负责人: Tiara C. Willie
• 金额: $ 108.77万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-21 至 2028-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10817423
• 关键词: AIDS prevention; Address; Adoption; Affect; Baltimore; Black race; Caring; Client; Clinic; Clinical; Collaborations; Community Healthcare; Consolidated Framework for Implementation Research; Data; Data Aggregation; Disparity population; Education; Educational Materials; Effectiveness; Eligibility Determination; Environment; Ethnic Population; Evaluation; Exposure to; Face; Gender; Geography; HIV; HIV Infections; HIV disparities; Health system; Healthcare; Healthcare Systems; Hybrids; Infection; Intervention; Interview; Knowledge; Learning; Mediator; Medical; Mississippi; Modeling; Monitor; Neighborhood Health Center; Outcome; Policies; Prevention strategy; Process; Protocols documentation; Provider; Public Health; Race; Randomized; Research; Sampling; Self Efficacy; Sexism; Social support; Stereotyping; Structure; Support Groups; Surveys; System; Training; Trauma; Woman; arm; black women; cis-female; community setting; design; effectiveness evaluation; effectiveness testing; effectiveness/implementation study; epidemic preparedness; epidemiologic data; experience; health care availability; health disparity populations; high risk; implementation evaluation; implementation outcomes; implementation strategy; implementation study; improved; innovation; insight; intersectionality; intervention cost; intimate partner violence; novel; patient-clinician communication; peer; peer support; post implementation; pre-exposure prophylaxis; prevent; racial disparity; racial population; racism; screening; social structure; structural determinants; theories; therapy design; traumatic event; treatment arm; two-arm trial; uptake

Project Summary Black cisgender women (hereafter, Black women) carry a disproportionate HIV burden than women in other racial and ethnic groups. Despite its promise, there is an unmet need for pre-exposure prophylaxis (PrEP) among Black women. Intimate partner violence (IPV) and gendered racism may exacerbate racial disparities in PrEP access and also curb potential real-world effectiveness. IPV reduces PrEP uptake among women. Black women also experience unfair treatment due to deeply ingrained stereotypes by healthcare systems. As such, Black women may feel uncomfortable discussing PrEP with a provider or provider biases may prevent PrEP access. Integrating trauma-informed care into community health centers that serve Black women may enhance PrEP adoption. Trauma-informed care can help providers understand IPV, medical mistrust and gendered racism within the context of Black women’s experiences. System policies can also be modified to be trauma-informed for both staff and Black women clients. In addition to changing health systems, peer navigation could be a successful model of care to improve PrEP engagement. Peer navigation can build self-efficacy in patient-provider communication and decrease medical mistrust offsetting the impact of socio-structural barriers. The proposed research aims to address this gap via the implementation and evaluation of a trauma-informed multilevel intervention designed to increase PrEP initiation among Black women. This intervention includes a trauma- informed PrEP Implementation Toolkit for staff in community healthcare clinics in addition to a trauma-informed peer navigation model. We propose a hybrid type 2 effectiveness-implementation study with clinical staff, peer navigators, and clients. Aim 1 includes adapting an existing trauma-informed peer navigation for PrEP-eligible Black women. Qualitative data from semi-structured interviews with 20 Black women clients will be used to adapt the peer navigation. Aim 2 includes assessing the effectiveness of the trauma-informed multilevel intervention. The toolkit will be employed in clinics using a stepped wedge design with monthly aggregated clinic data collected 8 months before and after toolkit implementation in each clinic. Toolkit effectiveness will be assessed using within- and between-clinic changes in PrEP initiation. Staff will complete baseline, immediate post, and 3-month post surveys to assess mechanisms of change. In a parallel two-arm trial, 300 Black women clients will be randomized to receive either peer navigation (intervention arm) or support group only (control arm) and will complete baseline, 1-, 3-, and 6- month post-randomization surveys. The primary client outcomes will be 1-, 3-, and 6-month PrEP initiation. Aim 3 includes assessing the implementation of the multilevel intervention. Adoption, acceptability, appropriateness, and sustainability will be assessed with 3-month post-toolkit staff surveys; and at 1-, 3-, and 6- month client post-randomization surveys. Intervention costs will be computed using an ingredients-based approach. Fidelity will be assessed with the fidelity-monitoring approach for multilevel trials.

项目概要 黑人顺性别女性（以下简称黑人女性）比其他地区的女性承受着不成比例的艾滋病毒负担 尽管有希望，但暴露前预防 (PrEP) 的需求尚未得到满足。 黑人女性亲密伴侣暴力 (IPV) 和性别种族主义可能会加剧 PrEP 中的种族差异。 的机会并抑制潜在的现实世界有效性。 由于医疗保健系统根深蒂固的刻板印象，黑人也遭受不公平的待遇。 女性可能会对与提供者讨论 PrEP 感到不舒服，或者提供者的偏见可能会阻碍 PrEP 的获得。 将创伤知情护理纳入为黑人妇女服务的社区卫生中心可能会增强 PrEP 收养创伤知情护理可以帮助提供者了解 IPV、医疗不信任和性别种族主义。 在黑人妇女经历的背景下，系统政策也可以进行修改，以了解创伤情况。 对于员工和黑人女性客户来说，除了改变卫生系统之外，同伴导航也可以成为一种选择。 提高 PrEP 参与度的成功护理模式可以建立患者-提供者的自我效能。 沟通并减少医疗不信任，抵消社会结构障碍的影响。 研究旨在通过实施和评估创伤知情的多层次方法来解决这一差距 旨在提高黑人女性 PrEP 启动率的干预措施 该干预措施包括创伤- 除了创伤知情外，还为社区医疗诊所的工作人员提供知情的 PrEP 实施工具包 我们提出了一项与临床工作人员、同行一起进行的混合 2 型有效性实施研究。 目标 1 包括针对符合 PrEP 资格的人员调整现有的创伤知情同伴导航。 来自对 20 名黑人女性客户的半结构化访谈的定性数据将用于调整。 目标 2 包括评估创伤知情多层次干预的有效性。 该工具包将在诊所中使用，采用阶梯式楔形设计，每月收集汇总的临床数据 每个诊所实施工具包之前和之后的 8 个月将使用工具包有效性进行评估。 工作人员将完成基线、立即发布和 3 个月的 PrEP 启动的内部和外部变化。 在一项平行的双臂试验中，将有 300 名黑人女性客户参与调查以评估变革机制。 随机接受同伴导航（干预组）或仅支持小组（对照组），并将 完整的基线、随机化后 1、3 和 6 个月的调查 主要客户结果将是 1、3、 目标 3 包括评估多层次干预的实施情况。 采用、可接受性、适当性和可持续性将由 3 个月后工具包工作人员进行评估 调查；以及 1、3 和 6 个月的客户随机化后调查成本将使用以下方法计算。 基于成分的方法将通过多级试验的保真度监测方法进行评估。