Five Point Initiative: A Cluster Randomized Trial of a Bundled Implementation Strategy to Address the HIV Epidemic in Black Communities

背景：虽然黑人占佛罗里达州迈阿密人口的16%，但他们占29% 新的艾滋病毒诊断3与结构性种族主义、其他主义及其表现有关。结构性的表现形式 种族主义包括医疗保健甜点，获得护理的障碍（即，距离，交通，财务），歧视，以及 医疗上的不信任阻碍了艾滋病毒检测和预防（PrEP）的接受。我们的五点倡议 (FPI)是一个本地开发的捆绑实施策略（BIS），以扩大循证临床 干预（即，艾滋病毒检测，PrEP，避孕套），利用与社区艾滋病毒的伙伴关系， 专家、当地企业和联邦政府资助的社区卫生组织，通过以下方式消除了获得服务的障碍： 社区，并通过种族/文化能力和生活经验增强信任。35 -36成功的1年 规划EHE补充（2019-2020）。我们在4个艾滋病毒高影响邮政编码（13家企业，5家 卫生伙伴，10项活动），试行该办法（例如，HIV检测是可选的），并参与居民（N=677）。 成功的2年EHE实施补充（2020-2022）。我们完善了FPI BIS，覆盖了1，887个社区 没有通过标准公共卫生方法达到的成员（64%不知道PrEP，只有4%规定 PrEP，46% HIV检测> 12个月; 40%无安全套性行为超过3个月），需要HIV检测（90% [4%反应性]），提供 PrEP信息（100%）和联系（22%），并扩大了覆盖范围（13个高影响力邮政编码，73家企业，54 8个健康伙伴）。概念模型：这一混合实施试验类型2提案的指导思想是 达到有效性采用实施维护框架（RE-AIM），以评估FPI实施情况 战略研究计划：通过一个群集阶梯式楔形随机对照试验，我们将随机引入8个HIV高影响邮政编码， 佛罗里达州迈阿密至FPI干预（21个月内每月2次外联活动[每个邮政编码共42次活动]）。我们将： (1)评估FPI干预措施是否在社区一级显著增加了（一）艾滋病毒检测（初级），（二） PrEP联系/处方（初级）和知识，以及（iii）避孕套的获取/使用。结果i-iii将通过 (a)干预前调查（n=225名居民，每8个邮政编码：共1800名居民）和干预后评估 （n=225名居民，每8个邮政编码：总共1800名居民）（B）来自FPI干预事件的数据，和（c）行政数据 在非干预期间（FPI干预前后），从公共资助的卫生合作伙伴处获得。(2)粮食安全与健康 合作伙伴的管理数据将用于评估（2a）FPI BIS在吸引黑人居民参与艾滋病毒检测方面的有效性 和PrEP联系（覆盖范围），（2b）描述FPI在谁（采用）和如何（忠诚度，适应性，成本）之间的关系 实施了干预措施，以及（2c）通过调查和定期反思评估可持续性 合作伙伴（维护）。(3)进行空间分析，以检查邮政编码中的FPI干预是否随机分配到 干预解释了结果的变化（目标1 i- iii;目标2a）和邻近邮政编码的艾滋病毒基本感染率， 他没有接受干预。影响：评估FPI的有效性和实施结果可能有助于 我们采取捆绑战略，增加黑人和其他少数民族社区的艾滋病毒检测和PrEP吸收。

Background: While Black individuals make up 16% of the population in Miami, FL (an epicenter) they account for 29% of new HIV diagnoses3 linked to structural racism, other isms, and their manifestations. Manifestations of structural racism include healthcare desserts, barriers to access care (i.e., distance, transportation, finances), discrimination, and medical mistrust that thwart HIV testing and prophylaxis (PrEP) uptake.47-49 Preliminary work. Our Five Point Initiative (FPI) is a locally developed bundled implementation strategy (BIS) to expand the reach of evidence-based clinical interventions (i.e., HIV testing, PrEP, condoms) to Black communities that harnesses partnerships with community HIV experts, local businesses, and federally funded community health organizations, removes barriers to access by going to communities, and enhances trust through racial/cultural competence and lived expertise.35-36 Successful 1-Year Planning EHE Supplement (2019-2020). We built partnerships across 4 HIV high impact zip codes (13 businesses, 5 health partners, 10 events), piloted the approach (e.g., HIV testing was optional), and engaged residents (N=677). Successful 2-Year EHE Implementation Supplement (2020-2022). We refined FPI BIS, reached 1,887 community members who are not reached by standard public health approach (64% no knowledge of PrEP, only 4% prescribed PrEP, 46% HIV test > 12 mons; 40% condomless sex past 3 mons), required HIV testing (90% [4% reactive]), provided PrEP information (100%) and linkage (22%), and expanded the reach (13 high impact zip codes, 73 businesses, 54 events, and 8 health partners). Conceptual Model: This hybrid implementation trial type 2 proposal is guided by the Reach Effectiveness Adoption Implementation Maintenance framework (RE-AIM) to evaluate the FPI implementation strategy. Research Plan: Via a cluster stepped wedged RCT we will randomly introduce 8 HIV high impact zip codes in Miami, FL to the FPI intervention (2 outreach events per month over 21 months [42 total events per zip code]). We will: (1) Assess whether the FPI intervention has a significant increase at the community level on (i) HIV testing (primary), (ii) PrEP linkage/prescription (primary) and knowledge, and (iii) condom access/use. Outcomes i-iii will be assessed via (a) pre-intervention surveys (n=225 residents per 8 zip codes: 1800 residents total) and post-intervention assessments (n=225 residents per 8 zip code: 1800 residents total) (b) data from FPI intervention events, and (c) administrative data from publicly funded health partners during non-intervention (pre- & post- FPI intervention) periods. (2) FPI and health partner administrative data will be used to assess (2a) how effective FPI BIS is at engaging Black residents in HIV testing and PrEP linkage (reach), (2b) describe among whom (adoption) and how (fidelity, adaptations, costs) the FPI intervention was implemented, and (2c) assess sustainability via survey and periodic reflections with implementation partners (maintenance). (3) Conduct spatial analysis to examine if the FPI intervention in zip codes randomized to the intervention explains variations in the outcomes (Aim 1 i– iii; Aim 2a) and HIV base rates for neighboring zip codes who did not receive the intervention. Implications: Assessing effectiveness and implementation outcomes of FPI may equip us with a bundled strategy to increase HIV testing and PrEP uptake among Black and other minoritized communities.