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(震中)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、其他主义及其表现形式有关。结构的表现形式 种族主义包括保健甜点、获得保健的障碍(即距离、交通、经济)、歧视和 阻碍艾滋病毒检测和预防(PrEP)的医学不信任。47-49初步工作。我们的五点倡议 (FPI)是本地开发的捆绑实施战略(BIS)，旨在扩大循证临床的覆盖范围 利用与社区艾滋病毒的伙伴关系对黑人社区进行干预(即艾滋病毒检测、PrEP、避孕套) 专家、当地企业和联邦资助的社区卫生组织，通过访问 社区，并通过种族/文化能力和生活专业知识增强信任。35-36成功1年 规划EHE副刊(2019-2020年)。我们在4个艾滋病毒高影响邮政编码(13家企业，5家)建立了合作伙伴关系 卫生伙伴，10个活动)，试点方法(例如，艾滋病毒检测是可选的)，并让居民参与(N=677)。 成功的2年期欧洲高等教育执行补充资料(2020-2022年)。我们改进了FPI BIS，覆盖了1887个社区 未达到标准公共卫生方法的成员(不知道PrEP，只有4%开出了处方 准备，46%的艾滋病毒检测和>12个月；40%的无避孕套性行为超过3个月)，需要艾滋病毒检测(90%[4%反应])，提供 准备信息(100%)和链接(22%)，并扩大了覆盖范围(13个高影响力的邮政编码，73个企业，54个 活动和8个卫生伙伴)。概念模型：此混合实现试验类型2提案由 REACH有效性采用实施维护框架(RE-AIM)以评估FPI实施 策略。研究计划：通过集群阶梯式RCT，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次外展活动[每个邮政编码42次活动])。我们会： (1)评估计划生育干预措施是否在社区一级显著增加(I)艾滋病毒检测(初级)，(Ii) 准备联系/处方(主要)和知识，以及(Iii)避孕套的获取/使用。成果I-III将通过以下方式进行评估 (A)干预前调查(每8个邮政编码225名居民：总共1800名居民)和干预后评估 (n=每8个邮政编码225名居民：总共1800名居民)(B)来自FP I干预事件的数据，以及(C)行政数据 在非干预(计划生育干预前和干预后)期间从公共资助的卫生合作伙伴那里获得。(2)空腹血糖与健康 合作伙伴管理数据将用于评估(2a)FPI BIS在让黑人居民参与艾滋病毒检测方面的有效性 和PrEP链接(REACH)，(2b)描述了哪些人(采用)以及如何(保真度、适应、成本)进行了FP I 实施了干预措施，以及(2c)通过调查和定期反思落实情况来评估可持续性 合作伙伴(维护)。(3)进行空间分析，检查邮政编码中的FPI干预是否随机化到 干预措施解释了结果(目标1I-III；目标2a)和邻近邮政编码的人的艾滋病毒基本感染率的差异 没有接受干预。影响：评估FP I的有效性和实施结果可能配备 美国采取捆绑战略，在黑人和其他小规模社区中增加艾滋病毒检测和PrEP感染。

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.