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

五点倡议：解决黑人社区艾滋病毒流行问题的捆绑实施策略的集群随机试验

• 批准号: 10742609
• 负责人: Sannisha K. Dale
• 金额: $ 136.64万
• 依托单位: UNIVERSITY OF MIAMI CORAL GABLES
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-05 至 2028-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10742609
• 关键词: AIDS prevention; Address; Adoption; American; Beauty; Black Populations; Black race; Businesses; Censuses; Clinical; Clinical effectiveness; Cluster randomized trial; Collaborations; Communities; Community Health; Community Surveys; Data; Diagnosis; Discrimination; Dryness; Electronics; Epidemic; Equity; Event; Florida; Funding; Future; Gases; HIV; HIV diagnosis; HIV risk; Hair; Health; Health Services Accessibility; Healthcare; Human immunodeficiency virus test; Hybrids; Individual; Institution; Intervention; Interview; Knowledge; Link; Maintenance; Medical; Modeling; Neighborhoods; Outcome; Outcome Study; Pamphlets; Participant; Periodicals; Policies; Population; Prophylactic treatment; Public Health; Public Health Practice; Race; Randomized; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Reporting; Research; Restaurants; Risk Factors; Services; Structural Racism; Surveys; System; Transportation; Trust; Unsafe Sex; Variant; Work; acceptability and feasibility; barrier to care; base; community intervention; condoms; cost; cultural competence; design; effectiveness evaluation; effectiveness outcome; effectiveness testing; evidence base; health inequalities; health organization; implementation evaluation; implementation outcomes; implementation strategy; implementation trial; improved; innovation; interest; member; minority communities; outcome disparities; outreach; post intervention; primary outcome; racial disparity; social health determinants; success; tool; uptake; volunteer; voucher

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.

背景：虽然黑人占佛罗里达州迈阿密（震中）人口的 16%，但黑人占人口的 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。 种族主义包括医疗甜点、获得护理的障碍（即距离、交通、财务）、歧视和 医疗不信任阻碍了艾滋病毒检测和预防 (PrEP) 的采用。47-49 我们的五点倡议的初步工作。 （FPI）是本地开发的捆绑实施策略（BIS），旨在扩大循证临床的覆盖范围 利用与社区艾滋病毒合作伙伴关系对黑人社区进行干预措施（即艾滋病毒检测、暴露前预防、避孕套） 专家、当地企业和联邦政府资助的社区卫生组织，通过访问消除获取障碍 社区，并通过种族/文化能力和生活专业知识增强信任。35-36 成功的 1 年 规划 EHE 补充（2019-2020 年） 我们在 4 个艾滋病高影响邮政编码（13 家企业、5 家）建立了合作伙伴关系。 健康合作伙伴，10 项活动），试点了该方法（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 EHE 实施补充（2020-2022 年）我们完善了 FPI BIS，覆​​盖了 1,887 个社区。 未达到标准公共卫生方法的成员（64% 不了解 PrEP，只有 4% 规定了预防措施） 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%) 和链接 (22%)，并扩大了覆盖范围（13 个高影响邮政编码、73 个企业、54 个 活动和 8 个卫生合作伙伴）：该混合实施试验类型 2 提案以 达到有效性采用实施维护框架 (RE-AIM) 来评估 FPI 实施情况 研究计划：通过集群阶梯式楔形 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，FPI 干预（21 个月内每月 2 次外展活动 [每个邮政编码共 42 次活动]）我们将： (1) 评估 FPI 干预措施在社区层面是否显着增加 (i) HIV 检测（初级）、(ii) PrEP 联系/处方（主要）和知识，以及 (iii) 安全套获取/使用将通过评估。 (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 FPI 干预事件的数据，以及 (c) 行政数据 (2) FPI 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 HIV 检测方面的有效性 和 PrEP 联系（范围），(2b) 描述 FPI 的对象（采用）以及如何（保真度、适应性、成本） 干预措施已实施，​​并且 (2c) 通过调查和定期反思来评估可持续性 (3) 进行空间分析以检查 FPI 对邮政编码的干预是否随机分配给 干预解释了结果的差异（目标 1 i– iii；目标 2a）以及邻近邮政编码的艾滋病毒基本率 影响：评估 FPI 的有效性和实施结果可能会有所帮助。 我们制定了一项捆绑策略，以增加黑人和其他少数族裔社区的艾滋病毒检测和 PrEP 接受率。