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人口的16％，但他们占29％ 新的HIV诊断3与结构性种族主义，其他ISM及其表现有关。结构的表现 种族主义包括医疗保健甜点，获得护理障碍（即距离，运输，财务），歧视和歧视 挫败艾滋病毒测试和预防（PREP）吸收的医学错误。47-49初步工作。我们的五点倡议 （FPI）是一种本地开发的捆绑实施策略（BIS），以扩大基于证据的临床范围 对与社区艾滋病毒建立伙伴关系的黑人社区的干预措施（即艾滋病毒测试，准备，避孕套） 专家，当地企业和联邦资助的社区卫生组织，通过前往的障碍 社区，并通过种族/文化能力和实时专业知识来增强信任。35-36成功1年 计划补充（2019-2020）。我们在4个HIV High Impact邮政编码上建立了合作伙伴关系（13个企业，5个 卫生伙伴，10个事件），试点该方法（例如，艾滋病毒测试是可选的），并参与了居民（n = 677）。 成功的2年实施补品（2020-2022）。我们完善了FPI bis，达到了1,887个社区 未通过标准公共卫生方法达到的成员（有64％的不知情，只有4％的规定 准备，46％的HIV测试> 12 MON； 40％的无避孕套性行为过去3个周一），所需的艾滋病毒测试（90％[4％反应性]），提供 准备信息（100％）和连锁（22％），并扩大了覆盖范围（13个高影响力邮政编码，73家企业，54 活动和8个卫生伙伴）。概念模型：该混合实施试验类型2提案由 达到有效性采用实施框架（RE-AIM）以评估FPI实施 战略。研究计划：通过一个群集踩踏的RCT，我们将在 佛罗里达州迈阿密进行FPI干预（每月2个外展活动，超过21个月[每条邮政编码总数42个事件]）。我们将： （1）评估FPI干预在（i）HIV测试（主要），（ii）的社区水平上是否有显着提高 准备连接/处方（主要）和知识，以及（iii）避孕套访问/使用。结果I-III将通过 （a）干预前调查（n =每8个邮政编码225个居民：1800名居民总计）和干预后评估 （n =每8个邮政编码225个居民：1800名居民总计）（b）FPI干预事件的数据，以及（c）行政数据 在不干预期间（FPI前后）期间，由公共资助的卫生伙伴开始。 （2）FPI和健康 合作伙伴行政数据将用于评估（2A）FPI BIS与黑人居民参与艾滋病毒测试的有效性 和准备连接（覆盖范围），（2b）描述谁（收养）以及如何（忠诚，改编，成本）FPI 实施了干预，（2C）通过调查和定期反思进行评估可持续性 合作伙伴（维护）。 （3）进行空间分析以检查邮政编码中的FPI干预是否随机为 干预措施解释了结果的变化（AIM 1 I – III； AIM 2A）和HIV基本率的邻近邮政编码的差异 没有接受干预。含义：评估FPI的有效性和实施结果可能会配备 我们采用捆绑的策略来增加黑人和其他少数化社区的艾滋病毒测试和预期吸收。