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

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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.