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HomeMy WebLinkAbout23363AGREEMENT INFORMATION AGREEMENT NUMBER 23363 NAME/TYPE OF AGREEMENT FLORIDA INTERNATIONAL UNIVERSITY DESCRIPTION GRANT AGREEMENT - TO ASSIST WITH CONVENING RESIDENTS FOR COVID-19 VACCINE FOCUS GROUPS AND EDUCATION EFFECTIVE DATE March 25, 2021 ATTESTED BY TODD B. HANNON ATTESTED DATE 3/26/2021 DATE RECEIVED FROM ISSUING DEPT. 4/2/2021 NOTE CITY OF MIAMI DOCUMENT ROUTING FORM ORIGINATING DEPARTMENT: Dept. of Human Services DEPT. CONTACT PERSON: Michael Roman EXT. 1618 NAME OF OTHER CONTRACTUAL PARTY/ENTITY: Florida International university IS THIS AGREEMENT A RESULT OF A .COMPETITIVE PROCUREMENT PROCESS? 0 YES 0 NO TOTAL CONTRACT AMOUNT: $ to.000 FUNDING INVOLVED? ❑■ " YES ❑ NO TYPE OF.AGREEMENT: 0 MANAGEMENT AGREEMENT ❑ PROFESSIONAL SERVICES AGREEMENT GRANT AGREEMENT ❑ EXPERT CONSULTANT AGREEMENT ❑ LICENSE AGREEMENT ❑ PUBLIC WORKS. AGREEMENT ❑. MAINTENANCE AGREEMENT ❑ INTER -LOCAL AGREEMENT ❑ LEASE AGREEMENT ❑ PURCHASE OR SALE AGREEMENT OTHER: (PLEASE SPECIFY) PURPOSE OF ITEM (BRIEF SUMMARY): To assist with convening residents for COVID-19 vaccine focus groups and education COMMISSION APPROVAL DATE: NA / / FILE ID: NA ENACTMENT NO.: NA IF THIS DOES NOT REQUIRE COMMISSION APPROVAL, PLEASE EXPLAIN: There is no cost involved to the City of Miami ROUTING'INFORMATI,ON Date PLEASE PRINT AND SIGN APPROVAL BY DEPARTMENTAL DIRECTOR PST: William .Porro SIGNATURE: Porro, Willarn = — SUBMITTED TO RISK MANAGEMENT PRINT:.ANN-MARIE SHARPE SIGNATURE: ;o tt.osuvaras as SUBMITTED TO CITY ATTORNEY (21-601 - JCP) PRINT: VICTORIA MEND_EZ SIGNATURE: /s Juan C. Perez APPROVAL BY ASSISTANT CITY MANAGER 5 PRINT: Natasha Colebrook -Williams SIGNATURE. RECEIVED BY CITY MANAGER 3 12.(0 PRINT: AR ORIEGA SIGNA • 1) ONCORIGINALITY'CLERK 2) ONE4 COPY xTOSCITYA-TTORNEY'S OFFICE; 3) REMAINING:ORIGINAL(Sj TOORIGINATING DEPARTMENT PRINT: SIGNATURE: SIGNATURE: PST: SIGNATURE: PLEASE ATTACH THIS ROUTING FORM TO ALL DOCUMENTS THAT REQUIRE EXECUTION BY THE CITY MANAGER CITY OF MIAML FLORIDA INTER -OFFICE MEMORANDUM TO: FROM: Art Noriega William Director Department uman Services DATE: Tuesday, March 16, 2021 REFERENCES: FILE: Florida Cominunity- Engaged Research Alliance. Against COVID-19 in Disproportionately Affected Communities (FL- CEAL) ENCLOSURES: FL CEAL Program Overview The Department of Human Services respectfully requests the acceptance of the attached donation of $10,000 from Florida International University's Robert Stempel College of Public Health & Social Work to assist with convening" residents for COVID-19 vaccine focus groups and. education. The goal of the Florida Community -Engaged Research Alliance Against COVID-19 .in Disproportionately Affected. Communities (FL-CEAL) is to establish effective, community -engaged strategies to enhance education, awareness, access, and inclusion of underserved communities in research designed to advance the prevention and treatment of COVID-19 and reduce COVED disparities in the State of Florida. I am respectfully requesting that youaccept these funds on behalf of the City. The section of the code is reference below: Section 18-1.15.Acceptance of Donation: The City Manager is authorized to accept the donation of goods and services. up to an estimated value of $25,000 on behalf of the City, per Ordinance Number 12271, § 2, 8:22.02. The Department is expected to receivethe funds prior to April 2021. Project Code: 45-45000FIU Should you need additional information, please feel free' to contact me at (305) 416-2181. Please indicate your approvalby signing below. Thank you for your cons i Ieration regarding this matter: APPROVED: ,Attachments: Date: 3/D5/a\ Cc: Leon Michel, Assistant Director, Office of Management & Budget Erica Paschal, Director, Department of Finance vonCarol Kinchens-Williams, Assistant Director, Department of Human Services Program Director/Principal Investigator (Last, First, Middle): Carrasquillo, Olveen Overview: The goal of the Florida Community -Engaged Research Alliance Against COVID-19 in Disproportionately Affected Communities (FL-CEAL) is to establish effective, community -engaged strategies toenhance education, awareness, access, and inclusion of underserved communities in research designed to advance the prevention and treatment of COVID-19 (hereafter referred to as COVID) and reduce COVID disparities in the state of Florida. Our statewide coalition is led by eleven established investigators whose careers have focused .on medically and socially underserved populations.. The application includes seven research studies from five of the state's leading academic institutions, all of which have community partnerships as a central component. Our Specific Aims are as follows, with a project period from.9/1/20 — 8/31 /21: 1. Determine the level of awareness and understanding of COVID and the barriers/ facilitators for participation in COVID research studies in. Florida's minority communities. (projects#1-5) 2. Using that information, develop community -based outreach and dissemination activities aimed at promoting evidence -based COVID health promotion practices and participation in.COVID clinical trials. (projects #1-5) 3. Implement and evaluate the impact of strategies that increase the enrollment of minorities into-COVID vaccine and therapeutic trials. (projects #6 and #7). A.1. Background: Florida: Our nation's leading laboratory for conducting minority research. With 22 million residents, Florida is our nation's third most populous state. It is also one of the nation's most diverse states; 17% of the population is Black and 27%°. Latino.' It is also third in the: country in the number of minorities living in the state. Already, among persons aged under 70, .Florida is; a minority -majority state with less than half the under 70 population being non Hispanic White (NHW).2 In addition, by 2050, Latinos alone will represent over 50% of Florida's population.3 Further, with 21 %° of the population being age 65 and over, it is the state with the highest proportion of elders. Within this context is Miami -Dade County (MDC). Of MDC's 3 million residents, 69% are Hispanic, 54% foreign -born and 74% speak a language other than English at home.4 Over the last twenty years, a rapid influx of Latinos from most regions. of Latin America now make Miami the most diverse Latino community in the US. This includes 65% of Latinos whom are Caribbean (55% Cubans, 8% Puerto Ricans, 5% Dominicans) and 35% from a wide range of countries in Central and South America. The 18% of the county which is Black is also quite diverse, with one-thiird.of Blacks in MDC being foreign -born, nearly half of whom are Haitian. Other Black subgroups come from English-speaking Caribbean countries (e.g. Bahamas, Jamaica, Trinidad. Accordingly, Miami is often looked at as our country's demographic frontier and an. archetype for the projected. future diverse composition of the US. A.2. Disparities in Florida: Similar to other parts of the country, Florida also has large social and health disparities.5 For example, 24%. of Blacks and 17% of Hispanics live below the poverty level versus 14% of NHWs. Also, 7% of Blacks and 8% of Latinos are homeless versus. 2% of NHWs. With 16% of the population lacking health insurance, Florida has the nation's second highest non -elderly uninsured populations Further, 17%. of Blacks and 21 % of Hispanics are uninsured versus 12% of NHWs.6 Blacks also suffer disproportionately from health disparities. For example, ratesof hospitalizations from heart disease are 387/100,00 in Blacks versus 258 in whites. The northern part of the state (the "Panhandle") experiences disproportionate rates of heart disease and strokes among Blacks "stroke belt." Another example is HIV where the death rate is 12.1/100,000 among Blacks and 3.8 among Hispanics versus 2.6 among whites. In South Florida, Blacks account for 18% of Miami's population but 64%. of AIDS -related deaths. A.3. COVID in Florida: COVID has created an unprecedented global health crisis. The'23 Million cases and 800,000 deaths have posed critical challenges for the public health, research, and medical communities across the planet.' The USA is the worst affected internationally with 5.7 million cases and 176,000 deaths;8 COVID is now ranked as the 3rd leading cause of the death.° Initially, the northeast was hit hardest, But, by July the southern parts of the county ('and California) emerged as most problematic. Florida has been particularly hard hit. With 605,000 cases, it now ranks second in the country in °COVID cases and third in number of cases per capita.8 South Florida, is the most affected area in the state. The three South Florida counties of Broward,_ Miami -Dade and Palm Beach account for 43% of state COVID. cases, 42% of hospitalizations and 43% of Florida's 10,000 deaths, Miami alone accounts for 25% of state:cases and 25% of all deaths and was recently described as the COVID epicenter of the world.10 A.4 COVID Disparities:. COVID has also had a disproportionate impact on communities of color.11,12 Through August, Blacks have experienced COVID death rates at 2.4 times the rate of whites (85/100,000 for Blacks, 53 OMB No. 0925-0001/0002 (Rev. 03/2020 Approved Through 02/28/2023) Page 1 Continuation Format Page ................. • Program Director/Principal Investigator (Last, First, Middle): Carrasquillo, Olveen for Native Americans, 52 for Hispanics versus 35 for whites).13'14 A study of 79 hotspot counties in June, showed Hispanics, Native Americans, and Blacks were overrepresented in all COVID morbidity and mortality.18 In Florida, Latinos, whom comprise 26% of the state's population, account for 30%. of all confirmed COVID cases. Blacks, whom account for 17% of the population, were 24% of COVID hospitalizations and 20% of deaths. In South Florida's Broward County, Blacks make up 30% of the population but represent 41 % of COVID hospitalizations and 38% of deaths. Most strained are safety nest institutions. Miami's Public Hospital System (Jackson Health System) has 25% of county hospital beds but 41% of all COVID discharges. The disproportionate toll COVID has had on minorities has not been a surprise to our team, many of whom have dedicated our professional careers to addressing health disparities. COVID follows the same pattern as most other major acute and chronic healthconditions, taking a disproportionate toll on the most vulnerable in our communities. Such health disparities are often the end result of the non-biologicforces commonly called "social determinants of health".16 It is the marked difference in factors such as socioeconomic status, housing, environment, and access to care that are. often the main driver of health disparities.17 Similarly, emerging consensus is that the inequities in COVID are also rooted in these social determinants of health placing racial and ethnic minorities at increased of COVID morbidity and mortality.18 Such factors include crowded housing conditions, inequities in educational access, .minorities working in low paying "essential worker" jobs having much higher exposure risks, limited access to high quality health care, immigration:status and subtle and occasionally overt forms of racism and .discrimination. Further, social determinants also result in minorities suffering disproportionally from medical conditions such as heart disease, diabetes, and asthma which also increases the risk of having severe COVID.19 Lastly, well-meaning strategies to slow viral spread, have resulted in negative impacts on minorities (e.g., lost jobs/wages, losing health insurance, and stress). A.5. Community engagement to address COVID Disparities: To date, one of the most successful approaches to address health inequities is to meaningfully involve community partners in research and interventions aimed at addressing disparities. This approach, often referred to as Community -Based Participatory Research (CBPR), is centered on collaborative partnerships designed to ensure and establish structures for participation by communities affected in all aspects of the research process.20.21 Similarly, addressing COVID disparities will also require culturally responsive, targeted interventions addressing social determinants developed in partnership with trusted leaders and community -based organizations. This message was again reiteratedat two community engagement forums held by the NIH on addressing the COVID epidemic.22 Among the key messages were that effective COVID interventions will require bi-directional community engagement, establishing trust, and meaningfully involving community partners at all stages of COVID intervention planning. "Address social determinants" was reiterated by nearly all of the presenters. A.6. Minority Participation in COVID Research: Another worrisome, emerging trend is that minorities whom are over -represented in COVID morbidity and mortality are being under -represented in COVID research, particularly vaccine studies. Of the 350,000 people who registered for a COVID vaccine registry, only 10% were Black or Latino.23 Of the 8,374 persons enrolled in the first three weeks of the Moderna vaccine trial, only 10% were Latino and 5% Black.24 This pattern is no different from other areas such as cardio-vascular disease and cancer which disproportionately affect minorities but where minorities were under -represented in many landmark trials.25,26 Initially, programs aimed at addressing such under -representation focused on participantbeliefs such as mistrust, fear, and lack of confidence in research due to well documented abuses of these communities, with the Tuskegee study being one of the most well-known of many such ethical lapses.27 Increasingly appreciated is that lack of equitable minority participation in research also reflect barriers and. challenges of some research teams leading such studies.28 These include lack of knowledge about the cultural norms of minority communities, use of non -tailored and ineffective minority outreach and recruitment strategies, failure to address logistical concerns such as childcare and lack of transportation, as well as more subtle forms of racism and discrimination. In addition, other contemporaneous factors make recruiting minorities into COVID trials more challenging. These include the recent racial/social unrest resulting from unjustified police killings, financial strain caused by a faltering economy, and the politicization of the COVID crisis. When minority communities see evidence -based effective strategies rejected based on political party affiliation and when political leaders espouse dangerous unproven interventions it sows fears and mistrust, particularly among those whose lived experiences have given then ample reasons to have a heightened sense OMB No. 0925-0001/0002 (Rev. 03/2020 Approved Through 02/28/2023) Page 2 Continuation Format Page Program Director/Principaf Investigator (Last, First, Middle): Carrasquillo, Olveen of fear and distrust. The consequences are of enormous concern. A recent poll found the proportion of persons willing to take a COVID vaccine (once approved) dropped from 66% in May to 56% in August.29 A.7. Potential Solutions: Despite these challenges, there are areas of opportunity. One benefit of meaningful CBPR partnerships is they lead to more equitable representation of minorities in research studies.30 When community members are fully engaged, members of these communities are more likely to participate in such research. In addition, teams led by investigators with community engagement expertise, willing to engage community partners in bi-directional partnerships and who value, trust andrespect the wisdom and knowledge such partners bring to the process are important to help ensure equitable minority representation. As described below (and in bio-sketches), all of the investigators in our coalition have many decades of experience and expertise in cross -disciplinary community -engaged research partnerships. As a result, our team has been highly successful in outreach, recruitment, and retention of minorities in our research. One of the most recent examples is the NIH's AllofUs research study.31 In Florida, in 18 months, we have enrolled over 13,000 participants of which 73% are Black and/or Latino, 24% low'income and 13% sexual minorities. While COVID presents a challenge unlike any in our nation's recent history, with effective, community -engaged strategies our nation can still effectively turn the tide, against this pandemic and eliminate COVID disparities. In response to this urgent need, we propose seven rapid deployment research projects focused on education, awareness, access, and inclusion of underserved communities in COVID research all designed to have impact within the next3-6 months. B. Research Team and Academic Partners: We have assembled a statewide coalition of established NIH investigators whose community -engaged research has focused on medically and socially underserved populations. Of theeleven investigators leading the collation, seven are Black and/or Hispanic, representing five academic institutions. These include Florida's two largest research universities: University of Miami (UM) and University of Florida (UF). Both have long records of community partnerships and collaborations, such as through their Clinical Translation Science AWard (CTSA) programs. The coalitionalso includes two of the state's largest minority serving institutions. Florida Agricultural and Mechanical University (FAMU), a Historically Black University (HBCU), and Florida International University (FIU), a Hispanic Serving Institution (HSI) and their respective Resource Centers for Minority Institutions (RCMI). The Moffitt Cancer Center, one of two NCI -designated Cancer Centers in the Florida, will be the 59' academic partner. Our leadership team also includes representation from the state's largest network of Federally Qualified Health Centers (FQHCs). B.1. Project Leaders at the University of Miami: Olveen Carrasquillo, MD, MPH (contact PI) has over 25 years of experience conducting community -engaged disparities research in various disease areas including heart disease, diabetes, stroke, HIV and cancer. He has led various NIH-funded disparities center grants. He is also co -director of the UM CTSA Community Engagement Core, directs the Behavioral and Community' Research Core of UM's NCI -designated Sylvester Comprehensive Cancer Center (SCCC), co -directs the Community Engagement Core for the UMNanderbilt/Meharry Precision Medicine Health Disparities Center, and is also co -director of stakeholder engagement for the One Florida Clinical Research Consortium. He is PI of UM' South -East Center for the AllofUs Research Program and co -leads the stakeholder engagement of the project. With respect to COVID, he was recently awarded a PCORI stakeholder engagement award on training Community Health Workers in three states (FL, CA, TX) on COVID awareness and research. He also serves as UM site co -PI of PCORIs COVID Health Care Worker Exposure Response and Outcomes (HERO) registry and hydroxychloroquine prophylaxis study. Last week, he was awarded a contract to serves as UM co -PI in the Janssen's COVID vaccine trials which seeks to recruit 2,000 participants from South Florida. Victoria Behar-Zusman, PhD has served for nearly 20 years as co -director, then director, of UM's NIMHD Center for Latino Health Research Opportunities, which in the current cycle partners with F.IU. Her comrnunity- engaged research is focused on disparities in substance abuse, violence and HIV/AIDS among Miami's most vulnerable Latinx communities. She leads theimplementation core for the NIMHD UMNanderbilt/Meharry Precision Medicine Health Disparities Center. She is also a member of the CTSA's Executive Committee. Previously she served as Associate Dean. for Research at UM's Schoolof Nursing and Health Studies; She also serves as chair of UM's Social and Behavioral Sciences IRB. Erin Kobetz, PhD, MPH, has over 15 years of NIH-funded cancer disparities research experience, including a long history of CBPR in Miami's Little Haiti community.32 She is Associate Director of the UM SCCC and directs the Cancer's Center Community Outreach and Engagement Program. She also co -directs the UM OMB No. 0925-0001/0002 (Rev. 03/2020 Approved Through 02/28/2023) Page 3 Continuation Format Page Program Director/Principal-Investigator (Last, First, Middle): Carrasquillo, Olveen CTSA Community Engagement and Team Science Cores. With respect to COVID, she led a county wide serological testing initiative that tested over 2,000 residents,33 directs a university -wide COVID contact tracing program, and is now leading a statewide study on sero-positivity among first responders. In June, she was named Vice Provost for Research at UM. B.2. Florida International University: Adriana Campa, PhD, leads the Community Engagement Core of the FIU RCMI and is also Chair of the Department of Dietetics and Nutrition. Her work is aimed at improving nutrition and quality of life. in South Florida and many other countries in Central and South America and Africa. She has a long experience leading research projects and recruiting minorities and hard to reach populations. Elena Bastida, PhD, is Chair of the Department of Health Promotion in FIU's College of Public Health and directs the .CoMmunity Engagement/Dissemination Core for FIU's Center for Latino Health Research Opportunities. She has over 25 years of CBPR research expertise focused on minority health, aging, women's health and life course research initially in the Texas -Mexico border and now for over ten years in Miami, including a research focus in the county's. Latin LGBT community. Eric Wagner, PhD, leads the FIU U54 RCMI and directs FIU's Community -Based Research Institute, whose mission is to reduce health risk behaviors, promote health and wellness, and promote health equity through community -university research partnerships. For the past 25 years, he has been conducting intervention - focused community -engaged research in partnership with Latinz, Black, and Native American communities. Mario R. De La Rosa, PhD, has over 30 years of experience. conducting CBPR. Heis one of Miami's pioneers iri substance abuse and HIV/AIDS research in Latinx populations. Along With UM's Behar-Zusman, he leads the FIU/UM U54 Center for Latino Health Research Opportunities. He directs FIU's nationally recognized multi -disciplinary center on research, education, and community outreach center to eliminate disparities, the Center for Research on US Latinos (CRUSADA). B.3. University of Florida: Elizabeth Shenkman, PhD, is Chair of UF's Department of Health Outcomes and Biioniledical Informatics and is also the co -director of the OF CTSA. Her work includes developing and implementing evidence -based strategies to reduce disparities in health outcomes and determining which combinations of health care delivery, community, and patient factors influence quality and outcomes of care. She is PI of PCORI's OneFlorida Clinical Research Consortium (project'#7) and is leading the Florida -wide COVID Health Care Worker Exposure Response and Outcomes (HERO) registry and prophylaxis studies. Folakemi Odedina, PhD, directs the NCI- funded (U54) Florida -California CaRE2 Health Equity Center. Her research has primarily focused on predictors of health disparities. and cost-effective, community -based behavioral interventions among Black men. She also directs the Research Core of the Florida Health Equity Research Institute (HERD, a collaboration among Florida's academic institutions (includingall those in this application), health care providers, government organizations, and community -based organizations address. health disparities in the state. Together with Dr.. Harris at FAMU (see below) she recently completed a study of over 2,000 Florida residents on COVID concerns and COVID-related stress: B.4. Florida A&M University: Cynthia Harris, PhD, is Associate Dean and Director of FAMU's.institute of Public Health. She is core director of the HERI Education and Training Core, directs the Florida Alliance for Health Professions Diversity (FAHPD)and serves as PI for the Florida Public Health Training Center. Her research includes HIV prevention, environmental exposures in underserved communities, diversity in the health workforce, training of community health workers, and community -based. interventions to reduce health disparities. Dr. Harris is now overseeing FAMU's COVID testing site, which has .completed more than 36,000 tests to date34in partnership with :Bond Community Health Center and the Leon County Health Department. B.5. Moffitt Cancer Center: Susan Vadaparampil, PhD, MPH, is Associate Director of Community Outreach & Engagement (COEE). Her research focuses on accelerating the adoption of advances in cancer prevention and treatment into the clinic and community. Community collaboration and health equity are foundational to her outreach and research efforts and through the COEE she has already supported and led numerous community -engaged COVID outreach and research efforts in Moffitt's catchment area. B.6. Health Choice Network: Timothy Long, MD, is the Chief Clinical Officer at Health Choice Network, one of the nation's largest network of FQHCs. His work is focused on preventive and community -based health care, chronic disease management, and HIV/AIDS care for the underserved. He has long been a strong supporter of patient engagement through technology, advancement of Patient Centered Medical Home, Care. Coordination and promotion of preventive healthcare for the underserved: OMB No. 0925-0001/0002 (Rev. 03/2020 Approved Through 02/28/2023) Page 4 Continuation Format Page Program Director/Principal Investigator (Last, First, Middle): Carrasquillo, Olveen C. Approach Overview: The mission of the FL-CEAL is to eliminate COVID disparities in Florida. We propose seven projects addressing our specific aims. Five projects will assess knowledge, attitudes and beliefs about COVI.D and participation in COVID research and use that information to develop COVID related outreach and education. Two additional studies will focus on increasing the participation of minorities in COVID trials. C.2. Geographic Focus: Our project includes partners in Florida's panhandle (FAMU), North and Central Florida (UF) .and Florida's West Coast (Moffitt). However, as noted above, three South Florida counties have been disproportionately affected by COVID accounting for over 40% of COVID cases and deaths in the state. As such, FL-CEAL will have a more focused effort in South Florida (UM, FIU and HCN). We hope our statewide efforts will contribute to NIH's goal of eliminating COVID disparities throughout the nation. As such, FL- CEAL will work collaboratively with other state teams. We will also participate, as appropriate, in implementation of core data collection strategies, data elements, and standard variables across the consortia. C.3. Overview of Aim #1: Projects #1-5 will determine the level of awareness and understanding of COVID and the barriers/ facilitators for participation in COVID research studies among minorities. As described below, the five FL-CEAL projects seek to examine knowledge, attitudes and beliefs among Florida's minority residents with regard to both COVID and to participation in COVID research. The projects will also examine the level of misinformation and miscommunication that currently exists surrounding COVID. Two of the projects will use a mixed -methods approach35 with qualitative approaches and rapid assessment surveys. All five projects will use focus groups and/or key informant interviews. Traditionally, when our teams conduct such research, we follow state of the art qualitative methodology including transcribing, coding, and rigorous analysis using appropriate software. However, since this aim is designed so that findings immediately inform Aim #2, our approach will use more contemporaneous rapid methods of qualitative data analysis.35 Such approaches have been found beneficial in highlighting context -specific issues that need to be addressed locally, population -level behaviors influencing health service use, and organizational challenges in response planning and irrmplementation.37 The two projects using rapid assessment surveys will use findings of the groups to develop their surveys, but given the need for rapid action will not undergo formalized survey development procedures such as psychometric testing.38 This will ensure that Aim #1 is completed within the first three months such that knowledge created will that leads to rapid actionable results. To the extent possible, project leaders will work together to ensure we establish core data collection strategies, data elements, and standardized variables across all four projects and potentially with other state -based CEAL teams. The FL-CEAL will complete this Aim withinthe first the monthsof the project. C.4. Overview of Aim #2: Use information from Aim #1 to develop outreach and dissemination activities and promote evidence -based health promotion and participation in COVID research. To accomplish this Aim as rapidly as possible, all five.projects plan to leverage existing resources. These include those made available to the state CEAL teams by the NIH for informing and recruiting participants into COVID prevention, treatment, and vaccine trials as well as supporting minority participation in research.39,4° Another important partner in the FL-CEAL will be the Florida Department of Health (FL -DOH). The Florida Department of Health (FL -DOH) has also developed a large number of resources dedicated to addressing COVID.41 Using the findings from Aim #1, and in consultation with community partners, all five teams will review existing COVID-19 resources and select those most relevant for their communities. Community input and advice will be critical on the adaptations and translations (Spanish, Haitian Creole) of these as well as on the development of new materials. Products may include educational materials in print, video, and/or social media platforms as well as information on local sites recruiting for COVID trials. Community partners will participate in developing a communication plan and strategic approaches for disseminating materials through their agencies including identifying modalities, spokespersons, etc. in each target community. All materials developed will be shared across other FL CEAL sites and with the national CEAL network. Dissemination activities will begin in month four and continue throughout the entire study period. Evaluation of community outreach and dissemination of Aim #2 will be led by the evaluation core of UM's CTSA and guided by RE -AIM framework.42 This framework has been extensively applied to public health planning and evaluation and is particularly appropriate for effecting and evaluating change on multiple levels of influence. As all funded projects in the national CEAL consortia will include community outreachand dissemination plans, we will work with other state CEAL teams to develop standardized processes, metrics, and evaluation strategies around this Aim. This phase will begin in the fourth month and continue throughout the remaining project period. OMB No. 0925-0001/0002 (Rev. 03/2020 Approved Through 02/28/2023) Page _ Continuation Format Page Program Director/Principal'lnvestigator (Last, First, Middle): Carrasquillo, Olveen C.5.1. Project #1 (UM/FIU: Behar-Zusman, De la Rosa and Bastida): Given current data on the depth and extent of COVID among the Latinx population. in Miami -Dade County (MDC), attention is needed to ensure the inclusion and participation of this population in research designed to advanceawareness and understanding of COVID and its prevention and treatment. In collaboration with community partners and the NIMHD-funded U54 Center for Latino Health Research Opportunities (CLaRO) we identified three underserved Latinx communities in Miami -Dade County (MDC): agricultural, low income urban (LIU), and sexual/gender minority (SGM) communities. These Latinx populations are most in need of culturally effective strategies and programs to expand understanding of COVID, feasible protective strategies, and acceptability of future COVID prevention treatment research, Thus, to advance interest in the prevention and treatment of COVID, we propose to conduct formative research on barriers/facilitators to COVID prevention, acceptance of treatment, and future participation in clinical trials (Aim 1) with the objective of identifying sociocultural, individual, interpersonal, and community attitudes, misconceptions and knowledge that residents from the three target Latinx communities (listed above) believe are essential to acceptance of COVIDprevention/treatments and possible participation in clinical trials. The research team will collaborate with the CLaRO Community Scientific Advisory Board (CSAB) and other community leaders in each community to develop research questions that will guide data collection activities and analysis (30-day outcome). Multi -level factors at the individual, interpersonal, community, and societal level that act as barriers/facilitators to research participation will be explored with a focus on participation in future treatment and prevention studies. A mixed methods approach will be utilized, with virtual focus groups (FG) to be conducted with a minimum of eight leaders and residents of each community (90-day outcome). A short electronic survey, minimum 30 surveys per community, will follow to explore emergent FG topics, beliefs, and perceptions about vaccines and treatments (120-day outcome). Project researchers will engage three community partners in data collection and dissemination activities: (1) Care Resource and (2) Martin Luther King Jr. Clinica Campesina Health Center of Community Health South Florida, Inc., and (3) Yes Institute. CARE resource is a community -based agency that has been deeply involved in conducting. COVID testing in the Latinx LIU and SGM communities in MDC. Clinical Campesina is a leading community -based agency that provides COVID testing to the MDC Latinx agricultural/farm working community. Yes Institute conducts community education serving sexual/gender minorities. Results will be used to guide the development of tailored community -based outreach and dissemination materials and activities aimed at promoting evidence based COVID health promotion practices and future participation in COVID clinical trials in these communities (Aim 2; 120-day and thereafter outcome). C.5.2. Project #2 (FIU: Wagner and Campa): The NIMHD-funded Research Center in a Minority Institution at Florida International University (FIU-RCMI) is devoted to community -university partnered clinical and behavioral research addressing health inequitiesand disparities affecting underrepresented minority (URM) communities in the three South Florida counties (Miami -Dade, Broward and Palm Beach). The FIU-RCMI FL- CEAL project will target disadvantaged populations living in urban areas in South Florida, with an emphasis on Blacks and the elderly. Across the five community partners, we will conduct: (a) three focus groups with at least 18 URM members, (b) surveys of at least 400 URM community members, (c) interventions (informed by the surveys and focus groups) designed to dispel myths and promote engagement in COVID prevention, testing, and vaccination, and (d) evaluation of interventions, with comparison to findings from previous studies of screening/participation rates in these populations. In the formative stages of the research (i.e., surveys, focus groups, intervention design), we primarily will focus on two overarching questions: (1) What are the perceived barriers/facilitators to testing and participating in vaccine trials? and, (2) What are .the best strategies to educate on the advantages of participating actively on the fight against COVID, and to reach populations suffering disparities and disproportionally affected by the COVID in South Florida? In the intervention stages, specific dissemination strategies will include developing educational materials specific to the needs of our target populations and consistent with CDC recommendations. We also will include training and education of healthcare professionals, caregivers, and clients, and we will publish and disseminate findings from the analyses of all the materials collected and developed in both community and academic venues. To address the overarching aims of the FLCEAL team, we will expand our existing community -university minority health research partnerships with five community partners. Two will recruit disadvantaged populations living in urban areas with poor access; to healthcare: 1. Care 4 U Community Health Center, Representative: Vanessa Mills, RN, BSN, MPH, FIU Collaborator: Dr. Jessy G. Devieux, and 2. Caridad Center, Representative: Jezebel OMB No. 0925-0001/0002 (Rev. 03/2020 Approved Through 02/28/2023) Page 6 Continuation Format Page Program Director/Principal Investigator (Last, First, Middle): Carrasquillo, Olveen Maisonet, FIU Collaborator: Dr. Sabrina Sales -Martinez. In addition, three long-term community-FIU minority health research partner will focus on disadvantaged and primarily Black populations in Liberty City, Overtown, and Little Haiti. 1. the City of Miami, 2. FIU Neighborhood Help, and 3. Borinquen Health Care Center. Together, these five community partners provide services for more than 50,000 members of medically underrepresented minority communities in South Florida. C.5.3. Project #3: (UF-Odedina/FAMU-Harris): This project will determinethe level of awareness and understanding of COVID and the barriers/ facilitators for participation in COVID research studies in north Florida's minority communities- with a particular focus on Blacks. For Project #3, UF will recruit participants from seven counties in north -central and north-eastern Florida while FAMU will recruit from Florida's panhandle. Also participating in this project will be FAMU's RCMI- Center for Health Disparities Research which has already begun establishing community partnerships to uncover the causes and consequences of the disproportionate burden of COVID-19 on racial, ethnic, and disadvantaged socioeconomic populations in North Florida. Community input and oversight will come from the CaRE2. Community Advisory Board (CAB), which we involve in all our research activities as well as the UF CTSI CAB. The two approaches we will use will be Virtual Informative Focus Group Interviews and Safe In -person Interviews. In both, the goals are to: (a) examine the level of awareness and understanding of COVID; (b) identify barriers/ facilitators for participation in COVID-19 research studies; and (c) identify appropriate strategy, content, channel and source(s) to provide community education and enhance participation in COVID-19 research studies. These activities will then be followed by two virtual Town Hall Meetings, which will be held to validate the themes identified from the focus group sessions and interviews. Based on these findings, the team will then develop a communication strategy plan to reach Black populations for participation in COVID research studies. In addition, through non-NIH funds we will also begin to develop a COVID Community Research Registry that will promote and -facilitate the recruitment and retention of diverse racial and ethnic populations in COVID intervention studies. C.5.4. Project #4: (Health Choice Network: Long): Based in Florida, Health Choice Network (HCN) HCN.is one of the nation's largest networks of Federally Qualified Health Centers (FQHCs) and includes 21 FQHCs in Florida covering 721,109 persons. HCN has been a longtime collaborator with both UM and FIU in numerous health disparities focused research projects. In this project, the goalis not only to address to COVID disparities but also ensuring that patient populations are adequately represented in COVID research studies, particularly vaccine trials. Health Center leaders have already been in conversations with HRSA about having FQHCs participate in COVID vaccine trials. In fact, when queried by HRSA, six. Chief Medical Officers from our Miami Based FQHCs expressed interest in supporting such work (Community Health of South Florida, Jessie Trice Community Health Services, Miami Beach Community Health Center, Borinquen Health Care Center, Care Resource, and Camillus Health Concern). In Project #4, we propose to examine the barriers/ facilitators that may exists among our patients for participation in COVID research studies and as well as the information and misunderstanding which may exist. We also seek to examine what are the,perceptions among providers about having their patients participate in such studies. We propose to conduct both key informant interviews and three virtual focus groups (8-10 per focus groups) with patients and providers (separately) in three of our South Florida FQHCs. The information we obtain from the focus groups and interviews will then be used to develop outreach and recruitment materials in support of Project #6. In that project, HCN will promote and facilitate the participation of patients from South Florida based FQHCs into the COVID vaccine studies being conducted at the University of Miami and other sites conducting such studies. C.5.5. Project #5: (Moffitt: Vadaparampil): The Moffitt Cancer. Center dissemination activities in FL-CEAL will focus on western portions of the state particularly in Tampa/St. Petersburg/Clearwater, an area where 30% of .the state's population resides. At present, Moffitt is participating in various COVID therapeutic trials, including a, community -based study to establish antibody prevalence in a sample of 1,200 residents and an ongoing multi -institutional study examining the impact of COVID-19 on patients and caregivers among 30,000 patients enrolled in Moffitt's research registry. For this project, Moffitt will focus on barriers/facilitators to participation in COVID research ranging from observational studies to -vaccines trials currently being offered or planned in the area, of West Central Florida, a 15-county area served by the center. The project seeks to gain an in-depth understanding of these issues among our most vulnerable populations. We will work with two community clinics (University of South Florida Bridge Clinic and Turley Health Center) that provide care to uninsured populations in our catchment area. Leveraging our expertise assessing patient and provider barriers OMB No. 0925-0001/0002 (Rev. 03/2020 Approved Through 02/28/2023) Page 7 Continuation Format Page Program Director/Principal Investigator (Last, First. Middle): Carrasquillo, Olveen to vaccination and vaccine hesitancy,43,44 we will use video -based interviews with 5 providers and 20 patients from each site. Our approach will allow us to identify areas of commonality and those that are unique between patients and health care providers. Importantly, we will leverage our well -established Community Advisory Board (CAB) that includes 27 community partners representing diverse organizations ranging from health care to faith -based groups.45 The CAB will advise on interview guide development, recruitmentstrategies, review of findings, and design of messaging and outreach strategies to increase community participation in COVID research. This understanding is critical when seeking to engage community members in research through settings where they routinely receive care. Upon completion of interviews information will be summarized and shared with our CAB, researchers, and our clinical partners to design community engaged recruitment approaches for planned and ongoing COVID-related research. The information will also be used to train our community outreach team to address questions regarding COVID research as they deliver education on a variety of topics across multiple venues (e.g., churches, senior centers). C.6. Overview of Aim #3: Implement and evaluate the impact of strategies that increase the enrollment of minorities into COVID vaccine and therapeutic trials. This aim will involve Florida's two largest research -intensive universities (UM and UF) who will carry out two projects specifically designed to enhance the inclusion of minorities into ongoing large scale COVID vaccine: and therapeutic trials at both universities. Activities for the two projects under this aim will begin during the first month of the study and continue until the selectedstudies are completed (enrollment likely in 6 months, but retention will be ongoing). Both projects will benefit from the findings being generated in Aim #1 during the first three months of the study and also from the ongoing community -based COVID educational campaigns under Aim #2,'which will begin in month four. C.6.1. Project #6: Recruitment of minorities in COVID vaccine trails (UM, Carrasquillo. Kobetz) UM's IRB has approved over 200 COVID-related research protocols.46 Last month, UM was selected to serve as the national launch site for the Moderna vaccine trial.47 For that study, UM will recruit 1,000 participants. Last week, we also received word that UM was approved to be one of the initial sites for the Janssen COVID vaccine study (VAC31518COV3001, ENSEMBLE). As site co -PI, Dr. Carrasquillo will be responsible for the recruitment of 2,000 participants from UM. In addition, through the ACTIV.network48 UM is also negotiating to be part of other COVID vaccine trials. This presents a unique opportunity forFL-CEAL to play a lead role in ensuring adequate representation of minorities in these vaccine trials. The primary approach to recruitment in these trials is through existing national registries developed by groups and intermediaries such as contract research organizations (CROs). To enhance that effort, we are also going to use UM's local research registry. This registry has patients from our health system (UHealth) whom have agreed to be contacted for potential research projects they may be eligible for. The registry includes over 120,000 persons. While use of electronic research registries is an important and efficient strategy for recruitment, one concern is that such an approach may not be the most appropriate to maximize minority participation in research. In Project #6, we will test the hypothesis that more community -based and informed approaches would result in an increase in the proportion of minorities we are able to recruit into our vaccine studies. The proposed intervention will be through Community Health Workers (CHWs). Our team has a Tong -term record in using CHWs in various disparities focused research projects such as diabetes,49 cancer,50,51 stroke,52 and HIV.53 Similar to others,54 in our studies CHWs have been able to develop innovative approaches to effectively address barriers such as language fluency, health/numeracy literacy, cultural norms and preferences, and employ more family centered engagement approaches. With PCORI support we have led statewide55 and national projects56 on CHW research training. This month we were notified that PCORI has also approved our proposal to enhance our CHW training with additional content specific to COVID. In Project #6, the recruitment approach we will use is similar to prior studies in which we have successfully recruited large numbers of minorities, where CHWs conduct outreach and engagement in community -based venues in high foot traffic areas (in the COVID-era using appropriate precautions and protective equipment). This includes tabling in strategically located in. areas. After individuals are engaged, if interested they complete contact cards which CHWS enter into a REDCAP database. Information collected includes name, phone, email, and best time to contact. Then, research staff follow-up with phone calls to provide more information about the study, screening for eligibility and potentially scheduling a study intake appointment. CHWs also do flyer distribution and when allowed temporary place posters and banners in high traffic community -based locations, OMB No. 0925-0001/0002 (Rev. 03/2020 Approved Through 02/28/2023) Page 8 Continuation Format Page Program Director/Principal Investigator (Last, First, Middle):. Carrasquillo, Olveen including businesses such as ethnic supermarkets, local grocery stores, barbershops and hair styling salons. For the project, two UM CHWs (one Latinx, one Haitian) would devote one day per week to this activity. In addition, we will also deploy CHWs from partnering community -based organizations (CBOs). The main partner will be HCN (see project #4) who will be supporting CHWs at three FQHCs. We will also issue smaller contracts to two other CBOs. One is the Miami -Dade -Area Health Education Center (MD-AHEC) whose mission is to improve access to quality, comprehensive health care and education for the underserved, uninsured, economically needy and other vulnerable individuals through academic -community partnerships. The MD-AHEC has been training and developing programs for educating CHWs who can be deployed in health care settings with the knowledge and expertise to engage patients in community -based settings and as an adjunct to clinical. care. Another is the Health Council of South Florida (HCSF), one of eleven local health councils created by the state and whose goals include health promotion and reducing_ health disparities in Miami -Dade and Monroe,counties. (Dr. Carrasquillo volunteers on the board of both non-profit CBOs). C.6.2. Project: #7: Ensure robust participation. of minorities in, two COVID trials (UF, Shenkman) The University of Florida is the coordinating center for the OneFlorida Clinical Research Consortium57— one of nine Patient Centered Outcomes Research Institute (PCORI)- funded networks nationally. OneFlorida is comprised of 12 health systems throughout Florida, including a key partnership. with the University of Miami. OneFlorida has a centralized Data Trust that contains electronic health record information for over 15M Floridians spanning from 2012 to the present and is refreshed quarterly. The Data Trust uses an honest broker system so that patients can be re -identified and contacted, for participation in interventional trials as well as studies focused on building trust in the community. OneFlorida has already approved 39 clinical protocols for use throughout the network. In Project #7, we will examine whether enhanced recruitment methods can help maximize the proportion of minorities and rural populations recruited and retained in two major COVID studies in the network. The first study, funded by NIAID, is the Immunophenotyping Assessment in a COVID Cohort (IMPACC). A growing body of literature suggests that in terms of direct pathogenic events that lead to deleterious outcomes in persons with COVID infections, two events (i.e., thrombosis58 and cytokine .storm59) appear key to adverse morbidity and mortality. We plan to enroll 100 hospitalized patients with COVID fromthree distinct geographic sites across the state, with UF serving as the coordinating center and hub. We are collecting and distributing samples to the consortium's core laboratories to support IMPACC's efforts for immunophenotyping sera, peripheral blood mononuclear cells (PBMCs). The follow-up period is 12. months and during that time direct contact via telephone and text messaging will be used. We are focused on enrolling a diverse representation of patients. Recruitment sites include UF Health in Jacksonville serving a predominantly urban African -American population, UF Health Gainesville, serving a predominantly rural population and Tampa General Hospital with a large African -American Population. For Project #7, we will examine whether using. direct outreach for targeted minority recruitment using face-to-face recruitment from the hospital can help increase the proportion of minorities. In addition, whether a mobile van can help ensure that individuals in rural areas and those in the urban areas with transportation barriers are retained in the study. The second study is a study funded by the ACTIV network- the ACTIV-IV trial. The ACTIV-IV Outpatient Project is addressing the question of reducing thromboembolic events in symptomatic COVID patientsnot admitted to the hospital butwho have high risk features (age =/>40 years, elevated. D-Dimer, and hsCRP >10). The trial will recruit potential participantsfrom the ED and outpatient clinics with serologically confirmed with COVID but whom do not require hospitalization. They will .be randomized in a 1:1:1:1 fashion to either ASA, apixaban 2.5 mg bid, apixaban 5.0 rng bid or placebo for 45 days. (Apixaban is provided). The primary endpoint is the occurrence of symptomatic deep venous thrombosis, pulmonary embolism, arterial HEALTH CARE SYSTEMS & AFFILIATED PRACTICES • University of Fonda and OF Health • Florida State University and Regional Campus Practice Partners • University of Miami and UHealth • Orlando Health System. • AdventHealth a Tallahassee Memorial Healthcare • Tampa General Hospital a Bond Community Health Center Inc • Nicklaus Children's Hospital Communi yHealth lT • Capital Health Plan • University of south Florida and USF Health STATE AGENCY & ORGANIZATION COLLABORATIONS Florida Agency for Health Care Administration Florida Department of Health ff OMB No. 0925-0001/0002 (Rev. 03/2020 Approved Through 02/28/2023) Page 9 Continuation Format Page Program Director/Principal Investigator (Last, First, Middle): Carrasquillo, Olveen thromboembolism, myocardial infarction, ischemic stroke, need for hospitalization for cardiovascular/pulmonary events, or all -cause death within 45 days after initiation of assigned treatment. We are using the OneFlorida Clinical Research Consortium and other hospitals around the state to enroll 7,000 participants. Already, multiple strategies are being used to recruit patients from the ED and outpatient clinics. One example, is using the OneFlorida Data Trust to locate patients meeting the ACTIV-IV study criteria and contact individuals using our honest broker system. OneFlorida has a special CVOVID-19 registry that is refreshed every two weeks and will also be a key component for this trial; another is a Facebook campaign. For Project #7, we are engaging diverse communities in partnership with Community Health IT — a group of FQHCs and other safety net providers, the Bond Clinic and its partnership with community agencies throughout the Big Bend region, which is a rural area with predominately lower income African -American and non -Hispanic White individuals. The approach will use CHWs located at the clinics whom will discuss the study with the patient (after the physician agrees refers the patient). We will evaluate whether the latter, more community -engaged approachleads to an increased proportion of minority populations who participate in the study versus the registry and social media approaches. Lastly, for both the IMPACC study and the COVID-IV Outpatient trial, we will also consent patients to be part of a OneFlorida Data Trust COVID registry. The projects will also be presented for input to the OF CTSA Community Advisory Board. C.7. Project organization and management: As agreed byall partners, UM will serve as the coordinating institution in this application. Project management will come from support from the UM CTSI. This includes. coordination of meetings among all project leaders and managing the project Listservs and other digital communication. Meetings of the project leaders will occur every two weeks in the first two months and monthly thereafter. Monthly reporting to the NIH will also be coordinated by. UM. UM will also be responsible for coordinating FL-CEAL's two advisory boards. The scientific advisory board (SAB) will be composed of five physicians and clinical researchers, from the five lead academic institutions, whom are not involved in the project. They will provide scientific and clinical oversight and also be available as a resource for any clinical questions or areas of uncertainly related to COVID and COVID. research. Examples from UM would be Maria Alcaide, MD, an infectious disease specialist and director of UM's infectious disease research unit. In addition,. while eachproject will have their own. Community Advisory Board (CAB), we will also have a FL-CEAL CAB composed of five community representatives, nominated by each of the partnering institutions. Their role will be to help provide an additional layer of'external feedback, input and oversight by community representatives not involved in the project. One example is Mr. Emmanuel Washington, a health counselor and leading health advocate in Miami's historically black neighborhood of Overtown. He has been instrumental in helping us design culturally tailored approaches to recruit black men into various UM -led research projects. We will invite the Florida Department of Health select representatives to participate in in FL-CEAL CAB and SAB. C7.1. Project Evaluation: The evaluation of the FL-CEAL will be led by the UM CTSI evaluation team ledby a Sr. Project Manager with support from a Project Manager, with direct oversight from the CTSI Executive Director, Strategic Operations. For project evaluation we will use a General Systems Approach.6° This evaluative methodology uses a dynamic process thatinvolves continuous communication in feedback loops between stakeholders. This iterative process includes tracking and reporting indicators related to the FL-CEAL milestones, measuring performance on an ongoing basis, and strengthening areas found underperformingor needing improvement. As needed, the evaluation team will provide support for each team in further refining their milestone -driven metrics, designing rapid assessment surveys, and tracking the impact of the program. C.7.2. Budget: We are requesting $1 million in total costs cost to support this project. Based on each institutions' F&A rate, this is approximately $622K in direct costs. Given the:Center's geographic focus, 65% of directs costs will be for work done. in South Florida. As outlined above, each project will also engage with community partners and CBOs. Each group will develop their own sub -agreements with the community partners they will be working with. One example are the agreements UM will be making with Health Choice Network (FQHCs), HCSF and MD-AHEC (see project #6), which at $105,000 accounts for 39% of UM's total costs of $427,000. The attached budget also provides an overview of major sources of program costs at each institution and :support to FL-CEAL from non--NIH sources. OMB No. 0925-0001/0002 (Rev. 03/2020 Approved Through 02/28/2023) Page 1 0 Continuation Format Page Program Director/Principal Investigator (Last, First, Middle): Carrasquillo, Olveen References 1 Population Estimates, American Community Survey, US Census Bureau. Census of Population and Housing. 2 Taylor N. Florida's under-70 population now majority -minority. Tampa Bay Times. June 20, 2019 3 U.S. Census Bureau; Population Projections, July 1,. 2010 to July 1, 2050. 4 U.S. Census Bureau (2018). American Community Survey 1-year estimates. Retrieved from Census Reporter Profile page for Miami -Dade County, FL <http://censusreporter.org/profiles/05000US12086-miami-dade- county-fl/> 5 Health Equity Profile: 2019. Florida Department of Health. https//www.flhealthcharts.com/ChartsReports/rdPage.aspx?rdReport=ChartsProfiles.HealthEquityMergeMHPro file 6 Uninsured Rates for the Nonelderly by Race/Ethnicity. State Health Facts. Kaiser Family Foundation estimates based on the 2008-2018 American Community Survey, 1-Year Estimates. 7 World Health Organization Coronavirus Disease (COVID,) Dashboard. https://covid19.who.int/ 8 US Centers for Disease Control. CDC COVID Data Tracker. https://www.cdc.govlcovid-data-tracker)#cases 9 Mascarenhas L, Yan H, Almasy S. COVID is now the No. 3 cause of death in the US. CNN Health. August 17, 2020. 90 Moshtaghian A. Miami is now the epicenter of the pandemic. CNN July 23, 2020. https://www. cnn.comlworld/live-news/coronavirus-pandemic-07-13-20- intl/h 919.7fd7b238b6e332da8bcbcab 170454 11 Price-Haygood EG,- Burton J, Fort D, Seoane L. Hospitalization and Mortality among Black'Patients and White Patients with COVID. N Engl J Med 2020._ DOI: https://doi.org/10.1056/nejmsa2011686external icon. 12 Stokes EK, Zambrano LD, Anderson KN, et al. Coronavirus Disease 2019 Case Surveillance —United States, January 22—May 30, 2020. MMWR Morb Mortal Wkly Rep 2020;69:759-765. DOI: http://dx.doi.org/10.15585/mmwr.mm6924e2external icon. 13 https://www.cdc.gov/coronavirus/2019-ncov/downloads/covid-data/hospitalization-death-by-race-ethnicity.pdf 14 The COVID Racial Tracker. https://covidtrackinq.com/race 15 Moore JT, Ricaldi JN, Rose CE, et al. Disparities in Incidence of COVID Among Underrepresented Racial/Ethnic Groups in Counties Identified as HotspotsDuring June 5-18, 2020 — 22 States, February —June 2020. MMWR Morb Mortal Wkly Rep 2020;69:1122-1126. 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August 2004. 21 Minkler M, Wallerstein N. Community -based participatory research for health: From process to outcomes. John Wiley & Sons; 2011. 22 July 10, 2020: NHLBI COVID Community -Engaged Research Roundtable & July 21, 2020: NIH Community Engagement Forum: A Call' to Action 2° Cohen C,. Vigue D. COVID vaccine trials have been slow to recruit Black and Latino people — and that could delay a vaccine CNN. Sun August 16, '2020: https://www.cnn.com/2020/08/16/health/COVID-vaccine-trial-black-minority- recru itment/i n d ex. htm l 24 Cohen E. First COVID vaccine trial moving at a good clip, but officials still "very concerned" CNN August.18, 2020.. hftps://www.cnn.com/2020/08/18/health/vaccine-trial-progress-moderna-volunteers/index.html OMB No. 0925-0001/0002 (Rev. 03/2020 Approved Through 02/28/2023) Page 11 Continuation Format Page Program Director/Principal Investigator (Last, First, Middle): Carrasquillo, Olveen zs Duma N, Vera Aguilera J, Paludo J, et al: Representation of Minorities and Women in Oncology Clinical Trials: Review of the Past 14 Years.. J Oncol Pract. 14:e1-e10,2018. 26 Ceron C, Vilcant V, Zeltser R, Makaryus A. Minority Representation n Cardiovascular Clinical Trials. J Am Coll Cardiol. 2019 Mar, 73 (9 Supplement 1) 3045. 27 Brown DL You've got bad blood: The horror of the Tuskegee syphilis experiment. Washington Post. May 16, 2017 28 George S, Duran N, Norris K. A Systematic Review of Barriers and Facilitators to Minority Research Participation Among African Americans, Latinos, Asian Americans, and Pacific Islanders. Am J Public Health. 2014 February; 104(2): e16-e31. 28 Declining number of Americans would take COVID vaccine; Result CNN Poll. Aug 19, 2020. https://www.cnn.com/videos/tv/2020/08/19/lead-dr-offit-live-iake-tapper.cnn 3o Ford JG, Howerton MW, Bolen S, et al. Knowledge and Access to Information. on Recruitment of Underrepresented Populations to Cancer Clinical Trials. Evidence Report/Technology Assessment No. 122 (Prepared by the Johns Hopkins University Evidence based Practice Center under Contract No. '290-02-0018.) AHRQ Publication No. 05-E019-2. Rockville, MD: Agency for Healthcare Research and Quality. June 2005. 31 All of Us Research Program Investigators. Th.e All of Us Research Program. The New England Journal of Medicine. 2019 August 15; 381(7):668-676. doi: 10.1056/NEJMsr1809937. 32 Kobetz E, Menard J, Diem J, et al. Community -based participatory research in Little Haiti: challenges and lessons learned.. Progress in Community Health Partnerships: Research, Education, and Action. 2009;3(2):133-137. 33 Kobetz E. How Sylvester's cancer outreach is used to monitor COVID in Miami -Dade. The Cancer Letter may 22, 2020. https://cancerletter.com/articles/20200522_4/ 34 FAMU to continue COVID test site indefinitely. WTXL News/ Tallahassee. June 15. 2020. https://www.wtxl.com/news/local-news/fa mu-to-continue-COVI D-test-site-indefinitely 35 Curry LA, Nembhard IM, Bradley EH. Qualitative and mixed methods provide unique contributions to outcomes research. Circulation. 2009;119(10):1442-1452. 36 Taylor B, Henshall C, Kenyon S, Litchfield I, Greenfield S. Can rapid approaches to qualitative analysis deliver timely, valid findings to clinical leaders? A mixed methods study comparing rapid and thematic analysis. BMJ Open. 2018;8(10):e019993. Published 2018 Oct 8. doi:10.1136/bmjopen-2017-019993 37 Johnson GA, Vindrola-Padros C. Rapid qualitative research methods during complex health emergencies: a. systematic review of the literature. Soc Sci Med 2017;189:63-75. 10.1016/j.socscimed.2017.07.029 38 Johnson RL, Morgan GB. Survey Scales: A Guide to Development, Analysis, and Reporting. Gulford Press New York, 2016 38 NIH COVID Communities Responding Together. List of downloadable resources available at: https://covid 19communitv.n ih.govl 4° NIH Corona Virus Prevention Network. https://coronaviruspreventionnetwork.org/ 41 COVID 19-Resources. Florida Department of Health. https://floridahealthcovidl9.gov/resources/ 42 Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE -AIM framework. American journal of public health. 1999;89(9):1322-1327. 43 Lake P, Kasting ML, Malo T, Giuliano AR, Vadaparampil ST. An environmental scan to examine stakeholder perspectives on human papillomavirus vaccination: A mixed methods study. Vaccine. 2019;37(1):187-194. doi:10.1016/j.vaccine.2018.06.073 44 Vadaparampil ST, Murphy D, Rodriguez M, Malo TL, Quinn GP. Qualitative responses to a national physician survey on HPV vaccination. Vaccine. 2013;31(18):2267-2272. doi:10.1016/j.vaccine.201.3.02.063 45 Gwede CK, Menard JM, Martinez -Tyson D, et al. Strategies for assessing community challenges and strengths for cancer disparities participatory research and .outreach. Health Promot Pract. 2010;11(6):876-887. doi: 10.1177/1524839909335803 46 List of approved and upcoming COVID-19 related studies. List developed by UM CTSI http://www.miamictsi.orq/coronavirus and https://miamiedu.sharepoint.com/:x:/s/MiamiCTSI/EToQNgzo- zhKiU1 u1 OCfl/mwBrHLXau8SvtGDH9sZ8L76mA?e=rCsnGa cited August 23, 2020 47 Vice President Pence Visits UM to Highlight Launch of Phase 3 COVID-19 Clinical Trial. July 28, 2020. https://physician-news.umiamiihealth.org/vice-president-pence-visits-um-to-hiohlight-launch-of-phase-3-covid- 19-clinical-trial/ OMB No. 0925-0001/0002 (Rev. 03/2020 Approved Through 02/28/2023) Page 12 Continuation Format Page Program Director/Principal Investigator (Last, First, Middle): Carrasquillo, Olveen 48 Collins FS, Stoffels P. Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) An Unprecedented Partnership for Unprecedented Times. AMA. 2020;323(24):2455-2457. doi:10.1001 /jama.2020.8920 49 Carrasquillo 0, Lebron C, Alonzo Y. Li.H, Chang A, Kenya S. A Randomized Trial of a Community Health. Worker Intervention among Latinos with Poorly Controlled Diabetes: The Miami Healthy Heart Initiative. JAMA Int Med 2017;77(7):948-954. 5o Carrasquillo 0, Seay J, Amofah A, Pierre L, Alonzo Y, McCann S, Gonzalez M, Trevil D, Koru-Sengul T, Kobetz E. HPV Self -Sampling for Cervical Cancer Screening Among Ethnic Minority Women in South Florida: a Randomized Trial. J Gen Intern Med. 2018 Jul; 33(7):1077-1083. 51 Kobetz E, Seay J, Koru-Sengul T, Bispo JB, Trevil D, Gonzalez M, Brickman A, Carrasquillo O. A randomized trial of mailed HPV self -sampling for cervical cancer screening among ethnic minority women in South Florida. Cancer Causes Control. 2018 Jul 11.. doi: 10.1007/s10552-018-1055-7. [Epub ahead of print] PMID:29995217 52 Carrasquillo 0, Young B„ Dang S, Fontan 0, Ferras N, Romano JG, Dong C, Kenya S. Hispanic Secondary Stroke Prevention Initiative Design: Study Protocol and Rationale for a Randomized Controlled Trial. JMIR research protocols. 2018 Oct 19;7(10):e11083. doi: 10.2196/11083. 53 Kenya S, Jones J, Arheart K, Chida N„ Baer R, Powell A, Symes. S, Hunte T, Monroe A, Kobetz E. Carraquillo O. Using Community Health Workers to Improve Clinical Outcomes among People Living with HIV: A Randomized Controlled Trial. AIDS and Behavior. 2013 Nov;17(9):2927-34. PMID: 23515640 54 Landers S, Levinson M. Mounting Evidence of the Effectiveness and Versatility of Community Health Workers.", Am J Pub Health 2016: 106(4), pp. 591-592. 55 PCORI Research Results. Statewide Partnership for Training Florida's Community Health Workers in Patient -Centered Research. https://www.pcori.org/research-results/2015/statewide-partnership-training- floridas-community-health-workers-patient. Cited April 15, 2020 ss PCORI Research Results. National Partnership for Training Florida's Community Health Workers in Patient - Centered Research https://www.pcori.org/research-results/2017/national-partnership-training-community- health-workers-patient-centered, Cited April 30, 2020 57 Shenkman E, Hurt M, Hogan W, Carrasquillo 0, Smith .S, Brickman A, Nelson D. OneFlorida Clinical Research Consortium: Linking a Clinical and Translational Science Institute With a Community -Based. Distributive Medical Education Model. Acad Med. 2018 Mar;93(3):451-455. doi: 10.1097/ 58 Ackermann M et al. Pulmonary Vascular Endothelialitis, Thrombosis, and Angiogenesis in Covid-19. N Engl J Med 2020; 383:120-128 59 Wu C, Chen X, Cai Y, et al. Risk factors associated with acute respiratory distress syndromeand death in patients with coronavirus disease 2019 pneumonia in Wuhan, China. JAMA Intern Med. 2020;180(7):934-943. s° Hummelbrunner, R. (2011). Systems thinking and evaluation. Evaluation, 17(4), 395-403. doi: 10.1177/1356389011421935 OMB No. 0925-0001/0002 (Rev. 03/2020 Approved Through 02/28/2023) Page 13 Continuation Format Page ATTEST: 41110111111... Todd B. Ha NW City Clerk APPROVED AS TO FORM AND CORRECTNESS By: 5aildLG.6 L. 71/14,1- e/i/d Victoria MfliSdez City Attorney (21-601 —JCP) THE CITY OF MIAMI, a municipal Corporation of the State of Florida By: Arthur Nie:a City Manager APPROVED AS TO INSURANCE REQUIREMENTS By: Ann -Marie Sharpe, Director Department of Risk Management Counterparts and Electronic Signatures. This Agreement may be executed in any number of counterparts, each of which so executed shall be deemed to be an original, and such counterparts shall together constitute but one and the same Agreement. The parties shall be entitled to sign and transmit an electronic signature of this Agreement (whether by facsimile, PDF or other email transmission), which signature shall be binding on the party whose name is contained therein. Any party providing an electronic signature agrees to promptly execute and deliver to the other parties an original signed Agreement upon request.