All of Us Participant Perspectives on the Return of Value in Research.

PURPOSE: To understand participant preferences for receiving specific types of research information, whether information preferences vary across sociodemographic groups, and the types of health providers participants could access to understand returned information. METHODS: All of Us Research Program participants completed a value of returning research information survey. Stratified sampling was implemented to enhance participant diversity and avoid non-coverage. We used weighted multivariable logistic regression to evaluate associations between the most valuable information types, access to providers, and sociodemographic variables. RESULTS: Participants (N=20,405) were diverse in their race/ethnicity (e.g., 52% were White, 18% were Hispanic/Latino or Spanish, 3% were Asian, and 20% were Black or African American). Most participants (78.6%) valued information about their risk of serious genetic diseases with available treatment. Primary care physicians, specialists, and genetic counselors were the top providers that participants could access for help understanding returned information. Information preferences and provider access varied across sociodemographic groups. For example, as income levels increased, the odds of placing value on genetic results indicating risk of serious disease with available treatment increased when compared to the lowest income levels (p-value<0.001). CONCLUSION: Although genetic information was most valuable to participants, preferences about specific information types varied across sociodemographic groups.

Expanding Outcomes in Cancer Screening Safety Net Programs: Promoting Sustainability and Policy Reform.

Community-engaged patient navigation safety net programs are established as an evidence-based approach to address cancer prevention and early detection efforts, but barriers to expand and sustain such programs persist. In addition, few studies describe how these programs impact buy-in among communities and policy change within health care systems and government. We describe how we used the Capacity for Sustainability Framework to guide efforts for program sustainability and community, institutional, and policy level change in a breast cancer screening and patient navigation safety net program. The nine domains of the Capacity for Sustainability Framework were used to develop program logic models, to inform program implementation and quality improvement agendas, and to guide multi-level partner and stakeholder engagement, outreach, and dissemination of outcomes. The program is currently in its seventh year and continues to be annually funded by a city public health department. In 2021, additional 5-year renewable funding from a state public health department was secured. In addition, institutional program support was expanded for patients diagnosed with breast cancer. Program leaders worked with policymakers to draft legislation to support training certification and third-payor reimbursement for patient navigators and community health workers. The program is well-known and trusted among community members, community-based organizations, and providers. Community, organizational, and policy-level outcomes demonstrate that community-engaged patient navigation safety net programs can influence more than individual and interpersonal outcomes and can be sustained over time.

Bridging the Gap: Engaging Black Men in Lung Cancer Research Through Barbershop Collaboration.

Health disparities persist among Black men, notably in the context of lung cancer and stress-related health outcomes. This study explores these disparities through a community-based participatory research (CBPR) approach, citizen science, and social network theory, leveraging the expertise and trust of Black barbers as community leaders. The purpose is to understand the nuanced connections between stress and lung cancer in this demographic. Engaging 161 Black men across four Chicago neighborhoods, the study successfully collected hair samples and survey data, emphasizing the importance of culturally sensitive recruitment strategies. Findings highlight the effectiveness of the collaboration, showcasing the role of barbershops as community hubs for research. The study concludes by advocating for sustained partnerships with community leaders, emphasizing transparency in research communication, and promoting culturally grounded approaches to address health disparities and enhance research participation among underrepresented populations.

Integrating participants as partners in research governance and operations: an approach from the All of Us Research Program Engagement Core.

OBJECTIVES: During the last two decades, researchers and funders increasingly recognised the value of engaging patients and communities in research. Despite progress, community engagement remains challenging. There are few examples of successful participant engagement in governance of large-scale research programmes. Here we describe efforts to engage participants as partners in new governance roles in the All of Us Research Program, a precision medicine research initiative which intends to enrol at least one million participants. Using intentional, participant-centric engagement strategies, the All of Us Engagement Core recruited and integrated a diverse group of participants into governance roles including Steering and Executive Committees. Evaluation measures included a survey to assess Consortium Members' readiness for participant engagement. RESULTS: Over a 3-year period, all items on the survey increased (higher readiness). Of the 291 respondents to the 2021 survey, respondents most frequently agreed that participant perspectives are essential (100%), participants understand enough to contribute meaningfully (94%) and participants should be involved in setting goals (96%). Respondents least frequently agreed that participants should have an equal voice in Working Groups (75%), Steering Committee (69%) and Executive Committee (63%). CONCLUSION: In conclusion, participants can be effectively integrated into large-scale research governance, which is associated with increased researcher readiness for engagement.

Mi-CARE: Comparing Three Evidence-Based Interventions to Promote Colorectal Cancer Screening among Ethnic Minorities within Three Different Clinical Contexts.

Multiple evidence-based interventions (EBIs) have been developed to improve the completion of colorectal cancer (CRC) screening within Federally Qualified Health Centers (FQHCs) and other safety net settings in marginalized communities. Little effort has been made, however, to evaluate their relative effectiveness across different clinical contexts and populations. To this end, we tested the relative effectiveness of three EBIs (mailed birthday cards, lay navigation, and provider-delivered education) among a convenience sample of 1252 patients (aged 50-75 years old, who were due for CRC screening and scheduled for a visit at one of three clinics within a network of Federally Qualified Health Centers (FQHCs) in the United States. To be eligible for the study, patients had to identify as African American (AA) or Latino American (LA). We compared the effects of the three EBIs on CRC screening completion using logistic regression. Overall, 20% of the study population, an increase from a baseline of 13%, completed CRC screening. Clinical demographics appeared to influence the effectiveness of the EBIs. Mailed birthday reminders appeared to be the most effective within the multi-ethnic clinic (p = 0.03), provider-delivered education within the predominantly LA clinic (p = 0.02), and lay navigation within the predominantly AA clinic (p = 0.03). These findings highlight the importance of understanding clinical context when selecting which evidence-based interventions to deploy.

Community-Driven Conversations: Partnership Building through CHEC-Ins.

BACKGROUND: Chicago's systemically underserved communities have disproportionately high cancer rates. The Chicago Cancer Health Equity Collaborative (ChicagoCHEC) brings together academic and community partners to address these health inequities. The community conversations known as "CHEC-Ins" provide a space for community members to voice their experiences and needs and for ChicagoCHEC to fulfill its commitment to advancing health equity through collaboration and action. OBJECTIVE: This paper presents a community-generated approach to social networking about cancer health issues known as CHEC-Ins. Through this innovative approach, community members and organizations share cancer related information and experiences, as well as needs and concerns, which are then channeled to ChicagoCHEC academic and administrative members who incorporate them into outreach and research activities. In this way, community members set the agenda and the process and collect the information they deem relevant and important. This paper describes the process of organizing and conducting two pilot CHEC-Ins and the model of this approach, which we intend to employ moving forward to advance partnership building and collaborative research practice between academic institutions and community partners and organizations. This paper contributes a unique model of community-generated and led outreach as a cornerstone of the ChicagoCHEC approach to community engagement. METHODS: The leaders of the ChicagoCHEC Community Steering Committee spearheaded the design and implementation of CHEC-Ins, including developing the question guide and hosting events within their organizations. LESSONS LEARNED: CHEC-Ins proved to be a valuable strategy for defining the role of community partners and establishing the basis for a bi-directional flow of information, resources, and productive action. The two pilot CHEC-Ins revealed important insights related to sources of cancer information, meanings and associated attitudes, barriers to access and use of health services, and social support systems in the communities where ChicagoCHEC works. We will implement this approach and continue to refine it as we conduct CHECIns moving forward.

The Integration of Value Assessment and Social Network Methods for Breast Health Navigation Among African Americans.

OBJECTIVES: A major strategy to reduce the impact of breast cancer (BC) among African Americans (AA) is patient navigation, defined here as individualized assistance for reducing barriers to healthcare use. The primary focus of this study was to estimate the added value of incorporating breast health promotion by navigated participants and the subsequent BC screenings that network members may obtain. METHODS: In this study, we compared the cost-effectiveness of navigation across 2 scenarios. First, we examine the effect of navigation on AA participants (scenario 1). Second, we examine the effect of navigation on AA participants and their networks (scenario 2). We leverage data from multiple studies in South Chicago. Our primary outcome (BC screening) is intermediate, given limited available quantitative data on the long-term benefits of BC screening for AA populations. RESULTS: When considering participant effects alone (scenario 1), the incremental cost-effectiveness ratio was $3845 per additional screening mammogram. When including participant and network effects (scenario 2), the incremental cost-effectiveness ratio was $1098 per additional screening mammogram. CONCLUSION: Our findings suggest that inclusion of network effects can contribute to a more precise, comprehensive assessment of interventions for underserved communities.

Associations in Cigarette Smoking and Health Conditions by Race/Ethnicity Among a Diverse Sample of Patients Receiving Treatment in a Federally Qualified Health Care Setting in Chicago.

Purpose: To examine the association of cigarette use and smoking-related health conditions by race/ethnicity among diverse and low-income patients at a federally qualified health center (FQHC). Methods: Demographics, smoking status, health conditions, death, and health service use were extracted from electronic medical data for patients seen between September 1, 2018, and August 31, 2020 (n=51,670). Smoking categories included everyday/heavy smoker, someday/light smoker, former smoker, or never smoker. Results: Current and former smoking rates were 20.1% and 15.2%, respectively. Males, Black, White, non-partnered, older, and Medicaid/Medicare patients were more likely to smoke. Compared with never smokers, former and heavy smokers had higher odds for all health conditions except respiratory failure, and light smokers had higher odds of asthma, chronic obstructive pulmonary disease, emphysema, and peripheral vascular disease. All smoking categories had more emergency department visits and hospitalizations than never smokers. The associations between smoking status and health conditions differed by race/ethnicity. White patients who smoked had a greater increase in odds of stroke and other cardiovascular diseases compared with Hispanic and Black patients. Black patients who smoked had a greater increase in odds of emphysema and respiratory failure compared with Hispanic patients. Black and Hispanic patients who smoked had a greater increase in emergency care use compared with White patients. Conclusion: Smoking was associated with disease burden and emergency care and differed by race/ethnicity. Health Equity Implications: Resources to document smoking status and offer cessation services should be increased in FQHCs to promote health equity for lower income populations.

Innovation in Large-Scale Research Programs: Elevating Research Participants to Governance Roles Through the All of Us Research Program Engagement Core.

PROBLEM: Despite the successes of community-engaged research in advancing research relevance and health equity for diverse communities, the impact of this research has been limited to local and regional programs. Engaging diverse community voices in large-scale, national research programs represents a paradigm shift in biomedical research. Still, disconnects remain between research decision makers and the communities they serve, impeding richer, bidirectional engagement. APPROACH: An engagement core team was established within National Institutes of Health All of Us Research Program (AoURP) in 2018 to synthesize community-engaged research practices and establish infrastructure that operationalizes diverse research participant engagement. The authors integrated research participants as "participant partners" within the AoURP governance, an approach that is embedded into the engagement core's 3 aims: (1) integrate a diverse pool of participants into the program, (2) identify and meaningfully engage a cadre of diverse participants into program governance, and (3) assess the impact of such engagement on research. Participant partners are compensated as consultants at approximately $50/hour. OUTCOMES: As of August 2022, more than 515,000 individuals consented to participate in the AoURP, with more than 49% representing racial/ethnic minorities. The authors invited participants to self-nominate if interested in engaging in research working groups, decision making, and governance. Also, consortium partners nominated individuals on AoURP community advisory and/or participant advisory boards to serve as participant ambassadors. Ten individuals were selected as participant partners for the 2022-2025 term. Eight serve on the steering committee; of those, 4 serve on the executive committee; 2 more serve on the advisory panel. An additional 23 serve as participant ambassadors. NEXT STEPS: The authors continue to increase the number of research participants serving as engaged partners in the program. Engagement approaches will be systematically evaluated with the goal of adoption by other large-scale research programs.

Patient Navigation Can Improve Breast Cancer Outcomes among African American Women in Chicago: Insights from a Modeling Study.

African American (AA) women experience much greater mortality due to breast cancer (BC) than non-Latino Whites (NLW). Clinical patient navigation is an evidence-based strategy used by healthcare institutions to improve AA women's breast cancer outcomes. While empirical research has demonstrated the potential effect of navigation interventions for individuals, the population-level impact of navigation on screening, diagnostic completion, and stage at diagnosis has not been assessed. An agent-based model (ABM), representing 50-74-year-old AA women and parameterized with locally sourced data from Chicago, is developed to simulate screening mammography, diagnostic resolution, and stage at diagnosis of cancer. The ABM simulated three counterfactual scenarios: (1) a control setting without any navigation that represents the "standard of care"; (2) a clinical navigation scenario, where agents receive navigation from hospital-affiliated staff; and (3) a setting with network navigation, where agents receive clinical navigation and/or social network navigation (i.e., receiving support from clinically navigated agents for breast cancer care). In the control setting, the mean population-level screening mammography rate was 46.3% (95% CI: 46.2%, 46.4%), the diagnostic completion rate was 80.2% (95% CI: 79.9%, 80.5%), and the mean early cancer diagnosis rate was 65.9% (95% CI: 65.1%, 66.7%). Simulation results suggest that network navigation may lead up to a 13% increase in screening completion rate, 7.8% increase in diagnostic resolution rate, and a 4.9% increase in early-stage diagnoses at the population-level. Results suggest that systems science methods can be useful in the adoption of clinical and network navigation policies to reduce breast cancer disparities.

The National Heart Lung and Blood Institute Disparities Elimination through Coordinated Interventions to Prevent and Control Heart and Lung Disease Alliance.

OBJECTIVE: To describe the National Heart Lung and Blood Institute (NHLBI) sponsored Disparities Elimination through Coordinated Interventions to Prevent and Control Heart and Lung Disease (DECIPHeR) Alliance to support late-stage implementation research aimed at reducing disparities in communities with high burdens of cardiovascular and/or pulmonary disease. STUDY SETTING: NHBLI funded seven DECIPHeR studies and a Coordinating Center. Projects target high-risk diverse populations including racial and ethnic minorities, urban, rural, and low-income communities, disadvantaged children, and persons with serious mental illness. Two projects address multiple cardiovascular risk factors, three focus on hypertension, one on tobacco use, and one on pediatric asthma. STUDY DESIGN: The initial phase supports planning activities for sustainable uptake of evidence-based interventions in targeted communities. The second phase tests late-stage evidence-based implementation strategies. DATA COLLECTION/EXTRACTION METHODS: Not applicable. PRINCIPAL FINDINGS: We provide an overview of the DECIPHeR Alliance and individual study designs, populations, and settings, implementation strategies, interventions, and outcomes. We describe the Alliance's organizational structure, designed to promote cross-center partnership and collaboration. CONCLUSIONS: The DECIPHeR Alliance represents an ambitious national effort to develop sustainable implementation of interventions to achieve cardiovascular and pulmonary health equity.

Corrigendum: A Study Protocol for Increasing Access to Smoking Cessation Treatments for Low-Income Minority Smokers.

[This corrects the article DOI: 10.3389/fpubh.2021.762784.].

Adapting a conceptual framework to engage diverse stakeholders in genomic/precision medicine research.

INTRODUCTION: Genomic/precision medicine offers a remarkable opportunity to improve health and address health disparities. Genomic medicine is the study of genes and their interaction with health. Precision medicine is an approach to disease prevention and treatment that considers individual variability in genes, environment and lifestyle. Conclusions from studies lacking diversity may hinder generalizability as genomic variation occurs within and between populations. Historical factors, such as medical mistrust, ethical issues related to decision making, and data sharing pose complex challenges that may further widen inequities in genomic/precision medicine if not appropriately addressed. Although few biomedical studies integrate priorities of community partners into their conceptual framework, effective implementation of genomic/precision medicine research calls for the involvement of diverse stakeholders to expand traditional unidirectional models of engagement in clinical research towards authentic bidirectional collaboration. METHODS: A multipronged approach was used integrating an evidence-based literature review and best practices in developing and evaluating the engagement of diverse stakeholders in genomic and precision medicine research. This was combined with expert consensus building to adapt a conceptual model from a community engagement framework to addressing genomics to be scalable to engagement science, which is challenging to genomic/precision medicine research. RESULTS: The final enhanced conceptual framework is composed of four overarching dimensions now inclusive of domains in trust, exploitation, discrimination, privacy risk, stigmatization, prior harms/injustices, failure to recognize coexisting governments, intersectionality and research transformation. This conceptual framework proposes effective participant research engagement strategies for upstream relationship building, distinct from downstream recruitment strategies in which the goal is enrolment. CONCLUSION: To further shape the evolution of genomic/precision medicine research, it is important to leverage existing partnerships, engage participants beyond recruitment and embrace diverse perspectives. PATIENT OR PUBLIC CONTRIBUTION: In preparation of this manuscript, the perspectives of the community partners on the impact of engaging in genomic/precision medicine research beyond research participation were integrated into this conceptual framework from various guided listening sessions held in diverse communities.

Navigated African American breast cancer patients as incidental change agents in their family/friend networks.

BACKGROUND: Patient navigation is an increasingly widespread intervention to address the persistent, severe, and disproportionate breast cancer (BC) burden that African Americans (AA) face. Navigation may have more widespread effects than previously estimated due to patient-driven diffusion of BC information. METHODS: This pilot study examined the network effects of a randomized controlled trial via recruitment of navigated and non-navigated AA BC patients as well as their network members. We estimated study arm differences in patient BC promotion (i.e., number of individuals to whom BC patients promote BC screening) and network BC screening (i.e., % BC screening among network members). RESULTS: Among our sample of 100 AA BC patients, navigated patients promoted BC screening to more individuals than non-navigated patients. BC patients were more likely to promote BC screening to children and individuals with whom they communicated more frequently. Some models further suggested more network BC screening among "navigated" network members relative to "non-navigated" network members. CONCLUSIONS: Navigated AA patients promoted BC screening more widely throughout their networks than non-navigated AA BC patients. There were also suggestive findings regarding increased BC screening among their network members. Our pilot study highlights the potential for social network analysis to improve the precision of intervention effect estimates and to inform future innovations (e.g., integrating navigation and network-based interventions) with multilevel effects on cancer health disparities.

A Study Protocol for Increasing Access to Smoking Cessation Treatments for Low-Income Minority Smokers.

Background: Smoking rates among low-income patients are double those of the general population. Access to health care is an essential social determinant of health. Federally qualified health care centers (FQHC) are government-supported and community-based centers to increase access to health care for non-insured and underinsured patients. However, barriers to implementation impact adherence and sustainability of evidence-based smoking cessation within FQHC settings. To address this implementation barrier, our multi-disciplinary team proposes Mi QUIT CARE (Mile Square QUIT Community-Access-Referral-Expansion) to establish the acceptability, feasibility, and capacity of an FQHC system to deliver an evidence-based and multi-level intervention to increase patient engagement with a state tobacco quitline. Methods: A mixed-method approach, rooted in an implementation science framework of RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance), will be used in this hybrid effectiveness-implementation design. We aim to evaluate the efficacy of a novel delivery system (patient portal) for increasing access to smoking cessation treatment. In preparation for a future randomized clinical trial of Mi QUIT CARE, we will conduct the following developmental research: (1) Examine the burden of tobacco among patient populations served by our partner FQHC, (2) Evaluate among FQHC patients and health care providers, knowledge, attitudes, barriers, and facilitators related to smoking cessation and our intervention components, (3) Evaluate the use of tailored communication strategies and patient navigation to increase patient portal uptake among patients, and (4) To test the acceptability, feasibility, and capacity of the partner FQHC to deliver Mi QUIT CARE. Discussion: This study provides a model for developing and implementing smoking and other health promotion interventions for low-income patients delivered via patient health portals. If successful, the intervention has important implications for addressing a critical social determinant of cancer and other tobacco-related morbidities. Trial Registration: U.S. National Institutes of Health Clinical Trials, NCT04827420, https://clinicaltrials.gov/ct2/show/NCT04827420.

Understanding the relationship between positive and negative social support and the quality of life among African American breast cancer survivors.

PURPOSE: Social support improves several quality of life (QOL) domains among African American breast cancer survivors. How different dimensions of social support are associated with QOL among African American breast cancer survivors may however differ from other populations. This study explores this hypothesis by examining associations of positive social support (supportive interactions that promote affection) and negative social support (non-supportive interactions wherein the provider of support may not have the best intended actions) with QOL among Chicago-based African American breast cancer survivors. METHODS: Study participants were eligible if they (1) were identified as being an African American female, (2) were at least 18 years of age or older, and (3) were diagnosed with breast cancer during or after navigation was implemented at the study hospital. Participants completed validated questionnaires via telephone or in-person interviews. RESULTS: Among our sample of 100 participants, positive support was associated with greater mental well-being in non-imputed (Std ß=1.60, CI: 0.51, 2.69, p= 0.004) and imputed models (Std ß= 1.67, CI: 0.68, 2.73, p=0.001). There was also a weaker inverse association with negative support and mental well-being when using non-imputed data (Std ß=-0.82, CI:-1.65, 0.02, p= 0.05). CONCLUSIONS: Our findings suggest that positive support, in particular, is highly influential for improving mental well-being among African American breast cancer survivors. Simultaneously, negative support appears to be an independent, albeit weaker, determinant of mental well-being.

Assessing the relationship between patient-provider communication quality and quality of life among rural cancer survivors.

PURPOSE: We explored relationships between patient-provider communication quality (PPCQ) and three quality of life (QOL) domains among self-identified rural cancer survivors: social well-being, functional well-being, and physical well-being. We hypothesized that high PPCQ would be associated with greater social and functional well-being, but be less associated with physical well-being, due to different theoretical mechanisms. METHODS: All data were derived from the 2017-2018 Illinois Rural Cancer Assessment (IRCA). To measure PPCQ and QOL domains, we respectively used a dichotomous measure from the Medical Expenditure Panel Survey's Experience Cancer care tool (high, low/medium) and continuous measures from the Functional Assessment of Cancer Therapy-General (FACT-G). RESULTS: Our sample of 139 participants was largely female, non-Hispanic White, married, and economically advantaged. After adjusting for demographic and clinical variables, patients who reported high PPCQ exhibited greater social well-being (Std. ß = 0.20, 95% CI: 0.03, 0.35, p = 0.02) and functional well-being (Std. ß = 0.20, 95% CI: 0.05, 0.35, p = 0.03) than patients with low/medium PPCQ. No association was observed between PPCQ and physical well-being (Std. ß = 0.06, 95% CI: - 2.51, 0.21, p = 0.41). Sensitivity analyses found similar, albeit attenuated, patterns. CONCLUSION: Our findings aligned with our hypotheses. Future researchers should explore potential mechanisms underlying these differential associations. Specifically, PPCQ may be associated with social and functional well-being through interpersonal mechanisms, but may not be as associated with physical well-being due to multiple contextual factor rural survivors disproportionately face (e.g., limited healthcare access, economic hardship) and stronger associations with clinical factors.

Comparing the roles of social context, networks, and perceived social functioning with health-related quality of life among self-reported rural female cancer survivors.

PURPOSE: Rural women, compared to urban, experience worse survivorship outcomes, including poorer health-related quality of life (QOL). There is a need to characterize the role of multilevel social factors that contribute to QOL, including context, networks, and functioning. Our objectives were to (1) use latent class analysis to identify distinct classes of social context and social networks and (2) examine how multilevel social factors (context, networks, and functioning) are associated with health-related QOL. METHODS: We recruited self-identified rural survivors to the Illinois Rural Cancer Assessment (2017-2018), via community-based sampling methods, and participants completed the survey online, by phone, or on paper. We used latent class analysis to generate multidimensional variables for contextual and network factors. We next modeled each social factor sas a predictor in separate, bivariable linear regressions for the QOL outcomes, followed by multivariable, adjusted regressions. RESULTS: For our first objective, there were three classes each of county-level contexts (1, highly rural, socioeconomically disadvantaged, and mostly lacking in cancer-related services; 2, mostly rural, moderately disadvantaged, and underserved; 3, mostly metropolitan, less disadvantaged, and most-resourced) and social networks (1, no caregivers; 2, only spousal caregivers with whom they communicated daily; 3, multiple caregivers with varying daily communication). For our second objective, among all social factors, only functioning was associated with better mental health-related QOL. No factors were associated with physical health-related QOL. CONCLUSIONS: Our findings suggest a rich diversity of social context and networks among rural female cancer survivors, and social functioning is particularly important for mental health-related QOL.

Performance of Prostate Health Index in Biopsy Naïve Black Men.

PURPOSE: The Prostate Health Index is validated for prostate cancer detection but has not been well validated for Gleason grade group 2-5 prostate cancer detection in Black men. We hypothesize that the Prostate Health Index has greater accuracy than prostate specific antigen for detection of Gleason grade group 2-5 prostate cancer. We estimated probability of overall and Gleason grade group 2-5 prostate cancer across previously established Prostate Health Index ranges and identified Prostate Health Index cutoffs that maximize specificity for Gleason grade group 2-5 prostate cancer with sensitivity >90%. MATERIALS AND METHODS: We recruited a "cancer-free" Black control cohort (135 patients) and a cohort of biopsy naïve Black men (158) biopsied for elevated prostate specific antigen. Descriptive statistics compared the prostate cancer cases and controls and the frequency of Gleason grade group 2-5 prostate cancer across Prostate Health Index scores. Receiver operating characteristics compared the discrimination of prostate specific antigen, Prostate Health Index and other prostate specific antigen related biomarkers. Sensitivity and specificity for Gleason grade group 2-5 prostate cancer detection were assessed at prostate specific antigen and Prostate Health Index thresholds alone and in series. RESULTS: Of biopsied subjects 32.9% had Gleason grade group 2-5 prostate cancer. In Blacks with prostate specific antigen from 4.0-10.0 ng/ml, Prostate Health Index and prostate specific antigen had similar discrimination for Gleason grade group 2-5 prostate cancer (0.63 vs 0.57, p=0.27). In Blacks with prostate specific antigen ≤10.0, a threshold of prostate specific antigen ≥4.0 had 90.4% sensitivity for Gleason grade group 2-5 prostate cancer; a threshold of prostate specific antigen ≥4.0 with Prostate Health Index ≥35.0 in series avoided unnecessary biopsy in 33.0% of men but missed 17.3% of Gleason grade group 2-5 prostate cancer. Prostate specific antigen ≥4.0 with Prostate Health Index ≥28.0 in series spared biopsy in 17.9%, while maintaining 90.4% sensitivity of Gleason grade group 2-5 prostate cancer. CONCLUSIONS: The Prostate Health Index has moderate accuracy in detecting Gleason grade group 2-5 prostate cancer in Blacks, but Prostate Health Index ≥28.0 can be safely used to avoid some unnecessary biopsies in Blacks.