Do no harm: the impact of implementing cancer prevention strategies on other preventive health measures.

BACKGROUND: Translational efforts to increase uptake of evidence-based practices typically look at those outcomes in isolation of their impact on other aspects of care delivery. If we are in fact to "do no harm", we must consider the possible negative impact of improving use of one practice on other quality measures. Alternatively, a focus on one practice could lead to spread of effective strategies to other practices, which would be highly beneficial. We studied the impact of a colorectal cancer (CRC) screening initiative on delivery of other preventive care measures. METHODS: We used an interrupted time series design with implementation year as the interruption point. The initiative was conducted between 2015 and 2020, with three staggered cohorts. Main outcomes were quality measures for colorectal cancer screening, cervical cancer screening, hypertension management, diabetes management, weight screening and follow-up, tobacco use screening and cessation treatment, and depression screening and follow-up. RESULTS: The initiative was associated with an increase in CRC screening (OR = 1.67, p ≤ 0.01; average marginal effect = 12.2% points), and did not reduce performance on other quality measures in the year of CRC program implementation or a change in their respective secular trends. CONCLUSIONS: The initiative led to a clinically meaningful increase in CRC screening and was not associated with reductions in delivery of six other preventive services. Quality improvement (QI) initiatives typically approach implementation with an eye towards reducing unintended impact and leveraging existing staff and resources. Implementation research studies may benefit from considering how QI initiatives factor in the local context in implementation efforts.

Bundling Colorectal Cancer Screening Outreach with Screening for Social Risk in Federally Qualified Health Centers: A Stepped-Wedge Implementation-Effectiveness Study.

BACKGROUND: Bundling is combining individual interventions to meet quality metrics. Bundling offers of cancer screening with screening for social determinants of health (SDOH) may enable health centers to assist patients with social risks and yield efficiencies. OBJECTIVE: To measure effects of bundling fecal immunochemical testing (FIT) and SDOH screening in federally qualified health centers (FQHCs). DESIGN: Clustered stepped-wedge trial. PARTICIPANTS: Four Massachusetts FQHCs randomized to implement bundled FIT-SDOH over 8-week "steps." INTERVENTION: Outreach to 50-75-year-olds overdue for CRC screening to offer FIT with SDOH screening. The implementation strategy used facilitation and training for data monitoring and reporting. MAIN MEASURES: Implementation process descriptions, data from facilitation meetings, and CRC and SDOH screening rates. Rates were compared between implementation and control FQHCs in each "step" by fitting generalized linear mixed-effects models with random intercepts for FQHCs, patients, and "step" by FQHC. KEY RESULTS: FQHCs tailored implementation processes to their infrastructure, workflows, and staffing and prioritized different groups for outreach. Two FQHCs used population health outreach, and two integrated FIT-SDOH within established programs, such as pre-visit planning. Of 34,588 patients overdue for CRC screening, 54% were female; 20% Black, 11% Latino, 10% Asian, and 47% white; 32% had Medicaid, 16% Medicare, 32% private insurance, and 11% uninsured. Odds of CRC screening completion in implementation "steps" compared to controls were higher overall and among groups prioritized for outreach (overall: adjusted odds ratio (aOR) 2.41, p = 0.005; prioritized: aOR 2.88, p = 0.002). Odds of SDOH screening did not differ across "steps." CONCLUSIONS: As healthcare systems are required to conduct more screenings, it is notable that outreach for a long-standing cancer screening requirement increased screening, even when bundled with a newer screening requirement. This outreach was feasible in a real-world safety-net clinical population and may conserve resources, especially compared to more complex or intensive outreach strategies. CLINICAL TRIALS REGISTRATION: NCT04585919.

"I'm on the Right Path": Exploring 1-Month Retention in a Homeless-Tailored Outpatient-Based Opioid Treatment Program.

BACKGROUND: Homeless-tailored office-based opioid treatment (OBOT) programs have been developed to address the ongoing opioid overdose crisis, which disproportionately affects people experiencing homelessness. The objective of this study was to evaluate the facilitators of and barriers to retention in a homeless-tailored OBOT program. METHODS: We performed in-depth qualitative interviews with 24 homeless-experienced adults who newly enrolled in Boston Health Care for the Homeless Program's OBOT program from January 6, 2022 through January 5, 2023. We purposively sampled participants based on whether they were retained at 1 month (n = 12) or not (n = 12). We used an abductive analytic process, applying codes to the interview transcripts from an a priori analytic framework based on the Behavioral Model for Vulnerable Populations and supplementing with emergent codes as needed. We compared themes by participants' 1-month retention status to explore facilitators of and barriers to retention in OBOT care. RESULTS: The average age was 41.9 years, 29.2% were female, 20.8% were Black, 58.3% were White, and 33.0% were Hispanic. Facilitators of retention common to many participants included the clinic experience, low-threshold model, clinic staff, and provision of comprehensive care. Among participants who were retained at 1-month, personal motivation, use of extended-release buprenorphine, and adequate buprenorphine efficacy were additional facilitators. Barriers to retention common to many participants included the clinic's surrounding environment, competing subsistence difficulties, and transportation difficulty. Among participants who were not retained at 1-month, opioid use severity, drug use in social networks, and inadequate buprenorphine efficacy represented additional barriers. CONCLUSIONS: We identified several common determinants of OBOT retention among our homeless-experienced participants as well as some facilitators and barriers that differed by 1-month retention status. These divergent factors represent potential points of intervention to promote retention in homeless-tailored OBOT programs.

Leveraging an implementation science partnership network to understand how Federally Qualified Health Centers operationalize and address health equity.

Health equity-focused implementation research requires using definitions and approaches that are relevant and meaningful to implementation partners. We examined how health equity was operationalized and addressed at Federally Qualified Health Centers (FQHCs). We conducted semi-structured interviews with leadership (n = 19) and staff (n = 12) at 10 FQHCs in an implementation science partnership network for cancer control equity to understand how they operationalized and addressed health equity. We performed rapid qualitative analysis and shared findings with a larger group of 13 community health centers (including the 10 FQHCs) at an Implementation Learning Community (ILC) to identify action areas for research and practice, followed by a second phase of synthesizing qualitative codes into themes and mapping themes onto a framework for advancing health equity in healthcare organizations. Participants defined health equity as central to the mission of FQHCs, and identified barriers (e.g. financing models) and facilitators (e.g. interpreter services) to advancing health equity at FQHCs. These findings resonated with ILC participants who emphasized the challenge of addressing root cause social determinants of inequities using limited available resources in FQHCs and the importance of developing meaningful collaboration with communities for data collection, data interpretation, data use, and data ownership. Themes captured recommendations to advance health equity in daily work at FQHCs, including investments in staffing, training, and resources. Mapping qualitative themes from health equity-centered interviews with FQHC partners onto a framework for advancing health equity in healthcare organizations can provide clear, context-specific direction for actions aimed at improving health and healthcare equity.

Health equity-focused implementation research requires using definitions and approaches that are relevant and meaningful to implementation partners. Toward this goal, our research team asked leadership and staff at Federally Qualified Health Centers (FQHCs) to share how they defined and addressed health equity at their practice settings. FQHC participants defined health equity as the essential mission of FQHCs as safety net organizations delivering care to medically underserved populations. In addition, key informants identified barriers (e.g. financing models) and facilitators (e.g. interpreter services) to advancing health equity at FQHCs. We presented these findings to a larger group of FQHC stakeholders who recommended that future implementation research and practice consider how FQHCs are challenged to address the root causes of healthcare inequities with limited resources. They also highlighted the importance of meaningful collaboration among researchers, FQHCs, and communities for data collection, data interpretation, data use, and data ownership to advance health equity. Conducting research to understand the perspectives and experiences of FQHC partners can provide clear, context-specific direction for actions to improve health equity and can inform future approaches to health equity-focused implementation research that ismeaningful to FQHC partners and the communities they serve.

Caregiver Perceptions of Social Risk Screening in Pediatric Liver Transplantation: From the Multicenter SOCIAL-Tx Study.

BACKGROUND: The social determinants of health contribute to adverse post-liver transplant outcomes. Identifying unmet social risks may enable transplant teams to improve long-term outcomes for at-risk children. However, providers may feel uncomfortable asking about household-level social risks in the posttransplant period because they might make their patients/families uncomfortable. METHODS: We conducted a mixed-methods analysis of caregiver participants (ie, parents/guardians of pediatric liver transplant recipients) in the Social and Contextual Impact on Children Undergoing Liver Transplantation study to assess their perceptions of provider-based social risk screening. Participants (N = 109) completed a 20-min social determinants of health questionnaire that included questions on the acceptability of being asked intimate social risk questions. A subset of participants (N = 37) engaged in an in-depth qualitative interview to share their perceptions of social risk screening. RESULTS: Of 109 participants across 9 US transplant centers, 60% reported financial strain and 30% reported at least 1 material economic hardship (eg, food insecurity, housing instability). Overall, 65% of respondents reported it very or somewhat appropriate and 25% reported being neutral to being screened for social risks in a liver transplant setting. In qualitative analyses, participants reported trust in the providers and a clear understanding of the intention of the screening as prerequisites for liver transplant teams to perform social risk screening. CONCLUSIONS: Only a small minority of caregivers found social risk screening unacceptable. Pediatric liver transplant programs should implement routine social risk screening and prioritize the patient and family voices when establishing a screening program to ensure successful implementation.

Challenges and recommendations for measuring time devoted to implementation and intervention activities in health equity-focused, resource-constrained settings: a qualitative analysis.

BACKGROUND: There is little guidance for conducting health equity-focused economic evaluations of evidence-based practices in resource-constrained settings, particularly with respect to staff time use. Investigators must balance the need for low-touch, non-disruptive cost data collection with the need for data on providing services to priority subpopulations. METHODS: This investigation took place within a pilot study examining the implementation of a bundled screening intervention combining screening for social determinants of health and colorectal cancer at four federally qualified health centers (FQHCs) in the Boston metropolitan area. Methods for collecting data on personnel costs for implementation and intervention activities, including passive (automatic) and active (non-automatic, requiring staff time and effort) data collection, as well as three alternate wordings for self-reporting time-use, were evaluated qualitatively using data collected through interviews with FQHC staff (including clinicians, population health staff, and community health workers) and assessments of data completeness. RESULTS: Passive data collection methods were simple to execute and resulted in no missing data, but missed implementation and intervention activities that took place outside planned meetings. Active cost data collection using spreadsheets was simple for users when applied to care processes already tracked in this fashion and yielded accurate time use data. However, for tasks where this was not typical, and when tasks were broken up over multiple sessions, spreadsheets were more challenging to use. Questions asking about time use for a typical rather than specific time period, and for typical patients, yielded the most reliable and actionable data. Still, even the best-performing question had substantial variability in time use estimates. Participants noted that patient characteristics of interest for equity-focused research, including language spoken, adverse social determinants of health, and issues related to poverty or mental health, all contributed significantly to this variability. CONCLUSIONS: Passively collected time use data are the least burdensome and should be pursued in research efforts when possible, but should be accompanied by qualitative assessments to ensure the data are an accurate reflection of effort. When workflows are already tracked by active data collection, these are also strong data collection methods. Self-reported time use will be most accurate when questions inquire about "typical" tasks and specific types of patients.

Embedding community-engaged research principles in implementation science: The implementation science center for cancer control equity.

Gaps in the implementation of effective interventions impact nearly all cancer prevention and control strategies in the US including Massachusetts. To close these implementation gaps, evidence-based interventions must be rapidly and equitably implemented in settings serving racially, ethnically, socioeconomically, and geographically diverse populations. This paper provides a brief overview of The Implementation Science Center for Cancer Control Equity (ISCCCE) and describes how we have operationalized our commitment to a robust community-engaged center that aims to close these gaps. We describe how ISCCCE is organized and how the principles of community-engaged research are embedded across the center. Principles of community engagement have been operationalized across all components of ISCCCE. We have intentionally integrated these principles throughout all structures and processes and have developed evaluation strategies to assess whether the quality of our partnerships reflects the principles. ISCCCE is a comprehensive community-engaged infrastructure for studying efficient, pragmatic, and equity-focused implementation and adaptation strategies for cancer prevention in historically and currently disadvantaged communities with built-in methods to evaluate the quality of community engagement. This engaged research center is designed to maximize the impact and relevance of implementation research on cancer control in community health centers.

Tobacco smoking and prevalence of communicable and non-communicable diseases in rural South Africa: A cross-sectional study.

Background: South Africa is facing a convergence of communicable diseases (CDs) and non-communicable diseases (NCDs). The contribution of tobacco use to the burden of these conditions is unknown. Methods: We analyzed the associations between current tobacco smoking and four important CDs and NCDs in Vukuzazi, a cross-sectional study of individuals aged 15 years and older conducted between 2018-2020 in a demographic surveillance area in KwaZulu-Natal, South Africa. Data on HIV, active tuberculosis (TB), hypertension and diabetes mellitus were collected via direct measurement from participants. Results: Of 18,024 participants (68% female, median age 37 years [interquartile rage 23-56 years]), 1,301 (7.2%) reported current smoking. Prevalence of HIV infection was similarly high among people who currently smoked (34.6%) and people who had never smoked (33.9%). However, among people living with HIV (PLWH), there was a higher prevalence of detectable viremia in people reporting current smoking compared to people who reported never smoking (28.8% vs. 16.6%; p-value < 0.001). Active TB was more prevalent in people who currently smoked than in people who never smoked (3.1% vs 1.3%, p < 0.001). In contrast, the prevalence of hypertension and diabetes mellitus were lower in people reporting current smoking than in people reporting never smoking (17.1% vs 26.0% (p < 0.001), and 2.5% vs 10.2% (p < 0.001), respectively). In sex-stratified multivariable analyses that were adjusted for potential confounding factors (including body mass index for the NCDs), the magnitude of differences in CD prevalence between people who currently smoked and people who never smoked decreased, whereas the lower prevalence of NCDs among people reporting current smoking persisted. Conclusions: In rural South Africa, smoking is associated with higher rates of active TB, and people with HIV who smoke have worse disease control. In contrast, hypertension and diabetes mellitus are less common in those who smoke. Interventions to screen for TB among those who smoke and to address smoking among people with HIV may be particularly impactful.

Creating research-ready partnerships: the initial development of seven implementation laboratories to advance cancer control.

BACKGROUND: In 2019-2020, with National Cancer Institute funding, seven implementation laboratory (I-Lab) partnerships between scientists and stakeholders in 'real-world' settings working to implement evidence-based interventions were developed within the Implementation Science Centers in Cancer Control (ISC3) consortium. This paper describes and compares approaches to the initial development of seven I-Labs in order to gain an understanding of the development of research partnerships representing various implementation science designs. METHODS: In April-June 2021, members of the ISC3 Implementation Laboratories workgroup interviewed research teams involved in I-Lab development in each center. This cross-sectional study used semi-structured interviews and case-study-based methods to collect and analyze data about I-Lab designs and activities. Interview notes were analyzed to identify a set of comparable domains across sites. These domains served as the framework for seven case descriptions summarizing design decisions and partnership elements across sites. RESULTS: Domains identified from interviews as comparable across sites included engagement of community and clinical I-Lab members in research activities, data sources, engagement methods, dissemination strategies, and health equity. The I-Labs use a variety of research partnership designs to support engagement including participatory research, community-engaged research, and learning health systems of embedded research. Regarding data, I-Labs in which members use common electronic health records (EHRs) leverage these both as a data source and a digital implementation strategy. I-Labs without a shared EHR among partners also leverage other sources for research or surveillance, most commonly qualitative data, surveys, and public health data systems. All seven I-Labs use advisory boards or partnership meetings to engage with members; six use stakeholder interviews and regular communications. Most (70%) tools or methods used to engage I-Lab members such as advisory groups, coalitions, or regular communications, were pre-existing. Think tanks, which two I-Labs developed, represented novel engagement approaches. To disseminate research results, all centers developed web-based products, and most (n = 6) use publications, learning collaboratives, and community forums. Important variations emerged in approaches to health equity, ranging from partnering with members serving historically marginalized populations to the development of novel methods. CONCLUSIONS: The development of the ISC3 implementation laboratories, which represented a variety of research partnership designs, offers the opportunity to advance understanding of how researchers developed and built partnerships to effectively engage stakeholders throughout the cancer control research lifecycle. In future years, we will be able to share lessons learned for the development and sustainment of implementation laboratories.

Opportunities and challenges for a standardized curriculum in a student-run clinic network.

PURPOSE: Student-run clinics (SRCs) are prevalent in medical schools. Although these are popular among students and provide ample learning opportunities, these opportunities are not well-characterized. SRCs are poised to support medical schools' ability to meet accreditation standards and student growth and learning, particularly in areas missing from traditional curricula, such as social determinants of health, interprofessional education and inequities. MATERIALS AND METHODS: At the Crimson Care Collaborative (CCC), a network of 7 Harvard Medical School affiliated student-faculty practices in the greater Boston area, we sought to understand what learning opportunities and challenges exist and if a standardized curriculum could improve learning and result in less duplication of teaching efforts. We conducted semi-structured individual interviews of student and faculty leaders and conducted a thematic analysis of the data. RESULTS: Four key themes emerged: (1) Standardization provides opportunities and challenges, (2) Embrace the unique learning opportunities of each clinic, (3) Educational coaches enhance learning opportunities and increase efficiency, (4) Reflection is a useful tool for improvement & learning. DISCUSSION: Our results demonstrate a benefit to both a standardized curriculum for all SRC sites focused on broad clinical, skill-based training and site-specific teaching focusing on the unique clinical needs of each student-run clinic.

Provider beliefs in effectiveness and recommendations for primary HPV testing in 3 health-care systems.

In 2018, the US Preventive Services Task Force endorsed primary human papillomavirus testing (pHPV) for cervical cancer screening. We aimed to describe providers' beliefs about pHPV testing effectiveness and which screening approach they regularly recommend. We invited providers who performed 10 or more cervical cancer screens in 2019 in 3 healthcare systems that had not adopted pHPV testing: Kaiser Permanente Washington, Mass General Brigham, and Parkland Health; 53.7% (501/933) completed the survey between October and December 2020. Response distributions varied across modalities (P < .001), with cytology alone or cotesting being more often viewed as somewhat or very effective for 30- to 65-year-olds compared with pHPV (cytology alone 94.1%, cotesting 96.1%, pHPV 66.0%). In 21- to 29-year-olds, the pattern was similar (cytology alone 92.2%, 64.7% cotesting, 50.8% pHPV). Most providers were either incorrect or unsure of the guideline-recommended screening interval for pHPV. Educational efforts are needed about the relative effectiveness and recommended use of pHPV to promote guideline-concordant care.

Medically tailored meals for food insecurity and type 2 diabetes: Protocol for the Food as Medicine for Diabetes (FAME-D) trial.

BACKGROUND: Food insecurity is associated with worse glycemic management for individuals with type 2 diabetes mellitus (T2DM), but whether medically tailored meals (MTM), a food insecurity intervention, can improve glycemic management is unclear. OBJECTIVE: To describe the protocol for a trial assessing whether an MTM plus lifestyle intervention improves hemoglobin A1c (HbA1c) and participant-reported outcomes, relative to a food subsidy (money that can be spent on foods participants choose), for adults with both T2DM and food insecurity. METHODS: The Food as Medicine for Diabetes (FAME-D) randomized clinical trial (goal n = 200) is a pragmatic trial with an active comparator. Participants, who will have T2DM and report food insecurity, will be randomly assigned to a 6-month MTM plus telephone-delivered lifestyle change intervention, or a 6-month food subsidy ($40/month). The primary outcome is HbA1c at 6 months. Secondary outcomes include HbA1c at 12 months to assess whether the intervention effect (if any) is sustained, along with weight, food insecurity, diabetes distress, and health-related quality of life. Qualitative analyses of semi-structured interviews will help understand why, how, and under what circumstances the intervention achieved its observed results. CONCLUSION: Results from FAME-D will help inform clinical management of food insecurity when it co-occurs with T2DM. Further, results may be useful as healthcare payors are considering coverage for MTM interventions. CLINICALTRIALS: gov: NCT04828785.

Student Faculty Collaborative Clinics Influence on Emergency Department Use.

Student-faculty collaborative clinics, like the Crimson Care Collaborative (CCC), provide primary care access to underserved communities. Affiliated with a community health center, CCC-Chelsea serves a largely immigrant and refugee population. This study aimed to analyze patients' reported ED use before and after they presented to CCC-Chelsea and whether types of insurance affect ED use. We prospectively surveyed 229 patients presenting to CCC-Chelsea between 2013 and 2019. Patients who presented for two or more visits at least one year apart were included in the study. A two-sided Wilcoxon signed rank test was used to compare reported ED use before and after presenting to CCC-Chelsea, and a Kruskal-Wallis test analyzed the association between ED use and insurance status. Most patients (77.7%) presenting to CCC-Chelsea identified as Hispanic, 70.9% were male, 50.6% of patients reported an income of less than $15,000 yearly, and 30.4% had an income between $15,000-$30,000. Most patients (51.9%) did not specify the type of insurance used, followed by public insurance (36.7%), with the remaining having private or no insurance. Results from our survey showed that patients who returned to CCC-Chelsea reported a decrease in the average number of yearly ED visits after attending CCC-Chelsea (pre-CCC 1.544, post-CCC 0.696, p < 0.001 at the 95% CI). There was no difference in reported average number of ED visits yearly and insurance type (p = 0.579). Patients' reported ED utilization after accessing care at CCC-Chelsea decreased. Increased access to student-faculty collaborative clinics could reduce ED use in underserved populations.

Mobile Health Services for COVID-19: Counseling, Testing, and Vaccination for Medically Underserved Populations.

Mobile health units can improve access to preventive health services, especially for medically underserved populations. However, there is little published experience of mobile health units being used to expand access to COVID-19 vaccination. In concert with local public health departments and community members, we implemented a mobile COVID-19 health unit and deployed it to 12 predominantly low-income and racial/ethnic minority communities in Massachusetts. We describe the success and challenges of this innovative program in expanding access to COVID-19 vaccination. (Am J Public Health. 2022;112(11):1556-1559. https://doi.org/10.2105/AJPH.2022.307021).

Stakeholder and Equity Data-Driven Implementation: a Mixed Methods Pilot Feasibility Study.

We conducted a mixed methods pilot feasibility study of a Stakeholder and Equity Data-Driven Implementation (SEDDI) process to facilitate using healthcare data to identify patient groups experiencing gaps in the use of evidence-based interventions (EBIs) and rapidly adapt EBIs to achieve greater access and equitable outcomes. We evaluated the feasibility and acceptability of SEDDI in a pilot hybrid type 2 effectiveness-implementation trial of a paired colorectal cancer (CRC) and social needs screening intervention at four federally qualified community health centers (CHCs). An external facilitator partnered with CHC teams to support initial implementation, followed by the SEDDI phase focused on advancing health equity. Facilitation sessions were delivered over 8 months. Preliminary evaluation of SEDDI involved convergent mixed methods with quantitative survey and focus group data. CHCs used data to identify gaps in outreach and completion of CRC screening with respect to race/ethnicity, gender, age, and language. Adaptations to improve access and use of the intervention included cultural, linguistic, and health literacy tailoring. CHC teams reported that facilitation and systematic review of data were helpful in identifying and prioritizing gaps. None of the four CHCs completed rapid cycle testing of adaptations largely due to competing priorities during the COVID-19 response. SEDDI has the potential for advancing chronic disease prevention and management by providing a stakeholder and data-driven approach to identify and prioritize health equity targets and guide adaptations to improve health equity. ClinicalTrials.gov Identifier: NCT04585919.

Applying mixed methods to pilot feasibility studies to inform intervention trials.

BACKGROUND: Pilot feasibility studies serve a uniquely important role in preparing for larger scale intervention trials by examining the feasibility and acceptability of interventions and the methods used to test them. Mixed methods (collecting, analyzing, and integrating quantitative and qualitative data and results) can optimize what can be learned from pilot feasibility studies to prepare rigorous intervention trials. Despite increasing use of mixed method designs in intervention trials, there is limited guidance on how to apply these approaches to address pilot feasibility study goals. The purpose of this article is to offer methodological guidance for how investigators can plan to integrate quantitative and qualitative methods within pilot feasibility studies to comprehensively address key research questions. METHODS: We used an informal consensus-based process informed by key methodological resources and our team's complementary expertise as intervention researchers and mixed methodologists to develop guidance for applying mixed methods to optimize what can be learned from pilot feasibility studies. We developed this methodological guidance as faculty in the Mixed Methods Research Training Program (MMRTP) for the Health Sciences (R25MH104660) funded by the National Institutes of Health through the Office of Behavioral and Social Science Research. RESULTS: We provide the following guidance for applying mixed methods to optimize pilot feasibility studies: (1) identify feasibility domain(s) that will be examined using mixed methods, (2) align quantitative and qualitative data sources for the domain(s) selected for mixing methods, (3) determine the timing of the quantitative and qualitative data collection within the flow of the pilot study, (4) plan integrative analyses using joint displays to understand feasibility, and (5) prepare to draw meta-inferences about feasibility and implications for the future trial from the integrated data. CONCLUSIONS: By effectively integrating quantitative and qualitative data within pilot feasibility studies, investigators can harness the potential of mixed methods for developing comprehensive and nuanced understandings about feasibility. Our guidance can help researchers to consider the range of key decisions needed during intervention pilot feasibility testing to achieve a rigorous mixed methods approach generating enhanced insights to inform future intervention trials.

Expanding COVID-19 vaccine access to underserved populations through implementation of mobile vaccination units.

COVID-19 has disproportionately impacted underserved populations, including racial/ethnic minorities. Prior studies have demonstrated that mobile health units are effective at expanding preventive services for hard-to-reach populations, but this has not been studied in the context of COVID-19 vaccination. Our objective was to determine if voluntary participants who access mobile COVID-19 vaccination units are more likely to be racial/ethnic minorities and adolescents compared with the general vaccinated population. We conducted a cross-sectional study of individuals who presented to three different mobile COVID-19 vaccination units in the Greater Boston area from May 20, 2021, to August 18, 2021. We acquired data regarding the general vaccinated population in the state and of target communities from the Massachusetts Department of Public Health. We used chi-square testing to compare the demographic characteristics of mobile vaccination unit participants and the general state and community populations that received COVID-19 vaccines during the same time period. We found that during this three-month period, mobile vaccination units held 130 sessions and administered 2622 COVID-19 vaccine doses to 1982 unique participants. The median (IQR) age of participants was 31 (16-46) years, 1016 (51%) were female, 1575 (80%) were non-White, and 1126 (57%) were Hispanic. Participants in the mobile vaccination units were more likely to be younger (p < 0.001), non-White race (p < 0.001), and Hispanic ethnicity (p < 0.001) compared with the general vaccinated population of the state and target communities. This study suggests that mobile vaccination units have the potential to improve access to COVID-19 vaccination for diverse populations.

Implementing expanded COVID-19 testing in Massachusetts community health centers through community partnerships: Protocol for an interrupted time series and stepped wedge study design.

BACKGROUND: Community Health Centers (CHCs) are a critical source of care for low-income and non-privately insured populations. During the pandemic, CHCs have leveraged their infrastructure and role as a trusted source of care to engage the communities they serve in COVID-19 testing. METHODS: To directly address the impact that COVID-19 has had on historically marginalized populations in Massachusetts, we designed a study of community-engaged COVID-19 testing expansion: (1) leveraging existing partnerships to accelerate COVID-19 testing and rapidly disseminate effective implementation strategies; (2) incorporating efforts to address key barriers to testing participation in communities at increased risk for COVID-19; (3) further developing partnerships between communities and CHCs to address testing access and disparities; (4) grounding the study in the development of a shared ethical framework for advancing equity in situations of scarcity; and (5) developing mechanisms for communication and science translation to support community outreach. We use a controlled interrupted time series design, comparing number of COVID-19 tests overall and among people identified as members of high-risk groups served by intervention CHCs compared with six matched control CHCs in Massachusetts, followed by a stepped wedge design to pilot test strategies for tailored outreach by CHCs. CONCLUSIONS: Here, we describe a community-partnered strategy to accelerate COVID-19 testing in historically marginalized populations that provides ongoing resources to CHCs for addressing testing needs in their communities. The study aligns with principles of community-engaged research including shared leadership, adequate resources for community partners, and the flexibility to respond to changing needs over time.