Understanding the Supports of and Challenges to Community Engagement in the CTSAs

Background

The Clinical and Translational Science Award (CTSA) program has raised the profile and the available funding for engagement in biomedical research. Such increased funding and attention may address known barriers to engagement. However, little work has been done to describe experiences across multiple CTSAs, especially how the CTSA structure supports or challenges engagement.

Objective

We sought to understand the supports and challenges experienced by multiple CTSAs as they pursued community engagement. This knowledge may help guide future efforts to support and enhance community engagement in biomedical research.

Methods

We conducted semi‐structured, in‐depth interviews with CTSA community engagement core leaders and staff from the 2006 cohort of CTSAs (n = 12).

Results

A total of 17 interviews with respondents from nine institutions identified three support themes, including: funding, existing relationships with communities, and leadership and a partnership approach at the institution. Six challenge themes arose: need for capacity development, lack of positive relationships with communities, lack of leadership, funding constraints, time and staff constraints, and unsustainable models.

Conclusion

The CTSAs have brought much‐needed attention to community engagement in research, but more can be done to adequately support engagement. Challenges remain that need to be addressed to achieve the potential benefits of engagement.     

Instruction in the Responsible Conduct of Research: An Inventory of Programs and Materials within CTSAs

The National Institutes of Health (NIH) require instruction in the responsible conduct of research (RCR) as a component of any Clinical and Translational Science Award (CTSA). The Educational Materials Group of the NIH CTSA Consortium''s Clinical Research Ethics Key Function Committee (CRE‐KFC) conducted a survey of the 38 institutions that held CTSA funding as of January 2009 to determine how they satisfy RCR training requirements. An 8‐item questionnaire was sent by email to directors of the Clinical Research Ethics, the Educational and Career Development, and the Regulatory Knowledge cores. We received 78 completed surveys from 38 CTSAs (100%). We found that there is no unified approach to RCR training across CTSAs, many programs lack a coherent plan for RCR instruction, and most CTSAs have not developed unique instructional materials tailored to the needs of clinical and translational scientists. We recommend collaboration among CTSAs and across CTSA key function committees to address these weaknesses. We also requested that institutions send electronic copies of original RCR training materials to share among CTSAs via the CTSpedia website. Twenty institutions submitted at least one educational product. The CTSpedia now contains more than 90 RCR resources.     

Survey of Community Engagement in NIH‐Funded Research

Community engagement is an innovative and required component for Clinical and Translational Science Awards (CTSAs) funded by the National Institutes of Health (NIH). However, the extent of community engagement in NIH‐funded research has not been previously examined. This study assessed baseline prevalence of community engagement activities among NIH‐funded studies at a large Midwestern university with a CTSA. An online survey was e‐mailed to principal investigators of recent NIH‐funded studies (N = 480). Investigators were asked to identify what types of community engagement activities had occurred for each study. Responses were received for 40.4% (194/480) of studies. Overall, 42.6% reported any community engagement activities. More collaborative types of engagement (e.g., community advisory board) were less common than activities requiring less engagement (e.g., sharing study results with community members). Studies with more collaborative community engagement were less likely to be described as basic or preclinical research compared to all other studies. Given NIH''s inclusive call for community engagement in research, relatively few NIH‐funded studies reported community engagement activities, although this study used a broad definition of community and a wide range of types of engagement. These findings may be used to inform the goals of CTSA community engagement programs. Clin Trans Sci 2010; Volume *: 1–4     

A National Survey of Mentoring Programs for KL2 Scholars

There is limited information on how academic institutions support effective mentoring practices for new investigators. A national semistructured telephone interview was conducted to assess current “state of the art” mentoring practices for KL2 scholars among the 46 institutions participating in the Clinical Translational Science Awards (CTSA) Consortium. Mentoring practices examined included: mentor selection, articulating and aligning expectations, assessing the mentoring relationship, and mentor training. Telephone interviews were conducted in winter/fall 2009, with 100% of the CTSAs funded (n= 46) through 2009, participating in the survey. Primary findings include: five programs selected mentors for K scholars, 14 programs used mentor contracts to define expectations, 16 programs reported formal mentor evaluation, 10 offered financial incentives to mentors, and 13 offered formal mentoring training. The interviews found considerable variation in mentoring practices for training new investigators among the 46 CTSAs. There was also limited consensus on “what works” and what are the core elements of “effective mentoring practices. Empirical research is needed to help research leaders decide on where and how to place resources related to mentoring. Clin Trans Sci 2010; Volume 3: 299–304     

Enhancing Dissemination,Implementation, and Improvement Science in CTSAs through Regional Partnerships

Background and Importance

Challenges in healthcare policy and practice have stimulated interest in dissemination and implementation science. The Institute of Medicine Committee on the Clinical Translational Science Award (CTSA) program recommended expanding the CTSA program''s investment and activity in this domain. Guidance is needed to facilitate successful growth of DII science infrastructure, activity and impacts.

Objectives

Several CTSAs in Southern California collaborated to identify and respond to local challenges and opportunities to expand dissemination, implementation and improvement research by strengthening capacity and relationships between DII researchers and community, health system, and population health partners.

Main outcomes

Planning and outreach by the Southern California CTSAs increased awareness and interest in DII research and generated recommendations for growth. Recommendations include: increasing strong partnerships with healthcare and population health systems to guide policy research agendas and collaborative DII science; promoting multi‐sector partnerships that involve researchers and delivery systems throughout DII processes; bringing together multiple disciplines; and addressing national and international barriers as well as opportunities in DII science.

Implications

CTSAs through regional collaboration can increase their contributions to improved community health via skill‐building, partnership development and enhanced outreach to local healthcare and public health agencies and delivery systems.     

Community Representatives’ Involvement in Clinical and Translational Science Awardee Activities

Objectives

To understand the formal roles of community representatives (CRs) in Clinical and Translational Science Awardee (CTSA) activities, to evaluate the extent of integration into the organizational and governance structures and to identify barriers to effective integration.

Methods

The inventory tool was distributed to each of the 60 CTSAs using a secure web application.

Results

Forty‐seven (78%) completed the inventory. The mean number of CRs per CTSA is 21.4 (SD: 14.8). Most CTSAs had community advisory boards (89%) and 94% included CRs in Community Engagement (CE) cores. Only 11% reported a CR being a member of the CTSA leadership team and 19% reported that CRs advise core programs beyond CE.CRs are compensated by 79% of CTSAs. Mean annual compensation is $753 (median: $400). Compensation directly correlated with the number of hours that CRs worked in CTSA activities (r = 0.64; P = 0.001).

Conclusions

This inventory allows CTSAs to better understand how CRs have engaged in activities and brings attention to the limited representation among cores and in leadership roles. CTSAs should, with substantive input from CRs, develop strategies to provide the resources and compensation necessary to better integrate the community in CTSA activities and fully realize the goals of the CTSA vision.     

Social Network Analysis to Assess the Impact of the CTSA on Biomedical Research Grant Collaboration

Success of the Clinical Translational Science Award (CTSA) program implicitly demands team science efforts and well‐orchestrated collaboration across the translational silos (T1–T4). Networks have proven to be useful abstractions of research collaborations. Networks provide novel system‐level insights and exhibit marked changes in response to external interventions, making them potential evaluation tools that complement more traditional approaches. This study is part of our ongoing efforts to assess the impact of the CTSA on Biomedical Research Grant Collaboration (BRGC). Collaborative research grants are a complex undertaking and an outcome of sustained interaction among researchers. In this report, BRGC networks representing collaborations among CTSA‐affiliated investigators constructed from grants management system data at the University of Kentucky across a period of six years (2007–2012) corresponding to pre‐ and post‐CTSA are investigated. Overlapping community structure detection algorithms, in conjunction with surrogate testing, revealed the presence of intricate research communities rejecting random graphs as generative mechanisms. The deviation from randomness was especially pronounced post‐CTSA, reflecting an increasing trend in collaborations and team‐science efforts potentially as a result of CTSA. Intercommunity cross talk was especially pronounced post‐CTSA.     

Community Engagement Strategies in the Original and Renewal Applications for CTSA Grant Funding

Purpose

The Clinical and Translational Science Award (CTSA) program has highlighted community engagement in research by requiring institutions to develop bidirectional relationships with communities to obtain funding. Little is known about how institutions have operationalized that requirement. This study aimed to describe the strategies proposed by the first institutions to receive CTSA funding and to undergo the CTSA renewal process.

Methods

The authors conducted a qualitative document analysis of the community engagement section of 12 original and 10 renewal grant applications of the 12 institutions awarded CTSA funding in 2006 and renewed in 2010.

Results

Institutions employed ‐ and research engagement strategies. Capacity‐building strategies included education, pilot grants, connecting potential partners, and community research centers. Research engagement strategies ranged from those that allowed for very little input from communities, such as announcements, to those that allowed for a high amount of input from communities, such as community‐researcher teams.

Conclusion

CTSA funding has supported capacity‐building for institutions and communities to partner. Engagement strategies employed by the institutions are largely known from prior community‐engaged research. Based on the grants from these institutions, the CTSA funding has largely enabled institutions to develop capacity to engage.     

Evaluation Guidelines for the Clinical and Translational Science Awards (CTSAs)

The National Center for Advancing Translational Sciences (NCATS), a part of the National Institutes of Health, currently funds the Clinical and Translational Science Awards (CTSAs), a national consortium of 61 medical research institutions in 30 states and the District of Columbia. The program seeks to transform the way biomedical research is conducted, speed the translation of laboratory discoveries into treatments for patients, engage communities in clinical research efforts, and train a new generation of clinical and translational researchers. An endeavor as ambitious and complex as the CTSA program requires high‐quality evaluations in order to show that the program is well implemented, efficiently managed, and demonstrably effective. In this paper, the Evaluation Key Function Committee of the CTSA Consortium presents an overall framework for evaluating the CTSA program and offers policies to guide the evaluation work. The guidelines set forth are designed to serve as a tool for education within the CTSA community by illuminating key issues and practices that should be considered during evaluation planning, implementation, and utilization. Additionally, these guidelines can provide a basis for ongoing discussions about how the principles articulated in this paper can most effectively be translated into operational reality.     

The CTSA Mentored Career Development Program: Supporting the Careers of Child Health Investigators

Training translational scientists is a priority of the Clinical and Translational Science Award (CTSA) consortium. Objectives: 1) Describe the landscape of CTSA Mentored Research Career Development Awards (CDA) and 2) evaluate participation and outcomes of child health investigators in these programs. Design: Survey of the CTSA Child Health Oversight Committee (CC‐CHOC) and review of nonresponders'' CTSA Websites. Results: Thirty‐two of 53 CC‐CHOC members (60%) responded and all nonresponder Websites were reviewed. Institutions supported 1,166 CDA positions from 2006 to 2011, with 134 awarded to child health investigators (11.5%). Respondents reported a mean of 29.8 KL2 positions (95% CI 17.5–42.2) during their award period, with a mean of 2.8 (95% CI 1.8–3.8) awarded to child health investigators. The proportion of child health awardees varied from 0% to 50% across institutions. We identified 45 subsequent National Institutes of Health (NIH) awards to the 134 child health investigators (34%). Conclusions: The CTSA program contributes substantially to training the next generation of translational investigators. One‐third of child health investigators obtained subsequent NIH awards in the short follow‐up period demonstrating success of the CTSA CDA programs. Child health investigators are represented variably across the consortium. Pediatric institutions can partner with the CTSA program to further support training child health investigators.     

Vision,Identity, and Career in the Clinical and Translational Sciences: Building upon the Formative Years

This paper is the second in a five‐part series on the clinical and translational science educational pipeline. It focuses on the role that Clinical and Translational Science Award (CTSA) programs can play in supporting science, technology, engineering, and math (STEM) education in primary and secondary schools, as well as in facilitating these interests during transition to undergraduate training. Special emphasis should be placed on helping to form and sustain an identity as a scientist, and on instilling the persistence necessary to overcome numerous barriers to its actualization. CTSAs can contribute to cementing this sense of self by facilitating peer support, mentorship, and family involvement that will reinforce early educational decisions leading to clinical and translational science research careers. Meanwhile, the interests, skills, and motivation induced by participation in STEM programs must be sustained in transition to the next level in the educational pipeline, typically undergraduate study. Examples of CTSA collaborations with local schools, businesses, interest groups, and communities at large illustrate the emerging possibilities and promising directions with respect to each of these challenges.     

Promotion and Tenure for Community‐Engaged Research: An Examination of Promotion and Tenure Support for Community‐Engaged Research at Three Universities Collaborating through a Clinical and Translational Science Award

Introduction

Community‐engaged health research, an approach to research which includes the participation of communities, promotes the translation of research to address and improve social determinants of health. As a way to encourage community‐engaged research, the National Institutes of Health required applicants to the Clinical and Translational Science Award (CTSA) to include a community engagement component. Although grant‐funding may support an increase in community‐engaged research, faculties also respond to the rewards and demands of university promotion and tenure standards. This paper measures faculty perception of how three institutions funded by a CTSA support community‐engaged research in the promotion and tenure process.

Methods

At three institutions funded by a CTSA, tenure track and nontenure track faculty responded to a survey regarding perceptions of how promotion and tenure committees value community‐engaged research.

Results

Faculty view support for community‐engaged research with some reserve. Only 36% agree that community‐engaged research is valued in the promotion and tenure process.

Discussion

Encouraging community‐engaged scholarship requires changing the culture and values behind promotion and tenure decisions. Institutions will increase community‐engaged research and more faculty will adopt its principles, when it is rewarded by promotion and tenure committees.     

A Sustainable Course in Research Mentoring

In this report, we describe a six‐year experience (2007‐2012) in a single CTSA awardee institution on the development, implementation and evaluation of a hybrid online mentoring curriculum that is applicable to CTSA trainees at various levels (graduate, medical students, and junior faculty) of career training. The curriculum offers convenience, engagement, and financial sustainability. Overall, we found high levels of satisfaction with the curriculum and mentoring experience among both protégés and mentors. Qualitative data showed remarkable consensus of 14 of the 15 domains of mentoring that form the framework of the mentoring curriculum: (1) accessibility, (2) selectivity, (3) engagement/support, (4) teaching/training, (5) clarity of performance/expectations, (6) sponsorship/sharing power judiciously, (7) demystifying the system (academia), (8) challenging/encouraging risk taking, (9) affirming, (10) providing exposure/visibility, (11) being an intentional role model, (12) protecting, (13) providing feedback, (14) self‐disclosure, and lastly (15) counseling, with the fifteenth domain “counseling” being the most controversial. Quantitative survey data of both mentors and protégés indicated a high degree of overall satisfaction in their mentor‐protégé dyad with 86% (59) of protégés and 86% (55) of mentors responding good or excellent to the “quality of time spent.” Mentors and protégés were most satisfied in the area of research, with 93% (62) of protégés and 96% (57) of mentors finding discussions in research very to somewhat useful for their own career advancement. Along with wide acceptability, this format is a useful option for institutions where face‐to‐face time is limited and education budgets are lean.     

Evaluating Various Areas of Process Improvement in an Effort to Improve Clinical Research: Discussions from the 2012 Clinical Translational Science Award (CTSA) Clinical Research Management Workshop

Emphasis has been placed on assessing the efficiency of clinical and translational research as part of the National Institutes of Health (NIH) goal to “improve human health.” Improvements identified and implemented by individual organizations cannot address the research infrastructure needs of all clinical and translational research conducted. NIH''s National Center for Advancing Translational Sciences (NCATS) has brought together 61 Clinical and Translational Science Award (CTSA) sites creating a virtual national laboratory that reflects the diversity and breadth of academic medical centers to collectively improve clinical and translational science. The annual Clinical Research Management workshop is organized by the CTSA consortium with participation from CTSA awardees, NIH, and others with an interest in clinical research management. The primary objective of the workshop is to disseminate information that improves clinical research management although the specific objectives of each workshop evolve within the consortium. The fifth annual workshop entitled “Learning by doing; applying evidence‐based tools to re‐engineer clinical research management” took place in June 2012. The primary objective of the 2012 workshop was to utilize data to evaluate, modify, and improve clinical research management. This report provides a brief summary of the workshop proceedings and the major themes discussed among the participants.     

Public Participation in,and Awareness about,Medical Research Opportunities in the Era of Clinical and Translational Research

Context

In the United States, levels of public participation in medical research in the era of Clinical and Translational Science Awards (CTSAs) are unknown.

Methods

In 2011, a household survey was administered to a sample of U.S. adults, asking whether they (and children <18 years old) had participated, or were aware of opportunities to participate, in medical research. Respondents living within 100 miles of CTSA sites were identified. Regression analyses of participation and awareness (PA) were performed, applying sampling weights to permit nationally representative inferences.

Results

Overall, 2,150 individuals responded (completion rate = 60%); 65% of adults and 63% of families with children resided within 100 miles of ≥1 CTSA location. Research participation rates were 11% among adults and 5% among children. Among nonparticipants, awareness rates were 64% among adults and 12% among parents of children. PA among adults was associated with higher income and education, older age, presence of chronic conditions, and living within 100 miles of four specific CTSA locations. For children, PA was associated with higher household income and parents’ chronic health conditions.

Conclusions

PA of medical research opportunities is substantially higher for adults than children. Higher PA levels near specific CTSAs merit investigation to identify their successful approaches.     

Models of Interinstitutional Partnerships between Research Intensive Universities and Minority Serving Institutions (MSI) across the Clinical Translational Science Award (CTSA) Consortium

Health disparities are an immense challenge to American society. Clinical and Translational Science Awards (CTSAs) housed within the National Center for Advancing Translational Science (NCATS) are designed to accelerate the translation of experimental findings into clinically meaningful practices and bring new therapies to the doorsteps of all patients. Research Centers at Minority Institutions (RCMI) program at the National Institute on Minority Health and Health Disparities (NIMHD) are designed to build capacity for biomedical research and training at minority serving institutions. The CTSA created a mechanism fostering formal collaborations between research intensive universities and minority serving institutions (MSI) supported by the RCMI program. These consortium‐level collaborations activate unique translational research approaches to reduce health disparities with credence to each academic institutions history and unique characteristics. Five formal partnerships between research intensive universities and MSI have formed as a result of the CTSA and RCMI programs. These partnerships present a multifocal approach; shifting cultural change and consciousness toward addressing health disparities, and training the next generation of minority scientists. This collaborative model is based on the respective strengths and contributions of the partnering institutions, allowing bidirectional interchange and leveraging NIH and institutional investments providing measurable benchmarks toward the elimination of health disparities.     

The CTSA as an Exemplar Framework for Developing Multidisciplinary Translational Teams

Translational science requires that scientists from multiple disciplines work together to improve the prevention, diagnosis, and treatment of human disease. Although a literature exists on the design and management of multidisciplinary teams, little has been written on multidisciplinary translational teams (MTTs). MTTs are distinct hybrid entities, with goals taken from both industry and academic models. We identified 30 design factors in 10 domains from a literature survey relevant to our MTT model: specific goals, structures, and processes. These dimensions were adapted to our own institutional environment in the selection and management of 11 MTTs that exploited resources of University of Texas Medical Branch (UTMB) Clinical and Translational Sciences Awards (CTSA). Case illustrations of two specific MTTs illustrate some of the challenges encountered and opportunities realized in terms of education and scientific advances. Network depiction of disciplinarity indicated that CTSA KRs and CTSA leadership contributed to discipline diversity especially in small (or nascent) MTTs. A separate depiction of MTT‐KR utilization indicated that data analysis, translational technologies, and novel methods were heavily utilized by MTTs, whereas other KRs contributed significant effort to infrastructure development. We conclude that the CTSA can provide a rich
infrastructural framework and scientific environment for the development of successful MTTs. Clin Trans Sci 2013; Volume 6: 60–71     

COVID‐19 in HIV‐positive patients: A systematic review of case reports and case series

IntroductionCoronavirus disease 2019 (COVID‐19) and acquired immune deficiency syndrome (AIDS) are two viral diseases for which there are currently no definitive treatments. Nowadays, because of the health system''s focus on the COVID‐19 epidemic, the control of human immunodeficiency virus (HIV) has received less attention. In this review, we will discuss the characteristics of COVID‐19 in HIV‐positive patients.Material and MethodsUsing the PRISMA guideline, the databases of Scopus, PubMed, and Web of Science were searched systematically from January 1, 2019 to February 24, 2021. The following keywords were used: “Human Immunodeficiency Virus,” “acquired immune deficiency syndrome,” “HIV,” “AIDS,” “COVID‐19,” “severe acute respiratory syndrome coronavirus 2,” “novel coronavirus,” “SARS‐CoV‐2,” “nCoV disease,” “SARS2,” and “2019‐nCoV disease.”ResultsTwenty‐one percent of studies were conducted in the USA (n = 13), 16% in China (n = 10), and 13% in Italy (n = 8), respectively. The majority of the patients were men (74.3%). Tenofovir disoproxil fumarate was used in 47.4% of patients, emtricitabine in 58.4%, and lamivudine in 34.8% to treat HIV. Symptoms of HIV patients with COVID‐19 included coughing (81.3%), fever (62.8%), and dyspnea (60%). Hydroxychloroquine (39.34%) and azithromycin (36.58%) were the common treatment options for COVID‐19. The total death rate in HIV‐positive patients with COVID‐19 was about 9%.ConclusionIn the current systematic review, we demonstrated that HIV‐positive patients co‐infected with COVID‐19 have high comorbidity of hypertension and diabetes mellitus. HIV/COVID‐19 co‐infection might have negatively influenced the HIV treatment and diagnosis, which indicates the need to regularly screen HIV patients in the COVID‐19 pandemic.     

Provider's Perspectives on Building Research and Quality Improvement Capacity in Primary Care: A Strategy to Improve Workforce Satisfaction

Objectives

Safety‐net populations are underrepresented in research and quality improvement (QI) studies despite the fact that safety‐net providers are uniquely positioned to engage in translational research. This study aimed to understand the current level of interest in, experience with, predicted career satisfaction associated with, and barriers experienced in conducting research and QI among primary care providers (PCPs) at 18 safety‐net practices in the Boston, Massachusetts area.

Methods

The Harvard Catalyst Safety‐net Infrastructure Initiative partnered with staff at a large academic public hospital system, including 15 primary care sites, to develop and administer an online survey. This survey was then adapted and administered at three other academically affiliated community health centers.

Results

Of the 260 providers surveyed, 136 (52%) responded. Nearly 80% reported interest in conducting either QI projects or clinical research and 95% of them believed it would enhance their career satisfaction. However, 63% did not report prior experience or training in research or QI and 93% reported at least one barrier to engagement.

Conclusion

While supporting safety‐net PCPs’ engagement in research and/or QI may improve career satisfaction there are numerous barriers that must be addressed to achieve this goal.