Inadequate recruitment and retention impede clinical trial goals. Emerging decentralized clinical trials (DCTs) leveraging digital health technologies (DHTs) for remote recruitment and data collection aim to address barriers to participation in traditional trials. The ACTIV-6 trial is a DCT using DHTs, but participants’ experiences of such trials remain largely unknown. This study explored participants’ perspectives of the ACTIV-6 DCT that tested outpatient COVID-19 therapeutics.

Participants in the ACTIV-6 study were recruited via email to share their day-to-day trial experiences during 1-hour virtual focus groups. Two human factors researchers guided group discussions through a semi-structured script that probed expectations and perceptions of study activities. Qualitative data analysis was conducted using a grounded theory approach with open coding to identify key themes.

Twenty-eight ACTIV-6 study participants aged 30+ years completed a virtual focus group including 1–4 participants each. Analysis yielded three major themes: perceptions of the DCT experience, study activity engagement, and trust. Participants perceived the use of remote DCT procedures supported by DHTs as an acceptable and efficient method of organizing and tracking study activities, communicating with study personnel, and managing study medications at home. Use of social media was effective in supporting geographically dispersed participant recruitment but also raised issues with trust and study legitimacy.

While participants in this qualitative study viewed the DCT-with-DHT approach as reasonably efficient and engaging, they also identified challenges to address. Understanding facilitators and barriers to DCT participation and DHT interaction can help improve future research design.

Many factors can impact survey completion rates, including survey length, sensitivity of the topics addressed, and clarity of wording. This study used cognitive interviews (CIs), a methodological tool that can aid in developing and refining elements for multi-faceted assessments, and previous survey response patterns to refine, streamline, and increase response rates of RADx-UP Common Data Elements (CDEs) for survey/questionnaire use.

Ten previously enrolled CO-CREATE study participants were interviewed between May–June 2023. Interviewees identified CDEs that were “confusing, uncomfortable, and/or not applicable,” along with their reasoning. Interview data were analyzed using a rapid qualitative analytic approach, resulting in a summary matrix categorized by language. For further contextualization, CDE response rates were calculated for the 9147 surveys administered during the CO-CREATE study (May 2021–March 2023) and compared against their survey position.

Of the 94 CDEs evaluated in the CIs, 20 (21.3%) were flagged by one or more interviewees. Nine (9.6%) English while fourteen (14.9%) Spanish CDEs were flagged by interviewees, with some overlap. Also, CDE response rates differed according to position in the survey, with lower response rates for questions positioned later in the survey. Following review by the research team and the RADx-UP program, 10 English and 15 Spanish were revised, and seven were removed in both languages in the final survey.

Our findings underscore the importance of integrating community member perspectives to enhance the relevance and clarity of assessment instruments, optimizing the impact of public health research among underrepresented populations.

Community-engaged partnerships (community/academia/government) can play a role in developing effective protocols that address public health crises. Systemic racism, prioritization of money over humanity, and the repression of the local democratic processes through the State of Michigan Emergency Manager Law (Order of Act 439) all played a role in the Flint Water Crisis. Despite decades of collaboration between Flint-based community organizations and academic institutions, ways to navigate such crises and conduct relevant research were ineffective.

The Michigan Institute for Clinical and Health Research Community Engagement program at the University of Michigan and Flint’s Community Based Organization Partners co-developed the Research Readiness and Partnership Protocol (R2P2) to provide community-engaged recommendations that inform a rapid research response to public health emergencies. The R2P2 Workgroup conducted an extensive literature review and key interviews to inform protocol development.

This manuscript provides an overview of the Workgroup’s methods, key interview findings, and the main principles identified. Detailed recommendations and key elements to address prior to and during a crisis will be presented including methods for: establishing and maintaining trust, ensuring transparency, supporting clear communication, establishing a “front door” to academic institutions including a means to “sound the alarm,” addressing academic incentives, achieving equitable resource sharing, and addressing systemic racism.

This manuscript of community perspectives provides essential elements to develop meaningful community-academic research partnerships to address public health crises impacting communities, particularly communities of color. Furthermore, this work highlights an opportunity for greater acknowledgment and utilization of community-based participatory research (CBPR) by academic institutions.

Lack of reliable, affordable transportation is a common barrier to clinical research participation, potentially contributing to health disparities. Insufficient and/or nonexistent institutional policies on research-related transportation make it challenging for research teams to effectively overcome transportation barriers and promote research participation among people from disadvantaged backgrounds. This study’s goal was to review research-related transportation policies across clinical research-involved institutions and propose recommendations for what such policies should address to help promote research engagement among diverse, representative populations.

We surveyed 28 recruitment sites, members of the National Institutes of Health-funded Healthy Brain and Child Development Consortium, poised to recruit over 7000 families, and completed an online search for each site’s policies relevant to research-related transportation (i.e., transportation of participants or research staff travel to/from research activities). We identified, reviewed, and thematically described content of the relevant policies and developed summary recommendations for institutional guidance components.

We identified seven policies (from five sites) on research-related transportation; four provided guidance on research-related transportation services; two on reimbursement; and one on when research staff transports participants. The online search identified publicly available business travel policies for 22 sites. No policy addressed research staff travel specifically for “study business” or research personnel transporting children for research purposes.

Few institutions involved in clinical research have policies guiding research-related transportation. Such policies, if adopted, could help support research-related transportation and, thus, participation of individuals from disadvantaged backgrounds, increasing generalizability of research results and contributing toward reducing social and health disparities.

A promising approach to assessing research impact draws on the Translational Science Benefits Model (TSBM), an evaluation model that tracks the applied benefits of research in four domains: Clinical and Medical; Community and Public Health; Economic; and Policy and Legislative. However, standardized methods to verify TSBM benefit data, to aid in aggregating impact data within quantitative summaries, do not currently exist.

A panel of 11 topic experts participated in a modified Delphi process for establishing content and face validity of a set of criteria for verifying qualitative TSBM data. Two survey rounds were completed by panelists, with a moderated discussion in between rounds to discuss criteria not reaching consensus. Criteria with panel consensus at or above 70% in the survey rounds were confirmed as validated.

Criteria fell into 9 categories: Content Relevant, Project Related, Who, Reach, What, How, Novel, Documented Evidence, and When. The Delphi process yielded 197 total criteria across the 30 benefits characterized by the TSBM (range = 5–8 criteria per benefit).

The results of this Delphi process lay the foundation for developing a TSBM coding tool for evaluating and quantifying TSBM data. Standardizing this process will enable data aggregation, group analysis, and the comparison of research impact across contexts.