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.

Responding to the need to investigate potential treatments of COVID-19, a research team employed a telehealth platform to determine whether niclosamide, an oral anthelmintic drug that had shown antiviral activity, reduced SARS-CoV-2 shedding and duration of symptoms in patients with mild-to-moderate symptoms of COVID-19. To encourage compliance with patient self-quarantine, this randomized placebo-controlled clinical trial was conducted utilizing a remote telehealth design to complete all study visits, monitor symptoms, and coordinate participant self-collected specimens.

A mixed methods approach employing surveys and interviews of trial participants and interviews of research team members was used to collect their experiences with and perspectives on the acceptability of the remote clinical trial design and delivery.

Of the 67 eligible trial participants invited to take part in a study to evaluate the telehealth platform, 46% (n = 31) completed a post-participation survey. While 97% (n = 30) of respondents had not previously participated in a clinical trial, 77% (n = 24) reported they would consider taking part in a future remote research study. The majority of respondents were moderately or very comfortable (93%) with using the technology.

The COVID-19 crisis was a call to action to expand understanding of the conduct of remote clinical trials, including the experiences of research participants. Our findings showed that this approach can be both effective for the conduct of research and positive for participants. Further research on the use of telehealth research platforms seems warranted in rural, underserved populations, and remote trials of prevention, screening, and treatment.

The validated long Research Participant Perception Survey (RPPS-Long) elicits valuable data at modest response rates.

To address this limitation, we developed shorter RPPS-Ultrashort and RPPS-Short versions, fielded them with the RPPS-Long to a random sample of a national research volunteer registry, and assessed response and completion rates, test/retest reliability, and demographics.

In total, 2228 eligible registry members received survey links. Response rates were 64% (RPPS-Ultrashort), 63% (RPPS-Short), and 51% (RPPS-Long), respectively (p<0.001). Completion rates were 63%, 54%, and 37%, respectively (p<0.001). All surveys were reliable with Cronbach α=0.81, 0.84, and 0.87, respectively. Retest reliability was highest for RPPS-short (κ=0.85). Provision of compensation increased RPPS-short completion rate from 54% to 71% (p<0.001). Compensated respondents were younger (p<0.001), with greater minority representation (p=0.03).

Shorter surveys were reliable and produced higher response and completion rates then long surveys. Compensation further increased completion rates and shifted sample age and race profiles.