{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,21]],"date-time":"2026-08-21T12:17:47Z","timestamp":1787314667802,"version":"build-2736575974"},"reference-count":36,"publisher":"Cambridge University Press (CUP)","issue":"1","license":[{"start":{"date-parts":[[2025,4,16]],"date-time":"2025-04-16T00:00:00Z","timestamp":1744761600000},"content-version":"unspecified","delay-in-days":105,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J. Clin. Trans. Sci."],"published-print":{"date-parts":[[2025]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec id=\"S205986612500069X_as1\">\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>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\u2019 experiences of such trials remain largely unknown. This study explored participants\u2019 perspectives of the ACTIV-6 DCT that tested outpatient COVID-19 therapeutics.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"S205986612500069X_as2\">\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"S205986612500069X_as3\">\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Twenty-eight ACTIV-6 study participants aged 30+ years completed a virtual focus group including 1\u20134 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"S205986612500069X_as4\">\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1017\/cts.2025.69","type":"journal-article","created":{"date-parts":[[2025,4,16]],"date-time":"2025-04-16T04:21:45Z","timestamp":1744777305000},"source":"Crossref","is-referenced-by-count":4,"title":["Participant experiences in a decentralized clinical trial using digital health technologies: The ACTIV-6 study"],"prefix":"10.1017","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9011-2692","authenticated-orcid":false,"given":"Carrie","family":"Reale","sequence":"first","affiliation":[{"name":"Center for Research and Innovation in Systems Safety (CRISS)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janelle","family":"Faiman","sequence":"additional","affiliation":[{"name":"Center for Research and Innovation in Systems Safety (CRISS)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Russ","family":"Beebe","sequence":"additional","affiliation":[{"name":"Center for Research and Innovation in Systems Safety (CRISS)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica S.","family":"Marlin","sequence":"additional","affiliation":[{"name":"Vanderbilt Institute for Clinical and Translational Research (VICTR)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sean","family":"Collins","sequence":"additional","affiliation":[{"name":"Education and Clinical Center (GRECC)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4715-0060","authenticated-orcid":false,"given":"David R.","family":"Boulware","sequence":"additional","affiliation":[{"name":"Department of Medicine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah E.","family":"Dunsmore","sequence":"additional","affiliation":[{"name":"National Center for Advancing Translational Sciences"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Florence","family":"Thicklin","sequence":"additional","affiliation":[{"name":"Stakeholder Advisory Committee"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5138-0758","authenticated-orcid":false,"given":"Thomas G.","family":"Stewart","sequence":"additional","affiliation":[{"name":"University of Virginia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3387-9616","authenticated-orcid":false,"given":"Adrian F.","family":"Hernandez","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Russell L.","family":"Rothman","sequence":"additional","affiliation":[{"name":"Institute for Medicine and Public Health"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3297-2811","authenticated-orcid":false,"given":"Christopher J.","family":"Lindsell","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shilo","family":"Anders","sequence":"additional","affiliation":[{"name":"Center for Research and Innovation in Systems Safety (CRISS)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"for the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)-6 Study Group and Investigators","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"56","published-online":{"date-parts":[[2025,4,16]]},"reference":[{"key":"S205986612500069X_ref29","unstructured":"29. FDA. Assessing COVID-19-related symptoms in outpatient adult and adolescent subjects in clinical trials of drugs and biological products for COVID-19 prevention or treatment [FDA Guidance Document]. February. 2024, Accessed September 3, 2024, https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/assessing-covid-19-related-symptoms-outpatient-adult-and-adolescent-subjects-clinical-trials-drugs"},{"key":"S205986612500069X_ref19","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijid.2022.12.028"},{"key":"S205986612500069X_ref6","doi-asserted-by":"publisher","DOI":"10.1016\/j.pec.2011.06.002"},{"key":"S205986612500069X_ref1","doi-asserted-by":"publisher","DOI":"10.1177\/1740774514558307"},{"key":"S205986612500069X_ref33","doi-asserted-by":"publisher","DOI":"10.1017\/cts.2023.671"},{"key":"S205986612500069X_ref18","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2020.8920"},{"key":"S205986612500069X_ref31","doi-asserted-by":"publisher","DOI":"10.1002\/jmrs.421"},{"key":"S205986612500069X_ref32","unstructured":"32. ISO. ISO 9241-210: 2019: Ergonomics of human-system interaction \u2014 part 210: Human-centred design for interactive systems, ISO, https:\/\/www.iso.org\/standard\/77520.html, Accessed May 9, 2024."},{"key":"S205986612500069X_ref21","doi-asserted-by":"publisher","DOI":"10.1093\/ofid\/ofaa602"},{"key":"S205986612500069X_ref23","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.2628"},{"key":"S205986612500069X_ref30","doi-asserted-by":"publisher","DOI":"10.1016\/j.jbi.2008.08.010"},{"key":"S205986612500069X_ref7","doi-asserted-by":"publisher","DOI":"10.1093\/arclin\/acab083"},{"key":"S205986612500069X_ref17","doi-asserted-by":"crossref","first-page":"e221","DOI":"10.1017\/cts.2023.644","article-title":"ACTIV-6: Operationalizing a decentralized, outpatient randomized platform trial to evaluate efficacy of repurposed medicines for COVID-19","volume":"7","author":"Lindsell","year":"2023","journal-title":"J Clin Transl Sci"},{"key":"S205986612500069X_ref5","doi-asserted-by":"publisher","DOI":"10.1016\/j.conctc.2021.100829"},{"key":"S205986612500069X_ref10","doi-asserted-by":"publisher","DOI":"10.1038\/s41746-023-00841-8"},{"key":"S205986612500069X_ref28","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.2011.10111704"},{"key":"S205986612500069X_ref35","doi-asserted-by":"publisher","DOI":"10.2196\/37832"},{"key":"S205986612500069X_ref16","doi-asserted-by":"publisher","DOI":"10.1038\/s41746-021-00473-w"},{"key":"S205986612500069X_ref24","doi-asserted-by":"publisher","DOI":"10.1017\/cts.2022.397"},{"key":"S205986612500069X_ref26","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.15003"},{"key":"S205986612500069X_ref13","doi-asserted-by":"publisher","DOI":"10.2196\/28259"},{"key":"S205986612500069X_ref11","doi-asserted-by":"publisher","DOI":"10.1017\/cts.2023.643"},{"key":"S205986612500069X_ref22","unstructured":"22. FDA. The evolving role of decentralized clinical trials and digital health technologies. FDA. Published online August 10, 2023. Accessed October 23, 2023, https:\/\/www.fda.gov\/drugs\/news-events-human-drugs\/evolving-role-decentralized-clinical-trials-and-digital-health-technologies"},{"key":"S205986612500069X_ref15","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacbts.2021.01.011"},{"key":"S205986612500069X_ref8","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-019-3444-y"},{"key":"S205986612500069X_ref36","doi-asserted-by":"publisher","DOI":"10.2196\/22179"},{"key":"S205986612500069X_ref27","doi-asserted-by":"publisher","DOI":"10.1017\/cts.2023.597"},{"key":"S205986612500069X_ref12","doi-asserted-by":"publisher","DOI":"10.3389\/fcdhc.2022.936752"},{"key":"S205986612500069X_ref9","unstructured":"9. National Heart, Lung, and Blood Institute. Digital clinical trials workshop: creating a vision for the future | NHLBI, NIH. April 1, 2019. Accessed October 13, 2023. https:\/\/www.nhlbi.nih.gov\/events\/2019\/digital-clinical-trials-workshop-creating-vision-future"},{"key":"S205986612500069X_ref14","doi-asserted-by":"publisher","DOI":"10.14309\/ajg.0000000000001545"},{"key":"S205986612500069X_ref34","doi-asserted-by":"publisher","DOI":"10.1200\/CCI.19.00128"},{"key":"S205986612500069X_ref25","doi-asserted-by":"publisher","DOI":"10.1017\/cts.2023.668"},{"key":"S205986612500069X_ref3","doi-asserted-by":"publisher","DOI":"10.1200\/EDBK_243729"},{"key":"S205986612500069X_ref20","doi-asserted-by":"publisher","DOI":"10.1001\/jamaoncol.2023.6565"},{"key":"S205986612500069X_ref4","doi-asserted-by":"publisher","DOI":"10.1016\/j.conctc.2018.08.001"},{"key":"S205986612500069X_ref2","unstructured":"2. Bull, J , Uhlenbrauck, G , Mahon, E , Furlong, P , Roberts, J. Barriers to clinical trial recruitment and possible solutions: a stakeholder survey. Applied Clinical Trials Online. September 3, 2015. Accessed October 13, 2023. https:\/\/www.appliedclinicaltrialsonline.com\/view\/barriers-clinical-trial-recruitment-and-possible-solutions-stakeholder-survey"}],"container-title":["Journal of Clinical and Translational Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.cambridge.org\/core\/services\/aop-cambridge-core\/content\/view\/S205986612500069X","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,7]],"date-time":"2025-10-07T15:38:53Z","timestamp":1759851533000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.cambridge.org\/core\/product\/identifier\/S205986612500069X\/type\/journal_article"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025]]},"references-count":36,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2025]]}},"alternative-id":["S205986612500069X"],"URL":"https:\/\/doi.org\/10.1017\/cts.2025.69","relation":{},"ISSN":["2059-8661"],"issn-type":[{"value":"2059-8661","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025]]},"article-number":"e121"}}