{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T03:22:53Z","timestamp":1792034573423,"version":"4.4.0"},"reference-count":45,"publisher":"Public Library of Science (PLoS)","issue":"8","license":[{"start":{"date-parts":[[2025,8,6]],"date-time":"2025-08-06T00:00:00Z","timestamp":1754438400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000030","name":"Centers for Disease Control and Prevention","doi-asserted-by":"publisher","award":["75D30120C08608"],"award-info":[{"award-number":["75D30120C08608"]}],"id":[{"id":"10.13039\/100000030","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS One"],"abstract":"<jats:sec id=\"sec001\">\n<jats:title>Background<\/jats:title>\n<jats:p>Controlled human infection model (CHIM) trials are useful tools for accelerating vaccine development through the deliberate infection of healthy volunteers in a controlled environment to study the course of disease in humans. CHIM trials may pose physical, psychological, and social harms to participants. Participants are subjected to long inpatient stays and daily sample collection, which may be uncomfortable. Very little is known about the CHIM trial participant experience and decision-making process.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec002\">\n<jats:title>Methods<\/jats:title>\n<jats:p>We conducted a modified grounded theory study, embedded within the Canadian Center for Vaccinology (CCfV)\u2019s <jats:italic><jats:italic>Bordetella pertussis<\/jats:italic><\/jats:italic> CHIM trial. Twenty six participants engaged in semi-structured interviews at four time periods throughout their year-long involvement in the CHIM trial, using a constant comparative approach of simultaneous data collection and analysis. This process continued until saturation was reached and an emerging theoretical model was constructed depicting the CHIM trial participant experience over time.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec003\">\n<jats:title>Results<\/jats:title>\n<jats:p>The emergent conceptual model centered around the core category \u201cA Trusting Partnership\u201d, depicting the evolution of the participant-researcher relationship throughout the experience. Establishing trust was critical during the decision-making phase, facilitated through transparent researcher-participant communication and consideration of past experiences and values. Supporting the trusting partnership during the inpatient isolation phase was facilitated through ongoing researcher-participant engagement and emotional support. During outpatient participation, maintaining the trusting partnership was achieved through effective communication, consistent follow-up care, and recognition of participants\u2019 contributions. Quality improvement (QI) recommendations were identified across all phases of CHIM trial participation.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec004\">\n<jats:title>Conclusions<\/jats:title>\n<jats:p>Researcher-participant trust is an integral component of the CHIM trial participant experience. QI recommendations should be taken into consideration when planning and coordinating future CHIM trials.<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0328378","type":"journal-article","created":{"date-parts":[[2025,8,6]],"date-time":"2025-08-06T17:24:39Z","timestamp":1754501079000},"page":"e0328378","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":2,"title":["Exploring the participant experience in controlled human infection model (CHIM) trials: A modified grounded theory study"],"prefix":"10.1371","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0009-0008-5664-6122","authenticated-orcid":true,"given":"Anna G.","family":"Mack","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Donna M.","family":"Halperin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bailey M.","family":"Selig","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian R.","family":"Condran","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott A.","family":"Halperin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2025,8,6]]},"reference":[{"issue":"7","key":"pone.0328378.ref001","doi-asserted-by":"crossref","first-page":"840","DOI":"10.1016\/S1473-3099(15)00068-7","article-title":"Design, recruitment, and microbiological considerations in human challenge studies","volume":"15","author":"TC Darton","year":"2015","journal-title":"Lancet Infect Dis"},{"issue":"1","key":"pone.0328378.ref002","doi-asserted-by":"crossref","first-page":"57","DOI":"10.1038\/nri2902","article-title":"Experimental human challenge infections can accelerate clinical malaria vaccine development","volume":"11","author":"RW Sauerwein","year":"2011","journal-title":"Nat Rev Immunol"},{"key":"pone.0328378.ref003","volume-title":"WHO guidance on the ethical conduct of controlled human infection studies","author":"World Health Organization","year":"2021"},{"issue":"7","key":"pone.0328378.ref004","doi-asserted-by":"crossref","first-page":"1028","DOI":"10.1086\/322664","article-title":"The ethical challenge of infection-inducing challenge experiments","volume":"33","author":"FG Miller","year":"2001","journal-title":"Clin Infect Dis"},{"key":"pone.0328378.ref005","doi-asserted-by":"crossref","first-page":"143","DOI":"10.12688\/wellcomeopenres.15337.1","article-title":"Expert voices and equal partnerships: establishing Controlled Human Infection Models (CHIMs) in Vietnam","volume":"4","author":"E Kestelyn","year":"2019","journal-title":"Wellcome Open Res"},{"issue":"1","key":"pone.0328378.ref006","doi-asserted-by":"crossref","first-page":"3","DOI":"10.1080\/08989629908573939","article-title":"Guinea pigs on the payroll: the ethics of paying research subjects","volume":"7","author":"T Lemmens","year":"1999","journal-title":"Account Res"},{"issue":"4","key":"pone.0328378.ref007","doi-asserted-by":"crossref","first-page":"365","DOI":"10.1177\/00912700222011409","article-title":"The Recruitment of Normal Healthy Volunteers: A Review of The Literature on the Use of Financial Incentives","volume":"42","author":"CL Tishler","year":"2002","journal-title":"The Journal of Clinical Pharma"},{"key":"pone.0328378.ref008","first-page":"36","article-title":"Guinea-pigging: Healthy human subjects for drug-safety trials are in demand. But is it a living?","author":"C Elliot","year":"2008","journal-title":"The New Yorker"},{"issue":"3","key":"pone.0328378.ref009","doi-asserted-by":"crossref","first-page":"342","DOI":"10.1016\/j.cct.2010.12.003","article-title":"More than the money: a review of the literature examining healthy volunteer motivations","volume":"32","author":"L Stunkel","year":"2011","journal-title":"Contemp Clin Trials"},{"issue":"11","key":"pone.0328378.ref010","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0275823","article-title":"Characterizing altruistic motivation in potential volunteers for SARS-CoV-2 challenge trials","volume":"17","author":"AA Marsh","year":"2022","journal-title":"PLoS ONE"},{"issue":"1","key":"pone.0328378.ref011","doi-asserted-by":"crossref","first-page":"49","DOI":"10.1177\/1556264618820219","article-title":"Exploring Ethical Concerns About Human Challenge Studies: A Qualitative Study of Controlled Human Malaria Infection Study Participants\u2019 Motivations and Attitudes","volume":"14","author":"SA Kraft","year":"2019","journal-title":"J Empir Res Hum Res Ethics"},{"issue":"7","key":"pone.0328378.ref012","article-title":"Money-oriented risk-takers or deliberate decision-makers: a cross-sectional survey study of participants in controlled human infection trials","volume":"10","author":"M-A Hoogerwerf","year":"2020","journal-title":"BMJ Open"},{"key":"pone.0328378.ref013","doi-asserted-by":"crossref","first-page":"39","DOI":"10.12688\/wellcomeopenres.14439.1","article-title":"Ethical considerations in Controlled Human Malaria Infection studies in low resource settings: Experiences and perceptions of study participants in a malaria Challenge study in Kenya","volume":"3","author":"M Njue","year":"2018","journal-title":"Wellcome Open Res"},{"issue":"3","key":"pone.0328378.ref014","doi-asserted-by":"crossref","first-page":"381","DOI":"10.1177\/1049732317697102","article-title":"A Guide to Field Notes for Qualitative Research: Context and Conversation","volume":"28","author":"J Phillippi","year":"2018","journal-title":"Qual Health Res"},{"issue":"3","key":"pone.0328378.ref015","doi-asserted-by":"crossref","first-page":"449","DOI":"10.1128\/CMR.00083-15","article-title":"Pertussis: Microbiology, Disease, Treatment, and Prevention","volume":"29","author":"PE Kilgore","year":"2016","journal-title":"Clin Microbiol Rev"},{"key":"pone.0328378.ref016","volume-title":"The discovery of grounded theory","author":"B Glaser","year":"1967"},{"issue":"8","key":"pone.0328378.ref017","doi-asserted-by":"crossref","first-page":"1045","DOI":"10.1177\/1077800413513733","article-title":"Pragmatism as a Paradigm for Social Research","volume":"20","author":"DL Morgan","year":"2014","journal-title":"Qualitative Inquiry"},{"key":"pone.0328378.ref018","doi-asserted-by":"crossref","first-page":"2050312118822927","DOI":"10.1177\/2050312118822927","article-title":"Grounded theory research: A design framework for novice researchers","volume":"7","author":"Y Chun Tie","year":"2019","journal-title":"SAGE Open Med"},{"key":"pone.0328378.ref019","unstructured":"IWK Health [Internet]. Patient and Family-Centered Care. Available from: http:\/\/www.iwk.nshealth.ca\/pfcc"},{"issue":"1","key":"pone.0328378.ref020","doi-asserted-by":"crossref","first-page":"7120","DOI":"10.5688\/ajpe7120","article-title":"A Review of the Quality Indicators of Rigor in Qualitative Research","volume":"84","author":"JL Johnson","year":"2020","journal-title":"Am J Pharm Educ"},{"issue":"6","key":"pone.0328378.ref021","doi-asserted-by":"crossref","first-page":"947","DOI":"10.1177\/1049732319899139","article-title":"Confused About Theoretical Sampling? Engaging Theoretical Sampling in Diverse Grounded Theory Studies","volume":"30","author":"C Conlon","year":"2020","journal-title":"Qual Health Res"},{"issue":"1","key":"pone.0328378.ref022","doi-asserted-by":"crossref","first-page":"68","DOI":"10.1177\/1744987107081254","article-title":"Memoing in qualitative research","volume":"13","author":"M Birks","year":"2008","journal-title":"Journal of Research in Nursing"},{"key":"pone.0328378.ref023","article-title":"Ensuring rigour and trustworthiness of qualitative research in clinical pharmacy","author":"MA Hadi","year":"2015","journal-title":"Int J Clin Pharm"},{"key":"pone.0328378.ref024","volume-title":"Basics of qualitative research: Grounded theory procedures and techniques","author":"A Strauss","year":"1990"},{"issue":"3","key":"pone.0328378.ref025","doi-asserted-by":"crossref","first-page":"295","DOI":"10.1016\/j.pec.2008.11.015","article-title":"How does communication heal? Pathways linking clinician-patient communication to health outcomes","volume":"74","author":"RL Street","year":"2009","journal-title":"Patient Educ Couns"},{"key":"pone.0328378.ref026","doi-asserted-by":"crossref","first-page":"153","DOI":"10.12688\/wellcomeopenres.15469.1","article-title":"Factors influencing participation in controlled human infection models: a pooled analysis from six enteric fever studies","volume":"4","author":"B Oguti","year":"2019","journal-title":"Wellcome Open Res"},{"issue":"1","key":"pone.0328378.ref027","doi-asserted-by":"crossref","first-page":"494","DOI":"10.1186\/s13063-021-05455-7","article-title":"Understanding the benefits and burdens associated with a malaria human infection study in Kenya: experiences of study volunteers and other stakeholders","volume":"22","author":"PC Chi","year":"2021","journal-title":"Trials"},{"issue":"1","key":"pone.0328378.ref028","doi-asserted-by":"crossref","first-page":"33","DOI":"10.1186\/s40900-021-00277-y","article-title":"Assessing public perception of a sand fly biting study on the pathway to a controlled human infection model for cutaneous leishmaniasis","volume":"7","author":"V Parkash","year":"2021","journal-title":"Res Involv Engagem"},{"issue":"1","key":"pone.0328378.ref029","doi-asserted-by":"crossref","first-page":"209","DOI":"10.1186\/s12916-020-01670-2","article-title":"Exploring the acceptability of controlled human infection with SARSCoV2-a public consultation","volume":"18","author":"D Gbesemete","year":"2020","journal-title":"BMC Med"},{"key":"pone.0328378.ref030","doi-asserted-by":"crossref","first-page":"89","DOI":"10.12688\/wellcomeopenres.16587.1","article-title":"\u201cAt first, I was very afraid\u201d-a qualitative description of participants\u2019 views and experiences in the first Human Infection Study in Malawi","volume":"6","author":"N Mtunthama Toto","year":"2021","journal-title":"Wellcome Open Res"},{"issue":"8","key":"pone.0328378.ref031","doi-asserted-by":"crossref","first-page":"819","DOI":"10.1111\/bioe.12781","article-title":"Deliberately infecting healthy volunteers with malaria parasites: Perceptions and experiences of participants and other stakeholders in a Kenyan\u2010based malaria infection study","volume":"34","author":"I Jao","year":"2020","journal-title":"Bioethics"},{"issue":"2","key":"pone.0328378.ref032","doi-asserted-by":"crossref","first-page":"289","DOI":"10.1016\/j.vaccine.2018.11.014","article-title":"Motivation for participating in phase 1 vaccine trials: Comparison of an influenza and an Ebola randomized controlled trial","volume":"37","author":"A Cattapan","year":"2019","journal-title":"Vaccine"},{"issue":"3","key":"pone.0328378.ref033","doi-asserted-by":"crossref","first-page":"198","DOI":"10.1056\/NEJM199907153410312","article-title":"What\u2019s the price of a research subject? Approaches to payment for research participation","volume":"341","author":"N Dickert","year":"1999","journal-title":"N Engl J Med"},{"issue":"1","key":"pone.0328378.ref034","doi-asserted-by":"crossref","first-page":"46","DOI":"10.1186\/s12910-022-00783-y","article-title":"Ethical considerations around volunteer payments in a malaria human infection study in Kenya: an embedded empirical ethics study","volume":"23","author":"PC Chi","year":"2022","journal-title":"BMC Med Ethics"},{"key":"pone.0328378.ref035","author":"L Ettinger","year":"2024"},{"issue":"4","key":"pone.0328378.ref036","doi-asserted-by":"crossref","first-page":"1049","DOI":"10.1007\/s11948-014-9579-z","article-title":"Deliberate Microbial Infection Research Reveals Limitations to Current Safety Protections of Healthy Human Subjects","volume":"21","author":"DL Evers","year":"2015","journal-title":"Sci Eng Ethics"},{"issue":"1","key":"pone.0328378.ref037","doi-asserted-by":"crossref","first-page":"110","DOI":"10.1136\/jme.2003.004440","article-title":"Challenge studies of human volunteers: ethical issues","volume":"30","author":"T Hope","year":"2004","journal-title":"J Med Ethics"},{"issue":"11","key":"pone.0328378.ref038","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pmed.1002698","article-title":"Healthy volunteers\u2019 perceptions of risk in US Phase I clinical trials: A mixed-methods study","volume":"15","author":"JA Fisher","year":"2018","journal-title":"PLoS Med"},{"issue":"2","key":"pone.0328378.ref039","doi-asserted-by":"crossref","first-page":"97","DOI":"10.1016\/j.jhin.2010.04.027","article-title":"Adverse effects of isolation in hospitalised patients: a systematic review","volume":"76","author":"C Abad","year":"2010","journal-title":"J Hosp Infect"},{"issue":"30","key":"pone.0328378.ref040","first-page":"53","article-title":"The experience of infectious patients in isolation","volume":"89","author":"HE Knowles","year":"1993","journal-title":"Nurs Times"},{"issue":"5","key":"pone.0328378.ref041","doi-asserted-by":"crossref","first-page":"31","DOI":"10.1080\/15265161.2020.1745936","article-title":"Bridging the Researcher-Participant Gap: A Research Agenda to Build Effective Research Relationships","volume":"20","author":"SA Kraft","year":"2020","journal-title":"Am J Bioeth"},{"issue":"5","key":"pone.0328378.ref042","doi-asserted-by":"crossref","first-page":"31","DOI":"10.1080\/15265161.2020.1745936","article-title":"Bridging the Researcher-Participant Gap: A Research Agenda to Build Effective Research Relationships","volume":"20","author":"SA Kraft","year":"2020","journal-title":"Am J Bioeth"},{"key":"pone.0328378.ref043","doi-asserted-by":"crossref","DOI":"10.2196\/38159","article-title":"Establishing Requirements for Technology to Support Clinical Trial Retention: Systematic Scoping Review and Analysis Using Self-determination Theory","volume":"25","author":"E Gamble","year":"2023","journal-title":"J Med Internet Res"},{"issue":"9","key":"pone.0328378.ref044","doi-asserted-by":"crossref","first-page":"992","DOI":"10.1097\/00001888-199909000-00010","article-title":"The importance of self-determination theory for medical education","volume":"74","author":"GC Williams","year":"1999","journal-title":"Acad Med"},{"key":"pone.0328378.ref045","first-page":"1","article-title":"Facilitating health behaviour change and its maintenance: Interventions based on Self-Determination Theory","volume":"10","author":"RM Ryan","year":"2008","journal-title":"European Health Psychologist"}],"container-title":["PLOS One"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0328378","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,8,6]],"date-time":"2025-08-06T17:24:46Z","timestamp":1754501086000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0328378"}},"subtitle":[],"editor":[{"given":"Primus Che","family":"Chi","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2025,8,6]]},"references-count":45,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2025,8,6]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0328378","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,8,6]]}}}