[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618785":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":50,"centralContacts":55,"locations":60,"responsibleParty":76,"collaborators":78,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":49,"eligibilityCriteria":88,"healthyVolunteers":89,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":49,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":105,"overallStatus":62,"whyStopped":49,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Thomas Jefferson University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: Evalyn Brush Self-Collection - Phase I (Validation)","EXPERIMENTAL","Participants will be provided the Evalyn Brush self-sample kit at their scheduled Pap smear; a self-collected HPV test will also be collected as part of validation purposes for the study. Results will be shared from both their regularly scheduled appointment and the HPV self sample kit.",[13],"Device: Evalyn® Brush",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm 2: Evalyn Brush Self-Collection - Phase II (Community Implementation)","Participants will be assigned to use the Evalyn Brush device to evaluate feasibility and acceptability of use. Trained bilingual community health workers (CHWs) will provide culturally-tailored community workshops about cervical health and cervical cancer prevention, distribution and collection of HPV self-collection, and follow-up from results when appropriate.",[13,18],"Behavioral: CHW4CervicalHealth",{"label":20,"type":10,"description":21,"interventionNames":22},"Arm 3: Copan FLOQSwab Self-Collection - Phase II (Community Implementation)","Participants will be assigned to use the Copan FLOQSwab device to evaluate feasibility and acceptability of use. Trained bilingual community health workers (CHWs) will provide culturally-tailored community workshops about cervical health and cervical cancer prevention, distribution and collection of HPV self-collection, and follow-up from results when appropriate.",[23,18],"Device: Copan Floqswab",[25,34,44],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DEVICE","Evalyn® Brush","Participants use Evalyn® Brush device to collect a cervical sample for HPV testing.",[9,15],[31,32,33],"Rovers® Self-Sampling Device","simply Evalyn","Viba-Brush®",{"type":26,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"Copan Floqswab","Participants use the Copan Floqswab device to collect a cervical sample for HPV testing.",[20],[39,40,41,42,43],"4N6FLOQSwabs® Genetics","eSwab®","hDNA Free FLOQSwabs®","flocked swabs","nylon-tipped swabs",{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"BEHAVIORAL","CHW4CervicalHealth","The CHW4CervicalHealth intervention is a community health care worker (CHW)-led education and support program designed to promote HPV self-collection among underserved women. Trained bilingual CHWs provide culturally-tailored community workshops about cervical health and cervical cancer prevention, distribution and collection of HPV self-collection, and follow-up from results when appropriate.",[15,20],null,[51],{"name":52,"affiliation":53,"role":54},"Sandra Dayaratna, MD, MBA","Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University","PRINCIPAL_INVESTIGATOR",[56],{"name":52,"role":57,"phone":58,"phoneExt":49,"email":59},"CONTACT","617-834-3894","Sandra.Dayaratna@jefferson.edu",[61],{"facility":5,"status":62,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"RECRUITING","Philadelphia","Pennsylvania","19107","United States","US",{"type":69,"coordinates":70},"Point",[71,72],-75.16362,39.95238,{"lat":72,"lon":71},[75],{"name":52,"role":57,"phone":58,"phoneExt":49,"email":59},{"type":77,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR",[79],{"name":80,"class":81},"Roche Pharma AG","INDUSTRY","100618785","popsci-chw4cervixhealth-100618785",false,"NCT07336134","PopSci CHW4CervixHealth","Uptake of HPV Self-sampling in Underserved Minority Women Using a Community Health Worker Model: Comparison of Evalyn Brush and Copan Floqswab","Inclusion Criteria:\n\nPhase I:\n\n* Women aged 25-65 years\n* Scheduled for a Pap smear test appointment at Jefferson OBGYN Center City location\n* Willing and able to provide informed consent for participation in the study\n* Agree to perform an HPV self-collection collection procedure during the same visit\n* Have not undergone a hysterectomy (intact cervix required)\n\nPhase II:\n\nThis intervention targets under-screened minority individuals who must meet all the following inclusion criteria to be eligible to participate in the study:\n\n* Women aged 25-65 years\n* Who has not had a Pap smear in the past three to five years based on age of prior screening and type of screening. If under the age of 30, in the past 3 years and if over the age of 30, in the past 5 years. Participant will self-report normal pap smear and date.\n* Self-identify as Hispanic, Black\u002FAfrican or Black Caribbean, Chinese, Korean, or Vietnamese\n* Competent to give consent and provide signed and dated informed consent form in their preferred language.\n\nExclusion Criteria:\n\nPhase I:\n\n* Current pregnancy (self-reported or confirmed)\n* Previous participation in an HPV self-collection study within the past 12 months\n* Presence of visible vaginal or cervical infection or symptoms suggestive of a current genital tract infection\n* Inability to comply with study procedures or follow instructions (e.g., due to language barriers or cognitive impairments)\n\nPhase II:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Have a history of hysterectomy, cervical cancer\n* Self-report participation in a cervical cancer screening or other prevention study\n* Pregnant (self-reported)\n* Inability to provide informed consent",true,"FEMALE","25 Years","65 Years",{"count":94,"type":95},120,"ESTIMATED","INTERVENTIONAL",[98],"NA","Phase I: Validating self-collection kit by comparing their results with clinical Pap smear results in a cohort of 20 patients.\n\nPhase II: Evaluate the feasibility and acceptability of the CHW4CervicalHealth: Use of a self-collection kit to improve cervical health screening intervention aimed to promote HPV self-collection uptake among screening-eligible and under-screened ethnic minority women in the community.",[101,102,103,104],"Cervical Cancer","Hpv","Human Papilloma Virus","HPV Infection",[106,27,107,108,109,110,111],"Copan FLOQswab","HPV self-collection","self-collection","community health workers","underscreened women","concordance","2026-01-09",{"date":114,"type":115},"2026-01-13","ACTUAL",{"date":117,"type":115},"2025-10-22",{"date":119,"type":95},"2026-07-01",{"name":5,"class":6},1]