[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07657104":3,"trial-entities:NCT07657104":114,"trial-summary:NCT07657104":119},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":36,"secondary_outcomes":41,"sex":57,"minimum_age":58,"maximum_age":59,"healthy_volunteers":60,"eligibility_criteria":61,"std_ages":77,"locations":80,"central_contacts":104,"overall_officials":108,"references":112,"see_also_links":113},"NCT07657104","Pro2025001198","Developing and Implementing HPV SCREENED","Developing and Implementing HPV SCREENED (Self-Collection REach and ENgagement in Emergency Departments) to Improve Cancer Equity","NOT_YET_RECRUITING","2027-09-30","2026-08","2026-08-11","2026-08-20","Rutgers, The State University of New Jersey","OTHER",false,"This study will assess the feasibility of implementing HPV self-sampling as a primary cervical cancer screening strategy for under-screened women in the emergency department (ED). Eligible participants will receive education and an HPV self-sampling kit to complete in the ED. Individuals with HPV-positive results will be guided to follow-up care at a local clinic.","The proposed study will implement HPV self-sampling as primary cervical screening for under-screened ED patients. The long-term goal is to increase access to cervical screening for women who may not routinely use primary care and thus face increased risk of cervical cancer. This pilot feasibility trial will implement HPV self-sampling kit distribution and navigation to follow-up care in the ED. The investigators hypothesize that ED-based in-person distribution and same-day return of HPV self-sampling kits will alleviate issues of prior mailed HPV self-sampling trials by reducing participant burden. Women (30-65 years with non-critically ill presentations) who present to the ED and are overdue for cervical screening will receive 1) cervical cancer screening education and 2) a HPV self-sampling kit where they return the kit immediately after self-sampling in the ED. ScreenNJ will navigate participants with HPV-positive results to follow-up care and management according to current standard guidelines at local clinics.",[19,20],"Cervical Cancer Screening","Human Papilloma Virus",[],"INTERVENTIONAL","SCREENING",[25],"NA",{"count":27,"type":28},100,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"BEHAVIORAL","HPV Self-collection in the ED","Participants will be asked to collect a vaginal sample for HPV screening.",[35],"HPV SCREENED",[37],{"measure":38,"description":39,"timeFrame":40},"Completion of ED-Based HPV Self-Sampling","Evaluate the proportion of eligible participants who complete HPV self-sampling during the emergency department visit.","Day 1",[42,46,49,53],{"measure":43,"description":44,"timeFrame":45},"HPV Self Sampling Acceptability","Acceptability of Intervention Measure (AIM) scale (Weiner et al., 2017). Scale values range from 1 to 5, where higher is more acceptable.","After results notification, an average of 1 week",{"measure":47,"description":48,"timeFrame":45},"HPV Self Sampling Feasibility","Feasibility of Intervention Measure (FIM) scale (Weiner et al., 2017). Scale values range from 1 to 5, where higher is more feasible.",{"measure":50,"description":51,"timeFrame":52},"HPV Knowledge","Cervical Cancer Knowledge Scale (CCKS)- 7 items where a higher score is more knowledge","Day 1 and after results notification- an average of 1 week",{"measure":54,"description":55,"timeFrame":56},"Screening Completion","Proportion of HPV+ women who complete follow-up screening","3 months","FEMALE","30 Years","65 Years",true,{"inclusion":62,"exclusion":71,"raw_text":76},[63,64,65,66,67,68,69,70],"biological women,","no prior hysterectomy or cervical cancer,","not pregnant,","last Pap \\>3 years, last co-test \\>5 years, or last HPV alone test \\>5 years,","speak English or Spanish,","has a working cellphone,","NJ residency","ED patient",[72,73,74,75],"currently pregnant (as diagnostic procedures for cervical cancer are often deferred during pregnancy);","previous hysterectomy;","previous diagnosis of cervical cancer;","current menses","Inclusion Criteria:\n\n* biological women,\n* no prior hysterectomy or cervical cancer,\n* not pregnant,\n* last Pap \\>3 years, last co-test \\>5 years, or last HPV alone test \\>5 years,\n* speak English or Spanish,\n* has a working cellphone,\n* NJ residency\n* ED patient\n\nExclusion Criteria:\n\n* currently pregnant (as diagnostic procedures for cervical cancer are often deferred during pregnancy);\n* previous hysterectomy;\n* previous diagnosis of cervical cancer;\n* current menses",[78,79],"ADULT","OLDER_ADULT",[81,94],{"facility":82,"city":83,"state":84,"zip":85,"country":86,"contacts":87,"geoPoint":91},"Robert Wood Johnson University Hospital","New Brunswick","New Jersey","08901","United States",[88],{"name":89,"role":90},"Sara Heinert, PhD, MPH","CONTACT",{"lat":92,"lon":93},40.48622,-74.45182,{"facility":95,"city":96,"state":84,"zip":97,"country":86,"contacts":98,"geoPoint":101},"University Hospital","Newark","07103",[99],{"name":100,"role":90},"Ronald Ikechi, MD",{"lat":102,"lon":103},40.73566,-74.17237,[105],{"name":89,"role":90,"phone":106,"email":107},"(732) 235-7872","sara.heinert@rutgers.edu",[109],{"name":89,"affiliation":110,"role":111},"Department of Emergency Medicine, Rutgers Robert Wood Johnson Medical School","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":115,"biomarkers":118},[116,117],"Cervical Carcinoma","Human Papillomavirus Infection",[],{"nct_id":4,"found":60,"summary":120,"prompt_version":130},{"design":121,"status":122,"heading":123,"summary":124,"follow_up":125,"word_count":126,"commitments":127,"compensation":128,"drugs_mentioned":129},"This is an interventional study with a planned enrollment of 100 participants. It is designed to test a behavioral intervention.","completed","HPV Self-Sampling in the Emergency Department for Cervical Cancer Screening","This study is looking at how well HPV self-sampling works for cervical cancer screening in women who don't get screened regularly. If you are a woman between 30 and 65 years old, live in New Jersey, have a working cellphone, and are in the emergency department, you might be able to join. You also need to have not had a hysterectomy or cervical cancer, not be pregnant, and be overdue for a Pap test or HPV test. The study will give you education and an HPV self-sampling kit to use while you are in the emergency department. The main goal is to see if people complete the self-sampling. If your HPV test is positive, you will be helped to get follow-up care at a local clinic. The current recruitment status is unclear.","Participants are followed to see if they complete the ED-based HPV self-sampling, measured at Day 1.",132,"You would be asked to collect a vaginal sample for HPV screening in the emergency department. This would happen on Day 1 of your participation.","Not stated in the trial record.",[],"v2"]