HPV Self-collection in the ED
BehavioralParticipants will be asked to collect a vaginal sample for HPV screening.
NCT Number: NCT07657104
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.
Trial opening soon.
Get Notified30 year–65 year
Female
Interventional
Not applicable
Robert Wood Johnson University Hospital, New Brunswick, New Jersey, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will be asked to collect a vaginal sample for HPV screening.
Time frame: Day 1
Evaluate the proportion of eligible participants who complete HPV self-sampling during the emergency department visit.
Time frame: After results notification, an average of 1 week
Acceptability of Intervention Measure (AIM) scale (Weiner et al., 2017). Scale values range from 1 to 5, where higher is more acceptable.
Time frame: After results notification, an average of 1 week
Feasibility of Intervention Measure (FIM) scale (Weiner et al., 2017). Scale values range from 1 to 5, where higher is more feasible.
Time frame: Day 1 and after results notification- an average of 1 week
Cervical Cancer Knowledge Scale (CCKS)- 7 items where a higher score is more knowledge
Time frame: 3 months
Proportion of HPV+ women who complete follow-up screening
Contact information is provided by the study sponsor or research team.
Rutgers, The State University of New Jersey
Other
Developing and Implementing HPV SCREENED (Self-Collection REach and ENgagement in Emergency Departments) to Improve Cancer Equity
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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