Developing and Implementing HPV SCREENED
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HPV Self-collection in the ED.
- Who it may be relevant to
- Registry conditions: Cervical Cancer Screening, Human Papilloma Virus. Basic parameters: 30 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Developing and Implementing HPV SCREENED (Self-Collection REach and ENgagement in Emergency Departments) to Improve Cancer Equity
Overview
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.
Detailed description
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.
Interventions
- Behavioral HPV Self-collection in the ED
Participants will be asked to collect a vaginal sample for HPV screening.
Primary outcome measures
- Completion of ED-Based HPV Self-Sampling [Time frame: Day 1]
Secondary outcome measures (4)
- HPV Self Sampling Acceptability [Time frame: After results notification, an average of 1 week]
- HPV Self Sampling Feasibility [Time frame: After results notification, an average of 1 week]
- HPV Knowledge [Time frame: Day 1 and after results notification- an average of 1 week]
- Screening Completion [Time frame: 3 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- currently pregnant (as diagnostic procedures for cervical cancer are often deferred during pregnancy);
- previous hysterectomy;
- previous diagnosis of cervical cancer;
- current menses
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 2 centers
- Robert Wood Johnson University Hospital — New Brunswick
- University Hospital — Newark
Identifiers
NCT: NCT07657104 · Pro2025001198