Developing and Implementing HPV SCREENED

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.

• HPV Self-collection in the ED (Behavioral): Participants will be asked to collect a vaginal sample for HPV screening.

Primary outcomes

• Completion of ED-Based HPV Self-Sampling [Day 1]: Evaluate the proportion of eligible participants who complete HPV self-sampling during the emergency department visit.

Secondary outcomes

• HPV Self Sampling Acceptability [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.
• HPV Self Sampling Feasibility [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.
• Screening Completion [3 months]: Proportion of HPV+ women who complete follow-up screening

Sex: Female, ages: 30 Years to 65 Years, accepts healthy volunteers

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

• Sara Heinert, PhD, MPH, Principal investigator, Department of Emergency Medicine, Rutgers Robert Wood Johnson Medical School