Cervical Cancer Screening, Human Papilloma Virus
Conditions
Brief summary
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
BEHAVIORALHPV Self-collection in the ED
Participants will be asked to collect a vaginal sample for HPV screening.
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| HPV Knowledge | 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 |
| Screening Completion | 3 months | Proportion of HPV+ women who complete follow-up screening |
Countries
United States
Contacts
CONTACTSara Heinert, PhD, MPH
PRINCIPAL_INVESTIGATORSara Heinert, PhD, MPH
Department of Emergency Medicine, Rutgers Robert Wood Johnson Medical School
Outcome results
None listed