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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPV SCREENED | Other | A single-arm pilot trial of HPV self-sampling among under-screened women in the ED |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPV Self-collection in the ED | Behavioral | Participants will be asked to collect a vaginal sample for HPV screening. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| HPV Self Sampling Feasibility |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara Heinert, PhD, MPH | Contact | (732) 235-7872 | sara.heinert@rutgers.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sara Heinert, PhD, MPH | Department of Emergency Medicine, Rutgers Robert Wood Johnson Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08901 | United States |
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Feasibility of Intervention Measure (FIM) scale (Weiner et al., 2017). Scale values range from 1 to 5, where higher is more feasible. |
| After results notification, an average of 1 week |
| 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 |
| Screening Completion | Proportion of HPV+ women who complete follow-up screening | 3 months |
| University Hospital | Newark | New Jersey | 07103 | United States |
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