Developing and Implementing HPV SCREENED

Developing and Implementing HPV SCREENED (Self-Collection REach and ENgagement in Emergency Departments) to Improve Cancer Equity

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cervical Cancer Screening; Human Papilloma Virus
• Intervention / Treatment: Behavioral: HPV Self-collection in the ED

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara Heinert, PhD, MPH; Phone Number: (732) 235-7872; Email: sara.heinert@rutgers.edu

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Robert Wood Johnson University Hospital
      • Contact: Sara Heinert, PhD, MPH
    • Newark, New Jersey, United States, 07103
      • University Hospital
      • Contact: Ronald Ikechi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: HPV SCREENED; A single-arm pilot trial of HPV self-sampling among under-screened women in the ED	Behavioral: HPV Self-collection in the ED; Participants will be asked to collect a vaginal sample for HPV screening.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: Sara Heinert, PhD, MPH, Department of Emergency Medicine, Rutgers Robert Wood Johnson Medical School

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: June 9, 2026
• First Submitted That Met QC Criteria: June 17, 2026
• First Posted (Actual): June 18, 2026

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 17, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Pro2025001198

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No