Developing and Implementing HPV SCREENED

NCT07657104 | Not Yet Recruiting

• 1 other identifier: Pro2025001198
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Cervical Cancer Screening; Human Papilloma Virus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• HPV Self Sampling Acceptability

  After results notification, an average of 1 week

• HPV Self Sampling Feasibility

  After results notification, an average of 1 week

• HPV Knowledge

  Day 1 and after results notification- an average of 1 week

• Screening Completion

  3 months

Study Arms (1)

HPV SCREENED

OTHER

A single-arm pilot trial of HPV self-sampling among under-screened women in the ED

Behavioral: HPV Self-collection in the ED

Interventions

HPV Self-collection in the ED BEHAVIORAL

Participants will be asked to collect a vaginal sample for HPV screening.

HPV SCREENED

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• currently pregnant (as diagnostic procedures for cervical cancer are often deferred during pregnancy);
• previous hysterectomy;
• previous diagnosis of cervical cancer;
• current menses

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (2)

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

Location

University Hospital

Newark, New Jersey, 07103, United States

Location

Study Officials

• Sara Heinert, PhD, MPH

  Department of Emergency Medicine, Rutgers Robert Wood Johnson Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Heinert, PhD, MPH

CONTACT

(732) 235-7872; sara.heinert@rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 18, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)