Recruiting

HPV Self-Sampling

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT07657104

Conditions

Cervical Cancer Screening

Human Papilloma Virus

Eligibility Criteria

Sex: Female

Age: 30 - 65

Healthy Volunteers: Accepted

Interventions

HPV Self-collection in the ED

Study Details

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

Study ID

NCT07657104

Start date

Oct 15, 2026

Status verified date

Oct, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 30 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

other: HPV SCREENED

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

Interventions

HPV Self-collection in the ED

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

Primary outcome measure

  • Completion of ED-Based HPV Self-Sampling [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Sara Heinert, PhD, MPH

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

Locations

Robert Wood Johnson University Hospital

Recruiting

New Brunswick, New Jersey, United States, 08901

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Oct 22, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2026-10-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.