Mail-in HPV Screening Program in NJ

NCT07575217 | Not Yet Recruiting

• 1 other identifier: Pro2025001687
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to help people who have missed their regular cervical cancer screening. The investigators are evaluating whether mailing an HPV self-sampling kit to participant home makes it easier and more convenient for people to get screened for cervical cancer. This study will also help to understand if people find this process acceptable and whether it is an effective way to improve screening rates.

Conditions

Cervical Cancer Screening

Outcome Measures

Primary Outcomes (1)

• Completion of CC screening within 6 months of initial outreach.

  Defined as either (a) return of a valid HPV self-sample kit to the processing laboratory, or (b) attendance for a clinic-based Pap test documented in the medical record.

  Outcome will be measured at 6 months post-initial outreach call.

Secondary Outcomes (9)

• Screening Pathway Choices and Performance

  From enrollment to the end of participation at 9 months

• Screening Pathway Choices and Performance

  From enrollment to the end of participation at 9 months

• Screening Pathway Choices and Performance

  From enrollment to the end of participation at 9 months

• Screening Pathway Choices and Performance

  From enrollment to the end of participation at 9 months

• Clinical Follow-Up and Downstream Outcomes

  From enrollment to the end of participation at 9 months

Other Outcomes (9)

• Reach and Adoption

  From enrollment to the end of participation at 9 months

• Reach and Adoption

  From enrollment to the end of participation at 9 months

• Reach and Adoption

  From enrollment to the end of participation at 9 months

Study Arms (2)

Standard Pap Smear

ACTIVE COMPARATOR

Participants will have the option to choose a standard pap smear for cervical cancer screening

Diagnostic Test: Standard Pap Smear

HPV Self-Sampling Test

EXPERIMENTAL

Participants are able to opt-in for an at-home self-sampling HPV test for cervical cancer screening

Diagnostic Test: BD Onclarity HPV test

Interventions

BD Onclarity HPV test DIAGNOSTIC_TEST

Self-collected cervicovaginal sample

HPV Self-Sampling Test

Standard Pap Smear DIAGNOSTIC_TEST

Healthcare provider collected (in a hospital or clinical setting) cervicovaginal sample

Standard Pap Smear

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women, transgender men, and nonbinary individuals aged 30 to 75 who have a cervix.
• No history of hysterectomy or cervical cancer.
• No documented cervical cancer screening within guideline-recommended intervals: specifically, no Pap test in the past 3.5 years, no Pap/HPV co-test in the past 5.5 years, and no standalone HPV test results in the past 5.5 years. (A 6-month grace period is included to allow time for response to usual care outreach.)
• At least two visits to University Hospital ambulatory care over the past five years, ensuring opportunity for follow-up and continuity of care.

You may not qualify if:

• History of cervical dysplasia within the past 3.5 years, reflecting those likely under active surveillance or treatment protocols.
• Currently pregnant, due to differing screening recommendations and clinical considerations.
• Prior or current diagnosis of cervical cancer or ongoing treatment for cervical neoplasia.
• Physical, cognitive, or functional limitations that would preclude use of the mailed self-sampling kit without assistance. Examples include severe arthritis or significant impairment affecting self-collection capability.
• Lack of a telephone number or reliable mailing address on file.
• Inability to communicate in English or Spanish, given study materials and staffing capabilities. Use of additional language services is not available.
• Current enrollment in other cervical cancer screening or intervention studies that may interfere with participation or outcomes.
• Inability to provide informed consent or comprehend study procedures based on cognitive capacity, as assessed by the Research Coordinator during initial contact.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Officials

• Ana Tergas, MD, MPH

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Tergas, MD, MPH

CONTACT

973-972-5055; ana.tergas@rutgers.edu

Yenny Tavarez, MPH

CONTACT

yenny.tavarez@rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Gynecologic Oncology

Model Details: Participants will have the option to op-in for an at-home HPV sampling test or receive a standard pap smear.

Study Record Dates

• First Submitted: February 8, 2026
• First Posted: May 8, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share