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Enrolling by invitation NCT07575217

Mail-in HPV Screening Program in NJ

No phase Interventional Cervical Cancer Screening

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BD Onclarity HPV test, Standard Pap Smear.
Who it may be relevant to
Registry conditions: Cervical Cancer Screening. Basic parameters: 30 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Mail-based HPV Sampling Program to Increase Cervical Cancer Screening in New Jersey

Overview

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.

Interventions

  • Diagnostic test BD Onclarity HPV test
    Self-collected cervicovaginal sample
  • Diagnostic test Standard Pap Smear
    Healthcare provider collected (in a hospital or clinical setting) cervicovaginal sample

Primary outcome measures

  • Completion of CC screening within 6 months of initial outreach. [Time frame: Outcome will be measured at 6 months post-initial outreach call.]
Secondary outcome measures (9)
  • Screening Pathway Choices and Performance [Time frame: From enrollment to the end of participation at 9 months]
  • Screening Pathway Choices and Performance [Time frame: From enrollment to the end of participation at 9 months]
  • Screening Pathway Choices and Performance [Time frame: From enrollment to the end of participation at 9 months]
  • Screening Pathway Choices and Performance [Time frame: From enrollment to the end of participation at 9 months]
  • Clinical Follow-Up and Downstream Outcomes [Time frame: From enrollment to the end of participation at 9 months]
  • Clinical Follow-Up and Downstream Outcomes [Time frame: From enrollment to the end of participation at 9 months]
  • Clinical Follow-Up and Downstream Outcomes [Time frame: From enrollment to the end of participation at 9 months]
  • Exploratory and Patient-Reported Outcomes [Time frame: From enrollment to the end of participation at 9 months]
  • Exploratory and Patient-Reported Outcomes [Time frame: From enrollment to the end of participation at 9 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Screening

Study locations

United States · 1 center
  • Rutgers New Jersey Medical School — Newark

Identifiers

NCT: NCT07575217 · Pro2025001687

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗