Mail-in HPV Screening Program in NJ

August 3, 2026 updated by: Ana Isabel Tergas, MD, MPH, Rutgers, The State University of New Jersey

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • Rutgers New Jersey Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard Pap Smear
Participants will have the option to choose a standard pap smear for cervical cancer screening
Diagnostic test: Standard Pap Smear
Healthcare provider collected (in a hospital or clinical setting) cervicovaginal sample
Experimental: HPV Self-Sampling Test
Participants are able to opt-in for an at-home self-sampling HPV test for cervical cancer screening
Diagnostic test: BD Onclarity HPV test
Self-collected cervicovaginal sample

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Completion of CC screening within 6 months of initial outreach.
Time Frame: Outcome will be measured at 6 months post-initial outreach call.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Screening Pathway Choices and Performance
Time Frame: From enrollment to the end of participation at 9 months
Proportion of participants selecting self-sampling vs clinic-based Pap test (percentage of women choosing each modality after initial outreach)
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
Timeliness of screening completion (measured as days from outreach to Pap attendance or kit return).
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 test result distribution (categorized as negative, positive, or inadequate, stratified by modality).
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
HPV genotype distribution among positive samples (individual and group reporting per lab protocol)
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 completion after abnormal results (attendance at colposcopy or initiation of treatment).
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
Detection of histologically confirmed cervical intraepithelial neoplasia grade 2 or higher (CIN2+) or invasive cervical cancer.
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
Treatment initiation and completion rates among those diagnosed with CIN2+ or cancer.
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
Associations between demographic/clinical factors and screening completion (e.g., race/ethnicity, insurance status, education, prior screening history).
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
Patient-reported experiences including satisfaction, ease of kit use, clarity of instructions, stress/anxiety during self-sampling, trust in results, and willingness to undergo self-sampling in future screening.
From enrollment to the end of participation at 9 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Reach and Adoption
Time Frame: From enrollment to the end of participation at 9 months
Proportion of eligible participants successfully contacted and offered the intervention.
From enrollment to the end of participation at 9 months
Reach and Adoption
Time Frame: From enrollment to the end of participation at 9 months
Participant acceptance vs refusal rates, stratified by screening modality.
From enrollment to the end of participation at 9 months
Reach and Adoption
Time Frame: From enrollment to the end of participation at 9 months
Equity assessment: Differences in screening uptake across demographic and socioeconomic subgroups.
From enrollment to the end of participation at 9 months
Feasibility and Fidelity
Time Frame: From enrollment to the end of participation at 9 months
Return rate of mailed self-sampling kits (valid, invalid, and late returns).
From enrollment to the end of participation at 9 months
Feasibility and Fidelity
Time Frame: From enrollment to the end of participation at 9 months
Proportion requiring replacement kits.
From enrollment to the end of participation at 9 months
Feasibility and Fidelity
Time Frame: From enrollment to the end of participation at 9 months
Staff adherence to outreach protocol (number, spacing, and mode of call attempts and reminders per protocol).
From enrollment to the end of participation at 9 months
Acceptability and Sustainability
Time Frame: From enrollment to the end of participation at 9 months
Barriers and facilitators to participation identified via telephone structured surveys.
From enrollment to the end of participation at 9 months
Acceptability and Sustainability
Time Frame: From enrollment to the end of participation at 9 months
Acceptability of self-sampling as routine care (participant endorsement of future use of mail-based HPV kits).
From enrollment to the end of participation at 9 months
Acceptability and Sustainability
Time Frame: From enrollment to the end of participation at 9 months
Institutional ability to sustain or scale implementation strategies (assessed through staff feedback and system-level considerations).
From enrollment to the end of participation at 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rutgers, The State University of New Jersey

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ana Tergas, MD, MPH, Rutgers, The State University of New Jersey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 16, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro2025001687

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

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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