Mail-in HPV Screening Program in NJ

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: Not yet recruiting
• Conditions: Cervical Cancer Screening
• Intervention / Treatment: Diagnostic test: Standard Pap Smear; Diagnostic test: BD Onclarity HPV test

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ana Tergas, MD, MPH; Phone Number: 973-972-5055; Email: ana.tergas@rutgers.edu
• Study Contact Backup: Name: Yenny Tavarez, MPH; Email: yenny.tavarez@rutgers.edu

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Screening Pathway Choices and Performance	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	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	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	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	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	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	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	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	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

Outcome Measure	Measure Description	Time Frame
Reach and Adoption	Proportion of eligible participants successfully contacted and offered the intervention.	From enrollment to the end of participation at 9 months
Reach and Adoption	Participant acceptance vs refusal rates, stratified by screening modality.	From enrollment to the end of participation at 9 months
Reach and Adoption	Equity assessment: Differences in screening uptake across demographic and socioeconomic subgroups.	From enrollment to the end of participation at 9 months
Feasibility and Fidelity	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	Proportion requiring replacement kits.	From enrollment to the end of participation at 9 months
Feasibility and Fidelity	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	Barriers and facilitators to participation identified via telephone structured surveys.	From enrollment to the end of participation at 9 months
Acceptability and Sustainability	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	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

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: Ana Tergas, MD, MPH, Rutgers, The State University of New Jersey

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: February 8, 2026
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID 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: No
• product manufactured in and exported from the U.S.: Yes