Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07575217

Mail-in HPV Screening Program in NJ

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

30 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BD Onclarity HPV test

Diagnostic Test

Self-collected cervicovaginal sample

Standard Pap Smear

Diagnostic Test

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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).

  3. 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).

  4. 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)

  5. 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).

  6. 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.

  7. 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.

  8. 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).

  9. 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.

Other outcomes

  1. 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.

  2. Reach and Adoption

    Time frame: From enrollment to the end of participation at 9 months

    Participant acceptance vs refusal rates, stratified by screening modality.

  3. 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.

  4. 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).

  5. Feasibility and Fidelity

    Time frame: From enrollment to the end of participation at 9 months

    Proportion requiring replacement kits.

  6. 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).

  7. 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.

  8. 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).

  9. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Ana Tergas, MD, MPH

CONTACT

[email protected]

973-972-5055

Yenny Tavarez, MPH

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 8, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.