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Could a Mail-In HPV test replace the pap smear?

NCT ID NCT07575217

Diagnosis Sponsor: Rutgers, The State University of New Jersey Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 4 times

Summary

This study tests whether mailing HPV self-sampling kits to people who are overdue for cervical cancer screening makes it easier for them to get tested. Researchers will enroll 200 women, transgender men, and nonbinary individuals aged 30-75 in New Jersey. Participants can choose to use the mailed kit or go to a clinic for a standard Pap smear. The goal is to see if this approach improves screening rates and is acceptable to users.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HPV self-sampling kit
What this could lead to
If successful, this could make cervical cancer screening more accessible and convenient for people who miss regular checkups.
What could go wrong
This is a small, early-stage study (200 participants) focused on feasibility, not on detecting cancer directly. The self-sampling method may not be as accurate as clinic-based tests.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 75 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical cancer screening

How to take part

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  1. The places running it

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  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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Contacts and locations

Locations

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07103, United States

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