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Mail-Order HPV test could save lives in underscreened appalachian women

NCT ID NCT04411849

Diagnosis Sponsor: Ohio State University Comprehensive Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

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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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether offering at-home HPV self-testing kits can increase cervical cancer screening among women in Appalachia who are overdue for screening. Over 800 women from participating clinics were given either usual care or a self-testing kit along with information and phone support. The goal was to see if the self-testing option makes it easier for women to get screened and catch cervical cancer early.

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-collection kit
What this could lead to
If successful, this approach could make cervical cancer screening more accessible and convenient for women in underserved areas, potentially catching more cases early.
What could go wrong
This is a completed study, so results are available but may not apply to all populations. Self-testing may not be as accurate as a clinic-based test, and some women might still need follow-up care.

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

802 people

The number who actually took part.

Started

Aug 2021

Finished

Jun 2024

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 64 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: * Not within recommended cervical cancer screening guidelines for women in this age range (i.e., no Papanicolaou \[Pap\] test in last 3 years or no Pap test plus clinic-based HPV test in last 5 years) * Resident of an Appalachian county * Not currently pregnant * Intact cervix * No history of invasive cervical cancer * Seen in a participating clinic/health system in last 2 years (i.e., active patient) * Have a working telephone

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Conditions

The condition(s) this trial relates to.

cervical carcinoma human papilloma virus infection Uterine Cervical Neoplasms

As listed by the trial registrant

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

Cervical carcinoma Human papillomavirus infection

Contacts and locations

Locations

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536, United States

  • University of Virginia

    Charlottesville, Virginia, 22908, United States

  • West Virginia University

    Morgantown, West Virginia, 26506, United States

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