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New Self-Test could slash cervical cancer rates in developing nations

NCT ID NCT07232355

Prevention Sponsor: Atila Biosystems Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study in Honduras tests a new way to prevent cervical cancer using a self-collected HPV test that gives results in under an hour, combined with AI-powered imaging. 5,000 women will participate to see if this same-day screening-and-treatment approach is accurate, feasible, and cost-effective. The goal is to make screening easier and reduce the number of women who miss follow-up care.

What this could mean

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

Active substance
AmpFire® HPV test (self-sampling kit) and Automated Visual Evaluation (AI imaging)
What this could lead to
If successful, this approach could make cervical cancer screening faster, cheaper, and more accessible in low-resource countries, potentially preventing many cases.
What could go wrong
This is a large feasibility study, not a final proof of cure. The test and AI triage may not perform as expected in real-world settings, and cost-effectiveness remains to be proven.

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.

Participants

About 5,000 people

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

Started

Aug 2023

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Regular screening population attending primary health units in Honduras.

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: * Presence of a cervix Exclusion Criteria: * Pregnancy * Cervical cancer screening in the past 2 years * Prior diagnosis or treatment of cervical cancer * Inability to tolerate a speculum exam

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Conditions

The condition(s) this trial relates to.

cervical intraepithelial neoplasia cervical intraepithelial neoplasia grade 2/3 human papilloma virus infection cervical cancer prevention target

As listed by the trial registrant

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

Human papilloma virus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atila Biosystems, Inc.

    RECRUITING

    Sunnyvale, California, 94085, United States

  • Basic Health International

    RECRUITING

    San Salvador, El Salvador

  • Centro de Salud Las Crucitas

    RECRUITING

    Tegucigalpa, Honduras

  • Ciudad Mujer Kennedy

    RECRUITING

    Tegucigalpa, Honduras

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