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Cervical Cancer Prevention Study Using AmpFire® Screening

This observational study is looking at new ways to prevent cervical cancer, especially in areas where it's harder to get screening. Researchers are testing a modified AmpFire® screening test, which checks for Human Papilloma Virus (HPV), the main cause of cervical cancer. They want to see how well this test works when people collect their own samples compared to samples collected by a healthcare provider. The study also aims to see if this test can make it easier to screen and treat cervical precancer in a single visit, and if it's cost-effective. You may be able to join if you are a woman between 30 and 64 years old and have a cervix. You cannot participate if you are pregnant, have had a cervical cancer screening in the past two years, or have a history of cervical cancer.

Study design
This is an observational study planning to enroll 5000 women. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure outcomes related to test performance, feasibility, and cost-effectiveness at 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07232355

Prevention of Cervical Cancer Using the Genotyping Screening and Same-day Self-sampling

Recruiting
Not specifiedAges 30–64Observational
Atila Biosystems Inc.
~5,000 participants
Updated 2025-11-19 on ClinicalTrials.gov

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Test performance of self- and provider- collected modified AmpFire® screening test.
Measured over 2 years
+2 more outcomes measured

Conditions

Human Papilloma Virus

Explore related trials

Human Papillomavirus Infection

Where it's being run

4 sites across 3 states
Honduras2
California1
El Salvador1

Who to contact

Miriam L Cremer, MD MPH
[email protected]
216-312-0618
Email the study team

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Eligibility criteria

Inclusion

Presence of a cervix

Exclusion

Pregnancy
Cervical cancer screening in the past 2 years
Prior diagnosis or treatment of cervical cancer
Inability to tolerate a speculum exam

What this trial measures

  • Test performance of self- and provider- collected modified AmpFire® screening test.2 years

    Evaluate sensitivity, specificity, positive predictive value and negative predictive value.

  • Feasibility of a single visit approach using a self-sampled modified AmpFire® screening test.2 years

    The primary feasibility outcome will be patient throughput, defined as the percentage of women screened, triaged and treated in the target time frames, and test processing time.

  • Cost-effectiveness2 years

    Incremental Cost Effectiveness Ratios (ICER) will be reported for each screening strategy as cost per life year saved and cost per DALY (disability-adjusted life years) averted.