NCT07232355 · Atila Biosystems Inc.
Prevention of Cervical Cancer Using the Genotyping Screening and Same-day Self-sampling
(PROGRESS)
What this study is about
In May 2018, the World Health Organization (WHO) launched a strategy to eliminate cervical cancer. While this strategy seeks to achieve coverage of 70% in disease testing and 90% in treatment by 2030, it is estimated that these goals will not be achieved by most low- and middle- income (LMICs) countries until 2120 under existing conditions.
View original scientific description
In May 2018, the World Health Organization (WHO) launched a strategy to eliminate cervical cancer. While this strategy seeks to achieve coverage of 70% in disease testing and 90% in treatment by 2030, it is estimated that these goals will not be achieved by most low- and middle- income (LMICs) countries until 2120 under existing conditions. Presently, more than 90% of worldwide cervical cancer cases occur in LMICs. To accelerate this timeline, there is an urgent need for accurate, affordable and rapid testing that can facilitate same-day screening-and-treatment of cervical precancer. The AmpFire® human papillomavirus (HPV) test (Atila Biosystems, CA) has the potential to meet these needs. The test has been adapted to classify HPV positive women into four categories according to their risk for cervical cancer development based on the specific HPV type found during the test. Moreover, results can be delivered in less than 20 minutes for the highest risk HPV type, and less than an hour for the remaining HPV types. This is a potential game changer for countries where treating all HPV positive women is unfeasible. A combination of HPV test with other image-based triage strategies can further reduce overtreatment while reaching the most at-risk women. The goal of this project is to evaluate the performance and feasibility of an innovative same-day screening-and-treatment strategy in Honduras based on the AmpFire® HPV test combined with imaging triage using artificial intelligence via the Automated Visual Evaluation (AVE). Additionally, the investigators will evaluate the cost-effectiveness of the proposed approach vs. the current strategy based on visual inspection with acetic acid (VIA). The investigators believe that the AmpFire® test will have the potential to detect at least 90% of women with cervical precancer (performance). Similarly, the investigators anticipate that combining AmpFire® with AVE triage in a same-day screening-and-treatment strategy will be feasible and acceptable to patients and providers. The successful completion of this project will provide crucial data on the effectiveness of a self-sample, same-day screening-and-treatment approach with the potential to increase early detection while reducing loss to follow-up, ultimately resulting in increased adoption of this technology.
Primary outcome measures
Test performance of self- and provider- collected modified AmpFire® screening test.
Time frame: 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.
Time frame: 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-effectiveness
Time frame: 2 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Presence of a cervix
Exclusion criteria
- Cervical cancer screening in the past 2 years
- Prior diagnosis or treatment of cervical cancer
- Inability to tolerate a speculum exam
Where
- Sunnyvale, California
Collaborators
Basic Health International, Inc.
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 19, 2025 · Source of record for eligibility and locations