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

NCT07232355 | Recruiting DMC

• 1 other identifier: 1R44CA272177-01
• Study Type: observational
• Target: 5,000
• Locations: 3 countries
• Sites: 4

Brief Summary

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.

Conditions

Human Papilloma Virus

Outcome Measures

Primary Outcomes (3)

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

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

  2 years

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

  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.

  2 years

• Cost-effectiveness

  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.

  2 years

Eligibility Criteria

• Age: 30 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Regular screening population attending primary health units in Honduras.

You may qualify if:

• Presence of a cervix

You may not qualify if:

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

Sponsors & Collaborators

• Atila Biosystems Inc.: lead
• Basic Health International: collaborator

Study Sites (4)

Atila Biosystems, Inc.

Sunnyvale, California, 94085, United States

RECRUITING

Basic Health International

San Salvador, El Salvador

RECRUITING

Centro de Salud Las Crucitas

Tegucigalpa, Honduras

RECRUITING

Ciudad Mujer Kennedy

Tegucigalpa, Honduras

RECRUITING

Central Study Contacts

Miriam L Cremer, MD MPH

CONTACT

216-312-0618; mcremer@basichealth.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: August 24, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 1 year after study completion

Locations

US (1); HO (2); EL (1)