Validation of a low-cost cervical cancer screening test
Official title: Validation of a Lab-free Low-cost Screening Test for Prevention of Cervical Cancer: Automated Visual Evaluation
Run by DL Analytics · NCT06815939 · Data updated 2026-11-12
This study is testing a new, low-cost cervical cancer screening tool to see if it works as well as traditional methods for women in El Salvador.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 30 Years to 59 Years |
| Sex | Women only |
| Enrollment | 10000 (estimated) |
| Sponsor | DL Analytics Industry-sponsored |
| Locations | 1 site (San Salvador) |
| Status | Recruiting |
| Started | February 12, 2025 |
| Main results expected | July 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | January 29, 2026 |
| Trial ID | NCT06815939 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are women aged 30 to 59 years living in San Salvador, El Salvador.
✕Probably not a fit
Patients who have had a hysterectomy, are currently pregnant, or have had a cervical cancer diagnosis or treatment in the last 5 years may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to validate the Automated Visual Evaluation (AVE), specifically the CINFinder version developed by DL Analytics, as a point-of-care screening tool for cervical cancer. The study will involve a prospective paired observational design with 10,000 women in San Salvador, El Salvador, comparing the sensitivity of AVE against traditional screening methods such as HPV tests and visual inspection with acetic acid. The goal is to improve cervical cancer screening in low-and middle-income countries where resources are limited and the disease burden is high.
Why it matters
Potential benefit: If successful, this study could provide a more accessible and effective screening method for cervical cancer, potentially reducing mortality rates in underserved populations.
How similar studies have gone: Other studies have explored automated visual evaluation technologies, but this specific application as a screening tool is novel and untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women between 30 and 59 years of age Exclusion Criteria: * Pregnancy at the time of colposcopy/biopsy * Hysterectomy with surgically absent cervix * HPV test in the last 5 years independently of negative or positive result * Previous cervical cancer diagnosis or treatment in the last 5 years * Lack of willingness or capacity to provide informed consent
Where it's running
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Ministerio de Salud
San Salvador, El Salvador Recruiting
Study contacts
- Principal investigator: Karla Alfaro, MD — Basic Health International, Inc.
- Study coordinator: David Levitz, PhD
- Email: levitz@dlanalytics.ai
- Phone: 817-966-5600
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.