Single Visit Clinical Validation of ScreenFire, a Low-cost HPV Test

NCT05431699 | Active Not Recruiting DMC

• 1 other identifier: 22-108
• Study Type: interventional
• Target: 9,100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to validate a new low-cost, self-collected HPV screening test (ScreenFire) and compare it to the standard provider collected careHPV, for the detection of high grade cervical cancer.

Conditions

Human Papilloma Virus

Outcome Measures

Primary Outcomes (3)

• Sensitivity

  Proportion of true HPV positive cases based on biopsy detected by ScreenFire test via self-collection compared to careHPV via provider collection

  4-years

• Lost to follow-up

  Proportion of participants who do not complete their treatment six months after screening.

  6-months

• 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.

  4-years

Secondary Outcomes (3)

• Specificity

  During specific Aim 1, at baseline visit

• Positive predictive value (PPV)

  During specific Aim 1, at baseline visit

• Negative predictive value (NPV)

  During specific Aim 1, at baseline visit

Study Arms (1)

Screening population

OTHER

Women eligible for HPV screening will receive both ScreenFire (experimental) and careHPV (active comparator) based on El Salvador's national guidelines.

Diagnostic Test: ScreenFire HPV test; Diagnostic Test: careHPV test; Procedure: Colposcopy and biopsy; Procedure: Gas-based cryotherapy; Procedure: Thermal ablation

Interventions

ScreenFire HPV test DIAGNOSTIC_TEST

ScreenFire HPV test (Atila BioSystems, Inc, Mountain View, CA) uses isothermal amplification to detect 13 high risk (hr)HPV types directly from clinical samples in approximately one hour. The test can be run on any real-time PCR machine and gives separate results for hrHPV types 16 and 18, as well as a pooled positive result for 13 other hrHPV types. The human cellular gene beta-globin is used as an internal control to measure sample adequacy. ScreenFire can be self-collected and does not require batching. AmpFire® obtained CE-mark in 2017.

Screening population

careHPV test DIAGNOSTIC_TEST

The careHPV (QIAGEN, Gaithersburg, MD) test was developed in a public-private partnership specifically for use in low-resource settings. It is a simplified, robust, and affordable HPV test that does not distinguish specific HPV types; rather, it gives a positive result if any of 14 hrHPV types is present in the specimen. Electricity is necessary to run the test, but it does not need running water or air conditioning. In order to be most cost effective, the samples must be run with a full plate of 96 samples. Results take 3-4 hours to complete.

Screening population

Colposcopy and biopsy PROCEDURE

A colposcopic exam with biopsy entails visual magnification of the cervix and the removal of a small piece of cervical tissue. After the application of acetic acid 5% onto the cervix, a device called a colposcope allows the clinician to visually identify changes consistent with HPV. Areas of the cervix where lesions appear (or if not, randomly selected sections) are then biopsied (small piece of sample removed) and an endocervical curettage is performed (removing a small section from the inside of the cervix). Tissue specimens are then sent to the lab for pathology diagnosis.

Screening population

Gas-based cryotherapy PROCEDURE

Cryotherapy is performed to treat high-grade cervical precancer. First, a speculum is introduced into the vagina to identify the cervix. Acetic acid 5% is applied to the cervix for one minute and the cervix is observed to look for changes consistent with precancer. If the cervix is able to be fully evaluated and there are no signs of invasive cancer, a metal probe is inserted into the vagina and the tip is pressed against the cervix. Compressed carbon dioxide or nitrous oxide gas at a temperature of approximately -50ºC/-58ºF freezes the tip and creates an "ice ball" on the cervix. The ice ball ablates or destroys the abnormal cells.

Screening population

Thermal ablation PROCEDURE

Thermal ablation is utilized to treat high-grade cervical precancer. First, a speculum is introduced into the vagina to identify the cervix. Acetic acid 5% is applied to the cervix for one minute and the cervix is observed to look for changes consistent with precancer. If the cervix is able to be fully evaluated and there are no signs of invasive cancer, the tip of the device is heated to 100ºC and applied directly to the cervix for 1-2 minutes, which ablates or destroys the abnormal cells.

Screening population

Eligibility Criteria

• Age: 30 Years - 59 Years
• Gender Eligibility Details: Only women will be enrolled in this study because the research question concerns cervical pathology, and is thus only relevant to women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female, aged 30-59

You may not qualify if:

• Pregnancy at time of colposcopy/biopsy
• Hysterectomy with surgically absent cervix
• Cervical cancer screening in the past two years
• Prior diagnosis or treatment of invasive cervical cancer

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Medical College of Wisconsin: collaborator
• University of North Carolina, Chapel Hill: collaborator
• Basic Health International, Inc.: collaborator

Study Sites (1)

Ministerio de Salud

San Salvador, El Salvador

Location

MeSH Terms

Interventions

Colposcopy; Biopsy; Transurethral Resection of Prostate

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Specimen Handling; Investigative Techniques; Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures

Study Officials

• Miriam Cremer, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 24, 2022
• Study Start: February 13, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EL (1)