Validation of a low-cost self-collected HPV test
SCALE: Single Visit Clinical Validation of ScreenFire, a Low-cost HPV Test: Efficacy and Cost Effectiveness
This study is testing a new low-cost, self-collected HPV test to see if it works as well as the standard test for detecting serious cervical cancer in women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12000 (estimated) |
| Ages | 30 Years to 59 Years |
| Sex | Female |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (San Salvador) |
| Trial ID | NCT05431699 on ClinicalTrials.gov |
What this trial studies
This study aims to validate a new low-cost, self-collected HPV screening test called ScreenFire by comparing its effectiveness to the standard provider-collected careHPV test for detecting high-grade cervical cancer. The study will enroll 12,000 women over 50 months, with community health promoters facilitating outreach and scheduling. Participants will complete a self-collection of the ScreenFire test and a provider-collected careHPV test during a standard exam, ensuring comprehensive data collection. All COVID-19 precautions will be strictly followed throughout the study.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 30-59 who have not undergone cervical cancer screening in the past two years.
Not a fit: Patients who are pregnant, have had a hysterectomy, or have a prior diagnosis or treatment of invasive cervical cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accessible and cost-effective method for HPV screening, potentially increasing early detection of cervical cancer.
How similar studies have performed: Other studies have shown promise in validating self-collected HPV tests, indicating that this approach is gaining traction in the field.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female, aged 30-59 Exclusion Criteria: * 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
Where this trial is running
San Salvador
- Ministerio de Salud — San Salvador, El Salvador (Recruiting)
Study contacts
- Principal investigator: Miriam Cremer, M.D. — The Cleveland Clinic
- Study coordinator: Miriam Cremer, M.D.
- Email: cremerm@ccf.org
- Phone: 216-312-0618
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.