Using a portable colposcope for cervical cancer screening
Development and Validation of an Artificial-Intelligence-enabled Portable Colposcopy Device for Optimizing Triage Alternatives for HPV-based Cervical Cancer Screening
This study is testing a portable device to help screen women for cervical cancer and HPV in Kenya, aiming to improve diagnosis and treatment options.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1079 (estimated) |
| Ages | 25 Years and up |
| Sex | Female |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Nairobi) |
| Trial ID | NCT06458062 on ClinicalTrials.gov |
What this trial studies
This study involves the use of a portable colposcope to screen women for cervical cancer and HPV infection in outpatient clinics in Kisumu County, Kenya. Women aged 25 to 65 who test positive for HPV will undergo colposcopy, where biopsies will be taken from any suspicious lesions or randomly if none are visible. Eligible participants will receive immediate treatment if appropriate, while those with concerning lesions will be referred for further procedures. The study aims to develop a CARE algorithm to assist in diagnosis based on the collected images.
Who should consider this trial
Good fit: Ideal candidates are women aged 25 to 65 who have tested positive for HPV within the last six months.
Not a fit: Patients who are pregnant, have a negative HPV test, or a history of cervical cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance cervical cancer screening and treatment accessibility for women in low-resource settings.
How similar studies have performed: Other studies using portable colposcopy have shown promise, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 30 years old and ≤ 64 years old; or Age ≥ 25 years old if women living with HIV (WLWH) 2. Sex: Female 3. Positive HPV test within past 6 months Exclusion Criteria: 1. Pregnant women (cannot perform a cervical biopsy on a patient who is pregnant unless absolutely indicated) 2. Women with a negative HPV test within the past 9 months 3. Patients incapable of giving informed consent 4. Women with a history of cervical cancer 5. Pelvic exam concerning for cervical cancer or cervical infection 6. History of hysterectomy
Where this trial is running
Nairobi
- Kenya Medical Research Institute — Nairobi, Kenya (Recruiting)
Study contacts
- Principal investigator: Megan Huchko, MD — Duke University
- Study coordinator: Megan Huchko, MD
- Email: megan.huchko@duke.edu
- Phone: 919-684-8111
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.