Same-day HPV self-testing with digital cytology triage in Cameroon
Evaluation of Digital Cytology for the Triage of HPV-positive Women in a Same-day "Test-triage-treat" Cervical Cancer Screening Strategy in Cameroon
This project will test whether HPV self-sampling followed by same-day digital telecytology can quickly find which HPV-positive women aged 30–49 (25–49 if HIV-positive) in Cameroon need treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1800 (estimated) |
| Ages | 25 Years to 50 Years |
| Sex | Female |
| Sponsor | University Hospital, Geneva Academic / other |
| Locations | 2 sites (Yaoundé and 1 other locations) |
| Trial ID | NCT07550010 on ClinicalTrials.gov |
What this trial studies
This is a prospective diagnostic accuracy and feasibility study at Yaoundé University Teaching Hospital using rapid HPV testing (GeneXpert) on self-collected samples. HPV-positive women are managed by an extended genotyping algorithm that directs immediate treatment for HPV16, same-day digital telecytology triage for several high-risk types, or follow-up for lower-risk types. Triage procedures include visual inspection with acetic acid (VIA), cytology, endocervical sampling, and biopsy as indicated, with histology as the reference standard for CIN2+. Secondary objectives include evaluating AI-assisted telecytology and the acceptability of screening and treatment strategies among women and providers.
Who should consider this trial
Good fit: Women living in or near Yaoundé who are 30–49 years old (25–49 if HIV-positive), able to consent, and able to attend same-day clinic procedures are ideal candidates.
Not a fit: Women who are HPV-negative, pregnant, have a prior hysterectomy, known cervical cancer, or conditions that prevent visualization of the cervix are excluded and would not benefit from this screening pathway.
Why it matters
Potential benefit: If successful, this approach could shorten the time to diagnosis and enable same-day treatment, reducing missed follow-up and progression to high-grade lesions.
How similar studies have performed: HPV self-sampling and test-triage-treat approaches have shown promise in low-resource settings, while AI-assisted and digital telecytology methods are newer and still undergoing validation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * HIV-negative women aged 30-49 and HIV-positive women aged 25-49 years old * Ability to understand study procedures and accepting voluntarily to participate by signing an informed consent form (ICF). Exclusion Criteria: * Pregnancy at the time of screening * Previous hysterectomy * Known cervical cancer * Symptoms of cervical cancer (e.g. metrorrhagia, known pelvic mass) * Conditions that can interfere with visualization of the cervix * Severe pre-existing medical conditions (e.g. advanced cancer, terminal renal failure) * Women who are not able to comply with the study protocol.
Where this trial is running
Yaoundé and 1 other locations
- Centre Hospitalier Universitaire de Yaoundé — Yaoundé, Cameroon (Recruiting)
- Yaoundé University Teaching Hospital (CHU) — Yaoundé, Cameroon (Recruiting)
Study contacts
- Study coordinator: Patrick Petignat, Doctor; Professor
- Email: patrick.petignat@hug.ch
- Phone: +41 22 37 24 432
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.