Actively Recruiting
Evaluation of Digital Cytology for the Triage of HPV-positive Women in a Same-day Test-triage-treat Cervical Cancer Screening Strategy in Cameroon
Led by University Hospital, Geneva · Updated on 2026-04-24
1800
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Geneva
Lead Sponsor
E
Ecole Polytechnique Fédérale de Lausanne (EPFL), Campus Biotech
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a same-day cervical cancer screening strategy in Cameroon that uses HPV self-sampling followed by digital telecytology triage for women who test positive for HPV. The study focuses on women aged 30 to 49 years, or 25 to 49 years if HIV-positive, aiming to assess the accuracy and practicality of this approach in detecting cervical intraepithelial neoplasia grade 2 or worse (CIN2+). The study also explores AI-assisted telecytology and visual inspection with acetic acid (VIA) as secondary tools, and assesses the acceptability of these screening and treatment methods among women and healthcare providers. Participants will collect vaginal samples for primary HPV testing using the GeneXpert system, which provides rapid detection and detailed genotyping. Women positive for HPV16 will be offered immediate thermal ablation treatment. Those positive for HPV types 18, 31, 33, 35, 45, 52, or 58 undergo same-day triage with digital telecytology, and if cytology shows abnormalities, thermal ablation is provided. Women positive for other HPV types will be followed up after 12 months without immediate treatment unless clinically needed. All HPV-positive women will receive endocervical sampling and biopsy as part of the diagnostic process. During the study, participants will undergo visual inspection, cytology slide preparation, and biopsies with remote evaluation by cytopathologists. Women with abnormal cytology are treated on the same day, and those diagnosed with CIN2+ receive appropriate treatment. Follow-up includes telephone calls 4 to 6 weeks after treatment to monitor side effects and acceptability, and a 12-month visit for repeat HPV testing and further examination when needed. The study will measure diagnostic accuracy, feasibility of the test-triage-treat method, AI tool performance, and acceptability over up to 26 months.
CONDITIONS
Brief Title
Digital Telecytology for Triage of HPV-Positive Women in Cameroon
Who Can Participate
Eligibility Criteria
You may qualify if you...
- HIV-negative women aged 30 to 49 years
- HIV-positive women aged 25 to 49 years
- Ability to understand study procedures
- Willingness to voluntarily participate by signing informed consent
You will not qualify if you...
- Pregnancy at the time of screening
- Previous hysterectomy
- Known cervical cancer
- Symptoms of cervical cancer such as metrorrhagia or pelvic mass
- Conditions interfering with cervix visualization
- Severe medical conditions like advanced cancer or terminal renal failure
- Inability to comply with study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Same day visit for test, triage, and treatment
Participants undergo primary HPV testing using self-collected vaginal samples with extended genotyping. HPV-positive women receive triage or treatment based on HPV type and cytology results as part of a same-day test-triage-treat strategy.
1 same-day visit (in-person)
Duration - Up to 12 months
Participants who receive treatment are followed by telephone at 4 to 6 weeks to assess adverse events and acceptability. All HPV-positive women are invited for a follow-up visit at 12 months including repeat HPV testing and additional examinations as clinically indicated.
1 telephone follow-up and 1 follow-up visit at 12 months (in-person and phone)
Trial Site Locations
Total: 2 locations
1
Centre Hospitalier Universitaire de Yaoundé
Yaoundé, Cameroon
Actively Recruiting
2
Yaoundé University Teaching Hospital (CHU)
Yaoundé, Cameroon
Actively Recruiting
Research Team
P
Patrick Petignat, Doctor; Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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