Digital Telecytology for Triage of HPV-Positive Women 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
University Hospital, Geneva
1,800 participants
Sep 8, 2025
INTERVENTIONAL
Conditions
Summary
This study evaluates the diagnostic accuracy and feasibility of a same-day cervical cancer screening strategy using HPV self-sampling followed by digital telecytology triage among HPV-positive women in Cameroon. Women aged 30-49 years (or 25-49 years if HIV-positive) will undergo primary HPV testing using the GeneXpert system. HPV-positive women will be managed according to an extended HPV genotyping-based algorithm, including immediate treatment, telecytology triage, or follow-up. Histological assessment serves as the reference standard for the detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+). Secondary objectives include evaluation of AI-assisted telecytology and visual inspection with acetic acid (VIA), as well as the acceptability of screening and treatment strategies among women and healthcare providers. The study aims to generate evidence to support scalable, WHO-recommended test-triage-treat approaches in low-resource settings
Eligibility
Inclusion Criteria2
- 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 Criteria7
- 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.
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Interventions
HPV testing performed on self-collected vaginal samples providing extended genotyping for high-risk HPV types.
Digital cytology performed on HPV-positive women, including slide preparation, digitization, and remote interpretation by trained cytology experts for the detection of cytological abnormalities (≥ ASC-US).
Artificial intelligence-assisted analysis of digital cytology images to support detection of cervical abnormalities in HPV-positive women.
Thermal ablation is used for treatment of women who are HPV16-positive, as well as for women positive for HPV types 18, 31, 33, 35, 45, 52, or 58 who have abnormal cytology results (≥ ASC-US).
Locations(2)
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NCT07550010