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
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).
Pregnancy at the time of screening
Previous hysterectomy
Known cervical cancer
Symptoms of cervical cancer (e.g. metrorrhagia, known pelvic mass)
Single group
HPV testing (self-sampling)
Diagnostic testHPV testing performed on self-collected vaginal samples providing extended genotyping for high-risk HPV types.
Digital telecytology
Diagnostic testDigital 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).
AI-assisted telecytology
Diagnostic testArtificial intelligence-assisted analysis of digital cytology images to support detection of cervical abnormalities in HPV-positive women.
Thermal ablation
Procedure/SurgeryThermal 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).
Diagnostic accuracy of HPV-based screening with digital cytology triage for detection of CIN2+
Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and likelihood ratios of HPV testing with digital cytology triage for the detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+), using histology as the reference standard.
Feasibility of same-day test-triage-treat strategy
Proportion of HPV-positive women who receive cytology results on the same day among all HPV-positive women undergoing triage.
Diagnostic performance of AI-assisted telecytology for detection of CIN2+
Sensitivity, specificity, positive predictive value, and negative predictive value of AI-assisted telecytology for detection of cervical intraepithelial neoplasia grade 2 or worse, using histology as the reference standard.
Detection rate of CIN2+ using AI-assisted VIA
Proportion of CIN2+ lesions detected by AI-assisted visual inspection with acetic acid (VIA) among HPV-positive women, using histology as reference.
Agreement between digital cytology and AI-assisted cytology
Agreement between standard digital cytology and AI-assisted cytology for the detection of cytological abnormalities (≥ ASC-US) among HPV-positive women.
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University Hospital, Geneva
Lead sponsor
Ecole Polytechnique Fédérale de Lausanne (EPFL), Campus Biotech
Collaborator