About this trial
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 criteria
Qualifiers
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).
Disqualifiers
Pregnancy at the time of screening
Previous hysterectomy
Known cervical cancer
Symptoms of cervical cancer (e.g. metrorrhagia, known pelvic mass)
Trial design
Treatments tested in this trial
- HPV testing (self-sampling)
- Digital telecytology
- AI-assisted telecytology
- Thermal ablation
Treatment groups
Sponsors and collaborators
University Hospital, Geneva
Lead sponsor
Ecole Polytechnique Fédérale de Lausanne (EPFL), Campus Biotech
Collaborator