Digital Telecytology for Triage of HPV-Positive Women in Cameroon

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-50
SponsorUniversity Hospital, Geneva

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

1,800 Participants
are divided into 1 treatment group

Sponsors and collaborators

University Hospital, Geneva

Lead sponsor

Ecole Polytechnique Fédérale de Lausanne (EPFL), Campus Biotech

Collaborator