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Digital Telecytology for Triage of HPV-Positive Women in Cameroon

RecruitingNAAges 25 Years - 50 YearsFemaleUniversity Hospital, Geneva
NCT07550010 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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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What it tests

  • HPV testing (self-sampling)
  • Digital telecytology
  • AI-assisted telecytology
  • Thermal ablation
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Where

2 sites
Centre Hospitalier Universitaire de Yaoundé
Yaoundé, Cameroon
Yaoundé University Teaching Hospital (CHU)
Yaoundé, Cameroon
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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