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Digital Telecytology for Triage of HPV-Positive Women in Cameroon

RECRUITINGN/ASponsored by University Hospital, Geneva
Actively Recruiting
PhaseN/A
SponsorUniversity Hospital, Geneva
Started2025-09-08
Est. completion2026-09-08
Eligibility
Age25 Years – 50 Years
SexFEMALE
Healthy vol.Accepted

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

Age: 25 Years – 50 YearsSex: FEMALEHealthy volunteers accepted
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.

Conditions4

CancerCervical Cancer Screening MethodsCervical Intraepithelial Neoplasia Grade 2 (CIN2)Human Papillomavirus Infection

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