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Evaluation of Digital Cytology for the Triage of HPV-positive Women in a Same-day Test-triage-treat Cervical Cancer Screening Strategy in Cameroon

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 25
Maximum Age: 50
Healthy Volunteers: t
View:

• 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).

Locations
Other Locations
Cameroon
Centre Hospitalier Universitaire de Yaoundé
RECRUITING
Yaoundé
Yaoundé University Teaching Hospital (CHU)
RECRUITING
Yaoundé
Contact Information
Primary
Patrick Petignat, Doctor; Professor
patrick.petignat@hug.ch
+41 22 37 24 432
Time Frame
Start Date: 2025-09-08
Estimated Completion Date: 2027-09-08
Participants
Target number of participants: 1800
Treatments
Experimental: HPV-based screening with digital telecytology triage in a same-day test-triage-treat strategy
Participants undergo primary HPV testing using self-collected vaginal samples with extended genotyping. Management is based on HPV genotype within a predefined test-triage-treat strategy:~* Women positive for HPV16 receive immediate treatment with thermal ablation.~* Women positive for HPV types 18, 31, 33, 35, 45, 52, or 58 undergo triage with digital telecytology. If cytology results are abnormal (≥ ASC-US), treatment with thermal ablation is provided.~* Women positive for HPV types 51, 59, 39, 56, 66, or 68 are managed with follow-up at 12 months without immediate treatment.~All HPV-positive women undergo endocervical sampling and biopsy, as the reference standard for diagnostic evaluation.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Geneva
Collaborators: Ecole Polytechnique Fédérale de Lausanne (EPFL), Campus Biotech

This content was sourced from clinicaltrials.gov

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