Digital Telecytology for Triage of HPV-Positive Women in Cameroon
Evaluation of Digital Cytology for the Triage of HPV-positive Women in a Same-day "Test-triage-treat" Cervical Cancer Screening Strategy in Cameroon
2 other identifiers
interventional
1,800
1 country
2
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2025
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 8, 2025
CompletedFirst Submitted
Initial submission to the registry
April 17, 2026
CompletedFirst Posted
Study publicly available on registry
April 24, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 8, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 8, 2027
April 24, 2026
September 1, 2025
1 year
April 17, 2026
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnostic accuracy of HPV-based screening with digital cytology triage for detection of CIN2+
Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and likelihood ratios of HPV testing with digital cytology triage for the detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+), using histology as the reference standard.
At baseline (initial screening visit)
Secondary Outcomes (5)
Feasibility of same-day test-triage-treat strategy
At baseline (same-day visit)
Diagnostic performance of AI-assisted telecytology for detection of CIN2+
At baseline
Detection rate of CIN2+ using AI-assisted VIA
At baseline
Agreement between digital cytology and AI-assisted cytology
At baseline
Acceptability of HPV-based screening and triage strategy
During study period (up to 26 months)
Study Arms (1)
HPV-based screening with digital telecytology triage in a same-day test-triage-treat strategy
EXPERIMENTALParticipants 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.
Interventions
HPV testing performed on self-collected vaginal samples providing extended genotyping for high-risk HPV types.
Digital cytology performed on HPV-positive women, including slide preparation, digitization, and remote interpretation by trained cytology experts for the detection of cytological abnormalities (≥ ASC-US).
Artificial intelligence-assisted analysis of digital cytology images to support detection of cervical abnormalities in HPV-positive women.
Thermal ablation is used for treatment of women who are HPV16-positive, as well as for women positive for HPV types 18, 31, 33, 35, 45, 52, or 58 who have abnormal cytology results (≥ ASC-US).
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Centre Hospitalier Universitaire de Yaoundé
Yaoundé, Cameroon
Yaoundé University Teaching Hospital (CHU)
Yaoundé, Cameroon
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of the Gynecologic Division
Study Record Dates
First Submitted
April 17, 2026
First Posted
April 24, 2026
Study Start
September 8, 2025
Primary Completion (Estimated)
September 8, 2026
Study Completion (Estimated)
September 8, 2027
Last Updated
April 24, 2026
Record last verified: 2025-09