Digital Telecytology for Triage of HPV-Positive Women in Cameroon

April 17, 2026 updated by: Prof. Patrick Petignat, University Hospital, Geneva

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective, single-center diagnostic accuracy and feasibility study conducted at the Yaoundé University Hospital in Cameroon. It evaluates a same-day cervical cancer screening strategy based on primary HPV testing with self-sampling, followed by triage using extended HPV genotyping and digital telecytology among HPV-positive women, within a test-triage-treat approach.

Women aged 30 to 49 years, and HIV-positive women aged 25 to 49 years, will be invited to participate following community-based awareness activities and hospital-based recruitment. After providing written informed consent, participants will perform HPV self-sampling. Primary screening will be conducted using the GeneXpert system, which provides rapid detection and genotyping of oncogenic HPV types.

Management of HPV-positive women will follow a predefined algorithm based on extended HPV genotyping. Women positive for HPV type 16 will be considered for immediate treatment following clinical assessment. Women positive for HPV types 18, 45, 31, 33, 35, 52, or 58 will undergo same-day triage using digital telecytology. Women positive for HPV types 51, 59, 39, 56, 66, or 68 will be scheduled for follow-up without immediate treatment unless clinically indicated.

For triage procedures, all HPV-positive women will undergo visual inspection with acetic acid (VIA), cervical cytology, and endocervical sampling, with either a VIA-directed biopsy or a random biopsy of the transformation zone, as appropriate. Cytology slides will be prepared locally and digitized for remote interpretation by trained cytopathologists. Women with cytological abnormalities of atypical squamous cells of undetermined significance (ASC-US) or worse will be offered same-day treatment with thermal ablation. Histological assessment of endocervical samples and biopsies will serve as the reference standard for the detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+).

Artificial intelligence-assisted telecytology and AI-assisted VIA will be evaluated as secondary diagnostic tools. These AI-based analyses will not be used for clinical decision-making but will be assessed retrospectively to determine their diagnostic performance and concordance with standard interpretation.

Eligible women diagnosed with CIN2+ will be offered treatment, if not already performed, primarily with thermal ablation, in accordance with World Health Organization eligibility criteria and local standards of care. Women with suspected invasive cancer will be referred for further diagnostic evaluation and appropriate management.

Participants who receive treatment will be followed by telephone at 4 to 6 weeks to assess adverse events and acceptability. All HPV-positive women will be invited for a follow-up visit at 12 months, including repeat HPV testing and additional examinations as clinically indicated. Acceptability of screening and treatment strategies will be assessed among participants and healthcare providers using standardized questionnaires.

The study aims to assess the diagnostic accuracy, feasibility, and acceptability of a scalable, same-day HPV-based cervical cancer screening strategy incorporating digital telecytology and artificial intelligence in a low-resource setting.

Study Type

Interventional

Enrollment (Estimated)

1800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Cameroon
      • Yaoundé, Cameroon
        • Recruiting
        • Centre Hospitalier Universitaire de Yaoundé
        • Contact:
      • Yaoundé, Cameroon
        • Recruiting
        • Yaoundé University Teaching Hospital (CHU)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Diagnostic test: HPV testing (self-sampling)
HPV testing performed on self-collected vaginal samples providing extended genotyping for high-risk HPV types.
Diagnostic test: Digital telecytology
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).
Diagnostic test: AI-assisted telecytology
Artificial intelligence-assisted analysis of digital cytology images to support detection of cervical abnormalities in HPV-positive women.
Procedure: Thermal ablation
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of HPV-based screening with digital cytology triage for detection of CIN2+
Time Frame: At baseline (initial screening visit)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of same-day test-triage-treat strategy
Time Frame: At baseline (same-day visit)
Proportion of HPV-positive women who receive cytology results on the same day among all HPV-positive women undergoing triage.
At baseline (same-day visit)
Diagnostic performance of AI-assisted telecytology for detection of CIN2+
Time Frame: At baseline
Sensitivity, specificity, positive predictive value, and negative predictive value of AI-assisted telecytology for detection of cervical intraepithelial neoplasia grade 2 or worse, using histology as the reference standard.
At baseline
Detection rate of CIN2+ using AI-assisted VIA
Time Frame: At baseline
Proportion of CIN2+ lesions detected by AI-assisted visual inspection with acetic acid (VIA) among HPV-positive women, using histology as reference.
At baseline
Agreement between digital cytology and AI-assisted cytology
Time Frame: At baseline
Agreement between standard digital cytology and AI-assisted cytology for the detection of cytological abnormalities (≥ ASC-US) among HPV-positive women.
At baseline
Acceptability of HPV-based screening and triage strategy
Time Frame: During study period (up to 26 months)
Acceptability of HPV self-sampling, digital cytology, AI-assisted methods, and treatment procedures among participants and healthcare providers, assessed using structured questionnaires.
During study period (up to 26 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Collaborators

Ecole Polytechnique Fédérale de Lausanne (EPFL), Campus Biotech

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2025

Primary Completion (Estimated)

September 8, 2026

Study Completion (Estimated)

September 8, 2027

Study Registration Dates

First Submitted

April 17, 2026

First Submitted That Met QC Criteria

April 17, 2026

First Posted (Actual)

April 24, 2026

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/09/1828/CE/CNERSH/SP
  • KFS-6044-02-2024 (Other Grant/Funding Number: Swiss Cancer Research)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Anonymized data may be shared upon reasonable request at the end of the study period.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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