Digital Telecytology for Triage of HPV-Positive Women in Cameroon

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

Conditions

• Human Papillomavirus Infection
• Cervical Intraepithelial Neoplasia Grade 2 (CIN2)
• Cervical Cancer Screening Methods

Interventions

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).

Sponsors & Collaborators

• Ecole Polytechnique Fédérale de Lausanne (EPFL), Campus Biotech

  collaborator UNKNOWN

• University Hospital, Geneva

  lead OTHER

Study Design

Allocation

NA

Purpose

SCREENING

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

25 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-09-08

Primary Completion

2026-09-08

Completion

2027-09-08

Countries

• Cameroon

Study Locations