Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer Screening Methods | — | UNRESOLVED | — |
| Cervical Intraepithelial Neoplasia Grade 2 (CIN2) | — | UNRESOLVED | — |
| Human Papillomavirus Infection | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AI-assisted telecytology | Diagnostic Test | — | UNRESOLVED |
| Digital telecytology | Diagnostic Test | — | UNRESOLVED |
| HPV testing (self-sampling) | Diagnostic Test | — | UNRESOLVED |
| Thermal ablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HPV-based screening with digital telecytology triage in a same-day test-triage-treat strategy
- description
- 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.
- interventionNames
- Diagnostic Test: HPV testing (self-sampling)
- Diagnostic Test: Digital telecytology
- Diagnostic Test: AI-assisted telecytology
- Procedure: Thermal ablation
Primary outcomes (1)
- measure
- Diagnostic accuracy of HPV-based screening with digital cytology triage for detection of CIN2+
- timeFrame
- At baseline (initial screening visit)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available