An interventional study of HPV testing (self-sampling) and Digital telecytology in Human Papillomavirus Infection, Cervical Intraepithelial Neoplasia Grade 2 (CIN2) and Cervical Cancer Screening Methods, sponsored by University Hospital, Geneva. Recruiting at 2 sites in Cameroon. Open to female participants aged 25 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-24.
Sponsored by University Hospital, Geneva · Not applicable, Interventional, and Screening
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
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.
576 studies on the registry are indexed under Papillomavirus Infections; 132 are open to participants now.
This study's planned enrollment of 1,800 is above the median of 235 across 402 interventional studies indexed under Papillomavirus Infections.
Browse Papillomavirus Infections studies →University Hospital, Geneva is the lead sponsor of 379 studies on the registry; 70 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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) · Diagnostic Test: Digital telecytology · Diagnostic Test: AI-assisted telecytology · Procedure: Thermal ablation
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).
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.
Time frame: At baseline (initial screening visit)
Feasibility of same-day test-triage-treat strategy
Proportion of HPV-positive women who receive cytology results on the same day among all HPV-positive women undergoing triage.
Time frame: At baseline (same-day visit)
Diagnostic performance of AI-assisted telecytology for detection of CIN2+
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.
Time frame: At baseline
Detection rate of CIN2+ using AI-assisted VIA
Proportion of CIN2+ lesions detected by AI-assisted visual inspection with acetic acid (VIA) among HPV-positive women, using histology as reference.
Time frame: At baseline
Agreement between digital cytology and AI-assisted cytology
Agreement between standard digital cytology and AI-assisted cytology for the detection of cytological abnormalities (≥ ASC-US) among HPV-positive women.
Time frame: At baseline
Acceptability of HPV-based screening and triage strategy
Acceptability of HPV self-sampling, digital cytology, AI-assisted methods, and treatment procedures among participants and healthcare providers, assessed using structured questionnaires.
Time frame: During study period (up to 26 months)
Plan to share: Undecided — Anonymized data may be shared upon reasonable request at the end of the study period.
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for Sep 2026, 12 months after the start.
Of 106 non-industry interventional studies with no phase under Papillomavirus Infections, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 12 months is below that.
Counting every sponsor, half of 115 studies reached it within 26 months; a quarter within 12 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
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