Comparing HPV Genotyping and Visual Inspection for Cervical Cancer Screening
Promoting Comprehensive Cervical Cancer Prevention and Better Women's Health in Low- and Medium Resource Settings HPV Screening With Triage by HPV Genotyping Versus Visual Inspection With Acetic Acid: a Randomized Controlled Trial
NA · University Hospital, Geneva · NCT05385406
This study is testing whether HPV genotyping or visual inspection is better for screening cervical cancer in women in Cameroon to help identify those who really need treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 5500 (estimated) |
| Ages | 25 Years to 49 Years |
| Sex | Female |
| Sponsor | University Hospital, Geneva (other) |
| Locations | 2 sites (Dschang, Menoua and 1 other locations) |
| Trial ID | NCT05385406 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate two cervical cancer screening methods in Cameroon: HPV genotyping and visual inspection with acetic acid (VIA). It focuses on identifying the most effective strategy for triaging HPV-positive women to reduce unnecessary treatments and improve resource allocation. The study will involve HIV-negative women aged 30-49 and HIV-positive women aged 25-49, who will be randomized to receive either HPV genotyping or VIA after primary HPV-based screening. The goal is to determine which method better targets women in need of treatment for cervical lesions.
Who should consider this trial
Good fit: Ideal candidates include HIV-negative women aged 30-49 and HIV-positive women aged 25-49 who can provide informed consent.
Not a fit: Patients who are pregnant, have had a hysterectomy, or have known cervical cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate cervical cancer screening and treatment strategies, ultimately reducing cervical cancer rates in low-resource settings.
How similar studies have performed: While the use of HPV genotyping as a triage method is emerging, this specific comparison with VIA has not been extensively tested, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Dschang, Menoua and 1 other locations
- Dschang Annex Regional Hospital — Dschang, Menoua, Cameroon (RECRUITING)
- Bafoussam Regional Hospital — Bafoussam, Mifi, Cameroon (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Patrick Petignat, PD — University Hospital, Geneva
- Study coordinator: Patrick Petignat, PD
- Email: patrick.petignat@hcuge.ch
- Phone: 22 37 24 432
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cervical Cancer, cervical cancer, human papillomavirus, screening, genotyping