Clinical trial · Interventional
HPV Screening With Triage by HPV Genotyping Versus Visual Inspection With Acetic Acid
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
- 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)
Cervical cancer is the leading cause of cancer death among women in sub-Saharan Africa, despite the existence of effective prevention and screening methods. Because vaccination rates against human papillomavirus (causing nearly all cervical cancers) are still insufficient in some low-resource countries, early detection and treatment of cervical lesions at risk of progressing to cancer are crucial components of cervical cancer control. Therefore, it is essential to find the most reliable and appropriate screening strategy in the context of low-resource countries in order to identify women in need of treatment and thus prevent the development of cervical cancer. The objective of our study is to compare two different methods of cervical cancer screening adapted to low-resource settings, in two study centers in Cameroon.
Conditions
Conditions (1)
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 | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HPV genotyping | Diagnostic Test | — | UNRESOLVED |
| Visual inspection after application of acetic acid | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Triage by genotyping
- description
- The study intervention will consist in applying HPV genotyping as a triage method of HPV-positive women for cervical cancer screening. After primary screening with the Xpert HPV test, positive women will be sorted according to two groups of genotypes: group 1 (HPV types 16,18,45, 31, 33, 35, 52 and/or 58 obtained from channels 1, 2 and 3) and group 2 (HPV types 51, 59, 39,56, 66 and/or 68 obtained from channels 4 and 5). Women of group 1 will immediately treated, while those of group 2 will not receive immediate treatment and will be followed-up at 12 months. An exception will be made for participants with lesions suspicious of invasive cancer upon examination, which will be referred for further investigations regardless of the HPV type.
- interventionNames
- Diagnostic Test: HPV genotyping
- type
- ACTIVE_COMPARATOR
- label
- Triage by visual inspection after application of acetic acid (VIA)
- description
- The control arm will consist in triage of HPV-positive women by VIA, as currently recommended by the WHO. Women with a positive VIA will be treated immediately, while VIA-negative women will not be treated and will be followed-up at 12 months.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 49 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