RecruitingNot ApplicableNCT05385406

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

Sponsor

Prof. Patrick Petignat

Enrollment

5,500 participants

Start Date

Dec 6, 2022

Study Type

INTERVENTIONAL

Conditions

Cervical Cancer

Summary

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.

Eligibility

Sex: FEMALEMin Age: 25 YearsMax Age: 49 Years

Plain Language Summary

Simplified for easier understanding

This trial compares two cervical cancer screening methods — HPV genotyping and visual inspection with acetic acid — to see which is more effective at identifying women at highest risk. **You may be eligible if...** - You are HIV-negative and between 30–49 years old, OR HIV-positive and between 25–49 years old - You understand the study and are willing to participate **You may NOT be eligible if...** - You are currently pregnant - You have had a hysterectomy - You have known or suspected cervical cancer - You have symptoms that may suggest cervical cancer (like irregular bleeding or a pelvic mass) - You have conditions that make it hard to see the cervix - You have a severe medical condition that would make study participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTHPV genotyping

Genotyping will be obtained by the Xpert system which uses 5 color channels containing primers and probes for the detection of specific genotypes or pooled results as follows: i) HPV 16, ii) HPV 18/45 in pooled result, iii) HPV types 31, 33, 35 52, or 58, in pooled result, iv) HPV types 51 or 59, in pooled result, and v) HPV types 39, 56, 66 or 68 in pooled result.

DIAGNOSTIC_TESTVisual inspection after application of acetic acid

After application of acetic acid and Lugol's iodine, the cervix will be assessed using simplified "ABCD criteria" (A= acetowhite lesion within the transformation zone, B = spontaneous bleeding or upon slight touch, C (optional) = Lugol-positive coloring of acetowhite lesions, D = diameter \> 5mm of acetowhite lesion).