RecruitingNot ApplicableNCT05413798

Urine HPV Testing for Cervical Cancer Screening Among Women Living With HIV in South Africa

Clinical Performance Validation of Urine HPV Testing for Cervical Cancer Screening Among Women Living With HIV in South Africa


Sponsor

UNC Lineberger Comprehensive Cancer Center

Enrollment

300 participants

Start Date

May 11, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study explores the usefulness of urine samples for cervical cancer screening in human immunodeficiency virus (HIV)-infected women. Cervical cancer occurs when women are infected with the human papillomavirus (HPV), which can cause changes in the cells that lead to cervical precancer and, eventually, cervical cancer if untreated. However, urine HPV testing has not been well validated low- and middle-income country settings, with no data available to guide its use in HIV-infected women.


Eligibility

Sex: FEMALEMin Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether urine-based HPV testing can replace or supplement traditional cervical swab testing (Pap smear/cervical HPV test) for cervical cancer screening in women living with HIV in South Africa. Women with HIV have higher cervical cancer risk. **You may be eligible if...** - You have confirmed HIV-1 infection - You are 25 years of age or older - You have not had cervical cancer screening in the past year - You are willing and able to provide written consent **You may NOT be eligible if...** - You are pregnant or plan to become pregnant within 90 days - You have an active sexually transmitted infection (unless treated) - You have had your cervix surgically removed - You have a history of cervical cancer - You have been fully vaccinated against HPV (all recommended doses) 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

OTHERUrine HPV testing

Human papillomavirus (HPV) testing in urine sample.

OTHERSelf-collected cervicovaginal specimen

Human papillomavirus (HPV) testing in self-collected cervicovaginal specimen sample.

OTHERProvider-collected cervical samples

Human papillomavirus (HPV) testing in healthcare provider collected cervicovaginal specimen sample.


Locations(1)

Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital

Westdene, Johannesburg, South Africa

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NCT05413798


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