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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: In order to participate in this study a subject must meet all of the eligibility criteria outlined below. 1. Confirmed HIV-1 infection 2. Age 25 years and older. 3. Be willing and able to provide written willing to sign a consent form. Who Should NOT Join This Trial: 1. Pregnant or intend to become pregnant within 90 days of enrollment 2. Have been screened for cervical cancer within the preceding year (365 days) 3. Have an active sexually transmitted infection (STI; women may participate once treated) 4. Have a surgically absent cervix 5. Have a history of cervical cancer 6. have been vaccinated against HPV. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: In order to participate in this study a subject must meet all of the eligibility criteria outlined below. 1. Confirmed HIV-1 infection 2. Age 25 years and older. 3. Be willing and able to provide written informed consent. Exclusion Criteria: 1. Pregnant or intend to become pregnant within 90 days of enrollment 2. Have been screened for cervical cancer within the preceding year (365 days) 3. Have an active sexually transmitted infection (STI; women may participate once treated) 4. Have a surgically absent cervix 5. Have a history of cervical cancer 6. have been vaccinated against HPV.

Treatments Being Tested

OTHER

Urine HPV testing

Human papillomavirus (HPV) testing in urine sample.

OTHER

Self-collected cervicovaginal specimen

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

OTHER

Provider-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