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

RecruitingNA

Sponsor: UNC Lineberger Comprehensive Cancer Center

Conditions: Cervical Cancer, CIN2, CIN3

Interventions: Urine HPV testing, Self-collected cervicovaginal specimen, Provider-collected cervical samples

Countries: South Africa

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 overview

Sex: FEMALE

Age: 25 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Westdene, Johannesburg, South Africa