Urine HPV Testing for Cervical Cancer Screening Among Women Living With HIV in South Africa
NCT ID: NCT05413798
Last Updated: 2025-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2023-05-11
2026-08-31
Brief Summary
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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.
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Detailed Description
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HIV-infected women in Africa are particularly affected and have an estimated invasive cervical cancer risk \~20-fold higher than women without HIV. Previous studies have been performed among only HIV-uninfected women or those whose HIV status was unknown. Additionally, HIV infected women are often diagnosed with invasive cervical cancer at younger ages.
Cervical cancer is preventable by regular screenings which includes doing a pap smear or HPV tests. There is also treatment of precancerous cervical lesions and vaccination against high risk types of HPV. World Health Organization currently recommends high risk HPV testing for cervical cancer screening in both high and low resources settings. National Guidelines in many low and middle income countries, including South Africa, have been updated to include plans to transition from cytology or visual screening to primary HPV screening. Urine HPV testing could provide a simpler approach for cervical screening that is more easily scaled in low and middle income countries.
The study hypothesizes that high-risk human papillomavirus (hrHPV) testing on urine specimens will be similar in sensitivity and specificity for the detection of cervical intra-epithelial neoplasia grade 2 or worse (CIN2+) compared to self- or clinician-collected sampling.
This study will investigate whether women can collect their own samples for HPV testing using either urine or a small brush in the vagina. The results of HPV tests on urine, self-collected vaginal samples, and provider-collected cervical samples will be compared to see which sample type works best.
Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Single Arm
This is a single arm study. All participants will receive same interventions.
Urine HPV testing
Human papillomavirus (HPV) testing in urine sample.
Self-collected cervicovaginal specimen
Human papillomavirus (HPV) testing in self-collected cervicovaginal specimen sample.
Provider-collected cervical samples
Human papillomavirus (HPV) testing in healthcare provider collected cervicovaginal specimen sample.
Interventions
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Urine HPV testing
Human papillomavirus (HPV) testing in urine sample.
Self-collected cervicovaginal specimen
Human papillomavirus (HPV) testing in self-collected cervicovaginal specimen sample.
Provider-collected cervical samples
Human papillomavirus (HPV) testing in healthcare provider collected cervicovaginal specimen sample.
Eligibility Criteria
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Inclusion Criteria
1. Confirmed HIV-1 infection
2. Age 25 years and older.
3. Be willing and able to provide written informed consent.
Exclusion Criteria
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.
25 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
UNC Lineberger Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Carla Chibwesha, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Division of Global Women's Health Department of Obstetrics and Gynecology, UNC Chapel Hill, NC
Locations
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Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital
Westdene, Johannesburg, South Africa
Countries
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Central Contacts
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Facility Contacts
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Related Links
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University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials
Other Identifiers
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IGHID12022
Identifier Type: -
Identifier Source: org_study_id
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