NCT05413798 Urine HPV Testing for Cervical Cancer Screening Among Women Living With HIV in South Africa
| NCT ID | NCT05413798 |
| Status | Recruiting |
| Phase | — |
| Sponsor | UNC Lineberger Comprehensive Cancer Center |
| Condition | Cervical Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-05-11 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2023-05-11 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Carla Chibwesha, MD, MSc
PRINCIPAL INVESTIGATOR
Division of Global Women's Health Department of Obstetrics and Gynecology, UNC Chapel Hill, NC
Frequently Asked Questions
Who can join the NCT05413798 clinical trial?
This trial is open to female participants only, aged 25 Years or older, studying Cervical Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05413798 currently recruiting?
Yes, NCT05413798 is actively recruiting participants. Contact the research team at cheryl_hendrickson@med.unc.edu for enrollment information.
Where is the NCT05413798 trial being conducted?
This trial is being conducted at Westdene, South Africa.
Who is sponsoring the NCT05413798 clinical trial?
NCT05413798 is sponsored by UNC Lineberger Comprehensive Cancer Center. The principal investigator is Carla Chibwesha, MD, MSc at Division of Global Women's Health Department of Obstetrics and Gynecology, UNC Chapel Hill, NC. The trial plans to enroll 300 participants.
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