NCT05413798Recruiting
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
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 7 Jun 2022
- Start date
- 11 May 2023
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Diseases
- HIV, Cervical cancer
- NCT number
- NCT05413798
What you commit to
- Study type: Interventional
- Planned participants: 300
- From 11 May 2023 to the primary completion date, 31 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Have been screened for cervical cancer within the preceding year (365 days)
- Have an active sexually transmitted infection (STI; women may participate once treated)
- Have a history of cervical cancer
Other
- Pregnant or intend to become pregnant within 90 days of enrollment
- Have a surgically absent cervix
- have been vaccinated against HPV.
Who the study is looking for
- In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
- Confirmed HIV-1 infection
- Age 25 years and older.
- Be willing and able to provide written informed consent.
Age in the registry: 25 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital Coordinator of this site? Confirm its status | Westdene | South Africa | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.