Urine HPV Testing for Cervical Cancer Screening Among Women Living With HIV in South Africa
Recruiting · NCT05413798 · Interventional (participants receive a specific treatment) · Lead sponsor: UNC Lineberger Comprehensive Cancer Center
View the official record on ClinicalTrials.gov →Interventions studied
Provider-collected cervical samplesSelf-collected cervicovaginal specimenUrine HPV testing
What this trial is about
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 can take part
Age range
25 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- Pregnant or intend to become pregnant within 90 days of enrollment
- 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 surgically absent cervix
- Have a history of cervical cancer
- have been vaccinated against HPV.
Where it is running
1 location listed.
- Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital - Westdene, Johannesburg, South Africa