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

NCT05413798 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-06-29

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Urine HPV testing

Human papillomavirus (HPV) testing in urine sample.

OTHER

Self-collected cervicovaginal specimen

Human papillomavirus (HPV) testing in self-collected cervicovaginal specimen sample.

OTHER

Provider-collected cervical samples

Human papillomavirus (HPV) testing in healthcare provider collected cervicovaginal specimen sample.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Carla Chibwesha, MD, MSc · Division of Global Women's Health Department of Obstetrics and Gynecology, UNC Chapel Hill, NC

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-11
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05413798 on ClinicalTrials.gov