NCT05413798

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress93%
May 2023Aug 2026

First Submitted

Initial submission to the registry

June 7, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 10, 2022

Completed
11 months until next milestone

Study Start

First participant enrolled

May 11, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

3.2 years

First QC Date

June 7, 2022

Last Update Submit

June 25, 2025

Conditions

Cervical CancerCIN2CIN3

Keywords

cervical cancerHPVurine testHIV

Outcome Measures

Primary Outcomes (1)

  • Clinical performance of hrHPV testing in the three sample types for the detection of CIN2

    The clinical performance (sensitivity, specificity, positive predictive value, and negative predictive value) for CIN2+ detection of sample collection methods namely urine, self-collected samples, and provider-collected samples will be determined.

    4 weeks (Entry visit)

Secondary Outcomes (2)

  • Clinical performance of hrHPV testing in in the three sample types for the detection of CIN3 or worse

    4 weeks

  • The proportion of participants positive for hrHPV

    4 weeks

Study Arms (1)

Single Arm

OTHER

This is a single arm study. All participants will receive same interventions.

Other: Urine HPV testingOther: Self-collected cervicovaginal specimenOther: Provider-collected cervical samples

Interventions

Urine HPV testingOTHER

Human papillomavirus (HPV) testing in urine sample.

Single Arm
Self-collected cervicovaginal specimenOTHER

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

Single Arm
Provider-collected cervical samplesOTHER

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

Single Arm

Eligibility Criteria

Age25 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study is cervical cancer screening and targets only female participants.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital

Westdene, Johannesburg, 2092, South Africa

RECRUITING

Related Links

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Carla Chibwesha, MD, MSc

    Division of Global Women's Health Department of Obstetrics and Gynecology, UNC Chapel Hill, NC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheryl Hendrickson

CONTACT

919-843-2541cheryl_hendrickson@med.unc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2022

First Posted

June 10, 2022

Study Start

May 11, 2023

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

June 29, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

The rights and privacy of individuals who participate in research will be protected at all times. Thus, data intended for broader use will be stripped of identifiers that would permit linkages to individual research participants or variables that could lead to deductive disclosure of the identity of individual subjects. Research data that documents, supports and validates research findings will be made available after the main findings from the final research dataset have been accepted for publication. Such research data will be redacted to prevent the disclosure of personal identifiers. All data sharing will abide by rules and/or policies defined by the sponsor, relevant IRBs, U.S. local, state, and federal laws and regulations, as well as South African laws and regulations.

Locations

ZA(1)