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Recruiting NCT05413798

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

No phase Interventional Cervical Cancer CIN2 CIN3

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Urine HPV testing, Self-collected cervicovaginal specimen, Provider-collected cervical samples.
Who it may be relevant to
Registry conditions: Cervical Cancer, CIN2, CIN3. Basic parameters: from 25 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Africa
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Clinical Performance Validation of Urine HPV Testing for Cervical Cancer Screening Among Women Living With HIV in South Africa

Overview

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.

Detailed description

Invasive cervical cancer is a significant health burden in low and middle income countries.

HIV-infected women in Africa are particularly affected and have an estimated invasive cervical cancer risk \~20-fold higher than women without HIV. Previous studies have been performed among only HIV-uninfected women or those whose HIV status was unknown. Additionally, HIV infected women are often diagnosed with invasive cervical cancer at younger ages.

Cervical cancer is preventable by regular screenings which includes doing a pap smear or HPV tests. There is also treatment of precancerous cervical lesions and vaccination against high risk types of HPV. World Health Organization currently recommends high risk HPV testing for cervical cancer screening in both high and low resources settings. National Guidelines in many low and middle income countries, including South Africa, have been updated to include plans to transition from cytology or visual screening to primary HPV screening. Urine HPV testing could provide a simpler approach for cervical screening that is more easily scaled in low and middle income countries.

The study hypothesizes that high-risk human papillomavirus (hrHPV) testing on urine specimens will be similar in sensitivity and specificity for the detection of cervical intra-epithelial neoplasia grade 2 or worse (CIN2+) compared to self- or clinician-collected sampling.

This study will investigate whether women can collect their own samples for HPV testing using either urine or a small brush in the vagina. The results of HPV tests on urine, self-collected vaginal samples, and provider-collected cervical samples will be compared to see which sample type works best.

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.

Primary outcome measures

  • Clinical performance of hrHPV testing in the three sample types for the detection of CIN2 [Time frame: 4 weeks (Entry visit)]
Secondary outcome measures (2)
  • Clinical performance of hrHPV testing in in the three sample types for the detection of CIN3 or worse [Time frame: 4 weeks]
  • The proportion of participants positive for hrHPV [Time frame: 4 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

South Africa · 1 center
  • Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital — Westdene

Identifiers

NCT: NCT05413798 · IGHID12022 · U54CA254564-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗