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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05413798
Recruitment Status : Not yet recruiting
First Posted : June 10, 2022
Last Update Posted : June 21, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

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.


Condition or disease Intervention/treatment Phase
Cervical Cancer CIN2 CIN3 Other: Urine HPV testing Other: Self-collected cervicovaginal specimen Other: Provider-collected cervical samples Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Clinical Performance Validation of Urine HPV Testing for Cervical Cancer Screening Among Women Living With HIV in South Africa
Estimated Study Start Date : August 2022
Estimated Primary Completion Date : August 2026
Estimated Study Completion Date : August 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Single Arm
This is a single arm study. All participants will receive same 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 :
  1. Clinical performance of hrHPV testing in the three sample types for the detection of CIN2 [ Time Frame: 4 weeks (Entry visit) ]
    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.


Secondary Outcome Measures :
  1. Clinical performance of hrHPV testing in in the three sample types for the detection of CIN3 or worse [ Time Frame: 4 weeks ]
    The clinical performance (sensitivity, specificity, positive predictive value, and negative predictive value) for CIN3+ detection or worse of sample collection methods namely urine, self-collected samples, and provider-collected samples will be determined.

  2. The proportion of participants positive for hrHPV [ Time Frame: 4 weeks ]
    The high-risk human papillomavirus (hrHPV) positivity detection of urine, self-collected cervicovaginal specimen, and provider-collected cervical samples will be compared.



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The study is cervical cancer screening and targets only female participants.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

  1. Confirmed HIV-1 infection
  2. Age 25 years and older.
  3. Be willing and able to provide written informed consent.

Exclusion Criteria:

  1. Pregnant or intend to become pregnant within 90 days of enrollment
  2. Have been screened for cervical cancer within the preceding year (365 days)
  3. Have an active sexually transmitted infection (STI; women may participate once treated)
  4. Have a surgically absent cervix
  5. Have a history of cervical cancer
  6. have been vaccinated against HPV.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05413798


Contacts
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Contact: Cheryl Hendrickson 919-843-2541 cheryl_hendrickson@med.unc.edu

Locations
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South Africa
Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital
Westdene, Johannesburg, South Africa, 2092
Contact: Sibusisiwe Luvuno    +27-11-276-8800    sluvuno@witshealth.co.za   
Principal Investigator: Carla Chibwesha, MD, MSc         
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Carla Chibwesha, MD, MSc Division of Global Women's Health Department of Obstetrics and Gynecology, UNC Chapel Hill, NC
Additional Information:
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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT05413798    
Other Study ID Numbers: IGHID12022
U54CA254564-01 ( U.S. NIH Grant/Contract )
First Posted: June 10, 2022    Key Record Dates
Last Update Posted: June 21, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
cervical cancer
HPV
urine test
HIV
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases