Urine HPV Testing for Cervical Cancer Screening Among Women Living With HIV in South Africa
Primary Purpose
Cervical Cancer, CIN2, CIN3
Status
Recruiting
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Urine HPV testing
Self-collected cervicovaginal specimen
Provider-collected cervical samples
Sponsored by
About this trial
This is an interventional screening trial for Cervical Cancer focused on measuring cervical cancer, HPV, urine test, HIV
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.
Sites / Locations
- Clinical HIV Research Unit Temba Lethu Wing Helen Joseph HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single Arm
Arm Description
This is a single arm study. All participants will receive same interventions.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Clinical performance of hrHPV testing in in the three sample types for the detection of CIN3 or worse
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.
The proportion of participants positive for hrHPV
The high-risk human papillomavirus (hrHPV) positivity detection of urine, self-collected cervicovaginal specimen, and provider-collected cervical samples will be compared.
Full Information
NCT ID
NCT05413798
First Posted
June 7, 2022
Last Updated
August 22, 2023
Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT05413798
Brief Title
Urine HPV Testing for Cervical Cancer Screening Among Women Living With HIV in South Africa
Official Title
Clinical Performance Validation of Urine HPV Testing for Cervical Cancer Screening Among Women Living With HIV in South Africa
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 11, 2023 (Actual)
Primary Completion Date
August 2026 (Anticipated)
Study Completion Date
August 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, CIN2, CIN3
Keywords
cervical cancer, HPV, urine test, HIV
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Other
Arm Description
This is a single arm study. All participants will receive same interventions.
Intervention Type
Other
Intervention Name(s)
Urine HPV testing
Intervention Description
Human papillomavirus (HPV) testing in urine sample.
Intervention Type
Other
Intervention Name(s)
Self-collected cervicovaginal specimen
Intervention Description
Human papillomavirus (HPV) testing in self-collected cervicovaginal specimen sample.
Intervention Type
Other
Intervention Name(s)
Provider-collected cervical samples
Intervention Description
Human papillomavirus (HPV) testing in healthcare provider collected cervicovaginal specimen sample.
Primary Outcome Measure Information:
Title
Clinical performance of hrHPV testing in the three sample types for the detection of CIN2
Description
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.
Time Frame
4 weeks (Entry visit)
Secondary Outcome Measure Information:
Title
Clinical performance of hrHPV testing in in the three sample types for the detection of CIN3 or worse
Description
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.
Time Frame
4 weeks
Title
The proportion of participants positive for hrHPV
Description
The high-risk human papillomavirus (hrHPV) positivity detection of urine, self-collected cervicovaginal specimen, and provider-collected cervical samples will be compared.
Time Frame
4 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
The study is cervical cancer screening and targets only female participants.
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cheryl Hendrickson
Phone
919-843-2541
Email
cheryl_hendrickson@med.unc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carla Chibwesha, MD, MSc
Organizational Affiliation
Division of Global Women's Health Department of Obstetrics and Gynecology, UNC Chapel Hill, NC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital
City
Westdene
State/Province
Johannesburg
ZIP/Postal Code
2092
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sibusisiwe Luvuno
Phone
+27-11-276-8800
Email
sluvuno@witshealth.co.za
First Name & Middle Initial & Last Name & Degree
Carla Chibwesha, MD, MSc
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Links:
URL
http://unclineberger.org/patientcare/clinical-trials/clinical-trials
Description
University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials
Learn more about this trial
Urine HPV Testing for Cervical Cancer Screening Among Women Living With HIV in South Africa
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