Cervical CancerNCT05413798
Urine HPV Testing for Cervical Cancer Screening Among Women Living With HIV in South Africa
A study testing Urine HPV testing, Self-collected cervicovaginal specimen and Provider-collected cervical samples in people with Cervical Cancer and CIN2, run by UNC Lineberger Comprehensive Cancer Center at 1 site in South Africa.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Cervical Cancer, CIN2, CIN3
- What is being tested?
- Urine HPV testing, Self-collected cervicovaginal specimen and Provider-collected cervical samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSouth Africa
- Study dates
- 11 May 2023to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Africa1 site, 1 recruiting
- Recruiting
Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital
Westdene, Johannesburg, 2092
Sibusisiwe Luvuno, +27-11-276-8800, sluvuno@witshealth.co.za
Carla Chibwesha, MD, MSc
About this study
Official title: Clinical Performance Validation of Urine HPV Testing for Cervical Cancer Screening Among Women Living With HIV in South Africa
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.
Read the 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.
- Conditions
- Cervical Cancer, CIN2, CIN3
- Being tested
- Urine HPV testing, Self-collected cervicovaginal specimen, Provider-collected cervical samples
- Keywords
- cervical cancer, HPV, urine test, HIV
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine HPV testingOther
Human papillomavirus (HPV) testing in urine sample.
Self-collected cervicovaginal specimenOther
Human papillomavirus (HPV) testing in self-collected cervicovaginal specimen sample.
Provider-collected cervical samplesOther
Human papillomavirus (HPV) testing in healthcare provider collected cervicovaginal specimen sample.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | This is a single arm study. All participants will receive same interventions. Receives: Other: Urine HPV testing; Other: Self-collected cervicovaginal specimen; Other: Provider-collected cervical samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 4 weeks
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start11 May 2023
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Carla Chibwesha, MD, MSc, Principal investigator, Division of Global Women's Health Department of Obstetrics and Gynecology, UNC Chapel Hill, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05413798
- Sponsor's protocol ID
- IGHID12022
- Other IDs
- U54CA254564-01
- Status last verified
- Sep 2026
- First submitted
- 7 Jun 2022
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance Validation of Urine HPV Testing for Cervical Cancer Screening Among Women Living With HIV in South Africa
- ClinicalTrials.gov ID
- NCT05413798
- Acronym / sponsor ID
- IGHID12022
- Conditions
- Cervical Cancer, CIN2, CIN3
- Keywords
- cervical cancer, HPV, urine test, HIV
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 May 2023 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 10 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Other: Urine HPV testing, Other: Self-collected cervicovaginal specimen, Other: Provider-collected cervical samplesThis is a single arm study. All participants will receive same interventions. |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urine HPV testingHuman papillomavirus (HPV) testing in urine sample. | Other | Single Arm |
| Self-collected cervicovaginal specimenHuman papillomavirus (HPV) testing in self-collected cervicovaginal specimen sample. | Other | Single Arm |
| Provider-collected cervical samplesHuman papillomavirus (HPV) testing in healthcare provider collected cervicovaginal specimen sample. | Other | Single Arm |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carla Chibwesha, MD, MSc principal investigator
Division of Global Women's Health Department of Obstetrics and Gynecology, UNC Chapel Hill, NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urine HPV testing, Self-collected cervicovaginal specimen and Provider-collected cervical samples in people with Cervical Cancer and CIN2, run by UNC Lineberger Comprehensive Cancer Center at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cheryl Hendrickson (919-843-2541, cheryl_hendrickson@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical performance of hrHPV testing in the three sample types for the detection of CIN2 (time frame: 4 weeks (Entry visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.