Health TrialsbyHealthPanel

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

ConditionsCervical CancerCIN2CIN3
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25+
SponsorUNC Lineberger Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed HIV-1 infection

Age 25 years and older.

Be willing and able to provide written informed consent.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Urine HPV testing

    Other intervention

    Human papillomavirus (HPV) testing in urine sample.

  • Self-collected cervicovaginal specimen

    Other intervention

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

  • Provider-collected cervical samples

    Other intervention

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

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Single ArmOther 3 interventions

Trial outcomes

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.

Time frame
4 weeks (Entry visit)

Secondary outcomes

1

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.

Time frame
4 weeks
2

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.

Time frame
4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

UNC Lineberger Comprehensive Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
Apply now