Clinical trial · Interventional
Urine HPV Testing for Cervical Cancer Screening Among Women Living With HIV in South Africa
Clinical Performance Validation of Urine HPV Testing for Cervical Cancer Screening Among Women Living With HIV in South Africa
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| CIN2 | — | UNRESOLVED | — |
| CIN3 | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Provider-collected cervical samples | Other | — | UNRESOLVED |
| Self-collected cervicovaginal specimen | Other | — | UNRESOLVED |
| Urine HPV testing | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Single Arm
- description
- This is a single arm study. All participants will receive same interventions.
- interventionNames
- Other: Urine HPV testing
- Other: Self-collected cervicovaginal specimen
- Other: Provider-collected cervical samples
Primary outcomes (1)
- measure
- Clinical performance of hrHPV testing in the three sample types for the detection of CIN2
- timeFrame
- 4 weeks (Entry visit)
- 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.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available