Clinical trial · Observational
Comparison of Cervical Cancer Screening Tests in HIV-infected Women in Lusaka, Zambia
Z 1313 - Comparison of Point-of-care Molecular Tests and Visual Inspection With Acetic Acid for Cervical Cancer Screening in HIV-infected Women in Lusaka, Zambia
NCT02688816CI-TRIAL-00021048completedClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study will compare the test performance characteristics of visual inspection with acetic acid (VIA), Xpert HPV, and OncoE6 in HIV-infected women, to inform the possible inclusion of these molecular tests in future cervical cancer screening
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OncoE6 | Device | — | UNRESOLVED |
| Xpert HPV | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Women undergoing cervical cancer screening
- description
- HIV-infected women will undergo a cervical cancer screening examination using the VIA method. A digital photograph of the cervix will also be taken to aide visual screening. This is known as digital cervicography, and it is currently standard of care within cervical cancer screening clinics in Zambia. Cervical samples will be collected for molecular testing using Xpert HPV, and OncoE6. Cervical biopsy samples will also be obtained for confirmatory histopathologic diagnosis.
- interventionNames
- Device: Xpert HPV
- Device: OncoE6
Primary outcomes (2)
- measure
- Proportion of VIA-, Xpert HPV-, and OncoE6-positive results that are correctly identified
- timeFrame
- once, at the enrollment visit
- description
- True positive rate (i.e., sensitivity) for CIN2+
- measure
- Proportion of VIA-, Xpert HPV-, and OncoE6-negative results that are correctly identified
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women 18 years and older. * Women with documented HIV-infection in their medical record or by on-site testing through voluntary counseling and testing. * Women willing to undergo pelvic examination and cervical cancer screening. * Women willing to provide written, informed consent. Exclusion Criteria: * Pregnancy
References
Publications (24)
- BACKGROUNDAndersson S, Dillner L, Elfgren K, Mints M, Persson M, Rylander E. A comparison of the human papillomavirus test and Papanicolaou smear as a second screening method for women with minor cytological abnormalities. Acta Obstet Gynecol Scand. 2005 Oct;84(10):996-1000. doi: 10.1111/j.0001-6349.2005.00702.x. PMID 16167918
- BACKGROUNDAbreu AL, Souza RP, Gimenes F, Consolaro ME. A review of methods for detect human Papillomavirus infection. Virol J. 2012 Nov 6;9:262. doi: 10.1186/1743-422X-9-262. PMID 23131123
- BACKGROUNDBosch FX, Manos MM, Munoz N, Sherman M, Jansen AM, Peto J, Schiffman MH, Moreno V, Kurman R, Shah KV. Prevalence of human papillomavirus in cervical cancer: a worldwide perspective. International biological study on cervical cancer (IBSCC) Study Group. J Natl Cancer Inst. 1995 Jun 7;87(11):796-802. doi: 10.1093/jnci/87.11.796. PMID 7791229
- BACKGROUNDDavidson M, Schnitzer PG, Bulkow LR, Parkinson AJ, Schloss ML, Fitzgerald MA, Knight JA, Murphy CM, Kiviat NB, Toomey KE, et al. The prevalence of cervical infection with human papillomaviruses and cervical dysplasia in Alaska Native women. J Infect Dis. 1994 Apr;169(4):792-800. doi: 10.1093/infdis/169.4.792. PMID 8133094
- BACKGROUNDElfgren K, Kalantari M, Moberger B, Hagmar B, Dillner J. A population-based five-year follow-up study of cervical human papillomavirus infection. Am J Obstet Gynecol. 2000 Sep;183(3):561-7. doi: 10.1067/mob.2000.106749. PMID 10992174
- BACKGROUNDFerlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010 Dec 15;127(12):2893-917. doi: 10.1002/ijc.25516. PMID 21351269
- BACKGROUNDFolpe AL, Agoff SN, Willis J, Weiss SW. Parachordoma is immunohistochemically and cytogenetically distinct from axial chordoma and extraskeletal myxoid chondrosarcoma. Am J Surg Pathol. 1999 Sep;23(9):1059-67. doi: 10.1097/00000478-199909000-00008.