Cervical Cancer
Conditions
Keywords
visual inspection with acetic acid, Xpert HPV, OncoE6, screening
Brief summary
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
Detailed description
This is a cross-sectional study taking place at cervical cancer prevention clinics in Lusaka, Zambia to determine the test performance characteristics (sensitivity, specificity, positive predictive value, and negative predictive value) of (1) visual inspection with acetic acid, (2) Xpert HPV, and (3) OncoE6 for the detection of CIN2+ among HIV-infected women. All cervical screening tests will be evaluated against a gold standard of histopathology obtained from cervical biopsies.
Interventions
Sponsors
National Cancer Institute (NCI)
Carla Chibwesha, MD
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of VIA-, Xpert HPV-, and OncoE6-positive results that are correctly identified | once, at the enrollment visit | True positive rate (i.e., sensitivity) for CIN2+ |
| Proportion of VIA-, Xpert HPV-, and OncoE6-negative results that are correctly identified | once, at the enrollment visit | True negative rate (i.e., specificity) for CIN2+ |
Countries
Zambia
Outcome results
None listed