Clinical trial NCT02688816: Comparison of Cervical Cancer Screening Tests in HIV-infected Women in Lusaka, Zambia
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Keywords: visual inspection with acetic acid
Xpert HPV
OncoE6
screening
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-02-23
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-infected women undergoing cervical cancer screening in Lusaka, Zambia

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of VIA-, Xpert HPV-, and OncoE6-positive results that are correctly identified
timeFrame: once, at the enrollment visit
measure: Proportion of VIA-, Xpert HPV-, and OncoE6-negative results that are correctly identified
timeFrame: once, at the enrollment visit
Secondary outcomes:
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: Adult Infectious Disease Centre at the University Teaching Hospital
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Carla Chibwesha, MD
role: PRINCIPAL_INVESTIGATOR
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