Comparison of Cervical Cancer Screening Tests in HIV-infected Women in Lusaka, Zambia

Carla Chibwesha, MD

Status: Completed

Conditions: Cervical Cancer

Treatments: Device: Xpert HPV; Device: OncoE6

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02688816

3 D43 CA15378403S1 (Other Grant/Funding Number)

14-0399

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

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.

Treatment:

Device: OncoE6

Device: Xpert HPV