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

Completed

• Conditions: Cervical Cancer
• Interventions: Device: Xpert HPV; Device: OncoE6

• Registration Number: NCT02688816
• Lead Sponsor: Carla Chibwesha, MD

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.

Study Timeline

• Study Start: 2014-08
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-02
• Study First Submitted: 2016-02-11
• Study First Submitted QC: 2016-02-17
• Last Update Submitted: 2016-02-17
• Study First Posted: 2016-02-23
• Last Update Posted: 2016-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women undergoing cervical cancer screening	Xpert HPV	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.
Women undergoing cervical cancer screening	OncoE6	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.

Primary Outcome Measures

Name	Time	Method
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+

Trial Locations

Locations (1)

Adult Infectious Disease Centre at the University Teaching Hospital; 🇿🇲 Lusaka, Zambia