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

Study Overview
=================
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.

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

Conditions
-----------------
Cervical Cancer

Intervention / Treatment
-----------------
* Device: Xpert HPV
* Device: OncoE6


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women undergoing cervical cancer screening<br>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. | Device: Xpert HPV<br>* Point-of-care HPV DNA PCR test<br>Device: OncoE6<br>* Point-of-care E6 oncoprotein test<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of VIA-, Xpert HPV-, and OncoE6-positive results that are correctly identified | True positive rate (i.e., sensitivity) for CIN2+ | once, at the enrollment visit | 
| Proportion of VIA-, Xpert HPV-, and OncoE6-negative results that are correctly identified | True negative rate (i.e., specificity) for CIN2+ | once, at the enrollment visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
visual inspection with acetic acid, Xpert HPV, OncoE6, screening