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Completed

NCT Number: NCT02688816

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

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

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Adult Infectious Disease Centre at the University Teaching Hospital

Lusaka, Zambia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xpert HPV

Device

Point-of-care HPV DNA PCR test

OncoE6

Device

Point-of-care E6 oncoprotein test

Primary outcomes

  1. Proportion of VIA-, Xpert HPV-, and OncoE6-positive results that are correctly identified

    Time frame: once, at the enrollment visit

    True positive rate (i.e., sensitivity) for CIN2+

  2. Proportion of VIA-, Xpert HPV-, and OncoE6-negative results that are correctly identified

    Time frame: once, at the enrollment visit

    True negative rate (i.e., specificity) for CIN2+

Sponsors and collaborators

Lead sponsor

Carla Chibwesha, MD

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 23, 2016
Registry last updated
Feb 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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