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Screening Test Accuracy of Gynocular™, HR-HPV Testing, VIA for Detection of Cervical Neoplastic Lesions, in Women Living With HIV

NCT03931083 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 450

Last updated 2020-11-03

No results posted yet for this study

Summary

Cervical cancer in HIV-positive women is largely preventable through regular screening. The World Health Organization (WHO) recommends cervical screening for HIV-positive women every three years. Currently the least costly method for screening and the most viable option for many countries is visual inspection after application of acetic acid (VIA). Alternative testing methods are HPV testing and assessment with a portable magnification device. The investigators plan to assess and compare the screening test accuracy of these screening tests in women living with HIV. All women will receive histopathology reference standard.

Conditions

Interventions

DIAGNOSTIC_TEST

Screening for CIN2+/HSIL

The investigators will compare three different screening methods: visual assessment with portable magnification device , visual inspection after application of acetic acid, screening for high risk variants of HPV. All patients will receive cervical biopsies and histopathological examination.

Sponsors & Collaborators

  • Centre for Infectious Disease Research in Zambia

    collaborator OTHER

  • Cervical Cancer Prevention Program in Zambia

    collaborator UNKNOWN

  • International Agency for Research on Cancer

    collaborator OTHER

  • University of Bern

    lead OTHER

Principal Investigators

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-08
Primary Completion
2021-01-01
Completion
2022-12-01

Countries

  • Zambia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03931083 on ClinicalTrials.gov