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

• Register: ClinicalTrials.gov
• Last refreshed on: 14 March 2016
• Main ID: NCT02688816
• Date of registration: 11/02/2016
• Prospective Registration: No
• Primary sponsor: Carla Chibwesha, MD
• Public title: Comparison of Cervical Cancer Screening Tests in HIV-infected Women in Lusaka, Zambia
• Scientific 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
• Date of first enrolment: August 2014
• Target sample size: 200
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02688816
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Cross-Sectional
• Phase: N/A

Countries of recruitment

Zambia

Contacts

• Name: Carla Chibwesha, MD
• Affiliation: University of North Carolina, Chapel Hill

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Cervical Cancer

Intervention(s)

Device: Xpert HPV

Device: OncoE6

Primary Outcome(s)

Proportion of VIA-, Xpert HPV-, and OncoE6-negative results that are correctly identified [Time Frame: once, at the enrollment visit]

Proportion of VIA-, Xpert HPV-, and OncoE6-positive results that are correctly identified [Time Frame: once, at the enrollment visit]

Secondary ID(s)

14-0399

3 D43 CA15378403S1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)