Modifiable Factors Predicting Persistence of Oncogenic HPV and Cervical Dysplasia in HIV Infected Kenyan Women
Sponsor study identifier
observational
223
3 countries
3
Study Start
September 21, 2015
Actual (reported)Primary Completion
November 5, 2020
Actual (reported)Study Completion
November 5, 2020
Actual (reported)This study will utilize a longitudinal study design to better understand the natural history of oncogenic Human Papillomavirus (HPV) infections in Human Immunodeficiency Virus (HIV)-infected and HIV-uninfected Kenyan women, including the potentially modifiable (and non-modifiable) factors that are associated with progression of oncogenic HPV infection to clinical disease, including cervical cancer.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 5, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 21, 2015
Actual (reported)July 8, 2019
Actual (reported)August 5, 2019
Actual (reported)November 5, 2020
Actual (reported)November 5, 2020
Actual (reported)Frequency of oncogenic Human Papillomavirus (HPV) in Human Immunodeficiency Virus(HIV)-infected women with a normal Visual Inspection with Acetic Acid (VIA) at baseline
HPV testing will occur through cervical swabs for HPV and CT/GC testing, cervical VIA, as well as HPV swab (anal, cervical) and rinse samples (oral)
Change in diagnosis from Baseline,months: 3,6,9,12,15,18,21,24,27,30,33,36,39,42,45,48 and follow-up (1 year after the last visit)
Frequency oncogenic HPV in non HIV-infected women with a normal VIA at baseline
HPV testing will occur through cervical swabs for HPV and CT/GC testing, cervical VIA, as well as HPV swab (anal, cervical) and rinse samples (oral)
change in diagnosis from Baseline, months: 3,6,9,12,15,18,21,24,27,30,33,36,39,42,45,48 and follow-up(1 year after the last visit)
Incidence of abnormal VIA
Baseline
Incidence of cervical dysplasia in Kenyan women with normal VIA at baseline, and who are HIV-infected during 4 years of observation
Incidence at Baseline, months: 3,6,9,12,15,18,21,24,27,30,33,36,39,42,45,48 and follow-up (1 year after the last visit)
Incidence of cervical dysplasia in Kenyan women with normal VIA at baseline, and who are HIV-uninfected during 4 years of observation
Incidence at Baseline, months: 3,6,9,12,15,18,21,24,27,30,33,36,39,42,45,48 and follow-up (1 year after the last visit)
Identify potentially modifiable sex behavioral risk factors associated with oncogenic HPV
Baseline, months: 3,6,9,12,15,18,21,24,27,30,33,36,39,42,45,48 and follow-up (1 year after the last visit)
Identify potentially modifiable sex behavioral risk factors associated with cervical dysplasia
Baseline, months: 3,6,9,12,15,18,21,24,27,30,33,36,39,42,45,48 and follow-up (1 year after the last visit)
Identify potentially modifiable health behavioral risk factors associated with oncogenic HPV
Baseline, months: 3,6,9,12,15,18,21,24,27,30,33,36,39,42,45,48 and follow-up (1 year after the last visit)
Kenyan women, some HIV-infected and some HIV-uninfected, VIA negative at enrollment.
HIV-infected and uninfected Kenyan women (age 18-45) living in or close to Eldoret who present to the AMPATH Cervical Cancer Screening Program (CCSP), at the Moi Referral and Teaching Hospital in Eldoret, Kenya for a cervical cancer screening will be asked if they would like information about this study.
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Moi University School of Medicine
Eldoret, Kenya
Infectious Disease Institute, Makerere University
Kampala, Uganda
Cervical and vaginal swabs Oral rinse or anal swab samples Serum
223 participants (actual enrollment reported by the registry).
First Submitted
July 8, 2019
First Posted
August 5, 2019
Study Start
September 21, 2015
Actual (reported)Interactions Between Antiretrovirals (ARVs) and Combined Oral Contraceptives (COCs)
Contact the study team to confirm eligibility.
Primary Completion
November 5, 2020
Actual (reported)Study Completion
November 5, 2020
Actual (reported)Last Updated
July 17, 2024
Record last verified: 2024-07
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Source: ClinicalTrials.gov.
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