- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04045652
Factors Predicting Persistence of Oncogenic HPV and Cervical Dysplasia in HIV Infected Kenyan Women
May 17, 2023 updated by: Patrick Joseph Loehrer Sr., Indiana University
Modifiable Factors Predicting Persistence of Oncogenic HPV and Cervical Dysplasia in HIV Infected Kenyan Women
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
220
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Darron Brown, MD
- Phone Number: 317-274-1425
- Email: darbrow@iupui.edu
Study Contact Backup
- Name: Patrick J Loehrer, MD
- Phone Number: 317-278-4190
- Email: ploehrer@iupui.edu
Study Locations
-
-
-
Eldoret, Kenya
- Recruiting
- Moi University School of Medicine
-
Contact:
- Elkanah O Omenge, MD
- Phone Number: 254722606132
- Email: Bworango2000@yahoo.com
-
-
-
-
-
Kampala, Uganda
- Recruiting
- Infectious Disease Institute, Makerere University
-
Contact:
- Miriam Nakalembe, MD
- Phone Number: 256753857433
- Email: mnakalembe@gmail.com
-
-
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Active, not recruiting
- Indiana University Melvin & Bren Simon Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
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.
Description
Inclusion Criteria:
- Kenyan women who present for a cervical cancer screening at AMPATH-cervical cancer screening clinics at MTRH or Webuye and living in or within 30 km of the respective clinic at the time of informed consent
- Between the ages of 18 -45 years old at the time of informed consent
- Ability to provide written informed consent and HIPAA authorization
- Must have a normal VIA
- Must be willing and able to come to the clinic for visits and return for a 4 year follow-up visit
Exclusion Criteria:
- History of an abnormal VIA or Pap smear
- Diagnosis of CIN or cervical cancer
- Signs or symptoms of a sexually transmitted infection (STI)
- Women who are currently pregnant
- Inability to understand and provide written informed consent due to a mental or physical disability, or a medical illness that has rendered the patient unable to understand consent or attend quarterly visits
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Kenyan women
Kenyan women, some HIV-infected and some HIV-uninfected, VIA negative at enrollment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of oncogenic Human Papillomavirus (HPV) in Human Immunodeficiency Virus(HIV)-infected women with a normal Visual Inspection with Acetic Acid (VIA) at baseline
Time Frame: 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)
|
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
Time Frame: 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)
|
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
Time Frame: Baseline
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of cervical dysplasia in Kenyan women with normal VIA at baseline, and who are HIV-infected during 4 years of observation
Time Frame: 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)
|
cervical and/or vaginal swabs for HPV and CT/GC testing
|
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
Time Frame: 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)
|
cervical and/or vaginal swabs for HPV and CT/GC testing
|
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
Time Frame: 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)
|
Through interviews/questionnaires
|
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
Time Frame: 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)
|
Through interviews/questionnaires
|
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
Time Frame: 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)
|
Through interviews/questionnaires
|
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 cervical dysplasia
Time Frame: 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)
|
Through interviews/questionnaires
|
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 potentially modifiable biological risk factors associated with oncogenic HPV through HPV testing will occur through cervical and/or vaginal swabs
Time Frame: 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)
|
HPV testing will occur through cervical and/or vaginal swabs
|
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 potentially modifiable biological behavioral risk factors associated with cervical dysplasia through cervical and/or vaginal swabs for HPV and CT/GC testing
Time Frame: 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)
|
cervical and/or vaginal swabs for HPV and CT/GC testing
|
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)
|
Time to HPV
Time Frame: Baseline to HPV diagnosis (up to 2 years)
|
Baseline to HPV diagnosis (up to 2 years)
|
|
Time to Cervical Dysplasia
Time Frame: HPV diagnosis to Cervical Dysplasia (up to 2 years)
|
HPV diagnosis to Cervical Dysplasia (up to 2 years)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 18, 2021
Primary Completion (Anticipated)
October 1, 2025
Study Completion (Anticipated)
October 1, 2026
Study Registration Dates
First Submitted
July 8, 2019
First Submitted That Met QC Criteria
August 2, 2019
First Posted (Actual)
August 5, 2019
Study Record Updates
Last Update Posted (Actual)
May 19, 2023
Last Update Submitted That Met QC Criteria
May 17, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IUCRO-0492
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
-
Boston Children's HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed