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

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

Study Contact Backup

Study Locations

      • Eldoret, Kenya
        • Recruiting
        • Moi University School of Medicine
        • Contact:
      • Kampala, Uganda
        • Recruiting
        • Infectious Disease Institute, Makerere University
        • Contact:
    • 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:

  1. 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
  2. Between the ages of 18 -45 years old at the time of informed consent
  3. Ability to provide written informed consent and HIPAA authorization
  4. Must have a normal VIA
  5. Must be willing and able to come to the clinic for visits and return for a 4 year follow-up visit

Exclusion Criteria:

  1. History of an abnormal VIA or Pap smear
  2. Diagnosis of CIN or cervical cancer
  3. Signs or symptoms of a sexually transmitted infection (STI)
  4. Women who are currently pregnant
  5. 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.

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

Keywords

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.

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