Factors Predicting Persistence of Oncogenic HPV and Cervical Dysplasia in HIV Infected Kenyan Women

Indiana University223 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

223

Conditions

HIV/AIDS Cervical Dysplasia HIV Infections

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (3)

Indiana University Melvin & Bren Simon Cancer Center

Indianapolis, Indiana, United States

Moi University School of Medicine

Eldoret, Kenya

Infectious Disease Institute, Makerere University

Kampala, Uganda

Outcomes

Primary Outcomes

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)

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)

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)

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)

Incidence of abnormal VIA

Time frame: Baseline

Secondary Outcomes

Incidence of cervical dysplasia in Kenyan women with normal VIA at baseline, and who are HIV-infected during 4 years of observation

cervical and/or vaginal swabs for HPV and CT/GC testing

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)

Incidence of cervical dysplasia in Kenyan women with normal VIA at baseline, and who are HIV-uninfected during 4 years of observation

cervical and/or vaginal swabs for HPV and CT/GC testing

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)

Identify potentially modifiable sex behavioral risk factors associated with oncogenic HPV

Data from ClinicalTrials.gov

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