Brief Title
Factors Predicting Persistence of Oncogenic HPV and Cervical Dysplasia in HIV Infected Kenyan Women
Official Title
Modifiable Factors Predicting Persistence of Oncogenic HPV and Cervical Dysplasia in HIV Infected Kenyan Women
Brief Summary
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
Primary Outcome
Frequency of oncogenic Human Papillomavirus (HPV) in Human Immunodeficiency Virus(HIV)-infected women with a normal Visual Inspection with Acetic Acid (VIA) at baseline
Secondary Outcome
Incidence of cervical dysplasia in Kenyan women with normal VIA at baseline, and who are HIV-infected during 4 years of observation
Condition
HIV/AIDS
Study Arms / Comparison Groups
Kenyan women
Description: Kenyan women, some HIV-infected and some HIV-uninfected, VIA negative at enrollment.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
220
Start Date
June 16, 2016
Completion Date
October 1, 2026
Primary Completion Date
October 1, 2025
Eligibility Criteria
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
Gender
Female
Ages
18 Years - 45 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Kenya
Location Countries
Kenya
Administrative Informations
NCT ID
NCT04045652
Organization ID
IUCRO-0492
Responsible Party
Principal Investigator
Study Sponsor
Indiana University
Study Sponsor
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Verification Date
April 2022