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

Completed

Conditions studied: HIV/AIDS, Cervical Dysplasia, HIV Infections

In brief

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.

Key facts

Study ID

NCT04045652

Run by

Indiana University

People needed

223

Starts

2015-09-21

Expected to finish

2020-11-05

Last updated by the study team

2024-07-17

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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