Status:
COMPLETED
Factors Predicting Persistence of Oncogenic HPV and Cervical Dysplasia in HIV Infected Kenyan Women
Lead Sponsor:
Indiana University
Conditions:
HIV/AIDS
Cervical Dysplasia
Eligibility:
FEMALE
18-45 years
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-u...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 21 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 5 2020
Estimated Enrollment :
223 Patients enrolled
Trial Details
Trial ID
NCT04045652
Start Date
September 21 2015
End Date
November 5 2020
Last Update
July 17 2024
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
2
Moi University School of Medicine
Eldoret, Kenya
3
Infectious Disease Institute, Makerere University
Kampala, Uganda