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

Indiana University

Status: Completed

Conditions: Cervical Dysplasia; HIV Infections; HIV/AIDS

Study type: Observational

Funder types: Other

Identifiers

NCT04045652

IUCRO-0492

Details and patient eligibility

About

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.

Enrollment: 223 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

223 participants in 1 patient group

Kenyan women

Description:

Kenyan women, some HIV-infected and some HIV-uninfected, VIA negative at enrollment.