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

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV/AIDS, Cervical Dysplasia, HIV Infections

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Kenyan women<br>Kenyan women, some HIV-infected and some HIV-uninfected, VIA negative at enrollment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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 |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | Through interviews/questionnaires | 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 cervical dysplasia | Through interviews/questionnaires | 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 health behavioral risk factors associated with oncogenic HPV | Through interviews/questionnaires | 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 health behavioral risk factors associated with cervical dysplasia | Through interviews/questionnaires | 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 potentially modifiable biological risk factors associated with oncogenic HPV through HPV testing will occur through cervical and/or vaginal swabs | HPV testing will occur through cervical and/or vaginal swabs | 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 potentially modifiable biological behavioral risk factors associated with cervical dysplasia through cervical and/or vaginal swabs for HPV and CT/GC testing | cervical and/or vaginal swabs for HPV and CT/GC testing | 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) | 
| Time to HPV |  | Baseline to HPV diagnosis (up to 2 years) | 
| Time to Cervical Dysplasia |  | HPV diagnosis to Cervical Dysplasia (up to 2 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV, HIV