Cervical Dysplasia, HIV/AIDS, HIV Infections
Conditions
Keywords
HPV, HIV
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.
Interventions
None listed
Sponsors
Indiana University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of oncogenic Human Papillomavirus (HPV) in Human Immunodeficiency Virus(HIV)-infected women with a normal Visual Inspection with Acetic Acid (VIA) at baseline | 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) | 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) |
| Frequency oncogenic HPV in non HIV-infected women with a normal VIA at baseline | 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) | 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) |
| Incidence of abnormal VIA | Baseline | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identify potentially modifiable sex behavioral risk factors associated with oncogenic HPV | 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) | Through interviews/questionnaires |
| Identify potentially modifiable sex behavioral risk factors associated with cervical dysplasia | 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) | Through interviews/questionnaires |
| Identify potentially modifiable health behavioral risk factors associated with oncogenic HPV | 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) | Through interviews/questionnaires |
| Incidence of potentially modifiable biological risk factors associated with oncogenic HPV through 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) | HPV testing will occur through cervical and/or vaginal swabs |
| Incidence of potentially modifiable biological behavioral risk factors associated with cervical dysplasia through 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) | cervical and/or vaginal swabs for HPV and CT/GC testing |
| Time to HPV | Baseline to HPV diagnosis (up to 2 years) | — |
| Time to Cervical Dysplasia | HPV diagnosis to Cervical Dysplasia (up to 2 years) | — |
| Identify potentially modifiable health behavioral risk factors associated with cervical dysplasia | 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) | Through interviews/questionnaires |
| Incidence of cervical dysplasia in Kenyan women with normal VIA at baseline, and who are HIV-infected during 4 years of observation | 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) | cervical and/or vaginal swabs for HPV and CT/GC testing |
| Incidence of cervical dysplasia in Kenyan women with normal VIA at baseline, and who are HIV-uninfected during 4 years of observation | 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) | cervical and/or vaginal swabs for HPV and CT/GC testing |
Countries
Kenya, Uganda, United States
Outcome results
None listed