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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kenyan women | Kenyan women, some HIV-infected and some HIV-uninfected, VIA negative at enrollment. |
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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HIV-infected and uninfected Kenyan women (age 18-45) living in or close to Eldoret who present to the AMPATH Cervical Cancer Screening Program (CCSP), at the Moi Referral and Teaching Hospital in Eldoret, Kenya for a cervical cancer screening will be asked if they would like information about this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Melvin & Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States | ||
| Moi University School of Medicine |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D002578 | Uterine Cervical Dysplasia |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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Cervical and vaginal swabs Oral rinse or anal swab samples Serum
| 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) |
| Eldoret |
| Kenya |
| Infectious Disease Institute, Makerere University | Kampala | Uganda |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |