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

Completed

• Conditions: Cervical Dysplasia; HIV/AIDS; HIV Infections

• Registration Number: NCT04045652
• Lead Sponsor: Indiana University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-09-21
• Study First Submitted: 2019-07-08
• Study First Submitted QC: 2019-08-02
• Study First Posted: 2019-08-05
• Primary Completion: 2020-11-05
• Study Completion: 2020-11-05
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 223

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)
Incidence of abnormal VIA	Baseline
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)

Secondary Outcome Measures

Name	Time	Method
Time to Cervical Dysplasia	HPV diagnosis to Cervical Dysplasia (up to 2 years)
Time to HPV	Baseline to HPV diagnosis (up to 2 years)
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
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
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
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
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 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
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 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

Trial Locations

Locations (3)

Moi University School of Medicine; 🇰🇪 Eldoret, Kenya

Indiana University Melvin & Bren Simon Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

Infectious Disease Institute, Makerere University; 🇺🇬 Kampala, Uganda