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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04045652
• Other study ID #: IUCRO-0492
• Status: Recruiting
• Start date: November 18, 2021
• Est. completion date: October 1, 2026

Study information

• Verified date: May 2023
• Source: Indiana University
• Contact: Darron Brown, MD
• Phone: 317-274-1425
• Email: darbrow[@]iupui.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: October 1, 2026
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Dysplasia
• HIV Infections
• HIV/AIDS
• Uterine Cervical Dysplasia

Locations

Country	Name	City	State
Kenya	Moi University School of Medicine	Eldoret
Uganda	Infectious Disease Institute, Makerere University	Kampala
United States	Indiana University Melvin & Bren Simon Cancer Center	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Countries where clinical trial is conducted

United States,  Kenya,  Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	Incidence of abnormal VIA		Baseline
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Time to HPV		Baseline to HPV diagnosis (up to 2 years)
Secondary	Time to Cervical Dysplasia		HPV diagnosis to Cervical Dysplasia (up to 2 years)