Skip to main content
OpenTrials
Completed

NCT Number: NCT04045652

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Cervical Dysplasia Communicable Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Neoplasms Precancerous Conditions RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Diseases Virus Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Moi University School of Medicine, Eldoret, Kenya

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Frequency of oncogenic Human Papillomavirus (HPV) in Human Immunodeficiency Virus(HIV)-infected women with a normal Visual Inspection with Acetic Acid (VIA) at baseline

    Time frame: 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)

  2. Frequency oncogenic HPV in non HIV-infected women with a normal VIA at baseline

    Time frame: 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)

  3. Incidence of abnormal VIA

    Time frame: Baseline

Secondary outcomes

  1. Incidence of cervical dysplasia in Kenyan women with normal VIA at baseline, and who are HIV-infected during 4 years of observation

    Time frame: 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

  2. Incidence of cervical dysplasia in Kenyan women with normal VIA at baseline, and who are HIV-uninfected during 4 years of observation

    Time frame: 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

  3. Identify potentially modifiable sex behavioral risk factors associated with oncogenic HPV

    Time frame: 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

  4. Identify potentially modifiable sex behavioral risk factors associated with cervical dysplasia

    Time frame: 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

  5. Identify potentially modifiable health behavioral risk factors associated with oncogenic HPV

    Time frame: 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

  6. Identify potentially modifiable health behavioral risk factors associated with cervical dysplasia

    Time frame: 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

  7. Incidence of potentially modifiable biological risk factors associated with oncogenic HPV through HPV testing will occur through cervical and/or vaginal swabs

    Time frame: 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

  8. Incidence of potentially modifiable biological behavioral risk factors associated with cervical dysplasia through cervical and/or vaginal swabs for HPV and CT/GC testing

    Time frame: 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

  9. Time to HPV

    Time frame: Baseline to HPV diagnosis (up to 2 years)

  10. Time to Cervical Dysplasia

    Time frame: HPV diagnosis to Cervical Dysplasia (up to 2 years)

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Aug 5, 2019
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.