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Completed

NCT Number: NCT03942705

A New Approach to Cervical Cancer Prevention in Kenya

The purpose of this study is to determine if the human papillomavirus (HPV) deoxyribonucleic acid (DNA) testing, performed on self-collected vaginal swabs, is acceptable, feasible, and sensitive and specific in detection of high-grade cervical lesions among Kenyan women, compared to the current standard of care.

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Key information

About this study

The purpose of this study is to test the hypothesis that effective cervical cancer screening can be performed in a high percentage of women, using HPV DNA of self-collected vaginal samples, provided by women attending either chamas (community groups) or in their own homes. HPV DNA testing will be used to triage women for a secondary screen by visual inspection with acetic acid (VIA) in a local clinic. The investigators will determine if HPV DNA testing, performed on self-collected vaginal swabs, is acceptable, feasible, and sensitive and specific in detection of high-grade cervical lesions among Kenyan women, compared to the current standard of care. In addition, women will bring their children to be vaccinated against HPV in these community meetings, using the standard of care for the approved HPV vaccine available in Kenya.

The investigators will test this approach by completing the following Specific Aims:

Specific Aim 1: Determine the percentage of women attending community meetings who will provide self-collected vaginal swabs for HPV DNA testing.

Specific Aim 2. Following HPV DNA screening using self-collected swabs, determine the percentage of these women who will attend the local clinic.

Specific Aim 3. Evaluate the statistical correlation between HPV DNA testing of self-collected vaginal swabs and VIA (as all women in this pilot study will undergo VIA).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Women who live in Kenya who are between the ages of 30 and 55, are willing to provide a self collected vaginal swab and willing to travel to the local clinic for a VIA

Exclusion criteria

  • current pregnancy, inability to consent due to mental or physical disability, or a medical illness that has rendered the patient unable to understand consent

Treatment and study plan

Primary outcomes

  1. Percentage of women attending community meetings who will provide self-collected vaginal swabs for HPV DNA testing.

    Time frame: anytime after informed consent up to 2 years

  2. Percentage of women who attend clinic after providing self-collected vaginal swabs

    Time frame: any time after completion of self-collected vaginal swab (up to 2 years)

Secondary outcomes

  1. HPV DNA vaginal swab testing results

    Time frame: any time after after self-collected vaginal swab, up to 2 years

    analyzed for the human reference gene (specimen adequacy), HPV 16/18, or any of 12 oncogenic HPV types.

  2. Visual inspection with acetic acid (VIA) testing results

    Time frame: any time after VIA is performed, up to 2 years

    Results reported as abnormal or normal

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Academic Model Providing Access to Healthcare (AMPATH)
  • Merck Sharp & Dohme LLC

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 8, 2019
Registry last updated
Jun 14, 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.

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