A New Approach to Cervical Cancer Prevention in Kenya

NCT03942705 | Completed DMC

• 1 other identifier: 1712513308
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

human papillomavirus (HPV); cervical cancer; prevention; Kenya

Outcome Measures

Primary Outcomes (2)

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

  anytime after informed consent up to 2 years

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

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

Secondary Outcomes (2)

• HPV DNA vaginal swab testing results

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

• Visual inspection with acetic acid (VIA) testing results

  any time after VIA is performed, up to 2 years

Study Arms (1)

Kenyan Women

Women living in western Kenya will be asked to complete a self collected vaginal sample for HPV DNA screening and asked to undergo a second screening by VIA. As per Kenyan standard of care, vaccination against HPV will be offered to children/grandchildren (boys and girls) of women, and to the women themselves if age 26 or younger. The second vaccine dose (for children ages 9 through 14) and third doses (for children and adult women ages 15 through 26) will be administered at subsequent visits. There will be no requirement for HPV vaccination (of children or mothers up to 26 years of age) for participation in the study. Results of the screening will be returned to participants and they will be referred to receive standard care as applicable.

Eligibility Criteria

• Age: 30 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Kenyan women between the ages of 18 and 60 who are willing to provide a self-collected vaginal swabs and willing to travel to the local clinic for VIA.

You may qualify if:

• \. 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

You may not qualify if:

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

Sponsors & Collaborators

• Indiana University: lead
• Merck Sharp & Dohme LLC: collaborator
• Academic Model Providing Access to Healthcare (AMPATH): collaborator

Study Sites (1)

Moi University

Eldoret, Kenya

Location

Biospecimen

Retention: SAMPLES WITH DNA

Cervico-vaginal swab

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Darron Brown, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 8, 2019
• Study Start: October 7, 2019
• Primary Completion: February 28, 2021
• Study Completion: May 31, 2021
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 3 to 12 months
• Access Criteria: Data will be available to researchers who provide a methodologically sound proposal.

Locations

KE (1)