NCT05470309

Brief Summary

This study offers Hispanic women who are eligible for cervical cancer screening residing in the Cleveland metropolitan area one of two possible community outreach-based cervical cancer screening modalities, self-collection home HPV test or clinic-based pap test, which is the current standard of care, to assess if these strategies improve cervical cancer screening rates in this population group.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2024

Completed
Last Updated

March 7, 2025

Status Verified

November 1, 2024

Enrollment Period

1.8 years

First QC Date

July 20, 2022

Last Update Submit

March 4, 2025

Conditions

Cervical Cancer

Keywords

Cervical Cancer ScreeningHome HPV Self-TestIn-office Pap TestHispanic WomenCleveland

Outcome Measures

Primary Outcomes (1)

  • Receipt of Cervical Cancer Screening

    Either return of a mailed home HPV test kit or receipt of in-office Pap test

    3 months

Eligibility Criteria

Age30 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hispanic women aged 30 and 65 years residing in the City of Cleveland who are not pregnant; did not have a hysterectomy; and are due for guideline-recommended cervical cancer screening

You may qualify if:

  • Hispanic women aged 30 and 65 years
  • Residing in the City of Cleveland

You may not qualify if:

  • Women who are pregnant
  • Had a hysterectomy
  • Women who had pap test in the past three years or hrHPV test in the past five years or co-testing (hrHPV + pap test) in the past five years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Kirsten Y Eom, PhD

    MetroHealth Population Health Research Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2022

First Posted

July 22, 2022

Study Start

February 1, 2023

Primary Completion

November 27, 2024

Study Completion

November 27, 2024

Last Updated

March 7, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)