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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05470309
Other study ID # STUDY00000024
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2023
Est. completion date April 30, 2024

Study information

Verified date June 2023
Source MetroHealth Medical Center
Contact Kirsten Y Eom, PhD
Phone 4122777058
Email keom1@metrohealth.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

This study is an observational community outreach-based feasibility study. The study intervention that is being evaluated includes two different strategies of cervical cancer screening: 1) a self-collection home HPV test and 2) an in-office pap test. Study subjects who choose the self-collection home HPV test will be provided with the following materials: 1) research information sheet that explains the study objective, the expected timeline of the results, 2) a letter recommending a routine pap test regardless of whether they chose to complete the self-sampling HPV test, 3) educational materials on how to self-collect and return a sample, and 4) a FDA-approved self-sampling kit. Self-collected samples will be tested by the FDA-approved procedure. Study subjects will be asked to choose the screening method of their preference: a self-collection HPV testing kit at home and return the kit within 1 month to the study team or a pap test at a local clinic, which is scheduled within a month. The at-home test only includes vaginal swab and not collection from the cervix. The study team will be notified of the results of HPV test or of pap test and inform the study subjects. If the study subject reports the study team of the loss of her home HPV test kit, it will be recorded as a study outcome of "loss of home HPV test kit". Study subjects who do not return their HPV test kit within 4 weeks will receive 3 reminder calls within a week. Study subjects who choose an in-office pap test will be scheduled for an annual gynecological exam that includes a pap test at a local clinic that the participant prefers by the study team. The standard-of-care in gynecology at the local clinic involves annual gynecological exam. Study subjects who choose an in-office pap test will receive two appointment reminder calls by the study team a week and three days prior to the scheduled appointment, respectively. No returning of the self-sampling home HPV kit and no show to the scheduled appointment for pap test will be recorded as study outcomes, and these study subjects will be considered enrolled in the study.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date April 30, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 30 Years to 65 Years
Eligibility Inclusion Criteria: - Hispanic women aged 30 and 65 years - Residing in the City of Cleveland Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States MetroHealth Medical Center Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
MetroHealth Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Receipt of Cervical Cancer Screening Either return of a mailed home HPV test kit or receipt of in-office Pap test 3 months
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