Using CHWs or Mailing Self Sampling Home Tests to Increase Cervical Cancer Screening in South Florida
NCT ID: NCT02202109
Last Updated: 2018-12-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
602 participants
INTERVENTIONAL
2015-01-31
2017-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
SINGLE
Study Groups
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CHWs facilitated Self-Sampling
CHW and Self-sampling for Cervical Cancer. Home visit, self-sampler, collection of test
CHW and Self-sampling for Cervical Cancer
Behavioral: CHW and Self-sampling for Cervical Cancer The intervention strategies will involve one home visit: 1) provide brief health education on cervical cancer screening, 2) provide and collect self-sampler test. We envision visits lasting no more than 60 minutes.
Mailed Self-Sampler
Mailed Self Sampler. Self sampler is mailed to participant; follow up by phone
Mailed Self Sampler
Mailed Self Sampler. Women randomized to this intervention arm will receive a self-sampling kit via mail. This kit will include: 1) the self-sampler; 2) the vial for collecting and storing the specimen; 3) a pre-addressed, stamped envelope for returning the vial; 4) a brief introductory letter/postcard which includes a picture of the CHE and the CHW and serves to re-orient the participant to the focus of the study; 5) instructional guide that visually depicts the steps for self-sampling;
Interventions
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CHW and Self-sampling for Cervical Cancer
Behavioral: CHW and Self-sampling for Cervical Cancer The intervention strategies will involve one home visit: 1) provide brief health education on cervical cancer screening, 2) provide and collect self-sampler test. We envision visits lasting no more than 60 minutes.
Mailed Self Sampler
Mailed Self Sampler. Women randomized to this intervention arm will receive a self-sampling kit via mail. This kit will include: 1) the self-sampler; 2) the vial for collecting and storing the specimen; 3) a pre-addressed, stamped envelope for returning the vial; 4) a brief introductory letter/postcard which includes a picture of the CHE and the CHW and serves to re-orient the participant to the focus of the study; 5) instructional guide that visually depicts the steps for self-sampling;
Eligibility Criteria
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Inclusion Criteria
* Haitian, Hispanic, or African American
* Ages 30-65 years
* Report not having had a pap smear in the last three years live in the cities of Miami/Little Haiti, Hialeah or unincorporated Southern Miami-Dade
Exclusion Criteria
* Women who have a history of cervical cancer
* Women who plan to move outside of Miami-Dade county during the next six months
* Women who are enrolled in any other cancer prevention/outreach related study
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
30 Years
65 Years
FEMALE
No
Sponsors
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Health Choice Network
OTHER
Center for Haitian Studies
OTHER
National Cancer Institute (NCI)
NIH
University of Miami
OTHER
Responsible Party
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Erin Kobetz-Kerman
Associate Professor
Principal Investigators
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Erin Kobetz, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Miami, Florida, United States
Countries
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References
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Kobetz E, Seay J, Amofah A, Pierre L, Bispo JB, Trevil D, Gonzalez M, Poitevien M, Koru-Sengul T, Carrasquillo O. Mailed HPV self-sampling for cervical cancer screening among underserved minority women: study protocol for a randomized controlled trial. Trials. 2017 Jan 13;18(1):19. doi: 10.1186/s13063-016-1721-6.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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20140249
Identifier Type: -
Identifier Source: org_study_id