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Using CHWs or Mailing Self Sampling Home Tests to Increase Cervical Cancer Screening in South Florida

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02202109
First Posted: July 28, 2014
Last Update Posted: November 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Health Choice Network
Center for Haitian Studies
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Erin Kobetz-Kerman, University of Miami
  Purpose
The study will test the significance of community health worker (CHW) participation by comparing self-sampling provided by a community health worker and self-sampling provided by mail. The study will enroll 700 participants in communities that lack access to medical care in South Florida.

Condition Intervention
Cervical Cancer Behavioral: CHW and Self-sampling for Cervical Cancer Behavioral: Mailed Self Sampler

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Screening
Official Title: Addressing Cervical Cancer Disparity in South Florida: CBPR in Action

Resource links provided by NLM:


Further study details as provided by Erin Kobetz-Kerman, University of Miami:

Primary Outcome Measures:
  • Having a self sampling test done [ Time Frame: 6 months ]
    The primary outcome is having had a self-sampling done since the initial evaluation. Participants who test negative will be encouraged to rescreen while Participants who test positive for HPV will be navigated to appropriate follow-up care. The CHWs will follow up with participants who do not return the kit within 60 days.


Secondary Outcome Measures:
  • Cervical Cancer Knowledge and Access to Care [ Time Frame: 6 months ]
    Cervical Cancer Knowledge: Baseline and follow-up knowledge information will also be examined as a secondary outcome. Access to Care: We will also examine access to care (having health insurance, usual of care of care and visits to a provider) as additional secondary outcome.


Other Outcome Measures:
  • Number of participant who used the mailed Self Sampler [ Time Frame: 6 months ]
    To determine if the method of delivery of the self sampler affected screening and if one of the two planned intervention was more efficacious among women in one location versus another. In addition using data obtained from our study questionnaire, we will also examine if there was a differential impact of the intervention among women who were uninsured, lower education, lower acculturation level or had lower levels of baseline cervical cancer knowledge.


Enrollment: 602
Actual Study Start Date: January 2015
Study Completion Date: August 2017
Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CHWs facilited Self-Sampling
CHW and Self-sampling for Cervical Cancer. Home visit, self-sampler, collection of test
Behavioral: 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.
Active Comparator: Mailed Self-Sampler
Mailed Self Sampler. Self sampler is mailed to participant; follow up by phone
Behavioral: 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

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Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women
  • 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 report having had a hysterectomy
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202109


Locations
United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Health Choice Network
Center for Haitian Studies
National Cancer Institute (NCI)
Investigators
Principal Investigator: Erin Kobetz, PhD University of Miami
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Erin Kobetz-Kerman, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT02202109     History of Changes
Other Study ID Numbers: 20140249
1R01CA183612-01 ( U.S. NIH Grant/Contract )
First Submitted: July 9, 2014
First Posted: July 28, 2014
Last Update Posted: November 10, 2017
Last Verified: November 2017

Keywords provided by Erin Kobetz-Kerman, University of Miami:
Screen
self-sampler
cervical, cancer
women
community health workers
Hispanic/ Latinas
Haitian
Focus of study is cervical cancer

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female