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

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. Identifier: NCT02202109
Recruitment Status : Completed
First Posted : July 28, 2014
Results First Posted : December 19, 2018
Last Update Posted : December 19, 2018
Health Choice Network
Center for Haitian Studies
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Erin Kobetz-Kerman, University of Miami

Brief Summary:
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 or disease Intervention/treatment Phase
Cervical Cancer Behavioral: CHW and Self-sampling for Cervical Cancer Behavioral: Mailed Self Sampler Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 602 participants
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
Actual Study Start Date : January 2015
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Active Comparator: CHWs facilitated 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;

Primary Outcome Measures :
  1. Number of Participants Completing a Self-sampling Test [ Time Frame: 2 to 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 :
  1. Proportion of Change in Cervical Cancer Knowledge Among Participants [ Time Frame: Baseline, 6 months ]
    Cervical cancer knowledge was measured with a series of questions asked at both pre(baseline) and post (exit). The questions were designed to measure participant's knowledge of cervical cancer prior to the study intervention and following the intervention. Cervical cancer knowledge is defined by participants answering 3 out 5 questions correctly.

  2. Proportion of Participants With a Change in Access to Care [ Time Frame: Baseline, 6 months ]
    Access to care was defined as having a routine source of care and measured at both pre(baseline) and post (exit).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

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 identifier (NCT number): NCT02202109

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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)
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Principal Investigator: Erin Kobetz, PhD University of Miami
  Study Documents (Full-Text)

Documents provided by Erin Kobetz-Kerman, University of Miami:
Study Protocol  [PDF] February 4, 2016
Statistical Analysis Plan  [PDF] February 2, 2017

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Erin Kobetz-Kerman, Associate Professor, University of Miami Identifier: NCT02202109    
Other Study ID Numbers: 20140249
1R01CA183612-01 ( U.S. NIH Grant/Contract )
First Posted: July 28, 2014    Key Record Dates
Results First Posted: December 19, 2018
Last Update Posted: December 19, 2018
Last Verified: December 2018
Keywords provided by Erin Kobetz-Kerman, University of Miami:
cervical, cancer
community health workers
Hispanic/ Latinas
Focus of study is cervical cancer
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases