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

Addressing Cervical Cancer Disparity in South Florida: CBPR in Action

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.

Study Overview

• Status: Completed
• Conditions: Cervical Cancer
• Intervention / Treatment: Behavioral: CHW and Self-sampling for Cervical Cancer; Behavioral: Mailed Self Sampler

• Study Type: Interventional
• Enrollment (Actual): 602
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Completing a Self-sampling Test	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.	2 to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Change in Cervical Cancer Knowledge Among Participants	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.	Baseline, 6 months
Proportion of Participants With a Change in Access to Care	Access to care was defined as having a routine source of care and measured at both pre(baseline) and post (exit).	Baseline, 6 months

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Cancer Institute (NCI); Health Choice Network; Center for Haitian Studies
• Investigators: Principal Investigator: Erin Kobetz, PhD, University of Miami

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: July 9, 2014
• First Submitted That Met QC Criteria: July 25, 2014
• First Posted (Estimate): July 28, 2014

Study Record Updates

• Last Update Posted (Actual): December 19, 2018
• Last Update Submitted That Met QC Criteria: December 13, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: women; Screen; community health workers; self-sampler; cervical, cancer; Hispanic/ Latinas; Haitian; Focus of study is cervical cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: 20140249; 1R01CA183612-01 (U.S. NIH Grant/Contract)