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

NCT02202109 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 602

Last updated 2018-12-19

Study results available
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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.

Conditions

Interventions

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.

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;

Sponsors & Collaborators

  • Health Choice Network

    collaborator OTHER

  • Center for Haitian Studies

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Miami

    lead OTHER

Principal Investigators

  • Erin Kobetz, PhD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02202109 on ClinicalTrials.gov