Using CHWs and HPV Home Tests to Increase Cervical Cancer Screening in Minority Populations (SUCCESS)

October 15, 2018 updated by: Olveen Carrasquillo, University of Miami

Research Project of the South Florida Center for Reducing Cancer Disparities (SUCCESS): Testing CHWs and HPV Self-Sampling to Increase Cervical Cancer Screening Among Minority Immigrants in Miami-Dade County:

Caribbean immigrants (both Hispanics and Blacks from Haiti) are less likely to be screened for cervical cancer than the general population. One promising approach is outreach strategies that employ Community Health Workers (CHWs). Yet even in well structured CHW programs, many women remain unscreened. In our NCI Community Networks sponsored project, we are testing an approach that combines CHWs with self sampling for the human papilloma virus (HPV) as a screening strategy among such hard to reach populations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Building on our existing community partnerships, we propose a randomized CBPR study among 600 women in three underserved communities in Miami-Dade County to determine optimal approaches to increase cervical cancer screening among Caribbean and other underserved women. The study is a three arm study with 200 women randomized at each site over 3 years. Women in the control group would be exposed to NCI approved culturally and linguistically appropriate outreach and educational materials on cervical cancer screening. Our two specific aims are 1) to determine if as compared to our control group, women randomized to the community health worker intervention group consisting one on one health education and facilitation of referrals to existing screening programs results in increase proportion of women who are screened 2) to determine if as compared to the CHW group, women randomized to a CHW intervention with the addition of a home based self-sampling strategy results in an additional increase in proportion of women who are screened versus the CHW group without HPV sampling. Secondary outcomes include comparisons of a) measures of access to care (health insurance, having a usual source of care, and visit to provider in six months) b) cost of providing the intervention in order to determine the cost of recruiting an individual woman into screening c) among women having abnormal screens, time to follow-up and further testing.

Study Type

Interventional

Enrollment (Actual)

601

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Haitian, Hispanic or African American women
  • ages 30-65 years
  • not having had a pap smear in the last three years
  • live in Miami-Dade County

Exclusion Criteria:

  • having had a hysterectomy
  • history of cervical cancer
  • plan to move out of the neighborhood during the next six months
  • are enrolled in any other cancer prevention/outreach related study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Outreach
Gets outreach materials and info on where to get screened by CHW.
Behavioral: CHW Outreach
The intervention strategies will involve three overlapping domains 1)provide health education on cervical cancer screening, 2) motivation to encourage women to have screening 3) provide navigation services to obtain the screening. We envision visits lasting no more than 60 minutes.
Active Comparator: CHW Outreach
Comprehensive CHW outreach including home visit, detailed 1:1 education, patient navigation
Behavioral: CHW Outreach and HPV Self-sampling
The intervention strategies will involve three overlapping domains 1)provide health education on cervical cancer screening, 2) motivation to encourage women to have screening 3) provide navigation services to obtain the screening. We envision visits lasting no more than 60 minutes. Women who are randomized to this arm will also include information on the alternative screening method. They will be told that cervical self-sampling is an alternative screening technique for the Pap smear and they will be offered the choice of having the HPV screen done during that home visit or have a Pap Smear at the participating FQHC.
Active Comparator: CHW Outreach and HPV Self-Sampling
Same as Arm 2 with a CHW outreach but also option of doing HPV home self-sampling
Behavioral: CHW Outreach
The intervention strategies will involve three overlapping domains 1)provide health education on cervical cancer screening, 2) motivation to encourage women to have screening 3) provide navigation services to obtain the screening. We envision visits lasting no more than 60 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Having had a pap smear in last 6 months
Time Frame: 6 months
Primary Outcome: The primary outcome is patient self-reporting on whether they had a Pap smear of HPV testing done since the initial evaluation. As an additional analysis, patients whom were contacted by phone but do no wish to return for follow-up evaluation will be asked by phone if they had the Pap Smear of HPV testing done.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subgroup Analysis
Time Frame: 6 months
Potential additional analysis will if the either 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

Health Choice Network
Center for Haitian Studies

Investigators

  • Principal Investigator: Olveen Carrasquillo, MD, MPH, University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2011

Primary Completion (Actual)

July 7, 2014

Study Completion (Actual)

February 17, 2015

Study Registration Dates

First Submitted

April 21, 2014

First Submitted That Met QC Criteria

April 21, 2014

First Posted (Estimate)

April 23, 2014

Study Record Updates

Last Update Posted (Actual)

October 17, 2018

Last Update Submitted That Met QC Criteria

October 15, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20100834

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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