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

Primary Purpose

Cervical Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CHW Outreach and HPV Self-sampling
CHW Outreach
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cervical Cancer focused on measuring Screen, cervical, cancer, HPV, women, community health workers, Hispanic/ Latinas, Haitian

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Outreach

CHW Outreach

CHW Outreach and HPV Self-Sampling

Arm Description

Gets outreach materials and info on where to get screened by CHW.

Comprehensive CHW outreach including home visit, detailed 1:1 education, patient navigation

Same as Arm 2 with a CHW outreach but also option of doing HPV home self-sampling

Outcomes

Primary Outcome Measures

Having had a pap smear in last 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.

Secondary Outcome Measures

Cervical Cancer Knowledge and Access to Care
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.

Full Information

First Posted
April 21, 2014
Last Updated
October 15, 2018
Sponsor
University of Miami
Collaborators
Health Choice Network, Center for Haitian Studies
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1. Study Identification

Unique Protocol Identification Number
NCT02121548
Brief Title
Using CHWs and HPV Home Tests to Increase Cervical Cancer Screening in Minority Populations
Acronym
SUCCESS
Official Title
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:
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 10, 2011 (Actual)
Primary Completion Date
July 7, 2014 (Actual)
Study Completion Date
February 17, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Health Choice Network, Center for Haitian Studies

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
Screen, cervical, cancer, HPV, women, community health workers, Hispanic/ Latinas, Haitian

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
601 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Outreach
Arm Type
Placebo Comparator
Arm Description
Gets outreach materials and info on where to get screened by CHW.
Arm Title
CHW Outreach
Arm Type
Active Comparator
Arm Description
Comprehensive CHW outreach including home visit, detailed 1:1 education, patient navigation
Arm Title
CHW Outreach and HPV Self-Sampling
Arm Type
Active Comparator
Arm Description
Same as Arm 2 with a CHW outreach but also option of doing HPV home self-sampling
Intervention Type
Behavioral
Intervention Name(s)
CHW Outreach and HPV Self-sampling
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CHW Outreach
Intervention Description
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.
Primary Outcome Measure Information:
Title
Having had a pap smear in last 6 months
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Cervical Cancer Knowledge and Access to Care
Description
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.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Subgroup Analysis
Description
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.
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olveen Carrasquillo, MD, MPH
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25056208
Citation
Carrasquillo O, McCann S, Amofah A, Pierre L, Rodriguez B, Alonzo Y, Ilangovan K, Gonzalez M, Trevil D, Byrne MM, Koru-Sengul T, Kobetz E. Rationale and design of the research project of the South Florida Center for the Reduction of Cancer Health Disparities (SUCCESS): study protocol for a randomized controlled trial. Trials. 2014 Jul 23;15:299. doi: 10.1186/1745-6215-15-299.
Results Reference
background
PubMed Identifier
26890012
Citation
Ilangovan K, Kobetz E, Koru-Sengul T, Marcus EN, Rodriguez B, Alonzo Y, Carrasquillo O. Acceptability and Feasibility of Human Papilloma Virus Self-Sampling for Cervical Cancer Screening. J Womens Health (Larchmt). 2016 Sep;25(9):944-51. doi: 10.1089/jwh.2015.5469. Epub 2016 Feb 18.
Results Reference
background
PubMed Identifier
27091604
Citation
Kenya S, Okoro IS, Wallace K, Ricciardi M, Carrasquillo O, Prado G. Can Home-Based HIV Rapid Testing Reduce HIV Disparities Among African Americans in Miami? Health Promot Pract. 2016 Sep;17(5):722-30. doi: 10.1177/1524839916629970. Epub 2016 Apr 18.
Results Reference
background
PubMed Identifier
25864021
Citation
Kenya S, Carrasquillo O, Fatil M, Jones J, Jean C, Huff I, Kobetz E. Human Papilloma Virus and Cervical Cancer Education Needs among HIV-Positive Haitian Women in Miami. Womens Health Issues. 2015 May-Jun;25(3):262-6. doi: 10.1016/j.whi.2014.12.007. Epub 2015 Apr 9.
Results Reference
background
PubMed Identifier
29594933
Citation
Carrasquillo O, Seay J, Amofah A, Pierre L, Alonzo Y, McCann S, Gonzalez M, Trevil D, Koru-Sengul T, Kobetz E. HPV Self-Sampling for Cervical Cancer Screening Among Ethnic Minority Women in South Florida: a Randomized Trial. J Gen Intern Med. 2018 Jul;33(7):1077-1083. doi: 10.1007/s11606-018-4404-z. Epub 2018 Mar 28.
Results Reference
result

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

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