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Increasing Uptake of Evidence-Based Screening Services Through CHW-led Multi-modality Intervention

Primary Purpose

Human Papillomavirus, Human Immunodeficiency Virus, Hepatitis C

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OraQuick Swab
Fecal Immunochemical Test
OraQuick Fingerstick
Standard Screening Tests
HPV Self-Sampling Test
Home Based Screening Tests
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Human Papillomavirus focused on measuring Increased Screening Uptake, Community Health Worker, Medically Underserved

Eligibility Criteria

50 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. live in one of the three target communities
  2. self-identify as Haitian, Hispanic and/or Black.
  3. be 50-64 years old
  4. need at least one of the four recommended screening services as per US Preventive Service Task Force 121 guidelines as follows: never having had a HIV test b) never having had a Hepatitis C Virus (HCV) test c) not having a Pap smear in the last three years d) not having had a colonoscopy in last 10 years and/or stool-based test in the last year.

Exclusion Criteria:

  1. plan to move out of the community during the next six months;
  2. current or prior enrollment (5 five years) in any research study that involved screening for these conditions.
  3. Are adults unable to consent
  4. Are individuals who are not yet adults (infants, children, teenagers)
  5. Pregnant women
  6. Prisoners

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Home Based Screening

Clinic Based Screening

Arm Description

The participant will be receiving home-based screening tests (OraQuick Swab, OraQuick Fingerstick, Human Papillomavirus (HPV) Self-Sampling Test, Fecal Immunochemical Test) delivered by the community health worker

The participant will meet the Community Health Worker and will be navigated to a clinic appointment for standard screening tests

Outcomes

Primary Outcome Measures

Percentage of Participants Who Are Screened for All Conditions
As evaluated by participant self report and completed sampling kits. Female participants are to be screened on 4 conditions: HIV, HCV, Human Papilloma Virus (HPV) and Fecal Immunochemical Testing (FIT). Male participants are to be screened on 3 conditions: HIV, Hepatitis C Virus (HCV) and FIT.

Secondary Outcome Measures

Change in Percentage of Participants Completing Screening Test From Baseline to 6 Months
As evaluated by participant self report and completed sampling kits. Female participants are to be screened on 4 conditions: HIV, HCV, HPV and FIT. Male participants are to be screened on 3 conditions: HIV, HCV and FIT.
Median Number of Screenings Completed
As evaluated by participant self report and completed sampling kits. Female participants are to be screened on 4 conditions: HIV, HCV, HPV and FIT. Male participants are to be screened on 3 conditions: HIV, HCV and FIT.

Full Information

First Posted
November 18, 2016
Last Updated
November 29, 2021
Sponsor
University of Miami
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT02970136
Brief Title
Increasing Uptake of Evidence-Based Screening Services Through CHW-led Multi-modality Intervention
Official Title
Increasing Uptake of Evidence-Based Screening Services Through CHW-led Multi-modality Intervention: South Florida Center for Reducing Health Disparities
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
April 11, 2017 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this research study is to determine the best way to increase screening for cervical cancer, colorectal cancer, HIV, and Hepatitis C among under screened Hispanic, Haitian and African-American individuals in Hialeah, South Dade, and Little Haiti. The investigator will compare home testing led by a community health worker (CHW) versus clinic testing guided by a CHW. Community Health Workers are people who have undergone several weeks of community outreach and health education training. During the study period the participant will continue to receive all of their regular medical care from their regular health care providers. If the participant does not have a health care provider, the Community Health Workers would be able to help in referring the participant for care at a local health care clinic located in their community.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papillomavirus, Human Immunodeficiency Virus, Hepatitis C, ColoRectal Cancer
Keywords
Increased Screening Uptake, Community Health Worker, Medically Underserved

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Home Based Screening
Arm Type
Experimental
Arm Description
The participant will be receiving home-based screening tests (OraQuick Swab, OraQuick Fingerstick, Human Papillomavirus (HPV) Self-Sampling Test, Fecal Immunochemical Test) delivered by the community health worker
Arm Title
Clinic Based Screening
Arm Type
Active Comparator
Arm Description
The participant will meet the Community Health Worker and will be navigated to a clinic appointment for standard screening tests
Intervention Type
Device
Intervention Name(s)
OraQuick Swab
Intervention Description
OraQuick for oral fluid HIV antibody testing
Intervention Type
Device
Intervention Name(s)
Fecal Immunochemical Test
Intervention Description
Fecal Immunochemical stool test specific for human hemoglobin
Intervention Type
Device
Intervention Name(s)
OraQuick Fingerstick
Intervention Description
Patients will be tested for Hepatitis C infection using a fingerstick
Intervention Type
Other
Intervention Name(s)
Standard Screening Tests
Intervention Description
Patients will be navigated to a local health center for standard screening tests
Intervention Type
Device
Intervention Name(s)
HPV Self-Sampling Test
Intervention Description
Patients will be using swab to check for HPV infection
Intervention Type
Other
Intervention Name(s)
Home Based Screening Tests
Intervention Description
Patients will provided screening tests and instructed by Community Health Worker on how to perform home screening tests
Primary Outcome Measure Information:
Title
Percentage of Participants Who Are Screened for All Conditions
Description
As evaluated by participant self report and completed sampling kits. Female participants are to be screened on 4 conditions: HIV, HCV, Human Papilloma Virus (HPV) and Fecal Immunochemical Testing (FIT). Male participants are to be screened on 3 conditions: HIV, Hepatitis C Virus (HCV) and FIT.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Change in Percentage of Participants Completing Screening Test From Baseline to 6 Months
Description
As evaluated by participant self report and completed sampling kits. Female participants are to be screened on 4 conditions: HIV, HCV, HPV and FIT. Male participants are to be screened on 3 conditions: HIV, HCV and FIT.
Time Frame
Baseline, Up to 6 months
Title
Median Number of Screenings Completed
Description
As evaluated by participant self report and completed sampling kits. Female participants are to be screened on 4 conditions: HIV, HCV, HPV and FIT. Male participants are to be screened on 3 conditions: HIV, HCV and FIT.
Time Frame
At baseline and at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: live in one of the three target communities self-identify as Haitian, Hispanic and/or Black. be 50-64 years old need at least one of the four recommended screening services as per US Preventive Service Task Force 121 guidelines as follows: never having had a HIV test b) never having had a Hepatitis C Virus (HCV) test c) not having a Pap smear in the last three years d) not having had a colonoscopy in last 10 years and/or stool-based test in the last year. Exclusion Criteria: plan to move out of the community during the next six months; current or prior enrollment (5 five years) in any research study that involved screening for these conditions. Are adults unable to consent Are individuals who are not yet adults (infants, children, teenagers) Pregnant women Prisoners
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olveen Carrasquillo, MD
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

Plan to Share IPD
No
Citations:
PubMed Identifier
32349789
Citation
Carrasquillo O, Seay J, Jhaveri V, Long T, Kenya S, Thomas E, Sussman D, Trevil D, Koru-Sengul T, Kobetz E. Increasing uptake of evidence-based screening services though a community health worker-delivered multimodality program: study protocol for a randomized pragmatic trial. Trials. 2020 Apr 29;21(1):368. doi: 10.1186/s13063-020-4213-7.
Results Reference
derived

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Increasing Uptake of Evidence-Based Screening Services Through CHW-led Multi-modality Intervention

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