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

ColoRectal Cancer Clinical Trial

Official title:

Increasing Uptake of Evidence-Based Screening Services Through CHW-led Multi-modality Intervention: South Florida Center for Reducing Health Disparities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02970136
• Other study ID #: 20160023
• Secondary ID: 1U01MD010614-01
• Status: Completed
• Phase: N/A
• Start date: April 11, 2017
• Est. completion date: October 30, 2020

Study information

• Verified date: November 2021
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 754
• Est. completion date: October 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• ColoRectal Cancer
• Hepatitis C
• HIV Infections
• Human Immunodeficiency Virus
• Human Papillomavirus

Intervention

Device:
• OraQuick Swab
OraQuick for oral fluid HIV antibody testing
• Fecal Immunochemical Test
Fecal Immunochemical stool test specific for human hemoglobin
• OraQuick Fingerstick
Patients will be tested for Hepatitis C infection using a fingerstick

Other:
• Standard Screening Tests
Patients will be navigated to a local health center for standard screening tests

Device:
• HPV Self-Sampling Test
Patients will be using swab to check for HPV infection

Other:
• Home Based Screening Tests
Patients will provided screening tests and instructed by Community Health Worker on how to perform home screening tests

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Secondary	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.	Baseline, Up to 6 months
Secondary	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.	At baseline and at 6 months