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

Not Applicable

Completed

• Conditions: ColoRectal Cancer; Human Papillomavirus; Human Immunodeficiency Virus; Hepatitis C
• Interventions: Device: OraQuick Swab; Other: Standard Screening Tests; Device: Fecal Immunochemical Test; Device: OraQuick Fingerstick; Device: HPV Self-Sampling Test; Other: Home Based Screening Tests

• Registration Number: NCT02970136
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-11-18
• Study First Submitted QC: 2016-11-18
• Study First Posted: 2016-11-21
• Study Start: 2017-04-11
• Primary Completion: 2020-10-30
• Study Completion: 2020-10-30
• Results First Submitted: 2021-10-29
• Status Verified: 2021-11
• Results First Submitted QC: 2021-11-29
• Last Update Submitted: 2021-11-29
• Results First Posted: 2021-12-28
• Last Update Posted: 2021-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 754

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home Based Screening	OraQuick Fingerstick	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
Home Based Screening	OraQuick Swab	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
Home Based Screening	Fecal Immunochemical Test	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
Clinic Based Screening	Standard Screening Tests	The participant will meet the Community Health Worker and will be navigated to a clinic appointment for standard screening tests
Home Based Screening	HPV Self-Sampling Test	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
Home Based Screening	Home Based Screening Tests	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

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Are Screened for All Conditions	Baseline	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

Name	Time	Method
Change in Percentage of Participants Completing Screening Test From Baseline to 6 Months	Baseline, Up 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	At baseline and at 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.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States