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

Study Overview
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Brief Summary
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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.

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

Conditions
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Human Papillomavirus, Human Immunodeficiency Virus, Hepatitis C, ColoRectal Cancer

Intervention / Treatment
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* Device: OraQuick Swab
* Device: Fecal Immunochemical Test
* Device: OraQuick Fingerstick
* Other: Standard Screening Tests
* Device: HPV Self-Sampling Test
* Other: Home Based Screening Tests


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home Based Screening<br>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 | Device: OraQuick Swab<br>* OraQuick for oral fluid HIV antibody testing<br>Device: Fecal Immunochemical Test<br>* Fecal Immunochemical stool test specific for human hemoglobin<br>Device: OraQuick Fingerstick<br>* Patients will be tested for Hepatitis C infection using a fingerstick<br>Device: HPV Self-Sampling Test<br>* Patients will be using swab to check for HPV infection<br>Other: Home Based Screening Tests<br>* Patients will provided screening tests and instructed by Community Health Worker on how to perform home screening tests<br>|
| Active Comparator: Clinic Based Screening<br>The participant will meet the Community Health Worker and will be navigated to a clinic appointment for standard screening tests | Other: Standard Screening Tests<br>* Patients will be navigated to a local health center for standard screening tests<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Increased Screening Uptake, Community Health Worker, Medically Underserved