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

University of Miami754 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Enrollment

754

Conditions

Human Papillomavirus Human Immunodeficiency Virus Hepatitis C

Interventions

OraQuick SwabDEVICE

OraQuick for oral fluid HIV antibody testing

Fecal Immunochemical TestDEVICE

Fecal Immunochemical stool test specific for human hemoglobin

OraQuick FingerstickDEVICE

Patients will be tested for Hepatitis C infection using a fingerstick

Standard Screening TestsOTHER

Patients will be navigated to a local health center for standard screening tests

HPV Self-Sampling TestDEVICE

Patients will be using swab to check for HPV infection

Home Based Screening TestsOTHER

Patients will provided screening tests and instructed by Community Health Worker on how to perform home screening tests

Eligibility

Sex: ALLMin age: 50 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Baseline

Secondary Outcomes

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.

Time frame: Baseline, Up to 6 months

Median Number of Screenings Completed

Time frame: At baseline and at 6 months