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

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.

Conditions

• Human Papillomavirus
• Human Immunodeficiency Virus
• Hepatitis C
• ColoRectal Cancer

Interventions

DEVICE

OraQuick Swab

OraQuick for oral fluid HIV antibody testing

DEVICE

Fecal Immunochemical Test

Fecal Immunochemical stool test specific for human hemoglobin

DEVICE

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

Sponsors & Collaborators

• National Institute on Minority Health and Health Disparities (NIMHD)

  collaborator NIH

• University of Miami

  lead OTHER

Principal Investigators

• Olveen Carrasquillo, MD · University of Miami

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-04-11

Primary Completion

2020-10-30

Completion

2020-10-30

FDA Device

Yes

Countries

• United States

Study Locations