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

NCT ID: NCT02970136

Last Updated: 2021-12-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

754 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-11

Study Completion Date

2020-10-30

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.

Detailed Description

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Conditions

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Human Papillomavirus Human Immunodeficiency Virus Hepatitis C ColoRectal Cancer

Keywords

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Increased Screening Uptake Community Health Worker Medically Underserved

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Home Based Screening

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

Group Type EXPERIMENTAL

OraQuick Swab

Intervention Type DEVICE

OraQuick for oral fluid HIV antibody testing

Fecal Immunochemical Test

Intervention Type DEVICE

Fecal Immunochemical stool test specific for human hemoglobin

OraQuick Fingerstick

Intervention Type DEVICE

Patients will be tested for Hepatitis C infection using a fingerstick

HPV Self-Sampling Test

Intervention Type DEVICE

Patients will be using swab to check for HPV infection

Home Based Screening Tests

Intervention Type OTHER

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

Clinic Based Screening

The participant will meet the Community Health Worker and will be navigated to a clinic appointment for standard screening tests

Group Type ACTIVE_COMPARATOR

Standard Screening Tests

Intervention Type OTHER

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

Interventions

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OraQuick Swab

OraQuick for oral fluid HIV antibody testing

Intervention Type DEVICE

Fecal Immunochemical Test

Fecal Immunochemical stool test specific for human hemoglobin

Intervention Type DEVICE

OraQuick Fingerstick

Patients will be tested for Hepatitis C infection using a fingerstick

Intervention Type DEVICE

Standard Screening Tests

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

Intervention Type OTHER

HPV Self-Sampling Test

Patients will be using swab to check for HPV infection

Intervention Type DEVICE

Home Based Screening Tests

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Olveen Carrasquillo

Professor of Medicine and Public Health Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Olveen Carrasquillo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami

Miami, Florida, United States

Site Status

Countries

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United States

References

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Carrasquillo O, Seay J, Jhaveri V, Long T, Kenya S, Thomas E, Sussman D, Trevil D, Koru-Sengul T, Kobetz E. Increasing uptake of evidence-based screening services though a community health worker-delivered multimodality program: study protocol for a randomized pragmatic trial. Trials. 2020 Apr 29;21(1):368. doi: 10.1186/s13063-020-4213-7.

Reference Type DERIVED
PMID: 32349789 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1U01MD010614-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20160023

Identifier Type: -

Identifier Source: org_study_id