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

University of Miami

Status: Completed

Conditions: Human Immunodeficiency Virus; Hepatitis C; ColoRectal Cancer; Human Papillomavirus

Treatments: Device: OraQuick Swab; Device: HPV Self-Sampling Test; Other: Home Based Screening Tests; Other: Standard Screening Tests; Device: Fecal Immunochemical Test; Device: OraQuick Fingerstick

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02970136

20160023

1U01MD010614-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 754 patients

Sex: All

Ages: 50 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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754 participants in 2 patient groups

Home Based Screening

Experimental group

Description:

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

Treatment:

Device: OraQuick Swab

Device: Fecal Immunochemical Test

Device: HPV Self-Sampling Test

Other: Home Based Screening Tests

Device: OraQuick Fingerstick

Clinic Based Screening

Active Comparator group

Description:

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

Treatment:

Other: Standard Screening Tests