Increasing Uptake of Evidence-Based Screening Services Through CHW-led Multi-modality Intervention
2 other identifiers
interventional
754
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2016
CompletedFirst Posted
Study publicly available on registry
November 21, 2016
CompletedStudy Start
First participant enrolled
April 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2020
CompletedResults Posted
Study results publicly available
December 28, 2021
CompletedDecember 28, 2021
November 1, 2021
3.6 years
November 18, 2016
October 29, 2021
November 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Change in Percentage of Participants Completing Screening Test From Baseline to 6 Months
Baseline, Up to 6 months
Median Number of Screenings Completed
At baseline and at 6 months
Study Arms (2)
Home Based Screening
EXPERIMENTALThe 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
Clinic Based Screening
ACTIVE COMPARATORThe participant will meet the Community Health Worker and will be navigated to a clinic appointment for standard screening tests
Interventions
Fecal Immunochemical stool test specific for human hemoglobin
Patients will be tested for Hepatitis C infection using a fingerstick
Patients will be navigated to a local health center for standard screening tests
Patients will be using swab to check for HPV infection
Patients will provided screening tests and instructed by Community Health Worker on how to perform home screening tests
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Miami
Miami, Florida, 33136, United States
Related Publications (1)
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.
PMID: 32349789DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Olveen Carrasquillo
- Organization
- University of Miami
Study Officials
- PRINCIPAL INVESTIGATOR
Olveen Carrasquillo, MD
University of Miami
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine and Public Health Sciences
Study Record Dates
First Submitted
November 18, 2016
First Posted
November 21, 2016
Study Start
April 11, 2017
Primary Completion
October 30, 2020
Study Completion
October 30, 2020
Last Updated
December 28, 2021
Results First Posted
December 28, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share