Clinical trial NCT02970136: Increasing Uptake of Evidence-Based Screening Services Through CHW-led Multi-modality Intervention
Official title: Increasing Uptake of Evidence-Based Screening Services Through CHW-led Multi-modality Intervention: South Florida Center for Reducing Health Disparities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papillomavirus
Human Immunodeficiency Virus
Hepatitis C
ColoRectal Cancer
Keywords: Increased Screening Uptake
Community Health Worker
Medically Underserved
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2016-11-21
Enrollment: 754
Sex: ALL
Minimum age (years): 50
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Who Are Screened for All Conditions
timeFrame: Baseline
Secondary outcomes:
measure: Change in Percentage of Participants Completing Screening Test From Baseline to 6 Months
timeFrame: Baseline, Up to 6 months
measure: Median Number of Screenings Completed
timeFrame: At baseline and at 6 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Olveen Carrasquillo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.