Clinical trial NCT05473936: A CHW Intervention to Identify and Decrease Barriers to COVID 19 Testing & Vaccination
Official title: A Community Health Worker Intervention to Identify and Decrease Barriers to Pre-Procedural COVID 19 Testing Among Los Angeles County Department of Health Safety-Net Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vaccine Hesitancy
COVID-19 Testing
Community Health Workers
Keywords: COVID-19 vaccine hesitancy
COVID-19 testing
Community Health Workers
Safety-Net Patients
Lead sponsor: Charles Drew University of Medicine and Science
Sponsor class: OTHER
Collaborators: name: Los Angeles County Department of Public Health
name: National Library of Medicine (NLM)
First posted: 2022-07-26
Enrollment: 66
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The objective of this study is to compare the results of a COVID-19 specific curriculum led by LACDHS Community Health Workers (CHWs) from these same communities of safety-net patients to effectively increase COVID-19 testing and vaccination for individual patients, and to facilitate needed healthcare in a timely manner for the safety net health system, and to develop a sustained public health presence in these communities to build trust and preparedness for critical COVID-19 related future needs.

Detailed description: This study represents the third aim of a grant with three aims. The study used unsupervised machine learning and qualitative interviews to develop a CHW intervention for this aim. The aim will compare and evaluate a Community Health Worker-led curriculum aimed to identify and address barriers to COVID-19 testing and vaccination among LACDHS safety-net patients.

For the study, the investigators will recruit 66 eligible safety-net patients for a COVID-19 specific curriculum, provided by Community Health Workers at Los Angeles County Department of Health Services. The study will take place remotely over the course of 6-weeks. Utilizing a randomized control design among African American and Latinx safety net patients, will assess the effect of the CHW hypothesis-driven intervention on trust, self-efficacy, and intent to participate in COVID-19 testing and vaccination.

The remote CHW intervention that the study participants will participate in and be compensated for is a pilot program intended to provide additional CHW training. Monthly calls from LACDHS to remind them of COVID-19 vaccination are standard of care for all empaneled LACDHS patients.

Eligibility criteria: Inclusion Criteria:

* Age 16 years and older
* Self-identify as African American or Latinx
* English Speaking
* Receives primary or specialty care treatment at an LACDHS facility
* Has either not completed lab orders for COVID-19 testing and/or vaccination at an LACDHS facility
* Have reliable internet access

Exclusion Criteria:

* Not meeting the inclusion criteria listed above

Primary outcomes:
measure: Project Survey: Phenx toolkit - Worry about COVID
timeFrame: Six weeks from start of project
measure: Project Survey: Phenx toolkit - Attitudes and Behavior
timeFrame: Six weeks from start of project
measure: Project Survey: Phenx toolkit - Perceived Coronavirus Threat
timeFrame: Six weeks from start of project
Secondary outcomes:
measure: Project Survey: Phenx toolkit - Intent to participate in COVID testing and vaccination
timeFrame: Six weeks from start of project
measure: Pre and Post Program Survey: Medical Mistrust Scale
timeFrame: Six weeks from start of project
measure: Sherer, et al.'s General Self-Efficacy Scale
timeFrame: Six weeks from start of project
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles Department of Public Health
state: California
city: Los Angeles
country: United States
facility: Charles Drew University of Medicine and Science
state: California
Study officials:
affiliation: Charles Drew University of Medicine and Science
name: Sheba George, PhD
role: PRINCIPAL_INVESTIGATOR
References: