Recruiting

CHW Intervention

Sponsor:

Charles Drew University of Medicine and Science

Code:

NCT05473936

Conditions

Vaccine Hesitancy

COVID-19 Testing

Community Health Workers

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Accepted

Interventions

Community Health Worker led curriculum

Study Details

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.

Conditions

Vaccine Hesitancy

COVID-19 Testing

Community Health Workers

Study ID

NCT05473936

Start date

Oct 11, 2022

Status verified date

Feb, 2023

Completion date

May, 2023

Anticipated

Primary completion date

Mar, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

66 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

no intervention: Control Arm - Standard Treatment (Group 1)

The standard care for the control arm will be: the LACDHS Vaccine Hesitancy Outreach Group calling patients once every month to remind patients of the need to be vaccinated and tested if needed. During the duration of the six weeks, the study participants will be exposed to the call from the LACDHS Vaccine Hesitancy Outreach Group.

Participants will receive two phone calls six-weeks apart, where they will complete a pre-survey in the first phone call, and 2 surveys (post-survey and CDE survey) in the second phone call. The survey will measure their trust in medical institutions, rate their self-efficacy, and intention, knowledge, and perceptions on COVID-19 testing and vaccination.

experimental: Intervention Arm - CHW-led curriculum (Group 2)

Participants assigned to the intervention group will complete the same activities as Group 1 and be asked to participate in the virtual intervention, consisting of six-weekly group classes via Zoom, and six-weekly personalized teleconsultations (via phone call or Zoom) at a suitable time for both participants and CHWs. Study participants will receive 6 linguistically and ethnically concordant weekly two-hour group classes and personalized teleconsultations led by CHWs. The total time commitment for Group 2 will be a maximum of 20 hours (6 two-hour group classes, + 6 one hour personal session, + 2 half hour phone calls), over the next 6 weeks.

Interventions

Community Health Worker led curriculum

The intervention arm will consist of a CHW-based health educational program via Zoom, where participants will be provided with information about COVID-19, COVID-19 resources and services in Los Angeles County, and engagement with Los Angeles County Department of Health Services CHWs who will lead the curriculum and be available to answer questions of the intervention arm patients.

Primary outcome measure

  • Project Survey: Phenx toolkit - Worry about COVID [ Time Frame: Six weeks from start of project ]
  • Project Survey: Phenx toolkit - Attitudes and Behavior [ Time Frame: Six weeks from start of project ]
  • Project Survey: Phenx toolkit - Perceived Coronavirus Threat [ Time Frame: Six weeks from start of project ]

Central Contacts and Locations

Central contacts

Junko Nishitani, PhD

323-563-4966junkonishitani@cdrewu.edu

Locations

Los Angeles Department of Public Health

Recruiting

Los Angeles, California, United States, 90012

Contacts

Lauren Daskivich, MD

lpdaskivich@dhs.lacounty.gov

Principal Investigator:

Lauren P Daskivich, MD

Charles Drew University of Medicine and Science

Recruiting

Los Angeles, California, United States, 90059

Contacts

Sheba George, PhD

323-249-5733denisseruiz@cdrewu.edu

Denisse A Ruiz, MPH

323-947-8045denisseruiz@cdrewu.edu

Principal Investigator:

Omolola Ogunyemi, PhD

More Information

Sponsor

Charles Drew University of Medicine and Science

Last update posted

Mar 2, 2023

Last verified

Feb, 2023

Keywords

  • COVID-19 vaccine hesitancy
  • COVID-19 testing
  • Community Health Workers
  • Safety-Net Patients

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Charles Drew University of Medicine and Science on 2023-03-02.