Working Towards Empowered Community-driven Approaches to Increase Vaccination and Preventive Care Engagement

NCT05841810 | Active Not Recruiting DMC

• 1 other identifier: R01MD017222
• Study Type: interventional
• Target: 398
• Locations: 1 country
• Sites: 4

Brief Summary

This study will optimize, implement, and test the impact of our multicomponent health program that includes three primary implementation strategies (Cultural Weavers and co-creation, mHealth strategies using culturally meaningful text and voice messages, and care coordination). The investigators will use a participatory approach to engage community members in co-creating and optimizing our mHealth outreach and enhanced care coordination program components. The investigators will use a hybrid type 3 effectiveness-implementation sequential multiple assignment randomized trial (SMART) design to assess the impact of our multicomponent health program on implementation and outcome measures.

Conditions

COVID-19

Keywords

implementation science; hybrid 3 effectiveness-implementation study; sequential multiple assignment randomized trial; COVID-19; underserved communities; health equity; care coordination; mHealth; preventive care

Outcome Measures

Primary Outcomes (4)

• COVID-19 vaccination rate

  Clinical assessment of COVID-19 vaccine status based on the total number of COVID-19 vaccines received (initial + boosters).

  8 months after starting the 1st stage intervention to determine response vs non-response for 2nd stage randomization.

• COVID-19 vaccination rate

  Clinical assessment of COVID-19 vaccine status based on the total number of COVID-19 vaccines received (initial + boosters).

  12 months after 2nd stage randomization

• COVID-19 vaccination rate

  Clinical assessment of COVID-19 vaccine status based on the total number of COVID-19 vaccines received (initial + boosters).

  24 months after 2nd stage randomization

• COVID-19 vaccination rate

  Clinical assessment of COVID-19 vaccine status based on the total number of COVID-19 vaccines received (initial + boosters).

  36 months after 2nd stage randomization

Secondary Outcomes (4)

• Preventive services engagement rate

  8 months after starting the 1st stage intervention to determine response vs non-response for 2nd stage randomization.

• Preventive services engagement rate

  12 months after 2nd stage randomization

• Preventive services engagement rate

  24 months after 2nd stage randomization

• Preventive services engagement rate

  36 months after 2nd stage randomization

Study Arms (5)

Stage 1 mHealth Outreach

EXPERIMENTAL

Other: mHealth Outreach

Stage 2 mHealth Outreach

EXPERIMENTAL

Other: mHealth Outreach

Stage 1 Standard of Care

NO INTERVENTION

Stage 2 Standard of Care

NO INTERVENTION

Stage 2 mHealth Outreach + Care Coordination

EXPERIMENTAL

Other: mHealth Outreach; Other: Care Coordination

Interventions

mHealth Outreach OTHER

Community outreach using mHealth messaging will be led by community weavers via SMS and voice messages about COVID-19 vaccines and preventive care engagement in languages spoken by patients (i.e., Spanish, Arabic, Vietnamese).

Stage 1 mHealth Outreach; Stage 2 mHealth Outreach; Stage 2 mHealth Outreach + Care Coordination

Care Coordination OTHER

Inclusive of standard of care coordination with added focus on completing outstanding preventive care practices. Care coordination will be focused on collaborative problem-solving and case management to help patients schedule and attend recommended annual preventive health care, including a routine physical exam, recommended preventive screenings and COVID-19 vaccination

Stage 2 mHealth Outreach + Care Coordination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older.
• Speaks Spanish, Arabic and/or Vietnamese.
• Current San Ysidro Health patient and receives care at select clinics in study locations (Escondido, El Cajon, Community Heights).

You may not qualify if:

• Not able to provide informed consent.
• \< 18 years old
• Does not speak Spanish, Arabic or Vietnamese
• Is not a current San Ysidro Health patient or is a current San Ysidro Health patient but does not receive care at select clinics in study locations (Escondido, El Cajon, Community Heights).

Sponsors & Collaborators

• University of California, San Diego: lead
• San Ysidro Health Center: collaborator

Study Sites (4)

San Ysidro Health Medical Center - El Cajon

El Cajon, California, 92020, United States

Location

Escondido Family Medicine

Escondido, California, 92025, United States

Location

University of California San Diego

La Jolla, California, 92093, United States

Location

Community Heights Family Medicine

San Diego, California, 92115, United States

Location

Related Publications (2)

• Stadnick NA, Geremia C, Cain KL, Oswald W, Watson P, Ibarra M, Nguyen M, Altemimi Z, Hammi N, Bautista M, Alrefaee M, Chu TM, Wagner NM, Vijaykumar S, O'Leary ST, Diaz EA, Aldous J, Rabin BA. Illustrating Key Components to Co-Creation Through Preventive Care mHealth Messaging with Underserved Communities and Expert Partners. J Med Syst. 2025 Dec 12;49(1):180. doi: 10.1007/s10916-025-02310-z.

  PMID: 41381776 DERIVED

• Rabin BA, Cain KL, Watson P Jr, Oswald W, Laurent LC, Meadows AR, Seifert M, Munoz FA, Salgin L, Aldous J, Diaz EA, Villodas M, Vijaykumar S, O'Leary ST, Stadnick NA. Scaling and sustaining COVID-19 vaccination through meaningful community engagement and care coordination for underserved communities: hybrid type 3 effectiveness-implementation sequential multiple assignment randomized trial. Implement Sci. 2023 Jul 14;18(1):28. doi: 10.1186/s13012-023-01283-2.

  PMID: 37443044 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The investigators will use a hybrid type 3 effectiveness-implementation sequential multiple assignment randomized trial (SMART) design to assess the impact of our multicomponent health program on implementation and outcome measures. As participants progress through multiple stages, each participant may be randomized to two or more intervention options allowing us to compare the relative effectiveness of multiple intervention options. Our experimental design follows a SMART randomized structure to introduce the more intensive care coordination component only to those who are not responding to usual care or the lower intensity and less resource intensive mHealth messaging component allowing for more efficient resource allocation.

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: May 3, 2023
• Study Start: August 20, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)