Community Care Intervention for COVID-19 Vaccination

Recruiting at 4 trial locations

Overseen By Andrea Cassells, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: RAND

Disqualifiers: Acutely sick, High suicide risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

800 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if working with community health workers can help more adults with chronic illnesses stay current on their COVID-19 and flu vaccines. Participants will either receive regular care or work with a community health worker who provides up to three sessions in English or Spanish to address reasons for not being vaccinated. The trial seeks adults who have received a COVID-19 vaccine before but are not currently up to date and have been diagnosed with conditions such as high blood pressure, diabetes, asthma, being overweight, or mental health issues like depression or anxiety. As an unphased trial, this study offers a unique opportunity to contribute to important research that could enhance community health strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your medications, but it's best to confirm with the trial organizers.

What prior data suggests that the Community Health Worker Intervention is safe?

Research has shown that programs involving community health workers (CHWs) are generally safe. These programs help people learn about vaccines and make healthier choices. In a previous study, using CHWs reduced hospital stays by 34% compared to regular care, indicating a positive safety profile. No specific reports of negative effects have been linked to CHW programs, suggesting they are well-tolerated. By focusing on education and support rather than medical treatments or drugs, these programs lower the risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Community Health Worker (CHW) intervention for COVID-19 vaccination because it takes a unique approach by focusing on personalized psychoeducational sessions. Unlike existing vaccines that rely on biological mechanisms to protect against the virus, the CHW intervention targets behavioral aspects of vaccination uptake using motivational interviewing techniques. This method addresses specific reasons why individuals might be hesitant or delayed in getting vaccinated, providing tailored support in either English or Spanish. By bridging the gap between vaccine availability and actual vaccination behavior, this approach could significantly enhance public health efforts in increasing vaccination rates.

What evidence suggests that the CHW intervention is effective for increasing COVID-19 vaccination rates?

Research has shown that community health workers (CHWs) can significantly increase vaccination rates. In this trial, participants in the Community Health Worker (CHW) Intervention arm will receive up to three psychoeducational sessions to address specific reasons for not being up to date with their COVID-19 vaccine. One study found that CHWs shared vaccine information with their community, increasing the number of vaccinated individuals from 44% to 76% in just one year. Another study in New York City demonstrated how CHWs improved vaccination, testing, and treatment during the COVID-19 pandemic. These findings suggest that CHWs effectively encourage vaccinations by providing personalized education and support. ^{1 2 6 7 8}

Who Is on the Research Team?

Marielena Lara, MD, MPH

Principal Investigator

RAND

Lisa Meredith, PhD

Principal Investigator

RAND

Jonathan Tobin, PhD

Principal Investigator

Clinical Directors Network

Andrea Cassells, MPH

Principal Investigator

Clinical Directors Network

Are You a Good Fit for This Trial?

This trial is for adults over 18 who speak English or Spanish and can complete an assessment without confusion. It's not for those unwilling to consent, acutely sick individuals, or people at high risk of suicide.

Exclusion Criteria

Not willing to consent

Acutely sick

Have high suicide risk

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the CHW group receive up to 3 psychoeducational sessions to address barriers to COVID-19 and influenza vaccination.

3 months

Up to 3 sessions (in-person or virtual)

Follow-up

Participants are monitored for vaccine acceptance and uptake at 3 months.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• CHW-VB

Trial Overview The study tests if a program by community health workers in health centers can boost COVID-19 and flu vaccination rates among adults with chronic illnesses.

How Is the Trial Designed?

Group I: Community Health Worker (CHW) Intervention to Enhance Vaccination Behavior Experimental Treatment 1 Intervention

Patients randomized to the CHW intervention will receive up to 3 psychoeducational sessions in English or Spanish targeting the specific reason(s) why a patient is not up to date with their COVID-19 vaccine. CHWs will use motivational interviewing techniques to promote vaccination behaviors.

Group II: Usual Care Active Control 1 Intervention

Patients will receive the care that they would usually receive independent of the study but won't have access to the intervention.

Who Is Running the Clinical Trial?

RAND

Lead Sponsor

Trials

145

Recruited

617,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Clinical Directors Network

Collaborator

Trials

13

Recruited

14,200+

Published Research Related to This Trial

Community health workers (CHWs) play a crucial role in promoting health equity and social justice, especially during the COVID-19 pandemic, as they leverage their trusted relationships with underresourced populations.

A focus group with CHW leaders identified key themes such as CHW resiliency and the need for better resources and training, highlighting the pandemic's impact on their ability to support communities facing health disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insights on COVID-19 From Community Health Worker State Leaders. Mayfield-Johnson, S., Smith, DO., Crosby, SA., et al.[2022]

Community health workers (CHWs) in a rural area of southern Nigeria demonstrated a low level of knowledge about COVID-19, with an average knowledge score of only 28.14%, and only 9.3% achieving a satisfactory score of 50% or higher.

The practice of preventive measures among CHWs was also inadequate, with only 50% regularly using face masks and just 12.8% correctly following the procedures for putting on and removing personal protective equipment (PPE).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge and practice of COVID-19 prevention among community health workers in rural Cross River State, Nigeria: implications for disease control in Africa. Omoronyia, O., Ekpenyong, N., Ukweh, I., et al.[2022]

The COVID-19 vaccine education toolkit was developed using the Health Belief Model and refined with community input, ensuring the content was accessible and actionable for community health workers and members.

Survey results showed that over two-thirds of community health workers felt more confident delivering vaccine information using the toolkit, and it positively influenced community members' decisions to get vaccinated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategic Combination of Theory, Plain Language, and Trusted Messengers Contribute to COVID-19 Vaccine Uptake: Lessons Learned from Development and Dissemination of a Community Toolkit. Caballero, A., Leath, KJ., Staton, AD.[2023]

A survey of 775 Community Health Workers (CHWs) in Brazil revealed that the COVID-19 pandemic has intensified challenges in their roles, particularly due to a rise in misinformation and denial about the virus, which hampers public health efforts.

The study highlights that the unique difficulties faced by CHWs in low-income communities during the pandemic have been largely overlooked in Brazilian health policies, suggesting a need for more tailored support and strategies for these essential workers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community health workers' attitudes, practices and perceptions towards the COVID-19 pandemic in brazilian low-income communities. do Rosário Costa, N., Bellas, H., da Silva, PRF., et al.[2021]

Community health workers (CHWs) have shown preliminary effectiveness in increasing access to healthcare, especially in underserved populations, according to a review of existing literature.

However, the impact of CHWs on health knowledge, health outcomes, and behavior changes remains inconclusive, highlighting the need for better study designs and clearer definitions of their roles and target populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome effectiveness of community health workers: an integrative literature review. Swider, SM.[2022]

A standardized community health worker (CHW) intervention significantly reduced total hospital days by 34% compared to usual care, with 849 days for the intervention group versus 1258 days for the control group, based on a pooled analysis of 1340 patients across three randomized clinical trials.

The intervention not only decreased the number of hospitalizations per patient but also shortened the average length of stay, indicating that CHWs can effectively lower hospitalization rates and improve health outcomes in high-poverty populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a standardized community health worker intervention on hospitalization among disadvantaged patients with multiple chronic conditions: A pooled analysis of three clinical trials. Vasan, A., Morgan, JW., Mitra, N., et al.[2021]

Only 19% of community health workers in India expressed willingness to participate in COVID-19 vaccine trials, while 40% intended to get vaccinated, highlighting a significant gap in trial participation and vaccination intention.

Factors such as knowledge about the vaccine development and male gender increased willingness to participate in trials, but increased knowledge about COVID-19 itself was associated with lower vaccine uptake, suggesting that simply informing people may not be enough to boost vaccine acceptance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community health workers willingness to participate in COVID-19 vaccine trials and intention to vaccinate: A cross-sectional survey in India. Goel, K., Sen, A., Goel, P., et al.[2023]

A survey of 74 community health workers (CHWs) and home visitors (HVs) in Wisconsin revealed that a majority discussed COVID-19 vaccination with clients, with 85% of CHWs and 46% of HVs planning to encourage vaccination.

Despite recognizing the COVID-19 pandemic as a significant health threat and believing in the effectiveness of mitigation strategies, there was inconsistency in the commitment of CHWs and HVs to promote vaccination, highlighting a need for further training and support in public health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caring for community members during the COVID-19 pandemic: results of a statewide survey. Jewell, T., Gillespie, KH., Schmuhl, NB., et al.[2023]

The pilot study involved 423 patients at an academic medical center and tested a community health worker (CHW) intervention that provided post-discharge support, with about 70% of patients receiving at least one call from a CHW.

While the intervention showed a trend towards lower hospital readmission rates (15.4% for CHW patients vs. 17.9% for usual care), the difference was not statistically significant, indicating the need for further research to confirm its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and evaluation of a pilot community health worker intervention to reduce hospital readmissions. Burns, ME., Galbraith, AA., Ross-Degnan, D., et al.[2023]

Community health workers (CHWs) have successfully administered vaccines in 20 countries, highlighting their potential to improve immunization access in underserved areas, but the majority of the estimated 3.3 million CHWs globally are not yet involved in vaccination efforts.

Key challenges faced by CHWs include inadequate training in supply chain management, insufficient cold chain equipment, and heavy workloads, indicating that for CHWs to effectively contribute to vaccination efforts, they need better support, supervision, and integration into health systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community Health Workers as Vaccinators: A Rapid Review of the Global Landscape, 2000-2021. Gibson, E., Zameer, M., Alban, R., et al.[2023]

Community health workers (CHWs) found that unhoused Peer Ambassadors (PAs) were effective in promoting COVID-19 vaccinations among their peers, helping to bridge the trust gap in healthcare.

CHWs emphasized the importance of building genuine trust and equitable relationships with PAs, while also expressing concerns about the ethical implications of leveraging the trust that PAs have within their communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community Health Worker Perspectives on Engaging Unhoused Peer Ambassadors for COVID-19 Vaccine Outreach in Homeless Encampments and Shelters. Choi, K., Romero, R., Guha, P., et al.[2023]

Scaling up community health worker (CHW) programs to deliver 30 evidence-based interventions could prevent up to 6.9 million maternal, neonatal, and child deaths between 2016 and 2020, especially benefiting the Africa Region which would account for 58% of lives saved at 90% coverage.

Key interventions that would have the greatest impact include nutritional support during pregnancy, malaria treatment with artemisinin, oral rehydration for diarrhea, hand washing, and antibiotics for pneumonia, highlighting the importance of these strategies in reducing preventable deaths.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expanding the population coverage of evidence-based interventions with community health workers to save the lives of mothers and children: an analysis of potential global impact using the Lives Saved Tool (LiST). Chou, VB., Friberg, IK., Christian, M., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06156254

Community Care Intervention to Decrease COVID-19 ... This study examines whether a CHW intervention can be effective in increasing vaccination rates by providing education, help with behavior changes, and ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1551714425000424

Boost your health (Refuerza tu Salud) This study develops and evaluates a CHW vaccination behavior (CHW-VB) intervention to increase COVID-19 and influenza vaccination among adult patients in ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40146972/

Community Health Worker Influence on COVID-19 Vaccine ... CHWs provided vaccine information to community residents 18 million times and increased community vaccine uptake from 44% to 76% (P < .001) in 1 year.

4. nyc.gov nyc.gov/assets/doh/downloads/pdf/about/community-health-worker-report-2025.pdf

Community Health Workers at Scale In New York City Their impact was demonstrated during COVID-19 through the. Public Health Corps (PHC), where nearly 500 CHWs improved vaccination, testing, and treatment and ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/16549716.2023.2292385

The effectiveness of rural community health workers in ... This CHW intervention was linked to a reduction in the incidence of COVID-19 cases in Thailand, from a peak of 188 cases per day to less than 10 cases per day ...

6. pih.org pih.org/sites/default/files/lc/COVID%20CHW%20Vaccine%20Impact%20Analysis%20Report_Final%20June%202024.pdf

Impact of NCDHHS COVID-19 Community Health Worker ... The primary outcome was the cumulative full vaccination rate per 10,000 population. Secondary outcomes included the cumulative partial vaccination rate and the ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11161953/

Community health workers' dissemination of COVID-19 ... We described how CHWs supported the dissemination of COVID-19 information and services during the early pandemic response.

8. withpower.com withpower.com/trial/phase-covid-19-8-2023-b078b

Community Care Intervention for COVID-19 Vaccination A standardized community health worker (CHW) intervention significantly reduced total hospital days by 34% compared to usual care, with 849 days for the ...