Vaccine HesitancyNCT06156228
Multilevel Intervention of COVID-19 Vaccine Uptake Among Latinos
A study testing Multilevel Intervention in people with Vaccine Hesitancy, run by San Diego State University at 2 sites in United States.
Trial summary
This study is significant as it targets a population that has exceptionally high rates of morbidity and mortality due to COVID-19, influenza, pneumococcal pneumonia and shingles; and who demonstrate significant mistrust towards the vaccines. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccine Hesitancy
- What is being tested?
- Multilevel Intervention
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Mar 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be a patient of an intervention participating clinic
- Be an adult 18+
- Self identify as Latino
Who cannot join
- Be planning to move out of San Diego County in the next 2 years
- Have cognitive impairment making them unable to complete informed consent
- Have any contraindications to receiving the 4 study vaccines (COVID-19, Pneumococcal, Shingles, Influenza)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Family Health Centers San Diego
San Diego, California, 92102
San Diego State University Research Foundation
San Diego, California, 92182
About this study
This study is significant as it targets a population that has exceptionally high rates of morbidity and mortality due to COVID-19, influenza, pneumococcal pneumonia and shingles; and who demonstrate significant mistrust towards the vaccines. It is innovative in that investigators will harness the research team's extensive experience in developing multi-level and tailored interventions working with community partners to increase adult vaccine uptake among Latinos. Through this project the investigators will develop the experience and infrastructure for a scalable community-academic model that can be deployed and adapted to other communities (especially those with prevalent vaccine resistance) and other emerging public health threats. There is great potential for short- and long-term public health/economic impact in increasing adult vaccine uptake among high risk populations such as Latinos. This work will contribute to the body of evidence for effective behavioral- and community-based strategies to improve the health of Latinos.
Read the detailed description
COVID-19 disparities are central to its local and national spread. Since the emergence of the novel coronavirus (SARS-CoV-2), there have been over 104.8 million confirmed cases worldwide, with the U.S. leading in number cases and deaths (as of this writing, >26.6 mil and 455K+, respectively)1 and California leading the U.S. with >3.3 mil cases.1 COVID-19 (the disease caused by SARS-CoV-2) is spread primarily from person-to-person through close and sustained contact with an infected individual. Unfortunately, the U.S. response to the pandemic has largely been left to state and local governments, which has resulted in mixed results. Ethnic/racial minority individuals are at an increased risk of acquiring SARS-CoV-2 infection compared to Whites, and demonstrate worse clinical outcomes from COVID-19. For example, Latinos experience a 2.5 times higher death rate from COVID-19 compared to Whites.2 In California, Latinos account for the highest percent of COVID-19 cases (55%) and deaths (46%) despite similar population percentages as Whites (38.9% vs. 36.6%, respectively).3 In San Diego County, Latinos have the highest case rates (56.3%) compared to any other ethnic group.4 These data show profound and clear disparities affecting Latinos in California and San Diego County.
Determinants of COVID-19 disparities among Latinos are the result of pervasive systemic socioeconomic disparities. Latinos are disproportionately represented in occupations deemed as 'essential' (78%)5 and suffer from high rates of poverty (18.3%) compared to Whites (59% and 8.7%, respectively).6 Together, these factors place Latinos at a greater need to continue working outside the home, thereby increasing risk of exposure to SARS-CoV-2. In addition, due to both economic and cultural factors, Latinos may live in smaller housing units with multi-generational households which makes practicing social distancing dificult.7 Latinos also have higher rates of obesity, hypertension and type 2 diabetes; all of which are known risk factors for severe COVID-19 complications.8 Lastly, due to educational disparities and historical distrust of government entities,9 Latinos may be more vulnerable to misinformation regarding COVID-19, and thus not adopt or adhere to preventive recommendations.10 These disparities highlight the urgent need to reduce the COVID-19 burden among Latinos.
Vaccine hesitancy and mistrust among Latinos can further exacerbate the burden of COVID-19 experienced by this group. To date, the national response to the COVID-19 pandemic and subsequent vaccination rollout has been largely inadequate. Common cited concerns of the COVID-19 vaccine include the speed at which they were developed and approved, the newness of the mRNA-based technology (Moderna \& Pfizer), the relatively short-term efficacy and safety data available, and the risk of potential side effects. To compound these concerns, social media and other platforms (e.g., Facebook \& YouTube) have been used to propagate misinformation regarding COVID-19 and the COVID-19 vaccines. These factors, in combination, have degraded the trust of Latinos for the COVID-19 vaccine. Thus, it is clear that Latinos are a priority group to implement strategies to increase trust in the COVID-19 vaccine and increase COVID-19 vaccine uptake. FHCSD provides an ideal setting to conduct research centered on establishing effective methods for reaching and serving large numbers of Latinos.
More recently, it has become apparent that COVID-19 vaccination will be a yearly and seasonal vaccine, similar to influenza. Given this, it is important to leverage vaccination efforts and communication campaigns that target multiple vaccines. These include: COVID-19, influenza, pneumococcal pneumonia and shingles. Evidence indicates that similar ethnic disparities exist for flu (11), pneumococcal pneumonia (12), and shingles (13).
- Conditions
- Vaccine Hesitancy
- Being tested
- Multilevel Intervention
- Keywords
- Vaccine Promotion
- Medical subject headings
- Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multilevel InterventionBehavioural
Clinic patients from the randomly assigned intervention clinics will be provided with additional vaccine information and will have the opportunity to ask any questions they might have about any of the 4 study focused vaccines (COVID-19, Shingles, Pneumococcal, Influenza). Health educators will provide them with additional information, address any misinformation and disinformation and will offer to schedule their vaccine appointment(s) for them.
| Study group | Role | What they receive |
|---|---|---|
| Multilevel Intervention | Experimental | The Multilevel Intervention condition will receive tailored and targeted messages about vaccination. Health educators will also deliver motivational interview sessions to patients eligible to receive the vaccines during the first 6 months of the study. To supplement these encounters, health educators will also send patients mail, emails and/or text message-based informational materials (including videos, testimonials, and resources) that reinforce the benfits of vaccines. Receives: Behavioral: Multilevel Intervention |
| Standard Clinical Practice | No intervention | Standard clinical practice consisting of generic patient outreach to promote vaccine uptake among Latino patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccination of Latino clinic patients
Test Multilevel Intervention effectiveness at baseline, 6-months \& 12-months on Latino patient's vaccine uptake for COVID-19, Pneumococcal, Shingles and Influenza vs. Latino patients receiving Standard Clinical Practice.
Measured: 1 year
Secondary outcomes (1)
Psychosocial and Individual-level outcomes
Test longer-term (24-mo) effectiveness of the Multilevel Intervention on psychosocial \& quality of life outcomes among a subgroup of 200 Latino clinic patients.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start6 Mar 2024
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Why it stopped: Grant funding was terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine HesitancyStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Investigators will implement a multilevel intervention in 10 clinics that will be randomized to either a Standard Clinical Practice consisting of standard clinic-based strategies to promote vaccine uptake among patients or a Multilevel Intervention consisting of an individualized/tailored intervention delivered by Health Educators working within the clinics plus a multi-component community intervention delivered by community promotores.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156228
- Sponsor's protocol ID
- HS-2022-0096
- Status last verified
- Jul 2025
- First submitted
- 30 Nov 2023
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multilevel Intervention of COVID-19 Vaccine Uptake Among Latinos
- ClinicalTrials.gov ID
- NCT06156228
- Acronym / sponsor ID
- HS-2022-0096
- Conditions
- Vaccine Hesitancy
- Keywords
- Vaccine Promotion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Grant funding was terminated.
- Enrolment
- 238 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 5 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is significant as it targets a population that has exceptionally high rates of morbidity and mortality due to COVID-19, influenza, pneumococcal pneumonia and shingles; and who demonstrate significant mistrust towards the vaccines. It is innovative in that investigators will harness the research team's extensive experience in developing multi-level and tailored interventions working with community partners to increase adult vaccine uptake among Latinos. Through this project the investigators will develop the experience and infrastructure for a scalable community-academic model that can be deployed and adapted to other communities (especially those with prevalent vaccine resistance) and other emerging public health threats. There is great potential for short- and long-term public health/economic impact in increasing adult vaccine uptake among high risk populations such as Latinos. This work will contribute to the body of evidence for effective behavioral- and community-based strategies to improve the health of Latinos.
Detailed description
COVID-19 disparities are central to its local and national spread. Since the emergence of the novel coronavirus (SARS-CoV-2), there have been over 104.8 million confirmed cases worldwide, with the U.S. leading in number cases and deaths (as of this writing, >26.6 mil and 455K+, respectively)1 and California leading the U.S. with >3.3 mil cases.1 COVID-19 (the disease caused by SARS-CoV-2) is spread primarily from person-to-person through close and sustained contact with an infected individual. Unfortunately, the U.S. response to the pandemic has largely been left to state and local governments, which has resulted in mixed results. Ethnic/racial minority individuals are at an increased risk of acquiring SARS-CoV-2 infection compared to Whites, and demonstrate worse clinical outcomes from COVID-19. For example, Latinos experience a 2.5 times higher death rate from COVID-19 compared to Whites.2 In California, Latinos account for the highest percent of COVID-19 cases (55%) and deaths (46%) despite similar population percentages as Whites (38.9% vs. 36.6%, respectively).3 In San Diego County, Latinos have the highest case rates (56.3%) compared to any other ethnic group.4 These data show profound and clear disparities affecting Latinos in California and San Diego County.
Determinants of COVID-19 disparities among Latinos are the result of pervasive systemic socioeconomic disparities. Latinos are disproportionately represented in occupations deemed as 'essential' (78%)5 and suffer from high rates of poverty (18.3%) compared to Whites (59% and 8.7%, respectively).6 Together, these factors place Latinos at a greater need to continue working outside the home, thereby increasing risk of exposure to SARS-CoV-2. In addition, due to both economic and cultural factors, Latinos may live in smaller housing units with multi-generational households which makes practicing social distancing dificult.7 Latinos also have higher rates of obesity, hypertension and type 2 diabetes; all of which are known risk factors for severe COVID-19 complications.8 Lastly, due to educational disparities and historical distrust of government entities,9 Latinos may be more vulnerable to misinformation regarding COVID-19, and thus not adopt or adhere to preventive recommendations.10 These disparities highlight the urgent need to reduce the COVID-19 burden among Latinos.
Vaccine hesitancy and mistrust among Latinos can further exacerbate the burden of COVID-19 experienced by this group. To date, the national response to the COVID-19 pandemic and subsequent vaccination rollout has been largely inadequate. Common cited concerns of the COVID-19 vaccine include the speed at which they were developed and approved, the newness of the mRNA-based technology (Moderna \& Pfizer), the relatively short-term efficacy and safety data available, and the risk of potential side effects. To compound these concerns, social media and other platforms (e.g., Facebook \& YouTube) have been used to propagate misinformation regarding COVID-19 and the COVID-19 vaccines. These factors, in combination, have degraded the trust of Latinos for the COVID-19 vaccine. Thus, it is clear that Latinos are a priority group to implement strategies to increase trust in the COVID-19 vaccine and increase COVID-19 vaccine uptake. FHCSD provides an ideal setting to conduct research centered on establishing effective methods for reaching and serving large numbers of Latinos.
More recently, it has become apparent that COVID-19 vaccination will be a yearly and seasonal vaccine, similar to influenza. Given this, it is important to leverage vaccination efforts and communication campaigns that target multiple vaccines. These include: COVID-19, influenza, pneumococcal pneumonia and shingles. Evidence indicates that similar ethnic disparities exist for flu (11), pneumococcal pneumonia (12), and shingles (13).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Investigators will implement a multilevel intervention in 10 clinics that will be randomized to either a Standard Clinical Practice consisting of standard clinic-based strategies to promote vaccine uptake among patients or a Multilevel Intervention consisting of an individualized/tailored intervention delivered by Health Educators working within the clinics plus a multi-component community intervention delivered by community promotores.
| Arm | Type | Receives |
|---|---|---|
| Multilevel Intervention | Experimental | Behavioral: Multilevel InterventionThe Multilevel Intervention condition will receive tailored and targeted messages about vaccination. Health educators will also deliver motivational interview sessions to patients eligible to receive the vaccines during the first 6 months of the study. To supplement these encounters, health educators will also send patients mail, emails and/or text message-based informational materials (including videos, testimonials, and resources) that reinforce the benfits of vaccines. |
| Standard Clinical Practice | No intervention | –Standard clinical practice consisting of generic patient outreach to promote vaccine uptake among Latino patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be a patient of an intervention participating clinic
- Be an adult 18+
- Self identify as Latino
Key exclusion criteria (3 listed)
- Be planning to move out of San Diego County in the next 2 years
- Have cognitive impairment making them unable to complete informed consent
- Have any contraindications to receiving the 4 study vaccines (COVID-19, Pneumococcal, Shingles, Influenza)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multilevel InterventionClinic patients from the randomly assigned intervention clinics will be provided with additional vaccine information and will have the opportunity to ask any questions they might have about any of the 4 study focused vaccines (COVID-19, Shingles, Pneumococcal, Influenza). Health educators will provide them with additional information, address any misinformation and disinformation and will offer to schedule their vaccine appointment(s) for them. | Behavioural | Multilevel Intervention |
Primary outcome
Vaccination of Latino clinic patients
Time frame: 1 year
Test Multilevel Intervention effectiveness at baseline, 6-months \& 12-months on Latino patient's vaccine uptake for COVID-19, Pneumococcal, Shingles and Influenza vs. Latino patients receiving Standard Clinical Practice.
1 secondary outcome
Psychosocial and Individual-level outcomes
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Grant funding was terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multilevel Intervention in people with Vaccine Hesitancy, run by San Diego State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Grant funding was terminated.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccination of Latino clinic patients (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.