Covid19NCT04761692
Increasing COVID-19, Influenza, and Pneumonia Vaccine Uptake
A study testing Full VEPMP Intervention, Partial VEPMP Intervention and Delayed VEPMP Intervention in people with Covid19 and Influenza, run by Charles Drew University of Medicine and Science at 1 site in United States.
Trial summary
This proposed study seeks to community knowledge and understand the experience of underserved communities in the exploration of reducing health disparities and increasing vaccine uptake and acceptability COVID-19, influenza, and pneumonia for AA and Latinx populations. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- What is being tested?
- Full VEPMP Intervention, Partial VEPMP Intervention and Delayed VEPMP Intervention
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to 31 Dec 2026
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Parishioner at a church receiving the VEPMP intervention
- Identify as African American or Latinx,
- at least 65 years and older
- Have Not received a vaccine for COVID-19, influenza, or pneumonia within the previous 24 months
- Agrees to study terms, which include follow-up interviews 9 and 18 months after study enrollment
Who cannot join
- Does not attend or identify as a Parishioner at a church receiving the VEPMP intervention
- Does not identify as African American or Latinx
- Under the age of 65 years
- Received all vaccine doses for COVID-19, influenza, or pneumonia within the previous 24 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Charles R. Drew University of Medicine & Science
Los Angeles, California, 90059
About this study
Official title: Improving Vaccine Acceptance and Uptake Among Underresourced African American and Latinx Older Adults: A Multidisciplinary and Culturally Based Training Program for Minority Churches
This proposed study seeks to community knowledge and understand the experience of underserved communities in the exploration of reducing health disparities and increasing vaccine uptake and acceptability COVID-19, influenza, and pneumonia for AA and Latinx populations. Unique in its design, it has the following characteristics: 1) multifaceted, 2) culturally tailored, 3) community-based, and 4) mixed methods in which the outcomes of interest will be measured before and after the intervention with 18-month interval. Furthermore, we seek to enhance our partnerships and collaborations with churches in South Los Angeles by supporting efforts to encourage COVID-19, influenza, and pneumonia vaccination uptake among underserved minorities in one of the most challenged and hard-to-reach population areas in the nation.
Read the detailed description
This study seeks to augment community knowledge and increase vaccine uptake among under-resourced African American and Latinx communities in South LA via leveraging trusted church leaders, educators and influencers to delivering COVID-19, influenza, and pneumonia education on vaccination. Unique in its design, this study has the following characteristics, beneficial to the acceptability and success of the proposal, it is: 1) multifaceted, 2) culturally tailored, and 3) community-based, in which the outcomes of interest will be compared longitudinally between arms 1-3, including measurement before and after the intervention with 9- and 18-month interval.
- Conditions
- Covid19, Influenza, Pneumonia, Vaccine Refusal
- Being tested
- Full VEPMP Intervention, Partial VEPMP Intervention, Delayed VEPMP Intervention
- Keywords
- African American, Latinx, Vaccine, Hispanic, Latino, COVID19 Vaccine
- Medical subject headings
- COVID-19, Influenza, Human, Pneumonia, Vaccination Refusal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full VEPMP InterventionBehavioural
Delivery of intrapersonal/interpersonal (i.e., motivational interviewing, vaccine educators, personal testimony, etc.), AND organizational (i.e., church-based sponsored events, seminars, web/online activities, bulletin inserts, etc.)
Partial VEPMP InterventionBehavioural
Delivery of iAND organizational (i.e., church-based sponsored events, seminars, web/online activities, bulletin inserts, etc.)
Delayed VEPMP InterventionBehavioural
Delayed implementation of delivery of intrapersonal/interpersonal AND organizational after 1 year of study start
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | This arm will include 5 churches who will receive all study activities in the Vaccine Education Promotion Management Plan Receives: Behavioral: Full VEPMP Intervention |
| Arm 2 | Experimental | This arm will include 5 churches who will receive some study activities in the Vaccine Education Promotion Management Plan Receives: Behavioral: Partial VEPMP Intervention |
| Arm 3 | Experimental | This arm will include 5 churches who will receive all study activities in the Vaccine Education Promotion Management Plan following completion of Arm 1 and 2. Receives: Behavioral: Delayed VEPMP Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of vaccination uptake for COVID-19, influenza, and pneumonia using Vaccination History Self Report
By comparison of pre-, post- intervention, and 9- and 18-months follow-up data, we anticipate the following compared to baseline: a 30% change in uptake for vaccination.
Measured: Intervention: 12 months; Follow-up Point: 9 & 18 months post-intervention
Secondary outcomes (3)
Percentage of Participants Achieving Adherence to COVID-19, influenza, and pneumonia vaccination schedules Risk Using the NIH Toolbox Surveys on COVID-19
By comparison of pre-, post- intervention, and 9 and 18-months follow-up data, we anticipate the following compared to baseline: a 30% change in adherence to COVID-19, influenza, and pneumonia vaccination schedules.
Measured: Intervention: 12 months; Follow-up Point: 9 & 18 months post-intervention
Percentage of Participants Achieving Decreased Vaccine Hesitancy Levels of COVID-19, influenza, and pneumonia Using the NIH Toolbox Surveys on COVID-19, influenza, and pneumonia
By comparison of pre-, post- intervention, and 9 and 18-months follow-up data, we anticipate the following compared to baseline: a 40% change in vaccine hesitancy toward COVID-19, influenza, and pneumonia vaccination
Measured: Intervention: 12 months; Follow-up Point: 9 & 18 months post-intervention
Percentage of Participants Achieving Decreased Levels of COVID-19, influenza, and pneumonia Mistrust and Barriers Using the NIH Toolbox Surveys on COVID-19, influenza, and pneumonia
By comparison of pre-, post- intervention, and 9 and 18-months follow-up data, we anticipate the following compared to baseline: a 40% change in mistrust and perceived barriers toward COVID-19, influenza, and pneumonia vaccination
Measured: Intervention: 12 months; Follow-up Point: 9 & 18 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Oct 2022 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Why it stopped: Study not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The VEPMP will consist of recruited churches in 15 cohorts of 2 churches per cohort (total n = 30). Each cohort of church will include an AA and a Latinx church. The 15 church cohorts will be randomized to three arms based on a 1:1:1 ratio, using an online random number generator.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles Drew University of Medicine and Science
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohsen Bazargan, PhD, Principal investigator, Charles R. Drew University of Medicine & Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761692
- Sponsor's protocol ID
- vaccineinc
- Status last verified
- Aug 2022
- First submitted
- 2 Feb 2021
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Vaccine Acceptance and Uptake Among Underresourced African American and Latinx Older Adults: A Multidisciplinary and Culturally Based Training Program for Minority Churches
- ClinicalTrials.gov ID
- NCT04761692
- Acronym / sponsor ID
- vaccineinc
- Conditions
- Covid19, Influenza, Pneumonia, Vaccine Refusal
- Keywords
- African American, Latinx, Vaccine, Hispanic, Latino, COVID19 Vaccine
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Charles Drew University of Medicine and ScienceUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Feb 2021 (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 proposed study seeks to community knowledge and understand the experience of underserved communities in the exploration of reducing health disparities and increasing vaccine uptake and acceptability COVID-19, influenza, and pneumonia for AA and Latinx populations. Unique in its design, it has the following characteristics: 1) multifaceted, 2) culturally tailored, 3) community-based, and 4) mixed methods in which the outcomes of interest will be measured before and after the intervention with 18-month interval. Furthermore, we seek to enhance our partnerships and collaborations with churches in South Los Angeles by supporting efforts to encourage COVID-19, influenza, and pneumonia vaccination uptake among underserved minorities in one of the most challenged and hard-to-reach population areas in the nation.
Detailed description
This study seeks to augment community knowledge and increase vaccine uptake among under-resourced African American and Latinx communities in South LA via leveraging trusted church leaders, educators and influencers to delivering COVID-19, influenza, and pneumonia education on vaccination. Unique in its design, this study has the following characteristics, beneficial to the acceptability and success of the proposal, it is: 1) multifaceted, 2) culturally tailored, and 3) community-based, in which the outcomes of interest will be compared longitudinally between arms 1-3, including measurement before and after the intervention with 9- and 18-month interval.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The VEPMP will consist of recruited churches in 15 cohorts of 2 churches per cohort (total n = 30). Each cohort of church will include an AA and a Latinx church. The 15 church cohorts will be randomized to three arms based on a 1:1:1 ratio, using an online random number generator.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: Full VEPMP InterventionThis arm will include 5 churches who will receive all study activities in the Vaccine Education Promotion Management Plan |
| Arm 2 | Experimental | Behavioral: Partial VEPMP InterventionThis arm will include 5 churches who will receive some study activities in the Vaccine Education Promotion Management Plan |
| Arm 3 | Experimental | Behavioral: Delayed VEPMP InterventionThis arm will include 5 churches who will receive all study activities in the Vaccine Education Promotion Management Plan following completion of Arm 1 and 2. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Parishioner at a church receiving the VEPMP intervention
- Identify as African American or Latinx,
- at least 65 years and older
- Have Not received a vaccine for COVID-19, influenza, or pneumonia within the previous 24 months
- Agrees to study terms, which include follow-up interviews 9 and 18 months after study enrollment
Key exclusion criteria (4 listed)
- Does not attend or identify as a Parishioner at a church receiving the VEPMP intervention
- Does not identify as African American or Latinx
- Under the age of 65 years
- Received all vaccine doses for COVID-19, influenza, or pneumonia within the previous 24 months
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 |
|---|---|---|
| Full VEPMP InterventionDelivery of intrapersonal/interpersonal (i.e., motivational interviewing, vaccine educators, personal testimony, etc.), AND organizational (i.e., church-based sponsored events, seminars, web/online activities, bulletin inserts, etc.) | Behavioural | Arm 1 |
| Partial VEPMP InterventionDelivery of iAND organizational (i.e., church-based sponsored events, seminars, web/online activities, bulletin inserts, etc.) | Behavioural | Arm 2 |
| Delayed VEPMP InterventionDelayed implementation of delivery of intrapersonal/interpersonal AND organizational after 1 year of study start | Behavioural | Arm 3 |
Primary outcome
Prevalence of vaccination uptake for COVID-19, influenza, and pneumonia using Vaccination History Self Report
Time frame: Intervention: 12 months; Follow-up Point: 9 & 18 months post-intervention
By comparison of pre-, post- intervention, and 9- and 18-months follow-up data, we anticipate the following compared to baseline: a 30% change in uptake for vaccination.
3 secondary outcomes
Percentage of Participants Achieving Adherence to COVID-19, influenza, and pneumonia vaccination schedules Risk Using the NIH Toolbox Surveys on COVID-19
Time frame: Intervention: 12 months; Follow-up Point: 9 & 18 months post-intervention
Percentage of Participants Achieving Decreased Vaccine Hesitancy Levels of COVID-19, influenza, and pneumonia Using the NIH Toolbox Surveys on COVID-19, influenza, and pneumonia
Time frame: Intervention: 12 months; Follow-up Point: 9 & 18 months post-intervention
Percentage of Participants Achieving Decreased Levels of COVID-19, influenza, and pneumonia Mistrust and Barriers Using the NIH Toolbox Surveys on COVID-19, influenza, and pneumonia
Time frame: Intervention: 12 months; Follow-up Point: 9 & 18 months post-intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Mohsen Bazargan, PhD principal investigator
Charles R. Drew University of Medicine & Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full VEPMP Intervention, Partial VEPMP Intervention and Delayed VEPMP Intervention in people with Covid19 and Influenza, run by Charles Drew University of Medicine and Science at 1 site 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 5 inclusion and 4 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: withdrawn, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 withdrawn before enrolling participants, so there are no results.
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?
Prevalence of vaccination uptake for COVID-19, influenza, and pneumonia using Vaccination History Self Report (time frame: Intervention: 12 months; Follow-up Point: 9 & 18 months post-intervention). 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 19 Aug 2022.