PneumoniaNCT06075732
ACTIVATE in Public Housing
A study testing Increasing Willingness and Uptake of Influenza, Pneumonia, Meningitis, HZV, and COVID-19 Vaccination in people with Pneumonia and Influenza, run by Charles Drew University of Medicine and Science at 1 site in United States.
Trial summary
This multilevel, multidisciplinary, theoretically based, culturally sensitive, community-engaged intervention sets out to mitigate uptake barriers and non-adherence to vaccination schedules as recommended by the CDC and increase influenza, meningitis, pneumonia, VZV, and COVID-19 vaccine rates among under-resourced… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumonia, Influenza, Varicella Zoster
- What is being tested?
- Increasing Willingness and Uptake of Influenza, Pneumonia, Meningitis, HZV, and COVID-19 Vaccination
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 2 Dec 2024
- 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
- identify as Latinx or African American
- age 18 or older
- reside in one of the six collaborating public housing area
- Speak either English or Spanish
- Report vaccine hesitancy
Who cannot join
- Not a resident at one of the collaborating public housing areas
- Does not self-identify as African American or Latinx
- Age 17 and younger
- Unable to speak either English or Spanish
- Received all recommended vaccines for Influenza, Pneumonia, Meningitis, VZV, and COVID-19
- No reporting of vaccine hesitancy
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: Academic-Community Team for Improving Vaccine Acceptability and Targeted Engagement: Public Housing
This multilevel, multidisciplinary, theoretically based, culturally sensitive, community-engaged intervention sets out to mitigate uptake barriers and non-adherence to vaccination schedules as recommended by the CDC and increase influenza, meningitis, pneumonia, VZV, and COVID-19 vaccine rates among under-resourced African American and Latino public housing residents in South Los Angeles.
Read the detailed description
Vaccinations are critical for preventing infectious diseases such as influenza, meningitis, pneumonia, varicella zoster virus (VZV), and COVID-19. Despite increasing national distribution and promotion of routine recommendations for adult vaccination, coverage remains low, with historically lower uptake among racial and ethnic minorities. This is compounded by higher levels of vaccine hesitancy, which may be attributed to a myriad of issues, including worsening social determinants, medical mistrust, and lack of access to health services. Specifically, African American and Latino public housing residents may benefit from public health campaigns and vaccination initiatives to support high vaccine uptake and confidence. This R01 proposal seeks to expand on a proven, multilevel, multidisciplinary, theoretically based, culturally sensitive, community-engaged intervention by expanding the Academic-Community Team for Improving Vaccine Acceptability and Targeted Engagement (ACTIVATE) program. Guided by a fusion of the Social-Ecological framework (SEM) and the Practical, Robust Implementation and Sustainability Model (PRISM), the ACTIVATE program is inclusive of health factors on the individual, interpersonal, community, and societal level and elements for successful implementation. Led by leadership triads of public housing resident leaders, nurse practitioner students, and public health students, the ACTIVATE program centers on mitigating uptake barriers and non-adherence to vaccination schedules as recommended by the CDC and to increase influenza, meningitis, pneumonia, VZV, and COVID-19 vaccine rates among under-resourced AA and Latino adults in South LA.
- Conditions
- Pneumonia, Influenza, Varicella Zoster, Meningitis, COVID-19, Vaccine Hesitancy
- Being tested
- Increasing Willingness and Uptake of Influenza, Pneumonia, Meningitis, HZV, and COVID-19 Vaccination
- Medical subject headings
- Pneumonia, Influenza, Human, Meningitis, COVID-19, Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increasing Willingness and Uptake of Influenza, Pneumonia, Meningitis, HZV, and COVID-19 VaccinationBehavioural
Provide/enhance knowledge, modify attitudes, motivate and provide skills and resources to reduce Influenza, Pneumonia, Meningitis, HZV, and COVID-19 vaccine hesitancy and increase willingness and uptake in Influenza, Pneumonia, Meningitis, HZV, and COVID-19 vaccination.
| Study group | Role | What they receive |
|---|---|---|
| ACTIVATE Leaders | Experimental | This is a one group pretest-posttest design to increase COVID-19 vaccine uptake and completion among African American and Latinx public housing residents in South Los Angeles. The proposed intervention will employ (1) culturally sensitive, (2) theoretically based intervention that will be jointly delivered by ACTIVATE triad leaders and researchers. The investigators will use the Information, Motivation, and Behavioral Skills (IMB) model and the Transtheoretical Model to implement the intervention. PRISM, a Dissemination and implementation (D\&I) D\&I-based model can guide the implementation of the ACTIVATE program for successfully expansion and maintenance in community settings, especially for under-resourced populations. Receives: Behavioral: Increasing Willingness and Uptake of Influenza, Pneumonia, Meningitis, HZV, and COVID-19 Vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of vaccination uptake for Influenza, Pneumonia, Meningitis, VZV, and COVID-19 using Vaccination History Self Report
By comparison of pre-, post- intervention, and 9- and 18-months follow-up data, the investigators anticipate the following compared to baseline: a 40% change in completion of Influenza, Pneumonia, Meningitis, VZV, and COVID-19 vaccination series
Measured: Intervention: 8 months; Follow-up Point: 3- and 9-months post-intervention
Secondary outcomes (2)
Percentage of Participants Achieving Decreased Vaccine Hesitancy Levels of Influenza, Pneumonia, Meningitis, VZV, and COVID-19 vaccine Using the NIH Toolbox Surveys on COVID-19
By comparison of pre-, post- intervention, and 3- and 9-months follow-up data, the investigators anticipate the following compared to baseline: a 40% change in hesitancy toward Influenza, Pneumonia, Meningitis, VZV, and COVID-19 vaccination
Measured: Intervention: 8 months; Follow-up Point: 3- and 9-months post-intervention
Percentage of Participants Achieving Increased Level of Behavior Change toward COVID-19 Vaccination Using the NIH Toolbox Surveys on Influenza, Pneumonia, Meningitis, VZV, and COVID-19
By comparison of pre-, post- intervention, and 3- and 9-months follow-up data, the investigators anticipate the following compared to baseline: a 40% change in their behavior stage of change toward Influenza, Pneumonia, Meningitis, VZV, and COVID-19 vaccination
Measured: Intervention: 8 months; Follow-up Point: 3- and 9-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 posted10 Oct 2023
- Study start1 Jul 2024
- Primary completion30 Nov 2024
- Study completion2 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles Drew University of Medicine and Science
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075732
- Sponsor's protocol ID
- vaccpublichousing
- Status last verified
- Feb 2025
- First submitted
- 4 Oct 2023
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Academic-Community Team for Improving Vaccine Acceptability and Targeted Engagement: Public Housing
- ClinicalTrials.gov ID
- NCT06075732
- Acronym / sponsor ID
- vaccpublichousing
- Conditions
- Pneumonia, Influenza, Varicella Zoster, Meningitis, COVID-19, Vaccine Hesitancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Charles Drew University of Medicine and ScienceUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 2 Dec 2024 (actual)
- First posted
- 10 Oct 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 multilevel, multidisciplinary, theoretically based, culturally sensitive, community-engaged intervention sets out to mitigate uptake barriers and non-adherence to vaccination schedules as recommended by the CDC and increase influenza, meningitis, pneumonia, VZV, and COVID-19 vaccine rates among under-resourced African American and Latino public housing residents in South Los Angeles.
Detailed description
Vaccinations are critical for preventing infectious diseases such as influenza, meningitis, pneumonia, varicella zoster virus (VZV), and COVID-19. Despite increasing national distribution and promotion of routine recommendations for adult vaccination, coverage remains low, with historically lower uptake among racial and ethnic minorities. This is compounded by higher levels of vaccine hesitancy, which may be attributed to a myriad of issues, including worsening social determinants, medical mistrust, and lack of access to health services. Specifically, African American and Latino public housing residents may benefit from public health campaigns and vaccination initiatives to support high vaccine uptake and confidence. This R01 proposal seeks to expand on a proven, multilevel, multidisciplinary, theoretically based, culturally sensitive, community-engaged intervention by expanding the Academic-Community Team for Improving Vaccine Acceptability and Targeted Engagement (ACTIVATE) program. Guided by a fusion of the Social-Ecological framework (SEM) and the Practical, Robust Implementation and Sustainability Model (PRISM), the ACTIVATE program is inclusive of health factors on the individual, interpersonal, community, and societal level and elements for successful implementation. Led by leadership triads of public housing resident leaders, nurse practitioner students, and public health students, the ACTIVATE program centers on mitigating uptake barriers and non-adherence to vaccination schedules as recommended by the CDC and to increase influenza, meningitis, pneumonia, VZV, and COVID-19 vaccine rates among under-resourced AA and Latino adults in South LA.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACTIVATE Leaders | Experimental | Behavioral: Increasing Willingness and Uptake of Influenza, Pneumonia, Meningitis, HZV, and COVID-19 VaccinationThis is a one group pretest-posttest design to increase COVID-19 vaccine uptake and completion among African American and Latinx public housing residents in South Los Angeles. The proposed intervention will employ (1) culturally sensitive, (2) theoretically based intervention that will be jointly delivered by ACTIVATE triad leaders and researchers. The investigators will use the Information, Motivation, and Behavioral Skills (IMB) model and the Transtheoretical Model to implement the intervention. PRISM, a Dissemination and implementation (D\&I) D\&I-based model can guide the implementation of the ACTIVATE program for successfully expansion and maintenance in community settings, especially for under-resourced populations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- identify as Latinx or African American
- age 18 or older
- reside in one of the six collaborating public housing area
- Speak either English or Spanish
- Report vaccine hesitancy
Key exclusion criteria (6 listed)
- Not a resident at one of the collaborating public housing areas
- Does not self-identify as African American or Latinx
- Age 17 and younger
- Unable to speak either English or Spanish
- Received all recommended vaccines for Influenza, Pneumonia, Meningitis, VZV, and COVID-19
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 |
|---|---|---|
| Increasing Willingness and Uptake of Influenza, Pneumonia, Meningitis, HZV, and COVID-19 VaccinationProvide/enhance knowledge, modify attitudes, motivate and provide skills and resources to reduce Influenza, Pneumonia, Meningitis, HZV, and COVID-19 vaccine hesitancy and increase willingness and uptake in Influenza, Pneumonia, Meningitis, HZV, and COVID-19 vaccination. | Behavioural | ACTIVATE Leaders |
Primary outcome
Prevalence of vaccination uptake for Influenza, Pneumonia, Meningitis, VZV, and COVID-19 using Vaccination History Self Report
Time frame: Intervention: 8 months; Follow-up Point: 3- and 9-months post-intervention
By comparison of pre-, post- intervention, and 9- and 18-months follow-up data, the investigators anticipate the following compared to baseline: a 40% change in completion of Influenza, Pneumonia, Meningitis, VZV, and COVID-19 vaccination series
2 secondary outcomes
Percentage of Participants Achieving Decreased Vaccine Hesitancy Levels of Influenza, Pneumonia, Meningitis, VZV, and COVID-19 vaccine Using the NIH Toolbox Surveys on COVID-19
Time frame: Intervention: 8 months; Follow-up Point: 3- and 9-months post-intervention
Percentage of Participants Achieving Increased Level of Behavior Change toward COVID-19 Vaccination Using the NIH Toolbox Surveys on Influenza, Pneumonia, Meningitis, VZV, and COVID-19
Time frame: Intervention: 8 months; Follow-up Point: 3- and 9-months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Increasing Willingness and Uptake of Influenza, Pneumonia, Meningitis, HZV, and COVID-19 Vaccination in people with Pneumonia 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 6 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: finished, as of the sponsor's last update on 17 Feb 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Influenza, Pneumonia, Meningitis, VZV, and COVID-19 using Vaccination History Self Report (time frame: Intervention: 8 months; Follow-up Point: 3- and 9-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 17 Feb 2025.