CoronavirusNCT04779138
Increasing Vaccine Uptake in Underresourced Public Housing Areas
A study testing Increasing Willingness and Uptake of COVID-19 Vaccination in people with Coronavirus and Vaccine Refusal, run by Charles Drew University of Medicine and Science at 1 site in United States.
Trial summary
This proposal seeks to enhance uptake and completion of COVID-19 vaccination among African American and Latinx public housing residents in South Los Angeles. Given the multiple disparities experienced by public housing residents, the investigators will utilize a theoretically-based, multidisciplinary and culturally… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronavirus, Vaccine Refusal
- What is being tested?
- Increasing Willingness and Uptake of 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
- 462 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2021to 1 Apr 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
- identify as Latinx or African American
- age 18 or older
Show all 9Show fewer
- 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
- Aim 3:
- Not a resident at one of the collaborating public housing areas
Show all 11Show fewer
- 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 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: Community Partnered Intervention to Increase COVID-19 Vaccine Uptake in Low Income Underresourced African Americans and Latinx Public Housing Residents
This proposal seeks to enhance uptake and completion of COVID-19 vaccination among African American and Latinx public housing residents in South Los Angeles. Given the multiple disparities experienced by public housing residents, the investigators will utilize a theoretically-based, multidisciplinary and culturally tailored intervention to provide education at multiple levels and implement innovate strategies to engage this population in the uptake of COVID-19 vaccination.
Read the detailed description
One particular group, African American and Latinx public housing residents, are facing adverse effects related to worsening social determinants and health disparities. Utilizing a community-driven approach, the overall objective of this proposed study is to increase COVID-19 vaccine uptake and completion the impact of COVID-19 among African American and Latinx public housing residents. Guided by the Community Based Participatory Model, the Information, Motivation, and Behavioral Skills (IMB) and the Transtheoretical Model will be utilized to carry out this intervention. Through this innovative program, we will establish Academic-Community Team for Improving Vaccine Acceptability and Targeted Engagement (ACTIVATE) program, which will develop leadership triads of public housing resident leaders, nurse practitioner students, and public health students to carry out this multilevel intervention.
- Conditions
- Coronavirus, Vaccine Refusal
- Being tested
- Increasing Willingness and Uptake of COVID-19 Vaccination
- Medical subject headings
- Coronavirus Infections, Vaccination Refusal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increasing Willingness and Uptake of COVID-19 VaccinationBehavioural
Provide/enhance knowledge, modify attitudes, motivate and provide skills and resources to reduce COVID-19 vaccine hesitancy and increase willingness and uptake in COVID-19 vaccination.
| Study group | Role | What they receive |
|---|---|---|
| Increasing Uptake of COVID-19 Vaccination | Experimental | This is a pre-experimental "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 our ACTIVATE triad leaders and our researchers. We will use the Information, Motivation, and Behavioral Skills (IMB) model and the Transtheoretical Model to implement the intervention. Receives: Behavioral: Increasing Willingness and Uptake of 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 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 40% change in completion of COVID-19 vaccination series
Measured: Intervention: 4 months; Follow-up Point: 3 months post-intervention
Secondary outcomes (2)
Percentage of Participants Achieving Decreased Vaccine Hesitancy Levels of COVID-19 vaccine Using the NIH Toolbox Surveys on COVID-19
- By comparison of pre-, post- intervention, and 3-months follow-up data, we anticipate the following compared to baseline: a 40% change in hesitancy toward COVID-19 vaccination.
Measured: Intervention: 4 months; Follow-up Point: 3 months post-intervention
Percentage of Participants Achieving Increased Level of Behavior Change toward COVID-19 Vaccination Using the NIH Toolbox Surveys on COVID-19
- By comparison of pre-, post- intervention, and 3-months follow-up data, we anticipate the following compared to baseline: a 40% change in their behavior stage of change toward COVID-19 vaccination
Measured: Intervention: 4 months; Follow-up Point: 3 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 posted3 Mar 2021
- Study start11 Sep 2021
- Primary completion30 Nov 2023
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoronavirusStudies 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
- 462 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles Drew University of Medicine and Science
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sharon Cobb, Principal investigator, Charles R. Drew University of Medicine & Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779138
- Sponsor's protocol ID
- vaccinehousing
- Status last verified
- Feb 2024
- First submitted
- 27 Feb 2021
- Last updated
- 24 Apr 2024
- 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 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Partnered Intervention to Increase COVID-19 Vaccine Uptake in Low Income Underresourced African Americans and Latinx Public Housing Residents
- ClinicalTrials.gov ID
- NCT04779138
- Acronym / sponsor ID
- vaccinehousing
- Conditions
- Coronavirus, Vaccine Refusal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 462 participants (actual)
- Lead sponsor
- Charles Drew University of Medicine and ScienceUniversity, hospital or other
- Study start
- 11 Sep 2021 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 3 Mar 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 proposal seeks to enhance uptake and completion of COVID-19 vaccination among African American and Latinx public housing residents in South Los Angeles. Given the multiple disparities experienced by public housing residents, the investigators will utilize a theoretically-based, multidisciplinary and culturally tailored intervention to provide education at multiple levels and implement innovate strategies to engage this population in the uptake of COVID-19 vaccination.
Detailed description
One particular group, African American and Latinx public housing residents, are facing adverse effects related to worsening social determinants and health disparities. Utilizing a community-driven approach, the overall objective of this proposed study is to increase COVID-19 vaccine uptake and completion the impact of COVID-19 among African American and Latinx public housing residents. Guided by the Community Based Participatory Model, the Information, Motivation, and Behavioral Skills (IMB) and the Transtheoretical Model will be utilized to carry out this intervention. Through this innovative program, we will establish Academic-Community Team for Improving Vaccine Acceptability and Targeted Engagement (ACTIVATE) program, which will develop leadership triads of public housing resident leaders, nurse practitioner students, and public health students to carry out this multilevel intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Increasing Uptake of COVID-19 Vaccination | Experimental | Behavioral: Increasing Willingness and Uptake of COVID-19 VaccinationThis is a pre-experimental "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 our ACTIVATE triad leaders and our researchers. We will use the Information, Motivation, and Behavioral Skills (IMB) model and the Transtheoretical Model to implement the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 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
- identify as Latinx or African American
Key exclusion criteria (11 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
- Not a resident at one of the collaborating public housing areas
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 COVID-19 VaccinationProvide/enhance knowledge, modify attitudes, motivate and provide skills and resources to reduce COVID-19 vaccine hesitancy and increase willingness and uptake in COVID-19 vaccination. | Behavioural | Increasing Uptake of COVID-19 Vaccination |
Primary outcome
Prevalence of vaccination uptake for COVID-19, influenza, and pneumonia using Vaccination History Self Report
Time frame: Intervention: 4 months; Follow-up Point: 3 months post-intervention
1. 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 completion of COVID-19 vaccination series
2 secondary outcomes
Percentage of Participants Achieving Decreased Vaccine Hesitancy Levels of COVID-19 vaccine Using the NIH Toolbox Surveys on COVID-19
Time frame: Intervention: 4 months; Follow-up Point: 3 months post-intervention
Percentage of Participants Achieving Increased Level of Behavior Change toward COVID-19 Vaccination Using the NIH Toolbox Surveys on COVID-19
Time frame: Intervention: 4 months; Follow-up Point: 3 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 24 Apr 2024.
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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.
Sharon Cobb 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 Increasing Willingness and Uptake of COVID-19 Vaccination in people with Coronavirus and Vaccine Refusal, 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 9 inclusion and 11 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 24 Apr 2024. 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 COVID-19, influenza, and pneumonia using Vaccination History Self Report (time frame: Intervention: 4 months; Follow-up Point: 3 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 24 Apr 2024.