COVID-19PR-COVACUPSNCT05468021
Puerto Rico COVID-19 Vaccine Uptake Study
A study testing Educational intervention in people with COVID-19, run by University of Puerto Rico at 2 sites in Puerto Rico.
Trial summary
The purpose of this study is to recruit a total of 386 participants to evaluate the effectiveness of an educational program to increase the proportion of men and women aged 21 years and older who have received the COVID-19 booster vaccine Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Educational intervention
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- 2 sitesPuerto Rico
- Study dates
- 26 Jun 2022to Jun 2023
- 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 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 21 years and older
- resident of Puerto Rico
- to be fully vaccinated (received the one-dose Jansen/Johnson \& Johnson vaccine, -OR- received both doses of the two-dose Pfizer or Moderna vaccine)
- have not received booster doses against COVID-19
- no history of allergic reactions to any vaccine,
- no history of mental health conditions that impede participation in the study
- able to read, write, and understand Spanish.
Who cannot join
- age 20 years and younger
- not a resident of Puerto Rico
- not to be fully vaccinated (have not received the one-dose Jansen/Johnson \& Johnson vaccine, -OR- have not received both doses of the two-dose Pfizer or Moderna vaccine)
- have received booster doses against COVID-19
- history of allergic reactions to any vaccine,
- history of mental health conditions that impede participation in the study
- not be able to read, write, and understand Spanish.
Trial locations and contacts
2 sites in 1 country.
Puerto Rico2 sites
Outpatient Clinic, School of Medicine, University of Puerto Rico
San Juan, 00921
University District Hospital
San Juan, 00921
About this study
The purpose of this study is to recruit a total of 386 participants to evaluate the effectiveness of an educational program to increase the proportion of men and women aged 21 years and older who have received the COVID-19 booster vaccine
Read the detailed description
This study will address vaccine hesitancy, evaluating the intervention's efficacy in a group of vulnerable and economically disadvantaged population in PR. Randomized Clinical Trial (study design) to evaluate the effectiveness of an educational intervention to increase vaccine uptake among socioeconomically disadvantaged adults. A total sample of 386 participants will be recruited. The duration of the study will consist of 1.5 hours for intervention group and 1 hour for control group.
Eligibility criteria for the study include the following: (1) age 21 years and older, (2) resident of Puerto Rico, (3) to be fully vaccinated (received the one-dose Jansen/Johnson \& Johnson vaccine, -OR- received both doses of the two-dose Pfizer or Moderna vaccine), have not received booster doses against COVID-19, (4) no history of allergic reactions to any vaccine, (5) no history of mental health conditions that impede participation in the study, and (6) able to read, write, and understand Spanish.
- Conditions
- COVID-19
- Being tested
- Educational intervention
- Keywords
- COVID-19 booster vaccine hesitancy, Educational intervention, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational interventionOther
Randomized Clinical Trial (study design) to evaluate the effectiveness of an educational intervention to increase vaccine uptake among socioeconomically disadvantaged adults. The intervention will consist of a health promoter with an educational toolkit addressing misinformation, distrust, and hesitancy regarding the COVID-19 vaccine. An educational website with videos addressing COVID-19 vaccine will be available to study participants to boost information provided in the educational toolkit.
| Study group | Role | What they receive |
|---|---|---|
| Comparison control | No intervention | The control condition will consist of standard of care. The participants in the control arm will not receive the educational intervention after assessment. |
| Intervention condition | Experimental | The participants in the intervention arm will receive the educational intervention after assessment. Receives: Other: Educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of COVID-19 vaccine completion
The investigators will record the vaccine brand of primary (Pfizer, Moderna, or Johnson \& Johnson) and capture the vaccine administration's completion (if necessary).
Measured: Up to 4 months
Rate of COVID-10 booster vaccine uptake
The investigators will capture the booster vaccine administration and record the vaccine brand (Pfizer, Moderna, or Johnson \& Johnson).
Measured: Up to 4 months
Secondary outcomes (2)
Participant's willingness to get vaccinated against COVID-19
Willingness to vaccinate against COVID-19 (vaccine confidence, vaccine convenience, vaccine complacency, and vaccine attitudes and beliefs), and receive the physician's recommendation to be vaccinated
Measured: Up to 4 months
Educational tool utilization by the participants
Evaluate if participant read the educational tool
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start26 Jun 2022
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study. 193 participants will be assigned to an educational intervention group and 193 will be assigned to a control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 394 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Puerto Rico
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Vivian Colon, University of Puerto Rico
- Investigators
- Emma Fernandez-Repollet, Ph D, Principal investigator, Deanship of Academic Affairs RCMI Center for Collaborative Research in Health Disparities
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468021
- Sponsor's protocol ID
- 3U54MD007600
- Other IDs
- 3U54MD007600
- Acronym
- PR-COVACUPS
- Status last verified
- Dec 2022
- First submitted
- 8 Jul 2022
- Last updated
- 16 Dec 2022
- 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 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Puerto Rico COVID-19 Vaccine Uptake Study
- ClinicalTrials.gov ID
- NCT05468021
- Acronym / sponsor ID
- PR-COVACUPS / 3U54MD007600
- Conditions
- COVID-19
- Keywords
- COVID-19 booster vaccine hesitancy, Educational intervention, COVID-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 394 participants (actual)
- Lead sponsor
- University of Puerto RicoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 26 Jun 2022 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 21 Jul 2022 (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.
The purpose of this study is to recruit a total of 386 participants to evaluate the effectiveness of an educational program to increase the proportion of men and women aged 21 years and older who have received the COVID-19 booster vaccine
Detailed description
This study will address vaccine hesitancy, evaluating the intervention's efficacy in a group of vulnerable and economically disadvantaged population in PR. Randomized Clinical Trial (study design) to evaluate the effectiveness of an educational intervention to increase vaccine uptake among socioeconomically disadvantaged adults. A total sample of 386 participants will be recruited. The duration of the study will consist of 1.5 hours for intervention group and 1 hour for control group.
Eligibility criteria for the study include the following: (1) age 21 years and older, (2) resident of Puerto Rico, (3) to be fully vaccinated (received the one-dose Jansen/Johnson \& Johnson vaccine, -OR- received both doses of the two-dose Pfizer or Moderna vaccine), have not received booster doses against COVID-19, (4) no history of allergic reactions to any vaccine, (5) no history of mental health conditions that impede participation in the study, and (6) able to read, write, and understand Spanish.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study. 193 participants will be assigned to an educational intervention group and 193 will be assigned to a control group.
| Arm | Type | Receives |
|---|---|---|
| Comparison control | No intervention | –The control condition will consist of standard of care. The participants in the control arm will not receive the educational intervention after assessment. |
| Intervention condition | Experimental | Other: Educational interventionThe participants in the intervention arm will receive the educational intervention after assessment. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- age 21 years and older
- resident of Puerto Rico
- to be fully vaccinated (received the one-dose Jansen/Johnson \& Johnson vaccine, -OR- received both doses of the two-dose Pfizer or Moderna vaccine)
- have not received booster doses against COVID-19
- no history of allergic reactions to any vaccine,
Key exclusion criteria (7 listed)
- age 20 years and younger
- not a resident of Puerto Rico
- not to be fully vaccinated (have not received the one-dose Jansen/Johnson \& Johnson vaccine, -OR- have not received both doses of the two-dose Pfizer or Moderna vaccine)
- have received booster doses against COVID-19
- history of allergic reactions to any vaccine,
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 |
|---|---|---|
| Educational interventionRandomized Clinical Trial (study design) to evaluate the effectiveness of an educational intervention to increase vaccine uptake among socioeconomically disadvantaged adults. The intervention will consist of a health promoter with an educational toolkit addressing misinformation, distrust, and hesitancy regarding the COVID-19 vaccine. An educational website with videos addressing COVID-19 vaccine will be available to study participants to boost information provided in the educational toolkit. | Other | Intervention condition |
Primary outcome
Rate of COVID-19 vaccine completion
Time frame: Up to 4 months
The investigators will record the vaccine brand of primary (Pfizer, Moderna, or Johnson \& Johnson) and capture the vaccine administration's completion (if necessary).
Rate of COVID-10 booster vaccine uptake
Time frame: Up to 4 months
The investigators will capture the booster vaccine administration and record the vaccine brand (Pfizer, Moderna, or Johnson \& Johnson).
2 secondary outcomes
Participant's willingness to get vaccinated against COVID-19
Time frame: Up to 4 months
Educational tool utilization by the participants
Time frame: Up to 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
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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.
Emma Fernandez-Repollet, Ph D principal investigator
Deanship of Academic Affairs RCMI Center for Collaborative Research in Health Disparities
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational intervention in people with COVID-19, run by University of Puerto Rico at 2 sites in Puerto Rico.
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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 16 Dec 2022. 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 Puerto Rico. 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?
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?
Rate of COVID-19 vaccine completion (time frame: Up to 4 months). The study lists 2 primary outcomes in all. 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 16 Dec 2022.