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Puerto Rico COVID-19 Vaccine Uptake Study (PR-COVACUPS)

Primary Purpose

COVID-19

Status
Active
Phase
Not Applicable
Locations
Puerto Rico
Study Type
Interventional
Intervention
Educational intervention
Sponsored by
University of Puerto Rico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for COVID-19 focused on measuring COVID-19 booster vaccine hesitancy, Educational intervention, COVID-19

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  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)
  4. have not received booster doses against COVID-19
  5. no history of allergic reactions to any vaccine,
  6. no history of mental health conditions that impede participation in the study
  7. able to read, write, and understand Spanish.

Exclusion Criteria:

  1. age 20 years and younger
  2. not a resident of Puerto Rico
  3. 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)
  4. have received booster doses against COVID-19
  5. history of allergic reactions to any vaccine,
  6. history of mental health conditions that impede participation in the study
  7. not be able to read, write, and understand Spanish.

Sites / Locations

  • Outpatient Clinic, School of Medicine, University of Puerto Rico
  • University District Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Comparison control

Intervention condition

Arm Description

The control condition will consist of standard of care. The participants in the control arm will not receive the educational intervention after assessment.

The participants in the intervention arm will receive the educational intervention after assessment.

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

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
Educational tool utilization by the participants
Evaluate if participant read the educational tool

Full Information

First Posted
July 8, 2022
Last Updated
December 15, 2022
Sponsor
University of Puerto Rico
Collaborators
National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT05468021
Brief Title
Puerto Rico COVID-19 Vaccine Uptake Study
Acronym
PR-COVACUPS
Official Title
Puerto Rico COVID-19 Vaccine Uptake Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 26, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Puerto Rico
Collaborators
National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19 booster vaccine hesitancy, Educational intervention, COVID-19

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
The participants will not be aware if they are assigned to an educational intervention nor control group. All will be assessed equally.
Allocation
Randomized
Enrollment
394 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Comparison control
Arm Type
No Intervention
Arm Description
The control condition will consist of standard of care. The participants in the control arm will not receive the educational intervention after assessment.
Arm Title
Intervention condition
Arm Type
Experimental
Arm Description
The participants in the intervention arm will receive the educational intervention after assessment.
Intervention Type
Other
Intervention Name(s)
Educational intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of COVID-19 vaccine completion
Description
The investigators will record the vaccine brand of primary (Pfizer, Moderna, or Johnson & Johnson) and capture the vaccine administration's completion (if necessary).
Time Frame
Up to 4 months
Title
Rate of COVID-10 booster vaccine uptake
Description
The investigators will capture the booster vaccine administration and record the vaccine brand (Pfizer, Moderna, or Johnson & Johnson).
Time Frame
Up to 4 months
Secondary Outcome Measure Information:
Title
Participant's willingness to get vaccinated against COVID-19
Description
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
Time Frame
Up to 4 months
Title
Educational tool utilization by the participants
Description
Evaluate if participant read the educational tool
Time Frame
Up to 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emma Fernandez-Repollet, Ph D
Organizational Affiliation
Deanship of Academic Affairs RCMI Center for Collaborative Research in Health Disparities
Official's Role
Principal Investigator
Facility Information:
Facility Name
Outpatient Clinic, School of Medicine, University of Puerto Rico
City
San Juan
ZIP/Postal Code
00921
Country
Puerto Rico
Facility Name
University District Hospital
City
San Juan
ZIP/Postal Code
00921
Country
Puerto Rico

12. IPD Sharing Statement

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Puerto Rico COVID-19 Vaccine Uptake Study

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