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

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

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19
• Intervention / Treatment: Other: Educational intervention

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 Type: Interventional
• Enrollment (Actual): 394
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00921
    • Outpatient Clinic, School of Medicine, University of Puerto Rico
  • San Juan, Puerto Rico, 00921
    • University District Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Comparison control; The control condition will consist of standard of care. The participants in the control arm will not receive the educational intervention after assessment.
Experimental: Intervention condition; The participants in the intervention arm will receive the educational intervention after assessment.	Other: Educational intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	Up to 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 4 months
Educational tool utilization by the participants	Evaluate if participant read the educational tool	Up to 4 months

Collaborators and Investigators

• Sponsor: University of Puerto Rico
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Emma Fernandez-Repollet, Ph D, Deanship of Academic Affairs RCMI Center for Collaborative Research in Health Disparities

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: July 8, 2022
• First Submitted That Met QC Criteria: July 19, 2022
• First Posted (Actual): July 21, 2022

Study Record Updates

• Last Update Posted (Actual): December 16, 2022
• Last Update Submitted That Met QC Criteria: December 15, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: COVID-19; Educational intervention; COVID-19 booster vaccine hesitancy
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 3U54MD007600 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No