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Puerto Rico COVID-19 Vaccine Uptake Study

Not Applicable
Active, not recruiting
Conditions
COVID-19
Interventions
Other: Educational intervention
Registration Number
NCT05468021
Lead Sponsor
University of Puerto Rico
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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
394
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Intervention conditionEducational interventionThe participants in the intervention arm will receive the educational intervention after assessment.
Primary Outcome Measures
NameTimeMethod
Rate of COVID-10 booster vaccine uptakeUp to 4 months

The investigators will capture the booster vaccine administration and record the vaccine brand (Pfizer, Moderna, or Johnson \& Johnson).

Rate of COVID-19 vaccine completionUp 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).

Secondary Outcome Measures
NameTimeMethod
Participant's willingness to get vaccinated against COVID-19Up to 4 months

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 participantsUp to 4 months

Evaluate if participant read the educational tool

Trial Locations

Locations (2)

Outpatient Clinic, School of Medicine, University of Puerto Rico

🇵🇷

San Juan, Puerto Rico

University District Hospital

🇵🇷

San Juan, Puerto Rico

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