Puerto Rico COVID-19 Vaccine Uptake Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Puerto Rico COVID-19 Vaccine Uptake Study

Conditions
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COVID-19

Intervention / Treatment
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* Other: Educational intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Comparison control<br>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<br>The participants in the intervention arm will receive the educational intervention after assessment. | Other: Educational intervention<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19 booster vaccine hesitancy, Educational intervention, COVID-19