Puerto Rico COVID-19 Vaccine Uptake Study

COVID-19 Clinical Trial

— PR-COVACUPS  

Official title:

Puerto Rico COVID-19 Vaccine Uptake Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05468021
• Other study ID #: 3U54MD007600
• Secondary ID: 3U54MD007600
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 26, 2022
• Est. completion date: June 2023

Study information

• Verified date: December 2022
• Source: University of Puerto Rico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 394
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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.

Locations

Country	Name	City	State
Puerto Rico	Outpatient Clinic, School of Medicine, University of Puerto Rico	San Juan
Puerto Rico	University District Hospital	San Juan

Sponsors (3)

Lead Sponsor	Collaborator
University of Puerto Rico	National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Educational tool utilization by the participants	Evaluate if participant read the educational tool	Up to 4 months