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

University of Puerto Rico (UPR)

Status: Active, not recruiting

Conditions: COVID-19

Treatments: Other: Educational intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05468021

3U54MD007600 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 394 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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394 participants in 2 patient groups

Comparison control

No Intervention group

Description:

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

Intervention condition

Experimental group

Description:

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

Treatment:

Other: Educational intervention