Clinical trial NCT05468021: Puerto Rico COVID-19 Vaccine Uptake Study
Official title: Puerto Rico COVID-19 Vaccine Uptake Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Keywords: COVID-19 booster vaccine hesitancy
Educational intervention
COVID-19
Lead sponsor: University of Puerto Rico
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2022-07-21
Enrollment: 394
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of COVID-19 vaccine completion
timeFrame: Up to 4 months
measure: Rate of COVID-10 booster vaccine uptake
timeFrame: Up to 4 months
Secondary outcomes:
measure: Participant's willingness to get vaccinated against COVID-19
timeFrame: Up to 4 months
measure: Educational tool utilization by the participants
timeFrame: Up to 4 months
Other outcomes:
Locations:
city: San Juan
country: Puerto Rico
facility: Outpatient Clinic, School of Medicine, University of Puerto Rico
city: San Juan
country: Puerto Rico
facility: University District Hospital
Study officials:
affiliation: Deanship of Academic Affairs RCMI Center for Collaborative Research in Health Disparities
name: Emma Fernandez-Repollet, Ph D
role: PRINCIPAL_INVESTIGATOR
References: