Puerto Rico COVID-19 Vaccine Uptake Study

NCT05468021 | Unknown

• 1 other identifier: 3U54MD007600
• Study Type: interventional
• Target: 394
• Locations: 1 country
• Sites: 2

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

Conditions

COVID-19

Keywords

COVID-19 booster vaccine hesitancy; Educational intervention; COVID-19

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Participant's willingness to get vaccinated against COVID-19

  Up to 4 months

• Educational tool utilization by the participants

  Up to 4 months

Study Arms (2)

Comparison control

NO INTERVENTION

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

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

Other: Educational intervention

Interventions

Educational intervention OTHER

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.

Intervention condition

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Puerto Rico: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (2)

Outpatient Clinic, School of Medicine, University of Puerto Rico

San Juan, 00921, Puerto Rico

Location

University District Hospital

San Juan, 00921, Puerto Rico

Location

MeSH Terms

Conditions

COVID-19

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Emma Fernandez-Repollet, Ph D

  Deanship of Academic Affairs RCMI Center for Collaborative Research in Health Disparities

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants will not be aware if they are assigned to an educational intervention nor control group. All will be assessed equally.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor at the University of Puerto Rico and Researcher at the Comprehensive Cancer Center.

Model Details: 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.

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: July 21, 2022
• Study Start: June 26, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: December 16, 2022

Record last verified: 2022-12

Locations

PR (2)