Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
394 participants
INTERVENTIONAL
2022-06-26
2023-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Comparison control
The control condition will consist of standard of care. The participants in the control arm will not receive the educational intervention after assessment.
No interventions assigned to this group
Intervention condition
The participants in the intervention arm will receive the educational intervention after assessment.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
21 Years
50 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institutes of Health (NIH)
NIH
National Institute on Minority Health and Health Disparities (NIMHD)
NIH
University of Puerto Rico
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Vivian Colon
Professor at the University of Puerto Rico and Researcher at the Comprehensive Cancer Center.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Emma Fernandez-Repollet, Ph D
Role: PRINCIPAL_INVESTIGATOR
Deanship of Academic Affairs RCMI Center for Collaborative Research in Health Disparities
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Outpatient Clinic, School of Medicine, University of Puerto Rico
San Juan, , Puerto Rico
University District Hospital
San Juan, , Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.