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| ID | Type | Description | Link |
|---|---|---|---|
| 3U54MD007600 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Educational tool utilization by the participants |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emma Fernandez-Repollet, Ph D | Deanship of Academic Affairs RCMI Center for Collaborative Research in Health Disparities | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Outpatient Clinic, School of Medicine, University of Puerto Rico | San Juan | 00921 | Puerto Rico | |||
| University District Hospital |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 25, 2023 | |
| Reset | Oct 18, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 25, 2023 | Oct 18, 2023 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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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.
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The participants will not be aware if they are assigned to an educational intervention nor control group. All will be assessed equally.
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Evaluate if participant read the educational tool |
| Up to 4 months |
| San Juan |
| 00921 |
| Puerto Rico |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011314 | Preventive Health Services |