Puerto Rico COVID-19 Vaccine Uptake Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 394
- 试验地点
- 4
- 主要终点
- Rate of COVID-10 booster vaccine uptake
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
The participants will not be aware if they are assigned to an educational intervention nor control group. All will be assessed equally.
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Rate of COVID-10 booster vaccine uptake
时间窗: Up to 4 months
The investigators will capture the booster vaccine administration and record the vaccine brand (Pfizer, Moderna, or Johnson \& Johnson).
Rate of COVID-19 vaccine completion
时间窗: Up to 4 months
The investigators will record the vaccine brand of primary (Pfizer, Moderna, or Johnson \& Johnson) and capture the vaccine administration's completion (if necessary).
次要结局
- Participant's willingness to get vaccinated against COVID-19(Up to 4 months)
- Educational tool utilization by the participants(Up to 4 months)
研究者
Vivian Colon
Professor at the University of Puerto Rico and Researcher at the Comprehensive Cancer Center.
University of Puerto Rico