COVIDVaxStories: A Pilot Double-blind Randomized, Parallel Design Trial of Storytelling to Reduce COVID-19 Vaccine Hesitation in Populations of Color Using a Respondent-driven Sampling Design
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in Vaccine Hesitancy
研究概览
简要总结
Pilot randomized controlled trial testing the investigator's previously developed storytelling method to create an interactive, multi-media storytelling intervention to address community-identified reasons for vaccine hesitancy among Black and Hispanic individuals in Central Massachusetts
详细描述
Intervention Development The investigators will recruit 64-80 Black and Hispanic community members for storytelling development groups (described below) through our already established COVID community advisory board (C-CAB). The C-CAB represents ten community organizations throughout the Greater Worcester area including churches and community centers. Further information on procedures for intervention development can be found in the "study procedures" section.
Pilot Randomized Controlled Trial (RCT) The investigators will conduct a pilot feasibility randomized controlled trial. The investigators will enroll approximately 50 Black persons who identify as Black and/or Hispanic in Central Massachusetts. The investigators will use a Respondent-Driven Sampling (RDS) Design, a quantitative form of the "snowballing" approach that has been proven effective in under-represented groups19-22 to pilot our recruitment strategy. In RDS a preset number of "seeds" are selected with the assistance of community partners. The seeds are community members with large social networks. Each seed recruits a preset number of participants utilizing their social networks and this process continues in waves until the predetermined sample size is met. Each seed is linked to their recruits to enable social network analysis.
Study procedures from consent to intervention will be delivered through Qualtrics, an online service that allows researchers to design and deliver online research instruments with minimal time and effort, and without extensive programming experience (Qualtrics.com). A short screening survey, e-informed-consent form, surveys, and videos (both English and Spanish versions) will be uploaded into Qualtrics. Qualtrics is available on both mobile devices and desktops,14 through mobile app or internet. The University of Massachusetts Chan Medical School (UMMS) has a university license to use Qualtrics, which provide robust data safety and privacy and is approved by our Institutional Review Board (IRB). The investigators will utilize the Quantitative Methods Core (QMC), a service core that has been formed under the auspices of the Division of Biostatistics and Health Services Research within the Department of Population and Health Sciences as well as our current research coordinator who have partnered to create a Qualtrics interface that delivers pre-intervention surveys, randomization, intervention delivery, and post intervention surveys, for our completed Enhancing racial and ethnic diversity in COVID-19 research participation through storytelling (COVIDstory)study. Qualtrics has also previously been used for the aforementioned features for an intervention aimed at increasing uptake of the Human Papillomavirus (HPV) vaccine among young Asian women.14 The investigators will build on this infrastructure to tailor the randomization, surveys, and intervention delivery for this intervention in this population.
Participants will be randomly assigned to either the storytelling arm or the comparison arm through a randomization algorithm embedded within Qualtrics. A stratified approach will be used, with equal enrollment by racial/ethnic category: Black or Hispanic. Each person recruited will be directed to Qualtrics which will be set to proceed in a systematic and sequential manner until the full sample size of 25 participants in the intervention group and 25 participants in the comparison group, stratified by race/ethnicity, are attained. Study subjects and investigators will be blinded as to group assignment. As with our current NCI funded project, all participant-facing aspects of Qualtrics (screening, consent, randomization, surveys, intervention videos) will be available in both English and Spanish. .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Participants will view either storytelling videos or learn more videos. They will not know which video they will get ahead of time nor will they know that they may get one or the other.
入排标准
- 年龄范围
- 18 Years 至 105 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •>= 18 years of age
- •identifies as Black and/or Hispanic
- •lives in Massachusetts
- •vaccinated for COVID-19.
排除标准
- •Unable to provide consent in English or Spanish
- •Has not completed the primary series of COVID-19 vaccinations (2 shots for Moderna or Pfizer, one shot for Johnson & Johnson).
研究组 & 干预措施
Storytelling
Participants will view short video narratives of community members speaking about why they chose to get vaccinated against Coronavirus Disease of 2019 (COVID-19) and how they overcame hesitancy. Participants will also view the informational videos described below.
干预措施: Storytelling (Behavioral)
Learn More
Participants will view short informational videos that provide factual information on the COVID-19 vaccines.
干预措施: Learn More (Active Comparator) (Behavioral)
结局指标
主要结局
Change in Vaccine Hesitancy
时间窗: From beginning of survey to end of survey typically, 30 minutes
Validated vaccine hesitancy questionnaire
次要结局
- Vaccine Uptake(6 months after participation)
研究者
Jeroan Allison
Chair, Population and Quantitative Health Sciences
University of Massachusetts, Worcester
