University of Glasgow, Glasgow, UK.
University of Sydney, Sydney, Australia.
Trials. 2021 Apr 29;22(1):311. doi: 10.1186/s13063-021-05277-7.
Uptake of vaccination against COVID-19 is key to controlling the pandemic. However, a significant proportion of people report that they do not intend to have a vaccine, often because of concerns they have about vaccine side effects or safety. This study will assess the impact of theory-based messages on COVID-19 vaccination intention, drawing on the Necessity-Concerns framework to address previously reported beliefs and concerns about COVID-19 vaccination, and assess whether hypothesised variables (illness coherence, perceived necessity and concerns) mediate change in vaccination intention.
Prospective, parallel two-arm, individually randomised (1:1) trial.
Adults aged over 18 years, living in Scotland and not vaccinated for COVID-19. A quota sampling approach will be used with the aim of achieving a nationally representative sample on gender, region and ethnic group, with oversampling of individuals with no educational qualifications or with only school-level qualifications.
Intervention: Brief exposure to online text and image-based messages addressing necessity beliefs and concerns about COVID-19 vaccination. Comparator: Brief exposure to online text and image-based messages containing general information about COVID-19 and COVID-19 vaccination.
Primary outcome: Self-reported intention to receive a vaccine for COVID-19 if invited, immediately post-intervention.
Self-reported COVID-19 illness coherence, perceived necessity of a COVID-19 vaccine and concerns about a COVID-19 vaccine, immediately post-intervention.
Quasi-randomisation performed automatically by online survey software, by creating a variable derived from the number of seconds in the minute that the participant initiates the survey. Participants starting the survey at 0-14 or 30-44 seconds in the minute are allocated to the intervention and 15-29 or 45-59 seconds to the comparator.
BLINDING (MASKING): Participants will not be blinded to group assignment but will not be informed of the purpose of the study until they have completed the follow-up survey. Investigators will be blinded to allocation as all procedures will be undertaken digitally and remotely without any investigator contact with participants.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE): A total of 1,094 will be randomised 1:1 into two groups with 547 individuals in each.
Protocol version number 1.0, 26 February 2021. Recruitment status: Not yet recruiting, set to start April 2021 and end April 2021.
ClinicalTrials.gov, NCT04813770 , 24 March 2021.
The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
接种 COVID-19 疫苗是控制大流行的关键。然而，相当一部分人表示他们不打算接种疫苗，这通常是因为他们对疫苗的副作用或安全性存在担忧。本研究将根据必要性-关注框架评估基于理论的信息对 COVID-19 疫苗接种意愿的影响，以解决先前报告的对 COVID-19 疫苗接种的信念和担忧，并评估假设变量（疾病一致性、感知必要性和关注）是否可以调节疫苗接种意愿的变化。
前瞻性、平行双臂、个体随机（1:1）试验。
年龄在 18 岁以上、居住在苏格兰且未接种 COVID-19 疫苗的成年人。将采用配额抽样方法，目标是在性别、地区和族裔群体上实现全国代表性样本，并对没有学历或只有学校学历的个体进行超额抽样。
干预：短暂接触针对 COVID-19 疫苗接种必要性信念和担忧的在线文本和图像信息。对照组：短暂接触包含有关 COVID-19 和 COVID-19 疫苗接种的一般信息的在线文本和图像信息。
主要结局：如果被邀请，立即接种 COVID-19 疫苗的自我报告意愿，干预后即刻。
干预后即刻的自我报告 COVID-19 疾病一致性、对 COVID-19 疫苗的感知必要性和对 COVID-19 疫苗的担忧。
通过在线调查软件自动进行准随机化，方法是创建一个由参与者开始调查的分钟内的秒数派生的变量。在分钟内的 0-14 秒或 30-44 秒开始调查的参与者被分配到干预组，在 15-29 秒或 45-59 秒开始调查的参与者被分配到对照组。
盲法（掩蔽）：参与者不会对分组进行盲法，但直到他们完成随访调查才会被告知研究的目的。由于所有程序都将在没有任何调查员与参与者接触的情况下以数字化和远程方式进行，因此调查员将对分组情况进行盲法。
随机化数量（样本量）：共将 1094 人随机分为 1:1 的两组，每组 547 人。
协议版本号 1.0，2021 年 2 月 26 日。招募状态：尚未招募，计划于 2021 年 4 月开始，2021 年 4 月结束。
ClinicalTrials.gov，NCT04813770，2021 年 3 月 24 日。
完整方案作为附加文件附在试验网站上（附加文件 1）。为了加快传播材料，省略了熟悉的格式；本信函是完整方案的关键要素摘要。
