Intervention Innovations Team Lab (IIT-Lab), NYU Silver School of Social Work, 1 Washington Square North, New York, NY, 10003, USA.
Center for Drug Use and HIV Research (CDUHR), NYU School of Global Public Health, 708 Broadway, New York, NY, 10003, USA.
BMC Public Health. 2022 Jun 21;22(1):1235. doi: 10.1186/s12889-022-13576-0.
Among those at highest risk for COVID-19 exposure is the large population of frontline essential workers in occupations such food service, retail, personal care, and in-home health services, among whom Black and Latino/Hispanic persons are over-represented. For those not vaccinated and at risk for exposure to COVID-19, including frontline essential workers, regular (approximately weekly) COVID-19 testing is recommended. However, Black and Latino/Hispanic frontline essential workers in these occupations experience serious impediments to COVID-19 testing at individual/attitudinal- (e.g., lack of knowledge of guidelines), social- (e.g., social norms), and structural-levels of influence (e.g., poor access), and rates of testing for COVID-19 are insufficient.
METHODS/DESIGN: The proposed community-engaged study uses the multiphase optimization strategy (MOST) framework and an efficient factorial design to test four candidate behavioral intervention components informed by an integrated conceptual model that combines critical race theory, harm reduction, and self-determination theory. They are A) motivational interview counseling, B) text messaging grounded in behavioral economics, C) peer education, and D) access to testing (via navigation to an appointment vs. a self-test kit). All participants receive health education on COVID-19. The specific aims are to: identify which components contribute meaningfully to improvement in the primary outcome, COVID-19 testing confirmed with documentary evidence, with the most effective combination of components comprising an "optimized" intervention that strategically balances effectiveness against affordability, scalability, and efficiency (Aim 1); identify mediators and moderators of the effects of components (Aim 2); and use a mixed-methods approach to explore relationships among COVID-19 testing and vaccination (Aim 3). Participants will be N = 448 Black and Latino/Hispanic frontline essential workers not tested for COVID-19 in the past six months and not fully vaccinated for COVID-19, randomly assigned to one of 16 intervention conditions, and assessed at 6- and 12-weeks post-baseline. Last, N = 50 participants will engage in qualitative in-depth interviews.
This optimization trial is designed to yield an effective, affordable, and efficient behavioral intervention that can be rapidly scaled in community settings. Further, it will advance the literature on intervention approaches for social inequities such as those evident in the COVID-19 pandemic.
ClinicalTrials.gov: NCT05139927 ; Registered on 11/29/2021. Protocol version 1.0. May 2, 2022, Version 1.0.
在新冠病毒暴露风险最高的人群中，有大量从事食品服务、零售、个人护理和家庭保健服务等一线基本职业的人员，其中黑人和拉丁裔/西班牙裔人口的比例过高。对于那些未接种疫苗且有感染新冠病毒风险的人，包括一线基本职业人员在内，建议定期（大约每周）进行新冠病毒检测。然而，从事这些职业的黑人和拉丁裔/西班牙裔一线基本职业人员在新冠病毒检测方面面临着严重的障碍，包括个人/态度层面的障碍（例如，缺乏对指南的了解）、社会层面的障碍（例如，社会规范）以及结构层面的障碍（例如，缺乏获取途径），而且他们进行新冠病毒检测的比例不足。
方法/设计：拟议的社区参与研究使用多阶段优化策略（MOST）框架和有效的析因设计，根据一个综合概念模型来测试四个候选行为干预组成部分，该模型结合了关键种族理论、减少伤害和自决理论。它们是 A）动机访谈咨询，B）基于行为经济学的短信，C）同伴教育，以及 D）检测（通过预约与自我检测试剂盒的途径）。所有参与者都接受关于新冠病毒的健康教育。具体目标是：确定哪些组成部分对主要结果（有文件证明的新冠病毒检测）的改善有重要意义，最有效的组成部分组合构成一个“优化”干预措施，该措施在有效性和可负担性、可扩展性和效率之间进行战略性权衡（目标 1）；确定组成部分效果的中介和调节因素（目标 2）；并使用混合方法来探索新冠病毒检测和疫苗接种之间的关系（目标 3）。参与者将是 N=448 名过去六个月未进行新冠病毒检测且未完全接种新冠病毒疫苗的黑人和拉丁裔/西班牙裔一线基本职业人员，他们将被随机分配到 16 种干预条件之一，并在基线后 6 周和 12 周进行评估。最后，N=50 名参与者将参与深入的定性访谈。
这项优化试验旨在产生一种有效、负担得起且高效的行为干预措施，可以在社区环境中迅速推广。此外，它将推进针对新冠病毒等大流行期间明显存在的社会不平等问题的干预方法的文献。
ClinicalTrials.gov：NCT05139927；注册于 2021 年 11 月 29 日。方案版本 1.0，2022 年 5 月 2 日，版本 1.0。
