PDF(Pubmed)
Abstract：
BACKGROUND: This update outlines amendments to the CHAMPION2/STRIPES2 cluster randomised trial protocol primarily made due to the COVID-19 pandemic and nationwide lockdown in India in 2020. These amendments were in line with national guidelines for health research during the COVID-19 pandemic.
METHODS: We did not change the original trial design, eligibility, and outcomes. Amendments were introduced to minimise the risk of COVID-19 transmission and ensure safety and wellbeing of trial staff, participants, and other villagers. CHAMPION2 intervention: participatory learning and action (PLA) and fixed day service (FDS) meeting were revised to incorporate social distancing and hygiene precautions. During the COVID-19 pandemic, PLA participation was limited to pregnant women and birthing partners. STRIPES2 intervention: before/after-school classes were halted for a period and then modified temporarily (reducing class sizes, and/or changing meeting places) with hygiene and safe distancing practices introduced.
METHODS: The research team gathered as much information as possible from participants by telephone. If the participant had no telephone or could not be contacted by telephone, data were collected in person. COVID-19 precautions: trial teams were trained on COVID-19 precautions and used personal protective equipment whilst in the villages for trial-related activities. After restarting the trial between June and September 2020 in a phased manner, some trial activities were suspended again in all the trial villages from April to June 2021 due to the second wave of COVID-19 cases and lockdown imposed in Satna, Madhya Pradesh. Trial timelines were also revised, with outcomes measured later than originally planned.
BACKGROUND: Clinical Trial Registry of India CTRI/2019/05/019296. Registered 23 May 2019. https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MzExOTg=&Enc=&userName=champion2 .
METHODS: We did not change the original trial design, eligibility, and outcomes. Amendments were introduced to minimise the risk of COVID-19 transmission and ensure safety and wellbeing of trial staff, participants, and other villagers. CHAMPION2 intervention: participatory learning and action (PLA) and fixed day service (FDS) meeting were revised to incorporate social distancing and hygiene precautions. During the COVID-19 pandemic, PLA participation was limited to pregnant women and birthing partners. STRIPES2 intervention: before/after-school classes were halted for a period and then modified temporarily (reducing class sizes, and/or changing meeting places) with hygiene and safe distancing practices introduced.
METHODS: The research team gathered as much information as possible from participants by telephone. If the participant had no telephone or could not be contacted by telephone, data were collected in person. COVID-19 precautions: trial teams were trained on COVID-19 precautions and used personal protective equipment whilst in the villages for trial-related activities. After restarting the trial between June and September 2020 in a phased manner, some trial activities were suspended again in all the trial villages from April to June 2021 due to the second wave of COVID-19 cases and lockdown imposed in Satna, Madhya Pradesh. Trial timelines were also revised, with outcomes measured later than originally planned.
BACKGROUND: Clinical Trial Registry of India CTRI/2019/05/019296. Registered 23 May 2019. https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MzExOTg=&Enc=&userName=champion2 .
摘要：
背景：此更新概述了对CHAMPION2/STRIPES2集群随机试验方案的修订，主要是由于2020年印度的COVID-19大流行和全国封锁而做出的。这些修正案符合COVID-19大流行期间国家卫生研究指南。
方法：我们没有更改原始试验设计，资格,和结果。引入了修正案，以最大程度地降低COVID-19传播的风险，并确保审判人员的安全和福祉，参与者,和其他村民。CHAMPION2干预：修改了参与式学习和行动（PLA）和固定日间服务（FDS）会议，以纳入社会距离和卫生预防措施。在COVID-19大流行期间，解放军的参与仅限于孕妇和分娩伙伴。STRIPES2干预：课前/课后课程暂停一段时间，然后暂时进行修改（减少班级规模，和/或改变会议地点)引入卫生和安全距离做法。
方法：研究小组通过电话从参与者那里收集尽可能多的信息。如果参与者没有电话或无法通过电话联系，数据是亲自收集的。COVID-19预防措施：试验小组接受了关于COVID-19预防措施的培训，并在村庄中使用个人防护设备进行试验相关活动。在2020年6月至9月分阶段重启试验后，2021年4月至6月，由于第二波COVID-19病例和萨特纳实施的封锁，所有审判村庄的一些审判活动再次暂停，中央邦.还修订了审判时间表，结果比原计划晚测量。
背景：印度CTRI/2019/05/019296临床试验注册。2019年5月23日注册。https://ctri.nic.在/临床试验/pmaindet2。php?EncHid=MzExOTg=&Enc=&userName=champion2.
方法：我们没有更改原始试验设计，资格,和结果。引入了修正案，以最大程度地降低COVID-19传播的风险，并确保审判人员的安全和福祉，参与者,和其他村民。CHAMPION2干预：修改了参与式学习和行动（PLA）和固定日间服务（FDS）会议，以纳入社会距离和卫生预防措施。在COVID-19大流行期间，解放军的参与仅限于孕妇和分娩伙伴。STRIPES2干预：课前/课后课程暂停一段时间，然后暂时进行修改（减少班级规模，和/或改变会议地点)引入卫生和安全距离做法。
方法：研究小组通过电话从参与者那里收集尽可能多的信息。如果参与者没有电话或无法通过电话联系，数据是亲自收集的。COVID-19预防措施：试验小组接受了关于COVID-19预防措施的培训，并在村庄中使用个人防护设备进行试验相关活动。在2020年6月至9月分阶段重启试验后，2021年4月至6月，由于第二波COVID-19病例和萨特纳实施的封锁，所有审判村庄的一些审判活动再次暂停，中央邦.还修订了审判时间表，结果比原计划晚测量。
背景：印度CTRI/2019/05/019296临床试验注册。2019年5月23日注册。https://ctri.nic.在/临床试验/pmaindet2。php?EncHid=MzExOTg=&Enc=&userName=champion2.
