Evidence of secular trends during the COVID-19 pandemic in a stepped wedge cluster randomized trial examining sexual and reproductive health outcomes among Indigenous youth.
Evidence of secular trends during the COVID-19 pandemic in a stepped wedge cluster randomized trial examining sexual and reproductive health outcomes among Indigenous youth.
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Nen nkUmbi/EdaHiYedo（“我们现在在这里，”或NE）是一项干预措施，旨在预防美国蒙大拿州佩克堡保留地的阿西尼博因和苏族青年的性传播感染、艾滋病毒、丙型肝炎和少女怀孕。一个集群随机步进楔形设计（SWD）试验是用来评估NE，集群是学校。本研究旨在评估是否有证据显示COVID-19大流行存在长期趋势。最初的研究设计是一个集群随机阶梯楔形设计（SWD），其中五所学校的青少年从佩克堡参加是集群被随机分为干预一次，所有学校最终被随机分为干预三个步骤。N/E是一项为期5年的研究，涉及456名15至18岁的青少年。在这项研究中，我们使用混合定量和定性方法来了解COVID-19大流行如何与研究的主要结果变量相关。数据来自第一个暴露于干预措施的集群和一个在实施COVID-19缓解措施期间尚未接受干预措施的对照集群。研究人员在实施的核心措施中增加了一份新冠肺炎疫情前后的调查问卷，并对年轻人进行了半结构化的定性访谈，了解他们对疫情如何改变其性行为的看法。118名青年回答了问卷，31名青年参加了半结构化的定性访谈。由于COVID-19，报告与更少人发生性关系的青年报告了更多的性行为（发病率比（IRR）=3.6，95% CI 1.6-8.1），与未报告与较少人发生性关系的人相比，以及报告因COVID-19与相同数量的人发生性关系的年轻人报告较少的性行为（IRR=0.31，95% CI 0.14-0.7）与那些没有报告与相同数量的人发生性关系的人相比。与未报告性行为次数较少的青少年相比，报告因COVID-19而发生性行为次数较少的青少年经历了更多的性行为（IRR=2.7，1.2-6.4）。结果表明，在大流行期间，性活跃的人更多地报告说，他们认为与更少的人发生性关系，性行为的频率也更低。COVID-19大流行期间可能与性活动分布的截断有关，这将使对干预效果的估计产生偏差。调查结果表明，长期趋势的证据。在试验结束时必须考虑这种趋势，并建议进行敏感性分析。记录和报告这些发现有助于在全球大流行期间实施SWD试验期间进行透明报告，并为终点分析提供信息。本试验在美国国立卫生研究院（NIH）美国国家医学图书馆的临床试验注册处注册。它于2018年10月1日注册。本手稿中介绍的研究由NIH国家少数民族健康和健康差异研究所（NIMHD）资助，奖项#R 01 MD 012761 -01，Elizabeth Rink（首席研究员）。该研究的ClinicalTrials.gov编号为NCT 03694418。在线版本包含补充材料，可通过10.1186/s13063-023-07223-1获得。
Nen ŨnkUmbi/EdaHiYedo (“We Are Here Now,” or NE) is an intervention to prevent STIs, HIV, HCV, and teen pregnancy among Assiniboine and Sioux youth of the Fort Peck Reservation in the state of Montana in the USA. A cluster-randomized stepped-wedge design (SWD) trial is used to evaluate NE, where clusters are schools. The purpose of this study is to evaluate whether there is evidence of a secular trend associated with the COVID-19 pandemic. The original study design is a cluster-randomized stepped-wedge design (SWD), in which five schools that youth from Fort Peck attend are the clusters to be randomized into the intervention one at a time, with all schools eventually being randomized to the intervention across three steps. N/E is a 5-year study involving 456 15- to 18-year-old youth. For this study, we use a mixed quantitative and qualitative methods approach to understand how the COVID-19 pandemic may have been associated with the study’s primary outcome variables. Data were drawn from the first cluster exposed to the intervention and one control cluster that did not yet receive the intervention during the period in which COVID-19 mitigation efforts were being implemented. A pre-post COVID questionnaire was added to core measures administered, and semistructured qualitative interviews were conducted with youths regarding their perceptions of how the pandemic altered their sexual behaviors. One hundred eighteen youth responded to the questionnaire and 31 youth participated in semistructured qualitative interviews. Youth reporting having sex with less people due to COVID-19 reported more sex acts (incident rate ratio (IRR)=3.6, 95% CI 1.6–8.1) in comparison to those who did not report having sex with less people, and youth who reported having sex with the same amount of people due to COVID-19 reported less sex acts (IRR=0.31, 95% CI 0.14–0.7) in comparison to those who did not report having sex with the same amount of people. Youth reporting having sex less times due to COVID-19 experienced a greater number of sex acts in comparison to those who did not report having sex less times (IRR=2.7, 1.2–6.4). Results suggest that more sexually active individuals reported perceiving having sex with less people and less frequent engagement in sex during the pandemic. It is possible that the COVID-19 pandemic period was associated with a truncation in the distribution of sexual activity that would bias an estimate of the intervention’s effect. Findings suggest evidence of a secular trend. This trend must be accounted for at trial end, and sensitivity analyses are recommended. Documenting and reporting on these findings encourages transparent reporting during the implementation of a SWD trial during a global pandemic, and informs endline analyses. This trial is registered with the Clinical trials registry of the US National Library of Medicine at the National Institutes of Health (NIH). It was registered on October 1, 2018. The study presented in this manuscript is funded by NIH National Institute on Minority Health and Health Disparities (NIMHD), Award # R01MD012761-01, Elizabeth Rink (Principal Investigator). The study’s ClinicalTrials.gov number is NCT03694418. The online version contains supplementary material available at 10.1186/s13063-023-07223-1.
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影响因子：
12.7
作者：
Kaufman, Carol E.;Whitesell, Nancy Rumbaugh;Mitchell, Christina M.
通讯作者：
Mitchell, Christina M.
DOI：
10.5820/aian.2902.2022.32
发表时间：
2022-01-01
影响因子：
1.3
作者：
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通讯作者：
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DOI：
10.5820/aian.2303.2016.187
发表时间：
2016-01-01
影响因子：
1.3
作者：
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通讯作者：
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影响因子：
2.5
作者：
Mitchell, Eleanor J.;Ahmed, Khaled;McDonald, Alison
通讯作者：
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影响因子：
5.5
作者：
Rink E;Knight K;Ellis C;McCormick A;FireMoon P;Held S;Webber E;Adams A
通讯作者：
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