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

• Published in: Trials
• Main Authors: Michael Anastario, Elizabeth Rink, Paula Firemoon, Nicole Carnegie, Olivia Johnson, Malory Peterson, Ana Maria Rodriguez
• Format: Article in Journal/Newspaper
• Language: English
• Published: BMC 2023
• Subjects: Stepped wedge design; Secular trend; American Indians; Sexual health; COVID-19 pandemic; Medicine (General); R5-920; assiniboine
• Online Access: https://doi.org/10.1186/s13063-023-07223-1; https://doaj.org/article/dfb13c6fac464890948eee64e631ed9e

Abstract Background 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. Methods 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. Results 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 ...