TY - JOUR
T1 - ADAPTATIONS DUE TO THE COVID-19 PANDEMIC IN A COMMUNITY-BASED PARTICIPATORY RESEARCH RANDOMIZED CONTROL TRIAL EXAMINING SEXUAL AND REPRODUCTIVE HEALTH OUTCOMES AMONG AMERICAN INDIAN YOUTH
AU - Rink, Elizabeth
AU - Johnson, Olivia
AU - Anastario, Michael
AU - Firemoon, Paula
AU - Peterson, Malory
AU - Baldwin, Julie
N1 - Funding Information:
The study presented in this manuscript is funded by the National Institute of Minority Health and Health Disparities, Award # R01MD012761, Dr. Elizabeth Rink is the study’s Principal Investigator. The study’s clinical trials number with clinicaltrials.gov is: NCT03694418.
Funding Information:
The authors would like to thank the youth and parents who participate in NE. We are grateful for our collaborations with the schools and the school personnel involved in the study. In addition, we thank the Fort Peck Tribes’ Executive Board for their ongoing support and belief in our research. We are appreciative of the ongoing guidance we receive from NE’s community advisory board members: Adriann Ricker, Bruce Bauer, Marty Reum, Alex Granbois, and Dana RunsAbove. FUNDING INFORMATION The study presented in this manuscript is funded by the National Institute of Minority Health and Health Disparities, Award # R01MD012761, Dr. Elizabeth Rink is the study’s Principal Investigator. The study’s clinical trials number with clinicaltrials.gov is: NCT03694418.
Publisher Copyright:
© 2022
PY - 2022
Y1 - 2022
N2 - In this manuscript, we present changes in study design and analytical strategy due to the COVID-19 pandemic for Nen ŨnkUmbi/EdaHiYedo (“We Are Here Now,” or NE). NE is a community-based participatory research multi-level randomized control trial using a stepped wedge design to address sexual and reproductive health disparities among American Indian youth. Adaptations in NE’s research design, data collection, and analysis due to the COVID-19 pandemic were made based on meetings with tribally based research team members and outside non-Indigenous researchers involved in NE, as well as the study’s Community Advisory Board and the Data Safety Monitoring Board. Based on these iterative discussions, decisions were made to: 1) reorganize the sequence of NE’s stepped wedge design clusters, and 2) include additional quantitative and qualitative data collection and analysis in the research design that specifically addressed the impact of COVID-19 on the research participants. These adaptations have the potential to foster greater scientific knowledge in understanding how to address unanticipated 3-way interaction effects in randomized control trials with tribal communities. Findings can also contribute to understanding how public health disasters impact sexual and reproductive health among American Indian youth.
AB - In this manuscript, we present changes in study design and analytical strategy due to the COVID-19 pandemic for Nen ŨnkUmbi/EdaHiYedo (“We Are Here Now,” or NE). NE is a community-based participatory research multi-level randomized control trial using a stepped wedge design to address sexual and reproductive health disparities among American Indian youth. Adaptations in NE’s research design, data collection, and analysis due to the COVID-19 pandemic were made based on meetings with tribally based research team members and outside non-Indigenous researchers involved in NE, as well as the study’s Community Advisory Board and the Data Safety Monitoring Board. Based on these iterative discussions, decisions were made to: 1) reorganize the sequence of NE’s stepped wedge design clusters, and 2) include additional quantitative and qualitative data collection and analysis in the research design that specifically addressed the impact of COVID-19 on the research participants. These adaptations have the potential to foster greater scientific knowledge in understanding how to address unanticipated 3-way interaction effects in randomized control trials with tribal communities. Findings can also contribute to understanding how public health disasters impact sexual and reproductive health among American Indian youth.
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U2 - 10.5820/aian.2902.2022.32
DO - 10.5820/aian.2902.2022.32
M3 - Article
C2 - 35881980
AN - SCOPUS:85135134719
VL - 29
SP - 32
EP - 48
JO - American Indian and Alaska Native Mental Health Research
JF - American Indian and Alaska Native Mental Health Research
SN - 0893-5394
IS - 2
ER -