TY - JOUR
T1 - Optimization of a new adaptive intervention using the SMART Design to increase COVID-19 testing among people at high risk in an urban community
AU - Windsor, Liliane
AU - Benoit, Ellen
AU - M. Pinto, Rogério
AU - Sarol, Jesus
N1 - The authors acknowledge the contributions of the study participants, members of the Newark Community Collaborative Board, and our research staff including Brianna Amos, Elizabeth Awoyemi, Bruno de Oliveira, Dan Gamino, Kim Garcia, Darris Hawkins, Letitia McBride, and Steve Morris. Liliane Windsor is the principal investigator; she conceived the study and led the proposal and the protocol development. Ellen Benoit is the local principal investigator; she participated in the conceptualization of the study and the protocol development. She oversees the data collection at the study’s site. Dr. Rogério Mireles Pinto is the co-investigator who provided support with the selection of interventions, the application of community-engaged research principles, and the literature review section of the proposal and protocol. Jesus Sarol is the study’s statistician. He developed the statistical analysis plan of the proposal and the protocol. All authors read and approved the final manuscript. Research reported in this publication was supported in full by the National Institute on Minority Health and Health Disparities of the National Institutes of Health under award number 3R01MD010629-04S2. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The funder had no participation in the study design; collection, management, analysis, and interpretation of the data; writing of this manuscript; or decision to submit this manuscript for publication. Data for this study will be collected through repeated quantitative surveys, observations, intervention sessions, and in-depth interviews and will be compiled into separate quantitative and qualitative databases. All databases will be stripped of personal identifiers, and code numbers will be replaced, to render data suitable for use by other investigators. Although the databases will be stripped of potentially identifying information prior to any sharing, we will make data and associated documentation available to users only through a controlled site and under a data-sharing agreement that includes a commitment to use the data only for research purposes and to protect privacy and confidentiality. All investigators funded under the NIH RADx-UP program are required to submit data from their studies to the CDCC at the Duke Clinical Research Institute (DCRI), the entity chosen by NIH to serve as the data storage hub for all RADx-UP studies. Dr. Windsor’s staff at the University of Illinois will submit the reports on common evaluation metrics on COVID-19 testing-related outcomes and implementation to the CDCC. These non-identifiable data are maintained in a database that DCRI will make available to other researchers. DCRI also maintains a separate database that is limited to identifiable information, collected only from participants who specifically consent to share such information and to be contacted by the DCRI for participation in future studies. DCRI will not share the information in this database.
Research reported in this publication was supported in full by the National Institute on Minority Health and Health Disparities of the National Institutes of Health under award number 3R01MD010629-04S2. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The funder had no participation in the study design; collection, management, analysis, and interpretation of the data; writing of this manuscript; or decision to submit this manuscript for publication.
PY - 2022/12
Y1 - 2022/12
N2 - Background: COVID-19 has impacted the health and social fabric of individuals and families living across the USA, and it has disproportionately affected people living in urban communities with co-morbidities, those working in high-risk settings, refusing or unable to adhere to CDC guidelines, and more. Social determinants of health (SDH), such as stigmatization, incarceration, and poverty, have been associated with increased exposure to COVID-19 and increased deaths. While vaccines and booster shots are available, it will take time to reach herd immunity, and it is unclear how long newly developed vaccines provide protection and how effective they are against emerging variants. Therefore, prevention methods recommended by the Centers for Disease and Control (CDC)—i.e., testing, hand-washing, social distancing, contact tracing, vaccination and booster shots, and quarantine—are essential to reduce the rates of COVID-19 in marginalized communities. This project will adapt and test evidence-based HIV interventions along the prevention and treatment cascade to help address COVID-19 prevention needs. Methods: The study aims to (1) optimize an adaptive intervention that will increase rates of testing and adherence to New Jersey State COVID-19 recommendations (testing, social distancing, quarantine, hospitalization, contact tracing, and acceptance of COVID-19 vaccination and booster shots) among high-risk populations and (2) identify predictors of testing completion and adherence to New Jersey recommendations. This study follows Community Based Participatory Research (CBPR) principles to conduct a Sequential, Multiple Assignment Randomized Trial (SMART) with 670 COVID-19 medically/socially vulnerable people. Participants will be recruited using a variety of strategies including advertisements on social media, posting fliers in public places, street outreach, facility-based, and snowball sampling. Participants complete a baseline survey and are randomized to receive navigation services or an electronic brochure. They then complete a follow-up 7 days after baseline and are randomized again to either continue with their original assignment or switch to the other intervention or critical dialog or brief counseling. Participants then complete a 5-week post-baseline follow-up. Guided by the COVID-19 Continuum of Prevention, Care, and Treatment, the analysis will explore the factors associated with COVID-19 testing within 7 days of the intervention. Discussion: This paper describes the protocol of the first study to use SMART following CBPR to adapt evidence-based HIV prevention interventions to COVID-19. The findings will inform the development of an effective and scalable adaptive intervention to increase COVID-19 testing and adherence to public health recommendations, including vaccination and booster shots, among a marginalized and difficult-to-engage population. Trial registration: ClinicalTrials.govNCT04757298. Registered on February 17, 2021.
AB - Background: COVID-19 has impacted the health and social fabric of individuals and families living across the USA, and it has disproportionately affected people living in urban communities with co-morbidities, those working in high-risk settings, refusing or unable to adhere to CDC guidelines, and more. Social determinants of health (SDH), such as stigmatization, incarceration, and poverty, have been associated with increased exposure to COVID-19 and increased deaths. While vaccines and booster shots are available, it will take time to reach herd immunity, and it is unclear how long newly developed vaccines provide protection and how effective they are against emerging variants. Therefore, prevention methods recommended by the Centers for Disease and Control (CDC)—i.e., testing, hand-washing, social distancing, contact tracing, vaccination and booster shots, and quarantine—are essential to reduce the rates of COVID-19 in marginalized communities. This project will adapt and test evidence-based HIV interventions along the prevention and treatment cascade to help address COVID-19 prevention needs. Methods: The study aims to (1) optimize an adaptive intervention that will increase rates of testing and adherence to New Jersey State COVID-19 recommendations (testing, social distancing, quarantine, hospitalization, contact tracing, and acceptance of COVID-19 vaccination and booster shots) among high-risk populations and (2) identify predictors of testing completion and adherence to New Jersey recommendations. This study follows Community Based Participatory Research (CBPR) principles to conduct a Sequential, Multiple Assignment Randomized Trial (SMART) with 670 COVID-19 medically/socially vulnerable people. Participants will be recruited using a variety of strategies including advertisements on social media, posting fliers in public places, street outreach, facility-based, and snowball sampling. Participants complete a baseline survey and are randomized to receive navigation services or an electronic brochure. They then complete a follow-up 7 days after baseline and are randomized again to either continue with their original assignment or switch to the other intervention or critical dialog or brief counseling. Participants then complete a 5-week post-baseline follow-up. Guided by the COVID-19 Continuum of Prevention, Care, and Treatment, the analysis will explore the factors associated with COVID-19 testing within 7 days of the intervention. Discussion: This paper describes the protocol of the first study to use SMART following CBPR to adapt evidence-based HIV prevention interventions to COVID-19. The findings will inform the development of an effective and scalable adaptive intervention to increase COVID-19 testing and adherence to public health recommendations, including vaccination and booster shots, among a marginalized and difficult-to-engage population. Trial registration: ClinicalTrials.govNCT04757298. Registered on February 17, 2021.
KW - Brief counseling
KW - COVID-19 testing
KW - COVID-19 treatment cascade
KW - Critical dialog
KW - Navigation services
KW - Sequential Multiple Assignment Randomized Trials (SMART)
KW - COVID-19
UR - https://www.scopus.com/pages/publications/85128254544
UR - https://www.scopus.com/pages/publications/85128254544#tab=citedBy
U2 - 10.1186/s13063-022-06216-w
DO - 10.1186/s13063-022-06216-w
M3 - Article
C2 - 35421999
SN - 1745-6215
VL - 23
JO - Trials
JF - Trials
IS - 1
M1 - 310
ER -