Optimization of a new adaptive intervention using the SMART Design to increase COVID-19 testing among people at high risk in an urban community

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.