dbGaP Study Accession: phs002584

NIH Institute/Center: NIDA

RADx Data Program: RADx-UP

Release Date: 08/30/2023

DOI: 10.60773/wbd9-yd79

Study Description: The global SARS-CoV-2 pandemic that causes the severe respiratory illness COVID-19 is the worst health crisis the United States has faced in a century. Although this highly contagious virus has infected millions of Americans, the disease burdens are disproportionately born to historically underserved populations such as Latinx communities. Nationally, Latinx people with COVID-19 are hospitalized at four times the rate of Whites and have much higher rates of morbidity and mortality. This disparity is notable in Oregon, where the 13% of the population that is Latinx represents approximately 44% of COVID-19 cases. An urgent need exists to reach Oregon's Latinx community with public health and prevention messages to increase testing. This project implemented a culturally-tailored community outreach and testing program to increase the reach, access, and uptake of testing in Latinx communities in Oregon. The project brought together a world-class team of prevention scientists, public health experts, Latinx researchers, community partners, and biologists who have been working together to conduct SARS-CoV-2 diagnostic testing since March, soon after the pandemic first arrived in the U.S. This team established a CLIA-certified laboratory and honed molecular testing protocols, hired and trained laboratory personnel and a field research team, procured diagnostic testing equipment and supplies, and partnered with county public health offices and hospitals throughout the state to conduct testing. The team also conducted a comprehensive community assessment using community-based participatory methods to gather Latinx community feedback on modes of communication, health messages, and testing protocols, and staffed multiple county-led testing sites serving Latinx communities. Using these resources and expertise as a foundation, a two-arm randomized controlled trial implemented community-level interventions to increase testing rates and health behaviors. Thirty-nine testing sites across 9 counties were randomized to receive one of two outreach interventions, Basic Outreach versus Promotores de Salud. Promotores de Salud was a culturally-informed intervention that included psychoeducation about COVID-19, motivational strategies, emotional support, and information support to engage individuals to attend a testing site. In addition, the study included a booster intervention for those who attend a Promotoras de Salud testing site. In the booster intervention, participants received an in-person Promotores de Salud intervention and a written pamphlet with information about health behaviors. Participants randomized to the control condition only received the written pamphlet. Participants in the research study were assessed via a survey at the time of testing and 1 month later. Site- and community-level assessments occurred at three timepoints in the study: immediate, mid-term, and primary outcomes, to measure the effects of the randomization and the on-site promotores intervention. Individual-level data were collected from 1,200 participants at two timelines when they were at a testing visit, and approximately one month later. Over time, this project helped communities institutionalize optimal local testing frameworks supported by laboratory facilities for testing capacity, technical support for testing logistics, and collection of data on health behaviors, testing rates, and sustainability. The resulting structures and systems were poised for future scale-up to other vulnerable communities and/or for other public health purposes (e.g., vaccination campaigns). This project aimed for a major reduction in COVID-19 health disparities in underserved populations.

Updated Date: 04/10/2024

Principal Investigator: Leve, Leslie Diane

Has Data Files: Yes

Study Domain: Testing Rate/Uptake; Community Outreach Programs; Virological Testing; Health Behaviors

Data Collection Method: Survey; Interview or Focus Group

Keywords: Prospective Sample; COVID Outreach/Education; Individual-Level Data

Study Design: Longitudinal Cohort

Multi-Center Study: FALSE

Data Types: Questionnaires/Surveys; Behavioral; Other

Data Types, Other: SARS-CoV-2 Infection Status

Study Start Date: 09/30/2020

Study End Date: 08/31/2022

Species: Human Data

Estimated Cohort Size: 11200

Study Population Focus: Older Adults or Elderly; Children; Racial and Ethnic Minorities; Underserved/Vulnerable Population; Hispanic and Latino; Adults

Publication URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9204550/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9827438/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9541743/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9707712/

Acknowledgement Statement: This study was supported through funding, 3P50DA048756-03S3, for the National Institute on Drug Abuse (NIDA) as part of the RADx-UP program. This work would not have been possible without the collaborative partnerships with the following community-based organizations: Vive NW, Unete, Mano Amigas, Centro de Ayuda, Centro Latino Americano, Euvalcree, the Oregon Health Authority, the many volunteers and service organizations who assisted with facilities and supports at testing events, and the study participants. Approved users should acknowledge the provision of data access by dbGaP for accession phs002584.v1.p1, and the NIH RADx Data Hub. Approved users should also acknowledge the specific version(s) of the dataset(s) obtained from the NIH RADx Data Hub.

Funding Opportunity Announcement (FOA) Number: PA-20-135

NIH Grant or Contract Number(s): 3P50DA048756-03S3

Consent/Data Use Limitations: General Research Use