dbGaP Study Accession: phs004006

NIH Institute/Center: NIMHD

RADx Data Program: RADx-UP

Release Date: 04/08/2025

Study Description: Arizona has one of the highest COVID-19 positivity test rates (approximately 19%) in the U.S. Positivity rates are disproportionately higher among Arizona's Latinx, American Indian and African American communities. The following community-driven and culturally congruent intervention aims to increase access to testing by identifying and decreasing barriers to testing in vulnerable and underserved communities across Arizona. The intervention aims at reducing disparities in COVID-19 diagnostics, education, wraparound services and referrals to a primary care provider, with the ultimate goal of improving the health of underserved communities. This approach empowers local communities, meets community members where they are, is data driven, and creates the infrastructure for continued community-driven delivery of care. Following a Community Based Participatory Research (CBPR) orientation, this project: (a) identified and prioritized testing deserts, (b) coordinated testing at different levels of the social ecosystem, (c) engaged and trained local Community Health Workers (CHWs) to deliver saliva-based COVID-19 testing to vulnerable and underserved community members, (d) delivered test results within 72 hours, (e) provided wrap-around services and provider referrals for those testing positive, and (f) sustained the intervention during a follow-up period. EHF serves as the lead community partner and convener of a growing COVID- 19 Coalition of Communities of Color Partners (CCCCP) from across Arizona. The ASU Biodesign Clinical Testing Laboratory (ABCTL) provided the saliva-based SARS-CoV-1 molecular diagnostic. The saliva test's main benefits are: a) minimal to no PPE requirements compared to nasopharyngeal (NP) swabs; b) convenience and economy of specimen collection; c) ease of repeat sampling; d) administration by minimally trained CHWs, and e) greater sensitivity and consistency of saliva tests than NP swabs. Under this project, 29,000 saliva tests were administered, 10,000-12,000 at identified testing deserts during the launching period, doubling the numbers during the follow-up period in Year 1, and 5,000 tests were added in Year 2. A longitudinal evaluation assessed the intervention's impact by comparing randomly selected participants in the R.A.P.I.D. intervention during the launching period (N=500) with a matched comparison group (N=500) randomly selected from standard testing sites.

Updated Date: 04/08/2025

Principal Investigator: Marsiglia, Flavio Francisco

Has Data Files: Yes

Study Domain: COVID Testing Deserts; Community Outreach Programs; Diagnostic Testing; Testing Rate or Uptake

Data Collection Method: Molecular Nucleic Acid or PCR Testing Device; Survey

Keywords: Community-based COVID-19 Testing; Home Visits; Saliva-based Testing; Testing Disparities; Testing Drives; Testing Intervention

Study Design: Interventional or Clinical Trial

Multi-Center Study: No

Data Types: Behavioral; Clinical; Cognitive; Psychological; Questionnaire or Survey; Social

Study Start Date: 09/22/2020

Study End Date: 06/30/2022

Species: Human

Estimated Cohort Size: 1000

Study Population Focus: Adults; African Americans; Hispanics or Latinos; Racial or Ethnic Minorities; Underserved or Vulnerable Populations

Acknowledgement Statement: This study was supported through funding, 3U54MD002316-15S2, for the National Institute on Minority Health and Health Disparities (NIMHD) as part of the RADx-UP program. Acknowledging our community partner, Equality Health Foundation, for leading efforts in the field, and to all participants in the study throughout Arizona. Approved users should acknowledge the provision of data access by dbGaP for accession phs004006.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): 3U54MD002316-15S2

Consent/Data Use Limitations: General Research Use