dbGaP Study Accession: phs003507

NIH Institute/Center: NIMHD

RADx Data Program: RADx-UP

DOI: 10.60773/w561-ag09

Release Date: 03/04/2024

Study Description: Low-Income Asian Americans (AA) with limited English proficiency (LEP) represent a meaningful proportion of low-wage frontline workers in essential service industries. Many also live in multigenerational households with crowded conditions and with their elderly relatives in ethnic neighborhoods, areas that have experienced high rates of COVID-19 infection. Unfortunately, AAs have encountered numerous barriers to COVID-19 testing across individual, provider/health system and community/societal levels, including anti-Asian racism and discrimination, fear of safety at test sites and on public transportation, lack of health insurance, lack of culturally and language-appropriate COVID-19 information and navigation, and limited access to COVID-19 testing sites. As a result, AAs have the lowest COVID-19 testing rate across all racial/ethnic groups. This is particularly concerning in light of the recent surge in cases due to the BA.2 variant and lifting of COVID restrictions, which has led to increases in COVID-19 infections and hospitalizations especially among vulnerable populations. FDA-approved over-the-counter (OTC) COVID-19 diagnostic tests offer a valuable evidence-based strategy for empowering vulnerable AAs (who are hesitant or otherwise unable to obtain in-person PCR testing) to complete self-testing. Although prior studies have demonstrated the feasibility of COVID-19 self-testing in communities with access barriers, no intervention study has focused on vulnerable low-income frontline workers and seniors with LEP across diverse AA ethnic groups (Chinese, Vietnamese, Korean, Filipino, Indian, and other South Asian Americans), the fastest growing US population. Thus, the overall goal of this application was to implement a community-engaged multifaceted intervention (IMPROVE intervention) to increase access to and uptake of rapid COVID-19 self-testing across diverse AA populations. Guided by the NIMHD Research Framework and Social Cognitive Theory to address sociocultural/environmental and individual/interpersonal influences for COVID self-testing, the central hypothesis was that trusted messengers (community health navigators, heath providers, and peer advocates) were essential to reducing testing barriers and increasing uptake of COVID-19 self-testing. The Specific Aims were to: (1) Engage community partners to implement a pragmatic cluster-randomized trial in 12 CBO sites to evaluate the effectiveness of the community-engaged and evidence-based IMPROVE intervention in increasing access to and uptake of COVID-19 self-testing (primary outcome) and changes in mitigation behaviors including adherence to mask wearing and COVID-19 vaccination (secondary outcomes) in underserved and vulnerable ethnic AAs (N=1200 AAs); and (2) Evaluate Intervention Reach, Effectiveness, Adoption, Implementation and Maintenance using the RE-AIM framework to facilitate IMPROVE intervention dissemination to more CBOs and enhance its sustainability over time. The primary outcomes included COVID-19 self-testing uptake (number of tests done and locations) and access to COVID-19 self-testing (difficulties of getting tested in the community, and access to at-home self-test kits, difficulties in using self-test kits). The secondary outcomes included changes in COVID-19 mitigation behaviors, including COVID-19 testing, COVID-19 testing intention if testing not performed, COVID-19 vaccine uptake (dosage and brands of vaccine received, to be verified via self-report or vaccine card upload), and intention/hesitancy; mask-wearing and other mitigation strategies, and treatment received and difficulties if positive. The project was one of the first to evaluate an evidence-based community-engaged approach to reducing systemic barriers and filled gaps in research on COVID-19 self-testing and mitigation adherence in above-stated ethnic AA vulnerable populations.

Updated Date: 03/04/2024

Principal Investigator: Ma, Grace X

Has Data Files: Yes

Study Domain: At-Home or Over-the-Counter (OTC) Self-Testing; Community Outreach Programs; Rapid Diagnostic Test (RDT); Social Determinants of Health; Testing Rate or Uptake; Vaccination Rate or Uptake

Data Collection Method: Antigen Testing Device; Survey

Keywords: Improving Access to COVID Information and Interventions; Individual-Level Data; Mitigation Strategies; Populations with Limited English Proficiency

Study Design: Longitudinal Cohort

Multi-Center Study: No

Data Types: Behavioral; Clinical; Family History; Questionnaire or Survey; Social

Study Start Date: 11/01/2022

Study End Date: 10/31/2024

Species: Human Data

Estimated Cohort Size: 1200

Study Population Focus: Adults; Asians; Children; Essential Workers; Lower Socioeconomic Status (SES) Populations; Older Adults or Elderly; Racial or Ethnic Minorities; Underserved or Vulnerable Populations

Acknowledgement Statement: This study was supported through funding, 3U01MD018320-01S1, for the National Institute on Minority Health and Health Disparities (NIMHD) as part of the RADx-UP program. The study team wanted to acknowledge RADx-UP program from NIH, collaborating community-based organizations, and the study participants for their support and contribution in study design and implementation. Approved users should acknowledge the provision of data access by dbGaP for accession phs003507.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: RFA-OD-22-006

NIH Grant or Contract Number(s): 3U01MD018320-01S1

Consent/Data Use Limitations: General Research Use