dbGaP Study Accession: phs003595

NIH Institute/Center: NIMHD

RADx Data Program: RADx-UP

Release Date: 09/13/2024

DOI: 10.60773/9br0-er28

Study Description: Many multilayered barriers increase risk for COVID-19 among AA including poverty, essential jobs with increased virus exposure, cultural norms (e.g., risk denial, medical/contact tracing mistrust), chronic health conditions, and limited access to healthcare and other services/resources. These barriers highlight the need for accessible, trusted COVID-19 testing and linkage to antiviral treatment and care services (LTC; e.g., health, prevention programs, community resources, contact tracing) and to community resources (e.g., food, rent assistance) to help slow COVID-19 spread in AA communities. The AA church is an institution with extensive influence in AA communities and may be an ideal setting for increasing reach of COVID-19 test-to-treat (TTT) interventions with LTC in hard hit AA communities. Yet, no controlled AA church-based studies exist on COVID-19 TTT interventions. The primary aim of this study was to fully test a culturally/religiously-tailored, church-based COVID-19 TTT with LTC intervention condition against a non-tailored education condition on COVID-19 rapid testing rates at 6 months with adult AA church members and the community members they serve. Churches were matched on membership size, denomination and past participation in church health intervention studies, then randomized to treatment condition. Twelve churches (6 churches per arm; 55 church and 20 community members/church; N=900 total) participated in the study. Antiviral and contact tracing intentions and use were examined at 6 months as secondary outcomes. Other types of COVID-19 testing and linkage to care use were also assessed. Guided by the Theory of Planned Behavior and Socioecological Model, the community-engaged approach included trained church leaders delivering a culturally, church-appropriate COVID-19 TTT Toolkit inclusive of digital tools: a) individual self-help materials and automated/tailored text messages; b) ministry group educational information; c) virtual/in-person church services with COVID-19 related materials/activities (e.g., sermons, pastors modeling rapid-self testing, testimonials, bulletins); and d) church-community level linkage to care (LTC) services (e.g., contact tracing, treatment, healthcare, community resources) provided by contact tracers serving as community health workers (CHW). Intervention churches hosted 2 COVID-19 TTT events and provided members with take-home COVID-19 rapid self-test kits. Potential mediators/moderators related to receipt of COVID-19 testing were evaluated, and a process evaluation was done to determine implementation facilitators, barriers, and fidelity related to increasing COVID-19 testing rates. This novel study was the first to fully test a COVID-19 TTT intervention in AA churches. It provided a theory-based, multilevel scalable model for equipping AA churches to deliver wide-reaching COVID-19 rapid testing and promote treatment with health agency partners.

Updated Date: 03/29/2024

Principal Investigator: Berkley-Patton, Jannette

Has Data Files: Yes

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

Data Collection Method: Survey

Keywords: Building Trust Amongst Marginalized Communities; Individual-Level Data; Influencing Factors; Mediation Analysis; Proof-of-Concept Model

Study Design: Longitudinal Cohort

Multi-Center Study: No

Data Types: Questionnaire or Survey

Study Start Date: 11/01/2022

Study End Date: 10/31/2024

Species: Human

Estimated Cohort Size: 900

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

Acknowledgement Statement: This study was supported through funding, 3U01MD018310-01S1, for the National Institute on Minority Health and Health Disparities (NIMHD) as part of the RADx-UP program. Approved users should acknowledge the provision of data access by dbGaP for accession phs003595.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): 3U01MD018310-01S1

Consent/Data Use Limitations: General Research Use