dbGaP Study Accession: phs003514

NIH Institute/Center: NIMHD

RADx Data Program: RADx-UP

Release Date: 03/04/2024

DOI: 10.60773/hwkn-r448

Study Description: This project employed a data-informed approach for implementing preventive interventions designed to advance health equity and ameliorate health disparities among vulnerable populations. Building on the successful Phase I and II projects, this project further tailored the Promotores de Salud COVID-19 evidence-based health promotion intervention to experimentally evaluate a brief behavioral self-affirming implementation intention (SAII) intervention; an approach that is evidence-based for increasing acceptance of health messaging, increasing intentions to change, increasing health promoting behaviors, and decreasing psychological distress. The study hypothesized (a) the SAII would increase SARS-CoV-2 rapid testing, testing and vaccine acceptance, and health outcomes through enhancing health promotion messaging, reducing stigma, and affirming self-perceptions; and (b) the SAII would serve as a buffer that moderates (lowers) negative effects of COVID-19-related stressors and discrimination on testing and health outcomes. The key targets of the intervention were structural social determinants of health (i.e., discrimination and mistrust) as barriers to testing acceptance. Project aims were: (1) To pilot test rapid SARS-CoV-2 test distribution and an English and Spanish version of the SAII intervention. The culturally tailored SAII intervention were offered in Spanish and English and can be administered orally and did not require English language proficiency or literacy; and (2) Conduct a clustered randomized trial (CRT) testing a health equity effectiveness hypothesis. The project used a 2-group × 2-time (pre-post) design to randomly assign 400 participants sampled from Mexican Consulate event attendees to either an SAII + Promotores de Salud condition or to a control condition (the Promotores de Salud intervention only) and test (a) hypothesized main effects of the intervention on testing and vaccine acceptance and health outcomes, and (b) hypothesized buffering effects of COVID-19 stressors and discrimination on testing and health outcomes. Linear and generalizable multilevel structural equation modeling were specified for evaluation. The study design was powered to detect moderate main effects (ES = .30) and moderating effects of the SAII intervention.

Updated Date: 03/04/2024

Principal Investigator: Degarmo, Dave

Has Data Files: Yes

Study Domain: Vaccination Rate/Uptake; Pandemic Perceptions and Decision-Making; Testing Rate/Uptake; Social Determinants of Health; Rapid Diagnostic Test (RDT)

Data Collection Method: Molecular (Nucleic Acid/PCR) Testing Device; Survey

Keywords: Behavioral Self-Affirming Implementation Intention (SAII) Intervention, COVID-Related Stressors; COVID Prevention; Preventative Interventions

Study Design: Interventional/Clinical Trial

Multi-Center Study: FALSE

Data Types: Questionnaires/Surveys; Behavioral

Study Start Date: 11/01/2022

Study End Date: 10/31/2024

Species: Human Data

Estimated Cohort Size: 400

Study Population Focus: Older Adults or Elderly; Adults; Underserved/Vulnerable Population

Acknowledgement Statement: This study was supported through funding, 3U01MD018311-01S1, for the National Institute on Minority Health and Health Disparities (NIMHD) as part of the RADx-UP program. This work would not have been possible without the collaborative partnerships with the following: Mexican Consulate, Oregon Health Authority, our Community and Scientific Advisory Board, and the study participants. Approved users should acknowledge the provision of data access by dbGaP for accession phs003514.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-22-005

NIH Grant or Contract Number(s): 3U01MD018311-01S1

Consent/Data Use Limitations: General Research Use