dbGaP Study Accession: phs002946

NIH Institute/Center: NIMHD

RADx Data Program: RADx-UP

Release Date: 12/07/2023

DOI: 10.60773/v1h1-pp81

Study Description: Latinx communities are disproportionately affected by the COVID-19 pandemic, with Spanish-speaking Latinx communities carrying even heavier burdens of infection, hospitalization, and mortality. Major barriers to COVID-19 testing and vaccination exist, and a profound need remains to understand and address the social, ethical, and behavioral implications (SEBI) of COVID-19 testing and vaccination within Latinx communities. The well-established community-academic partnership proposed a rigorous mixed-methods, community-based participatory research (CBPR) study to better understand the SEBI of COVID-19 testing and vaccination and to refine and test a novel and culturally congruent intervention to increase COVID-19 testing and vaccination within Spanish-speaking Latinx communities. In Aim 1, the study conducted individual in-depth interviews with health providers and representatives from Latinx-serving community-based organizations and focus groups with Spanish-speaking Latinx community members to expand understanding of the individual, interpersonal, institutional, community, and policy factors influencing COVID-19 testing and vaccination within Spanish-speaking Latinx communities. In Aim 2, the study integrated findings from other relevant COVID-19 studies and from Aim 1 to refine a Spanish-language intervention known as Nuestra Salud Segura (Our Safe Health) designed to increase COVID-19 testing and vaccination among Spanish-speaking Latinx persons. Nuestra Salud Segura harnessed the complementary strengths of peer navigation and mHealth. The study also tested the intervention using a longitudinal group-randomized trial design assessing participants at: (1) baseline and (2) immediate post intervention. The study anticipated that participants in the intervention group, relative to their counterparts in the delayed-intervention group, would demonstrate increased COVID-19 testing and vaccination. In Aim 3, the study developed and disseminated practice, research, intervention, and policy priorities and recommendations to increase COVID-19 testing and vaccination, reduce COVID-19 disparities, and promote health equity in Spanish-speaking Latinx communities by conducting an empowerment theory-based community forum. This CBPR study advanced prevention science and practice through increased understanding of the SEBI of COVID-19 testing and vaccination and testing an innovative intervention to promote and support COVID-19 testing and vaccination among a particularly underserved and vulnerable population -Spanish-speaking Latinx communities in the United States.

Updated Date: 04/10/2024

Principal Investigator: Rhodes, Scott D

Has Data Files: Yes

Study Domain: Vaccination Rate/Uptake; Community Outreach Programs; Social Determinants of Health; Testing Rate/Uptake; Diagnostic Testing

Data Collection Method: Interview or Focus Group; Survey

Keywords: mHealth

Study Design: Interventional/Clinical Trial

Multi-Center Study: FALSE

Data Types: Behavioral; Questionnaires/Surveys; Psychological; Social; Cognitive

Study Start Date: 01/01/2022

Study End Date: 11/30/2023

Species: Human Data

Estimated Cohort Size: 290

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

ClinicalTrials.gov URL: https://clinicaltrials.gov/study/NCT05302908

Acknowledgement Statement: This study was supported through funding, 5U01MD017431-02, for the National Institute on Minority Health and Health Disparities (NIMHD) as part of the RADx-UP program. We thank the project team at Wake Forest University School of Medicine, the University of North Carolina Greensboro, and the Hispanic League; the North Carolina Community Research Partnership, a long-standing community-based research (CBPR) partnership with members throughout NC; and project participants who gave their time and insights and participants in this important project. Approved users should acknowledge the provision of data access by dbGaP for accession phs002946.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-21-009

NIH Grant or Contract Number(s): 5U01MD017431-02

Consent/Data Use Limitations: General Research Use