dbGaP Study Accession: phs002634

NIH Institute/Center: NIAID; NIMHD

RADx Data Program: RADx-UP

DOI: 10.60773/ad5b-vx98

Release Date: 08/31/2023

Updated Date: 04/17/2024

Study Description: This study tested an adaptation of the HIV Continuum of Prevention, Care, and Treatment Framework (CoPCT) for use in tracking COVID-19 testing and follow-up in a medically and socially vulnerable population. Utilizing the integrated research collaborative framework that facilitates dialogue among researchers, community members, and service providers as a tool for optimizing the adaptive intervention, this study took place at the North Jersey Community Research Initiative (NJCRI). The Multiphase Optimization Strategy (MOST) was used to optimize an adaptive intervention that successfully navigates COVID-19 medically or socially vulnerable people through a continuum of prevention, care and treatment (CoPCT) modeled on the HIV CoPCT. The COVID-19 CoPCT starts with testing and continues with successful adherence to prevention or treatment guidelines to help prevent and/or treat COVID-19. The study assessed the effectiveness of Navigation Services compared to referrals in increasing COVID-19 testing and Brief Counseling in increasing adherence to the State of NJ recommendations for COVID-19 prevention and treatment. The effect of Critical Dialogue on testing behavior among people who decline to be tested for COVID-19 was also examined. The investigators developed decision rules about what evidence-based-interventions work best for what types of people (e.g., those who test right away, versus decliners) and in what period of the COVID-19 continuum. This study shed light on factors associated with testing and adherence to NJ recommendations. Investigators followed Community Based Participatory Research principles in implementing a sequential, multiple assignment randomized trial (SMART) design.

Principal Investigator: Windsor, Liliane Cambraia

Has Data Files: Yes

Study Domain: Virological Testing; Testing Rate/Uptake; Health Behaviors

Data Collection Method: Survey; Interview or Focus Group

Keywords: Questionnaires/Surveys

Study Design: Interventional/Clinical Trial

Multi-Center Study: TRUE

Study Sites: University of Illinois Urbana Champaign; North Jersey Community Research Initiative; University of Michigan

Data Types: Clinical; Questionnaires/Surveys; Psychological; Social; Supporting Documents; Cognitive; Behavioral; Family History

Study Start Date: 01/12/2022

Study End Date: 12/31/2023

Species: Human Data

Estimated Cohort Size: 670

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

ClinicalTrials.gov URL: https://clinicaltrials.gov/study/NCT04757298

Publication URL: https://pubmed.ncbi.nlm.nih.gov/35421999/

Acknowledgement Statement: This study was supported through funding, 3R01MD010629-04S2 and 5U01AI169469-02, from the National Institute on Minority Health and Health Disparities (NIMHD) and the National Institute of Allergy and Infectious Diseases (NIAID) as part of the RADx-UP program. The research team thanks the participants and community members who have contributed to the development, implementation, analyses, and evaluation of this study. Approved users should acknowledge the provision of data access by dbGaP for accession phs002634.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-21-008

NIH Grant or Contract Number(s): 3R01MD010629-04S2; 5U01AI169469-02

Consent/Data Use Limitations: General Research Use