U01AI169469

COVID-19 Treatment Cascade Optimization Study - Project Summary

COVID-19 has impacted the health and social fabric of individuals and families living across the United States. It has disproportionately affected people living in urban communities with co-morbidities, those working in high-risk settings, refusing or unable to adhere to CDC guidelines, and more. Social determinants of health (SDH), such as stigma, racial discrimination, xenophobia, incarceration, and poverty, have been associated with increased exposure to COVID-19 and increased deaths.

Marginalized communities, defined as low-income and racial/ethnic minority neighborhoods, where residents experience increased barriers (e.g., inadequate housing, high-risk jobs) to prevention and treatment, bear disproportionately higher rates of co-morbidities associated with more severe cases of COVID-19.

While effective and potent vaccines are becoming more available, it will take time to reach herd immunity, and it is unclear how long newly-developed vaccines provide protection and how effective they are against emerging variants. Therefore, prevention methods recommended by the Centers for Disease Control (CDC) – i.e., testing, hand-washing, social distancing, contact tracing, vaccination, and quarantine – are essential to reduce the rates of COVID-19 in marginalized communities.

Research about COVID-19 testing and vaccine uptake in these communities must occur in real time and must account for the fast-changing landscape of the pandemic, including the impact of vaccine availability on testing uptake.

Two cost-effective, evidence-based, and culturally appropriate interventions have been effective in engaging people in HIV prevention and treatment. These can be adapted and tested to help address COVID-19 prevention needs. Specifically, navigation services (NS) have shown to increase HIV testing and adherence to treatment while addressing structural barriers that deter treatment engagement in high-risk communities. Brief counseling (BC) has shown to increase HIV treatment engagement.

This study uses a sequential, multiple assignment randomized trial (SMART) with 1,218 COVID-19 medically/socially vulnerable people. Guided by the COVID-19 Continuum of Prevention, Care, and Treatment, analysis will explore factors associated with testing and adherence to CDC COVID-19 prevention and treatment recommendations.

The study aims include:

1. To examine the effectiveness of an adaptive intervention to increase COVID-19 testing and adherence to CDC recommendations of preventive behaviors – social distancing, hand-washing, inoculation, mask-wearing, vaccination – on comparable but distinct samples. We will control for baseline, time, demographics, and COVID risk.

2. To examine the immediate and medium-term impact of the adaptive intervention on COVID testing and adherence to recommendations by collecting follow-up data at 2, 5, 12, and 24 weeks post baseline.

Implementation aim: To collect intervention implementation data (context, cost, barriers, lessons learned) and develop implementation materials (facilitator training, intervention manual, treatment fidelity measure).

This study has...

University Of Illinois

TO ASSIST PUBLIC AND PRIVATE NONPROFIT INSTITUTIONS AND INDIVIDUALS TO ESTABLISH, EXPAND AND IMPROVE BIOMEDICAL RESEARCH AND RESEARCH TRAINING IN INFECTIOUS DISEASES AND RELATED AREAS, TO CONDUCT DEVELOPMENTAL RESEARCH, TO PRODUCE AND TEST RESEARCH MATERIALS. TO ASSIST PUBLIC, PRIVATE AND COMMERCIAL INSTITUTIONS TO CONDUCT DEVELOPMENTAL RESEARCH, TO PRODUCE AND TEST RESEARCH MATERIALS, TO PROVIDE RESEARCH SERVICES AS REQUIRED BY THE AGENCY FOR PROGRAMS IN INFECTIOUS DISEASES, AND CONTROLLING DISEASE CAUSED BY INFECTIOUS OR PARASITIC AGENTS, ALLERGIC AND IMMUNOLOGIC DISEASES AND RELATED AREAS. PROJECTS RANGE FROM STUDIES OF MICROBIAL PHYSIOLOGY AND ANTIGENIC STRUCTURE TO COLLABORATIVE TRIALS OF EXPERIMENTAL DRUGS AND VACCINES, MECHANISMS OF RESISTANCE TO ANTIBIOTICS AS WELL AS RESEARCH DEALING WITH EPIDEMIOLOGICAL OBSERVATIONS IN HOSPITALIZED PATIENTS OR COMMUNITY POPULATIONS AND PROGRESS IN ALLERGIC AND IMMUNOLOGIC DISEASES. BECAUSE OF THIS DUAL FOCUS, THE PROGRAM ENCOMPASSES BOTH BASIC RESEARCH AND CLINICAL RESEARCH. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM EXPANDS AND IMPROVES PRIVATE SECTOR PARTICIPATION IN BIOMEDICAL RESEARCH. THE SBIR PROGRAM INTENDS TO INCREASE AND FACILITATE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM STIMULATES AND FOSTERS SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. RESEARCH CAREER DEVELOPMENT AWARDS SUPPORT THE DEVELOPMENT OF SCIENTISTS DURING THE FORMATIVE STAGES OF THEIR CAREERS. INDIVIDUAL NATIONAL RESEARCH SERVICE AWARDS (NRSAS) ARE MADE DIRECTLY TO APPROVE APPLICANTS FOR RESEARCH TRAINING IN SPECIFIED BIOMEDICAL SHORTAGE AREAS. IN ADDITION, INSTITUTIONAL NATIONAL RESEARCH SERVICE AWARDS ARE MADE TO ENABLE INSTITUTIONS TO SELECT AND MAKE AWARDS TO INDIVIDUALS TO RECEIVE TRAINING UNDER THE AEGIS OF THEIR INSTITUTIONAL PROGRAM.

93.360 - Biomedical Advanced Research and Development Authority (BARDA), Biodefense Medical Countermeasure Development

National Institute of Allergy and Infectious Diseases (NIAID) [HHS - NIH]

Illinois United States

State-Wide

Emergency Awards: Community-engaged COVID-19 Testing Interventions among Underserved and Vulnerable Populations RADx-UP Phase II (U01 Clinical Trial Optional) (RFA-OD-21-008)

COVID-19 $1,567,331 (100%) percent of this Cooperative Agreement was funded by COVID-19 emergency acts including the American Rescue Plan Act of 2021.
Amendment Since initial award the total obligations have increased 61% from $975,705 to $1,567,331.