dbGaP Study Accession: phs002872

NIH Institute/Center: NCI

RADx Data Program: RADx-UP

Release Date: 08/30/2023

DOI: 10.60773/02m0-qe56

Updated Date: 04/17/2024

Study Description: This competitive revision submitted to the RADx-UP Initiative (NOT-20-121) aimed to extend the infrastructure of P50 Implementation Science Center for Cancer Control Equity (ISCCCE) to accelerate COVID testing in 9 hotspot communities in MA. ISCCCE is a strong partnership with the Massachusetts League of Community Health Centers, in which the team co-designed studies to increase implementation of evidence-based practices focused on equity. Together, this study was extremely well-positioned to extend the community-engaged efforts to COVID-19 testing, and to build an infrastructure that would support future COVID-related mitigation and prevention efforts in the vulnerable communities that the community health centers (CHCs) serve. This project included 6 community health center- community partnerships in nine vulnerable communities that continue to be COVID hot spots. These communities collectively had 1.3 million residents. Partner CHCs focused on COVID-19 testing for diagnostic purposes in symptomatic individuals, with limited outreach testing in high-risk communities. This project expanded the scope of testing to include prospective surveillance activities using dedicated testing and outreach teams. Accelerated testing efforts focused on CHC patients and community members who had significant social and medical vulnerabilities to COVID, per the NOSI, including those living in congregate housing, people experiencing homelessness, those with substance use disorders, low wage essential workers, and those with limited English proficiency. The partnership was well-integrated into the State's testing and contact tracing strategy, and well-positioned to leverage those resources. The study drew on a strongly community-engaged, equity-focused approach to implementation, and on Mass League's extensive experience in HIV testing and contact tracing. This study used an interrupted time series design to evaluate the impact of the enhanced outreach efforts on testing rates overall and on priority populations in the context of different phases of re-opening and restrictions. This study also used an exploratory sequential mixed methods approach to conduct a series of community-engaged pilot studies to address key barriers to testing and different approaches to return of results. The Human Participant Research Unit, co-led by academic and community-based investigators, guided the partnership's work through an ethics and equity lens. The study supported the CHC-community partnerships through the Testing Capacity and Innovation Team, which provided infectious disease expertise and technical guidance on COVID testing. The Community Communications Team used educational and communication design strategies to develop culturally and linguistically appropriate materials to support the testing activities.

Principal Investigator: Emmons, Karen M

Has Data Files: Yes

Study Domain: COVID Hotspots; Testing Rate/Uptake; Diagnostic Testing; Community Outreach Programs; Substance Use

Data Collection Method: Survey; Contact Tracing

Keywords: Diagnostic Testing; Individual-Level Data; Congregate Settings; COVID Hotspot Communities; Limited English Proficiency Populations

Study Design: Longitudinal Cohort

Multi-Center Study: FALSE

Data Types: Clinical; Questionnaires/Surveys; Behavioral; Electronic Medical Records

Study Start Date: 09/01/2020

Study End Date: 08/31/2022

Species: Human Data

Estimated Cohort Size: 125000

Study Population Focus: Underserved/Vulnerable Population; Older Adults or Elderly; Adults; Racial and Ethnic Minorities; Children; Essential Workers; Homeless/Unhoused; Lower Socioeconomic Status (SES) Population

ClinicalTrials.gov URL: https://clinicaltrials.gov/study/NCT04802187

Publication URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8987278/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9558183/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9404072/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9076025/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8987278/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8525052/; https://pubmed.ncbi.nlm.nih.gov/36404728/

Acknowledgement Statement: This study was supported through funding, 5P50CA244433-04, for the National Cancer Institute (NCI) as part of the RADx-UP program. This data was collected as part of a partnership between the Implementation Science Center for Cancer Control Equity, the Massachusetts League of Community Health Centers, and participating community health centers. Approved users should acknowledge the provision of data access by dbGaP for accession phs002872.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-CA-19-006

NIH Grant or Contract Number(s): 5P50CA244433-04

Consent/Data Use Limitations: General Research Use