dbGaP Study Accession: phs003123

NIH Institute/Center: NIDA

RADx Data Program: RADx-UP

DOI: 10.60773/eg9v-8e46

Release Date: 08/29/2023

Updated Date: 04/17/2024

Study Description: Through the RADx-UP Phase I study, correlates of point-of-care COVID-19 testing (POCT) uptake at baseline and reuptake at a 3-month follow-up visit among WWUD (N=250) in Baltimore, MD were examined. In this Phase II, C2SPARC study, this study examined POCT uptake in both research and service delivery contexts. Specifically, the study proposed adding a 6-month visit (C2SPARC visit) among the CARE cohort in order to examine trends in POCT uptake over time. Secondly, in partnership with the SPARC Center, a leading harm reduction organization that serves WWUD, the study proposed designing and implementing POCT on their nighttime mobile outreach van that provides harm reduction supplies (e.g., condoms, naloxone, syringes), basic necessities (e.g., food, clothing), and trauma informed micro-counseling. C2SPARC leveraged long-term community partnerships (see letters of support), an existing Community Advisory Board (CAB), and a well-established research infrastructure. The study employed Andersen's Behavioral Model10 (Aim 1), PRISM (Practical, Robust, Implementation, and Sustainability Model)11 (Aim 2), and the Theoretical Framework of Acceptability (TFA)12 (Aim 3) to meet the following aims. 1. To examine predisposing (e.g., social - homelessness, food insecurity; individual - drug use, race/ ethnicity, health beliefs) and enabling (prior COVID-19 testing, vaccine uptake) factors that predict uptake of POCT over a six-month period in WWUD (N=250) in Baltimore, Maryland. 2. To collaborate with the SPARC Center to develop and implement POCT on their mobile outreach van that primarily serves WWUD in Baltimore City, Maryland. 3. To examine the feasibility (e.g., testing uptake) and acceptability (e.g., participant burden, testing self-efficacy) of mobile POCT among WWUD (N=250) who are clients of SPARC outreach. Through Aim 1, the study examined a range of predisposing (social and individual) and enabling factors that predict POCT uptake over a six-month period. By leveraging Phase I's existing cohort and data collection, the C2SPARC visit doubles the follow-up length, allowing for longitudinal data analysis. Predictors of POCT uptake are shaped by Andersen's Behavioral framework and informed by the extensive prior research with the study population. The C2SPARC visit leveraged the existing Phase I CARE research infrastructure, which is built on 15 years of community-engaged field research among WWUD and female sex workers (FSW) who use drugs. This additional data collection wave deepened the understanding of the drivers of COVID-19 testing uptake among this highly marginalized population in the context of a rapidly evolving testing and vaccine landscape. Through Aim 2, the study investigators partnered with the SPARC Center to develop, pilot, and implement a POCT service two nights per week on their outreach van (see Preliminary Studies). This implementation process was informed by Aim 1 findings and by formative qualitative data collection including key informant interviews with outreach staff (N=5) and systematic observations (N=6) of the SPARC outreach van, guided by the PRISM framework. Through Aim 3, the study investigators assessed the program feasibility (i.e., testing uptake) of POCT on SPARC outreach through analyzing SPARC outreach administrative data. The study employed the TFA framework to measure acceptability of COVID-19 testing via a brief anonymous survey administered to SPARC clients (N=250) when POCT is offered. C2SPARC was innovative in leveraging the Phase I cohort in examining drivers of POCT uptake longitudinally, which then informed the implementation of POCT on a highly subscribed mobile outreach van. Further, situating POCT in the context of existing relationships with trusted service providers was urgently needed. The study's impact and sustainability was further enhanced by the engagement of a seasoned CAB. C2SPARC was responsive to NOT-OD-21-103 in that it expanded the RADx-UP Phase I study to build enhanced point-of-care infrastructures that can be sustained beyond the current pandemic. Study results were quickly disseminated to the target population, service providers, and policy makers through products (i.e., fact sheets, manuscripts) and events (i.e., community forums) to inform community-based testing and eventual vaccination programs targeting WWUD and similarly marginalized populations.

Principal Investigator: Sherman, Susan G

Has Data Files: Yes

Study Domain: Mobile Unit Testing; Substance Use; Social Determinants of Health; Point-of-Care (POC) Testing; Testing Rate/Uptake; Rapid Diagnostic Test (RDT)

Data Collection Method: Antigen Testing Device; Survey; Interview or Focus Group

Keywords: Near Patient Testing; Marginalized Populations

Study Design: Longitudinal Cohort

Multi-Center Study: FALSE

Data Types: Social; Behavioral; Questionnaires/Surveys

Study Start Date: 09/15/2021

Study End Date: 08/31/2023

Species: Human Data

Estimated Cohort Size: 500

Study Population Focus: Adults; Older Adults or Elderly; Lower Socioeconomic Status (SES) Population; Underserved/Vulnerable Population

Acknowledgement Statement: This study was supported through funding, 3R01DA041243-05S4, for the National Institute on Drug Abuse (NIDA) as part of the RADx-UP program. Dr. Sherman is supported by an endowment from the Bloomberg American Health Initiative. We would like to thank CARE study participants who trusted us with their stories and experiences. Approved users should acknowledge the provision of data access by dbGaP for accession phs003123.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: PA-12-281

NIH Grant or Contract Number(s): 3R01DA041243-05S4

Consent/Data Use Limitations: General Research Use