dbGaP Study Accession: phs002799

NIH Institute/Center: NIDA

RADx Data Program: RADx-UP

Release Date: 08/30/2023

DOI: 10.60773/ywfr-4e53

Updated Date: 04/17/2024

Study Description: Until the advent of treatment or a vaccine, the ability to contain COVID-19 relied on widespread identification of (asymptomatic) positive cases, their subsequent quarantine, and contact tracing of those potentially exposed. Therefore testing efforts must be targeted to those highly vulnerable yet unserved populations, including individuals who use opioids and other substances. These individuals may have had poor respiratory or pulmonary health due to substance use (e.g. opioids, methamphetamine), which may have made them more susceptible to the virus. Also, these individuals were also more likely to have been incarcerated, or reside on the street, in shelters or in crowded accommodation, further placing them at risk for transmission. This study proposed research to establish efficacy and sustainability of a community-social network outreach model that partnered infectious disease health providers with community based organizations to successfully implement (reach, uptake, delivery and sustainment) COVID-19 point of service, rapid-testing among a highly vulnerable and often underserved population, those who use opioids and other substances. Two distinct social network recruitment strategies with demonstrated efficacy identifying hidden populations and increasing uptake of HIV testing will be adapted and compared. Guided by the EPIS framework, social cognitive theory, and Andersen's model, this study comprised three phases. Phase 1: Adaptation of outreach recruitment strategies, worked with the project community advisory board (CAB) to adapt chain-referral and credible messenger strategies for uptake of COVID-19 testing, to finalize recruitment and on-site testing protocols, and to train the CAB in the new protocols and in continuous quality improvement strategies (Aim 1). Phase 2: Strategy Efficacy Trial and Implementation Evaluation, compared the two strategies in a cross-over design at two community based organizations (CBOs) with longstanding history of serving hard-to-reach populations in their communities. The comparison of strategies was not to identify the statistical superiority of one sampling strategy in providing population estimates over the other, but instead to identify the ability of each recruitment strategy to reach the target population and increase uptake of COVID-19 tests. This study examined the impact of each strategy on (i) reach (recruitment of target population), (ii) COVID-19 testing/repeat testing, and (iii) service delivery (i.e. quarantine, medical care and contact tracing) among those who test positive for COVID-19 (exploratory) (Aim 2). Phase 3: Sustainment, CBOs implemented the strategy proven efficacious based on outcomes, and this study examined their sustainment of the program (Aim 3). Implementation evaluation identified participant-, staff-, and organizational-level factors that influence the feasibility, acceptability, and sustainability of each strategy in these CBOs. (Aim 4). This investigation provided much needed information to improve health outcomes and to identify effective system-level responses to prevent or arrest the spread of COVID-19 among the social networks of those who use opioids and other substances, a highly vulnerable and often overlooked population.

Principal Investigator: Elkington, Katherine S

Has Data Files: Yes

Study Domain: Rapid Diagnostic Test (RDT); Comorbidities; Substance Use; Community Outreach Programs; Social Determinants of Health; Testing Rate/Uptake

Data Collection Method: Antigen Testing Device; Survey; Interview or Focus Group; Molecular (Nucleic Acid/PCR) Testing Device

Keywords: In-person Testing; Pulmonary Issues; Respiratory Issues; Opioid Users

Study Design: Longitudinal Cohort

Multi-Center Study: FALSE

Data Types: Questionnaires/Surveys; Social; Behavioral

Study Start Date: 11/01/2020

Study End Date: 10/31/2022

Species: Human Data

Estimated Cohort Size: 500

Study Population Focus: Incarcerated/Institutionalized (or Criminal Legal System Involvement); Lower Socioeconomic Status (SES) Population; Homeless/Unhoused; Underserved/Vulnerable Population; African American; Hispanic and Latino; Adults; Older Adults or Elderly

ClinicalTrials.gov URL: https://clinicaltrials.gov/study/NCT04873401

Acknowledgement Statement: This study was supported through funding, 3UG1DA050071-04S1, for the National Institute on Drug Abuse (NIDA) as part of the RADx-UP program. We'd like to acknowledge Alwyn Cohall, MD, Renee Cohall, LCSW-R, Katherine Elkington, Ph.D., Peter Gordon, MD, Corianna E. Sichel, Ph.D., Patrick Wilson, Ph.D., Daniel Winetsky, MD, MS, Maya Holcomb, Jiaxin Santos, Stephanie Campos, Fairy Martin, Perla Romero, Sharen Duke, Dan Lowy, George Beckham, Rudy Sabio, Sixta Council, Howard Thomas, Sarah Morris, Anna Mena, Juan Fuentes. Approved users should acknowledge the provision of data access by dbGaP for accession phs002799.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-DA-19-025

NIH Grant or Contract Number(s): 3UG1DA050071-04S1

Consent/Data Use Limitations: General Research Use