dbGaP Study Accession: phs002948

NIH Institute/Center: NIDA

RADx Data Program: RADx-UP

Release Date: 08/29/2023

DOI: 10.60773/83zk-vv89

Study Description: People who inject drugs (PWIDs) are highly vulnerable to contracting SARS-CoV-2 and to the effects of the disease caused by SARS-CoV-2, coronavirus disease 2019 (COVID-19). PWIDs experience underlying medical conditions and unstable housing that put them at increased risk for COVID-19 morbidity and mortality. PWIDs also experience barriers such as a history of stigmatization and discrimination by health care systems and exposure to misinformation that reduces access to health care services, such as SARS-CoV-2 testing and vaccination. This project built on the Phase I Rapid Acceleration of Diagnostics project (#67; PI: Stormshak) that successfully embedded SARS-CoV-2 testing into syringe exchange programs (SEPs) across the state of Oregon, in collaboration with HIV Alliance (HIVA). The testing program's success was linked to a contingency management (CM) intervention that increased the rates of testing utilization from 4% to 24% (d = 1.36), even as nationwide testing utilization was decreasing. The first aim of the project was to test the sustained effectiveness of CM on testing outcomes, given the current context of increasing COVID-19 vaccine accessibility. Testing remains critical to prevent the transmission of SARS-CoV-2 among PWIDs who continue to be at high exposure risk, and for whom vaccine hesitancy is high. The study also leveraged the partnership with HIVA to establish a COVID-19 vaccine program at HIVA's SEPs. The second aim was to conduct a randomized control trial (RCT) to examine whether a brief motivational enhancement (ME) intervention (i.e., Connect2Test) augments the effects of CM on SARS-CoV-2 testing and vaccination uptake. The Phase I study demonstrated that CM improves SARS-CoV-2 testing utilization. CM is also known to increase immunization rates against other infectious diseases, such as Hepatitis B. Additionally, consistent with research showing that ME enhances the effects of CM on health behavior outcomes, the study anticipated that Connect2Test will augment CM's effects on testing and vaccination among PWIDs. Moreover, because ME elicits and strengthens motivation for long-term behavior change, whereas CM prompts immediate and short-term behavior change, the study anticipated that CM + ME, versus CM alone, will have long-term effects on SARS-CoV-2 testing, evidenced by participation in repeated testing over time. The third aim of the proposed project was to assess CM and Connect2Test implementation, including a cost-effectiveness analysis of CM alone versus CM plus Connect2Test, to improve long-term sustainability of testing, vaccination, and intervention approaches to mitigate the spread of SARS-CoV-2.

Updated Date: 04/17/2024

Principal Investigator: Mauricio, Anne Marie

Has Data Files: Yes

Study Domain: Testing Rate/Uptake; Social Determinants of Health; Vaccination Rate/Uptake; Diagnostic Testing; Community Outreach Programs; Substance Use

Data Collection Method: Survey; Interview or Focus Group

Keywords: Contigency Manangement; Motivational Enhancement

Study Design: Case-Control

Multi-Center Study: FALSE

Data Types: Questionnaires/Surveys; Other; Social; Behavioral

Data Types, Other: Interviews with staff and clients, COVID-19 testing results

Study Start Date: 01/15/2022

Study End Date: 12/31/2022

Species: Human Data

Estimated Cohort Size: 7000

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

ClinicalTrials.gov URL: https://clinicaltrials.gov/study/NCT05534061

Acknowledgement Statement: This study was supported through funding, 1U01DA055982-01, for the National Institute on Drug Abuse (NIDA) as part of the RADx-UP program. We would like to acknowledge project staff Anne Marie Mauricio, Camille Cioffi, Jeff Gau, Llewellyn Fernandes, Larisa Lilles, Hannah Tavalire, Brooke Thompson, Renne Yandel, Amanda McCluskey, and additional HIV Alliance staff and participants. This work would not have been possible without their time and valuable contributions. Approved users should acknowledge the provision of data access by dbGaP for accession phs002948.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): 1U01DA055982-01

Consent/Data Use Limitations: General Research Use