Ending Transmission of HIV, HCV, and STDs and Overdose in Rural Communities of People Who Inject Drugs (ETHIC) (ETHIC)

This study will evaluate the referral to harm reduction services (HRS) including syringe services, naloxone overdose prevention, substance use treatment referral, HIV, HCV, and STD testing and referral and linkage to care through capacity building of existing programs through client services data.

Study Overview

• Status: Completed
• Conditions: Hepatitis C; HIV; Opioid-use Disorder; Injection Drug Use
• Intervention / Treatment: Behavioral: Referral to harm reduction services

Detailed Description

This is a prospective longitudinal Type 1 Hybrid Implementation Effectiveness Study on the expansion of harm reduction services for people who inject drugs (PWID) and people who use opioids (PWUO) residing in high risk areas of rural southern Illinois. This study record describes one component of the larger Ending transmission of HIV, HCV, and STDs and overdose in rural communities of people who inject drugs (ETHIC) study Community Response Plan (CRP) framework, specifically the expansion of harm reduction services intervention (HRS). The aim is to assess the effectiveness of expansion of evidenced based harm reduction services through our CRP framework comprising: a) geographically targeted recruitment based on hot spot and vulnerability analyses, b) community engagement, c) recruitment via Respondent Driven Sampling (RDS), d) expanded surveillance for HIV and HCV, and e) concomitant HCV and opioid use treatment capacity expansion through the Extension of Community Healthcare Outcomes (ECHO) model. Examination of facilitators and barriers impacting implementation of service delivery is evaluated through mixed methods process evaluation. The Type 1 Hybrid design is supported by conditions including the existing evidence based for benefits and minimal harm of "harm reduction services" and strong base for applicability of this intervention in the study setting (ie rural opioid use)

• Study Type: Interventional
• Enrollment (Actual): 306
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Carbondale, Illinois, United States, 62901
      • Southern Illinois University
    • Murphysboro, Illinois, United States, 62966
      • The Community Action Place, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 15 years of age and older
• Injected any drug in the past 30 days
• Used any opioids non-medically in the past 30 days
• English speaking
• Able to provide informed consent at the time of the study visit

Exclusion Criteria:

• Less than 15 years of age
• Not injected any drug in the past 30 days
• Not used any opioids non-medically in past 30 days
• Non-English speaking
• Has not injected any opioid drug to get high in the past 30 days
• Unable to provide informed consent at the time of the study visit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Referral to harm reduction services; Participants will be taken through the study survey and interview, blood and urine toxicology testing and given a referral to a harm reduction organization.	Behavioral: Referral to harm reduction services; Participants are referred to harm reduction services

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Participants Who Received Referrals to the Harm Reduction Services Organization	Number of participants who accept referral to the intervention (divided by the total enrolled who did not have previous engagement prior to the study with the harm reduction services organization).	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Locations Where Participants Received Most of Syringes or Needles	Number of unique zip codes that participants received most of their syringes or needles based on mobile unit delivery.	2 years
Number of Times Sterile Syringes and/or Equipment Obtained From an Intervention	This was counted as the number of visits made by the hard reduction service organization to distribute sterile syringes and/or equipment.	2 years
Number of Times Participants Used a Syringe or Needle That They Knew Was Used by Somebody Else	"How many times (encounters) in the past 30 days did you inject using a syringe or needle that you know had been used by somebody else?"	2 years
Number of Times Participants Used a Cotton, Cooker, Spoon, or Water for Rinsing or Mixing That They Knew Was Used by Somebody Else	"How many times (encounters) in the past 30 days did you use a cotton, cooker, spoon or water for rinsing or mixing that you know had been used by somebody else?"	2 years
Number of Times Participants Let Someone Else Use a Cotton, Cooker, Spoon, or Water for Rinsing or Mixing After They Used it	"How many times (encounters) in the past 30 days did you let someone else use a cotton, cooker, spoon, or water for rinsing or mixing after you used it?"	2 years
Number of Participants With Drive Time Less Than 30 Minutes to Nearest Syringe or Needle Exchange	Number of participants with drive time less than 30 minutes to nearest syringe or needle exchange.	2 years
Number of Participants That Currently Have Naloxone	"Do you currently have naloxone or Narcan with you or at home?"	2 years
Number of Participants Who Received Substance Use Disorders (SUD) Treatment Referrals	Total number of participants who received a substance use disorder referrals made by the hard reduction services organization.	2 years
Total Number of Participants Who Received an HIV Screening	Total number of tests that participants screened for HIV, from baseline to follow-up.	2 years
Total Number of Participants Who Received an HCV Screening	Total participants screened for HCV at least once during baseline and follow-up. For those who had a HCV reactive test were then later referred to further services.	2 years
Number of Participants With Knowledge of PrEP	"Have you ever heard of medicine people can take to prevent HIV?"	6 months
Number of Participants Diagnosed With HIV Who Have Access to HIV Care	Total number of participants who were newly diagnosed with HIV during the study period.	2 years
Number of Participants Diagnosed With HCV Who Have Access to HCV Care	Total number of participants who were newly diagnosed with chronic Hep C who were referred to Hep C care.	2 years
Number of Times a Participant Engaged in Condomless Sex (Vaginal or Anal)	"In the last 30 days, how many times did you have vaginal or anal sex without a condom?"	6 months

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: National Institute on Drug Abuse (NIDA); New York University; University of Illinois at Chicago; University of Washington; Southern Illinois University; The Community Action Place, Inc.
• Investigators: Principal Investigator: Mai Pho, PhD, University of Chicago

Publications and helpful links

General Publications

• Rains A, York M, Bolinski R, Ezell J, Ouellet LJ, Jenkins WD, Pho MT. Attitudes toward harm reduction and low-threshold healthcare during the COVID-19 pandemic: qualitative interviews with people who use drugs in rural southern Illinois. Harm Reduct J. 2022 Nov 19;19(1):128. doi: 10.1186/s12954-022-00710-9.
• Walters SM, Bolinski RS, Almirol E, Grundy S, Fletcher S, Schneider J, Friedman SR, Ouellet LJ, Ompad DC, Jenkins W, Pho MT. Structural and community changes during COVID-19 and their effects on overdose precursors among rural people who use drugs: a mixed-methods analysis. Addict Sci Clin Pract. 2022 Apr 25;17(1):24. doi: 10.1186/s13722-022-00303-8.

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2020
• Primary Completion (Actual): August 16, 2023
• Study Completion (Actual): August 16, 2023

Study Registration Dates

• First Submitted: June 8, 2020
• First Submitted That Met QC Criteria: June 8, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: HIV; Hepatitis C; Opioid-use Disorder; Injection Drug Use; Harm Reduction Services
• Additional Relevant MeSH Terms: Blood-Borne Infections; Narcotic-Related Disorders; Mental Disorders; Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Flaviviridae Infections; Hepatitis; Opioid-Related Disorders; Hepatitis C
• Other Study ID Numbers: IRB17-1630; 4UH3DA044829-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The ETHIC study is participating site of the Rural Opioid Initiative (ROI), a collaborative funded by NIDA. The ROI includes a Data Coordinating Center (DCC) housed at the University of Washington. The University of Chicago will submit de-identified data from the study to the DCC as covered under a data use agreement for the purposes of performing cross-site analyses using a harmonized data set. No parties outside of the ROI will have access to the combined dataset. All project proposals will be subject to approval by the ROI. The data will be available after encrypted submission to the DCC and will remain for the duration in accordance to the data use agreement.
• IPD Sharing Time Frame: Data will be available at the DCC for the time frame indicated in the data use agreement.
• IPD Sharing Access Criteria: Data will be shared among researchers in the Rural Opioid Initiative (ROI) cooperative agreement as described above
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No