Ending Transmission of HIV, HCV, and STDs and Overdose in Rural Communities of People Who Inject Drugs (ETHIC) (ETHIC)
Primary Purpose
HIV, Hepatitis C, Opioid-use Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Referral to harm reduction services
Sponsored by
About this trial
This is an interventional health services research trial for HIV focused on measuring HIV, Hepatitis C, Opioid-use Disorder, Injection Drug Use, Harm Reduction Services
Eligibility Criteria
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
Sites / Locations
- Southern Illinois University
- The Community Action Place, Inc.
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Referral to harm reduction services
Arm Description
Participants will be taken through the study survey and interview, blood and urine toxicology testing and given a referral to a harm reduction organization.
Outcomes
Primary Outcome Measures
Referrals to the harm reduction organization
Number of participants who accept referral to the intervention (divided by the total enrolled)
Secondary Outcome Measures
Number of locations where participants received most of syringes or needles
Number of times clean syringes and/or equipment obtained from an intervention
Number of times participants used a syringe or needle that they knew was used by somebody else
Number of times participants used a cotton, cooker, spoon, or water for rinsing or mixing that they knew was used by somebody else
Number of times participants let someone else use a cotton, cooker, spoon, or water for rinsing or mixing after they used it
Amount of time to travel to the nearest syringe or needle exchange
Number of participants that currently have naloxone
Number of substance use disorders (SUD) treatment referrals made
Number of HIV screenings and referrals
Number of HCV screenings and referrals
Number of participants with knowledge of PrEP
Number of participants diagnosed with HIV who have access to HIV care
Number of participants diagnosed with HCV who have access to HCV care
Number of participants who have condomless sex (vaginal or anal)
Full Information
NCT ID
NCT04427202
First Posted
June 8, 2020
Last Updated
August 18, 2023
Sponsor
University of Chicago
Collaborators
Southern Illinois University, The Community Action Place, Inc., New York University, University of Illinois at Chicago, University of Washington, National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT04427202
Brief Title
Ending Transmission of HIV, HCV, and STDs and Overdose in Rural Communities of People Who Inject Drugs (ETHIC)
Acronym
ETHIC
Official Title
Ending Transmission of HIV, HCV, and STDs and Overdose in Rural Communities of People Who Inject Drugs (ETHIC)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 14, 2020 (Actual)
Primary Completion Date
August 16, 2023 (Actual)
Study Completion Date
August 16, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
Southern Illinois University, The Community Action Place, Inc., New York University, University of Illinois at Chicago, University of Washington, National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Hepatitis C, Opioid-use Disorder, Injection Drug Use
Keywords
HIV, Hepatitis C, Opioid-use Disorder, Injection Drug Use, Harm Reduction Services
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
309 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Referral to harm reduction services
Arm Type
Other
Arm Description
Participants will be taken through the study survey and interview, blood and urine toxicology testing and given a referral to a harm reduction organization.
Intervention Type
Behavioral
Intervention Name(s)
Referral to harm reduction services
Intervention Description
Participants are referred to harm reduction services
Primary Outcome Measure Information:
Title
Referrals to the harm reduction organization
Description
Number of participants who accept referral to the intervention (divided by the total enrolled)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Number of locations where participants received most of syringes or needles
Time Frame
2 years
Title
Number of times clean syringes and/or equipment obtained from an intervention
Time Frame
2 years
Title
Number of times participants used a syringe or needle that they knew was used by somebody else
Time Frame
2 years
Title
Number of times participants used a cotton, cooker, spoon, or water for rinsing or mixing that they knew was used by somebody else
Time Frame
2 years
Title
Number of times participants let someone else use a cotton, cooker, spoon, or water for rinsing or mixing after they used it
Time Frame
2 years
Title
Amount of time to travel to the nearest syringe or needle exchange
Time Frame
2 years
Title
Number of participants that currently have naloxone
Time Frame
2 years
Title
Number of substance use disorders (SUD) treatment referrals made
Time Frame
2 years
Title
Number of HIV screenings and referrals
Time Frame
2 years
Title
Number of HCV screenings and referrals
Time Frame
2 years
Title
Number of participants with knowledge of PrEP
Time Frame
2 years
Title
Number of participants diagnosed with HIV who have access to HIV care
Time Frame
2 years
Title
Number of participants diagnosed with HCV who have access to HCV care
Time Frame
2 years
Title
Number of participants who have condomless sex (vaginal or anal)
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mai Pho, PhD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern Illinois University
City
Carbondale
State/Province
Illinois
ZIP/Postal Code
62901
Country
United States
Facility Name
The Community Action Place, Inc.
City
Murphysboro
State/Province
Illinois
ZIP/Postal Code
62966
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
36403075
Citation
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.
Results Reference
derived
PubMed Identifier
35468860
Citation
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.
Results Reference
derived
Learn more about this trial
Ending Transmission of HIV, HCV, and STDs and Overdose in Rural Communities of People Who Inject Drugs (ETHIC)
We'll reach out to this number within 24 hrs