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

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ClinicalTrials.gov Identifier: NCT04427202
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : June 21, 2021
Sponsor:
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)
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
HIV Hepatitis C Opioid-use Disorder Injection Drug Use Behavioral: Referral to harm reduction services Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Ending Transmission of HIV, HCV, and STDs and Overdose in Rural Communities of People Who Inject Drugs (ETHIC)
Actual Study Start Date : August 14, 2020
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Referrals to the harm reduction organization [ Time Frame: 2 years ]
    Number of participants who accept referral to the intervention (divided by the total enrolled)


Secondary Outcome Measures :
  1. Number of locations where participants received most of syringes or needles [ Time Frame: 2 years ]
  2. Number of times clean syringes and/or equipment obtained from an intervention [ Time Frame: 2 years ]
  3. Number of times participants used a syringe or needle that they knew was used by somebody else [ Time Frame: 2 years ]
  4. 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 ]
  5. 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 ]
  6. Amount of time to travel to the nearest syringe or needle exchange [ Time Frame: 2 years ]
  7. Number of participants that currently have naloxone [ Time Frame: 2 years ]
  8. Number of substance use disorders (SUD) treatment referrals made [ Time Frame: 2 years ]
  9. Number of HIV screenings and referrals [ Time Frame: 2 years ]
  10. Number of HCV screenings and referrals [ Time Frame: 2 years ]
  11. Number of participants with knowledge of PrEP [ Time Frame: 2 years ]
  12. Number of participants diagnosed with HIV who have access to HIV care [ Time Frame: 2 years ]
  13. Number of participants diagnosed with HCV who have access to HCV care [ Time Frame: 2 years ]
  14. Number of participants who have condomless sex (vaginal or anal) [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04427202


Contacts
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Contact: Mai Pho, MD 773-834-3689 mpho@bsd.uchicago.edu
Contact: Christian Johnson cjohnson5@medicine.bsd.uchicago.edu

Locations
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United States, Illinois
Southern Illinois University Recruiting
Carbondale, Illinois, United States, 62901
The Community Action Place, Inc. Recruiting
Murphysboro, Illinois, United States, 62966
Sponsors and Collaborators
University of Chicago
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)
Investigators
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Principal Investigator: Mai Pho, PhD University of Chicago
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT04427202    
Other Study ID Numbers: IRB17-1630
4UH3DA044829-03 ( U.S. NIH Grant/Contract )
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: June 21, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: Data will be available at the DCC for the time frame indicated in the data use agreement.
Access Criteria: Data will be shared among researchers in the Rural Opioid Initiative (ROI) cooperative agreement as described above

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Chicago:
HIV
Hepatitis C
Opioid-use Disorder
Injection Drug Use
Harm Reduction Services
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis
Opioid-Related Disorders
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders