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

NCT ID: NCT04427202

Last Updated: 2024-12-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-14

Study Completion Date

2023-08-16

Brief Summary

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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

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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)

Conditions

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HIV Hepatitis C Opioid-use Disorder Injection Drug Use

Keywords

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HIV Hepatitis C Opioid-use Disorder Injection Drug Use Harm Reduction Services

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Referral to harm reduction services

Intervention Type BEHAVIORAL

Participants are referred to harm reduction services

Interventions

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Referral to harm reduction services

Participants are referred to harm reduction services

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southern Illinois University

OTHER

Sponsor Role collaborator

Community Action Place, Inc.

OTHER

Sponsor Role collaborator

New York University

OTHER

Sponsor Role collaborator

University of Illinois at Chicago

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mai Pho, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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Southern Illinois University

Carbondale, Illinois, United States

Site Status

The Community Action Place, Inc.

Murphysboro, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36403075 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35468860 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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4UH3DA044829-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB17-1630

Identifier Type: -

Identifier Source: org_study_id