Clinical trial NCT04427202: Ending Transmission of HIV, HCV, and STDs and Overdose in Rural Communities of People Who Inject Drugs (ETHIC)
Official title: Ending Transmission of HIV, HCV, and STDs and Overdose in Rural Communities of People Who Inject Drugs (ETHIC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Hepatitis C
Opioid-use Disorder
Injection Drug Use
Keywords: HIV
Hepatitis C
Opioid-use Disorder
Injection Drug Use
Harm Reduction Services
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Southern Illinois University
name: Community Action Place, Inc.
name: New York University
name: University of Illinois at Chicago
name: University of Washington
name: National Institute on Drug Abuse (NIDA)
First posted: 2020-06-11
Enrollment: 306
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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)

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

Primary outcomes:
measure: Total Participants Who Received Referrals to the Harm Reduction Services Organization
timeFrame: 2 years
Secondary outcomes:
measure: Number of Locations Where Participants Received Most of Syringes or Needles
timeFrame: 2 years
measure: Number of Times Sterile Syringes and/or Equipment Obtained From an Intervention
timeFrame: 2 years
measure: Number of Times Participants Used a Syringe or Needle That They Knew Was Used by Somebody Else
timeFrame: 2 years
measure: Number of Times Participants Used a Cotton, Cooker, Spoon, or Water for Rinsing or Mixing That They Knew Was Used by Somebody Else
timeFrame: 2 years
measure: Number of Times Participants Let Someone Else Use a Cotton, Cooker, Spoon, or Water for Rinsing or Mixing After They Used it
timeFrame: 2 years
measure: Number of Participants With Drive Time Less Than 30 Minutes to Nearest Syringe or Needle Exchange
timeFrame: 2 years
measure: Number of Participants That Currently Have Naloxone
timeFrame: 2 years
measure: Number of Participants Who Received Substance Use Disorders (SUD) Treatment Referrals
timeFrame: 2 years
measure: Total Number of Participants Who Received an HIV Screening
timeFrame: 2 years
measure: Total Number of Participants Who Received an HCV Screening
timeFrame: 2 years
measure: Number of Participants With Knowledge of PrEP
timeFrame: 6 months
measure: Number of Participants Diagnosed With HIV Who Have Access to HIV Care
timeFrame: 2 years
measure: Number of Participants Diagnosed With HCV Who Have Access to HCV Care
timeFrame: 2 years
measure: Number of Times a Participant Engaged in Condomless Sex (Vaginal or Anal)
timeFrame: 6 months
Other outcomes:
Locations:
city: Carbondale
country: United States
facility: Southern Illinois University
state: Illinois
city: Murphysboro
country: United States
facility: The Community Action Place, Inc.
state: Illinois
Study officials:
affiliation: University of Chicago
name: Mai Pho, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.