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

Not Applicable

Completed

Conditions: HIV
Opioid-use Disorder
Hepatitis C
Injection Drug Use

Interventions: Behavioral: Referral to harm reduction services

Registration Number: NCT04427202

Lead Sponsor: 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.

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)

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 306

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Referral to harm reduction services	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.

Primary Outcome Measures

Name	Time	Method
Total Participants Who Received Referrals to the Harm Reduction Services Organization	2 years	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).

Secondary Outcome Measures

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

Trial Locations

Locations (2): Southern Illinois University
🇺🇸
Carbondale, Illinois, United States
The Community Action Place, Inc.
🇺🇸
Murphysboro, Illinois, United States