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

HIV Clinical Trial

— ETHIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04427202
• Other study ID #: IRB17-1630
• Secondary ID: 4UH3DA044829-03
• Status: Completed
• Phase: N/A
• Start date: August 14, 2020
• Est. completion date: August 16, 2023

Study information

• Verified date: August 2023
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 309
• Est. completion date: August 16, 2023
• Est. primary completion date: August 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• HIV
• Injection Drug Use
• Opioid-Related Disorders
• Opioid-use Disorder

Intervention

Behavioral:
• Referral to harm reduction services
Participants are referred to harm reduction services

Locations

Country	Name	City	State
United States	Southern Illinois University	Carbondale	Illinois
United States	The Community Action Place, Inc.	Murphysboro	Illinois

Sponsors (7)

Lead Sponsor	Collaborator
University of Chicago	National Institute on Drug Abuse (NIDA), New York University, Southern Illinois University, The Community Action Place, Inc., University of Illinois at Chicago, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Referrals to the harm reduction organization	Number of participants who accept referral to the intervention (divided by the total enrolled)	2 years
Secondary	Number of locations where participants received most of syringes or needles		2 years
Secondary	Number of times clean syringes and/or equipment obtained from an intervention		2 years
Secondary	Number of times participants used a syringe or needle that they knew was used by somebody else		2 years
Secondary	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
Secondary	Number of times participants let someone else use a cotton, cooker, spoon, or water for rinsing or mixing after they used it		2 years
Secondary	Amount of time to travel to the nearest syringe or needle exchange		2 years
Secondary	Number of participants that currently have naloxone		2 years
Secondary	Number of substance use disorders (SUD) treatment referrals made		2 years
Secondary	Number of HIV screenings and referrals		2 years
Secondary	Number of HCV screenings and referrals		2 years
Secondary	Number of participants with knowledge of PrEP		2 years
Secondary	Number of participants diagnosed with HIV who have access to HIV care		2 years
Secondary	Number of participants diagnosed with HCV who have access to HCV care		2 years
Secondary	Number of participants who have condomless sex (vaginal or anal)		2 years