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

November 18, 2024 updated by: University of Chicago
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
306

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Illinois
      • Carbondale, Illinois, United States, 62901
        • Southern Illinois University
      • Murphysboro, Illinois, United States, 62966
        • The Community Action Place, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total Participants Who Received Referrals to the Harm Reduction Services Organization
Time Frame: 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).
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Locations Where Participants Received Most of Syringes or Needles
Time Frame: 2 years
Number of unique zip codes that participants received most of their syringes or needles based on mobile unit delivery.
2 years
Number of Times Sterile Syringes and/or Equipment Obtained From an Intervention
Time Frame: 2 years
This was counted as the number of visits made by the hard reduction service organization to distribute sterile syringes and/or equipment.
2 years
Number of Times Participants Used a Syringe or Needle That They Knew Was Used by Somebody Else
Time Frame: 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?"
2 years
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
"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?"
2 years
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
"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?"
2 years
Number of Participants With Drive Time Less Than 30 Minutes to Nearest Syringe or Needle Exchange
Time Frame: 2 years
Number of participants with drive time less than 30 minutes to nearest syringe or needle exchange.
2 years
Number of Participants That Currently Have Naloxone
Time Frame: 2 years
"Do you currently have naloxone or Narcan with you or at home?"
2 years
Number of Participants Who Received Substance Use Disorders (SUD) Treatment Referrals
Time Frame: 2 years
Total number of participants who received a substance use disorder referrals made by the hard reduction services organization.
2 years
Total Number of Participants Who Received an HIV Screening
Time Frame: 2 years
Total number of tests that participants screened for HIV, from baseline to follow-up.
2 years
Total Number of Participants Who Received an HCV Screening
Time Frame: 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.
2 years
Number of Participants With Knowledge of PrEP
Time Frame: 6 months
"Have you ever heard of medicine people can take to prevent HIV?"
6 months
Number of Participants Diagnosed With HIV Who Have Access to HIV Care
Time Frame: 2 years
Total number of participants who were newly diagnosed with HIV during the study period.
2 years
Number of Participants Diagnosed With HCV Who Have Access to HCV Care
Time Frame: 2 years
Total number of participants who were newly diagnosed with chronic Hep C who were referred to Hep C care.
2 years
Number of Times a Participant Engaged in Condomless Sex (Vaginal or Anal)
Time Frame: 6 months
"In the last 30 days, how many times did you have vaginal or anal sex without a condom?"
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Chicago

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)
New York University
University of Illinois at Chicago
University of Washington
Southern Illinois University
The Community Action Place, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mai Pho, PhD, University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 14, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 16, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 16, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB17-1630
  • 4UH3DA044829-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Time Frame

Data will be available at the DCC for the time frame indicated in the data use agreement.

IPD Sharing Access Criteria

Data will be shared among researchers in the Rural Opioid Initiative (ROI) cooperative agreement as described above

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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