HIVETHICNCT04427202
Ending Transmission of HIV, HCV, and STDs and Overdose in Rural Communities of People Who Inject Drugs (ETHIC)
A study testing Referral to harm reduction services in people with HIV and Hepatitis C, run by University of Chicago at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- HIV, Hepatitis C, Opioid-use Disorder
- What is being tested?
- Referral to harm reduction services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Aug 2020to 16 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Southern Illinois University
Carbondale, Illinois, 62901
The Community Action Place, Inc.
Murphysboro, Illinois, 62966
About this study
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.
Read the 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)
- Conditions
- HIV, Hepatitis C, Opioid-use Disorder, Injection Drug Use
- Being tested
- Referral to harm reduction services
- Keywords
- HIV, Hepatitis C, Opioid-use Disorder, Injection Drug Use, Harm Reduction Services
- Medical subject headings
- Hepatitis C, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Referral to harm reduction servicesBehavioural
Participants are referred to harm reduction services
| Study group | Role | What they receive |
|---|---|---|
| Referral to harm reduction services | Other | Participants will be taken through the study survey and interview, blood and urine toxicology testing and given a referral to a harm reduction organization. Receives: Behavioral: Referral to harm reduction services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Participants Who Received Referrals to the Harm Reduction Services Organization
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).
Measured: 2 years
Secondary outcomes (14)
Number of Locations Where Participants Received Most of Syringes or Needles
Number of unique zip codes that participants received most of their syringes or needles based on mobile unit delivery.
Measured: 2 years
Number of Times Sterile Syringes and/or Equipment Obtained From an Intervention
This was counted as the number of visits made by the hard reduction service organization to distribute sterile syringes and/or equipment.
Measured: 2 years
Number of Times Participants Used a Syringe or Needle That They Knew Was Used by Somebody Else
"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?"
Measured: 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
"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?"
Measured: 2 years
Number of Times Participants Let Someone Else Use a Cotton, Cooker, Spoon, or Water for Rinsing or Mixing After They Used it
"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?"
Measured: 2 years
Number of Participants With Drive Time Less Than 30 Minutes to Nearest Syringe or Needle Exchange
Number of participants with drive time less than 30 minutes to nearest syringe or needle exchange.
Measured: 2 years
Number of Participants That Currently Have Naloxone
"Do you currently have naloxone or Narcan with you or at home?"
Measured: 2 years
Number of Participants Who Received Substance Use Disorders (SUD) Treatment Referrals
Total number of participants who received a substance use disorder referrals made by the hard reduction services organization.
Measured: 2 years
Total Number of Participants Who Received an HIV Screening
Total number of tests that participants screened for HIV, from baseline to follow-up.
Measured: 2 years
Total Number of Participants Who Received an HCV Screening
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.
Measured: 2 years
Number of Participants With Knowledge of PrEP
"Have you ever heard of medicine people can take to prevent HIV?"
Measured: 6 months
Number of Participants Diagnosed With HIV Who Have Access to HIV Care
Total number of participants who were newly diagnosed with HIV during the study period.
Measured: 2 years
Number of Participants Diagnosed With HCV Who Have Access to HCV Care
Total number of participants who were newly diagnosed with chronic Hep C who were referred to Hep C care.
Measured: 2 years
Number of Times a Participant Engaged in Condomless Sex (Vaginal or Anal)
"In the last 30 days, how many times did you have vaginal or anal sex without a condom?"
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start14 Aug 2020
- Primary completion16 Aug 2023
- Study completion16 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Southern Illinois University, Community Action Place, Inc., New York University, University of Illinois Chicago, University of Washington, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Mai Pho, PhD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427202
- Sponsor's protocol ID
- IRB17-1630
- Other IDs
- 4UH3DA044829-03
- Acronym
- ETHIC
- Status last verified
- Aug 2023
- First submitted
- 8 Jun 2020
- Last updated
- 12 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 36403075Walters 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.
PubMed 35468860
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ending Transmission of HIV, HCV, and STDs and Overdose in Rural Communities of People Who Inject Drugs (ETHIC)
- ClinicalTrials.gov ID
- NCT04427202
- Acronym / sponsor ID
- ETHIC / IRB17-1630
- Conditions
- HIV, Hepatitis C, Opioid-use Disorder, Injection Drug Use
- Keywords
- HIV, Hepatitis C, Opioid-use Disorder, Injection Drug Use, Harm Reduction Services
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Southern Illinois University, Community Action Place, Inc., New York University, University of Illinois Chicago, University of Washington, National Institute on Drug Abuse (NIDA)
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- 16 Aug 2023 (actual)
- Study completion
- 16 Aug 2023 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Posted 12 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Referral to harm reduction services | Other | Behavioral: Referral to harm reduction servicesParticipants will be taken through the study survey and interview, blood and urine toxicology testing and given a referral to a harm reduction organization. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Referral to harm reduction servicesParticipants are referred to harm reduction services | Behavioural | Referral to harm reduction services |
Primary outcome
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).
14 secondary outcomes
Number of Locations Where Participants Received Most of Syringes or Needles
Time frame: 2 years
Number of Times Sterile Syringes and/or Equipment Obtained From an Intervention
Time frame: 2 years
Number of Times Participants Used a Syringe or Needle That They Knew Was Used by Somebody Else
Time frame: 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
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
Number of Participants With Drive Time Less Than 30 Minutes to Nearest Syringe or Needle Exchange
Time frame: 2 years
Number of Participants That Currently Have Naloxone
Time frame: 2 years
Number of Participants Who Received Substance Use Disorders (SUD) Treatment Referrals
Time frame: 2 years
Total Number of Participants Who Received an HIV Screening
Time frame: 2 years
Total Number of Participants Who Received an HCV Screening
Time frame: 2 years
Number of Participants With Knowledge of PrEP
Time frame: 6 months
Number of Participants Diagnosed With HIV Who Have Access to HIV Care
Time frame: 2 years
Number of Participants Diagnosed With HCV Who Have Access to HCV Care
Time frame: 2 years
Number of Times a Participant Engaged in Condomless Sex (Vaginal or Anal)
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36403075Rains 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.
- Derived from this study: PubMed 35468860Walters 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mai Pho, PhD principal investigator
University of Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Referral to harm reduction services in people with HIV and Hepatitis C, run by University of Chicago at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Participants Who Received Referrals to the Harm Reduction Services Organization (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04427202, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.