Hepatitis C, HIV, Injection Drug Use, Opioid-use Disorder
Conditions
Keywords
HIV, Hepatitis C, Opioid-use Disorder, Injection Drug Use, Harm Reduction Services
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)
Interventions
BEHAVIORALReferral to harm reduction services
Participants are referred to harm reduction services
Sponsors
Southern Illinois University
Community Action Place, Inc.
New York University
University of Illinois at Chicago
University of Washington
National Institute on Drug Abuse (NIDA)
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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. |
| 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? |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort Participants will be taken through the study survey and interview, blood and urine toxicology testing and given a referral to a harm reduction organization | 306 |
| Total | 306 |
Baseline characteristics
| Characteristic | Cohort |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 297 Participants |
| Age, Continuous | 42.0 years STANDARD_DEVIATION 11.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 296 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 63 Participants |
| Race (NIH/OMB) More than one race | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 230 Participants |
| Sex/Gender, Customized Sex Female | 106 Participants |
| Sex/Gender, Customized Sex Intersex | 1 Participants |
| Sex/Gender, Customized Sex Male | 199 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 306 |
| other Total, other adverse events | 0 / 306 |
| serious Total, serious adverse events | 5 / 306 |
Outcome results
Primary
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).
Time frame: 2 years
Population: These participants who did not have previous engagement prior to the study with the harm reduction services organization.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort | Total Participants Who Received Referrals to the Harm Reduction Services Organization | 121 Participants |
Secondary
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.
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort | Number of Locations Where Participants Received Most of Syringes or Needles | 92 Unique zip codes |
Secondary
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.
Time frame: 2 years
Population: Total number of participants who had a positive confirmatory HCV test (e.g. positive viral load).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort | Number of Participants Diagnosed With HCV Who Have Access to HCV Care | 11 Participants |
Secondary
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.
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort | Number of Participants Diagnosed With HIV Who Have Access to HIV Care | 0 Participants |
Secondary
Number of Participants That Currently Have Naloxone
Do you currently have naloxone or Narcan with you or at home?
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort | Number of Participants That Currently Have Naloxone | 93 Participants |
Secondary
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.
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort | Number of Participants Who Received Substance Use Disorders (SUD) Treatment Referrals | 102 Participants |
Secondary
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.
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort | Number of Participants With Drive Time Less Than 30 Minutes to Nearest Syringe or Needle Exchange | 148 Participants |
Secondary
Number of Participants With Knowledge of PrEP
Have you ever heard of medicine people can take to prevent HIV?
Time frame: 6 months
Population: Participants did not respond to question (n=5)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort | Number of Participants With Knowledge of PrEP | 155 Participants |
Secondary
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?
Time frame: 6 months
Population: A number of participants did not respond to this question (n=10).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort | Number of Times a Participant Engaged in Condomless Sex (Vaginal or Anal) | 9.9 Encounters | Standard Deviation 16.2 |
Secondary
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?
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort | Number of Times Participants Let Someone Else Use a Cotton, Cooker, Spoon, or Water for Rinsing or Mixing After They Used it | 2.3 Encounters | Standard Deviation 8.4 |
Secondary
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?
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort | Number of Times Participants Used a Cotton, Cooker, Spoon, or Water for Rinsing or Mixing That They Knew Was Used by Somebody Else | 2.5 Encounters | Standard Deviation 9.5 |
Secondary
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?
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort | Number of Times Participants Used a Syringe or Needle That They Knew Was Used by Somebody Else | 0.9 Encounters | Standard Deviation 3 |
Secondary
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.
Time frame: 2 years
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cohort | Number of Times Sterile Syringes and/or Equipment Obtained From an Intervention | 2.5 Visits |
Secondary
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.
Time frame: 2 years
Population: Participants who already were told they had HCV prior to this study (n=76) were removed from the denominator.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort | Total Number of Participants Who Received an HCV Screening | 213 Participants |
Secondary
Total Number of Participants Who Received an HIV Screening
Total number of tests that participants screened for HIV, from baseline to follow-up.
Time frame: 2 years
Population: Participants who already knew their HIV+ diagnoses prior to this study (n=4) and thus, removed from the denominator.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort | Total Number of Participants Who Received an HIV Screening | 288 Participants |