Drug Use Disorders, Harm Reduction, Hepatitis C, Opioid-use Disorder
Conditions
Brief summary
The goal of this study was to effectively use a client-centered community-based intervention to engage people who inject drugs (PWIDs) in healthcare that helps reduce risky behaviors and lower infectious disease risks. Participants in the intervention group of this study received a 12-week intensive multilevel harm reduction case-management intervention at three rural Vivent Health offices. Service coordination aimed to reduce human immunodeficiency virus (HIV), hepatitis C virus (HCV), and overdose risks in PWIDs. Prevention Navigators (PNs) at each office helped to coordinate referrals to reduce substance use disorder and increase engagement in the substance use disorder care cascades.
Detailed description
This project was conducted by an experienced, interdisciplinary team working across academic, public health, and non-government sectors. The main community partner Vivent Health, formerly known as the AIDS Resource Center of Wisconsin (ARCW), is a unique, state-wide organization that provides harm reduction services, including syringe services and confidential HIV and HCV testing, to clients at 10 fixed sites and numerous mobile units reaching all 72 Wisconsin counties. Based on the investigators' preliminary studies and prior collaborations, the investigators selected 6 counties in rural Wisconsin. The Client-Centered Prevention Home intervention model was implemented at 3 Vivent Health field offices in 3 of these counties, and 3 other counties served as usual services, or control sites. Participants in the intervention underwent a 12-week intensive multilevel harm reduction case-management intervention geared towards coordinating referrals to reduce substance use disorder and increase engagement in the substance use disorder care cascades, and reduce vulnerability to HIV, STIs, and HCV and increase in engagement in the HIV, STI, and HCV care cascades. Participants in the intervention arm worked with Prevention Navigators to undergo a risk assessment and identify problems and create goals that they want to achieve. Each session after that was used to review the needs assessment and goals. During their last meeting, participants and prevention navigators developed a discharge plan that will enable the participants to work on their goals on their own. Participants at all six sites were offered rapid testing for HIV, HCV, and STIs, and fill out survey questionnaires to evaluate risk behaviors, intervention effectiveness, and general needs of the communities.
Interventions
OTHERCommunity-Based, Client-Centered Prevention Home
Prevention Navigators at Vivent Helath offices will engage participants in risk assessments, goal planning, and treatment referrals based on their needs and desires.
Sponsors
Tulane University
National Institute on Drug Abuse (NIDA)
University of Wisconsin, Madison
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Participants were enrolled in a 2-arm, non-randomized intervention trial based on the location where they received harm reduction services. Harm reduction clients receiving services at offices in 3 selected Wisconsin counties (La Crosse, Brown, and Marathon) were assigned to work with a Prevention Navigator at the office location, while clients receiving services in other counties (Douglas, Eau Claire, and Outagamie) received usual services.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* has injected drugs in the past 30 days, resides in Wisconsin, over 18 years of age * able to read and write in English
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Addiction Treatment Accessibility and Utilization as Assessed by Change in Likert Scale | Pre-intervention, post intervention (3 months) | The following question was asked on a scale of 0 to 4, where 0=strongly disagree and 4=strongly agree: If I wanted to start medical treatment for opioid or heroin addiction, I could easily get buprenorphine or Suboxone or Subutex. The outcome is represented as the mean response in each intervention group (min 0, max 4) |
| Change in the Addiction Treatment Accessibility and Utilization as Assessed by Change in Frequency of Yes Answers | Pre-intervention, post intervention (3 months) | Following questions will be asked with yes or no answers. In the past 3 months, have you gotten buprenorphine maintenance medication-like Suboxone or Subutex-from a doctor or program? Responses were coded as 0 = No and 1 = Yes. Summary statistics presented as mean below represent the proportion responding yes. |
| Change in the Risk of HIV as Assessed by Change in Likert Scale | Pre-intervention, post intervention (3 months) | Following questions will be asked to gauge ease of accessing clean injecting equipment to assess how risky the participants behaviors are in relation to HIV transmission. It's easy for me to get new, clean syringes or needles. Questions will be answered on a scale of 0 to 4, with 0=strongly disagree and 4=strongly agree. An increase in the Likert scale among intervention participants is associated with increased access to HIV prevention compared to the controls. |
| Change in the Risk of HIV as Assessed by Risky Behavior Frequencies | Pre-intervention, post intervention (3 months) | Participants were asked to gauge frequency of safe injection behaviors that reduce the risk of HIV. Participants will be asked how many times in the last 30 days they have practiced these behaviors. In the last 3 months, how often have you shared needles with someone else, used a syringe more than once, used equipment you knew wasn't clean, or received equipment from a potentially unsafe source? Responses were coded 0=never and 1=at least once |
| Change in the Risk of Drug Overdose as Assessed by Change in Likert Scale | Pre-intervention, post intervention (3 months) | Following question will be asked on a scale of 0 to 4, where 0=strongly disagree and 4=strongly agree If I wanted the overdose reversal drug naloxone or Narcan, I could easily get it. |
Other
| Measure | Time frame |
|---|---|
| Addiction Treatment Accessibility and Utilization Frequency Assessment From Long Term Medicaid Data | Year 2 |
| Change in the Risk of Viral Hepatitis as Assessed by Change in Likert Scale | Baseline, 3 months, and 6 months |
| Hepatitis C Treatment Frequency From Long Term Medicaid Data | Year 2 |
| Change in Smoking Frequency as Assessed by Self-reported Behaviors | Baseline, 3 months, and 6 months |
| Change in Self-stigma as Assessed by Change in Likert Scale | Baseline, 3 months, and 6 months |
| Change in the Risk of Drug Overdose as Assessed by Change in Frequency of Narcan Distribution | Baseline, 3 months, and 6 months |
| Change in the Treatment Frequency of Viral Hepatitis as Assessed by Wisconsin(WI) Surveillance Databases and Medicaid Data | Baseline, 3 months, and 6 months |
Countries
United States
Participant flow
Pre-assignment details
A total of 343 individuals enrolled in the study and provided informed consent. Of these, 16 withdrew from the study or were lost to follow-up before participating in any data collection. Results are therefore reported only for N=327 who completed at least a baseline study assessment.
Participants by arm
| Arm | Count |
|---|---|
| Usual Services Participants enrolled in this arm will receive services as usual from Vivent Health and will not engage in the intervention. | 133 |
| Prevention Navigation Participants enrolled in this arm will receive a 12-week community-based, client-centered, prevention intervention.
Community-Based, Client-Centered Prevention Home: Prevention Navigators at Vivent Helath offices will engage participants in risk assessments, goal planning, and treatment referrals based on their needs and desires. | 194 |
| Total | 327 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 75 | 108 |
Baseline characteristics
| Characteristic | Usual Services | Prevention Navigation | Total |
|---|---|---|---|
| Age, Continuous | 38.1 years STANDARD_DEVIATION 10.1 | 38.2 years STANDARD_DEVIATION 10 | 38.2 years STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 13 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 128 Participants | 180 Participants | 308 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 22 Participants | 27 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 8 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 7 Participants | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) White | 121 Participants | 154 Participants | 275 Participants |
| Region of Enrollment United States | 133 participants | 194 participants | 327 participants |
| Sex/Gender, Customized Female | 49 Participants | 84 Participants | 133 Participants |
| Sex/Gender, Customized Male | 83 Participants | 107 Participants | 190 Participants |
| Sex/Gender, Customized Other | 1 Participants | 2 Participants | 3 Participants |
| Sex/Gender, Customized Unknown | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 133 | 2 / 194 |
| other Total, other adverse events | 0 / 133 | 0 / 194 |
| serious Total, serious adverse events | 0 / 133 | 0 / 194 |
Outcome results
Primary
Change in the Addiction Treatment Accessibility and Utilization as Assessed by Change in Frequency of Yes Answers
Following questions will be asked with yes or no answers. In the past 3 months, have you gotten buprenorphine maintenance medication-like Suboxone or Subutex-from a doctor or program? Responses were coded as 0 = No and 1 = Yes. Summary statistics presented as mean below represent the proportion responding yes.
Time frame: Pre-intervention, post intervention (3 months)
Population: Only participants responding to the survey question were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Services | Change in the Addiction Treatment Accessibility and Utilization as Assessed by Change in Frequency of Yes Answers | Pre-Intervention | 0.17 proportion of Yes responses | Standard Deviation 0.38 |
| Usual Services | Change in the Addiction Treatment Accessibility and Utilization as Assessed by Change in Frequency of Yes Answers | Post-Intervention | 0.037 proportion of Yes responses | Standard Deviation 0.19 |
| Prevention Navigation | Change in the Addiction Treatment Accessibility and Utilization as Assessed by Change in Frequency of Yes Answers | Pre-Intervention | 0.16 proportion of Yes responses | Standard Deviation 0.37 |
| Prevention Navigation | Change in the Addiction Treatment Accessibility and Utilization as Assessed by Change in Frequency of Yes Answers | Post-Intervention | 0.11 proportion of Yes responses | Standard Deviation 0.31 |
Primary
Change in the Addiction Treatment Accessibility and Utilization as Assessed by Change in Likert Scale
The following question was asked on a scale of 0 to 4, where 0=strongly disagree and 4=strongly agree: If I wanted to start medical treatment for opioid or heroin addiction, I could easily get buprenorphine or Suboxone or Subutex. The outcome is represented as the mean response in each intervention group (min 0, max 4)
Time frame: Pre-intervention, post intervention (3 months)
Population: Participants responding to the survey question were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Services | Change in the Addiction Treatment Accessibility and Utilization as Assessed by Change in Likert Scale | Pre-intervention | 1.26 score on a scale | Standard Deviation 1.1 |
| Usual Services | Change in the Addiction Treatment Accessibility and Utilization as Assessed by Change in Likert Scale | Post-intervention | 1.12 score on a scale | Standard Deviation 1.15 |
| Prevention Navigation | Change in the Addiction Treatment Accessibility and Utilization as Assessed by Change in Likert Scale | Pre-intervention | 1.07 score on a scale | Standard Deviation 1.21 |
| Prevention Navigation | Change in the Addiction Treatment Accessibility and Utilization as Assessed by Change in Likert Scale | Post-intervention | 1.03 score on a scale | Standard Deviation 1.3 |
p-value: 0.84t-test, 2 sided
Primary
Change in the Risk of Drug Overdose as Assessed by Change in Likert Scale
Following question will be asked on a scale of 0 to 4, where 0=strongly disagree and 4=strongly agree If I wanted the overdose reversal drug naloxone or Narcan, I could easily get it.
Time frame: Pre-intervention, post intervention (3 months)
Population: Participants responding to the survey question were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Services | Change in the Risk of Drug Overdose as Assessed by Change in Likert Scale | Pre-intervention | 0.52 score on a scale | Standard Deviation 0.82 |
| Usual Services | Change in the Risk of Drug Overdose as Assessed by Change in Likert Scale | Post-intervention | 0.57 score on a scale | Standard Deviation 1.01 |
| Prevention Navigation | Change in the Risk of Drug Overdose as Assessed by Change in Likert Scale | Pre-intervention | 0.42 score on a scale | Standard Deviation 0.85 |
| Prevention Navigation | Change in the Risk of Drug Overdose as Assessed by Change in Likert Scale | Post-intervention | 0.56 score on a scale | Standard Deviation 1.17 |
Primary
Change in the Risk of HIV as Assessed by Change in Likert Scale
Following questions will be asked to gauge ease of accessing clean injecting equipment to assess how risky the participants behaviors are in relation to HIV transmission. It's easy for me to get new, clean syringes or needles. Questions will be answered on a scale of 0 to 4, with 0=strongly disagree and 4=strongly agree. An increase in the Likert scale among intervention participants is associated with increased access to HIV prevention compared to the controls.
Time frame: Pre-intervention, post intervention (3 months)
Population: Only participants responding to the survey question were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Services | Change in the Risk of HIV as Assessed by Change in Likert Scale | Pre-intervention | 1.05 score on a scale | Standard Deviation 1.01 |
| Usual Services | Change in the Risk of HIV as Assessed by Change in Likert Scale | Post-intervention | 1.28 score on a scale | Standard Deviation 1.04 |
| Prevention Navigation | Change in the Risk of HIV as Assessed by Change in Likert Scale | Pre-intervention | 1.09 score on a scale | Standard Deviation 1.05 |
| Prevention Navigation | Change in the Risk of HIV as Assessed by Change in Likert Scale | Post-intervention | 0.86 score on a scale | Standard Deviation 1.17 |
Primary
Change in the Risk of HIV as Assessed by Risky Behavior Frequencies
Participants were asked to gauge frequency of safe injection behaviors that reduce the risk of HIV. Participants will be asked how many times in the last 30 days they have practiced these behaviors. In the last 3 months, how often have you shared needles with someone else, used a syringe more than once, used equipment you knew wasn't clean, or received equipment from a potentially unsafe source? Responses were coded 0=never and 1=at least once
Time frame: Pre-intervention, post intervention (3 months)
Population: Participants who responded to the survey question were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Services | Change in the Risk of HIV as Assessed by Risky Behavior Frequencies | Pre-intervention | 0.24 proportion reporting at least once | Standard Deviation 0.43 |
| Usual Services | Change in the Risk of HIV as Assessed by Risky Behavior Frequencies | Post-intervention | 0.19 proportion reporting at least once | Standard Deviation 0.4 |
| Prevention Navigation | Change in the Risk of HIV as Assessed by Risky Behavior Frequencies | Pre-intervention | 0.25 proportion reporting at least once | Standard Deviation 0.44 |
| Prevention Navigation | Change in the Risk of HIV as Assessed by Risky Behavior Frequencies | Post-intervention | 0.21 proportion reporting at least once | Standard Deviation 0.41 |
Other Pre-specified
Addiction Treatment Accessibility and Utilization Frequency Assessment From Long Term Medicaid Data
Time frame: Year 2
Other Pre-specified
Change in Self-stigma as Assessed by Change in Likert Scale
Time frame: Baseline, 3 months, and 6 months
Other Pre-specified
Change in Smoking Frequency as Assessed by Self-reported Behaviors
Time frame: Baseline, 3 months, and 6 months
Other Pre-specified
Change in the Risk of Drug Overdose as Assessed by Change in Frequency of Narcan Distribution
Time frame: Baseline, 3 months, and 6 months
Other Pre-specified
Change in the Risk of Viral Hepatitis as Assessed by Change in Likert Scale
Time frame: Baseline, 3 months, and 6 months
Other Pre-specified
Change in the Treatment Frequency of Viral Hepatitis as Assessed by Wisconsin(WI) Surveillance Databases and Medicaid Data
Time frame: Baseline, 3 months, and 6 months
Other Pre-specified
Hepatitis C Treatment Frequency From Long Term Medicaid Data
Time frame: Year 2