18 and older, any sex, with Drug Use Disorders or Hepatitis C. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in the Addiction Treatment Accessibility and Utilization as Assessed by Change in Likert ScalePrimary· 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)
Pre-intervention
Group
Value
95% CI
Usual Services
1.26
± 1.10
Prevention Navigation
1.07
± 1.21
Post-intervention
Group
Value
95% CI
Usual Services
1.12
± 1.15
Prevention Navigation
1.03
± 1.30
Change in the Addiction Treatment Accessibility and Utilization as Assessed by Change in Frequency of "Yes" AnswersPrimary· 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.
Pre-Intervention
Group
Value
95% CI
Usual Services
0.17
± 0.38
Prevention Navigation
0.16
± 0.37
Post-Intervention
Group
Value
95% CI
Usual Services
0.037
± 0.19
Prevention Navigation
0.11
± 0.31
Change in the Risk of HIV as Assessed by Change in Likert ScalePrimary· 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.
Pre-intervention
Group
Value
95% CI
Usual Services
1.05
± 1.01
Prevention Navigation
1.09
± 1.05
Post-intervention
Group
Value
95% CI
Usual Services
1.28
± 1.04
Prevention Navigation
0.86
± 1.17
Change in the Risk of HIV as Assessed by Risky Behavior FrequenciesPrimary· 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"
Pre-intervention
Group
Value
95% CI
Usual Services
0.24
± 0.43
Prevention Navigation
0.25
± 0.44
Post-intervention
Group
Value
95% CI
Usual Services
0.19
± 0.40
Prevention Navigation
0.21
± 0.41
Change in the Risk of Drug Overdose as Assessed by Change in Likert ScalePrimary· 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."
Pre-intervention
Group
Value
95% CI
Usual Services
0.52
± 0.82
Prevention Navigation
0.42
± 0.85
Post-intervention
Group
Value
95% CI
Usual Services
0.57
± 1.01
Prevention Navigation
0.56
± 1.17
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Wisconsin, Madison
Last refreshed: 1 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04268173.