Community-Based, Client-Centered Prevention Homes to Address the Rural Opioid Epidemic- Aim 3

NCT04268173 | Completed Results DMC

• 5 other identifiers: 2017-0866UH3DA044826A534265SMPH/MEDICINE/INFECT DISProtocol Version 2/1/2023
• Study Type: interventional
• Target: 343
• Locations: 1 country
• Sites: 6

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.

Conditions

Drug Use Disorders; Hepatitis C; Harm Reduction; Opioid-use Disorder

Outcome Measures

Primary Outcomes (5)

• 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)

  Pre-intervention, post intervention (3 months)

• 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.

  Pre-intervention, post intervention (3 months)

• 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.

  Pre-intervention, post intervention (3 months)

• 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"

  Pre-intervention, post intervention (3 months)

• 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."

  Pre-intervention, post intervention (3 months)

Other Outcomes (7)

• Change in the Risk of Viral Hepatitis as Assessed by Change in Likert Scale

  Baseline, 3 months, and 6 months

• 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

Study Arms (2)

Prevention Navigation

EXPERIMENTAL

Participants enrolled in this arm will receive a 12-week community-based, client-centered, prevention intervention.

Other: Community-Based, Client-Centered Prevention Home

Usual Services

NO INTERVENTION

Participants enrolled in this arm will receive services as usual from Vivent Health and will not engage in the intervention.

Interventions

Community-Based, Client-Centered Prevention Home OTHER

Prevention Navigators at Vivent Helath offices will engage participants in risk assessments, goal planning, and treatment referrals based on their needs and desires.

Also known as: Prevention Navigation

Prevention Navigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• has injected drugs in the past 30 days, resides in Wisconsin, over 18 years of age
• able to read and write in English

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Tulane University: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (6)

Vivent Health

Appleton, Wisconsin, 54911, United States

Location

Vivent Health

Eau Claire, Wisconsin, 54701, United States

Location

Vivent Health

Green Bay, Wisconsin, 54301, United States

Location

Vivent Health

La Crosse, Wisconsin, 54603, United States

Location

Vivent Health

Schofield, Wisconsin, 54476, United States

Location

Vivent Health

Superior, Wisconsin, 54880, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Hepatitis C; Harm Reduction; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Behavior; Narcotic-Related Disorders

Limitations and Caveats

This trial was conducted in a challenging community setting among a vulnerable population affected by severe substance use disorder, unstable housing, and frequent criminal legal system involvement. As a result, we experienced very high levels of attrition in both study arms. The resulting level of missing data significantly impedes the ability to draw conclusions about the relationship between intervention exposure and any of the study outcomes.

Results Point of Contact

• Title: Dr. Ryan Westergaard
• Organization: University of Wisconsin-Madison

rpw@medicine.wisc.edu

(608) 265-7927

Study Officials

• Ryan Westergaard, MD, PhD, MPH

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 13, 2020
• Study Start: March 12, 2020
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: August 1, 2024
• Results First Posted: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available after upload to the data coordinating center at University of Washington and will remain for the time records must be held for, according to our data use agreement.
• Access Criteria: Data will only be shared among researchers in the cooperative agreement.

Locations

US (6)