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Completed

NCT Number: NCT04268173

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

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.

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Key information

Conditions

Drug Use Disorders Behavior Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Digestive System Diseases Flaviviridae Infections Harm Reduction Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Opioid-use Disorder RNA Virus Infections Substance-Related Disorders Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vivent Health, Appleton, Wisconsin, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

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.

Other names: Prevention Navigation

Primary outcomes

  1. Change in the Addiction Treatment Accessibility and Utilization as Assessed by Change in Likert Scale

    Time frame: 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)

  2. Change in the Addiction Treatment Accessibility and Utilization as Assessed by Change in Frequency of "Yes" Answers

    Time frame: 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.

  3. Change in the Risk of HIV as Assessed by Change in Likert Scale

    Time frame: 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.

  4. Change in the Risk of HIV as Assessed by Risky Behavior Frequencies

    Time frame: 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"

  5. Change in the Risk of Drug Overdose as Assessed by Change in Likert Scale

    Time frame: 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 outcomes

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

    Time frame: Baseline, 3 months, and 6 months

  2. Change in Smoking Frequency as Assessed by Self-reported Behaviors

    Time frame: Baseline, 3 months, and 6 months

  3. Change in Self-stigma as Assessed by Change in Likert Scale

    Time frame: Baseline, 3 months, and 6 months

  4. Change in the Risk of Drug Overdose as Assessed by Change in Frequency of Narcan Distribution

    Time frame: Baseline, 3 months, and 6 months

  5. 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

  6. Addiction Treatment Accessibility and Utilization Frequency Assessment From Long Term Medicaid Data

    Time frame: Year 2

  7. Hepatitis C Treatment Frequency From Long Term Medicaid Data

    Time frame: Year 2

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • Tulane University

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 13, 2020
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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