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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04268173
Recruitment Status : Recruiting
First Posted : February 13, 2020
Last Update Posted : September 14, 2021
Sponsor:
Collaborators:
Tulane University
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
The goal of this study is 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 will undergo a 12-week intensive multilevel harm reduction case-management intervention at three rural Vivent Health offices geared towards reducing human immunodeficiency virus (HIV), hepatitis C virus (HCV), and overdose risks in PWIDs. Prevention Navigators (PNs) at each office will help coordinate referrals to reduce substance use disorder and increase engagement in the substance use disorder care cascades. PNs will also engage participants in HIV, HCV, and sexually transmitted infections(STIs) care cascades.

Condition or disease Intervention/treatment Phase
Drug Use Disorders Hepatitis C Harm Reduction Opioid-use Disorder Other: Community-Based, Client-Centered Prevention Home Phase 3

Detailed Description:

This project will be 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 investigator's preliminary studies and prior collaborations, investigator has selected 6 counties in rural Wisconsin, three of which investigator will deploy and evaluate the Client-Centered Prevention Home intervention model at Vivent Health field offices located within these service areas. Participants in the intervention will undergo 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 will work with Prevention Navigators to undergo a risk assessment and identify problems and create goals that they want to achieve. Each session after that will be used to review the needs assessment and goals. During their last meeting, participants and prevention navigators will develop a discharge plan that will enable the participants to work on their goals on their own. Participants at all six sites will undergo rapid testing for HIV, HCV, and STIs, and fill out survey questionnaires to evaluate risk behaviors, intervention effectiveness, and general needs of the communities. There are three groups in this study which consist of intervention, delayed intervention (3 month wait-list period before intervention begins), and a nonintervention control group.

Per the protocol amendment approved on 9/3/2021, no additional participants will be recruited into the delayed intervention arm and therefore the anticipated enrollment has change to 405.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 405 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be enrolled using a parallel crossover and cross-site study design. At three sites, participants will be enrolled in immediate intervention, or a 3 month wait list intervention, serving as a control for three months before engaging in the intervention. At three other sites, participants will serve as controls, receiving treatment as usual.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Community-Based, Client-Centered Prevention Homes to Address the Rural Opioid Epidemic- Aim 3
Actual Study Start Date : March 12, 2020
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hepatitis

Arm Intervention/treatment
Experimental: Immediate Intervention
Participants enrolled in this arm will receive a 12-week community-based, client-centered, prevention intervention.
Other: 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.
Other Name: Prevention Navigation

Experimental: Delayed Intervention

Participants enrolled in this arm will receive a 12-week community-based, client-centered, prevention intervention after being put on a wait-list for three months.

Per the protocol amendment approved on 9/3/2021, no additional participants will be recruited into the delayed intervention arm.

Other: 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.
Other Name: Prevention Navigation

No Intervention: Nonintervention
Participants enrolled in this arm will receive services as usual from Vivent Health and will not engage in the intervention.



Primary Outcome Measures :
  1. Change in the addiction treatment accessibility and utilization as assessed by change in Likert scale [ Time Frame: Baseline, 3 months, and 6 months ]

    Following questions will be asked on a scale of 1 to 5, where 1=strongly disagree and 5=strongly agree:

    1. If I wanted to start a medical treatment for opioid or heroine addiction, I could easily get into a methadone program
    2. If I wanted to start medical treatment for opioid or heroin addiction, I could easily get buprenorphine or Suboxone or Subutex.

    An increase in the Likert scale among intervention participants is associated with increased access to addiction treatment programs compared to the controls.


  2. Change in the addiction treatment accessibility and utilization as assessed by change in frequency of "Yes" answers [ Time Frame: Baseline, 3 months, and 6 months ]

    Following questions will be asked with yes or no answers.

    1. In the last 3 months, have you gone to a self-help group like Narcotics Anonymous, Alcoholics Anonymous, Celebrate Recovery, or Rational Recovery?
    2. In the past 3 months, have you received outpatient counseling from a provider or program?
    3. In the past 3 months, have you stayed overnight at a residential or inpatient drug treatment facility?
    4. In the past 3 months, have you been in detox?
    5. In the past 3 months, have you stayed overnight at a sober house?
    6. In the past 3 months, have you gotten buprenorphine maintenance medication-like Suboxone or Subutex-from a doctor or program?
    7. In the past 3 months, have you gotten methadone maintenance from a clinic?
    8. In the past 3 months, have you gotten buprenorphine shots - like Sublocade - from a doctor or program?

    Among the intervention group, an increase number of "yes" answers over time will show an improvement in this outcome, compared to the control group.


  3. Change in the risk of viral hepatitis as assessed by change in Likert scale [ Time Frame: Baseline, 3 months, and 6 months ]

    Following question will be asked on a scale of 1 to 5, where 1=strongly disagree and 5=strongly agree.

    a. I am certain that I got all 3 recommended shots for Hepatitis B.

    A shift to a total score of 5 would show improvement in this outcome. In combination of viral hepatitis prevalence, investigators are interested to know the change in hepatitis risk. This question will ask about Hepatitis B vaccination specifically.


  4. Change in the risk of HIV as assessed by change in Likert scale [ Time Frame: Baseline, 3 months, and 6 months ]

    Following questions will be asked to gauge ease of accessing condoms and clean injecting equipment to assess how risky the participants behaviors are in relation to HIV transmission.

    1. It's easy for me to get new, clean syringes or needles.
    2. It's easy for me and my sex partners to get condoms.

    Questions will be answered on a scale of 1 to 5, with 1=strongly disagree and 5=strongly agree. An increase in the Likert scale among intervention participants is associated with increased access to HIV prevention compared to the controls.


  5. Change in the risk of HIV as assessed by risky behavior frequencies [ Time Frame: Baseline, 3 months, and 6 months ]

    Six questions will be asked to gauge frequency of safe injection and sex behaviors that reduce the risk of HIV. Participants will be asked how many times in the last 30 days they have practiced these behaviors. An increase in frequency in any of the following six behaviors will be considered a success for this outcome in the intervention group.

    1. Have you ever heard of medicine people can take to prevent HIV?
    2. Have you had sex without a condom?
    3. Were you diagnosed with an STD in the past?
    4. Have you had sex with more than one person in the past 6 months?
    5. In the last 3 months, where have you gotten most of your syringes?
    6. 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?

  6. Change in the risk of drug overdose as assessed by change in Likert scale [ Time Frame: Baseline, 3 months, and 6 months ]

    Following question will be asked on a scale of 1 to 5, where 1=strongly disagree and 5=strongly agree

    a. If I wanted the overdose reversal drug naloxone or Narcan, I could easily get it.

    An increase in the Likert scale among intervention participants is associated with a decreased risk of overdose death compared to the controls.


  7. Change in smoking frequency as assessed by self-reported behaviors [ Time Frame: Baseline, 3 months, and 6 months ]

    A change in smoking behavior frequency will be assessed by asking participants how often they are smoking cigarettes. A decrease in frequency is considered a success in this outcome. Following questions will be asked

    1. Do you smoke cigarettes?
    2. On average, how many cigarettes do you smoke a day?

  8. Change in Self-stigma as assessed by change in Likert scale [ Time Frame: Baseline, 3 months, and 6 months ]

    Five questions will be asked to gauge feelings of shame, fear, and other negative emotions surrounding drug use. Following questions will be answered on a scale of 1 to 5, with 1=strongly disagree and 5=strongly agree.

    1. How much do you feel ashamed of using drugs?
    2. How much do you feel people avoid you because you use drugs?
    3. How much do you fear you will lose your friends because you use drugs?
    4. How much do you fear family will reject you because you use drugs?
    5. How much do you think other people are uncomfortable being around you because you use drugs?

    A decrease in the Likert scale among intervention participants is associated with decreased self-stigma compared to the controls.



Secondary Outcome Measures :
  1. Change in the risk of drug overdose as assessed by change in frequency of narcan distribution [ Time Frame: Baseline, 3 months, and 6 months ]
    ServicePoint data from Vivent Health will be used to understand the frequency of Narcan distribution over the time of the study. Any increase in study participants receiving Narcan would be considered a success for this outcome.

  2. 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 ]
    Frequency of viral hepatitis treatment in participants will be assessed by accessing the WI disease surveillance database known as Wisconsin Electronic Disease Surveillance System (WEDSS). An increase in number of participants receiving treatment will be a success for this outcome. Medicaid data will be monitored to evaluate frequency of treatment.


Other Outcome Measures:
  1. Addiction treatment accessibility and utilization frequency assessment from long term Medicaid data. [ Time Frame: Year 2 ]
    Long term changes in frequency of addiction treatment services will be assessed by reviewing Medicaid data over time.

  2. Hepatitis C treatment frequency from long term Medicaid data. [ Time Frame: Year 2 ]
    Long term changes in frequency of HCV treatment services will be assesses by reviewing Medicaid data over time.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04268173


Contacts
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Contact: Ryan Westergaard, MD, PhD, MPH 608-265-7927 rpw@medicine.wisc.edu
Contact: Alexandria Moellner, MPH 608-572-3514 amoellner@medicine.wisc.edu

Locations
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United States, Wisconsin
Vivent Health Recruiting
Appleton, Wisconsin, United States, 54911
Contact: Mikaela Becker, MPH       mikaela.becker@viventhealth.org   
Vivent Health Recruiting
Eau Claire, Wisconsin, United States, 54701
Contact: Mikaela Becker, MPH       mikaela.becker@viventhealth.org   
Vivent Health Recruiting
Green Bay, Wisconsin, United States, 54301
Contact: Mikaela Becker, MPH       mikaela.becker@viventhealth.org   
Vivent Health Recruiting
La Crosse, Wisconsin, United States, 54603
Contact: Mikaela Becker, MPH       mikaela.becker@viventhealth.org   
University of Wisconsin, Madison Recruiting
Madison, Wisconsin, United States, 53706
Contact: Alexandria Moellner, MPH    608-572-3514    amoellner@medicine.wisc.edu   
Principal Investigator: Ryan Westergaard, MD, PhD, MPH         
Vivent Health Recruiting
Schofield, Wisconsin, United States, 54476
Contact: Mikaela Becker, MPH       mikaela.becker@viventhealth.org   
Vivent Health Recruiting
Superior, Wisconsin, United States, 54880
Contact: Mikaela Becker, MPH       mikaela.becker@viventhealth.org   
Sponsors and Collaborators
University of Wisconsin, Madison
Tulane University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Ryan Westergaard, MD, PhD, MPH University of Wisconsin, Madison
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT04268173    
Other Study ID Numbers: 2017-0866
UH3DA044826 ( U.S. NIH Grant/Contract )
A534265 ( Other Identifier: UW Madison )
SMPH/MEDICINE/INFECT DIS ( Other Identifier: UW Madison )
Protocol Version 9/1/2021 ( Other Identifier: UW Madison )
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data collected during the trial, after deidentification. Proposals should be directed to the Data coordinating center at University of Washington. If approved after review, requestors will enter into a formal data sharing agreement. Data will be shared via encrypted single-user file transmission protocol.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis C
Disease
Opioid-Related Disorders
Substance-Related Disorders
Pathologic Processes
Hepatitis
Liver Diseases
Digestive System Diseases
Blood-Borne Infections
Communicable Diseases
Infections
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Narcotic-Related Disorders
Chemically-Induced Disorders
Mental Disorders