- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04268173
Community-Based, Client-Centered Prevention Homes to Address the Rural Opioid Epidemic- Aim 3
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Wisconsin
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Appleton, Wisconsin, United States, 54911
- Vivent Health
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Eau Claire, Wisconsin, United States, 54701
- Vivent Health
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Green Bay, Wisconsin, United States, 54301
- Vivent Health
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La Crosse, Wisconsin, United States, 54603
- Vivent Health
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Madison, Wisconsin, United States, 53706
- University of Wisconsin, Madison
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Schofield, Wisconsin, United States, 54476
- Vivent Health
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Superior, Wisconsin, United States, 54880
- Vivent Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Immediate Intervention
Participants enrolled in this arm will receive a 12-week community-based, client-centered, prevention intervention.
|
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:
|
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. |
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:
|
No Intervention: Nonintervention
Participants enrolled in this arm will receive services as usual from Vivent Health and will not engage in the intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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:
An increase in the Likert scale among intervention participants is associated with increased access to addiction treatment programs compared to the controls. |
Baseline, 3 months, and 6 months
|
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.
Among the intervention group, an increase number of "yes" answers over time will show an improvement in this outcome, compared to the control group. |
Baseline, 3 months, and 6 months
|
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. |
Baseline, 3 months, and 6 months
|
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.
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. |
Baseline, 3 months, and 6 months
|
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.
|
Baseline, 3 months, and 6 months
|
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. |
Baseline, 3 months, and 6 months
|
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
|
Baseline, 3 months, and 6 months
|
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.
A decrease in the Likert scale among intervention participants is associated with decreased self-stigma compared to the controls. |
Baseline, 3 months, and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, 3 months, and 6 months
|
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.
|
Baseline, 3 months, and 6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Year 2
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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.
|
Year 2
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ryan Westergaard, MD, PhD, MPH, University of Wisconsin, Madison
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Narcotic-Related Disorders
- Hepatitis
- Substance-Related Disorders
- Hepatitis C
- Opioid-Related Disorders
Other Study ID Numbers
- 2017-0866
- A534265 (Other Identifier: UW, Madison)
- SMPH/MEDICINE/INFECT DIS (Other Identifier: UW Madison)
- UH3DA044826 (U.S. NIH Grant/Contract)
- Protocol Version 2/1/2023 (Other Identifier: UW Madison)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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