Clinical trial NCT04268173: Community-Based, Client-Centered Prevention Homes to Address the Rural Opioid Epidemic- Aim 3
Official title: Community-Based, Client-Centered Prevention Homes to Address the Rural Opioid Epidemic- Aim 3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Use Disorders
Hepatitis C
Harm Reduction
Opioid-use Disorder
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Tulane University
name: National Institute on Drug Abuse (NIDA)
First posted: 2020-02-13
Enrollment: 343
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: 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.

Eligibility 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:

-

Primary outcomes:
measure: Change in the Addiction Treatment Accessibility and Utilization as Assessed by Change in Likert Scale
timeFrame: Pre-intervention, post intervention (3 months)
measure: Change in the Addiction Treatment Accessibility and Utilization as Assessed by Change in Frequency of "Yes" Answers
timeFrame: Pre-intervention, post intervention (3 months)
measure: Change in the Risk of HIV as Assessed by Change in Likert Scale
timeFrame: Pre-intervention, post intervention (3 months)
measure: Change in the Risk of HIV as Assessed by Risky Behavior Frequencies
timeFrame: Pre-intervention, post intervention (3 months)
measure: Change in the Risk of Drug Overdose as Assessed by Change in Likert Scale
timeFrame: Pre-intervention, post intervention (3 months)
Secondary outcomes:
Other outcomes:
measure: Change in the Risk of Viral Hepatitis as Assessed by Change in Likert Scale
timeFrame: Baseline, 3 months, and 6 months
measure: Change in Smoking Frequency as Assessed by Self-reported Behaviors
timeFrame: Baseline, 3 months, and 6 months
measure: Change in Self-stigma as Assessed by Change in Likert Scale
timeFrame: Baseline, 3 months, and 6 months
measure: Change in the Risk of Drug Overdose as Assessed by Change in Frequency of Narcan Distribution
timeFrame: Baseline, 3 months, and 6 months
measure: Change in the Treatment Frequency of Viral Hepatitis as Assessed by Wisconsin(WI) Surveillance Databases and Medicaid Data
timeFrame: Baseline, 3 months, and 6 months
measure: Addiction Treatment Accessibility and Utilization Frequency Assessment From Long Term Medicaid Data
timeFrame: Year 2
measure: Hepatitis C Treatment Frequency From Long Term Medicaid Data
timeFrame: Year 2
Locations:
city: Appleton
country: United States
facility: Vivent Health
state: Wisconsin
city: Eau Claire
country: United States
facility: Vivent Health
state: Wisconsin
city: Green Bay
country: United States
facility: Vivent Health
state: Wisconsin
city: La Crosse
country: United States
facility: Vivent Health
state: Wisconsin
city: Schofield
country: United States
facility: Vivent Health
state: Wisconsin
city: Superior
country: United States
facility: Vivent Health
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Ryan Westergaard, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: