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

NCT ID: NCT04268173

Last Updated: 2024-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 343 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-12
• Study Completion Date: 2023-07-31

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Prevention Navigation

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

Group Type: EXPERIMENTAL

Community-Based, Client-Centered Prevention Home

Intervention Type: OTHER

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

Usual Services

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Prevention Navigation

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

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tulane University

OTHER

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ryan Westergaard, MD, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

Vivent Health

Appleton, Wisconsin, United States

Vivent Health

Eau Claire, Wisconsin, United States

Vivent Health

Green Bay, Wisconsin, United States

Vivent Health

La Crosse, Wisconsin, United States

Vivent Health

Schofield, Wisconsin, United States

Vivent Health

Superior, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

UH3DA044826

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A534265

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/MEDICINE/INFECT DIS

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 2/1/2023

Identifier Type: OTHER

Identifier Source: secondary_id

2017-0866

Identifier Type: -

Identifier Source: org_study_id