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

Hepatitis C Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Drug Use Disorders
• Harm Reduction
• Hepatitis C
• Opioid-Related Disorders
• Opioid-use Disorder
• Substance-Related Disorders

• NCT number: NCT04268173
• Study type: Interventional
• Source: University of Wisconsin, Madison
• Status: Completed
• Phase: Phase 3
• Start date: March 12, 2020
• Completion date: July 31, 2023