Drug Use DisordersNCT04268173

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

A study testing Community-Based, Client-Centered Prevention Home in people with Drug Use Disorders and Hepatitis C, run by University of Wisconsin, Madison at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Drug Use Disorders, Hepatitis C, Harm Reduction
What is being tested?: Community-Based, Client-Centered Prevention Home
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 343 participants
Where: 6 sitesUnited States
Study dates: 12 Mar 2020to 31 Jul 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

has injected drugs in the past 30 days, resides in Wisconsin, over 18 years of age
able to read and write in English

Who cannot join

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Vivent Health
Appleton, Wisconsin, 54911
Vivent Health
Eau Claire, Wisconsin, 54701
Vivent Health
Green Bay, Wisconsin, 54301
Vivent Health
La Crosse, Wisconsin, 54603
Vivent Health
Schofield, Wisconsin, 54476
Vivent Health
Superior, Wisconsin, 54880

Other trials in United States

About this study

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.

Read the 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
Being tested: Community-Based, Client-Centered Prevention Home
Medical subject headings: Substance-Related Disorders, Hepatitis C, Harm Reduction, Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Community-Based, Client-Centered Prevention HomeOther
Also called Prevention Navigation
Prevention Navigators at Vivent Helath offices will engage participants in risk assessments, goal planning, and treatment referrals based on their needs and desires.

Study groups in NCT04268173
Study group	Role	What they receive
Prevention Navigation	Experimental	Participants enrolled in this arm will receive a 12-week community-based, client-centered, prevention intervention. Receives: Other: Community-Based, Client-Centered Prevention Home
Usual Services	No intervention	Participants enrolled in this arm will receive services as usual from Vivent Health and will not engage in the intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in the Addiction Treatment Accessibility and Utilization as Assessed by Change in Likert Scale
The following question was asked on a scale of 0 to 4, where 0=strongly disagree and 4=strongly agree:
If I wanted to start medical treatment for opioid or heroin addiction, I could easily get buprenorphine or Suboxone or Subutex.
The outcome is represented as the mean response in each intervention group (min 0, max 4)
Measured: Pre-intervention, post intervention (3 months)
Change in the Addiction Treatment Accessibility and Utilization as Assessed by Change in Frequency of "Yes" Answers
Following questions will be asked with yes or no answers.
In the past 3 months, have you gotten buprenorphine maintenance medication-like Suboxone or Subutex-from a doctor or program? Responses were coded as 0 = "No" and 1 = "Yes." Summary statistics presented as "mean" below represent the proportion responding yes.
Measured: Pre-intervention, post intervention (3 months)
Change in the Risk of HIV as Assessed by Change in Likert Scale
Following questions will be asked to gauge ease of accessing clean injecting equipment to assess how risky the participants behaviors are in relation to HIV transmission.
"It's easy for me to get new, clean syringes or needles."
Questions will be answered on a scale of 0 to 4, with 0=strongly disagree and 4=strongly agree. An increase in the Likert scale among intervention participants is associated with increased access to HIV prevention compared to the controls.
Measured: Pre-intervention, post intervention (3 months)
Change in the Risk of HIV as Assessed by Risky Behavior Frequencies
Participants were asked to gauge frequency of safe injection behaviors that reduce the risk of HIV. Participants will be asked how many times in the last 30 days they have practiced these behaviors.
"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?"
Responses were coded 0="never" and 1="at least once"
Measured: Pre-intervention, post intervention (3 months)
Change in the Risk of Drug Overdose as Assessed by Change in Likert Scale
Following question will be asked on a scale of 0 to 4, where 0=strongly disagree and 4=strongly agree
"If I wanted the overdose reversal drug naloxone or Narcan, I could easily get it."
Measured: Pre-intervention, post intervention (3 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Mar 202031 Jul 2023

First posted13 Feb 2020
Study start12 Mar 2020
Primary completion31 Jul 2023
Study completion31 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Drug Use DisordersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Parallel groups
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.
Masking: None (open label)
Enrolment: 343 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04268173
Sponsor's protocol ID: 2017-0866
Other IDs: UH3DA044826, A534265, SMPH/MEDICINE/INFECT DIS, Protocol Version 2/1/2023
Status last verified: Jul 2024
First submitted: 11 Feb 2020
Last updated: 1 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Community-Based, Client-Centered Prevention Homes to Address the Rural Opioid Epidemic- Aim 3
ClinicalTrials.gov ID: NCT04268173
Acronym / sponsor ID: 2017-0866
Conditions: Drug Use Disorders, Hepatitis C, Harm Reduction, Opioid-use Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 343 participants (actual)
Lead sponsor: University of Wisconsin, MadisonUniversity, hospital or other
Collaborators: Tulane University, National Institute on Drug Abuse (NIDA)
Study start: 12 Mar 2020 (actual)
Primary completion: 31 Jul 2023 (actual)
Study completion: 31 Jul 2023 (actual)
First posted: 13 Feb 2020 (actual)
Results: Posted 1 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
Prevention Navigation	Experimental	Other: Community-Based, Client-Centered Prevention HomeParticipants enrolled in this arm will receive a 12-week community-based, client-centered, prevention intervention.
Usual Services	No intervention	–Participants enrolled in this arm will receive services as usual from Vivent Health and will not engage in the intervention.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

has injected drugs in the past 30 days, resides in Wisconsin, over 18 years of age
able to read and write in English

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Community-Based, Client-Centered Prevention HomeAlso: Prevention NavigationPrevention Navigators at Vivent Helath offices will engage participants in risk assessments, goal planning, and treatment referrals based on their needs and desires.	Other	Prevention Navigation

Primary outcome

Change in the Addiction Treatment Accessibility and Utilization as Assessed by Change in Likert Scale
Time frame: Pre-intervention, post intervention (3 months)
The following question was asked on a scale of 0 to 4, where 0=strongly disagree and 4=strongly agree: If I wanted to start medical treatment for opioid or heroin addiction, I could easily get buprenorphine or Suboxone or Subutex. The outcome is represented as the mean response in each intervention group (min 0, max 4)
Change in the Addiction Treatment Accessibility and Utilization as Assessed by Change in Frequency of "Yes" Answers
Time frame: Pre-intervention, post intervention (3 months)
Following questions will be asked with yes or no answers. In the past 3 months, have you gotten buprenorphine maintenance medication-like Suboxone or Subutex-from a doctor or program? Responses were coded as 0 = "No" and 1 = "Yes." Summary statistics presented as "mean" below represent the proportion responding yes.
Change in the Risk of HIV as Assessed by Change in Likert Scale
Time frame: Pre-intervention, post intervention (3 months)
Following questions will be asked to gauge ease of accessing clean injecting equipment to assess how risky the participants behaviors are in relation to HIV transmission. "It's easy for me to get new, clean syringes or needles." Questions will be answered on a scale of 0 to 4, with 0=strongly disagree and 4=strongly agree. An increase in the Likert scale among intervention participants is associated with increased access to HIV prevention compared to the controls.
Change in the Risk of HIV as Assessed by Risky Behavior Frequencies
Time frame: Pre-intervention, post intervention (3 months)
Participants were asked to gauge frequency of safe injection behaviors that reduce the risk of HIV. Participants will be asked how many times in the last 30 days they have practiced these behaviors. "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?" Responses were coded 0="never" and 1="at least once"
Change in the Risk of Drug Overdose as Assessed by Change in Likert Scale
Time frame: Pre-intervention, post intervention (3 months)
Following question will be asked on a scale of 0 to 4, where 0=strongly disagree and 4=strongly agree "If I wanted the overdose reversal drug naloxone or Narcan, I could easily get it."

Results and safety

Results posted to the registry on 1 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Usual Services	133	58
Prevention Navigation	194	86

Primary outcome: Change in the Addiction Treatment Accessibility and Utilization as Assessed by Change in Likert Scale

Time frame: Pre-intervention, post intervention (3 months). Mean (Standard Deviation). Unit: score on a scale

Measure	Usual Services n = 103	Prevention Navigation n = 148
Pre-intervention	1.26 (1.10)	1.07 (1.21)
Post-intervention	1.12 (1.15)	1.03 (1.30)

Prevention Navigation: p = 0.84, t-test, 2 sided

Population analysed: Participants responding to the survey question were analyzed

Primary outcome: Change in the Addiction Treatment Accessibility and Utilization as Assessed by Change in Frequency of "Yes" Answers

Time frame: Pre-intervention, post intervention (3 months). Mean (Standard Deviation). Unit: proportion of "Yes" responses

Measure	Usual Services n = 132	Prevention Navigation n = 185
Pre-Intervention	0.17 (0.38)	0.16 (0.37)
Post-Intervention	0.037 (0.19)	0.11 (0.31)

Population analysed: Only participants responding to the survey question were analyzed

Primary outcome: Change in the Risk of HIV as Assessed by Change in Likert Scale

Time frame: Pre-intervention, post intervention (3 months). Mean (Standard Deviation). Unit: score on a scale

Measure	Usual Services n = 112	Prevention Navigation n = 135
Pre-intervention	1.05 (1.01)	1.09 (1.05)
Post-intervention	1.28 (1.04)	0.86 (1.17)

Population analysed: Only participants responding to the survey question were analyzed

Primary outcome: Change in the Risk of HIV as Assessed by Risky Behavior Frequencies

Time frame: Pre-intervention, post intervention (3 months). Mean (Standard Deviation). Unit: proportion reporting "at least once"

Measure	Usual Services n = 131	Prevention Navigation n = 190
Pre-intervention	0.24 (0.43)	0.25 (0.44)
Post-intervention	0.19 (0.40)	0.21 (0.41)

Population analysed: Participants who responded to the survey question were analyzed

Adverse events

Time frame: The time period during which participants were observed lasted from the date of enrollment until completion of the final follow-up survey (approximately 3-6 months).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Services	0 of 133 (0%)	0 of 133 (0%)	0 of 133
Prevention Navigation	0 of 194 (0%)	0 of 194 (0%)	2 of 194

Limitations and caveats (from the sponsor): This trial was conducted in a challenging community setting among a vulnerable population affected by severe substance use disorder, unstable housing, and frequent criminal legal system involvement. As a result, we experienced very high levels of attrition in both study arms. The resulting level of missing data significantly impedes the ability to draw conclusions about the relationship between intervention exposure and any of the study outcomes.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ryan Westergaard, MD, PhD, MPH principal investigator

University of Wisconsin, Madison

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Community-Based, Client-Centered Prevention Home in people with Drug Use Disorders and Hepatitis C, run by University of Wisconsin, Madison at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Addiction Treatment Accessibility and Utilization as Assessed by Change in Likert Scale (time frame: Pre-intervention, post intervention (3 months)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04268173.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.