Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UH3DA044826 | U.S. NIH Grant/Contract | View source | |
| A534265 | Other Identifier | UW Madison | |
| SMPH/MEDICINE/INFECT DIS | Other Identifier | UW Madison | |
| Protocol Version 2/1/2023 | Other Identifier | UW Madison |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Tulane University | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prevention Navigation | Experimental | Participants 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community-Based, Client-Centered Prevention Home | Other | Prevention Navigators at Vivent Helath offices will engage participants in risk assessments, goal planning, and treatment referrals based on their needs and desires. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. | 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. | 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" |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Risk of Viral Hepatitis as Assessed by Change in Likert Scale | Baseline, 3 months, and 6 months | |
| Change in Smoking Frequency as Assessed by Self-reported Behaviors | Baseline, 3 months, and 6 months |
Inclusion Criteria:
Exclusion Criteria:
-
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ryan Westergaard, MD, PhD, MPH | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vivent Health | Appleton | Wisconsin | 54911 | United States | ||
| Vivent Health |
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.
Data will be available after upload to the data coordinating center at University of Washington and will remain for the time records must be held for, according to our data use agreement.
Data will only be shared among researchers in the cooperative agreement.
Not provided
A total of 343 individuals enrolled in the study and provided informed consent. Of these, 16 withdrew from the study or were lost to follow-up before participating in any data collection. Results are therefore reported only for N=327 who completed at least a baseline study assessment.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Usual Services | Participants enrolled in this arm will receive services as usual from Vivent Health and will not engage in the intervention. |
| FG001 | Prevention Navigation | Participants enrolled in this arm will receive a 12-week community-based, client-centered, prevention intervention. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2023 |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
|
| 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." | Pre-intervention, post intervention (3 months) |
| Change in Self-stigma as Assessed by Change in Likert Scale | Baseline, 3 months, and 6 months |
| Change in the Risk of Drug Overdose as Assessed by Change in Frequency of Narcan Distribution | Baseline, 3 months, and 6 months |
| Change in the Treatment Frequency of Viral Hepatitis as Assessed by Wisconsin(WI) Surveillance Databases and Medicaid Data | Baseline, 3 months, and 6 months |
| Addiction Treatment Accessibility and Utilization Frequency Assessment From Long Term Medicaid Data | Year 2 |
| Hepatitis C Treatment Frequency From Long Term Medicaid Data | Year 2 |
| Eau Claire |
| Wisconsin |
| 54701 |
| United States |
| Vivent Health | Green Bay | Wisconsin | 54301 | United States |
| Vivent Health | La Crosse | Wisconsin | 54603 | United States |
| Vivent Health | Schofield | Wisconsin | 54476 | United States |
| Vivent Health | Superior | Wisconsin | 54880 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Usual Services | Participants enrolled in this arm will receive services as usual from Vivent Health and will not engage in the intervention. |
| BG001 | Prevention Navigation | Participants enrolled in this arm will receive a 12-week community-based, client-centered, prevention intervention. 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex/Gender, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Participants responding to the survey question were analyzed | Posted | Mean | Standard Deviation | score on a scale | Pre-intervention, post intervention (3 months) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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. | Only participants responding to the survey question were analyzed | Posted | Mean | Standard Deviation | proportion of "Yes" responses | Pre-intervention, post intervention (3 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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. | Only participants responding to the survey question were analyzed | Posted | Mean | Standard Deviation | score on a scale | Pre-intervention, post intervention (3 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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" | Participants who responded to the survey question were analyzed | Posted | Mean | Standard Deviation | proportion reporting "at least once" | Pre-intervention, post intervention (3 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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." | Participants responding to the survey question were analyzed | Posted | Mean | Standard Deviation | score on a scale | Pre-intervention, post intervention (3 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in the Risk of Viral Hepatitis as Assessed by Change in Likert Scale | Not Posted | Baseline, 3 months, and 6 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Smoking Frequency as Assessed by Self-reported Behaviors | Not Posted | Baseline, 3 months, and 6 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Self-stigma as Assessed by Change in Likert Scale | Not Posted | Baseline, 3 months, and 6 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in the Risk of Drug Overdose as Assessed by Change in Frequency of Narcan Distribution | Not Posted | Baseline, 3 months, and 6 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in the Treatment Frequency of Viral Hepatitis as Assessed by Wisconsin(WI) Surveillance Databases and Medicaid Data | Not Posted | Baseline, 3 months, and 6 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Addiction Treatment Accessibility and Utilization Frequency Assessment From Long Term Medicaid Data | Not Posted | Year 2 | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Hepatitis C Treatment Frequency From Long Term Medicaid Data | Not Posted | Year 2 | Participants |
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).
Because this is a minimal risk study, in which procedures were limited to collection of survey data, the frequency of specific adverse events were not systematically collected. If the study team became aware of a participant hospitalization or death, however, information about the event would be recorded and shared with the institutional review board.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Services | Participants enrolled in this arm will receive services as usual from Vivent Health and will not engage in the intervention. | 0 | 133 | 0 | 133 | 0 | 133 |
| EG001 | Prevention Navigation | Participants enrolled in this arm will receive a 12-week community-based, client-centered, prevention intervention. 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. | 2 | 194 | 0 | 194 | 0 | 194 |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ryan Westergaard | University of Wisconsin-Madison | (608) 265-7927 | rpw@medicine.wisc.edu |
| May 27, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 3, 2020 | May 27, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D006526 | Hepatitis C |
| D040261 | Harm Reduction |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D001519 | Behavior |
| D000079524 | Narcotic-Related Disorders |
Not provided
Not provided
| Male |
|
| Other |
|
| Unknown |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Post-intervention |
|
|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|