Trial Outcomes & Findings for Community-Based, Client-Centered Prevention Homes to Address the Rural Opioid Epidemic- Aim 3 (NCT NCT04268173)
NCT ID: NCT04268173
Last Updated: 2024-08-01
Results Overview
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)
COMPLETED
NA
343 participants
Pre-intervention, post intervention (3 months)
2024-08-01
Participant Flow
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.
Participant milestones
| Measure |
Usual Services
Participants enrolled in this arm will receive services as usual from Vivent Health and will not engage in the intervention.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
133
|
194
|
|
Overall Study
COMPLETED
|
58
|
86
|
|
Overall Study
NOT COMPLETED
|
75
|
108
|
Reasons for withdrawal
| Measure |
Usual Services
Participants enrolled in this arm will receive services as usual from Vivent Health and will not engage in the intervention.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
75
|
108
|
Baseline Characteristics
Community-Based, Client-Centered Prevention Homes to Address the Rural Opioid Epidemic- Aim 3
Baseline characteristics by cohort
| Measure |
Usual Services
n=133 Participants
Participants enrolled in this arm will receive services as usual from Vivent Health and will not engage in the intervention.
|
Prevention Navigation
n=194 Participants
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.
|
Total
n=327 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.1 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
38.2 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
38.2 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
49 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
83 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Other
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
128 Participants
n=5 Participants
|
180 Participants
n=7 Participants
|
308 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
121 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
275 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
133 participants
n=5 Participants
|
194 participants
n=7 Participants
|
327 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-intervention, post intervention (3 months)Population: Participants responding to the survey question were analyzed
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)
Outcome measures
| Measure |
Usual Services
n=103 Participants
Participants enrolled in this arm will receive services as usual from Vivent Health and will not engage in the intervention.
|
Prevention Navigation
n=148 Participants
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.
|
|---|---|---|
|
Change in the Addiction Treatment Accessibility and Utilization as Assessed by Change in Likert Scale
Pre-intervention
|
1.26 score on a scale
Standard Deviation 1.10
|
1.07 score on a scale
Standard Deviation 1.21
|
|
Change in the Addiction Treatment Accessibility and Utilization as Assessed by Change in Likert Scale
Post-intervention
|
1.12 score on a scale
Standard Deviation 1.15
|
1.03 score on a scale
Standard Deviation 1.30
|
PRIMARY outcome
Timeframe: Pre-intervention, post intervention (3 months)Population: Only participants responding to the survey question were analyzed
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.
Outcome measures
| Measure |
Usual Services
n=132 Participants
Participants enrolled in this arm will receive services as usual from Vivent Health and will not engage in the intervention.
|
Prevention Navigation
n=185 Participants
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.
|
|---|---|---|
|
Change in the Addiction Treatment Accessibility and Utilization as Assessed by Change in Frequency of "Yes" Answers
Pre-Intervention
|
0.17 proportion of "Yes" responses
Standard Deviation 0.38
|
0.16 proportion of "Yes" responses
Standard Deviation 0.37
|
|
Change in the Addiction Treatment Accessibility and Utilization as Assessed by Change in Frequency of "Yes" Answers
Post-Intervention
|
0.037 proportion of "Yes" responses
Standard Deviation 0.19
|
0.11 proportion of "Yes" responses
Standard Deviation 0.31
|
PRIMARY outcome
Timeframe: Pre-intervention, post intervention (3 months)Population: Only participants responding to the survey question were analyzed
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.
Outcome measures
| Measure |
Usual Services
n=112 Participants
Participants enrolled in this arm will receive services as usual from Vivent Health and will not engage in the intervention.
|
Prevention Navigation
n=135 Participants
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.
|
|---|---|---|
|
Change in the Risk of HIV as Assessed by Change in Likert Scale
Pre-intervention
|
1.05 score on a scale
Standard Deviation 1.01
|
1.09 score on a scale
Standard Deviation 1.05
|
|
Change in the Risk of HIV as Assessed by Change in Likert Scale
Post-intervention
|
1.28 score on a scale
Standard Deviation 1.04
|
0.86 score on a scale
Standard Deviation 1.17
|
PRIMARY outcome
Timeframe: Pre-intervention, post intervention (3 months)Population: Participants who responded to the survey question were analyzed
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"
Outcome measures
| Measure |
Usual Services
n=131 Participants
Participants enrolled in this arm will receive services as usual from Vivent Health and will not engage in the intervention.
|
Prevention Navigation
n=190 Participants
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.
|
|---|---|---|
|
Change in the Risk of HIV as Assessed by Risky Behavior Frequencies
Pre-intervention
|
0.24 proportion reporting "at least once"
Standard Deviation 0.43
|
0.25 proportion reporting "at least once"
Standard Deviation 0.44
|
|
Change in the Risk of HIV as Assessed by Risky Behavior Frequencies
Post-intervention
|
0.19 proportion reporting "at least once"
Standard Deviation 0.40
|
0.21 proportion reporting "at least once"
Standard Deviation 0.41
|
PRIMARY outcome
Timeframe: Pre-intervention, post intervention (3 months)Population: Participants responding to the survey question were analyzed
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."
Outcome measures
| Measure |
Usual Services
n=126 Participants
Participants enrolled in this arm will receive services as usual from Vivent Health and will not engage in the intervention.
|
Prevention Navigation
n=180 Participants
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.
|
|---|---|---|
|
Change in the Risk of Drug Overdose as Assessed by Change in Likert Scale
Pre-intervention
|
0.52 score on a scale
Standard Deviation 0.82
|
0.42 score on a scale
Standard Deviation 0.85
|
|
Change in the Risk of Drug Overdose as Assessed by Change in Likert Scale
Post-intervention
|
0.57 score on a scale
Standard Deviation 1.01
|
0.56 score on a scale
Standard Deviation 1.17
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3 months, and 6 monthsOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3 months, and 6 monthsOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3 months, and 6 monthsOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3 months, and 6 monthsOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3 months, and 6 monthsOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Year 2Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Year 2Outcome measures
Outcome data not reported
Adverse Events
Usual Services
Prevention Navigation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place