An interventional study of Patient Navigator and Mobile Health Unit in Opioid Use Disorder, Infectious Disease and Risk Reduction Behavior, sponsored by Yale University. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Yale University · Not applicable, Interventional, and Supportive care
This is a 5-year Hybrid Type 1 Effectiveness-Implementation Randomized Control Trial (RCT) that compares two models of linking and retaining individuals recently released from justice involvement to the continuum of community-based HIV prevention and treatment, HCV treatment, STI treatment, and opioid use disorder (OUD) prevention and treatment, medication for opioid use disorder (MOUD) service cascades of care.
This 5-year Hybrid Type 1 Effectiveness-Implementation RCT trial compares two models of linking and retaining individuals recently released from justice involvement to the continuum of community-based HIV and OUD prevention and treatment (MOUD) service cascades of care. A significant innovation of this RCT is that it will be delivered within 4 communities where coalition infrastructures have been established as part of the Justice Community Opioid Innovation Network (JCOIN) studies, a National Institute on Drug Abuse (NIDA)-funded Cooperative Agreement initiative to mitigate the impact criminal justice (CJ)-involved individuals with OUD are having on local communities, and the investigators will be able to build on that existing infrastructure. Specifically, up to 960 CJ-involved individuals will be recruited across 2 CT (New London/Middlesex Counties and Windham/Tolland/New Haven/Hartford Counties) \& 2 Texas (Dallas and Tarrant Counties) high risk communities. HIV status will be assessed via rapid testing at initial point of contact. Participants will be randomized to receive at post-release either: a) a Patient Navigator (PN) system for care, wherein navigators will assist linking study participants to appropriate community service providers (e.g., OUD/SUD treatment including MOUD, and HCV testing and treatment; those not living with HIV will be provided access to pre-exposure prophylaxis (PrEP) services, and those living with HIV will receive assistance with gaining initial or continued access to antiretroviral therapy (ART) services, or b) services delivered via a Mobile Health Unit (MHU) within the participants community where participants will receive PrEP/ART, MOUD, and harm reduction services on the MHU or assistance from a community health worker (CHW) in linking to appropriate community-based OUD and other medical and behavioral health providers. The interventions will last for 6 months post-release from custody. The focus of this study is the randomized controlled trial.
Study objectives:
Aim 1 (Intervention Effectiveness) Primary: To compare the effectiveness of PN vs. MHU service delivery on participant length of time to initiating post-release PrEP (prevention)/ART (treatment) medication within 6 months following release from justice involvement. Secondary outcomes will examine the continuum of PrEP and HIV care outcomes, including (but not limited to) the following additional HIV-related measures: viral suppression for people living with HIV (PLH), PrEP adherence, HIV risk behaviors; HCV Measures: HCV testing \& linkage to treatment. Importantly, the investigators will also assess OUD and Substance Use Disorders (SUD)-related measures: OUD/SUD diagnoses, MOUD prescription receipt \& retention, opioid \& stimulant use, and overdose incidents. Other outcomes of interest include sexually transmitted infection (STI) incidence; and primary medical care appointments.
Aim 2 (Implementation): To evaluate Patient Navigation (PN ) and Mobile Health Unit (MHU) feasibility, acceptability, and costs. Primary implementation outcomes include feasibility (health care utilization impact among released individuals, contributions of interagency workgroup members on outcomes); acceptability (participant satisfaction, perceived usefulness); sustainment (continued utilization), and costs required to implement and sustain the approaches as well as to scale-up in additional communities. Additional outcomes will examine the broader impact on community health care including other health services accessed, expanded OUD services, and common barriers (e.g., stigma) to service access across the community provider spectrum. The investigators will also assess cost offsets and effectiveness of the service delivery models on the cascade outcomes. A Persons Who Inject Drugs (PWID) sub-study will focus on gaining insight into participant and social context (inner and outer) factors associated with the effectiveness outcomes.
Note: The study sample size was revised from 864 to 538 participants following identification of an error in the original power analysis, which incorrectly used HIV-positive initiation rates to estimate the overall effect size. A revised power analysis was conducted, and the updated sample size was reviewed and approved by the Data and Safety Monitoring Board (DSMB) during its August 2023 review.
1,472 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's enrollment of 601 is above the median of 63 across 1,166 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Navigators will assist linking study participants to appropriate community service providers
Behavioral: Patient Navigator
Study participants will be linked to a MHU within their community
Behavioral: Mobile Health Unit
Linkage to services for OUD/SUD treatment including MOUD, Hepatitis C virus (HCV) testing and treatment; those not living with HIV infection will be provided access to PrEP services, and those living with HIV will receive assistance with gaining initial or continued access to ART services during the 6-month post-release intervention period
Participants will receive HIV PrEP/ HIV ART, MOUD, harm reduction services on the MHU and or assistance from a community health worker in linking to appropriate community-based OUD and other medical and behavioral health providers across the 6 month post-release intervention period
Mean Time to Post-release Initiation of ART Medication
Restricted mean survival was used to reflect the number of days a person was without medication. Measured by self-reported initiation within 6-months. ART initiation will be measured as the date of self-reported initiation within the 6-month intervention period.
Time frame: From the day of release/randomization to initiation of ART up to 6 months
Mean Time to Post-release Initiation of PrEP Medication
Restricted mean survival was used to reflect the number of days a person was without medication. Measured by self-reported initiation within 6-months. PrEP initiation will be measured as the date of self-reported initiation within the 6-month intervention period.
Time frame: From the day of release/randomization to initiation of PrEP up to 6 months
Number of Participants That Initiate PrEP
The proportion of participants who initiate PrEP, of those who are not living with HIV, will be assessed via self-report and through confirmation with community provider
Time frame: From the day of release/randomization to initiation of PrEP up to 6 months
Proportion of Participants Prescribed PrEP at End of Intervention.
Proportion of participants prescribed PrEP at end of intervention via self-report and through confirmation with community provider
Time frame: 6 months
Number of Participants Adherent to PrEP by Self-report
For participants who initiate PrEP, adherence will be assessed by self-reported PrEP adherence via Visual Analog Scale (VAS), 0-100, higher scores mean better adherence. 80% or greater on the VAS scale was considered adherent.
Time frame: 6 months
Change in HIV Status
Change in HIV status for participants testing negative using rapid point of care (POC) via Orasure tests at baseline that have a follow-up reactive HIV point of care test
Time frame: Baseline and 12 months
Number of Participants Adherent to ART by Self-report
For PLH, adherence to ART treatment will be assessed by self-reported ART adherence via Visual Analog Scale (VAS) 0-100, higher scores mean better adherence. 80% or greater on the VAS scale was considered adherent.
Time frame: 6 months
HIV Viral Suppression
For PLH, HIV viral suppression, for those with HIV at time of randomization: the percent who maintain or achieve HIV viral load \< 200 copies/mL at 6 months
Time frame: 6 months
Number of Participants With Changes in Sexual Risk Behaviors
Changes in injection and sexual risk behaviors, a summary item from Dr. Springer's HIV Risk Behavior tool created for NIDA Seek, Test, Treat, and Retain (STTR) will be used to assess sharing of injection equipment and other drug and sexual risk behaviors
Time frame: from baseline up to 6 months
Number of Participants With Changes in HIV Injection Risk Behaviors
Changes in injection and sexual risk behaviors, a summary item from Dr. Springer's HIV Risk Behavior tool created for NIDA Seek, Test, Treat, and Retain (STTR) will be used to assess sharing of injection equipment and other drug and sexual risk behaviors
Time frame: from baseline up to 6 months
Number of Participants That Used Opioids by Opioid Type
Type of opioids used (not as prescribed) will be assessed by the Texas Christian University Drug Screen 5.
Time frame: 6 months
Opioid Abstinence
The mean days of opioid use by self-report via the timeline followback (TLFB).
Time frame: 6 months
Number of Participants With Substance Use Treatment Participation
Substance use treatment participation will be collected via self-report. Treatments include detoxification, residential treatment, and medication treatments.
Time frame: 6 months
Number of Participants That Used Substances by Type of Substance
Types of other substances used (e.g. stimulant, benzodiazepine, marijuana, synthetic cannabinoids, and alcohol) not as prescribed will be assessed self-reported via Texas Christian University Drug Screen 5
Time frame: 6 months
Substance Use Related Overdoses at 6 Months
Occurrence of non-fatal and fatal substance use related overdoses, through self-report, confirmation with medical providers, and mortality index data
Time frame: 6 months
Substance Use Related Overdoses at 12 Months
Occurrence of non-fatal and fatal substance use related overdoses, through self-report, confirmation with medical providers, and mortality index data
Time frame: From Month 6 to Month 12
PrEP Adherence by Dried Blood Spot (DBS) Testing
For participants who initiate PrEP, adherence will be measured by DBS testing (Orasure, Inc.) and defined as a tenofovirdisoproxil diphosphate (TFV-DP) level \>700 fmol/punch at 6 months, reflecting cumulative dosing over 6-8 weeks and consistent with 4 or more doses of PrEP per week.
Time frame: 6 months
PrEP Adherence by Urine Sample Analysis
For participants who initiate PrEP, adherence will be assessed by TFV-DP urine testing, which measures recent (past 48 hour) dosing (Orasure, Inc.)
Time frame: 6 months
PrEP Adherence Assessed by Prescription Refill Data
For participants who initiate PrEP, the proportion who are adherent based on continuous PrEP prescription refill will be assessed by date of prescription refill and number of pills per refill, via pharmacy data.
Time frame: up to 6 months
Retention in HIV PrEP Care
Retention in PrEP care defined as attending 2 or more visits in 6 months post-release will be assessed via self-report and through confirmation with community provider
Time frame: up to 6 months
ART Adherence by DBS Testing
For participants living with HIV (PLH), adherence to ART treatment measured via the dry blood spot for TFV-DP, level \>700 fmol/punch at 6 months
Time frame: 6 months
ART Adherence by Urine Sample Analysis
For PLH, adherence to ART treatment measured via urine testing for TFV-DP based regimens.
Time frame: 6 months
ART Adherence by Prescription Refill
For participants who are prescribed ART, the proportion who are adherent based on continuous ART prescription refill will be assessed by date of prescription refill and number of pills per refill, via pharmacy data.
Time frame: up to 6 months
Retention in HIV ART Care
For PLH, retention in HIV ART care: defined as attending 2 or more visits in 6 months post-release will be assessed via selfreport and through confirmation with community provider
Time frame: up to 6 months
Hepatitis C Incidence at Baseline
The proportion who test positive on rapid POC Hepatitis C virus (HCV) test with confirmatory reflex HCV viral load at baseline
Time frame: at baseline
Hepatitis C Incidence
The proportion who test positive on rapid POC HCV test with confirmatory HCV viral load at 6 months
Time frame: 6 months
Hepatitis C Linkage
Time to linked appointment for HCV treatment during the 6 month intervention will be assessed via self-report and through confirmation with community provider
Time frame: Day of release/randomization to appointment time up to 6 months
Hepatitis C Medication Initiation Via Self-report
Time to HCV direct acting antiviral treatment (DAAs) during the 6 month will be assessed via self-report VAS
Time frame: From baseline to reported treatment up to 6 months
Hepatitis C Medication Initiation by Prescription Refill
HCV direct acting antiviral treatment (DAAs) during the 6 month will be assessed via prescription refill data
Time frame: up to 6 months
Hepatitis C Medication Initiation by Confirmation From Provider
Initiation of HCV direct acting antiviral treatment (DAAs) during the 6 month will be assessed via confirmation with community provider
Time frame: up to 6 months
Hepatitis C Medication Completion by Self-report
The proportion of participants prescribed DAAs who complete treatment will be assessed via self-report at 6 months
Time frame: 6 months
Hepatitis C Medication Completion by Prescription Refill
The proportion of participants prescribed DAAs who complete treatment will be assessed via prescription refill data at 6 months
Time frame: 6 months
Hepatitis C Medication Completion by Confirmation From Provider
The proportion of participants prescribed DAAs, who complete treatment will be assessed via confirmation with community provider at 6 months
Time frame: 6 months
Hepatitis C Sustained Viral Remission (SVR)
The proportion of participants who achieve SVR at week 12 upon completion of DAA prescription medication, assessed as undetectable HCV viral load.
Time frame: up to 6 months
Hepatitis C Re-infection
The proportion of participants, of those that achieve HCV SVR, that are re-infected with HCV at 12 months, via reactive rapid HCV POC test result
Time frame: 12 months
Opioid Use
Opioid use (not as prescribed) will be assessed by the proportion of monthly urine samples negative vs. positive/missing
Time frame: 6 months
Number of Opioid Use Days
Number of days of opioid use, not as prescribed, will be assessed using the timeline follow back (TLFB) method
Time frame: 6 months
Linkage to Medications for Opioid Use Disorder (MOUD) Via Self-report
Time to linked appointment for MOUD treatment during the 6 month intervention will be assessed via self-report
Time frame: From day of release/randomization to appointment for MOUD up to 6 months
Linkage to Medications for Opioid Use Disorder (MOUD) Via Community Provider
Time to linked appointment for MOUD treatment during the 6 month intervention will be assessed via confirmation with community provider
Time frame: From day of release/randomization to appointment for MOUD up to 6 months
MOUD Retention by Community Provider
Retention on MOUD type and dose of MOUD via confirmation from community provider
Time frame: up to 6 months
MOUD Retention by Self-report
Retention on MOUD, using the Justice Community Opioid Innovation Network (JCOIN) instrument via self-reported type and dose of MOUD
Time frame: up to 6 months
Substance Use
Use of other substances (e.g. stimulant, benzodiazepine, methylenedioxymethamphetamine, marijuana, and alcohol) not as prescribed, will be assessed by the proportion of monthly urine samples negative vs. positive/missing
Time frame: 6 months
| Milestone | Patient Navigator | Mobile Health Unit |
|---|---|---|
| Started | 295 | 306 |
| Completed | 295 | 306 |
| Not completed | 0 | 0 |
Restricted mean survival was used to reflect the number of days a person was without medication. Measured by self-reported initiation within 6-months. ART initiation will be measured as the date of self-reported initiation within the 6-month intervention period.
| days | Patient Navigator | Mobile Health Unit |
|---|---|---|
| Mean Time to Post-release Initiation of ART Medication | 51 ± 17 | 54.9 ± 25 |
Restricted mean survival was used to reflect the number of days a person was without medication. Measured by self-reported initiation within 6-months. PrEP initiation will be measured as the date of self-reported initiation within the 6-month intervention period.
| days | Patient Navigator | Mobile Health Unit |
|---|---|---|
| Mean Time to Post-release Initiation of PrEP Medication | 178.83 (175.75 to 181.91) | 172.53 (167.87 to 177.19) |
The proportion of participants who initiate PrEP, of those who are not living with HIV, will be assessed via self-report and through confirmation with community provider
| Participants | Patient Navigator | Mobile Health Unit |
|---|---|---|
| Number of Participants That Initiate PrEP | 7 | 22 |
Proportion of participants prescribed PrEP at end of intervention via self-report and through confirmation with community provider
| Participants | Patient Navigator | Mobile Health Unit |
|---|---|---|
| Proportion of Participants Prescribed PrEP at End of Intervention. | 7 | 22 |
For participants who initiate PrEP, adherence will be assessed by self-reported PrEP adherence via Visual Analog Scale (VAS), 0-100, higher scores mean better adherence. 80% or greater on the VAS scale was considered adherent.
| Participants | Patient Navigator | Mobile Health Unit |
|---|---|---|
| Number of Participants Adherent to PrEP by Self-report | 2 | 7 |
Change in HIV status for participants testing negative using rapid point of care (POC) via Orasure tests at baseline that have a follow-up reactive HIV point of care test
| Participants | Patient Navigator | Mobile Health Unit |
|---|---|---|
| Change in HIV Status | 1 | 0 |
For PLH, adherence to ART treatment will be assessed by self-reported ART adherence via Visual Analog Scale (VAS) 0-100, higher scores mean better adherence. 80% or greater on the VAS scale was considered adherent.
| Participants | Patient Navigator | Mobile Health Unit |
|---|---|---|
| Number of Participants Adherent to ART by Self-report | 9 | 13 |
For PLH, HIV viral suppression, for those with HIV at time of randomization: the percent who maintain or achieve HIV viral load \< 200 copies/mL at 6 months
| Participants | Patient Navigator | Mobile Health Unit |
|---|---|---|
| HIV Viral Suppression | 6 | 9 |
Changes in injection and sexual risk behaviors, a summary item from Dr. Springer's HIV Risk Behavior tool created for NIDA Seek, Test, Treat, and Retain (STTR) will be used to assess sharing of injection equipment and other drug and sexual risk behaviors
| Participants | Patient Navigator | Mobile Health Unit |
|---|---|---|
| Number of Participants With Changes in Sexual Risk Behaviors | 74 | 84 |
Changes in injection and sexual risk behaviors, a summary item from Dr. Springer's HIV Risk Behavior tool created for NIDA Seek, Test, Treat, and Retain (STTR) will be used to assess sharing of injection equipment and other drug and sexual risk behaviors
| Participants | Patient Navigator | Mobile Health Unit |
|---|---|---|
| Number of Participants With Changes in HIV Injection Risk Behaviors | 5 | 3 |
Type of opioids used (not as prescribed) will be assessed by the Texas Christian University Drug Screen 5.
| Participants | Patient Navigator | Mobile Health Unit |
|---|---|---|
| Heroin | 14 | 10 |
| Fentanyl | 20 | 19 |
| Prescription opioid medication | 3 | 6 |
The mean days of opioid use by self-report via the timeline followback (TLFB).
| days | Patient Navigator | Mobile Health Unit |
|---|---|---|
| Opioid Abstinence | 20 ± 45 | 24 ± 48 |
Substance use treatment participation will be collected via self-report. Treatments include detoxification, residential treatment, and medication treatments.
| Participants | Patient Navigator | Mobile Health Unit |
|---|---|---|
| Number of Participants With Substance Use Treatment Participation | 56 | 49 |
Types of other substances used (e.g. stimulant, benzodiazepine, marijuana, synthetic cannabinoids, and alcohol) not as prescribed will be assessed self-reported via Texas Christian University Drug Screen 5
| Participants | Patient Navigator | Mobile Health Unit |
|---|---|---|
| Alcohol | 18 | 19 |
| Cannabis | 8 | 7 |
| Cocaine | 31 | 29 |
| Methamphetamine | 26 | 27 |
| Prescription stimulant medication | 0 | 2 |
| Benzodiazepine | 0 | 3 |
| Synthetic cannabinoids | 0 | 1 |
Occurrence of non-fatal and fatal substance use related overdoses, through self-report, confirmation with medical providers, and mortality index data
| Participants | Patient Navigator | Mobile Health Unit |
|---|---|---|
| Non-fatal overdose | 10 | 23 |
| Fatal overdose | 3 | 2 |
Occurrence of non-fatal and fatal substance use related overdoses, through self-report, confirmation with medical providers, and mortality index data
| Participants | Patient Navigator | Mobile Health Unit |
|---|---|---|
| Non-fatal overdose | 10 | 17 |
| Fatal overdose | 0 | 0 |
For participants who initiate PrEP, adherence will be measured by DBS testing (Orasure, Inc.) and defined as a tenofovirdisoproxil diphosphate (TFV-DP) level \>700 fmol/punch at 6 months, reflecting cumulative dosing over 6-8 weeks and consistent with 4 or more doses of PrEP per week.
Results for this outcome have not been posted.
For participants who initiate PrEP, adherence will be assessed by TFV-DP urine testing, which measures recent (past 48 hour) dosing (Orasure, Inc.)
Results for this outcome have not been posted.
For participants who initiate PrEP, the proportion who are adherent based on continuous PrEP prescription refill will be assessed by date of prescription refill and number of pills per refill, via pharmacy data.
Results for this outcome have not been posted.
Retention in PrEP care defined as attending 2 or more visits in 6 months post-release will be assessed via self-report and through confirmation with community provider
Results for this outcome have not been posted.
For participants living with HIV (PLH), adherence to ART treatment measured via the dry blood spot for TFV-DP, level \>700 fmol/punch at 6 months
Results for this outcome have not been posted.
For PLH, adherence to ART treatment measured via urine testing for TFV-DP based regimens.
Results for this outcome have not been posted.
For participants who are prescribed ART, the proportion who are adherent based on continuous ART prescription refill will be assessed by date of prescription refill and number of pills per refill, via pharmacy data.
Results for this outcome have not been posted.
For PLH, retention in HIV ART care: defined as attending 2 or more visits in 6 months post-release will be assessed via selfreport and through confirmation with community provider
Results for this outcome have not been posted.
The proportion who test positive on rapid POC Hepatitis C virus (HCV) test with confirmatory reflex HCV viral load at baseline
Results for this outcome have not been posted.
The proportion who test positive on rapid POC HCV test with confirmatory HCV viral load at 6 months
Results for this outcome have not been posted.
Time to linked appointment for HCV treatment during the 6 month intervention will be assessed via self-report and through confirmation with community provider
Results for this outcome have not been posted.
Time to HCV direct acting antiviral treatment (DAAs) during the 6 month will be assessed via self-report VAS
Results for this outcome have not been posted.
HCV direct acting antiviral treatment (DAAs) during the 6 month will be assessed via prescription refill data
Results for this outcome have not been posted.
Initiation of HCV direct acting antiviral treatment (DAAs) during the 6 month will be assessed via confirmation with community provider
Results for this outcome have not been posted.
The proportion of participants prescribed DAAs who complete treatment will be assessed via self-report at 6 months
Results for this outcome have not been posted.
The proportion of participants prescribed DAAs who complete treatment will be assessed via prescription refill data at 6 months
Results for this outcome have not been posted.
The proportion of participants prescribed DAAs, who complete treatment will be assessed via confirmation with community provider at 6 months
Results for this outcome have not been posted.
The proportion of participants who achieve SVR at week 12 upon completion of DAA prescription medication, assessed as undetectable HCV viral load.
Results for this outcome have not been posted.
The proportion of participants, of those that achieve HCV SVR, that are re-infected with HCV at 12 months, via reactive rapid HCV POC test result
Results for this outcome have not been posted.
Opioid use (not as prescribed) will be assessed by the proportion of monthly urine samples negative vs. positive/missing
Results for this outcome have not been posted.
Number of days of opioid use, not as prescribed, will be assessed using the timeline follow back (TLFB) method
Results for this outcome have not been posted.
Time to linked appointment for MOUD treatment during the 6 month intervention will be assessed via self-report
Results for this outcome have not been posted.
Time to linked appointment for MOUD treatment during the 6 month intervention will be assessed via confirmation with community provider
Results for this outcome have not been posted.
Retention on MOUD type and dose of MOUD via confirmation from community provider
Results for this outcome have not been posted.
Retention on MOUD, using the Justice Community Opioid Innovation Network (JCOIN) instrument via self-reported type and dose of MOUD
Results for this outcome have not been posted.
Use of other substances (e.g. stimulant, benzodiazepine, methylenedioxymethamphetamine, marijuana, and alcohol) not as prescribed, will be assessed by the proportion of monthly urine samples negative vs. positive/missing
Results for this outcome have not been posted.
Collected over 12 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patient Navigator | 7/295 (2.4%) | 34/295 (11.5%) | 127/295 (43.1%) |
| Mobile Health Unit | 4/306 (1.3%) | 39/306 (12.7%) | 132/306 (43.1%) |
| Event | Patient Navigator | Mobile Health Unit |
|---|---|---|
| Non-fatal overdoseInjury, poisoning and procedural complications | 4/295 | 2/306 |
| pneumoniaRespiratory, thoracic and mediastinal disorders | 4/295 | 2/306 |
| Infection - skinInfections and infestations | 3/295 | 4/306 |
| Substance use withdrawalInjury, poisoning and procedural complications | 0/295 | 4/306 |
| General injury (falls and fights)Injury, poisoning and procedural complications | 2/295 | 4/306 |
| Fatal overdoseInjury, poisoning and procedural complications | 3/295 | 2/306 |
| Infection - skeletalInfections and infestations | 1/295 | 3/306 |
| FractureInjury, poisoning and procedural complications | 2/295 | 3/306 |
| Motor vehicle accidentInjury, poisoning and procedural complications | 2/295 | 1/306 |
| Unknown cause of deathInjury, poisoning and procedural complications | 2/295 | 2/306 |
| Event | Patient Navigator | Mobile Health Unit |
|---|---|---|
| Incarceration/reincarcerationSocial circumstances | 108/295 | 110/306 |
| Nonfatal overdoseInjury, poisoning and procedural complications | 19/295 | 34/306 |
| Age, Continuous(years) | Patient Navigator | Mobile Health Unit | Total |
|---|---|---|---|
| Mean | 41.9 ± 10.4 | 42.2 ± 10.4 | 42.1 ± 10.4 |
| Sex: Female, Male(Participants) | Patient Navigator | Mobile Health Unit | Total |
|---|---|---|---|
| Female | 66 | 79 | 145 |
| Male | 229 | 227 | 456 |
| Race (NIH/OMB)(Participants) | Patient Navigator | Mobile Health Unit | Total |
|---|---|---|---|
| American Indian or Alaska Native | 5 | 2 | 7 |
| Asian | 3 | 2 | 5 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 79 | 79 | 158 |
| White | 167 | 178 | 345 |
| More than one race | 18 | 21 | 39 |
| Unknown or Not Reported | 22 | 24 | 46 |
| Ethnicity (NIH/OMB)(Participants) | Patient Navigator | Mobile Health Unit | Total |
|---|---|---|---|
| Hispanic or Latino | 74 | 74 | 148 |
| Not Hispanic or Latino | 221 | 232 | 453 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Patient Navigator | Mobile Health Unit | Total |
|---|---|---|---|
| United States | 295 | 306 | 601 |
| Education, High School or above(Participants) | Patient Navigator | Mobile Health Unit | Total |
|---|---|---|---|
| Count of participants | 230 | 234 | 464 |
| Health Insurance Coverage(Participants) | Patient Navigator | Mobile Health Unit | Total |
|---|---|---|---|
| None/Uninsured | 107 | 104 | 211 |
| Charity Care | 19 | 21 | 40 |
| Medicare | 7 | 9 | 16 |
| Medicaid | 122 | 122 | 244 |
| Other government (VA, etc.) | 4 | 5 | 9 |
| Private insurance | 31 | 38 | 69 |
| Supplemental (Medigap/single insurance) | 1 | 0 | 1 |
| Unknown/Did not respond | 3 | 6 | 9 |
| Missing | 1 | 1 | 2 |
| Housing Status last 30 days/30 days prior to incarceration(Participants) | Patient Navigator | Mobile Health Unit | Total |
|---|---|---|---|
| Stable Housing | 81 | 77 | 158 |
| Unstable Housing | 140 | 146 | 286 |
| Unhoused | 74 | 83 | 157 |
6 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes
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