Opioid Use DisorderACTIONNCT05286879
Addressing Risk Through Community Treatment for Infectious Disease and Opioid Use Disorder Now (ACTION) Among Justice-involved Populations
A study testing Patient Navigator and Mobile Health Unit in people with Opioid Use Disorder and Infectious Disease, run by Yale University at 3 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder, Infectious Disease, Risk Reduction Behavior
- What is being tested?
- Patient Navigator and Mobile Health Unit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 601 participants
- Where
- 3 sitesUnited States
- Study dates
- 31 Mar 2022to 12 Dec 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Living in one of our research areas
- Age 18 or older
- Able to provide written informed consent in English or Spanish
- Involvement with the criminal justice system within the last 6 months
- Living with HIV or being at risk of acquiring HIV and willing to learn about PrEP
- Willing to be tested for HIV (unless already confirmed via medical record)
- Having a history of opioid and/or stimulant use within 12 months prior to being in a controlled setting and/or in the last 6 months within the community
- Having a history of condomless sexual intercourse, STI diagnosis, and/or IDU within 6 months prior to being in a controlled setting and/or in the last 6 months within the community
Who cannot join
- Severe medical or psychiatric disability making participation unsafe
- Unable to provide consent
- Not remaining in the local area after release from custody
- Being released to inpatient care
- Potential risk to research staff
Trial locations and contacts
3 sites in 1 country.
United States3 sites
UT Southwestern
Dallas, Texas, 75390
Texas Christian University
Fort Worth, Texas, 76129
Yale School of Medicine
New Haven, Connecticut, 06510
About this study
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.
Read the detailed description
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.
- Conditions
- Opioid Use Disorder, Infectious Disease, Risk Reduction Behavior, Substance Use, Substance Abuse, Stimulant Use Disorder
- Being tested
- Patient Navigator, Mobile Health Unit
- Keywords
- Justice involvement, HIV Prevention, Hepatitis C Prevention
- Medical subject headings
- Opioid-Related Disorders, Communicable Diseases, Risk Reduction Behavior, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient NavigatorBehavioural
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
Mobile Health UnitBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Patient Navigator | Other | Navigators will assist linking study participants to appropriate community service providers Receives: Behavioral: Patient Navigator |
| Mobile Health Unit | Other | Study participants will be linked to a MHU within their community Receives: Behavioral: Mobile Health Unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From the day of release/randomization to initiation of PrEP up to 6 months
Secondary outcomes (14)
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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 6 months
Opioid Abstinence
The mean days of opioid use by self-report via the timeline followback (TLFB).
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: From Month 6 to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start31 Mar 2022
- Primary completion31 Jul 2025
- Study completion12 Dec 2025
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 601 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Sandra A Springer, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05286879
- Sponsor's protocol ID
- 2000029346
- Other IDs
- 1U01DA053039-01
- Acronym
- ACTION
- Status last verified
- Aug 2026
- First submitted
- 25 Feb 2022
- Last updated
- 21 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Villaire S, Sease T, Pankow J, Bennett A, Pulitzer Z, Hansen L, Frank C, Di Paola A, Lehman W, Sanchez M, McQuaid A, Schultheis A, Stein B, Springer SA, Nijhawan AE, Knight K. A qualitative examination of barriers and facilitators to HIV prevention and treatment for people involved with the criminal justice system. Health Justice. 2025 Jun 6;13(1):37. doi: 10.1186/s40352-025-00344-6.
PubMed 40478391Springer SA, Nijhawan AE, Knight K, Kuo I, Di Paola A, Schlossberg E, Frank CA, Sanchez M, Pankow J, Proffitt RP, Lehman W, Pulitzer Z, Thompson K, Violette S, Harding KK; ACTION Cooperative Group. Study protocol of a randomized controlled trial comparing two linkage models for HIV prevention and treatment in justice-involved persons. BMC Infect Dis. 2022 Apr 15;22(1):380. doi: 10.1186/s12879-022-07354-x.
PubMed 35428213
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Risk Through Community Treatment for Infectious Disease and Opioid Use Disorder Now (ACTION) Among Justice-involved Populations
- ClinicalTrials.gov ID
- NCT05286879
- Acronym / sponsor ID
- ACTION / 2000029346
- Conditions
- Opioid Use Disorder, Infectious Disease, Risk Reduction Behavior, Substance Use, Substance Abuse, Stimulant Use Disorder
- Keywords
- Justice involvement, HIV Prevention, Hepatitis C Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 601 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 18 Mar 2022 (actual)
- Results
- Posted 21 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Navigator | Other | Behavioral: Patient NavigatorNavigators will assist linking study participants to appropriate community service providers |
| Mobile Health Unit | Other | Behavioral: Mobile Health UnitStudy participants will be linked to a MHU within their community |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Living in one of our research areas
- Age 18 or older
- Able to provide written informed consent in English or Spanish
- Involvement with the criminal justice system within the last 6 months
- Living with HIV or being at risk of acquiring HIV and willing to learn about PrEP
Key exclusion criteria (5 listed)
- Severe medical or psychiatric disability making participation unsafe
- Unable to provide consent
- Not remaining in the local area after release from custody
- Being released to inpatient care
- Potential risk to research staff
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 |
|---|---|---|
| Patient NavigatorLinkage 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 | Behavioural | Patient Navigator |
| Mobile Health UnitParticipants 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 | Behavioural | Mobile Health Unit |
Primary outcome
Mean Time to Post-release Initiation of ART Medication
Time frame: From the day of release/randomization to initiation of ART up to 6 months
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.
Mean Time to Post-release Initiation of PrEP Medication
Time frame: From the day of release/randomization to initiation of PrEP up to 6 months
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.
14 secondary outcomes
Number of Participants That Initiate PrEP
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.
Time frame: 6 months
Number of Participants Adherent to PrEP by Self-report
Time frame: 6 months
Change in HIV Status
Time frame: Baseline and 12 months
Number of Participants Adherent to ART by Self-report
Time frame: 6 months
HIV Viral Suppression
Time frame: 6 months
Number of Participants With Changes in Sexual Risk Behaviors
Time frame: from baseline up to 6 months
Number of Participants With Changes in HIV Injection Risk Behaviors
Time frame: from baseline up to 6 months
Number of Participants That Used Opioids by Opioid Type
Time frame: 6 months
Opioid Abstinence
Time frame: 6 months
Number of Participants With Substance Use Treatment Participation
Time frame: 6 months
Number of Participants That Used Substances by Type of Substance
Time frame: 6 months
Substance Use Related Overdoses at 6 Months
Time frame: 6 months
Substance Use Related Overdoses at 12 Months
Time frame: From Month 6 to Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40478391Villaire S, Sease T, Pankow J, Bennett A, Pulitzer Z, Hansen L, Frank C, Di Paola A, Lehman W, Sanchez M, McQuaid A, Schultheis A, Stein B, Springer SA, Nijhawan AE, Knight K. A qualitative examination of barriers and facilitators to HIV prevention and treatment for people involved with the criminal justice system. Health Justice. 2025 Jun 6;13(1):37. doi: 10.1186/s40352-025-00344-6.
- Derived from this study: PubMed 35428213Springer SA, Nijhawan AE, Knight K, Kuo I, Di Paola A, Schlossberg E, Frank CA, Sanchez M, Pankow J, Proffitt RP, Lehman W, Pulitzer Z, Thompson K, Violette S, Harding KK; ACTION Cooperative Group. Study protocol of a randomized controlled trial comparing two linkage models for HIV prevention and treatment in justice-involved persons. BMC Infect Dis. 2022 Apr 15;22(1):380. doi: 10.1186/s12879-022-07354-x.
- Individual participant dataSharing planned: Yes
Related trials for Opioid Use Disorder
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
Opioid Use Disorder
Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse
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.
Sandra A Springer, MD principal investigator
Yale University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Navigator and Mobile Health Unit in people with Opioid Use Disorder and Infectious Disease, run by Yale University at 3 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 8 inclusion and 5 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 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 21 Sep 2026). 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?
Mean Time to Post-release Initiation of ART Medication (time frame: From the day of release/randomization to initiation of ART up to 6 months). The study lists 2 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 NCT05286879, which also lists 2 linked publications.
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 21 Sep 2026.