Community Treatment for Infectious Diseases and Opioid Use Disorder

(ACTION Trial)

Recruiting at 2 trial locations

Overseen By Sandra Springer, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Severe disability, Inpatient care, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

600 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the idea that Community Treatment for Infectious Diseases and Opioid Use Disorder is an effective treatment?

The available research shows that mobile health units and patient navigators are effective in increasing access to treatment for people with opioid use disorder. For example, a study on a mobile community-based team for veterans experiencing homelessness found that using mobile technology helped them access buprenorphine treatment, which is often underutilized. Another study highlighted that mobile engagement units successfully connected individuals with opioid use disorder to treatment programs. Additionally, a group-based program in Philadelphia showed that a low-barrier, person-centered approach increased patient access and retention. These findings suggest that community treatment models can effectively reach underserved populations and improve treatment engagement. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Mobile Health Unit, Patient Navigator for infectious diseases and opioid use disorder?

Research shows that mobile health units and patient navigators can effectively connect people with opioid use disorder to treatment programs, especially those facing barriers to traditional care. These approaches have been successful in increasing access to care and improving treatment engagement for underserved populations. ^{1 2 3 4 5}

What safety data exists for mobile health units treating opioid use disorder?

The research indicates that mobile health units, such as the Road to Care and Community Care in Reach, have been successfully implemented to provide addiction treatment and harm reduction services. These programs have demonstrated the ability to deliver high-quality overdose prevention services, including the distribution of naloxone and buprenorphine, to underserved populations. The studies suggest that these mobile services are effective in engaging vulnerable populations, such as those experiencing homelessness, and reducing barriers to treatment. However, specific safety data, such as adverse events or complications, is not detailed in the provided abstracts. ^{1 4 6 7 8}

Is the mobile health unit treatment safe for humans?

The mobile health unit treatment, which provides addiction care and harm reduction services, has been used safely in community settings, including for people experiencing homelessness and those with opioid use disorder. Over two years, it has successfully provided services to over 1,121 individuals without reported safety issues. ^{1 4 6 7 8}

Is the treatment in the trial 'Community Treatment for Infectious Diseases and Opioid Use Disorder' a promising treatment?

Yes, the treatment is promising because it uses mobile units to bring addiction care directly to people who face barriers to accessing traditional healthcare. This approach increases access to important resources like safer consumption supplies, naloxone, and medications for opioid use disorder, especially for vulnerable populations such as those experiencing homelessness. It has shown success in engaging new and underserved communities in addiction services and providing high-quality overdose prevention. ^{1 2 4 6 7}

How does this treatment for opioid use disorder differ from others?

This treatment is unique because it uses mobile units to deliver addiction care directly to people who face barriers to accessing traditional office-based services, such as those experiencing homelessness. It combines harm reduction strategies with medication for opioid use disorder, like buprenorphine, and provides a wide range of primary and preventative care, making it more accessible and convenient for vulnerable populations. ^{1 2 4 6 7}

Research Team

Sandra A Springer, MD

Principal Investigator

Yale University

Eligibility Criteria

This trial is for individuals recently involved with the justice system who have used opioids or stimulants in the past year. Participants should intend to stay locally post-release, consent to HIV testing, and be open to learning about PrEP if HIV-negative. Those with severe medical/psychiatric issues or not staying local are excluded.

Inclusion Criteria

I am open to starting or learning about PrEP if I do not have HIV.

Have been HIV tested or be willing to have testing performed

Involvement with the justice system in last 30 days

Exclusion Criteria

Potential risk to research staff

I am being discharged to a hospital for further care.

Not remaining in the local area after release from custody

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either Patient Navigator (PN) or Mobile Health Unit (MHU) services for linking to community-based HIV and OUD prevention and treatment

6 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention, including assessments of HIV, HCV, and OUD outcomes

6 months

Long-term Follow-up

Participants are monitored for long-term outcomes such as substance use related overdoses and HCV re-infection

12 months

Treatment Details

Interventions

• Mobile Health Unit
• Patient Navigator

Trial Overview The study compares two methods of connecting people released from custody to community services for HIV prevention and opioid use disorder treatment. It involves a Patient Navigator and Mobile Health Unit over five years, assessing effectiveness in linking participants to care.

Participant Groups

Group I: Patient Navigator Experimental Treatment 1 Intervention

Navigators will assist linking study participants to appropriate community service providers

Group II: Mobile Health Unit Experimental Treatment 1 Intervention

Study participants will be linked to a MHU within their community

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

The Mobile Community-based Access Team (M-CAT) pilot program successfully provided buprenorphine (BUP) treatment to veterans experiencing homelessness, showing potential to increase treatment engagement in this high-risk population.

While retention in treatment was lower in M-CAT (19.2 months) compared to the usual BUP clinic (36 months), a significant 66.7% of M-CAT participants remained on BUP at the study's endpoint, indicating that mobile technology can help facilitate access to essential opioid use disorder treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile, Community-Based Buprenorphine Treatment for Veterans Experiencing Homelessness With Opioid Use Disorder: A Pilot, Feasibility Study. Iheanacho, T., Payne, K., Tsai, J.[2022]

A study involving 468 Medicaid-enrolled individuals found that a mobile engagement unit significantly increased access to outpatient substance use treatment services and methadone maintenance for those with opioid use disorder (OUD).

Participants transported by the mobile unit showed a 23 percentage point increase in outpatient treatment utilization and a 32 percentage point increase in methadone maintenance compared to those who accessed treatment through traditional referral routes, indicating the effectiveness of mobile units in connecting underserved populations to necessary care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transporting to treatment: Evaluating the effectiveness of a mobile engagement unit. Stewart, RE., Shen, L., Kwon, N., et al.[2021]

The low-threshold group-based MOUD program at a federally qualified health center in Philadelphia effectively increased patient access and retention through its person-centered harm reduction approach and integration into primary care.

Challenges included varying staff acceptance of harm reduction principles and the need to manage clinic workflow, highlighting the importance of understanding both strengths and challenges for similar programs in other clinics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"It's a place that gives me hope": A qualitative evaluation of a buprenorphine-naloxone group visit program in an urban federally qualified health center. Lai, S., Li, E., Silverio, A., et al.[2022]

The Community Care in Reach® model utilizes mobile units to deliver harm reduction and addiction treatment services directly to individuals facing barriers to traditional office-based care, addressing the rising overdose death rates.

This evaluation will use the RE-AIM framework to measure the effectiveness of these mobile services in engaging new and underserved communities in both addiction treatment and primary care, highlighting the model's potential for improving access to essential health resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for the implementation of a statewide mobile addiction program. Tschampl, CA., Regis, C., Johnson, NE., et al.[2023]

There is a significant gap in the literature regarding effective models for linking individuals recently released from the criminal justice system to integrated prevention and treatment services for HIV, Hepatitis C, and opioid use disorder.

The manuscript compares two models—Peer/Patient Navigation and Mobile Health Units—highlighting the need for more research on their effectiveness in improving access to care and addressing geographical differences in service implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Linking criminal justice-involved individuals to HIV, Hepatitis C, and opioid use disorder prevention and treatment services upon release to the community: Progress, gaps, and future directions. Taweh, N., Schlossberg, E., Frank, C., et al.[2022]

The mobile addiction service, Road to Care, successfully provided holistic addiction care to 1,121 individuals over two years, addressing barriers to treatment access for opioid use disorder, particularly in underserved communities.

The program prescribed buprenorphine/naloxone to 330 patients and distributed nearly 250 naloxone kits, demonstrating its effectiveness in overdose prevention and facilitating further engagement in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mobile addiction service for community-based overdose prevention. Pepin, MD., Joseph, JK., Chapman, BP., et al.[2023]

In 2017, opioid overdoses resulted in 47,600 deaths in the U.S., highlighting a critical public health crisis, especially among vulnerable populations like the homeless.

The Community Care in Reach mobile health initiative, launched in 2018, aims to provide harm reduction and medication for opioid use disorder directly to those at highest risk, showing promise as a model for improving access to addiction care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community Care in Reach: Mobilizing Harm Reduction and Addiction Treatment Services for Vulnerable Populations. Regis, C., Gaeta, JM., Mackin, S., et al.[2022]

The NavSTAR intervention, which provided patient navigation for hospitalized patients with comorbid substance use disorders, resulted in significant cost savings of $17,780 per participant by reducing emergency department visits and inpatient hospital stays over a 12-month period.

The study suggests that implementing patient navigation services can be an effective strategy for healthcare payors and policymakers to lower hospital costs associated with patients suffering from substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost and Cost Savings of Navigation Services to Avoid Rehospitalization for a Comorbid Substance Use Disorder Population. Orme, S., Zarkin, GA., Dunlap, LJ., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Mobile, Community-Based Buprenorphine Treatment for Veterans Experiencing Homelessness With Opioid Use Disorder: A Pilot, Feasibility Study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Transporting to treatment: Evaluating the effectiveness of a mobile engagement unit. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

"It's a place that gives me hope": A qualitative evaluation of a buprenorphine-naloxone group visit program in an urban federally qualified health center. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Protocol for the implementation of a statewide mobile addiction program. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Linking criminal justice-involved individuals to HIV, Hepatitis C, and opioid use disorder prevention and treatment services upon release to the community: Progress, gaps, and future directions. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

A mobile addiction service for community-based overdose prevention. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Community Care in Reach: Mobilizing Harm Reduction and Addiction Treatment Services for Vulnerable Populations. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Cost and Cost Savings of Navigation Services to Avoid Rehospitalization for a Comorbid Substance Use Disorder Population. [2023]