Community Treatment for Infectious Diseases and Opioid Use Disorder

(ACTION Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best ways to connect people recently released from the justice system with community-based treatments for HIV, hepatitis C, sexually transmitted infections (STIs), and opioid use issues. The study compares two approaches: a Mobile Health Unit (a mobile clinic providing healthcare services) and a Patient Navigator (a guide to help participants access the right services). It targets individuals recently involved with the criminal justice system who have a history of opioid use or risky behaviors, such as unprotected sex. Participants should have HIV, be at risk of HIV, or be willing to learn about HIV prevention.

As an unphased trial, this study offers a unique opportunity to contribute to innovative healthcare solutions and improve community health services.

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 prior data suggests that these models are safe for linking and retaining individuals in community-based care?

Research has shown that using a Mobile Health Unit to deliver medications for opioid use disorder (MOUD) is promising. These units reach more people who need treatment, especially those who might not receive care otherwise. Studies suggest that mobile units effectively increase access and reduce stigma, without reporting any specific safety issues.

The Patient Navigator program also appears well-received. Research indicates that individuals with patient navigators tend to manage their opioid use better. Specifically, one study found that patients with navigator support used opioids less. The studies do not mention any specific safety concerns, suggesting this approach is safe.

Together, both treatments aim to improve access and support without reported safety issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for infectious diseases and opioid use disorder because they offer a new approach to care. Unlike traditional treatments that often require patients to visit healthcare facilities, the Mobile Health Unit brings care directly to patients in their communities, making access more convenient and immediate. Additionally, the Patient Navigator helps link individuals to the right community services, ensuring they receive comprehensive support tailored to their specific needs. These innovations could significantly improve engagement and outcomes by removing barriers to access and personalizing care pathways.

What evidence suggests that this trial's treatments could be effective for infectious diseases and opioid use disorder?

Research has shown that mobile health units, a treatment option in this trial, effectively provide healthcare to individuals with opioid use disorder (OUD) who might not otherwise have access. These units deliver essential services, such as medications and medical care, directly to communities, helping to prevent opioid overdoses. Studies have found that these units effectively keep people engaged in treatment programs by making healthcare more accessible.

Patient navigators, another treatment option in this trial, positively impact individuals with substance use disorders (SUD) by reducing hospital visits and improving treatment outcomes. One study found that patients using navigator services significantly reduced their opioid doses over time. Navigators connect people to vital community services, leading to better health outcomes and fewer hospital readmissions. ^{3 6 7 8 9}

Who Is on the Research Team?

Sandra A Springer, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9705076/

Using Data Science to Improve Outcomes for Persons with ... Data science may be valuable and promising for improving MOUD retention by using “big data” (eg, electronic health record data, claims data mobile/sensor data, ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2949875924001401

Mobile clinics for opioid use disorders: What they do and ... This study provides insight into how mobile clinics address the gaps in care for persons with OUD and fatal opioid overdoses.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39299504/

An economic analysis of the cost of mobile units for harm ... The economic costs of mobile substance use treatment and harm reduction units are substantial but vary by community settings and services ...

4. ascpjournal.biomedcentral.com ascpjournal.biomedcentral.com/articles/10.1186/s13722-023-00427-5

Mobile service delivery in response to the opioid epidemic in ... MOCUs provide a range of services, including medications for OUD, wound care, medical services, case management, and screening for infectious ...

5. academic.oup.com academic.oup.com/ofid/article/12/4/ofaf200/8118989

Open Forum Infectious Diseases | Oxford Academic Health services delivered through an MPC demonstrate the potential to address healthcare gaps for PWUD and warrant exploration and expansion.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10947870/

Mobile Treatment for Opioid Use Disorder: Implementation ... Abstract. Background: Medications for Opioid Use Disorder (MOUD) are lifesaving, but <20% of individuals in the US who could benefit receive them.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2949875923003247

Mobile treatment for opioid use disorder: Implementation of ... Mobile MOUD units as an innovative way to expand access to life-saving medications, promote equity in MOUD treatment, and overcome stigma.

8. aspe.hhs.gov aspe.hhs.gov/sites/default/files/documents/80100760ee84168f3fbc1dd56184c121/implementation-mobile-medication-units.pdf

Implementation of Mobile Medication Units: Findings from a ... The growth of opioid-related deaths has emphasized the importance of expanding access to medications for opioid use disorder (MOUD) to people ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8741230/

Awareness, perception and utilization of a mobile health ... Mobile health clinics (MHC) are an innovative, cost-effective health care delivery approach that increases healthcare access to vulnerable populations.