Community Treatment for Infectious Diseases and Opioid Use Disorder
(ACTION Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Overseen BySandra A Springer, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Yale University
No Placebo Group
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.
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.
12345What 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.
14678Is 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.
12467Eligibility 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
+4 more
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
+2 more
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Patient NavigatorExperimental Treatment1 Intervention
Navigators will assist linking study participants to appropriate community service providers
Group II: Mobile Health UnitExperimental Treatment1 Intervention
Study participants will be linked to a MHU within their community
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UT SouthwesternDallas, TX
Yale School of MedicineNew Haven, CT
Texas Christian UniversityFort Worth, TX
Loading ...
Who Is Running the Clinical Trial?
Yale UniversityLead Sponsor
National Institute on Drug Abuse (NIDA)Collaborator
References
Mobile, Community-Based Buprenorphine Treatment for Veterans Experiencing Homelessness With Opioid Use Disorder: A Pilot, Feasibility Study. [2022]Adults experiencing homelessness with opioid use disorder (OUD) utilize buprenorphine (BUP), a first-line medication for OUD, at very low rates. Innovative and tailored approaches are needed to reduce barriers to treatment and increase utilization of BUP in this population. This study describes a pilot Mobile Community-based Access Team (M-CAT) that used mobile technology and FaceTime in addition to existing community-based case management programs to provide BUP treatment for veterans with OUD experiencing homelessness who had difficulties engaging in the regular BUP clinic.
Transporting to treatment: Evaluating the effectiveness of a mobile engagement unit. [2021]Substance use treatment providers have increasingly developed novel engagement and low-threshold treatment services (such as mobile treatment units) to meet the needs of people with opioid use disorder (OUD). Use of these service models has outpaced the research on their effectiveness. The current study examines the effectiveness of a mobile engagement unit in connecting individuals with OUD to a treatment program.
"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]Background: Medication for opioid use disorder (MOUD) with buprenorphine is effective in treating opioid use disorder yet remains underutilized. Scant research has examined the experience of patients, clinic staff, and providers in a "low-threshold" group-based MOUD program. This study evaluates a "low-threshold" MOUD program at a federally qualified health center (FQHC) in Philadelphia, Pennsylvania through the perspectives of its key stakeholders. Methods: This qualitative study involved focus groups of patients, providers, and clinic staff. Focus groups were conducted between October 2017 and June 2018. Grounded theory was used for analysis. Results: There were a total of 10 focus groups, including 20 patient participants and 26 staff members. Program participants noted that a strength of the program is its person-centered harm reduction approach, which is reflected in the program's policies and design. Program participants discussed the programmatic design choices that facilitated their participation and engagement in the program: ease of access, integration into primary care, and group-based visit model. Challenges in program implementation included varying acceptance and understanding of harm reduction among staff, the unpredictability of clinic volume and workflow, and the need to balance access to primary care and MOUD. Conclusion: This group-based MOUD program's philosophy of person-centered harm reduction, low-barrier approach, the structure of group-based visits, and integrated care contributes to increased patient access and retention. Understanding the strengths and challenges of the program may be useful for other safety-net clinics considering a MOUD program.
Protocol for the implementation of a statewide mobile addiction program. [2023]With overdose deaths increasing, improving access to harm reduction and low barrier substance use disorder treatment is more important than ever. The Community Care in Reach® model uses a mobile unit to bring both harm reduction and clinical care for addiction to people experiencing barriers to office-based care. These mobile units provide many resources and services to people who use drugs, including safer consumption supplies, naloxone, medication for substance use disorder treatment, and a wide range of primary and preventative care. This protocol outlines the evaluation plan for the Community in Care® model in MA, USA. Using the RE-AIM framework, this evaluation will assess how mobile services engage new and underserved communities in addiction services and primary and preventative care.
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]Improving HIV and Hepatitis C Virus (HCV) management among people involved in the criminal justice (CJ) system who use drugs, in particular those with opioid use disorder (OUD), requires effective approaches to screening, linkage, and adherence to integrated prevention and treatment services across correctional and community agencies and providers. This manuscript reviews the literature to explore gaps in HIV, Hepatitis C, and OUD prevention, treatment, and delivery cascades of care for persons involved in the CJ system. Specifically, we compare two models of linkage to prevention and treatment services: Peer/Patient Navigation (PN) wherein the PN links CJ-involved individuals to community-based infectious disease (ID) and substance use prevention and treatment services, and Mobile Health Units (MHU) wherein individuals are linked to a MHU within their community that provides integrated ID and substance use prevention and treatment services. The most notable finding is a gap in the literature, with few to no comparisons of models linking individuals recently released from the CJ system to integrated HIV, Hepatitis C, and OUD prevention and treatment and other harm reduction services. Further, few published studies address the geographical distinctions that affect service implementation and their effects on these substance use, ID and harm reduction care cascades. This manuscript makes specific recommendations to fill this gap through a detailed evaluation of PN and MHU linkage models to co-located and integrated HIV, Hepatitis C, and OUD prevention and treatment services across different communities within the U.S.
A mobile addiction service for community-based overdose prevention. [2023]Mainstays of opioid overdose prevention include medications for opioid use disorder (e.g., methadone or buprenorphine) and naloxone distribution. Inadequate access to buprenorphine limits its uptake, especially in communities of color, and people with opioid use disorders encounter multiple barriers to obtaining necessary medications including insurance, transportation, and consistent availability of telephones. UMass Memorial Medical Center and our community partners sought to alleviate these barriers to treatment through the deployment of a mobile addiction service, called the Road to Care. Using this approach, multidisciplinary and interprofessional providers deliver holistic addiction care by centering our patients' needs with respect to scheduling, location, and convenience. This program also extends access to buprenorphine and naloxone among people experiencing homelessness. Additional systemic and individualized barriers encountered are identified, as well as potential solutions for future mobile addiction service utilization. Over a two-year period, we have cared for 1,121 individuals who have accessed our mobile addiction service in over 4,567 encounters. We prescribed buprenorphine/naloxone (Suboxone®) to 330 individuals (29.4% of all patients). We have distributed nearly 250 naloxone kits directly on-site or and more than 300 kits via prescriptions to local pharmacies. To date, 74 naloxone rescue attempts have been reported back to us. We have demonstrated that a community-based mobile addiction service, anchored within a major medical center, can provide high-volume and high-quality overdose prevention services that facilitate engagement with additional treatment. Our experience is described as a case study below.
Community Care in Reach: Mobilizing Harm Reduction and Addiction Treatment Services for Vulnerable Populations. [2022]Opioid overdoses killed 47,600 people in the United States in 2017. Despite increasing availability of office-based addiction treatment programs, the prevalence of opioid overdose is historically high and disproportionately affects vulnerable populations, including people experiencing homelessness. Despite availability of effective treatment, many at greatest risk of death from overdose experience myriad barriers to care. Launched in 2018, the Community Care in Reach mobile health initiative uses a data-driven approach to bring harm reduction and medication for opioid use disorder directly to those at highest risk of near-term death. Proof-of-concept results suggest that mobile addiction services may serve as a model for expanding access to addiction care for the most vulnerable.
Cost and Cost Savings of Navigation Services to Avoid Rehospitalization for a Comorbid Substance Use Disorder Population. [2023]A randomized clinical trial found that patient navigation for hospital patients with comorbid substance use disorders (SUDs) reduced emergency department (ED) and inpatient hospital utilization compared with treatment-as-usual.