Yale-HIV

ACTION Study – Addressing Risk Through Community Treatment for Infectious Disease and Opioid Use Disorder Now

The JCOIN Yale HIV Hub is conducting a type 1 effectiveness-implementation random control trial study to compare two models, Patient Navigation (PN) and Mobile Health Unit (MHU) service delivery, for linking individuals recently involved in the justice system (prison, jail, mandated substance use treatment program, probation, parole) to the continuum of community-based HIV and opioid use disorder (OUD) prevention and treatment service cascades of care.

The study team is recruiting justice-involved adults age 18 or older who are being released to communities in Connecticut and Texas who have pre-incarceration histories of opioid and/or stimulant use, and who are living with or at risk of HIV. Participants are randomized to receive either: (a) PN system of care, wherein patient navigators link study participants to community-based service providers during the six-month post-release intervention period (those without HIV will be provided access to Pre-Exposure Prophylaxis (PrEP) services, and those living with HIV will receive access to ART services; as well as care for hepatitis c virus [HCV], bacterial sexually transmitted infections [STIs], and stimulant and opioid use disorder treatment including medication treatment for opioid use disorder [MOUD]), or (b) MHU service delivery paired with a clinician and a community health worker (CHW), wherein study participants are linked to an MHU within their community, where they receive integrated PrEP/ART, MOUD, HCV, and bacterial STI care during the six-month post-release intervention period.

Study Details

Study Aims

Intervention effectiveness: The study compares the impact of service delivery of PN vs MHU measuring participant length of time to taking initial post-release PrEP (prevention)/ART (treatment) medication within six months following release from custody. Secondarily, researchers will examine the continuum of PrEP and HIV care outcomes, including (but not limited to) the following additional measures: HIV viral suppression for PLH, PrEP adherence, HIV risk behaviors; HCV measures such as HCV testing and linkage to treatment; STI incidence (GC, Chlamydia, Syphilis, HBV); and primary medical care appointments. Importantly, we will also assess OUD and SUD-related measures: OUD/SUD diagnoses, MOUD prescription receipt and retention, opioid & stimulant use, & overdose incidents.

Implementation: To evaluate PN and MHU feasibility, acceptability, and costs. Primary implementation outcomes include feasibility (healthcare 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. Barriers to service access across the community provider spectrum will be assessed as well.

Study Sites

Connecticut Northeast (Hartford, New Haven, Tolland, and Windham Counties)

Connecticut Southeast (Middlesex and New London Counties)

Texas (Dallas County)

Texas (Tarrant County)

Study Settings

Community and justice settings in Connecticut and Texas

Map of Connecticut and Texas Sites

Principal Investigators

Photo of Sandra Springer

Sandra A. Springer, MD (Contact PI)

Professor of Medicine, Yale School of Medicine, Department of Internal Medicine, Section of Infectious Diseases

Photo of Kevin Knight

Kevin Knight, PhD (MPI)

Professor and Director of the Institute of Behavioral Research
Texas Christian University

Photo of Ank Nijhawan

Ank Nijhawan, MD, MPH, MSCS (MPI)

Professor in the Department of Internal Medicine, Division of Infectious Diseases and Geographic Medicine
University of Texas Southwestern Medical Center

Key Co-Investigators

  • Brent Vander Wyk, PhD
    Biostatistician
    Yale School of Medicine
  • Sandra Violette
    Deputy Warden of Addiction Services
    Connecticut Department of Corrections
  • Irene Kuo, MPH, PhD
    Associate Research Professor
    Milken Institute School of Public Health, George Washington University
  • Jennifer Pankow, PhD
    Research Scientist
    Texas Christian University
  • Randi Proffitt, PhD
    Associate Research Scientist
    Texas Christian University
  • Czarina Navos Behrends, PhD
    Assistant Professor of Population Health Sciences
    Weil Cornell Medical College, Cornell University

Community Partners

  • Connecticut (Northeast and Southeast sites)
    Jennifer Muggeo, Ledge Light Health District
    Jill Corbin, Saint Vincent De Paul Place
    Kisha Ellis, Sierra Work Release Program Center
    Jackie Riberidy, Connecticut Food Share
  • Texas (Dallas County site)
    Donna Persaud, MD, Parkland Homeless Outreach Medical Services (HOMES) Program
    Ellen Kitchell, MD, Parkland HIV Services
  • Texas (Tarrant County site)
    Melissa Acosta, John Peter Smith Hospital
    Lynnette Howington, TCU Harris School of Nursing
    Gary Kesling, Tarrant County Public Health Department
    Amy Chairez, My Health My Resources (MHMR) of Tarrant County
    Lonnetta Wilson, Tarrant County HIV Administration

Justice Agency Partners

  • Connecticut (Northeast and Southeast sites)
    Sandra Violette, Connecticut Department of Corrections
    Christine Bachman, Connecticut Department of Corrections
    Jennifer Baldwin, Senior Assistant Public Defender at State of Connecticut
  • Texas (Dallas county site)
    Vonda Freeman, Dallas Country Community Supervision and Corrections Department
    Frank Davis, Gateway Foundation Corrections
  • Texas (Tarrant county site)
    Cobi Tittle, Tarrant Country Community Supervision and Corrections Department

Study Logo

Action study logo

Our Website

Manuscripts

JCOIN Yale HIV Papers

  1. Springer S.A., Nijhawan A.E., Knight K., Kuo I., Di Paola A., Schlossberg E., Frank C.A., Sanchez M., Pankow J., Proffitt R.P., Lehman W., Pulitzer Z., Thompson K., Violette S., Harding K.K.; (2022, April 15). ACTION Cooperative Group. Study protocol of a randomized controlled trial comparing two linkage models for HIV prevention and treatment in justice-involved persons. BMC Infectious Diseases, 22(1), 380. doi: 10.1186/s12879-022-07354-x. PMID: 35428213; PMCID: PMC9013109.
  2. Taweh N., Schlossberg E., Frank C., Nijhawan A., Kuo I., Knight K., Springer S.A. (2021, October). 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. International Journal of Drug Policy. 96:103283. doi: 10.1016/j.drugpo.2021.103283. Epub 2021 May 18. PMID: 34020864; PMCID: PMC8568621.
  3. Nijhawan A.E., Pulitzer Z., Torres B., Noreen N., Schultheis A., Frank C., Colon R., Brooks R., Proffitt R., Pankow J., Bennett A., Salyards M., Kuo I., Knight K., Springer S.A. Indications for HIV pre-exposure prophylaxis (PrEP) in a Justice-involved Population: Intersection of substance use and sexual risk. Emerging Infectious Diseases. Accepted November 2023. In Press.

Photos of Our Mobile Health Units (MHU)

Connecticut Northeast Mobile Health Unit

Connecticut Northeast MHU

Connecticut Northeast Mobile Health Unit
Texas Tarrant County Mobile Health Unit

Texas Tarrant County MHU

Texas Tarrant County Mobile Health Unit
Dallas Mobile Health Unit

Texas Dallas County MHU

Dallas Mobile Health Unit