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Yale ACTION Study Enrolling Patients

June 22, 2022
by Julie Parry

A new clinical trial, the ‘Addressing Risk Through Community Treatment for Infectious Disease and Opioid Use Disorder Now (ACTION)’ initiative, is currently recruiting participants.

The study is open to individuals who have had involvement with the justice system with pre-justice history of opioid use and/or stimulant use, who are at risk or living with HIV. It is run through the Yale Department of Internal Medicine’s Section of Infectious Diseases, InSTRIDE program. The trial will compare care through a patient navigation system that links individuals to clinics in the community that provide substance use treatment, harm reduction services, HIV prevention with pre-exposure prophyaxis (PrEP), HIV treatment, and Hepatitis C treatment to a one-stop mobile health clinic service delivery model where all services are provided.

The study locations are in New London, Middlesex, Windham, and Tolland counties and partners with Alliance For Living, an HIV/AIDS service organization and resource center in southeastern Connecticut and the Connecticut Department of Corrections (CT DOC).

Primary investigator Sandra Ann Springer, MD, associate professor of medicine (infectious diseases) and associate clinical professor of nursing; described the study.

“The study can include people who are being released from a confined setting with justice involvement, like prison and jail, or they could be in the community already and have had justice experience, which can include parole, probation, or recently released. All they have to have is prior opioid or stimulant use,” explained Springer. “No matter what arm [of the study] they're randomized to, everyone will receive HIV testing, hepatitis B and C testing, sexually transmitted infection (STI) testing (gonorrhea, chlamydia, syphilis), and opioid use disorder diagnosis, and then they are randomized to either the individual patient navigator arm or the mobile health clinic arm to receive care. They will get access to clinicians to provide care for PrEP, HIV, HCV, STI, opioid use disorder, as well as help with other substance use and mental health. If they are linked to a clinic, or if they're on the mobile health unit arm, they'll get all those services from the mobile health clinic.”

Study participants will be linked to community-based HIV and opioid use disorder prevention and treatment service care, including pre-exposure prophylaxis (PrEP), antiretroviral therapy, medications for opioid use disorder, hepatitis C treatment, naloxone, and syringe services programs. In addition, they will receive a mental health assessment and opioid overdose education.

Regardless of the treatment arm, participants will all have an in-depth needs assessment and receive assistance with communication (including cell phone provision), housing, transportation, and food, if needed.

“When designing the study, we looked at the rise of overdoses in Connecticut and access to PrEP and antiretroviral therapy. In the areas of the state that we are targeting (the northeast and southeast territories that the four counties encompass) we're seeing a rise in non-fatal and fatal overdoses,” said Mark Sanchez, MHA, project coordinator for the ACTION study. “These areas have been historically underserved and are lacking resources. People in those areas typically must travel far to access medical services and treatment facilities. So, we wanted to try to bring care to people, to help them get back on their feet.”

This work has gained the support of United States Senators Christopher S. Murphy and Richard Blumenthal. In an April 23, 2020, letter to Nora D. Volkow, MD, director of the National Institute on Drug Abuse at the National Institutes of Health, Senators Murphy and Blumenthal wrote that, “in Connecticut, ACTION will help provide needed services to persons in New London, Windham, and Tolland counties. We believe this project is a critical component to addressing the opioid epidemic challenges we face in our state.”

Additionally, Michael E. Passero, mayor of New London, authored a letter of support. He wrote, “We are excited to participate in another study with you that seeks to provide treatment for criminal justice involved persons with opiate use disorders, and are confident that this grant proposal will improve their access to treatment for OUD, HIV, HCV, and help with other healthcare needs.”

The study protocol was published in BMC Infectious Diseases.

Funding is through a grant from the National Institute on Drug Abuse (U01DA053039). This study is also being conducted in two areas in Texas: Texas Christian University in Fort Worth County, by multiple principal investigator Kevin Knight, PhD, and University of Texas Southwestern Medical Center in Dallas Country, by multiple principal investigator Ank Nijhawan, MD.

To learn more or register, please call 877-55-HELPU (43578).

The ACTION study staff is from the Sections of Infectious Diseases and General Internal Medicine, and community healthcare providers. Along with Springer and Sanchez, other support personnel include Cyndi Frank, PhD, RN, Program Director; Alysse Schultheis, MA, Project Coordinator; Angela Di Paola, PhD, Project Coordinator; Esther Schlossberg, BA, Project Coordinator; Ralph Brooks, Data Manager; Brent Vander Wyk, PhD, Biostatistician; Sarah Esteves, MA, Research Assistant; Linda Lopez, Research Assistant; Stazja Stuccio, BA, Community Health Worker; Sharanya Thanapathy, Community Health Worker with Alliance for Living; Lauren Sgro, MBA, Patient Navigator; Tiyana Hock, Patient Navigator with Alliance for Living; Jamal Hanley, Patient Navigator; Kristen Fernandez, RN, Research Clinician; Robert Heimer, PhD, Co-Investigator; Mary Kay Wegman, MSN, APRN, Mobile Health Unit Clinician; Steven Farber, JD, PA-C, Mobile Health Unit Clinician; Kimberly Sue, MD, PhD, Mobile Health Unit Clinician; Kelly Thompson, Co-Investigator, President & CEO at Alliance for Living; Sandra Violette, Co-Investigator, Deputy Warden of Addiction Service at CT Department of Correction, and Jennifer Muggeo, Deputy Director at Ledge Light Health District.

Submitted by Julie Parry on June 21, 2022