Research

This five-year study will compare Patient Navigation to Mobile Health Unit service delivery for individuals who are released from prisons and jails with a history of pre-incarceration opioid use and/ or injection drug use who are either living with HIV or at risk of acquiring HIV. Individuals recently released from prison and jail 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.

• Funding: National Institute on Drug Abuse (U01DA053039)
• Project Period: September 30, 2020 – July 31, 2025
• PIs: Sandra Springer, MD; Kevin Knight, PhD (Texas Christian University); Ank Nijhawan, MD (University of Texas Southwestern)
• Contact: Richard Colon – 203-815-7380, Esther Schlossberg – 203-494-5393

This pioneer award aims to address the gaps in the Ending the HIV Epidemic Plan for PWUD by BRINGING evidenced-based integrated opioid and HIV services to them wherever they live (housed or unhoused) through a mobile hub and spokes model. Mobile hubs that are pharmacies and clinics on wheels will dispense pre-exposure prophylaxis (PrEP), antiretroviral therapy (ART) and medication treatment for opioid use disorder (OUD; MOUD). Community Health Workers from communities affected by overdoses will identify those in need, perform rapid HIV testing and OUD screening, work with telehealth clinicians and in-person pharmacists to provide rapid PrEP, ART and MOUD as part of mobile rapid response teams (the mobile spokes).

• Funding: National Institute on Drug Abuse (DP1)
• Project period: June 15, 2022 – May 31, 2027
• PIs: Sandra Springer, MD
• Contact: Angela DiPaola - 475-306-1608

STOP (Shared decision making to Treat Or Prevent) HIV in Justice Populations

This research study seeks to compare the effectiveness of two Patient Navigation models of care to evaluate the proportion who initiate PrEP/ART and substance use/substance use disorder (SU/SUD) treatment. A standardized Patient Navigation (PN) arm will be compared with a shared decision-making model in the form of Patient Choice (PN + PC) through the offer of a menu of existing community-based health service delivery options. PNs can assist with setting up medical care appointments, provide resources such as clothing, toiletries, and cell phones, and link and refer to services such as housing, employment, IDs.

• Funding: National Institute on Drug Abuse (1R61DA060625)
• Project Period: May 15, 2024 – April 30, 2025
• PIs: Sandra Springer, MD, Kevin Knight, PhD, Ank Nijhawan, MD, Michele, Staton, PhD
• Contact: Adati Tarfa – 319-350-1530, Alysse Schultheis – 203-231-2454

The BIO study establishes a new Yale University blood/fluid specimen and data repository. This blood and cerebrospinal fluid (CSF) repository will be used to better understand the effects of opioid use disorder and its treatment on the central nervous system of people with HIV (PWH).

The study aims to explore the effects of opioid use disorder (OUD) and the different medications for opioid use disorder (MOUD) on the central nervous system in PWH. The repository will store both specimens (blood and CSF) and data (clinical and demographic data). Establishing this repository will allow investigators to have sufficient data to answer questions surrounding the effects of MOUD in the central nervous system and examine possible differences between the central nervous system and the peripheral blood. It will also allow for future studies of HIV viral changes that occur in the context of OUD and MOUD.

• Funding: National Institute on Drug Abuse (1R01DA060493)
• Project Period: July 1, 2024 – April 30, 2029
• PIs: Shelli Farhadian, MD, PhD and Sandra Springer, MD
• Contact: Tracy Ghantous – 203-836-4285

This study seeks to meaningfully address the U.S. opioid epidemic by implementing evidence-based treatment in correctional settings by comparing the effectiveness of two medications used to treat opioid use disorder, extended-release buprenorphine (XR-B) vs. extended-release naltrexone (XR-NTX), among adults currently incarcerated in U.S. jails and prisons at 5 distinct trial sites. This study will allow providers, correctional and public health authorities, payers and policy makers’ timely and relevant data to assess the effectiveness of XR-B (as well as XR-NTX) as a potentially useful re-entry treatment option considering the majority of opioid users leaving jail or prison will inevitably return to their homes and communities untreated and prone to relapse. We believe findings from this study will have important implications for limiting the greater public safety and societal costs of heroin, fentanyl, and prescription opioid addictions.

• Funding: National Institute on Drug Abuse (1U01DA047982)
• Project Period: August 1, 2019 - April 30, 2024
• PIs: Joshua Lee MD MSc (NYU), Sandra Springer MD, Lisa Marsch PhD (Dartmouth), Elizabeth Waddell PhD (OHSU), David Farabee PhD (OHSU), and Robert Schwartz MD (Friends Research Institute)
• Contact: Angela DiPaola – 475-306-1608, Tracy Ghantous – 203-836-4285

Opioid use disorders (OUD) have significantly increased in the U.S. and are associated with a rise in invasive bacterial infections and new epidemics of HIV and HCV, related to injection drug use. Infectious Disease (ID) specialists and hospitalists are a critical and logical resource to build capacity and increase access to medication treatment for this severely ill population of patients with OUD and infections. We will conduct a randomized controlled trial of a new model of care in which OUD is managed by ID specialists and hospitalists concurrent with management of the OUD-related infections using long acting injectable buprenorphine with the hypothesis that this model of care will increase successful referral and transition to community-based outpatient medication treatment for OUD, reducing opioid use and related morbidity.

• Funding: National Center for Advancing Translational Sciences (1U01TR002763)
• Project Period: July 18, 2019 - June 30, 2023
• PIs: Sandra Springer, MD; Kathleen Brady, MD, PhD (MUSC); Edward Nunes, MD (Columbia); Francis Levin, MD (Columbia)
• Contact: Victor Neirinckx – 203-641-9751, Esther Schlossberg - 203-494-5393

This study aims to determine whether a 28-day administered injectable buprenorphine (INJ-BUP) is superior to daily sublingual buprenorphine/naloxone (SL-BUP/NLX) for Veterans with moderate to severe DSM-5 diagnosed opioid use disorder. Measures will be assessed through 1) retention in pharmacotherapy and 2) increased opioid abstinence based on self-report and negative urine toxicology screens over 52 weeks. This study's findings would lead to widespread adoption by clinicians, through well-established methods of dissemination throughout the Veterans Health Administration (VHA) that would reduce opioid use among Veterans, likely improve Veterans’ medical, psychological, and social outcomes, and undoubtedly save lives. It would also be applicable to much of the non-VA opioid use disorder treatment community and would contribute substantially to the nation’s ability to respond effectively to our current opioid epidemic. No healthcare system is better positioned to conduct such a trial than the VHA because of its national electronic health records and its exceptionally integrated continuity of care, and no treatment offers more promise to Veterans with OUD to date.

• Funding: Veteran's Affairs
• Project Period: March 31, 2019- March 30, 2023
• PIs: Sandra Springer, MD and Ismene L. Petrakis, MD

Opioid use disorders (OUD) have significantly increased in the United States and are associated with HIV transmission and interfering with the HIV continuum of care. There are three forms of medications approved for the treatment of OUD (MOUD) that are all effective at reducing opioid use yet differ in their actions at the opioid µ receptor (methadone, buprenorphine, extended-release naltrexone). We propose to study the HIV-1 expression, proviral landscape and genomic architecture in response to different forms of MOUD in a group of persons living with HIV and OUD beginning MOUD.

• Funding: National Institute on Drug Abuse (5R61DA047037)
• Project period: September 1, 2018- July 31, 2021
• PIs: Sandra Springer, MD; Ya-Chi Ho, MD; Yuval Kluger, PhD
• Contact: Cyndi Frank – 203-745-8630

Project INSPIRE was a randomized, double-blind, placebo-controlled trial of extended-release injectable naltrexone (Brand name: Vivitrol) for treatment of alcohol dependence and hazardous drinking among HIV-infected individuals transitioning from prison to the community. A total of 125 incarcerated, HIV-infected individuals who met pre-incarceration DSM-IV criteria for alcohol dependence or hazardous drinking and were within 6 months of reentry to the community were enrolled in the study. Primary outcomes for this study were retention in HIV care, time to relapse to alcohol use, and acceptability of medication assisted therapy.

• Funding: National Institute on Drug Abuse
• Project Period: September 1, 2009 – August 31, 2014
• PIs: Rick Altice, MD and Sandra Springer, MD

NIDA funded (K23) Buprenorphine administered to released prisoners / jail detainees living with HIV and OUD. Non-randomized prospective trial among 90 participants – sublingual buprenorphine reduced opioid use, craving, and improve HIV viral suppression.

Opioid use disorders (OUD) have become an epidemic of serious proportions in the United States; while medications such as methadone or buprenorphine (medications for OUD, MOUD) can be very effective in treating opioid addiction, it remains unclear whether there are biologic differences between these treatments that could guide their use, and how HIV disease affects the function of these drugs. This study prospectively looks at changes in blood cell function, gene expression, metabolism and alterations in immune function associated with medication assisted therapy (MAT) (e.g. methadone or buprenorphine) to better inform treatment choice.

• Funding: National Institute on Drug Abuse (5R01DA043337)
• Project period: September 1, 2016- May 31, 2021
• PIs: Sandra Springer, MD and Albert Shaw, MD, PhD
• Contact: Mark Sanchez – 203-641-0872

Project NEW HOPE was a double-blinded placebo controlled RCT of XR NTX among HIV+ prisoners with opioid dependence who were transitioning from the prison to the community setting. HIV treatment (HIV-1 RNA levels, CD4 count), substance abuse treatment (time to relapse to opioid use, percent of days using opioids, percent of days abstinent from opioids, addiction severity), adverse side effects, and HIV risk behavior (sexual and drug-related risks) outcomes were assessed. This project was conducted in New Haven, Hartford, and Springfield in collaboration with Baystate Medical Center.

• Funding: National Institute on Drug Abuse
• Project Period: September 1, 2010 – August 31, 2015
• PIs: Sandra Springer, MD