Project T-SHARP: study protocol for a multi-site randomized controlled trial of tele-harm reduction for people with HIV who inject drugs.

BACKGROUND: The resurgence of HIV outbreaks and rising prevalence among people who inject drugs (PWID) remain exigent obstacles to Ending the HIV Epidemic in the USA. Adapting a low threshold, comprehensive treatment model for PWID with HIV can leverage syringe services programs (SSPs) to increase availability and accessibility of antiretrovirals (ART), medications for opioid use disorder (MOUD), and hepatitis C cure. We developed Tele-Harm Reduction, a telehealth-enhanced, harm reduction intervention delivered within an SSP venue. METHODS: The T-SHARP trial is an open-label, multi-site, randomized controlled superiority trial with two parallel treatment arms. Participants (n=240) recruited from SSPs in Miami, Ft. Lauderdale, and Tampa, Florida, who are PWID with uncontrolled HIV (i.e., HIV RNA>200) will be randomized to Tele-Harm Reduction or off-site linkage to HIV care. The primary objective is to compare the efficacy of Tele-Harm Reduction for initiation of ART at SSPs vs. off-site linkage to an HIV clinic with respect to viral suppression across follow-up (suppression at 3, 6, and 12 months post randomization). Participants with HIV RNA<200 copies/ml will be considered virally suppressed. The primary trial outcome is time-averaged HIV viral suppression (HIV RNA <200 copies/ml) over 3-, 6-, and 12-month follow-up. Secondary outcomes include initiation of MOUD measured by urine drug screen and HCV cure, defined as achieving 12-week sustained virologic response (negative HCV RNA at 12 weeks post treatment completion). A cost-effectiveness analysis will be performed. DISCUSSION: The T-SHARP Trial will be the first to our knowledge to test the efficacy of an innovative telehealth intervention with PWID with uncontrolled HIV delivered via an SSP to support HIV viral suppression. Tele-Harm Reduction is further facilitated by a peer to support adherence and bridge the digital divide. This innovative, flipped healthcare model sets aside the traditional healthcare system, reduces multi-level barriers to care, and meets PWID where they are. The T-SHARP trial is a pragmatic clinical trial that seeks to transform the way that PWID access HIV care and improve HIV clinical outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT05208697. Trial registry name: Tele-Harm Reduction. Registration date: January 26, 2022.

Implementation and first-year operating costs of an academic medical center-based syringe services program.

BACKGROUND: Syringe services programs (SSPs) remain highly effective, cost-saving interventions for the prevention of blood-borne infections among people who inject drugs. However, there have been restrictions regarding financial resources allocated to these programs, particularly in the US South. This study aimed to provide cost data regarding the implementation and first-year operations of an academic-based SSP utilizing fixed and mobile strategies, including the integration of onsite wound care. METHODS: We conducted a micro-costing study that retrospectively collected detailed resource utilization and unit cost data for both the fixed and mobile SSP strategies, including onsite wound care, from both healthcare and societal perspectives. A three-step approach was used to identify, measure, and value intervention costs, and cost components were categorized into implementation, variable program, and time-dependent costs. Sensitivity analysis was performed to examine the impact of SSP operational changes (i.e., needs-based distribution and opt-out HIV/HCV testing) on the cost-per-participant. Cost data we presented as overall cost and cost-per-participant adjusted to 2017 US dollars. RESULTS: A total of 452 and 129 participants enrolled in fixed and mobile SSP services, respectively. The total cost associated with implementation and first year operations for the fixed site was $407,217.22 or $729.72 per participant and $311,625.52 or $2415.70 per participant for the mobile unit. The largest cost component for both modalities was time-dependent costs (personnel and overhead), while intervention materials (syringes, injection equipment, naloxone) were less than 15% of the total program cost. DISCUSSION/CONCLUSION: Implementation and operation of new SSP models continue to be low cost compared to treatment for the multitude of harms PWID face without access to evidence-based prevention. Future cost-effectiveness and cost-benefit analyses integrating a comprehensive SSP model within an academic institution, including onsite wound care and other medical services, will provide a more comprehensive understanding of this model, and state-level policy action must be taken to lift the prohibition of state and local funds for the implementation, sustainability, and maintenance of these programs in Florida.

Massachusetts Justice Community Opioid Innovation Network (MassJCOIN).

A major driver of the U.S. opioid crisis is limited access to effective medications for opioid use disorder (MOUD) that reduce overdose risks. Traditionally, jails and prisons in the U.S. have not initiated or maintained MOUD for incarcerated individuals with OUD prior to their return to the community, which places them at high risk for fatal overdose. A 2018 law (Chapter 208) made Massachusetts (MA) the first state to mandate that five county jails deliver all FDA-approved MOUDs (naltrexone [NTX], buprenorphine [BUP], and methadone). Chapter 208 established a 4-year pilot program to expand access to all FDA-approved forms of MOUD at five jails, with two more MA jails voluntarily joining this initiative. The law stipulates that MOUD be continued for individuals receiving it prior to detention and be initiated prior to release among sentenced individuals where appropriate. The jails must also facilitate continuation of MOUD in the community on release. The Massachusetts Justice Community Opioid Innovation Network (MassJCOIN) partnered with these seven diverse jails, the MA Department of Public Health, and community treatment providers to conduct a Type 1 hybrid effectiveness-implementation study of Chapter 208. We will: (1) Perform a longitudinal treatment outcome study among incarcerated individuals with OUD who receive NTX, BUP, methadone, or no MOUD in jail to examine postrelease MOUD initiation, engagement, and retention, as well as fatal and nonfatal opioid overdose and recidivism; (2) Conduct an implementation study to understand systemic and contextual factors that facilitate and impede delivery of MOUDs in jail and community care coordination, and strategies that optimize MOUD delivery in jail and for coordinating care with community partners; (3) Calculate the cost to the correctional system of implementing MOUD in jail, and conduct an economic evaluation from state policy-maker and societal perspectives to compare the value of MOUD prior to release from jail to no MOUD among matched controls. MassJCOIN made significant progress during its first six months until the COVID-19 pandemic began in March 2020. Participating jail sites restricted access for nonessential personnel, established other COVID-19 mitigation policies, and modified MOUD programming. MassJCOIN adapted research activities to this new reality in an effort to document and account for the impacts of COVID-19 in relation to each aim. The goal remains to produce findings with direct implications for policy and practice for OUD in criminal justice settings.