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Principal Investigator: Joshua Adam Barocas
Organization: UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
Fiscal Year: 2024
Award: $619,921
Funding agency: National Institute on Drug Abuse
ABSTRACT
People who inject drugs (PWID) remain a high priority population under the Ending the HIV Epidemic: Plan for
America (EHE) with 11% of new HIV infections attributable to injection drug use (IDU). IDU has led to multiple
recent outbreaks of HIV in the US, driven primarily by the ongoing opioid and stimulant crises, creating an
obstacle in meeting EHE goals of a 90% reduction in incident HIV infections by 2030 through the 4 pillars –
diagnose, treat, prevent, and respond. EHE has identified evidence-based interventions within these pillars,
including rapid HIV testing, antiretrovirals, comprehensive syringe services programs (SSPs), and PrEP that
need to be implemented, scaled, and sustained within communities most affected by HIV. To maximize and
extend the effectiveness of these interventions among PWID, differentiated, simplified, integrated, and
comprehensive healthcare models need to be developed, tested, and deployed where they are in comfortable,
destigmatizing environments that simultaneously address a key driver of HIV—substance use disorder (SUD).
In addition to HIV, PWID continue to be impacted by a myriad of harmful health conditions such as hepatitis C
virus (HCV), overdose, bacterial infections and sexually transmitted infections (STIs) due to structural, economic,
social, and policy constraints. PWID often experience discrimination, stigma, and considerable social
disadvantage, leading to almost universal poorer health outcomes than comparable populations who do not
inject drugs. The need for innovative, efficacious, scalable, and community-driven models of healthcare in
destigmatizing settings for PWID is crucial. Our team has led the development and testing of Tele-Harm
Reduction (THR): a telehealth-based, multicomponent, adaptive care model for PWID living with HIV. Building
on this work, we now seek to rapidly adapt and test Comprehensive-THR (C-THR) for comprehensive HIV
prevention services delivered via an SSP. We propose a hybrid type I effectiveness-implementation randomized
controlled trial (n=350) to evaluate the efficacy of the C-THR model vs. offsite referral and peer navigation for
engagement in HIV prevention (i.e., PrEP or medications for OUD). PWID will be recruited from an academic
medical center-based syringe services program (SSP) in Miami, FL (IDEA Miami) from both fixed and mobile
SSP modalities. There are three overall aims of the proposed study: (1) to determine if the C-THR model
increases engagement in HIV prevention compared to offsite referral and peer navigation, (2) to examine the
long-term clinical and cost-effectiveness of the C-THR model, and (3) to assess the implementation and
scalability of the C-THR model in diverse SSP settings. The co-primary outcome is tenofovir on dried blood spot
or buprenorphine on urine drug screen across follow-up at 3,6,9 and 12 months. Secondary outcomes will include
engagement in HIV/HCV/STI testing and sustained virologic response (SVR, cure) for HCV. The cost-
effectiveness analysis, long-term modeling, and mixed-methods implementation and scalability evaluation will
provide compelling data on the sustainability and possible impact of C-THR on comprehensive HIV prevention
delivered via SSPs in the COVID era and beyond.
Terms: <AIDS Virus><AIDS prevention><AIDS test><AIDS/HIV test><Academic Medical Centers><Acquired Immune Deficiency Syndrome Virus><Acquired Immunodeficiency Syndrome Virus><Active Follow-up><Address><Adherence><Adoption><Affect><Anti-Retroviral Agents><Assess implementation><Award><Bacterial Infections><Blood><Blood Reticuloendothelial System><Buprenorphine><COVID crisis><COVID epidemic><COVID pandemic><COVID-19 crisis><COVID-19 epidemic><COVID-19 era><COVID-19 global health crisis><COVID-19 global pandemic><COVID-19 health crisis><COVID-19 pandemic><COVID-19 period><COVID-19 public health crisis><COVID-19 years><Caring><Clinic><Clinical effectiveness><Cognitive Discrimination><Communities><Comprehensive Health Care><Comprehensive Healthcare><Cost Effectiveness Analysis><Data><Development><Diagnosis><Discrimination><Disease Outbreaks><Drug Screening><Drug usage><Drug user><Drugs><Dryness><Economics><Effectiveness><Effectiveness of Interventions><Enrollment><Environment><Epidemic><Evaluation><Evidence based intervention><Foundations><Future><Goals><HCV><HCV infection><HCV/HIV><HIV><HIV Infections><HIV Prevention><HIV and HCV><HIV and hepatitis C><HIV risk><HIV test><HIV-1 test><HIV-2 test><HIV-HCV><HIV/AIDS prevention><HIV/HCV><HIV/Hepatitis C><HTLV-III Infections><HTLV-III-LAV Infections><Harm Minimization><Harm Reduction><Health><Health Care Systems><Healthcare Systems><Hepatitis C><Hepatitis C virus><Hepatitis C virus infection><Hepatitis, Viral, Non-A, Non-B, Parenterally-Transmitted><Hepatitus C><Human Immunodeficiency Viruses><Human T-Lymphotropic Virus Type III Infections><Human immunodeficiency virus test><Hybrids><Implementation assessment><Infection><Injecting drug user><Injection Drug User><Institution><Interdisciplinary Research><Interdisciplinary Study><Intervention><Intervention Strategies><Interview><LAV-HTLV-III><Lymphadenopathy-Associated Virus><Medication><Methods><Modality><Modeling><Multidisciplinary Collaboration><Multidisciplinary Research><NIDA><National Institute of Drug Abuse><National Institute on Drug Abuse><Needle-Exchange Programs><Opiates><Opioid><Outbreaks><Overdose><PRISM framework><PRISM model><PWID><PWUD><Participant><Persons><Pharmaceutical Preparations><Policies><Population><Position><Positioning Attribute><PrEP><Practical Robust Implementation and Sustainability Model><Pragmatic, Robust Implementation and Sustainability Model><Randomized><Randomized, Controlled Trials><Research><SARS-CoV-2 epidemic><SARS-CoV-2 global health crisis><SARS-CoV-2 global pandemic><SARS-CoV-2 pandemic><SARS-coronavirus-2 epidemic><SARS-coronavirus-2 pandemic><Services><Severe Acute Respiratory Syndrome CoV 2 epidemic><Severe Acute Respiratory Syndrome CoV 2 pandemic><Severe acute respiratory syndrome coronavirus 2 epidemic><Severe acute respiratory syndrome coronavirus 2 pandemic><Sexually Transmitted Diseases><Sexually Transmitted Disorder><Sexually Transmitted Infection><Site><Spottings><Stimulant><Substance Use Disorder><Survey Instrument><Surveys><Syringe-Exchange Programs><Syringes><Tenofovir><Testing><Trust><University Medical Centers><Urine><Venereal Diseases><Venereal Disorders><Venereal Infections><Viral><Viread><Virus-HIV><Work><acceptability and feasibility><active followup><anti-retroviral><antiretroviral therapy><antiretroviral treatment><bacteria infection><bacterial disease><barriers to implementation><care outcomes><care services><care systems><comprehensive care><coronavirus disease 2019 crisis><coronavirus disease 2019 epidemic><coronavirus disease 2019 global health crisis><coronavirus disease 2019 global pandemic><coronavirus disease 2019 health crisis><coronavirus disease 2019 pandemic><coronavirus disease 2019 public health crisis><coronavirus disease crisis><coronavirus disease epidemic><coronavirus disease pandemic><coronavirus disease-19 global pandemic><coronavirus disease-19 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challenges><implementation evaluation><implementation process><implementation/effectiveness><infection by hepatitis c virus><injection drug use><innovate><innovation><innovative><interventional strategy><medication for opioid use disorder><meeting><meetings><model-based simulation><models and simulation><naloxone availability><naloxone dispensary><naloxone dispensation><naloxone dispensing><naloxone distribution><naloxone provision><needle exchange><non A, non B hepatitis><non-A, non-B hepatitis><novel><opiate crisis><opioid crisis><opioid epidemic><overdose education><patient navigation><peer><people who inject drugs><people who inject illicit drugs><people who use drugs><people who use illicit drugs><perceived discrimination><perception of discrimination><persons who inject drugs><persons who use drugs><pilot test><poor health outcome><pre-exposure prophylaxis><prevent><preventing><prevention service><primary outcome><process evaluation><provide naloxone><randomisation><randomization><randomized control trial><randomly assigned><recruit><reduced health outcome><response><scale up><screening><screenings><secondary outcome><self-reported discrimination><service programs><severe acute respiratory syndrome coronavirus 2 global health crisis><severe acute respiratory syndrome coronavirus 2 global pandemic><sexually acquired infection><social><social disadvantage><social disparities><social inequality><social stigma><standard of care><stigma><substance use><substance use and disorder><substance using><syringe exchange><syringe exchange services><syringe service programs><telehealth><uptake><worse health outcome>