grant

Implementing a Low-Threshold Hepatitis C Treatment in a Jail Setting

Organization RHODE ISLAND HOSPITALLocation PROVIDENCE, UNITED STATESPosted 15 Sept 2024Deadline 31 Aug 2027
NIHUS FederalResearch GrantFY2025AIDS VirusAccess to CareAcquired Immune Deficiency Syndrome VirusAcquired Immunodeficiency Syndrome VirusActive Follow-upAddressAdministratorAdoptionAnti-viral AgentsCaringCell PhoneCellular PhoneCellular TelephoneClinicCoinCollaborationsCommunicable DiseasesCommunitiesCommunity Health AidesCommunity Health CareCommunity ServicesDataDrug usageDrugsEffectivenessEpidemicFundingGeneral PopulationGeneral PublicGoalsGrantGuidelinesHCVHCV co-infectionHCV coinfectionHCV diseaseHCV therapyHCV treatmentHCV/HIVHIVHIV SeroprevalenceHIV and HCVHIV and hepatitis CHIV-HCVHIV/HCVHIV/Hepatitis CHealthHealth Services AccessibilityHepatitis CHepatitis C TherapeuticsHepatitis C TherapyHepatitis C Virus TreatmentHepatitis C co-infectionHepatitis C treatmentHepatitis C virusHepatitis, Viral, Non-A, Non-B, Parenterally-TransmittedHepatitus CHomeHospitalsHumanHuman Immunodeficiency VirusesHybridsImprisonmentIndividualInfectious DiseasesInfectious DisorderInjecting drug userInjection Drug UserInterventionInterviewJailJusticeKnowledgeLAV-HTLV-IIILifeLinkLymphadenopathy-Associated VirusMaintenanceMedicalMedical StaffMedicationMobile PhonesModelingModern ManMonitorMorbidityMorbidity - disease rateNational Institutes of HealthOutcomePWIDParticipantPatient RecruitmentsPatientsPersonsPharmaceutical PreparationsPilot ProjectsPopulationPrevalencePrisonsProtocolProtocols documentationPublic HealthRE-AIMReach, Effectiveness, Adoption, Implementation, and MaintenanceResearchResearch ResourcesResourcesRhode IslandSeroprevalencesServicesSiteSocietiesStructureSystemTestingTransportationUnited StatesUnited States National Institutes of HealthUniversitiesViralVirus-HIVVisitWorkaccess to health servicesaccess to servicesaccess to treatmentaccessibility to health servicesactive followupanti-viral compoundanti-viral drugsanti-viral medicationanti-viral therapeuticanti-viralsarmavailability of servicescare accessclinical trial implementationco-infectioncoinfectioncommunity carecommunity health workercost estimatecost estimationdrug usedrug/agenteffectiveness and implementation trialeffectiveness outcomeeffectiveness-related outcomeseffectiveness/implementation hybrid trialeffectiveness/implementation trialepidemic virusexperiencefollow upfollow-upfollowed upfollowupformative assessmentformative evaluationfuture implementationhealth service accesshealth services availabilityhep ChepChepatitis C coinfectionhepatitis C virus co-infectionhepatitis C virus coinfectionhepatitis non A non Bhigh riskhomesiPhoneimplementation determinantsimplementation factorsimplementation of clinical trialsimplementation outcomesimplementation/effectivenessincarceratedincarcerationinfection rateinjection drug useinnovateinnovationinnovativemortalitynon A, non B hepatitisnon-A, non-B hepatitisnovelparticipant recruitmentpatient navigationpatient populationpeerpeer supportpeople who inject drugspeople who inject illicit drugspersons who inject drugspilot studypilot trialpractical implementationpragmatic implementationrate of infectionreach, efficacy, adoption, implementation, and maintenanceresponseservice availabilityside effectsmart phonesmartphonesuccesstreatment accesstreatment programtreatment strategyuptakeviral hepatitis C
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Full Description

PROJECT SUMMARY
Carceral facilities, particularly jails, present a unique opportunity to address the public health crisis of

hepatitis C virus (HCV) and HIV among people who inject drugs (PWID). With two-thirds of PWID experiencing

incarceration in the United States and a high HCV/HIV seroprevalence in these settings, jails become a critical

access point for addressing the hepatitis C epidemic. Recent studies demonstrate the potential for low-barrier

HCV treatment models (e.g., the “minimal monitoring” MINMON protocol) to cure hepatitis C, even among

high-risk patient populations including those with active drug use. Despite this, HCV treatment in jails, which

are characterized by high turnover and short-term stays, is rare. This represents a missed public health

opportunity, contrasting with the success of HCV treatment seen in long-term prison facilities.

This planning grant seeks to fill this critical gap by piloting an innovative, low-barrier HCV treatment

strategy in a jail setting. Coined “MINMON-J,” this approach modifies the MINMON protocol for use in jails.

MINMON-J incorporates take-home HCV medication and collaboration with a community Transitions Clinic,

leveraging community health workers (CHWs) to support patient navigation and post-release linkage to care.

In Aim 1, the study aims to evaluate the feasibility and effectiveness of MINMON-J through a single-arm

pilot trial involving jailed PWID with HCV mono-infection or co-infection with HIV. Participants will receive rapid

HCV treatment initiation while incarcerated. Individuals released before treatment will receive all remaining

medication and CHW-facilitated peer navigation. Outcomes, assessed using the RE-AIM/PRISM framework,

will include HCV cure rates and various implementation outcomes to inform a subsequent stepped-wedge

Type 1 hybrid effectiveness-implementation trial.

In Aim 2, in-depth interviews will help characterize facilitators and barriers to low-barrier HCV treatment

in a jail to refine the approach for broader implementation in similar settings.

This research serves to establish a transformative, community-informed strategy for HCV treatment in

jail settings, addressing a significant public health need. The outcomes of this pilot study have the potential to

shift paradigms in HCV elimination strategies, particularly for PWID and people living with HIV, aligning with

the goals of national health agencies, and contributing to the broader effort of HCV elimination.

Grant Number: 5R34DA061732-02
NIH Institute/Center: NIH

Principal Investigator: Justin Berk

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