2022
Study protocol of a randomized controlled trial comparing two linkage models for HIV prevention and treatment in justice-involved persons
Springer SA, Nijhawan AE, Knight K, Kuo I, Di Paola A, Schlossberg E, Frank CA, Sanchez M, Pankow J, Proffitt RP, Lehman W, Pulitzer Z, Thompson K, Violette S, Harding KK. Study protocol of a randomized controlled trial comparing two linkage models for HIV prevention and treatment in justice-involved persons. BMC Infectious Diseases 2022, 22: 380. PMID: 35428213, PMCID: PMC9013109, DOI: 10.1186/s12879-022-07354-x.Peer-Reviewed Original ResearchConceptsJustice-involved individualsAntiretroviral treatmentHIV preventionUse disordersStudy participantsStimulant useSubstance use disorder servicesCommunity-based HIVPost-release interventionsPrimary implementation outcomeHIV viral loadPre-exposure prophylaxisOpioid use disorderTreatment of HIVHIV risk behaviorsRisk of HIVSubstance use disordersHigh-risk communitiesHybrid type 1Justice-involved personsHCV testingLinkage interventionHIV careSecondary outcomesART adherenceRationale, design and methods of VA-BRAVE: a randomized comparative effectiveness trial of two formulations of buprenorphine for treatment of opioid use disorder in veterans
Petrakis I, Springer SA, Davis C, Ralevski E, Gu L, Lew R, Hermos J, Nuite M, Gordon AJ, Kosten TR, Nunes EV, Rosenheck R, Saxon AJ, Swift R, Goldberg A, Ringer R, Ferguson R. Rationale, design and methods of VA-BRAVE: a randomized comparative effectiveness trial of two formulations of buprenorphine for treatment of opioid use disorder in veterans. Addiction Science & Clinical Practice 2022, 17: 6. PMID: 35101115, PMCID: PMC8802273, DOI: 10.1186/s13722-022-00286-6.Peer-Reviewed Original ResearchConceptsOpioid use disorderVeterans Healthcare AdministrationFormulations of buprenorphineComparative effectiveness trialOpioid useEffectiveness trialUse disordersOpioid epidemicSublingual buprenorphine/naloxoneSevere opioid use disorderBuprenorphine/naloxoneUS opioid epidemicClinical effectiveness trialStandard of careEffective medication treatmentsExtended-release formulationUrgent clinical needLong-term trialsHepatitis BSecondary outcomesSevere sequelaeOpioid abstinencePrimary outcomeMedication treatmentTRIAL REGISTRATION
2021
Design and methods of a multi-site randomized controlled trial of an integrated care model of long-acting injectable buprenorphine with infectious disease treatment among persons hospitalized with infections and opioid use disorder
Seval N, Frank CA, Litwin AH, Roth P, Schade MA, Pavlicova M, Levin FR, Brady KT, Nunes EV, Springer SA. Design and methods of a multi-site randomized controlled trial of an integrated care model of long-acting injectable buprenorphine with infectious disease treatment among persons hospitalized with infections and opioid use disorder. Contemporary Clinical Trials 2021, 105: 106394. PMID: 33838307, PMCID: PMC8172465, DOI: 10.1016/j.cct.2021.106394.Peer-Reviewed Original ResearchConceptsOpioid use disorderInfectious disease treatmentUse disordersCo-occurring opioid use disorderTreatment of OUDLife-threatening infectious diseaseSubstantial healthcare utilizationProportion of patientsInfectious disease specialistsInjection drug usePrimary outcome measureIntegrated care modelDisease treatmentMulti-site trialInjectable buprenorphineOpioid useSecondary outcomesHealthcare utilizationInfection morbidityDisease specialistsMedication treatmentSerious infectionsMonthly formulationDrug overdoseID specialists
2018
Extended-release Naltrexone Improves Viral Suppression Among Incarcerated Persons Living with HIV and Alcohol use Disorders Transitioning to the Community
Springer SA, Di Paola A, Barbour R, Azar MM, Altice FL. Extended-release Naltrexone Improves Viral Suppression Among Incarcerated Persons Living with HIV and Alcohol use Disorders Transitioning to the Community. JAIDS Journal Of Acquired Immune Deficiency Syndromes 2018, 79: 92-100. PMID: 29781884, PMCID: PMC6092223, DOI: 10.1097/qai.0000000000001759.Peer-Reviewed Original ResearchConceptsAlcohol use disorderViral suppressionExtended-release naltrexoneXR-NTXPlacebo groupPlacebo-controlled trialMonthly injectionsSecondary outcomesTreat analysisIncarcerated individualsEligible participantsWhite raceUse disordersAlcohol consumptionHIVMonthsNaltrexoneBaselineDisordersInjectionIncarcerated peopleParticipantsPlaceboGroupSuppression
2009
Persistence of Virological Benefits Following Directly Administered Antiretroviral Therapy Among Drug Users: Results From a Randomized Controlled Trial
Maru DS, Bruce RD, Walton M, Springer SA, Altice FL. Persistence of Virological Benefits Following Directly Administered Antiretroviral Therapy Among Drug Users: Results From a Randomized Controlled Trial. JAIDS Journal Of Acquired Immune Deficiency Syndromes 2009, 50: 176-181. PMID: 19131891, PMCID: PMC2670996, DOI: 10.1097/qai.0b013e3181938e7e.Peer-Reviewed Original ResearchConceptsSelf-administered therapyHIV-1 RNACD4 lymphocyte countVirological successDrug usersAntiretroviral therapyLymphocyte countMonths postinterventionLog10 HIV-1 RNAProportion of subjectsActive drug usersVirological benefitVirological outcomesSecondary outcomesControlled TrialsPrimary outcomeBlood samplesDAARTMultivariate analysisBenefits persistTherapyTrialsAdditional strategiesOutcomesPostintervention
2007
Superiority of Directly Administered Antiretroviral Therapy over Self-Administered Therapy among HIV-Infected Drug Users: A Prospective, Randomized, Controlled Trial
Altice FL, Maru DS, Bruce RD, Springer SA, Friedland GH. Superiority of Directly Administered Antiretroviral Therapy over Self-Administered Therapy among HIV-Infected Drug Users: A Prospective, Randomized, Controlled Trial. Clinical Infectious Diseases 2007, 45: 770-778. PMID: 17712763, PMCID: PMC2693907, DOI: 10.1086/521166.Peer-Reviewed Original ResearchConceptsHIV-1 RNA levelsSelf-administered therapyT-lymphocyte countsDrug usersAntiretroviral therapyLymphocyte countRNA levelsPrimary outcomeProportion of patientsGreater mean reductionHIV treatment programsLog10 copies/Human immunodeficiency virusCopies/mLDAART groupVirologic outcomesSecondary outcomesControlled TrialsImmunodeficiency virusPoor adherenceTreatment adherenceEntry criteriaTreat approachCopies/Mean change