2023
Adaptive evaluation of mHealth and conventional adherence support interventions to optimize outcomes with new treatment regimens for drug-resistant tuberculosis and HIV in South Africa (ADAP-TIV): study protocol for an adaptive randomized controlled trial
Ross J, Perumal R, Wolf A, Zulu M, Guzman K, Seepamore B, Reis K, Nyilana H, Hlathi S, Narasimmulu R, Cheung Y, Amico K, Friedland G, Daftary A, Zelnick J, Naidoo K, O’Donnell M. Adaptive evaluation of mHealth and conventional adherence support interventions to optimize outcomes with new treatment regimens for drug-resistant tuberculosis and HIV in South Africa (ADAP-TIV): study protocol for an adaptive randomized controlled trial. Trials 2023, 24: 776. PMID: 38037105, PMCID: PMC10691086, DOI: 10.1186/s13063-023-07520-9.Peer-Reviewed Original ResearchConceptsMultidrug-resistant tuberculosisAdherence support interventionsAntiretroviral therapyTreatment regimensAdherence supportPrimary outcomeTreatment supportPsychosocial supportMDR-TB treatment regimensUndetectable HIV viral loadSupport interventionsIntegrase strand transfer inhibitorsAdherence support strategiesComposite clinical outcomeMDR-TB regimensNegative TB culturesCombination antiretroviral therapyComposite primary outcomeHIV treatment outcomesHIV viral loadDrug-resistant tuberculosisStandard of careNew treatment regimensDifferentiated service deliveryStrand transfer inhibitors
2022
Bedaquiline Adherence Measured by Electronic Dose Monitoring Predicts Clinical Outcomes in the Treatment of Patients With Multidrug-Resistant Tuberculosis and HIV/AIDS
O'Donnell MR, Padayatchi N, Wolf A, Zelnick J, Daftary A, Orrell C, Nimmo C, Baldwin M, Boodhram R, Maharaj B, Amico KR, Naidoo K, Friedland G. Bedaquiline Adherence Measured by Electronic Dose Monitoring Predicts Clinical Outcomes in the Treatment of Patients With Multidrug-Resistant Tuberculosis and HIV/AIDS. JAIDS Journal Of Acquired Immune Deficiency Syndromes 2022, 90: 325-332. PMID: 35195572, PMCID: PMC11077859, DOI: 10.1097/qai.0000000000002940.Peer-Reviewed Original ResearchConceptsMDR-TB treatment outcomesResistance-associated variantsTreatment outcomesAntiretroviral therapyMDR-TBART adherenceMultidrug-resistant tuberculosis treatmentHIV treatment outcomesProspective cohort studyMultidrug-resistant tuberculosisEnd of treatmentTreatment of patientsSuccessful treatment outcomeElectronic dose monitoring devicesHIV/AIDSCohort studyClinical outcomesMultivariable analysisNovel regimensMedication adherenceAdherence thresholdTuberculosis treatmentTreatment completionLow adherenceDose monitoringAdherence Measured Using Electronic Dose Monitoring is Associated with Emergent Antiretroviral Resistance and Poor Outcomes in People with Human Immunodeficiency Virus/AIDS and Multidrug-Resistant Tuberculosis
Bateman M, Wolf A, Chimukangara B, Brust JCM, Lessells R, Amico R, Boodhram R, Singh N, Orrell C, Friedland G, Naidoo K, Padayatchi N, O’Donnell MR. Adherence Measured Using Electronic Dose Monitoring is Associated with Emergent Antiretroviral Resistance and Poor Outcomes in People with Human Immunodeficiency Virus/AIDS and Multidrug-Resistant Tuberculosis. Clinical Infectious Diseases 2022, 75: 1489-1496. PMID: 35352097, PMCID: PMC9617578, DOI: 10.1093/cid/ciac232.Peer-Reviewed Original ResearchConceptsMultidrug-resistant tuberculosisHuman immunodeficiency virusMDR-TB treatmentART adherenceART resistanceHuman immunodeficiency virus/AIDSEmergent resistanceStandard of careResource-limited settingsTB regimensAntiretroviral resistanceHIV RNAProspective cohortMedication adherenceImmunodeficiency virusPoor outcomeShort followAdherence thresholdCopies/Treatment outcomesDose monitoringResistance mutationsResistance testingPublic hospitalsLinear association
2012
The immune reconstitution inflammatory syndrome after antiretroviral therapy initiation in patients with tuberculosis: findings from the SAPiT trial.
Naidoo K, Yende-Zuma N, Padayatchi N, Naidoo K, Jithoo N, Nair G, Bamber S, Gengiah S, El-Sadr WM, Friedland G, Abdool Karim S. The immune reconstitution inflammatory syndrome after antiretroviral therapy initiation in patients with tuberculosis: findings from the SAPiT trial. Annals Of Internal Medicine 2012, 157: 313-24. PMID: 22944873, PMCID: PMC3534856, DOI: 10.7326/0003-4819-157-5-201209040-00004.Peer-Reviewed Original ResearchMeSH KeywordsAdultAIDS-Related Opportunistic InfectionsAntibiotics, AntitubercularAnti-Retroviral AgentsCD4 Lymphocyte CountFemaleHIV InfectionsHumansImmune Reconstitution Inflammatory SyndromeImmunocompromised HostIncidenceKaplan-Meier EstimateMaleProspective StudiesRifampinRisk FactorsSeverity of Illness IndexTuberculosisConceptsImmune reconstitution inflammatory syndromeSequential treatment groupIncidence of IRISReconstitution inflammatory syndromeAntiretroviral therapy initiationART initiationTreatment groupsIRIS incidenceSAPiT trialInflammatory syndromeTherapy initiationTreatment initiationTuberculosis treatmentOpen-label clinical trialCells/LCo-infected patientsEarly ART initiationInitiation of ARTTuberculosis treatment initiationSmear-negative tuberculosisHigher hospitalization ratesWeeks of completionBaseline CD4Antituberculosis treatmentNonambulatory patients
2011
Household contact investigation of multidrug-resistant and extensively drug-resistant tuberculosis in a high HIV prevalence setting
Vella V, Racalbuto V, Guerra R, Marra C, Moll A, Mhlanga Z, Maluleke M, Mhlope H, Margot B, Friedland G, Shah N, Gandhi N. Household contact investigation of multidrug-resistant and extensively drug-resistant tuberculosis in a high HIV prevalence setting. The International Journal Of Tuberculosis And Lung Disease 2011, 15: 1170-1175. PMID: 21943840, DOI: 10.5588/ijtld.10.0781.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAntitubercular AgentsExtensively Drug-Resistant TuberculosisFamily CharacteristicsFemaleFollow-Up StudiesHIV InfectionsHumansIncidenceMaleMicrobial Sensitivity TestsMiddle AgedPrevalenceProspective StudiesSouth AfricaTime FactorsTuberculosis, Multidrug-ResistantYoung AdultConceptsDrug-resistant tuberculosisHousehold contactsXDR-TBIndex caseMDR-TBPrevalence settingsHigh human immunodeficiency virus (HIV) prevalence settingsMDR-TB index casesHigh HIV prevalence settingsAdult household contactsHousehold contact investigationIndex case diagnosisMost secondary casesHIV prevalence settingsRate of MDRDrug susceptibility testingDiagnosis of MDRPublic health activitiesActive tuberculosisNosocomial transmissionContact investigationMedian timeIncidence rateSecondary casesObservational studyRapid Diagnosis of Tuberculosis and Multidrug Resistance by the Microscopic-Observation Drug-Susceptibility Assay
Shah NS, Moodley P, Babaria P, Moodley S, Ramtahal M, Richardson J, Heysell S, Li X, Moll A, Friedland G, Sturm AW, Gandhi NR. Rapid Diagnosis of Tuberculosis and Multidrug Resistance by the Microscopic-Observation Drug-Susceptibility Assay. American Journal Of Respiratory And Critical Care Medicine 2011, 183: 1427-1433. PMID: 21297071, DOI: 10.1164/rccm.201009-1449oc.Peer-Reviewed Original ResearchConceptsDrug susceptibility testingMDR-TB diagnosisMDR-TBHIV statusMultidrug-resistant (MDR) TBProportion methodRapid diagnosisProspective diagnostic accuracy studyAdult TB suspectsMicroscopic-Observation DrugReference standard cultureMedian CD4 countPatient's HIV statusHIV prevalence settingsIndirect proportion methodMycobacterial growth indicator tube (MGIT) cultureMedian turnaround timeResource-limited settingsReference standardDiagnostic accuracy studiesCD4 countMycobacterium tuberculosis detectionConsecutive adultsTB suspectsHIV prevalence
2010
Antiretroviral medication adherence and class-specific resistance in a large prospective clinical trial
Gardner EM, Hullsiek KH, Telzak EE, Sharma S, Peng G, Burman WJ, MacArthur RD, Chesney M, Friedland G, Mannheimer SB. Antiretroviral medication adherence and class-specific resistance in a large prospective clinical trial. AIDS 2010, 24: 395-403. PMID: 20099399, PMCID: PMC2886717, DOI: 10.1097/qad.0b013e328335cd8a.Peer-Reviewed Original ResearchConceptsInitial virological failureCumulative adherenceVirological failureMedian timeNucleoside reverse transcriptase inhibitor resistanceProspective clinical trial dataInhibitor strategiesLarge prospective clinical trialsReverse transcriptase inhibitor resistanceInhibitor resistanceAntiretroviral-naive participantsProspective clinical trialsCox regression analysisTranscriptase inhibitor resistanceAntiretroviral medication adherenceProtease inhibitor resistanceClinical trial dataProtease inhibitorsMedication resistanceAntiretroviral therapyHIV RNANNRTI resistanceMedication adherenceClinical trialsGenotypic resistance
2009
Successful Integration of Tuberculosis and HIV Treatment in Rural South Africa: The Sizonq'oba Study
Gandhi NR, Moll AP, Lalloo U, Pawinski R, Zeller K, Moodley P, Meyer E, Friedland G. Successful Integration of Tuberculosis and HIV Treatment in Rural South Africa: The Sizonq'oba Study. JAIDS Journal Of Acquired Immune Deficiency Syndromes 2009, 50: 37-43. PMID: 19295333, DOI: 10.1097/qai.0b013e31818ce6c4.Peer-Reviewed Original ResearchMeSH KeywordsAdultAnti-HIV AgentsAntitubercular AgentsFemaleHIV InfectionsHumansMaleProspective StudiesRural PopulationSouth AfricaTuberculosisViral LoadConceptsTB/HIV-coinfected patientsHIV treatmentCubic millimeterCD4 count increaseDaily antiretroviral therapyImmune reconstitution eventsIntegration of tuberculosisMedian CD4 countUndetectable viral loadSevere adverse eventsDrug-resistant tuberculosisRural resource-poor settingsCause of deathHome-based therapyResource-poor settingsRural KwaZulu-NatalARV dosesTreatment defaultAntiretroviral therapyCD4 countHIV careOperational research studyTB patientsAdverse eventsObserved therapy
2008
Differential adherence to combination antiretroviral therapy is associated with virological failure with resistance
Gardner EM, Sharma S, Peng G, Hullsiek KH, Burman WJ, MacArthur RD, Chesney M, Telzak EE, Friedland G, Mannheimer SB. Differential adherence to combination antiretroviral therapy is associated with virological failure with resistance. AIDS 2008, 22: 75-82. PMID: 18090394, PMCID: PMC2405889, DOI: 10.1097/qad.0b013e3282f366ff.Peer-Reviewed Original ResearchConceptsNon-nucleoside reverse transcriptase inhibitorInitial virological failureCombination antiretroviral therapyVirological failureAntiretroviral resistanceAntiretroviral therapyTreatment-naive HIV-1-infected individualsDifferential adherenceProspective clinical trial dataHIV-1-infected individualsMultivariate Cox regression analysisProtease inhibitorsTime-updated variablesCox regression analysisDisease-specific factorsReverse transcriptase inhibitorClinical trial dataMedication resistanceAntiretroviral medicationsRandomized trialsMonths 1Transcriptase inhibitorSame timepointsTrial dataSecondary analysis
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
2005
Quality of life in HIV-infected individuals receiving antiretroviral therapy is related to adherence
Mannheimer S, Matts J, Telzak E, Chesney M, Child C, Wu A, Friedland G, Aids F. Quality of life in HIV-infected individuals receiving antiretroviral therapy is related to adherence. AIDS Care 2005, 17: 10-22. PMID: 15832830, DOI: 10.1080/09540120412331305098.Peer-Reviewed Original ResearchConceptsAntiretroviral therapyART adherenceQOL scoresQuality of lifeTerry Beirn Community ProgramsNewer ART regimensSummary QoL scoresCells/mm3Mean QOL scoreAntiretroviral clinical trialsHigher QoL scoresBaseline CD4ART regimensART-naïveHIV populationMean agePoor adherenceSF-12Clinical trialsImproved QoLClinical researchQoLAdherenceMonthsHIV
1996
A prospective study of syphilis and HIV infection among injection drug users receiving methadone in the Bronx, NY.
Gourevitch M, Hartel D, Schoenbaum E, Selwyn P, Davenny K, Friedland G, Klein R. A prospective study of syphilis and HIV infection among injection drug users receiving methadone in the Bronx, NY. American Journal Of Public Health 1996, 86: 1112-5. PMID: 8712270, PMCID: PMC1380622, DOI: 10.2105/ajph.86.8_pt_1.1112.Peer-Reviewed Original ResearchConceptsInjection drug usersHIV-seronegative patientsHIV-seropositive patientsDrug usersHIV infectionEarly syphilisProspective studyHuman immunodeficiency virus (HIV) infectionHigh-risk sexual activityPercent of HIVImmunodeficiency virus infectionMethadone maintenance treatmentDrug-using womenMultiple sex partnersDiagnosis of syphilisEarly syphilis incidenceFemale drug usersHIV seroconversionHIV seroconvertersMaintenance treatmentIncidence rateIndependent riskVirus infectionSyphilis incidencePatients
1994
Laboratory markers and the risk of developing HIV-1 disease among injecting drug users
Alcabes P, Selwyn P, Davenny K, Hartel D, Buono D, Schoenbaum E, Klein R, Friedland G. Laboratory markers and the risk of developing HIV-1 disease among injecting drug users. AIDS 1994, 8: 107-116. PMID: 7912083, DOI: 10.1097/00002030-199401000-00016.Peer-Reviewed Original ResearchConceptsCD4 lymphocyte countHIV-1-related outcomesLow CD4 lymphocyte countCD4 lymphocyte numbersPyogenic bacterial infectionsHIV-1 diseaseLymphocyte countLaboratory markersLymphocyte numbersClinical eventsAIDS diagnosisRelative riskDrug usersBacterial infectionsHIV-1-associated diseaseBeta 2M levelsSerum beta 2M levelsDifferent laboratory markersMultiple constitutional symptomsAIDS riskMethadone treatment programsPredictors of progressionHIV-1 infectionLow platelet countLower leukocyte counts
1993
A prospective four-year follow-up of neuropsychological function in HIV seropositive and seronegative methadone-maintained patients
Silberstein C, O'Dowd M, Chartock P, Schoenbaum E, Friedland G, Hartel D, McKegney F. A prospective four-year follow-up of neuropsychological function in HIV seropositive and seronegative methadone-maintained patients. General Hospital Psychiatry 1993, 15: 351-359. PMID: 8112557, DOI: 10.1016/0163-8343(93)90001-5.Peer-Reviewed Original ResearchConceptsHuman immunodeficiency virus (HIV) infectionCentral nervous system impairmentHIV antibody testingImmunodeficiency virus infectionMethadone-maintained patientsSymptoms/signsNervous system impairmentMethadone maintenance clinicsNeuropsychological Screening BatteryTrail Making B testSubtle cognitive deficitsHIV infectionAntibody testingPhysical examMaintenance clinicsVirus infectionBaseline testingNeuropsychological functionCognitive deficitsNP assessmentFinger tappingSystem impairmentScreening batteryLongitudinal studyPatients
1992
Clinical Manifestations and Predictors of Disease Progression in Drug Users with Human Immunodeficiency Virus Infection
Selwyn P, Alcabes P, Hartel D, Buono D, Schoenbaum E, Klein R, Davenny K, Friedland G. Clinical Manifestations and Predictors of Disease Progression in Drug Users with Human Immunodeficiency Virus Infection. New England Journal Of Medicine 1992, 327: 1697-1703. PMID: 1359411, DOI: 10.1056/nejm199212103272401.Peer-Reviewed Original ResearchMeSH KeywordsAcquired Immunodeficiency SyndromeAdultAIDS-Related Opportunistic InfectionsBacterial InfectionsCandidiasis, OralCD4-Positive T-LymphocytesFemaleFollow-Up StudiesHIV InfectionsHumansLeukocyte CountMaleMultivariate AnalysisNew York CityProportional Hazards ModelsProspective StudiesRacial GroupsSubstance Abuse, IntravenousZidovudineConceptsHuman immunodeficiency virus (HIV) infectionImmunodeficiency virus infectionDevelopment of AIDSInjection drug usersBacterial infectionsDisease progressionOral candidiasisVirus infectionSite primary medical careMultiple constitutional symptomsPyogenic bacterial infectionsHIV-seropositive patientsPercentage of CD4Cohort of patientsDiagnosis of AIDSMethadone treatment programsProportional hazards regressionProduct-limit survival analysisIncidence of AIDSPrimary medical careRate of progressionRisk of AIDSSeronegative patientsConstitutional symptomsSeropositive patientsHigh Risk of Active Tuberculosis in HIV-Infected Drug Users With Cutaneous Anergy
Selwyn P, Sckell B, Alcabes P, Friedland G, Klein R, Schoenbaum E. High Risk of Active Tuberculosis in HIV-Infected Drug Users With Cutaneous Anergy. JAMA 1992, 268: 504-509. PMID: 1619742, DOI: 10.1001/jama.1992.03490040080029.Peer-Reviewed Original ResearchConceptsHIV serological statusAnergic subjectsActive tuberculosisTuberculin reactorsCutaneous anergyDrug injectorsIsoniazid chemoprophylaxisIsoniazid prophylaxisHIV infectionTuberculosis incidenceTuberculin testingSerological statusHigh riskDelayed-type hypersensitivity skin testingDelayed-type hypersensitivity testingPositive tuberculin test resultsStudy periodAdvanced HIV diseaseHIV disease statusMonths of prophylaxisT lymphocyte levelsHypersensitivity skin testingProspective observational studyTuberculosis incidence rateMycobacterium tuberculosis infection
1991
Human T Lymphotropic Virus Type II (HTLV-II) Infection in a Cohort of New York Intravenous Drug Users: An Old Infection?
Khabbaz R, Hartel D, Lairmore M, Horsburgh C, Schoenbaum E, Roberts B, Hartley T, Friedland G. Human T Lymphotropic Virus Type II (HTLV-II) Infection in a Cohort of New York Intravenous Drug Users: An Old Infection? The Journal Of Infectious Diseases 1991, 163: 252-256. PMID: 1988509, DOI: 10.1093/infdis/163.2.252.Peer-Reviewed Original ResearchConceptsIntravenous drug usersHuman T-lymphotropic virus type II (HTLV-II) infectionHTLV-II infectionType II infectionPolymerase chain reactionRisk factorsHTLV-IIDrug usersHuman immunodeficiency virus (HIV) infectionHIV infection statusImmunodeficiency virus infectionIntravenous drug useMethadone maintenance programTransfusion historyNeedle sharingVirus infectionSerologic resultsSex partnersDrug useShooting galleriesEndemic infectionInfectionOlder ageInfection statusOld infection
1990
A prospective comparison of neuropsychologic function in HIV-seropositive and seronegative methadone-maintained patients
McKegney F, O'Dowd M, Feiner C, Selwyn P, Drucker E, Friedland G. A prospective comparison of neuropsychologic function in HIV-seropositive and seronegative methadone-maintained patients. AIDS 1990, 4: 565-570. PMID: 2386618, DOI: 10.1097/00002030-199006000-00011.Peer-Reviewed Original ResearchConceptsPsychological Screening TestMethadone clinic patientsMethadone-maintained populationsEvidence of HIVMethadone-maintained patientsDigit spanProspective longitudinal studyPsychosocial functioningNeuropsychologic functionRace/ethnicityPsychosocial assessmentCognitive impairmentHIV antibodiesHIV infectionLongitudinal studyUnivariate analysisMean intervalProspective comparisonSerological testingSerological statusPhysical symptomsDrug useBaseline testingScreening testSeropositives
1989
Prospective Study of Human Immunodeficiency Virus Infection and Pregnancy Outcomes in Intravenous Drug Users
Selwyn P, Schoenbaum E, Davenny K, Robertson V, Feingold A, Shulman J, Mayers M, Klein R, Friedland G, Rogers M. Prospective Study of Human Immunodeficiency Virus Infection and Pregnancy Outcomes in Intravenous Drug Users. JAMA 1989, 261: 1289-1294. PMID: 2915455, DOI: 10.1001/jama.1989.03420090053030.Peer-Reviewed Original ResearchConceptsIntravenous drug usersHuman immunodeficiency virus (HIV) infectionImmunodeficiency virus infectionPregnancy outcomesDrug usersVirus infectionFemale intravenous drug usersHIV disease statusSeropositive pregnant womenAdverse pregnancy outcomesAsymptomatic HIV infectionNeonatal complicationsEctopic pregnancyPreterm deliveryHIV antibodiesBreech presentationHIV infectionSymptomatic diseaseBacterial pneumoniaHIV statusPregnant womenProspective studyWeight birthsAdditional womenMethadone programsA Prospective Study of the Risk of Tuberculosis among Intravenous Drug Users with Human Immunodeficiency Virus Infection
Selwyn P, Hartel D, Lewis V, Schoenbaum E, Vermund S, Klein R, Walker A, Friedland G. A Prospective Study of the Risk of Tuberculosis among Intravenous Drug Users with Human Immunodeficiency Virus Infection. New England Journal Of Medicine 1989, 320: 545-550. PMID: 2915665, DOI: 10.1056/nejm198903023200901.Peer-Reviewed Original ResearchConceptsHIV-seropositive subjectsIntravenous drug usersPositive PPD testHuman immunodeficiency virus (HIV) infectionImmunodeficiency virus infectionActive tuberculosisPPD testDrug usersSeronegative subjectsSeropositive subjectsTuberculous infectionSkin testingVirus infectionHIV-seronegative intravenous drug usersHIV-seronegative subjectsLatent tuberculous infectionRisk of tuberculosisTuberculin skin testingCases of tuberculosisMethadone maintenance programHIV antibodiesHIV-seropositiveHIV infectionProspective studyProtein derivative (PPD) tuberculin