2024
Demonstrating service delivery models for effective initiation and retention on pre-exposure prophylaxis (PrEP) among female bar workers in Dar es Salaam, Tanzania: A double randomized intervention study protocol
Chebet J, Akyoo W, Goymann H, Harling G, Barnhart D, Mosha I, Kamori D, Gandhi M, Mbunda T, Kipeleka J, Sando D, Spiegelman D, Mpembeni R, Bärnighausen T. Demonstrating service delivery models for effective initiation and retention on pre-exposure prophylaxis (PrEP) among female bar workers in Dar es Salaam, Tanzania: A double randomized intervention study protocol. PLOS ONE 2024, 19: e0304077. PMID: 38935796, PMCID: PMC11210872, DOI: 10.1371/journal.pone.0304077.Peer-Reviewed Original ResearchConceptsFemale bar workersPre-exposure prophylaxisIntention-to-treatBar workersPrimary outcomeRisk of HIV infectionAdherence to PrEPRisk of HIV acquisitionImprove PrEP adherenceGerman Clinical Trials RegisterPublic sector clinicsService delivery modelsRandomized trial designHIV negative womenPrevent HIV infectionHIV infectionPrEP provisionClinical Trials RegisterHIV testingPrEP initiationHealth facilitiesPromote PrEPPrEP adherenceDelivery modelsReduce barriers
2022
Design and Implementation of a Culturally-Tailored Randomized Pilot Trial: Puerto Rican Optimized Mediterranean-Like Diet
Mattei J, Díaz-Alvarez C, Alfonso C, O’Neill H, Ríos-Bedoya C, Malik V, Godoy-Vitorino F, Cheng C, Spiegelman D, Willett W, Hu F, Rodríguez-Orengo J. Design and Implementation of a Culturally-Tailored Randomized Pilot Trial: Puerto Rican Optimized Mediterranean-Like Diet. Current Developments In Nutrition 2022, 7: 100022. PMID: 37181130, PMCID: PMC10100940, DOI: 10.1016/j.cdnut.2022.100022.Peer-Reviewed Original ResearchMediterranean-like dietNutritional counseling sessionsPilot trialHealthier cardiometabolic profileIndividual cardiometabolic factorsCardiometabolic risk factorsRandomized pilot trialDisease prevention programsCounseling sessionsDaily text messagesFree-living adultsCardiometabolic factorsCardiometabolic profileCardiometabolic healthSecondary outcomesPrimary outcomeRisk factorsDietary intakeIntervention groupChronic diseasesTwo-armOutcome measuresHigh riskMediterranean dietPsychosocial factorsEffectiveness of a community-based education and peer support led by women’s self-help groups in improving the control of hypertension in urban slums of Kerala, India: a cluster randomised controlled pragmatic trial
Suseela R, Ambika R, Mohandas S, Menon J, Numpelil M, Vasudevan B, Ved R, Danaei G, Spiegelman D. Effectiveness of a community-based education and peer support led by women’s self-help groups in improving the control of hypertension in urban slums of Kerala, India: a cluster randomised controlled pragmatic trial. BMJ Global Health 2022, 7: e010296. PMID: 36384950, PMCID: PMC9670931, DOI: 10.1136/bmjgh-2022-010296.Peer-Reviewed Original ResearchConceptsMean systolic BPSystolic BPControl armIntervention armPragmatic trialUrban slumsTarget blood pressure goalsMajor public health problemBlood pressure goalsSelf-help group membersControl of hypertensionStandard of carePublic health problemPrimary healthcare systemSelf-help groupsCommunity-based educationPeer support programAntihypertensive medicationsUncontrolled hypertensionUsual careHypertension managementPrimary outcomeHypertensionHealthy behaviorsHealth problemsThe impact of a community health worker intervention on uptake of antenatal care: a cluster-randomized pragmatic trial in Dar es Salaam
Regan M, Cheng C, Mboggo E, Larson E, Lema I, Magesa L, Machumi L, Ulenga N, Sando D, Mwanyika-Sando M, Barnhart D, Hong B, Mungure E, Li N, Siril H, Mujinja P, Naburi H, Kilewo C, Ekström A, Geldsetzer P, Fawzi W, Bärnighausen T, Sudfeld C, Spiegelman D. The impact of a community health worker intervention on uptake of antenatal care: a cluster-randomized pragmatic trial in Dar es Salaam. Health Policy And Planning 2022, 38: 279-288. PMID: 36377764, PMCID: PMC10019560, DOI: 10.1093/heapol/czac100.Peer-Reviewed Original ResearchConceptsMore ANC visitsCommunity health worker interventionHealth worker interventionAntenatal careANC visitsPragmatic trialHigh-quality antenatal carePragmatic cluster-randomized trialUptake of ANCDar es SalaamWorker interventionLarge-scale pragmatic trialsCluster-randomized pragmatic trialModest beneficial effectStandard of careRoutine health system dataCluster-randomized trialHealth system dataANC uptakeCare armCHW interventionPrimary outcomeIntervention armFirst trimesterPregnant women
2020
The Moderate Alcohol and Cardiovascular Health Trial (MACH15): Design and methods for a randomized trial of moderate alcohol consumption and cardiometabolic risk
Spiegelman D, Lovato LC, Khudyakov P, Wilkens TL, Adebamowo CA, Adebamowo SN, Appel LJ, Beulens JW, Coughlin JW, Dragsted LO, Edenberg HJ, Eriksen JN, Estruch R, Grobbee DE, Gulayin PE, Irazola V, Krystal JH, Lazo M, Murray MM, Rimm EB, Schrieks IC, Williamson JD, Mukamal KJ. The Moderate Alcohol and Cardiovascular Health Trial (MACH15): Design and methods for a randomized trial of moderate alcohol consumption and cardiometabolic risk. European Journal Of Preventive Cardiology 2020, 27: 1967-1982. PMID: 32250171, PMCID: PMC7541556, DOI: 10.1177/2047487320912376.Peer-Reviewed Original ResearchConceptsModerate alcohol consumptionCardiovascular Health TrialAlcohol consumptionHealth trialsCardiovascular diseaseModerate alcoholNon-fatal ischemic strokeNon-fatal myocardial infarctionPrimary composite endpointCongestive heart failureCoronary heart diseaseModerate alcohol consumersAdults 50 yearsPublic health guidelinesAlcohol use disorderPreferred alcoholic beverageCardiometabolic effectsCardiometabolic riskCarotid revascularizationIschemic strokeSecondary outcomesComposite endpointHeart failurePrimary outcomeMyocardial infarctionVitamin D Supplements for Prevention of Tuberculosis Infection and Disease
Ganmaa D, Uyanga B, Zhou X, Gantsetseg G, Delgerekh B, Enkhmaa D, Khulan D, Ariunzaya S, Sumiya E, Bolortuya B, Yanjmaa J, Enkhtsetseg T, Munkhzaya A, Tunsag M, Khudyakov P, Seddon JA, Marais BJ, Batbayar O, Erdenetuya G, Amarsaikhan B, Spiegelman D, Tsolmon J, Martineau AR. Vitamin D Supplements for Prevention of Tuberculosis Infection and Disease. New England Journal Of Medicine 2020, 383: 359-368. PMID: 32706534, PMCID: PMC7476371, DOI: 10.1056/nejmoa1915176.Peer-Reviewed Original ResearchConceptsVitamin D groupAcute respiratory infectionsVitamin D supplementationPlacebo groupRespiratory infectionsTuberculosis infectionD groupVitamin DTuberculosis diseaseD supplementationAdverse eventsQFT resultsPositive QFT resultWeekly oral doseVitamin D supplementsQuantiFERON-TB GoldProportion of childrenD supplementsSecondary outcomesPrimary outcomeOral doseD levelsImmune responseLower riskInfection
2019
Substituting brown rice for white rice on diabetes risk factors in India: a randomised controlled trial
Malik V, Sudha V, Wedick N, RamyaBai M, Vijayalakshmi P, Lakshmipriya N, Gayathri R, Kokila A, Jones C, Hong B, Li R, Krishnaswamy K, Anjana R, Spiegelman D, Willett W, Hu F, Mohan V. Substituting brown rice for white rice on diabetes risk factors in India: a randomised controlled trial. British Journal Of Nutrition 2019, 121: 1389-1397. PMID: 31006420, PMCID: PMC6948352, DOI: 10.1017/s000711451900076x.Peer-Reviewed Original ResearchConceptsBrown rice groupMetabolic syndromePrimary outcomeRisk factorsHigh-sensitivity C-reactive proteinRandomised cross-over trialT2D risk factorsDiabetes risk factorsC-reactive proteinCross-over trialType 2 diabetesWhite rice groupMeals/dHs-CRPSecondary outcomesElevated BMIWashout periodInsulin resistanceBlood glucoseEpidemiological evidenceWhite riceT2D riskUrban South IndiaBMISyndrome
2004
A Randomized Trial of Multivitamin Supplements and HIV Disease Progression and Mortality
Fawzi WW, Msamanga GI, Spiegelman D, Wei R, Kapiga S, Villamor E, Mwakagile D, Mugusi F, Hertzmark E, Essex M, Hunter DJ. A Randomized Trial of Multivitamin Supplements and HIV Disease Progression and Mortality. New England Journal Of Medicine 2004, 351: 23-32. PMID: 15229304, DOI: 10.1056/nejmoa040541.Peer-Reviewed Original ResearchConceptsVitamin AHIV diseaseMultivitamin supplementsHuman immunodeficiency virus (HIV) diseasePlacebo-controlled trialHIV disease progressionStage 4 diseaseLow viral loadHigher CD4Antiretroviral therapyPrimary outcomeImmunodeficiency syndromeRandomized trialsViral loadPregnant womenDisease progressionRelative riskObservational studyDaily supplementCell countEnd pointMicronutrient statusMultivitaminsDiseaseProgression
2001
House Dust Endotoxin and Wheeze in the First Year of Life
PARK J, GOLD D, SPIEGELMAN D, BURGE H, MILTON D. House Dust Endotoxin and Wheeze in the First Year of Life. American Journal Of Respiratory And Critical Care Medicine 2001, 163: 322-328. PMID: 11179100, DOI: 10.1164/ajrccm.163.2.2002088.Peer-Reviewed Original ResearchConceptsElevated endotoxinEndotoxin exposureMultivariate modelLower respiratory illnessMultivariate relative riskHistory of asthmaLow birth weightSignificant univariate associationsFirst yearHouse dust endotoxinRoom dustRace/ethnicityMaternal asthmaPrimary outcomeRespiratory illnessAbove covariatesBirth weightDust endotoxinRelative riskCockroach allergensUnivariate associationsFamilial predispositionBedroom floorWheezeBirth cohort