2022
Proactive strategies to optimize engagement of Black, Hispanic/Latinx, transgender, and nonbinary individuals in a trial of a novel agent for HIV pre-exposure prophylaxis (PrEP)
Cespedes M, Das M, Hojilla JC, Blumenthal J, Mounzer K, Ramgopal M, Hodge T, Torres TS, Peterson C, Shibase S, Elliott A, Demidont AC, Callaghan L, Watson CC, Carter C, Kintu A, Baeten JM, Ogbuagu O. Proactive strategies to optimize engagement of Black, Hispanic/Latinx, transgender, and nonbinary individuals in a trial of a novel agent for HIV pre-exposure prophylaxis (PrEP). PLOS ONE 2022, 17: e0267780. PMID: 35657826, PMCID: PMC9165827, DOI: 10.1371/journal.pone.0267780.Peer-Reviewed Original ResearchConceptsClinical trialsHIV incidencePre-exposure prophylaxis clinical trialHispanic/LatinxRecruitment goalsGood participatory practice guidelinesOngoing phase 3 trialsHIV pre-exposure prophylaxisTransgender womenTransgender menPhase 3 trialPre-exposure prophylaxisCommunity-based clinicsFuture clinical trialsClinical trial numberEvidence-informed recommendationsLatinx MSMGender nonbinary individualsCisgender MSMNovel agentsPractice guidelinesStudy populationBlack MSMUS sitesTrials
2021
Long-term safety and efficacy of emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV-1 pre-exposure prophylaxis: week 96 results from a randomised, double-blind, placebo-controlled, phase 3 trial
Ogbuagu O, Ruane PJ, Podzamczer D, Salazar LC, Henry K, Asmuth DM, Wohl D, Gilson R, Shao Y, Ebrahimi R, Cox S, Kintu A, Carter C, Das M, Baeten JM, Brainard DM, Whitlock G, Brunetta JM, Kronborg G, Spinner CD, team D, Antinori A, Apea V, Asmuth D, Avery A, Benson P, Bergin C, Berhe M, Brar I, Brinson C, Brunetta J, Burack J, Campbell T, Cespedes M, Clarke A, Coleman M, Coll J, Casal M, Creticos C, Crofoot G, Cruickshank F, Cua E, Daar E, de Wet J, DeJesus E, Del Romero Guerrero J, Dinges W, Doblecki-Lewis S, Donovan T, Dosekun O, Flamm J, Gallant J, Gerstoft J, Gilson R, Gladstein J, Grant R, Grossberg R, Haas B, Halperin J, Hardy W, Hare C, Hassler S, Hengel R, Henry W, Hodge T, Hosek S, Hurt C, Iandiorio M, Jessen H, Kegg S, Knecht G, Kronborg G, Krznaric I, LaMarca A, Larsen C, Larsen O, Lazzarin A, Leen C, Lucasti C, Mallon P, Mannheimer S, Markowitz M, Martorell C, Mayer K, Mills A, Molina J, Morris S, Mounzer K, Nwokolo N, Ogbuagu O, Osiyemi O, Petroll A, Philibert P, Phoenix J, Pialoux G, Podzamczer D, Post F, Prins M, Ramgopal M, Rashbaum B, Reeves I, Richmond G, Rieger A, Ruane P, Salazar L, Scarsella A, Schembri G, Scott M, Shalit P, Sinclair G, Sobieszczyk M, Spinner C, Stephens J, Szabo J, Taylor S, Thompson M, Tremblay C, Trottier B, Voskuhl G, Wade B, Wohl D, Workowski K, Yawetz S, Young B. Long-term safety and efficacy of emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV-1 pre-exposure prophylaxis: week 96 results from a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet HIV 2021, 8: e397-e407. PMID: 34197772, DOI: 10.1016/s2352-3018(21)00071-0.Peer-Reviewed Original ResearchConceptsTenofovir disoproxil fumaratePre-exposure prophylaxisTenofovir alafenamideDisoproxil fumarateBone mineral densityHIV infectionPlacebo tabletsMineral densityHIV preventionHIV-1 pre-exposure prophylaxisTransgender womenAdult cisgender menNon-inferior efficacyWeek 96 resultsPrimary efficacy outcomeCisgender menPhase 3 trialIncident HIV infectionHIV-1 infectionNon-inferiority trialLong-term safetyMore weight gainRenal safety biomarkersSelf-reported sexual behaviorStudy medication