Protocol Operations Core – Publications
- Amico KR, Mayer KH, Landovitz RJ, Marzinke M, Hendrix C, McCauley M, Wilkin T, and Gulick R. Influence of participant perceptions of adherence-related interactions with study/study team on drug levels: HPTN069 Analysis of self-reported adherence experiences while on study. AIDS Behav. 3/2024; 28(3):1058-1067 [PMC10896804].
- Bayan MH, Smalls T, Boudreau A, Mizra A, Pasco C, Demko Z, Rothman R, Hsieh Y-H, Eshleman SH, Chavez PR, Emerson B, Gonzalez-Jimenez N, Delaney KP, MacGowan RJ, Manabe YC, and Hamill MW. Evaluating the impact of point-of-care HIV viral load assessment on linkage to care in Baltimore, MD: a randomized controlled trial. BMC ID. 9/2023; 23: 570 [PMC10474693].
- Goodman-Meza D, Shoptaw S, Hanscom B, Smith LR, Andrew P, Kuo I, Lake JE, Metzger D, Morrison EAB, Cummings M, Fogel JM, Richardson P, Harris J, Heitner J, Stansfield S, and El-Bassel N. Delivering integrated strategies from a mobile unit to address the intertwining epidemics of HIV and addiction in people who inject drugs: the HPTN 094 randomized controlled trial protocol (the INTEGRA Study). Trials. 2/2024; 25:124 [PMC10870682].
- Grant-McAuley W, Morgenlander W, Hudelson SE, Thakar M, Piwowar-Manning E, Clarke W, Breaud A, Blankson J, Wilson E, Ayles H, Bock P, Moore A, Kosloff B, Shanaube K, Meehan S, van Deventer A, Fidler S, Hayes R, Ruczinski I, Kammers K, Laeyendecker O, Larman HB and Eshleman SH. Comprehensive profiling of pre-infection antibodies identifies HIV targets associated with viremic control and viral load. Front Immunol. 9/2023; 14:1178520 [PMC10512082].
- Grant-McAuley W, Piwowar-Manning E, Clarke W, Breaud A, Blankson J, Zewdie K, Moore A, Ayles H, Kosloff B, Shanaube K, Bock P, Meehan SA, Maarman G, Fidler S, Hayes R, Donnell D, and Eshleman SH. Population-level analysis of natural control of HIV infection in Zambia and South Africa: HPTN 071 (PopART). J Int AIDS Soc. 10/2023; 26(10):e26179 [PMC10603557].
- Hall M, Golubchik T, Bonsall D, Abeler-Dorner L, Limbada M, Kosloff B, Schaap A, de Cesare M, Mackintyre-Cocket G, Probert W, Ratmann O, Cruz AB, Piwowar-Manning E, Burns DN, Cohen MS, Donnell DJ, Eshleman SH, Simwinga M, Hayes R, Fidler S, Ayles H, and Fraser C. Demographics of sources of HIV-1 transmission in Zambia: a molecular epidemiology analysis of the HPTN 071 PopART study. Lancet Microbe. 1/2024 ;5(1):e62-e7100220 [PMC10789608].
- Hazra A, Landovitz RJ, Marzinke MA, Quinby C, and Creticos C. Breakthrough HIV-1 infection in setting of cabotegravir for HIV pre-exposure prophylaxis. AIDS. 9/2023; 37(11)1711-1714 [PMC: In Process].
- Justman J, Skalland T, Moore A, Amos CI, Marzinke MA, Zangeneh SZ, Kelley CF, Singer R, Mayer S, Hirsch-Moverman Y, Doblecki-Lewis S, Metzger D, Barranco E, Ho K, Marques ETA, Powers-Fletcher M, Kissinger PJ, Farley JE, Knowlton C, Sobieszczyk ME, Swaminathan S, Reed D, Tapsoba JD, Emel L, Bell I, Yuhas K, Schrumpf L, Mkumba L, Davis J, Lucas J, Piwowar-Manning E, and Ahmed S; for the CoVPN 5002 COMPASS Study Team. Prevalence of SARS-CoV-2 infection among children and adults in 15 US communities, 2021. Emerg Infect Dis. 2/2024;30(2):245-254 [PMC10826749].
- Landovitz RJ, Hanscom B, Clement M, Tran HV, Kallas EG, Magnus M, Sued O, Sanchez J, Scott H, Eron J, del Rio C, Fields S, Marzinke MA, Eshleman SH, Donnell D, Spinelli M, Kofron R, Berman R, Piwowar-Manning E, Richardson P, Sullivan P, Lucas J, Anderson P, Hendrix C, Adeyeye A, Rooney JF, Rinehart AR, Cohen MS, McCauley M, and Grinztejn. Efficacy and safety of long-acting cabotegravir compared with daily oral tenofovir disoproxil fumarate plus emtricitabine to prevent HIV infection in cisgender men and transgender women who have sex with men 1 year after study unblinding: a secondary analysis of the phase 2b and 3 HPTN 083 randomised controlled trial. Lancet HIV. 11/2023; 10(12)e767-778 [PMC10842527].
- Marzinke MA, Hanscom B, Wang Z, Safren S, Psaros C, Donnell D, Richardson P, Sullivan P, Eshleman SH, Jennings A, Gomez Feliciano K, Jalil E, Cardozo N, Maia B, Khan T, Singh Y, Middelkoop K, Franks J, Valencia J, Sanchez N, Lucas J, Rooney JF, Rinehart A, Ford S, Adeyeye A, Cohen MS, McCauley M, Landovitz RJ, and Beatriz Grinsztejn. Efficacy, safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir for HIV pre-exposure prophylaxis in transgender women: a secondary analysis of the HPTN 083 trial. Lancet HIV. 11/2023; 10(11)e703-712 [PMC10842527].
- Moore HP, Palumbo PJ, Notarte KI, Fogel JM, Cummings V, Gamble T, Del Rio C, Batey DS, Mayer KH, Farley JE, Remien RH, Beyrer C, Hudelson SE, and Eshleman SH. Performance of the Applied Biosystems HIV-1 Genotyping Kit with Integrase. J Clin Microbiol. 6/2024; 12;62(6):e0013624 [PMC11237527].
- Sandfort TGM, Kreniske P, Mbeda C, Reynolds D, Tshabalala G, Madiwati B, Ogendo A, Dominquez K, Panchia R, Gondwe D, Hamilton E, Guo X, and Cummings V. Interest in I-PrEP and willingness to participate in clinical trials among men and transfeminine persons who have sex with men in sub-Saharan Africa: Quantitative and qualitative findings from HPTN 075. AIDS and Behav. 7/2024; 28(7):2361-2377 [PMC11199096].
- Fogel JM, Piwowar-Manning E, Moser A, Hill T, Ahmed S, Cummings V, Mostafa HH, Wang Z, McCauley M, Gallardo-Cartagena JA, Figueroa MI, St Clair M, Rinehart AR, Adeyeye A, Rooney JF, Cohen MS, B, Landovitz RL, and Eshleman SH. Evaluation of Xpert point-of-care assays for detection of HIV infection in persons using long-acting cabotegravir for pre-exposure prophylaxis. Microbiol. Spectrum. In Press. {PMC: Available free on line].
- Grant-McAuley W, Morganlander WR, Ruczinski I, Kammers K, Laeyendecker O, Hudelson SE, Thakar M, Piwowar-Manning E, Clarke W, Breaud A, Ayles H, Bock P, Moore A, Kosloff B, Shanaube K, Meehan S-A, van Deventer A, Fidler S, Hayes R, Larman HB, and Eshleman SH. Identification of antibody targets associated with lower HIV viral load and viremic control. PLoS One. In Press.
- Landovitz RJ, Delany-Moretlwe S, Fogel JM, Marzinke MA, Piwowar-Manning E, Richardson P, Halvas EK, Mellors JW, Persaud D, Kofron R, McCauley M, Rose S, Rinehart AR, Rooney JF, Adeyeye A, Cohen MS, Donnell D, Mosseinipour M, Grinsztejn B, and Eshleman SH. Features of HIV infection in the context of long-acting cabotegravir pre-exposure prophylaxis. New Engl J Med. In Press.
- Landovitz RJ, Li S, Grinsztejn B, Dawood H, Liu AY, Magnus M, Hosseinipour MC, Panchia R, Cottle L, Chau G, Richardson P, Marzinke MA, Hendrix CW, Eshleman SH, Zhang Y, Tolley E, Sugarman J, Kofron R, Adeyeye A, Burns D, Rinehart AR, Margolis D, Spreen WR, Cohen MS, McCauley M, Eron JJ . Safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir in low-risk HIV-uninfected individuals: HPTN 077, a phase 2a randomized controlled trial. PLoS Med. 2018, 15: e1002690
- Landovitz RJ, Zangeneh SZ, Chau G, Grinsztejn B, Eron JJ, Dawood H, Liu AY, Panchia R, Hosseinipour MC, Kofron R, Margolis DA, Rinehart A, Adeyeye A, Burns D, McCauley M, Cohen MS, Currier JS . Cabotegravir is Not Associated with Weight Gain in HIV-uninfected Individuals in HPTN 077. Clin Infect Dis. 2019
- Yu Y, Bigos KL, Marzinke MA, Landovitz RJ, McCauley M, Ford S, Hendrix CW, Bies RR, Weld ED, HPTN 077 Study Team . A population pharmacokinetic model based on HPTN 077 of long-acting injectable cabotegravir for HIV PrEP. Br J Clin Pharmacol. 2022 Oct;88(10):4623-4632.
Abstracts
- Kim S, Martin MA, Galiwango RM, Laeyendecker O, Quinn TC, Kigozi G, Ssekubugu R, Bonsall D, Reynolds SJ, Foley B, Abeler-Dorner L, Fraser C, Ratmann O, Kagaayi J, and Grabowski K. Increasing intra- and inter-subtype HIV diversity despite rapidly declining HIV incidence in Uganda. Conference on Retroviruses and Opportunistic Infections. March 3-6, 2024, Denver CO. Abstract #1068.
- Landovitz RJ, Voldal E, Hanscom B, Eshleman SH, Piwowar-Manning E, Sullivan P, McCauley M, Soto-Torres L, Rooney JF, Rinehart AR, Cohen MS, Hosseinipour M, Delany-Moretlwe S, and Grinsztejn B. Site-based HIV testing assay performance for cabotegravir and TDF-FTC PrEP failure in HPTN 083. Conference on Retroviruses and Opportunistic Infections. March 3-6, 2024, Denver CO. Abstract #128
- Moser A, Hill T, Ahmed S, Cummings V, Wang Z, McCauley M, Grinsztejn B, Landovitz RJ, Fogel M, Eshleman SH, and Piwowar-Manning E. Comparison of assays for detection of HIV infection in persons using long-acting cabotegravir PrEP. Clinical Virology Symposium. 9/2023. West Palm Beach, FL. Abstract 27.
- Clement ME, Wang Z, Fitchtenbaum CJ, Thomas S, Bazan JA, Richardson P, Spinelli MA, Hanscom B, Rinehart AR, Rooney JF, Adeyeye A, McCauley M, Jennings A, Gomez K, Cohen M, Grinsztejn B, and Landovitz RJ. Pre-Exposure prophylaxis product choice of participants in HPTN 083. IAS 2024. 7/2024. Munich, Germany.
- Landovitz RJ, Gao F, Fogel JM, Hanscom B, Clement M, Ha VT, Guar A, Fitchtenbaum C, Piwowar-Manning E, Moser A, Marzinke M, Mellors JM, Halvas EK, McCauley M, Gomez-Feliciano K, Jennings A, Soto-Torres L, Zwerski S, Rooney JF, Rinehart AR, Cohen MS, Grinsztejn B, and Eshleman SH. Performance characteristics of HIV RNA screening with long-acting injectable cabotegravir (CAB-LA) pre-exposure prophylaxis (PrEP) in HPTN 083. IAS 2024, 7/2024. Munich, Germany.
Paul Richardson graduated from Manchester Polytechnic in England and is a registered multidisciplinary Biomedical Scientist with the Health Care Professions Council (UK). Paul later received his Fellowship of the Institute of Biomedical Sciences (London) in 1991 followed by a Master of Science in Biomedical Science from the Manchester Metropolitan University in 1999. His experience includes working in multiple hospital clinical laboratories, instrument sales and technical support. He is currently a Senior International QA/QC Coordinator for the HPTN Laboratory Center at Johns Hopkins University in Baltimore and has been involved in HPTN studies since 2005
Amber Moser graduated from Stevenson University with a Medical Laboratory Scientist degree and is American Society of Clinical Pathology MLS (ASCP) certified. Prior to working at the Johns Hopkins Hospital and University School of Medicine she worked at Sinai Hospital in the core laboratory and at Northwest Hospital as the team leader of the laboratory.
Tinia Hill graduated from Harrisburg University of Science and Technology with her Bachelors in Biology. She then went on to University of Maryland, School of Medicine and enrolled in their Department of Medical Research and Technology categorical program. She graduated in 2016 and is ASCP certified in Hematology. Prior to working at Johns Hopkins University School of Medicine, she worked at University of Maryland Medical Center in the HLA lab. She also has worked in other area clinical labs as a generalist.
Danielle Heyl graduated from Ferris State University with a Medical technology degree and is American Society of Clinical Pathology MLS (ASCP) certified. Prior to working at the Johns Hopkins University School of Medicine, she worked at Rex Hospital, KRR Laboratory as well as the Maryland Zoo’s Animal Hospital and AniLab, a full service clinical laboratory, specializing exclusively in veterinary testing.
Anjali Shankar graduated from George Washington University with a BS in Public Health with a concentration in bioinformatics, and from Johns Hopkins University with an MS in Biotechnology. Prior to working to at Johns Hopkins Hospital, she worked as a research assistant at Children’s National and as a scribe at The George Washington University Hospital. Currently, she is a research technologist at the HPTN LC Core Laboratory.
Meagan Peoples graduated from Johns Hopkins University with a double major in Chemistry and Writing Seminars. Prior to working at the Johns Hopkins Hospital and University School of Medicine, she worked as an interfaces engineer at Epic Systems, first in Wisconsin and then later abroad at their Bristol office.
Shahnaz Ahmed graduated from the University of Bombay with a Bachelor’s degree in Microbiology and a postgraduate degree in Medical Technology. She began her laboratory career in Bombay before moving to the USA. In the USA, Shahnaz completed her MLT ASCP certification before working as a generalist at Cleveland Clinic Hospital, Ohio. She then took on the role of Lab Supervisor at Frisco Urgent Care in Texas In 2018, Shahnaz joined Johns Hopkins University, where she currently serves as the International Lab QA/QC Coordinator.
Janet Small has been with Johns Hopkins Medicine since 2015. Prior to working at the Johns Hopkins University School of Medicine, she worked for Johns Hopkins Community Physicians as a Medical Office Assistant, as well as Quest Diagnostics. She worked at Quest Diagnostics for 22 years, starting out in Client Services, where she provided technical information to Doctors and their staff, became a Group Lead, and in 2014 became the Supervisor of the Department. In 2015 Janet started working at JHCP as a Medical Office Assistant, then in 2018 moved to HPTN LC as the Administrative Coordinator.
Yaw Agyei is a graduate of the University of Maryland with a medical technology degree and is American Society of Clinical Pathology MLS (ASCP). He worked at the Johns Hopkins Hospital Core Laboratory following an internship right after Medical Technology school. He stayed there for five years before joining the HIV Prevention Trails Network-Laboratory Center (HPTN- LC). He is a senior laboratory QA/QC coordinator and has spent many years working in different countries in Southern Africa, where his cultural background has helped in building capacity across local labs. In addition to his laboratory training, Yaw holds a Masters in Public Health (MPH) degree.
