UNC Center for AIDS Research

It's about a real-life response to AIDS - a fierce commitment to creating and translating knowledge that advances the fight against HIV & AIDS

Biostatistics Core
DESCRIPTIONPERSONNELINTERNSHIPSPUBLICATIONSRESOURCES

Mission

 

The purpose of the CFAR Biostatistics Core is to accelerate successful HIV/AIDS research by direct provision of biostatistical support and by arranging mutually beneficial collaborations between CFAR researchers and statistical scientists.

We provide biostatistical support that is readily available to CFAR investigators and to other CFAR Cores. In addition to making strategic contributions to the CFAR’s scientific dialog, we provide statistical consulting services that range from brief professional consultations to invention of new statistical methods. We collaborate on the framing of hypotheses and on the development of study designs, grant applications, journal articles and presentations, selection of statistical methods, performance of statistical computations and interpretive analyses, and research database management consultation and support.

The Biostatistics Core brings together CFAR investigators and professional biostatisticians who possess specialized expertise needed for CFAR research projects. We promote opportunities for faculty and students in the statistical sciences at UNC to participate in HIV/AIDS-related research and become members of the CFAR. The participating faculty of the Biostatistics Department forms an important component of the Biostatistics Core.

We also promote training opportunities for CFAR investigators who are interested in the application of best statistical methods, and provide training opportunities for students and fellows who are assisting in AIDS-related studies. We recommend that investigators contact the Biostatistics Core in the earliest stage of new research efforts and well in advance of deadlines for grant applications, abstract submissions and protocol development.

Please contact the CFAR Biostatistics Core with new requests by e-mailing us at CFARbios@bios.unc.edu.

Michael Hudgens, Ph.D.

Core Director

Dr. Michael Hudgens is a Professor and Associate Chair of the Department of Biostatistics at UNC-Chapel Hill and is Director of the Biostatistics Core of the UNC Center for AIDS Research. He has experience in collaborative research and statistical methodology development related to studies of infectious diseases, with emphasis on HIV. Professor Hudgens has co-authored more than 250 peer-reviewed papers in statistical journals such as Biometrics, Biometrika, JASA and JRSS-B as well as biomedical journals such as the Lancet, Nature and New England Journal of Medicine. He currently serves as an Associate Editor for Biometrics. He is an elected Fellow of the American Statistical Association and has taught graduate level biostatistics courses at UNC for over 15 years.

 

3101D McGavran-Greenberg
Chapel Hill, NC
mhudgens@bios.unc.edu
Office Phone: 919-966-7253

 

Stephen R Cole, Ph.D.

Associate Core Director

Stephen ColeDr. Cole is a Professor of Epidemiology at UNC with an interest in quantitative epidemiologic methods. He is Associate Director of the Biostatistics Core of the UNC Center for AIDS Research, as well as Director of the Epidemiology and Biostatistics Core of the CFAR Network of Integrated Clinical Systems (CNICS). His research focuses on the use of structural models to explore the causal effect of antiretroviral therapies on HIV disease progression, and direct and indirect causal effects of alcohol intake on HIV acquisition. He is also a member of a Causal Inference Research Group (CIRG) at UNC.

 

 

2105E McGavran-Greenberg Hall
Chapel Hill, NC
cole@unc.edu
Office Phone: 919-966-7415

 

Bonnie Shook-Sa, Dr.P.H.

Assistant Core Director

Dr. Bonnie Shook-Sa is an Assistant Professor in the Department of Biostatistics. She has over 14 years of experience in collaborative public health research and statistical methods development with over 40 peer-reviewed publications. Her research focuses on survey sampling and causal inference methods and their applications to HIV research. Dr. Shook-Sa is the instructor for the graduate-level Sample Survey Methodology course in the Department of Biostatistics at UNC and is a member of a Causal Inference Research Group (CIRG). Her statistical experience includes study design, sampling frame development and evaluation, statistical analysis plan development, and complex modeling.

 

3103B McGavran-Greenberg Hall
Chapel Hill, NC 27516
bshooksa@email.unc.edu
Office Phone: 919-966-3794

 

Katie Mollan, M.S.

Principal Biostatistician

Katie Mollan, Principal Biostatistician at UNC-Chapel Hill School of Medicine, has >17 years of full-time experience in infectious disease and comorbidities research. Her expertise includes leading the statistical design and analysis of clinical trials and longitudinal cohort studies. Mollan mentors graduate students and supervises undergraduate students in collaborative research. Her research interests include comparative effectiveness, women’s health, mental health, and applied causal inference. Mollan has co-authored >70 peer-reviewed articles, with lead authorships in Annals of Internal Medicine, AJE, JID, and CID. She is experienced at analyzing a broad range of clinical, laboratory, and patient-reported outcomes data from both U.S. and international studies. Mollan earned her M.S. in Statistics at the Ohio State University (2006) and worked at the Harvard T.H. Chan School of Public Health, Center for Biostatistics in AIDS Research (2006-2012). She previously served as Manager (2016-2020) of the UNC CFAR Biostatistics Core and founded the Core’s internship program.

3126 McGavran-Greenberg Hall
Chapel Hill, NC
kmollan@email.unc.edu
Office Phone: 919-966-8421

 

Fei Zou, Ph.D.

Participating Faculty


Dr. Zou is a Professor in the Department of Biostatistics and the Department of Genetics at the University of North Carolina at Chapel Hill. Her research interest is in the development of theoretical methodologies appropriate for interpretation of high-dimensional genetics and genomics data. She is highly experienced in gene expression data analysis, genome wide association (GWA) mapping, and next-generation sequencing data analysis. She is also experienced in designing clinical trials, and analysis of complex observational data.

4115D McGavran-Greenberg Hall
Chapel Hill, NC
feizou@email.unc.edu
Office Phone: 919-843-4822

 

Jessica Keys, Ph.D.

Research Analyst

Jessica Keys,

Dr. Keys joined the Biostatistics Core at the UNC Center for AIDS Research to offer support to new and ongoing clinical research. She received her doctorate in epidemiology from the UNC Gillings School of Global Public Health where her research focused on measuring HIV drug resistance and its impact on clinical care. She has worked collaboratively with laboratory scientists, clinical care providers, and biostatisticians, and she has experience in both academic and corporate settings, where she developed skills in data management and analytics. As a Research Analyst with the Core, she is primarily available to provide support to investigators looking for assistance with data capture, oversight, and integrity.

 

 

 

Monika Caruso

Core Administrator

Monika Caruso HeadshotMs. Caruso provides administrative support to the Biostatistics Core. As the Contracts & Grants Manager for the Department of Biostatistics, Caruso provides pre-award support as needed for grant applications supported by the Biostatistics Core. She also assists with meeting scheduling, project tracking, RPPR preparation, overseeing NIH-related publication compliance, and other administrative needs of the Core.

 

 

 

3104D McGavran-Greenberg Hall
Chapel Hill, NC
mcaruso@bios.unc.edu
Office Phone: 919-966-7268

 

Ann Marie Weideman, M.S.

Research Assistant

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Ann Marie Weideman is a Ph.D. candidate in biostatistics who joined the CFAR Biostatistics Core in 2018. Her research is focused on using biostatistics to support clinical trials, specifically those that entail Bayesian methodology and high-performance computing. Her prior education and research background reflect her appreciation for rigorous mathematical and statistical theory and how it can be utilized to advance the medical sciences. She received graduate degrees in mathematics and biostatistics, while conducting over a decade of collaborative research in basic research laboratories, radiation epidemiology, cardiovascular disease, diabetes, neuroimmunological diseases, HIV/AIDS, and cancer genomics.

 

 

 

Yen Chang, M.S.

Research Assistant

Yen Chang Headshot

Yen Chang is a PhD student in the Biostatistics department at UNC. She received a B.S. degree in Life Science and a M.S. degree in Molecular and Cellular Biology from National Tsing Hua University in Taiwan, and a M.S. degree in Biostatistics from UNC. She assists Dr. Julie Dumond’s research on pharmacokinetics/pharmacodynamics of HIV antiretrovirals in WIHS and MACS cohorts.

 

 

 

 

Taylor Krajewski, M.A.

Research Assistant

TK HeadshotTaylor Krajewski is a Ph.D. candidate in the Biostatistics Department at UNC. She received her B.S. in Mathematics and her M.A. in Mathematics Education from the University of Pittsburgh. Before coming to UNC, she was the mathematics department chair and a mathematics teacher at a high school in the Philadelphia, PA area for several years. In addition to working for the CFAR, she is also a predoctoral trainee on the National Institute of Environmental Health Sciences training program in Environmental Biostatistics.

 

 

 

Kaitlyn Cross, M.S.

Research Assistant

KC Headshot black and whiteKaitlyn Cross is a PhD student in the Biostatistics department at UNC. She received her B.S. in Biochemistry & Molecular Biology from the University of Richmond and her M.S. in Statistics from George Washington University. Before joining the CFAR, she worked as a biostatistician at the Emmes Company, where she led clinical trials focusing on vaccines and therapeutics for respiratory infectious diseases.

 

 

 

 

Brain Richardson, B.S.P.H., B.A.

Research Assistant

Headshot of Brian RichardsonBrian Richardson is a PhD student in the UNC Biostatistics department. He received his B.S.P.H. in Biostatistics and a B.A. in Mathematics from UNC. Brian works as a research assistant for the CFAR and is a predoctoral trainee on the National Institute of Environmental Health Sciences training program “Biostatistics for Research in Environmental Health.”

 

 

 

 

 

Amber Young, B.S.

Research Assistant

Headshot of Amber YoungAmber Young is a PhD student in the department of Biostatistics at UNC. She received her B.S. in Mathematics and Statistics from Purdue University. In addition to working for CFAR, she is a predoctoral trainee on the National Cancer Institute training grant “Biostatistics for Research in Genomics and Cancer.” Her academic interests include replicability, machine learning, and clinical trial design. Amber also enjoys skiing and making pottery. 

 

 

 

 

Chanhwa Lee, B.S.

Research Assistant

Headshot of Chanhwa-LeeChanhwa Lee is a Ph.D. student in the Biostatistics Department at UNC and is a member of a Causal Inference Research Group (CIRG). He received his B.S. in Statistics and Mathematics from Seoul National University in Korea. He has a solid theoretical and mathematical background and is experienced in statistical modeling, from classical parametric models to machine learning and nonparametric models. His research interest is in the nonparametric estimation of intervention effects under interference, semiparametric theory, and precision medicine. As a member of the CFAR, he assists in grant writing, power and sample size calculation, and the analysis of observational and randomized trial data.  

 

 

Mingwei Fei

Research Assistant

Head shot of Mingwei Fei

Mingwei Fei is a PhD student in biostatistics, newly back to school after over 10 years’ experience in clinical trials in oncology as well as hematopoietic and solid organ transplantation. 

I am very interested in biostatistics and clinical trials in cancer oncology therapeutics research, including cell therapy and drug development. 

 

 

 

 

Melissa Mischell, B.A.

Research Assistant

Head shot of Melissa-MischellMelissa Mischell is a PhD student in the Biostatistics Department at UNC. She received her B.A. in Mathematics with a minor in Data Analysis from Wesleyan University. Before coming to UNC, she worked as a data scientist at Penguin Random House.  

 

 

 

 

 

Past Graduate Students (2012-Present)

    • Sam Hawke, B.S.
    • Wenwen Mei, B.S.P.H.
    • Pooja Saha, Ph.D.
    • Bonnie Shook-Sa, Dr.P.H
    • Sarah Reifeis, Ph.D.
    • Ilana Trumble, M.S.
    • Andrew G. Allmon, B.S.
    • Pedro Baldoni, M.S.
    • Owen Francis, M.S.
    • Brian Barkley, Ph.D
    • Joseph Rigdon, Ph.D.
    • Lu Mao, Ph.D.
    • Amy Richardson, Ph.D.

UNC CFAR Biostatistics Summer Internship

CFAR Interns

Tianhong (Theo) Wu

Tianhong (Theo) Wu
(UNC Class of 2024)
Yating Zou (2022)
(UNC Class of 2022)
Michelle Castillo Rzepka (2022)
(UNC Class of 2023)

Mincen Liu (2021)
[UNC Class of 2022]
A person in a suit and tie Description automatically generated with medium confidence
Matthew Dinwiddie (2021)
[UNC Class of 2022]
Gabrielle Streeter (2020)
[UNC Class of 2021]
Carolina Ha Headshot Black and White
Caroline Ha (2020)
[UNC Class of 2022]
A person smiling with her hand on her face Description automatically generated with low confidence
HarLeigh Haynie (2019)
[Winston-Salem State University]

Emma Crenshaw (2018)
[UNC Class of 2019]

Jake Mathura (2018)
[Class of 2020]

 Orlando Ferrer, B.S. (2017)
[Doctoral Student, Wake Forest]

 Sumati Sridhar (2017)
(UNC Class of 2019)

 

 

The UNC CFAR Biostatistics Core offers a range of services to CFAR investigators, including:

• Study Design and Planning
• Grant Proposal Support
• Statistical Computation, Derivation, Interpretive Analysis, and Publication
• Data Carpentry and Visualizations
• Statistical Methods Research and Development
• Database Consultation
• Training and Tutorial Consultation
• Mentoring
• Referrals

Publications

2023

Boyce RM, Ndizeye R, Ngelese H, Baguma E, Shem B, Rubinstein RJ, Rockwell E, Lotspeich SC, Shook-Sa BE, Ntaro M, Nyehangane D, Wohl DA, Siedner MJ, Mulogo EM. It takes more than a machine: A pilot feasibility study of point-of-care HIV-1 viral load testing at a lower-level health center in rural western Uganda. PLOS Glob Public Health. 2023 Mar 27;3(3):e0001678. PMID: 36972208; PMCID: PMC10042348.

 

Cole SR, Edwards JK, Breskin A, Rosin S, Zivich PN, Shook-Sa BE, Hudgens MG. Illustration of 2 Fusion Designs and Estimators. Am J Epidemiol. 2023 Feb 24;192(3):467-474. PMID: 35388406.

 

Cole SR, Zivich PN, Edwards JK, Shook-Sa BE, Hudgens MG. Sensitivity Analyses for Means or Proportions with Missing Outcome Data. Epidemiology. 2023 May 9.  PMID: 37155639.

 

Cole SR, Zivich PN, Edwards JK, Ross RK, Shook-Sa BE, Price JT, Stringer JSA. Missing Outcome Data in Epidemiologic Studies. Am J Epidemiol. 2023 Jan 6;192(1):6-10. PMID: 36222655; PMCID: PMC10144620.

 

DeMonte J, McCumber M, Slye N, Amico KR, Arnold EM, Comulada WS, Hayati Rezvan P, Hightow-Weidman LB, Muessig KE, Nichols SL, Nielsen-Saines K, Sanchez TH, Shook-Sa BE, Swendeman D, Valencia RK, Hudgens MG. Adolescents Living With or at Risk for HIV: A Pooled Descriptive Analysis of Studies From the Adolescent Medicine Trials Network for HIV/AIDS Interventions. J Adolesc Health. 2023 May;72(5):712-721. PMID: 36803999; PMCID: PMC10121857.

 

Edwards JK, Cole SR, Shook-Sa BE, Zivich PN, Zhang N, Lesko CR. When Does Differential Outcome Misclassification Matter for Estimating Prevalence? Epidemiology. 2023 Mar 1;34(2):192-200. PMID: 36722801; PMCID: PMC10237297.

 

Harper GW, Cherenack EM, Slye N, Jadwin-Cakmak L, Hudgens M. Pilot Trial of a Critical Consciousness-Based Intervention for Black Young Gay and Bisexual Men Living with HIV: Mobilizing Our Voices for Empowerment (MOVE). J Racial Ethn Health Disparities. 2023 Feb;10(1):64-82. PMID: 35048310; PMCID: PMC9296697.

 

Jetsupphasuk M, Hudgens MG, Lu H, Cole SR, Edwards JK, Adimora AA, Althoff KN, Silverberg MJ, Rebeiro PF, Lima VD, Marconi VC, Sterling TR, Horberg MA, Gill MJ, Kitahata MM, Moore RD, Lang R, Gebo K, Rabkin C, Eron JJ. Optimizing Treatment for Human Immunodeficiency Virus to Improve Clinical Outcomes Using Precision Medicine. Am J Epidemiol. 2023 Mar 15:kwad057. PMID: 36922393.

 

LeMasters K, Benson A, Corsi C, Krajewski T, Seide K, Brinkley-Rubinstein L, Nowotny K. Collateral consequences of COVID-19 for people on probation and parole. Health Justice. 2023 Mar 30;11(1):18. PMID: 36995422; PMCID: PMC10060932.

 

LeMasters K, Krajewski T, Nowotny K, Oser C, Mollan K, Brinkley-Rubinstein L. Context specific HIV risk: evidence from screening into the southern pre-exposure prophylaxis study (SPECS). AIDS Care. 2023 Apr;35(4):474-479. PMID: 35377251; PMCID: PMC9530063.

 

Lindsey JC, Hudgens M, Gaur AH, Horvath KJ, Dallas R, Heckman B, Mueller Johnson M, Amico KR. Electronic Dose Monitoring Device Patterns in Youth Living With HIV Enrolled in an Adherence Intervention Clinical Trial. J Acquir Immune Defic Syndr. 2023 Mar 1;92(3):231-241. PMID: 36730762; PMCID: PMC9928806.

 

Milligan EC, Olstad K, Williams CA, Mallory M, Cano P, Cross KA, Munt JE, Garrido C, Lindesmith L, Watanabe J, Usachenko JL, Hopkins L, Immareddy R, Shaan Lakshmanappa Y, Elizaldi SR, Roh JW, Sammak RL, Pollard RE, Yee JL, Herbek S, Scobey T, Miehlke D, Fouda G, Ferrari G, Gao H, Shen X, Kozlowski PA, Montefiori D, Hudgens MG, Edwards DK, Carfi A, Corbett KS, Graham BS, Fox CB, Tomai M, Iyer SS, Baric R, Reader R, Dittmer DP, Van Rompay KKA, Permar SR, De Paris K. Infant rhesus macaques immunized against SARS-CoV-2 are protected against heterologous virus challenge 1 year later. Sci Transl Med. 2023 Mar;15(685):eadd6383. PMID: 36454813; PMCID: PMC9765459.

 

Rosenberg NE, Shook-Sa BE, Liu M, Stranix-Chibanda L, Yotebieng M, Sam-Agudu NA, Hudgens MG, Phiri SJ, Mutale W, Bekker LG, Moyo S, Zuma K, Charurat ME, Justman J, Chi BH. Adult HIV-1 incidence across 15 high-burden countries in sub-Saharan Africa from 2015 to 2019: a pooled analysis of nationally representative data. Lancet HIV. 2023 Mar;10(3):e175-e185. PMID: 36702151; PMCID: PMC10126805.

 

Sadinski LM, Westreich D, Edmonds A, Breger TL, Cole SR, Ramirez C, Brown TT, Ofotokun I, Konkle-Parker D, Kassaye S, Jones DL, D’Souza G, Cohen MH, Tien PC, Taylor TN, Anastos K, Adimora AA. Hypertension and one-year risk of all-cause mortality among women with treated HIV in the United States. AIDS. 2023 Mar 15;37(4):679-688. PMID: 36728933; PMCID: PMC9974900.

 

Sanusi B, Cai J, Hudgens MG. Nonparametric estimation of marked survival data in the presence of dependent censoring. Stat Med. 2023 May 30;42(12):1995-2008. PMID: 36945185; PMCID: PMC10192031.

 

Vias, N.P., Cassidy, C.E., Edwards, J.K., Xiong, K., Parker, C.B., Aiello, A.E., Boyce, R.M., Shook-Sa, B.E.“Accounting for outcome misclassification in complex sample designs: estimation of SARS-CoV-2 seroprevalence in central North Carolina.” Epidemiology, In press.

 

Zalla LC, Cole SR, Eron JJ, Adimora AA, Vines AI, Althoff KN, Silverberg MJ, Horberg MA, Marconi VC, Coburn SB, Lang R, Williams EC, Gill MJ, Gebo KA, Klein M, Sterling TR, Rebeiro PF, Mayor AM, Moore RD, Edwards JK. Association of Race and Ethnicity With Initial Prescription of Antiretroviral Therapy Among People With HIV in the US. JAMA. 2023 Jan 3;329(1):52-62. PMID: 36594946; PMCID: PMC9856806.

 

Zivich PN, Cole SR, Edwards JK, Mulholland GE, Shook-Sa BE, Tchetgen Tchetgen EJ. Introducing Proximal Causal Inference for Epidemiologists. Am J Epidemiol. 2023 Mar 31:kwad077. PMID: 37005072.

 

2022

 

Boyce RM, Muhindo E, Baguma E, Muhindo R, Shem B, François R, Hawke S, Shook-Sa BE, Ntaro M, Nalusaji A, Nyehangane D, Reyes R, Juliano JJ, Siedner MJ, Staedke SG, Mulogo EM. Permethrin-treated baby wraps for the prevention of malaria: results of a randomized controlled pilot study in rural Uganda. Malar J. 2022 Feb 23;21(1):63. PMID: 35197060; PMCID: PMC8864600.

 

Breger TL, Westreich D, Edmonds A, Edwards JK, Zalla LC, Cole SR, Ramirez C, Ofotokun I, Kassaye SG, Brown TT, Konkle-Parker D, Jones DL, D’Souza G, Cohen MH, Tien PC, Taylor TN, Anastos K, Adimora AA. A new smoking cessation ‘cascade’ among women with or at risk for HIV infection. AIDS. 2022 Jan 1;36(1):107-116. PMID: 34586086; PMCID: PMC8819357.

 

Cerami C, Popkin-Hall ZR, Rapp T, Tompkins K, Zhang H, Muller MS, Basham C, Whittelsey M, Chhetri SB, Smith J, Litel C, Lin KD, Churiwal M, Khan S, Rubinstein R, Claman F, Mollan K, Wohl D, Premkumar L, Powers KA, Juliano JJ, Lin FC, Lin JT. Household Transmission of Severe Acute Respiratory Syndrome Coronavirus 2 in the United States: Living Density, Viral Load, and Disproportionate Impact on Communities of Color. Clin Infect Dis. 2022 May 30;74(10):1776-1785. PMID: 34383889; PMCID: PMC8436395.

 

Chibwesha CJ, Mollan KR, Ford CE, Shibemba A, Saha PT, Lusaka M, Mbewe F, Allmon AG, Lungu R, Spiegel HML, Mweni E, Mwape H, Kankasa C, Chi BH, Stringer JSA. A Randomized Trial of Point-of-Care Early Infant Human Immunodeficiency Virus (HIV) Diagnosis in Zambia. Clin Infect Dis. 2022 Aug 25;75(2):260-268. PMID: 34718462; PMCID: PMC9410723.

 

Clutton GT, Weideman AMK, Goonetilleke NP, Maurer T. An expanded population of CD8dim T cells with features of mitochondrial dysfunction and senescence is associated with persistent HIV-associated Kaposi’s sarcoma under ART. Front Cell Dev Biol. 2022 Sep 29;10:961021. PMID: 36247006; PMCID: PMC9557199.

 

Conner MG, Vwalika B, Freeman BL, Sebastião YV, Mabula-Bwalya CM, Cole SR, Stringer EM, Kasaro MP, Stringer JSA, Price JT. Effect of weekly 17-hydroxyprogesterone caproate on small for gestational age among pregnant women with HIV in Zambia. AIDS. 2022 Nov 15;36(14):2079-2081. PMID: 36305188; PMCID: PMC9624437.

 

Curtis AD 2nd, Saha PT, Dennis M, Berendam SJ, Ramasubramanian P, Cross KA, Alam SM, Ferrari G, Kozlowski PA, Fouda GG, Hudgens MG, Van Rompay KKA, Pollara J, Permar SR, De Paris K. Vaccine-Induced, High-Magnitude HIV Env-Specific Antibodies with Fc-Mediated Effector Functions Are Insufficient to Protect Infant Rhesus Macaques against Oral SHIV Infection. mSphere. 2022 Feb 23;7(1):e0083921. PMID: 35196125; PMCID: PMC8865927.

 

Edwards JK, Cole SR, Breger TL, Filiatreau LM, Zalla L, Mulholland GE, Horberg MA, Silverberg MJ, John Gill M, Rebeiro PF, Thorne JE, Kasaie P, Marconi VC, Sterling TR, Althoff KN, Moore RD, Eron JJ. Five-Year Mortality for Adults Entering Human Immunodeficiency Virus Care Under Universal Early Treatment Compared With the General US Population. Clin Infect Dis. 2022 Sep 14;75(5):867-874. PMID: 34983066; PMCID: PMC9477443.

 

Fischer WA 2nd, Eron JJ Jr, Holman W, Cohen MS, Fang L, Szewczyk LJ, Sheahan TP, Baric R, Mollan KR, Wolfe CR, Duke ER, Azizad MM, Borroto-Esoda K, Wohl DA, Coombs RW, James Loftis A, Alabanza P, Lipansky F, Painter WP. A phase 2a clinical trial of molnupiravir in patients with COVID-19 shows accelerated SARS-CoV-2 RNA clearance and elimination of infectious virus. Sci Transl Med. 2022 Jan 19;14(628):eabl7430. PMID: 34941423.

 

Ha TV, Hoffman IF, Miller WC, Mollan KR, Lancaster KE, Richardson P, Zeziulin O, Djoerban Z, Sripaipan T, Chu VA, Guo X, Hanscom B, Go VF. Association between drug use and ART use among people living with HIV who inject drugs in Vietnam, Ukraine and Indonesia: results from HPTN 074. J Subst Use. 2022;27(6):648-657.  PMID: 36742268; PMCID: PMC9897261.

 

Knittel AK, Rudolph JE, Shook-Sa BE, Edmonds A, Ramirez C, Cohen M, Taylor T, Adedimeji A, Michel KG, Milam J, Cohen J, Donohue JD, Foster A, Fischl MA, Long DM, Adimora AA. Self-Reported Sexually Transmitted Infections After Incarceration in Women with or at Risk for HIV in the United States, 2007-2017. J Womens Health (Larchmt). 2022 Mar;31(3):382-390. PMID: 34967695; PMCID: PMC8972014.

 

Li F, Buchanan AL, Cole SR. Generalizing trial evidence to target populations in non-nested designs: Applications to AIDS clinical trials. J R Stat Soc Ser C Appl Stat. 2022 Jun;71(3):669-697. PMID: 35968541; PMCID: PMC9367209.

 

Li L, Lee C, Cruz DF, Krovi SA, Hudgens MG, Cottrell ML, Johnson LM. Reservoir-Style Polymeric Drug Delivery Systems: Empirical and Predictive Models for Implant Design. Pharmaceuticals (Basel). 2022 Oct 3;15(10):1226. PMID: 36297338; PMCID: PMC9610229.

 

Li X, May S, Trumble IM, Archin NM, Hudgens MG. Paired serial limiting dilution assays. Stat Med. 2022 Oct 30;41(24):4809-4821. PMID: 35975729; PMCID: PMC9588648.

 

Lu H, Cole SR, Westreich D, Hudgens MG, Adimora AA, Althoff KN, Silverberg MJ, Buchacz K, Li J, Edwards JK, Rebeiro PF, Lima VD, Marconi VC, Sterling TR, Horberg MA, Gill MJ, Kitahata MM, Eron JJ, Moore RD; North American AIDS Cohort Collaboration on Research, Design of the International Epidemiologic Databases to Evaluate AIDS. Virologic outcomes among adults with HIV using integrase inhibitor-based antiretroviral therapy. AIDS. 2022 Feb 1;36(2):277-286. PMID: 34934020; PMCID: PMC9048218.

 

McNeil CJ, Lee JS, Cole SR, Patel SA, Martin J, Mathews WC, Moore RD, Mayer KH, Eron JJ, Saag MS, Kitahata MM, Achenbach CJ; Centers for AIDS Research (CFAR) Network of Integrated Clinical Systems (CNICS). Anal cancer incidence in men with HIV who have sex with men: are black men at higher risk? AIDS. 2022 Apr 1;36(5):657-664. PMID: 34923519; PMCID: PMC10115425.

 

Mollan KR, Eron JJ, Krajewski TJ, Painter W, Duke ER, Morse CG, Goecker EA, Premkumar L, Wolfe CR, Szewczyk LJ, Alabanza PL, Loftis AJ, Degli-Angeli EJ, Brown AJ, Dragavon JA, Won JJ, Keys J, Hudgens MG, Fang L, Wohl DA, Cohen MS, Baric RS, Coombs RW, Sheahan TP, Fischer WA. Infectious Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Virus in Symptomatic Coronavirus Disease 2019 (COVID-19) Outpatients: Host, Disease, and Viral Correlates. Clin Infect Dis. 2022 Aug 24;75(1):e1028-e1036. PMID: 35022711; PMCID: PMC9402664.

 

Nelson AN, Dennis M, Mangold JF, Li K, Saha PT, Cronin K, Cross KA, Kumar A, Mangan RJ, Shaw GM, Bar KJ, Haynes B, Moody AM, Munir Alam S, Pollara J, Hudgens MG, Van Rompay KKA, De Paris K, Permar SR. Leveraging antigenic seniority for maternal vaccination to prevent mother-to-child transmission of HIV-1. NPJ Vaccines. 2022 Jul 30;7(1):87. PMID: 35907918; PMCID: PMC9338948.

 

Pokaprakarn T, Prieto JC, Price JT, Kasaro MP, Sindano N, Shah HR, Peterson M, Akapelwa MM, Kapilya FM, Sebastião YV, Goodnight W 3rd, Stringer EM, Freeman BL, Montoya LM, Chi BH, Rouse DJ, Cole SR, Vwalika B, Kosorok MR, Stringer JSA. AI Estimation of Gestational Age from Blind Ultrasound Sweeps in Low-Resource Settings. NEJM Evid. 2022 May;1(5):10.1056/evidoa2100058. PMID: 36875289; PMCID: PMC9980216.

 

Price JT, Sebastião YV, Vwalika B, Cole SR, Mbewe FM, Phiri WM, Freeman BL, Kasaro MP, Peterson M, Rouse DJ, Stringer EM, Stringer JSA. Risk of Adverse Birth Outcomes in Two Cohorts of Pregnant Women With HIV in Zambia. Epidemiology. 2022 May 1;33(3):422-430. PMID: 35067569; PMCID: PMC9516482.

 

Rosenberg NE, Tembo TA, Simon KR, Mollan K, Rutstein SE, Mwapasa V, Masiano S, Huffstetler HE, Go V, Kim MH. Development of a Blended Learning Approach to Delivering HIV-Assisted Contact Tracing in Malawi: Applied Theory and Formative Research. JMIR Form Res. 2022 Apr 19;6(4):e32899. PMID: 35438644; PMCID: PMC9066333.

 

Shook-Sa BE, Hudgens MG, Kavee AL, Rosen DL. Estimating the Number of Persons with HIV in Jails via Web Scraping and Record Linkage. J R Stat Soc Ser A Stat Soc. 2022 Dec;185(Suppl 2):S270-S287. PMID: 36860267; PMCID: PMC9970294.

 

Vijayan KKV, Cross KA, Curtis AD 2nd, Van Rompay KKA, Pollara J, Fox CB, Tomai M, Hanke T, Fouda G, Hudgens MG, Permar SR, De Paris K. Early Post-Vaccination Gene Signatures Correlate With the Magnitude and Function of Vaccine-Induced HIV Envelope-Specific Plasma Antibodies in Infant Rhesus Macaques. Front Immunol. 2022 Apr 27;13:840976. PMID: 35572573; PMCID: PMC9094446.

 

Wang C, Ong JJ, Zhao P, Weideman AM, Tang W, Smith MK, Marks M, Fu H, Cheng W, Terris-Prestholt F, Zheng H, Tucker JD, Yang B. Expanding syphilis test uptake using rapid dual self-testing for syphilis and HIV among men who have sex with men in China: A multiarm randomized controlled trial. PLoS Med. 2022 Mar 2;19(3):e1003930. Erratum in: PLoS Med. 2022 Aug 4;19(8):e1004071. PMID: 35235573; PMCID: PMC8890628.

 

Xu Y, Weideman AM, Abad-Fernandez M, Mollan KR, Kallon S, Samir S, Warren JA, Clutton G, Roan N, Adimora AA, Archin N, Kuruc J, Gay C, Hudgens MG, Goonetilleke N. CD8 T Cell Virus Inhibition Assay Protocol. Bio Protoc. 2022 Mar 20;12(6):e4354. PMID: 35434196; PMCID: PMC8983397.

 

Zhou S, Hill CS, Spielvogel E, Clark MU, Hudgens MG, Swanstrom R. Unique Molecular Identifiers and Multiplexing Amplicons Maximize the Utility of Deep Sequencing To Critically Assess Population Diversity in RNA Viruses. ACS Infect Dis. 2022 Dec 9;8(12):2505-2514. PMID: 36326446; PMCID: PMC9742341.

 

Zhou Y, Lu Y, Ni Y, Wu D, He X, Ong JJ, Tucker JD, Sylvia SY, Jing F, Li X, Huang S, Shen G, Xu C, Xiong Y, Sha Y, Cheng M, Xu J, Jiang H, Dai W, Huang L, Zou F, Wang C, Yang B, Mei W, Tang W. Monetary incentives and peer referral in promoting secondary distribution of HIV self-testing among men who have sex with men in China: A randomized controlled trial. PLoS Med. 2022 Feb 14;19(2):e1003928. PMID: 35157727; PMCID: PMC8887971.

 

2021

Boyce RM, Shook-Sa BE, Aiello AE. A Tale of 2 Studies: Study Design and Our Understanding of Severe Acute Respiratory Syndrome Coronavirus 2 Seroprevalence. Clin Infect Dis. 2021 Nov 2;73(9):e3124-e3126. PMID: 33338219; PMCID: PMC7799336.

 

Breskin A, Cole SR, Edwards JK, Brookmeyer R, Eron JJ, Adimora AA. Fusion designs and estimators for treatment effects. Stat Med. 2021 Jun 15;40(13):3124-3137. Erratum in: Stat Med. 2023 Feb 28;42(5):730. PMID: 33783011; PMCID: PMC8237350.

 

Breskin A, Edmonds A, Cole SR, Westreich D, Cocohoba J, Cohen MH, Kassaye SG, Metsch LR, Sharma A, Williams MS, Adimora AA. G-computation for policy-relevant effects of interventions on time-to-event outcomes. Int J Epidemiol. 2021 Jan 23;49(6):2021-2029. Erratum in: Int J Epidemiol. 2021 May 17;50(2):701. PMID: 33141177; PMCID: PMC7825964.

 

Ceriani C, Streeter GS, Lemu KJ, James KS, Ghofrani S, Allard B, Shook-Sa BE, Margolis DM, Archin NM. Defining stable reference genes in HIV latency reversal experiments. J Virol. 2021 May 10;95(11):e02305-20. PMID: 33762410; PMCID: PMC8139712.

 

Cole SR, Edwards JK, Breskin A, Hudgens MG. Comparing Parametric, Nonparametric, and Semiparametric Estimators: The Weibull Trials. Am J Epidemiol. 2021 Aug 1;190(8):1643-1651. PMID: 33569578; PMCID: PMC8484780.

 

Davy-Mendez T, Napravnik S, Eron JJ, Cole SR, Van Duin D, Wohl DA, Gebo KA, Moore RD, Althoff KN, Poteat T, Gill MJ, Horberg MA, Silverberg MJ, Nanditha NGA, Thorne JE, Berry SA; North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD) of IeDEA. Racial, ethnic, and gender disparities in hospitalizations among persons with HIV in the United States and Canada, 2005-2015. AIDS. 2021 Jul 1;35(8):1229-1239. PMID: 33710020; PMCID: PMC8172437.

 

Davy-Mendez T, Napravnik S, Eron JJ, Cole SR, van Duin D, Wohl DA, Hogan BC, Althoff KN, Gebo KA, Moore RD, Silverberg MJ, Horberg MA, Gill MJ, Mathews WC, Klein MB, Colasanti JA, Sterling TR, Mayor AM, Rebeiro PF, Buchacz K, Li J, Nanditha NGA, Thorne JE, Nijhawan A, Berry SA; North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD) of the International Epidemiology Databases to Evaluate AIDS (IeDEA). Current and Past Immunodeficiency Are Associated With Higher Hospitalization Rates Among Persons on Virologically Suppressive Antiretroviral Therapy for up to 11 Years. J Infect Dis. 2021 Aug 16;224(4):657-666. PMID: 34398239; PMCID: PMC8366443.

 

 

Diepstra KL, Barr L, Palm D, Hogg E, Mollan KR, Henley L, Stover AM, Simoni JM, Sugarman J, Brown B, Sauceda JA, Deeks S, Fox L, Gandhi RT, Smith D, Li JZ, Dubé K. Participant Perspectives and Experiences Entering an Intensively Monitored Antiretroviral Pause: Results from the AIDS Clinical Trials Group A5345 Biomarker Study. AIDS Res Hum Retroviruses. 2021 Jun;37(6):489-501. PMID: 33472545; PMCID: PMC8213012.

Edmonds A, Breskin A, Cole SR, Westreich D, Ramirez C, Cocohoba J, Wingood G, Cohen MH, Golub ET, Kassaye SG, Metsch LR, Sharma A, Konkle-Parker D, Wilson TE, Adimora AA. Poverty, Deprivation, and Mortality Risk Among Women With HIV in the United States. Epidemiology. 2021 Nov 1;32(6):877-885. PMID: 34347686; PMCID: PMC8478815.

 

Edwards JK, Cole SR, Breger TL, Rudolph JE, Filiatreau LM, Buchacz K, Humes E, Rebeiro PF, D’Souza G, Gill MJ, Silverberg MJ, Mathews WC, Horberg MA, Thorne J, Hall HI, Justice A, Marconi VC, Lima VD, Bosch RJ, Sterling TR, Althoff KN, Moore RD, Saag M, Eron JJ. Mortality Among Persons Entering HIV Care Compared With the General U.S. Population : An Observational Study. Ann Intern Med. 2021 Sep;174(9):1197-1206. PMID: 34224262; PMCID: PMC8453103.

 

Falcinelli SD, Kilpatrick KW, Read J, Murtagh R, Allard B, Ghofrani S, Kirchherr J, James KS, Stuelke E, Baker C, Kuruc JD, Eron JJ, Hudgens MG, Gay CL, Margolis DM, Archin NM. Longitudinal Dynamics of Intact HIV Proviral DNA and Outgrowth Virus Frequencies in a Cohort of Individuals Receiving Antiretroviral Therapy. J Infect Dis. 2021 Jul 2;224(1):92-100. PMID: 33216132; PMCID: PMC8253129.

 

Garrido C, Curtis AD 2nd, Dennis M, Pathak SH, Gao H, Montefiori D, Tomai M, Fox CB, Kozlowski PA, Scobey T, Munt JE, Mallory ML, Saha PT, Hudgens MG, Lindesmith LC, Baric RS, Abiona OM, Graham B, Corbett KS, Edwards D, Carfi A, Fouda G, Van Rompay KKA, De Paris K, Permar SR. SARS-CoV-2 vaccines elicit durable immune responses in infant rhesus macaques. Sci Immunol. 2021 Jun 15;6(60):eabj3684. PMID: 34131024; PMCID: PMC8774290.

 

Knittel AK, Shook-Sa BE, Rudolph JE, Edmonds A, Ramirez C, Cohen MH, Adedimeji A, Taylor TN, Michel KG, Milam J, Cohen J, Donohue JD, Foster A, Fischl M, Konkle-Parker D, Adimora AA. Incidence and Prevalence of Incarceration in a Longitudinal Cohort of Women at Risk for Human Immunodeficiency Virus in the United States, 2007-2017. J Womens Health (Larchmt). 2021 May;30(5):694-704. PMID: 33544023; PMCID: PMC8112715.

 

Lancaster KE, Mollan KR, Hanscom BS, Shook-Sa BE, Ha TV, Dumchev K, Djoerban Z, Rose SM, Latkin CA, Metzger DS, Go VF, Dvoriak S, Reifeis SA, Piwowar-Manning EM, Richardson P, Hudgens MG, Hamilton EL, Eshleman SH, Susami H, Chu VA, Djauzi S, Kiriazova T, Nhan DT, Burns DN, Miller WC, Hoffman IF. Engaging People Who Inject Drugs Living With HIV in Antiretroviral Treatment and Medication for Opioid Use Disorder: Extended Follow-up of HIV Prevention Trials Network (HPTN) 074. Open Forum Infect Dis. 2021 May 29;8(8):ofab281. PMID: 34458390; PMCID: PMC8391093.

 

LeMasters K, Oser C, Cowell M, Mollan K, Nowotny K, Brinkley-Rubinstein L. Longitudinal pre-exposure prophylaxis (PrEP) acceptability, initiation and adherence among criminal justice-involved adults in the USA: the Southern PrEP Cohort Study (SPECS) protocol. BMJ Open. 2021 Jul 16;11(7):e047340. PMID: 34272219; PMCID: PMC8287623.

 

Lin JT, Mollan KR, Cerami C. The Consequences of Isolating at Home. Clin Infect Dis. 2021 Nov 2;73(9):e2823. PMID: 32986803.

 

Lu H, Cole SR, Westreich D, Hudgens MG, Adimora AA, Althoff KN, Silverberg MJ, Buchacz K, Li J, Edwards JK, Rebeiro PF, Lima VD, Marconi VC, Sterling TR, Horberg MA, Gill MJ, Kitahata MM, Eron JJ, Moore RD. Clinical Effectiveness of Integrase Strand Transfer Inhibitor-Based Antiretroviral Regimens Among Adults With Human Immunodeficiency Virus: A Collaboration of Cohort Studies in the United States and Canada. Clin Infect Dis. 2021 Oct 5;73(7):e1408-e1414. Erratum in: Clin Infect Dis. 2022 Mar 1;74(4):755. PMID: 32780095; PMCID: PMC8492356.

 

Mollan KR, Pence BW, Xu S, Edwards JK, Mathews WC, O’Cleirigh C, Crane HM, Eaton EF, Collier AC, Weideman AMK, Westreich D, Cole SR, Tierney C, Bengtson AM; CFAR Network of Integrated Clinical Systems and the AIDS Clinical Trials Group. Transportability From Randomized Trials to Clinical Care: On Initial HIV Treatment With Efavirenz and Suicidal Thoughts or Behaviors. Am J Epidemiol. 2021 Oct 1;190(10):2075-2084. PMID: 33972995; PMCID: PMC8576379.

 

Mutale W, Freeborn K, Graybill LA, Lusaka MM, Mollan KR, Mweemba O, Kasaro M, Lungu R, Kumwenda A, Saidi F, Powers KA, Maman S, Rosenberg NE, Chi BH. Addition of HIV self-test kits to partner notification services to increase HIV testing of male partners of pregnant women in Zambia: two parallel randomised trials. Lancet Glob Health. 2021 Dec;9(12):e1719-e1729. PMID: 34735862; PMCID: PMC8644317.

 

Price JT, Vwalika B, Edwards JK, Cole SR, Kasaro MP, Rittenhouse KJ, Kumwenda A, Lubeya MK, Stringer JSA. Maternal HIV Infection and Spontaneous Versus Provider-Initiated Preterm Birth in an Urban Zambian Cohort. J Acquir Immune Defic Syndr. 2021 Jun 1;87(2):860-868. PMID: 33587508; PMCID: PMC8131221.

 

Price JT, Vwalika B, Freeman BL, Cole SR, Saha PT, Mbewe FM, Phiri WM, Peterson M, Muyangwa D, Sindano N, Mwape H, Smithmyer ME, Kasaro MP, Rouse DJ, Goldenberg RL, Chomba E, Stringer JSA. Weekly 17 alpha-hydroxyprogesterone caproate to prevent preterm birth among women living with HIV: a randomised, double-blind, placebo-controlled trial. Lancet HIV. 2021 Oct;8(10):e605-e613. PMID: 34509197; PMCID: PMC8476342.

 

Smith JS, Backes DM, Hudgens MG, Mei W, Chakraborty H, Rohner E, Moses S, Agot K, Meijer CJLM, Bailey RC. Male Circumcision Reduces Penile HPV Incidence and Persistence: A Randomized Controlled Trial in Kenya. Cancer Epidemiol Biomarkers Prev. 2021 Jun;30(6):1139-1148. PMID: 33972367; PMCID: PMC8172477.

 

Wahl A, Gralinski LE, Johnson CE, Yao W, Kovarova M, Dinnon KH 3rd, Liu H, Madden VJ, Krzystek HM, De C, White KK, Gully K, Schäfer A, Zaman T, Leist SR, Grant PO, Bluemling GR, Kolykhalov AA, Natchus MG, Askin FB, Painter G, Browne EP, Jones CD, Pickles RJ, Baric RS, Garcia JV. SARS-CoV-2 infection is effectively treated and prevented by EIDD-2801. Nature. 2021 Mar;591(7850):451-457. PMID: 33561864; PMCID: PMC7979515.

 

Xu Y, Weideman AM, Abad-Fernandez M, Mollan KR, Kallon S, Samir S, Warren JA, Clutton G, Roan NR, Adimora AA, Archin N, Kuruc J, Gay C, Hudgens MG, Goonetilleke N. Reliable Estimation of CD8 T Cell Inhibition of In Vitro HIV-1 Replication. Front Immunol. 2021 Jun 30;12:666991. Erratum in: Front Immunol. 2023 Jan 03;13:1104661. PMID: 34276657; PMCID: PMC8278574.

 

Zalla LC, Edwards JK, Cole SR, Rudolph JE, Breger TL, Virkud A, Johnson AS, Hall HI. Demographic Trends in US HIV Diagnoses, 2008-2017: Data Movies. Am J Public Health. 2021 Apr;111(4):529-532. PMID: 33689438; PMCID: PMC7958054.

 

Zeziulin O, Mollan KR, Shook-Sa BE, Hanscom B, Lancaster KE, Dumchev K, Go VF, Chu VA, Kiriazova T, Syarif Z, Dvoryak S, Reifeis SA, Hamilton E, Sarasvita R, Rose S, Richardson P, Clarke W, Latkin CA, Metzger DS, Hoffman IF, Miller WC. Depressive symptoms and use of HIV care and medication-assisted treatment among people with HIV who inject drugs. AIDS. 2021 Mar 1;35(3):495-501. PMID: 33252489; PMCID: PMC7855840.

 

2020

Barzin A, Schmitz JL, Rosin S, Sirpal R, Almond M, Robinette C, Wells S, Hudgens M, Olshan A, Deen S, Krejci P, Quackenbush E, Chronowski K, Cornaby C, Goins J, Butler L, Aucoin J, Boyer K, Faulk J, Alston-Johnson D, Page C, Zhou Y, Fiscus L, Damania B, Dittmer DP, Peden DB. SARS-CoV-2 Seroprevalence among a Southern U.S. Population Indicates Limited Asymptomatic Spread under Physical Distancing Measures. mBio. 2020 Sep 29;11(5):e02426-20. PMID: 32994333; PMCID: PMC7527736.

 

Benkeser D, Horvath K, Reback CJ, Rusow J, Hudgens M. Design and analysis considerations for a sequentially randomized HIV prevention trial. Stat Biosci. 2020 Dec;12(3):446-467. PMID: 33767798; PMCID: PMC7986973.

 

Breger TL, Edwards JK, Cole SR, Saag M, Rebeiro PF, Moore RD, Eron JJ. Estimating a Set of Mortality Risk Functions with Multiple Contributing Causes of Death. Epidemiology. 2020 Sep;31(5):704-712. PMID: 32541609; PMCID: PMC7822729.

 

Breger TL, Edwards JK, Cole SR, Westreich D, Pence BW, Adimora AA. Two-stage g-computation: Evaluating Treatment and Intervention Impacts in Observational Cohorts When Exposure Information Is Partly Missing. Epidemiology. 2020 Sep;31(5):695-703. PMID: 32657953; PMCID: PMC8725064.

 

Cope AB, Edmonds A, Ludema C, Cole SR, Eron JJ, Anastos K, Cocohoba J, Cohen M, Ofotokun I, Golub ET, Kassaye S, Konkle-Parker D, Metsch LR, Wilson TE, Adimora AA. Neighborhood Poverty and Control of HIV, Hypertension, and Diabetes in the Women’s Interagency HIV Study. AIDS Behav. 2020 Jul;24(7):2033-2044.  PMID: 31907676; PMCID: PMC7319872.

 

Curtis AD 2nd, Dennis M, Eudailey J, Walter KL, Cronin K, Alam SM, Choudhary N, Tuck RH, Hudgens M, Kozlowski PA, Pollara J, Ferrari G, Van Rompay KKA, Permar S, De Paris K. HIV Env-Specific IgG Antibodies Induced by Vaccination of Neonatal Rhesus Macaques Persist and Can Be Augmented by a Late Booster Immunization in Infancy. mSphere. 2020 Mar 25;5(2):e00162-20. PMID: 32213623; PMCID: PMC7096624.

 

Dumond JB, Bay CP, Nelson JAE, Davalos A, Edmonds A, De Paris K, Sykes C, Anastos K, Sharma R, Kassaye S, Tamraz B, French AL, Gange S, Ofotokun I, Fischl MA, Vance DE, Adimora AA. Intracellular Tenofovir and Emtricitabine Concentrations in Younger and Older Women with HIV Receiving Tenofovir Disoproxil Fumarate/Emtricitabine. Antimicrob Agents Chemother. 2020 Aug 20;64(9):e00177-20. PMID: 32631821; PMCID: PMC7449168.

 

Edwards JK, Cole SR, Fox MP. Flexibly Accounting for Exposure Misclassification With External Validation Data. Am J Epidemiol. 2020 Aug 1;189(8):850-860. PMID: 31971584; PMCID: PMC7608057.

 

Falcinelli SD, Shook-Sa BE, Dewey MG, Sridhar S, Read J, Kirchherr J, James KS, Allard B, Ghofrani S, Stuelke E, Baker C, Roan NR, Eron JJ, Kuruc JD, Ramirez C, Gay C, Mollan KR, Margolis DM, Adimora AA, Archin NM. Impact of Biological Sex on Immune Activation and Frequency of the Latent HIV Reservoir During Suppressive Antiretroviral Therapy. J Infect Dis. 2020 Nov 9;222(11):1843-1852. PMID: 32496542; PMCID: PMC7653086.

 

Gay CL, Kuruc JD, Falcinelli SD, Warren JA, Reifeis SA, Kirchherr JL, James KS, Dewey MG, Helms A, Allard B, Stuelke E, Gamble A, Plachco A, Gorelick RJ, Eron JJ, Hudgens M, Garrido C, Goonetilleke N, DeBenedette MA, Tcherepanova IY, Nicolette CA, Archin NM, Margolis DM. Assessing the impact of AGS-004, a dendritic cell-based immunotherapy, and vorinostat on persistent HIV-1 Infection. Sci Rep. 2020 Mar 20;10(1):5134. PMID: 32198428; PMCID: PMC7083965.

 

Gilbert PB, Blette BS, Shepherd BE, Hudgens MG. Post-randomization Biomarker Effect Modification Analysis in an HIV Vaccine Clinical Trial. J Causal Inference. 2020;8(1):54-69. PMID: 33777613; PMCID: PMC7996712.

 

Gilliland WM , White NR , Yam BH , Mwangi JN , Prince HMA , Weideman AM , Kashuba ADM , Rosen EP . Influence of hair treatments on detection of antiretrovirals by mass spectrometry imaging. Analyst. 2020 Jul 7;145(13):4540-4550. PMID: 32420552; PMCID: PMC8290328.

 

Graybill LA, Kasaro M, Freeborn K, Walker JS, Poole C, Powers KA, Mollan KR, Rosenberg NE, Vermund SH, Mutale W, Chi BH. Incident HIV among pregnant and breast-feeding women in sub-Saharan Africa: a systematic review and meta-analysis. AIDS. 2020 Apr 1;34(5):761-776. PMID: 32167990; PMCID: PMC7275092.

 

James KS, Trumble I, Clohosey ML, Moeser M, Roan NR, Adimora AA, Joseph SB, Archin NM, Hudgens M, Soriano-Sarabia N. Measuring the contribution of γδ T cells to the persistent HIV reservoir. AIDS. 2020 Mar 1;34(3):363-371. PMID: 31764074; PMCID: PMC6994336.

 

Knittel AK, Shook-Sa BE, Rudolph J, Edmonds A, Ramirez C, Cohen M, Adedimeji A, Taylor T, Michel KG, Milam J, Cohen J, Donohue J, Foster A, Fischl M, Konkle-Parker D, Adimora AA. Incarceration and Number of Sexual Partners After Incarceration Among Vulnerable US Women, 2007-2017. Am J Public Health. 2020 Jan;110(S1):S100-S108. PMID: 31967873; PMCID: PMC6987934.

 

Mollan KR, Trumble IM, Reifeis SA, Ferrer O, Bay CP, Baldoni PL, Hudgens MG. Precise and accurate power of the rank-sum test for a continuous outcome. J Biopharm Stat. 2020 Jul 3;30(4):639-648. PMID: 32126888; PMCID: PMC7316590.

 

Nelson JAE, De Paris K, Ramirez C, Edmonds A, Mollan KR, Bay CP, Compliment K, Herold BC, Anastos K, Minkoff H, Kassaye S, Seidman DL, French AL, Golub ET, Sheth AN, Ochsenbauer C, Swanstrom R, Eron JJ, Adimora AA. Female genital tract shedding of HIV-1 is rare in women with suppressed HIV-1 in plasma. AIDS. 2020 Jan 1;34(1):39-46. PMID: 31483374; PMCID: PMC6910230.

 

Pilcher CD, Westreich D, Hudgens MG. Group Testing for Severe Acute Respiratory Syndrome- Coronavirus 2 to Enable Rapid Scale-up of Testing and Real-Time Surveillance of Incidence. J Infect Dis. 2020 Aug 17;222(6):903-909. PMID: 32592581; PMCID: PMC7337777.

 

Rohner E, Edelman C, Sanusi B, Schmitt JW, Baker A, Chesko K, Faherty B, Gregory SM, Romocki LS, Sivaraman V, Nelson JAE, O’Connor S, Hudgens MG, Knittel AK, Rahangdale L, Smith JS. Extended HPV Genotyping to Compare HPV Type Distribution in Self- and Provider-Collected Samples for Cervical Cancer Screening. Cancer Epidemiol Biomarkers Prev. 2020 Dec;29(12):2651-2661. PMID: 32943435; PMCID: PMC7710587.

 

Yang F, Zhang TP, Tang W, Ong JJ, Alexander M, Forastiere L, Kumar N, Li KT, Zou F, Yang L, Mi G, Wang Y, Huang W, Lee A, Zhu W, Luo D, Vickerman P, Wu D, Yang B, Christakis NA, Tucker JD. Pay-it-forward gonorrhoea and chlamydia testing among men who have sex with men in China: a randomised controlled trial. Lancet Infect Dis. 2020 Aug;20(8):976-982. PMID: 32530426; PMCID: PMC8957706.

 

2019

Amico KR, Dunlap A, Dallas R, Lindsey J, Heckman B, Flynn P, Lee S, Horvath K, West Goolsby R, Hudgens M, Filipowicz T, Polier M, Hill E, Mueller Johnson M, Miller J, Neilan A, Ciaranello A, Gaur A. Triggered Escalating Real-Time Adherence Intervention to Promote Rapid HIV Viral Suppression Among Youth Living With HIV Failing Antiretroviral Therapy: Protocol for a Triggered Escalating Real-Time Adherence Intervention. JMIR Res Protoc. 2019 Mar 18;8(3):e11416. PMID: 30882360; PMCID: PMC6441855.

 

Bansi-Matharu L, Rodriguez Loria G, Cole SR, Mugerwa H, Vecino I, Lundgren J, Pulik P, Smith C, Phillips AN; INSIGHT START Study Group. Risk factors for antiretroviral therapy (ART) discontinuation in a large multinational trial of early ART initiators. AIDS. 2019 Jul 1;33(8):1385-1390. PMID: 30932953; PMCID: PMC6546512.

 

Belenky N, Pence BW, Cole SR, Dusetzina SB, Edmonds A, Oberlander J, Plankey M, Adedimeji A, Wilson TE, Cohen J, Cohen MH, Milam JE, Adimora AA. Impact of Medicare Part D on mental health treatment and outcomes for dual eligible beneficiaries with HIV. AIDS Care. 2019 Apr;31(4):505-512. PMID: 30189747; PMCID: PMC6342646.

 

Breskin A, Westreich D, Cole SR, Edwards JK. Using Bounds to Compare the Strength of Exchangeability Assumptions for Internal and External Validity. Am J Epidemiol. 2019 Jul 1;188(7):1355-1360. PMID: 30834430; PMCID: PMC6601532.

 

Breskin A, Westreich D, Hurt CB, Cole SR, Hudgens MG, Seaberg EC, Thio CL, Tien PC, Adimora AA. The Effects of Hepatitis C Treatment Eligibility Criteria on All-cause Mortality Among People With Human Immunodeficiency Virus. Clin Infect Dis. 2019 Oct 15;69(9):1613-1620. PMID: 30615096; PMCID: PMC6792128.

 

Cao B, Saha PT, Leuba SI, Lu H, Tang W, Wu D, Ong J, Liu C, Fu R, Wei C, Tucker JD. Recalling, Sharing and Participating in a Social Media Intervention Promoting HIV Testing: A Longitudinal Analysis of HIV Testing Among MSM in China. AIDS Behav. 2019 May;23(5):1240-1249. PMID: 30632008; PMCID: PMC6511317.

 

Clutton G, Mollan K, Hudgens M, Goonetilleke N. A Reproducible, Objective Method Using MitoTracker® Fluorescent Dyes to Assess Mitochondrial Mass in T Cells by Flow Cytometry. Cytometry A. 2019 Apr;95(4):450-456. Erratum in: Cytometry A. 2021 Jul;99(7):753. PMID: 30576071; PMCID: PMC6461488.

 

Cole SR, Hudgens MG, Edwards JK, Brookhart MA, Richardson DB, Westreich D, Adimora AA. Nonparametric Bounds for the Risk Function. Am J Epidemiol. 2019 Apr 1;188(4):632-636. PMID: 30698633; PMCID: PMC6438811.

 

Conserve DF, Bay C, Kilonzo MN, Makyao NE, Kajula L, Maman S. Sexual and Social Network Correlates of Willingness to Self-Test for HIV Among Ever-Tested and Never-Tested Men: Implications for the Tanzania STEP Project. AIDS Care. 2019 Feb;31(2):169-176. PMID: 30362377; PMCID: PMC7295037.

 

Davis NL, Corbett A, Kaullen J, Nelson JAE, Chasela CS, Sichali D, Hudgens MG, Miller WC, Jamieson DJ, Kourtis AP. Antiretroviral Drug Concentrations in Breastmilk, Maternal HIV Viral Load, and HIV Transmission to the Infant: Results From the BAN Study. J Acquir Immune Defic Syndr. 2019 Apr 1;80(4):467-473. PMID: 30570527; PMCID: PMC6391211.

 

Edwards JK, Bakoyannis G, Yiannoutsos CT, Mburu MW, Cole SR. Nonparametric estimation of the cumulative incidence function under outcome misclassification using external validation data. Stat Med. 2019 Dec 20;38(29):5512-5527. PMID: 31647581; PMCID: PMC7223030.

 

Fatukasi TV, Edmonds A, Gustafson DR, Cole SR, Edwards JK, Bolivar H, Cohen M, Fischl MA, Gange S, Konkle-Parker D, Moran CA, Plankey M, Sharma A, Tien PC, Adimora AA. Prevalence and 1-year incidence of frailty among women with and without HIV in the Women’s Interagency HIV Study. AIDS. 2019 Feb 1;33(2):357-359.  PMID: 30562174; PMCID: PMC6487202.

 

Fitzpatrick T, Tang W, Mollan K, Pan X, Chan PL, Zhou K, Cheng Y, Li L, Wong WC, Tucker JD. A crowdsourced intervention to promote hepatitis B and C testing among men who have sex with men in China: A nationwide online randomized controlled trial. EClinicalMedicine. 2019 Nov 18;16:64-73. PMID: 31832621; PMCID: PMC6890946.

 

Hong JL, Webster-Clark M, Jonsson Funk M, Stürmer T, Dempster SE, Cole SR, Herr I, LoCasale R. Comparison of Methods to Generalize Randomized Clinical Trial Results Without Individual-Level Data for the Target Population. Am J Epidemiol. 2019 Feb 1;188(2):426-437. PMID: 30312378; PMCID: PMC6357813.

 

Horner MJ, Chasimpha S, Spoerri A, Edwards J, Bohlius J, Tweya H, Tembo P, Nkhambule F, Phiri EM, Miller WC, Malisita K, Phiri S, Dzamalala C, Olshan AF, Gopal S. High Cancer Burden Among Antiretroviral Therapy Users in Malawi: A Record Linkage Study of Observational Human Immunodeficiency Virus Cohorts and Cancer Registry Data. Clin Infect Dis. 2019 Aug 16;69(5):829-835. PMID: 30452634; PMCID: PMC6773978.

 

Kay ES, Batey DS, Westfall AO, Christopoulos K, Cole SR, Geng EH, Mathews WC, Moore RD, Mugavero MJ. Compound Retention in Care and All-Cause Mortality Among Persons Living With Human Immunodeficiency Virus. Open Forum Infect Dis. 2019 Mar 7;6(4):ofz120. PMID: 31041339; PMCID: PMC6483128.

 

Lodi S, Phillips A, Lundgren J, Logan R, Sharma S, Cole SR, Babiker A, Law M, Chu H, Byrne D, Horban A, Sterne JAC, Porter K, Sabin C, Costagliola D, Abgrall S, Gill J, Touloumi G, Pacheco AG, van Sighem A, Reiss P, Bucher HC, Montoliu Giménez A, Jarrin I, Wittkop L, Meyer L, Perez-Hoyos S, Justice A, Neaton JD, Hernán MA; INSIGHT START Study Group and the HIV-CAUSAL Collaboration. Effect Estimates in Randomized Trials and Observational Studies: Comparing Apples With Apples. Am J Epidemiol. 2019 Aug 1;188(8):1569-1577. PMID: 31063192; PMCID: PMC6670045.

 

Lu H, Cole SR, Hall HI, Schisterman EF, Breger TL, K Edwards J, Westreich D. Generalizing the per-protocol treatment effect: The case of ACTG A5095. Clin Trials. 2019 Feb;16(1):52-62. PMID: 30326736; PMCID: PMC6693502.

 

Naar S, Hudgens MG, Brookmeyer R, Idalski Carcone A, Chapman J, Chowdhury S, Ciaranello A, Comulada WS, Ghosh S, Horvath KJ, Ingram L, LeGrand S, Reback CJ, Simpson K, Stanton B, Starks T, Swendeman D. Improving the Youth HIV Prevention and Care Cascades: Innovative Designs in the Adolescent Trials Network for HIV/AIDS Interventions. AIDS Patient Care STDS. 2019 Sep;33(9):388-398. PMID: 31517525; PMCID: PMC6745528.

 

Neilan AM, Patel K, Agwu AL, Bassett IV, Amico KR, Crespi CM, Gaur AH, Horvath KJ, Powers KA, Rendina HJ, Hightow-Weidman LB, Li X, Naar S, Nachman S, Parsons JT, Simpson KN, Stanton BF, Freedberg KA, Bangs AC, Hudgens MG, Ciaranello AL. Model-Based Methods to Translate Adolescent Medicine Trials Network for HIV/AIDS Interventions Findings Into Policy Recommendations: Rationale and Protocol for a Modeling Core (ATN 161). JMIR Res Protoc. 2019 Apr 16;8(4):e9898. PMID: 30990464; PMCID: PMC6488956.

 

Nelson AN, Goswami R, Dennis M, Tu J, Mangan RJ, Saha PT, Cain DW, Curtis AD, Shen X, Shaw GM, Bar K, Hudgens M, Pollara J, De Paris K, Van Rompay KKA, Permar SR. Simian-Human Immunodeficiency Virus SHIV.CH505-Infected Infant and Adult Rhesus Macaques Exhibit Similar Env-Specific Antibody Kinetics, despite Distinct T-Follicular Helper and Germinal Center B Cell Landscapes. J Virol. 2019 Jul 17;93(15):e00168-19. PMID: 31092583; PMCID: PMC6639294.

 

Price JT, Vwalika B, Freeman BL, Cole SR, Mulenga HB, Winston J, Mbewe FM, Chomba E, Mofenson LM, Rouse DJ, Goldenberg RL, Stringer JSA. Intramuscular 17-hydroxyprogesterone caproate to prevent preterm birth among HIV-infected women in Zambia: study protocol of the IPOP randomized trial. BMC Pregnancy Childbirth. 2019 Feb 27;19(1):81. PMID: 30813934; PMCID: PMC6391830.

 

Price JT, Winston J, Vwalika B, Cole SR, Stoner MCD, Lubeya MK, Kumwenda A, Stringer JSA. Quantifying bias between reported last menstrual period and ultrasonography estimates of gestational age in Lusaka, Zambia. Int J Gynaecol Obstet. 2019 Jan;144(1):9-15. PMID: 30267538; PMCID: PMC6283668.

 

Price JT, Vwalika B, Hobbs M, Nelson JAE, Stringer EM, Zou F, Rittenhouse KJ, Azcarate-Peril A, Kasaro MP, Stringer JSA. Highly diverse anaerobe-predominant vaginal microbiota among HIV-infected pregnant women in Zambia. PLoS One. 2019 Oct 2;14(10):e0223128. PMID: 31577818; PMCID: PMC6774526.

 

Robertson KR, Jiang H, Kumwenda J, Supparatpinyo K, Marra CM, Berzins B, Hakim J, Sacktor N, Campbell TB, Schouten J, Mollan K, Tripathy S, Kumarasamy N, La Rosa A, Santos B, Silva MT, Kanyama C, Firhnhaber C, Murphy R, Hall C, Marcus C, Naini L, Masih R, Hosseinipour MC, Mngqibisa R, Badal-Faesen S, Yosief S, Vecchio A, Nair A; AIDS Clinical Trials Group. Human Immunodeficiency Virus-associated Neurocognitive Impairment in Diverse Resource-limited Settings. Clin Infect Dis. 2019 May 2;68(10):1733-1738. PMID: 30219843; PMCID: PMC6495019.

 

Rudolph JE, Cole SR, Eron JJ, Kashuba AD, Adimora AA. Estimating Human Immunodeficiency Virus (HIV) Prevention Effects in Low-incidence Settings. Epidemiology. 2019 May;30(3):358-364. PMID: 30640216; PMCID: PMC6456405.

 

Rudolph JE, Cole SR, Edwards JK. Correction to: Parametric assumptions equate to hidden observations: comparing the efficiency of nonparametric and parametric models for estimating time to AIDS or death in a cohort of HIV-positive women. BMC Med Res Methodol. 2019 Mar 15;19(1):58. Erratum for: BMC Med Res Methodol. 2018 Nov 19;18(1):142. PMID: 30871478; PMCID: PMC6419485.

 

Sugarman J, Trumble I, Hamilton E, Sarasvita R, Dumchev K, Viet H, Hoffman I, Miller W, Hanscom B. Reported Participation Benefits in International HIV Prevention Research with People Who Inject Drugs. Ethics Hum Res. 2019 Sep;41(5):28-34. PMID: 31541541; PMCID: PMC8792865.

 

Tang W, Mao J, Liu C, Mollan K, Zhang Y, Tang S, Hudgens M, Ma W, Kang D, Wei C, Tucker JD; SESH study group. Reimagining Health Communication: A Noninferiority Randomized Controlled Trial of Crowdsourced Intervention in China. Sex Transm Dis. 2019 Mar;46(3):172-178. PMID: 30741854; PMCID: PMC6380681.

 

Xiao J, Hudgens MG. On nonparametric maximum likelihood estimation with double truncation. Biometrika. 2019 Dec;106(4):989-996. PMID: 31754284; PMCID: PMC6845852.

 

Xu Y, Trumble IM, Warren JA, Clutton G, Abad-Fernandez M, Kirchnerr J, Adimora AA, Deeks SG, Margolis DM, Kuruc JD, Gay CL, Archin NM, Mollan KR, Hudgens M, Goonetilleke N. HIV-Specific T Cell Responses Are Highly Stable on Antiretroviral Therapy. Mol Ther Methods Clin Dev. 2019 Aug 14;15:9-17. PMID: 31534983; PMCID: PMC6745511.

 

Zhang TP, Yang F, Tang W, Alexander M, Forastiere L, Kumar N, Li K, Zou F, Yang L, Mi G, Wang Y, Huang W, Lee A, Zhu W, Vickerman P, Wu D, Yang B, Christakis NA, Tucker JD. Pay-it-forward gonorrhea and chlamydia testing among men who have sex with men in China: a study protocol for a three-arm cluster randomized controlled trial. Infect Dis Poverty. 2019 Aug 16;8(1):76. PMID: 31426869; PMCID: PMC6700988.

 

2018

Belenky N, Pence BW, Cole SR, Dusetzina SB, Edmonds A, Oberlander J, Plankey MW, Adedimeji A, Wilson TE, Cohen J, Cohen MH, Milam JE, Golub ET, Adimora AA. Associations Between Medicare Part D and Out-of-Pocket Spending, HIV Viral Load, Adherence, and ADAP Use in Dual Eligibles With HIV. Med Care. 2018 Jan;56(1):47-53. PMID: 29227443; PMCID: PMC5728680.

 

Bengtson AM, Pence BW, Eaton EF, Edwards JK, Eron JJ, Mathews WC, Mollan K, Moore RD, O’Cleirigh C, Geng E, Mugavero MJ. Patterns of efavirenz use as first-line antiretroviral therapy in the United States: 1999-2015. Antivir Ther. 2018;23(4):363-372. PMID: 29424697; PMCID: PMC6085156.

 

Buchanan AL, Hudgens MG, Cole SR, Mollan KR, Sax PE, Daar ES, Adimora AA, Eron JJ, Mugavero MJ. Generalizing Evidence from Randomized Trials using Inverse Probability of Sampling Weights. J R Stat Soc Ser A Stat Soc. 2018 Oct;181(4):1193-1209. PMID: 30555215; PMCID: PMC6289264.

 

Buchanan AL, Hudgens MG, Cole SR. Generalizing Evidence from HIV Trials Using Inverse Probability of Sampling Weights. In Quantitative Methods for HIV/AIDS Research, Chan C, Chow SC, Hudgens MG (Eds.). CRC Press, 2018.

 

Chi BH, Rosenberg NE, Mweemba O, Powers KA, Zimba C, Maman S, Kasaro M, Mollan KR, Stringer JS, Mutale W. Involving both parents in HIV prevention during pregnancy and breastfeeding. Bull World Health Organ. 2018 Jan 1;96(1):69-71. Erratum in: Bull World Health Organ. 2018 Mar 1;96(3):220. Erratum in: Bull World Health Organ. 2018 Apr 1;96(4):296. PMID: 29403103; PMCID: PMC5791874.

 

Chung Y, Ivanova A, Hudgens MG, Fine JP. Partial likelihood estimation of isotonic proportional hazards models. Biometrika. 2018 Mar 1;105(1):133-148. PMID: 29808076; PMCID: PMC5969539.

 

Cole SR, Edwards JK, Westreich D, Lesko CR, Lau B, Mugavero MJ, Mathews WC, Eron JJ Jr, Greenland S; CNICS Investigators. Estimating multiple time-fixed treatment effects using a semi-Bayes semiparametric marginal structural Cox proportional hazards regression model. Biom J. 2018 Jan;60(1):100-114. PMID: 29076182; PMCID: PMC6771415.

 

Edwards JK, Cole SR, Hall HI, Mathews WC, Moore RD, Mugavero MJ, Eron JJ; CNICS investigators. Virologic suppression and CD4+ cell count recovery after initiation of raltegravir or efavirenz-containing HIV treatment regimens. AIDS. 2018 Jan 14;32(2):261-266. PMID: 29112076; PMCID: PMC5736462.

 

Edwards JK, Cole SR, Moore RD, Mathews WC, Kitahata M, Eron JJ. Sensitivity Analyses for Misclassification of Cause of Death in the Parametric G-Formula. Am J Epidemiol. 2018 Aug 1;187(8):1808-1816. PMID: 29420696; PMCID: PMC6070049.

 

Eudailey JA, Dennis ML, Parker ME, Phillips BL, Huffman TN, Bay CP, Hudgens MG, Wiseman RW, Pollara JJ, Fouda GG, Ferrari G, Pickup DJ, Kozlowski PA, Van Rompay KKA, De Paris K, Permar SR. Maternal HIV-1 Env Vaccination for Systemic and Breast Milk Immunity To Prevent Oral SHIV Acquisition in Infant Macaques. mSphere. 2018 Jan 10;3(1):e00505-17. PMID: 29359183; PMCID: PMC5760748.

 

Howe CJ, Dulin-Keita A, Cole SR, Hogan JW, Lau B, Moore RD, Mathews WC, Crane HM, Drozd DR, Geng E, Boswell SL, Napravnik S, Eron JJ Jr, Mugavero MJ; CFAR Network of Integrated Clinical Systems. Evaluating the Population Impact on Racial/Ethnic Disparities in HIV in Adulthood of Intervening on Specific Targets: A Conceptual and Methodological Framework. Am J Epidemiol. 2018 Feb 1;187(2):316-325. PMID: 28992096; PMCID: PMC5860258.

 

Lesko CR, Edwards JK, Cole SR, Moore RD, Lau B. When to Censor? Am J Epidemiol. 2018 Mar 1;187(3):623-632. PMID: 29020256; PMCID: PMC6248498.

 

Menezes P, Mollan K, Hoffman E, Xie Z, Wills J, Marcus C, Rublein J, Hudgens M, Eron JJ Jr. Stable Caloric Intake and Continued Virologic Suppression for HIV-Positive Antiretroviral Treatment-Experienced Women After Switching to a Single-Tablet Regimen of Emtricitabine, Rilpivirine, and Tenofovir Disoproxil Fumarate. AIDS Res Hum Retroviruses. 2018 Jun;34(6):481-485. PMID: 29607652; PMCID: PMC5994664.

 

Rudolph JE, Cole SR, Edwards JK, Moore R, O’Cleirigh C, Mathews WC, Christopoulos K; Center for AIDS Research Network of Integrated Clinical Systems. At-Risk Alcohol Use Among HIV-Positive Patients and the Completion of Patient-Reported Outcomes. AIDS Behav. 2018 Apr;22(4):1313-1322. PMID: 28620802; PMCID: PMC5971659.

 

Stoner MCD, Cole SR, Price J, Winston J, Stringer JSA. Timing of Initiation of Antiretroviral Therapy and Risk of Preterm Birth in Studies of HIV-infected Pregnant Women: The Role of Selection Bias. Epidemiology. 2018 Mar;29(2):224-229. PMID: 29045283; PMCID: PMC5792303.

 

Wang C, Mollan KR, Hudgens MG, Tucker JD, Zheng H, Tang W, Ling L. Generalisability of an online randomised controlled trial: an empirical analysis. J Epidemiol Community Health. 2018 Feb;72(2):173-178. PMID: 29183956; PMCID: PMC5880638.

 

Willis SJ, Cole SR, Westreich D, Edmonds A, Hurt CB, Albrecht S, Anastos K, Augenbraun M, Fischl M, French AL, Kalapila AG, Karim R, Peters MG, Plankey M, Seaberg EC, Tien PC, Adimora AA. Chronic hepatitis C virus infection and subsequent HIV viral load among women with HIV initiating antiretroviral therapy. AIDS. 2018 Mar 13;32(5):653-661. PMID: 29334550; PMCID: PMC6024258.

 

2017

Adimora AA, Cole SR, Eron JJ. US Black Women and Human Immunodeficiency Virus Prevention: Time for New Approaches to Clinical Trials. Clin Infect Dis. 2017 Jul 15;65(2):324-327. Erratum in: Clin Infect Dis. 2019 Jan 18;68(3):534. PMID: 28383649; PMCID: PMC5850546.

 

Bengtson AM, Pence BW, Mollan KR, Edwards JK, Moore RD, OʼCleirigh C, Eaton EF, Eron JJ, Kitahata MM, Mathews WC, Crane H, Mugavero MJ. The Relationship Between Efavirenz as Initial Antiretroviral Therapy and Suicidal Thoughts Among HIV-Infected Adults in Routine Care. J Acquir Immune Defic Syndr. 2017 Dec 1;76(4):402-408. PMID: 28749824; PMCID: PMC5659970.

 

Chandler R, Gordon MS, Kruszka B, Strand LN, Altice FL, Beckwith CG, Biggs ML, Cunningham W, Chris Delaney JA, Flynn PM, Golin CE, Knight K, Kral AH, Kuo I, Lorvick J, Nance RM, Ouellet LJ, Rich JD, Sacks S, Seal D, Spaulding A, Springer SA, Taxman F, Wohl D, Young JD, Young R, Crane HM. Cohort profile: seek, test, treat and retain United States criminal justice cohort. Subst Abuse Treat Prev Policy. 2017 May 16;12(1):24. PMID: 28511680; PMCID: PMC5433052.

 

Cole SR, Edwards JK, Hall HI, Brookhart MA, Mathews WC, Moore RD, Crane HM, Kitahata MM, Mugavero MJ, Saag MS, Eron JJ; Centers for AIDS Research Network of Integrated Clinical Systems (CNICS) Investigators. Incident AIDS or Death After Initiation of Human Immunodeficiency Virus Treatment Regimens Including Raltegravir or Efavirenz Among Adults in the United States. Clin Infect Dis. 2017 Jun 1;64(11):1591-1596. Erratum in: Clin Infect Dis. 2017 Oct 15;65(8):1431-1433. PMID: 28498892; PMCID: PMC6059161.

 

Davis NL, Wiener J, Juliano JJ, Adair L, Chasela CS, Kayira D, Hudgens MG, van der Horst C, Jamieson DJ, Kourtis AP; Breastfeeding, Antiretrovirals and Nutrition (BAN) Study Team; Breastfeeding, Antiretrovirals and Nutrition (BAN) Study Team. Co-trimoxazole Prophylaxis, Asymptomatic Malaria Parasitemia, and Infectious Morbidity in Human Immunodeficiency Virus-Exposed, Uninfected Infants in Malawi: The BAN Study. Clin Infect Dis. 2017 Aug 15;65(4):575-580. PMID: 28444232; PMCID: PMC5850033.

 

Drozd DR, Saag MS, Westfall AO, Mathews WC, Haubrich R, Boswell SL, Cole SR, Porter D, Kitahata MM, Juday T, Rosenblatt L; CFAR Network of Integrated Clinical Systems (CNICS). Comparative effectiveness of single versus multiple tablet antiretroviral therapy regimens in clinical HIV practice. Medicine (Baltimore). 2017 Apr;96(14):e6275. PMID: 28383402; PMCID: PMC5411186.

 

Edmonds A, Ludema C, Eron JJ Jr, Cole SR, Adedimeji AA, Cohen MH, Cooper HL, Fischl M, Johnson MO, Krause DD, Merenstein D, Milam J, Wilson TE, Adimora AA. Effects of Health Insurance Interruption on Loss of Hypertension Control in Women With and Women Without HIV. J Womens Health (Larchmt). 2017 Dec;26(12):1292-1301. PMID: 28682658; PMCID: PMC5733655.

 

Ewing AC, King CC, Wiener JB, Chasela CS, Hudgens MG, Kamwendo D, Tegha G, Hosseinipour MC, Jamieson DJ, Van der Horst C, Kourtis AP. Effects of concurrent exposure to antiretrovirals and cotrimoxazole prophylaxis among HIV-exposed, uninfected infants. AIDS. 2017 Nov 28;31(18):2455-2463. PMID: 28926409; PMCID: PMC6059368.

 

Fatukasi TV, Cole SR, Moore RD, Mathews WC, Edwards JK, Eron JJ; CNICS investigators. Risk factors for delayed antiretroviral therapy initiation among HIV-seropositive patients. PLoS One. 2017 Jul 10;12(7):e0180843. PMID: 28700693; PMCID: PMC5507276.

 

Honeycutt JB, Thayer WO, Baker CE, Ribeiro RM, Lada SM, Cao Y, Cleary RA, Hudgens MG, Richman DD, Garcia JV. HIV persistence in tissue macrophages of humanized myeloid-only mice during antiretroviral therapy. Nat Med. 2017 May;23(5):638-643. PMID: 28414330; PMCID: PMC5419854.

 

Jiang R, Lu W, Song R, Hudgens MG, Naprvavnik S. DOUBLY ROBUST ESTIMATION OF OPTIMAL TREATMENT REGIMES FOR SURVIVAL DATA-WITH APPLICATION TO AN HIV/AIDS STUDY. Ann Appl Stat. 2017 Sep;11(3):1763-1786. PMID: 29308102; PMCID: PMC5749433.

 

Kessing CF, Nixon CC, Li C, Tsai P, Takata H, Mousseau G, Ho PT, Honeycutt JB, Fallahi M, Trautmann L, Garcia JV, Valente ST. In Vivo Suppression of HIV Rebound by Didehydro-Cortistatin A, a “Block-and-Lock” Strategy for HIV-1 Treatment. Cell Rep. 2017 Oct 17;21(3):600-611. PMID: 29045830; PMCID: PMC5653276.

 

Lee JS, Cole SR, Richardson DB, Dittmer DP, Miller WC, Moore RD, Kitahata M, Mathews C, Mayer K, Geng E, Achenbach CJ, Eron JJ Jr; Center for AIDS Research Network of Integrated Clinical Systems. Incomplete viral suppression and mortality in HIV patients after antiretroviral therapy initiation. AIDS. 2017 Sep 10;31(14):1989-1997. PMID: 28650383; PMCID: PMC5695564.

 

Lesko CR, Buchanan AL, Westreich D, Edwards JK, Hudgens MG, Cole SR. Generalizing Study Results: A Potential Outcomes Perspective. Epidemiology. 2017 Jul;28(4):553-561. Erratum in: Epidemiology. 2018 Mar;29(2):e16. PMID: 28346267; PMCID: PMC5466356.

 

Lesko CR, Todd JV, Cole SR, Edmonds A, Pence BW, Edwards JK, Mack WJ, Bacchetti P, Rubtsova A, Gange SJ, Adimora AA; WIHS Investigators. Mortality under plausible interventions on antiretroviral treatment and depression in HIV-infected women: an application of the parametric g-formula. Ann Epidemiol. 2017 Dec;27(12):783-789.e2. PMID: 28939001; PMCID: PMC5714697.

 

Ludema C, Cole SR, Eron JJ Jr, Holmes GM, Anastos K, Cocohoba J, Cohen MH, Cooper HLF, Golub ET, Kassaye S, Konkle-Parker D, Metsch L, Milam J, Wilson TE, Adimora AA. Health Insurance Type and Control of Hypertension Among US Women Living With and Without HIV Infection in the Women’s Interagency HIV Study. Am J Hypertens. 2017 Jun 1;30(6):594-601. PMID: 28407044; PMCID: PMC5861569.

 

Mollan KR, Tierney C, Hellwege JN, Eron JJ, Hudgens MG, Gulick RM, Haubrich R, Sax PE, Campbell TB, Daar ES, Robertson KR, Ventura D, Ma Q, Edwards DRV, Haas DW; AIDS Clinical Trials Group. Race/Ethnicity and the Pharmacogenetics of Reported Suicidality With Efavirenz Among Clinical Trials Participants. J Infect Dis. 2017 Sep 1;216(5):554-564. PMID: 28931220; PMCID: PMC5853681.

 

O’Donnell JK, Gaynes BN, Cole SR, Edmonds A, Thielman NM, Quinlivan EB, Heine A, Modi R, Pence BW. Stressful and traumatic life events as disruptors to antiretroviral therapy adherence. AIDS Care. 2017 Nov;29(11):1378-1385. PMID: 28351158; PMCID: PMC6538389.

 

Phillips B, Fouda GG, Eudailey J, Pollara J, Curtis AD 2nd, Kunz E, Dennis M, Shen X, Bay C, Hudgens M, Pickup D, Alam SM, Ardeshir A, Kozlowski PA, Van Rompay KKA, Ferrari G, Moody MA, Permar S, De Paris K. Impact of Poxvirus Vector Priming, Protein Coadministration, and Vaccine Intervals on HIV gp120 Vaccine-Elicited Antibody Magnitude and Function in Infant Macaques. Clin Vaccine Immunol. 2017 Oct 5;24(10):e00231-17. PMID: 28814388; PMCID: PMC5629672.

 

Price JT, Mollan KR, Fuseini NM, Freeman BL, Mulenga HB, Corbett AH, Vwalika B, Stringer JSA. Vaginal progesterone to reduce preterm birth among HIV-infected pregnant women in Zambia: a feasibility study protocol. Pilot Feasibility Stud. 2017 Jul 18;4:21. Erratum in: Pilot Feasibility Stud. 2017 Oct 24;3:48. PMID: 28729911; PMCID: PMC5516378.

 

SESH Study Group; Tucker JD. Crowdsourcing to promote HIV testing among MSM in China: study protocol for a stepped wedge randomized controlled trial. Trials. 2017 Oct 2;18(1):447. Erratum in: Trials. 2017 Oct 23;18(1):495. PMID: 28969702; PMCID: PMC5625620.

 

Smith JS, Sanusi B, Swarts A, Faesen M, Levin S, Goeieman B, Ramotshela S, Rakhombe N, Williamson AL, Michelow P, Omar T, Hudgens MG, Firnhaber C. A randomized clinical trial comparing cervical dysplasia treatment with cryotherapy vs loop electrosurgical excision procedure in HIV-seropositive women from Johannesburg, South Africa. Am J Obstet Gynecol. 2017 Aug;217(2):183.e1-183.e11. PMID: 28366730.

 

Stringer JS, Stoner MC, Kasaro MP, Vwalika B, Cole SR. Preconception ART and preterm birth: real effect or selection bias? Lancet HIV. 2017 Apr;4(4):e150. PMID: 28359444.

 

Sung JA, Sholtis K, Kirchherr J, Kuruc JD, Gay CL, Nordstrom JL, Bollard CM, Archin NM, Margolis DM. Vorinostat Renders the Replication-Competent Latent Reservoir of Human Immunodeficiency Virus (HIV) Vulnerable to Clearance by CD8 T Cells. EBioMedicine. 2017 Sep;23:52-58. PMID: 28803740; PMCID: PMC5605299.

 

Tang W, Mao J, Tang S, Liu C, Mollan K, Cao B, Wong T, Zhang Y, Hudgens M, Qin Y, Han L, Ma B, Yang B, Ma W, Wei C, Tucker JD; SESH Study Group. Disclosure of sexual orientation to health professionals in China: results from an online cross-sectional study. J Int AIDS Soc. 2017 Feb 6;20(1):21416. PMID: 28361498; PMCID: PMC5467583.

 

Todd JV, Cole SR, Pence BW, Lesko CR, Bacchetti P, Cohen MH, Feaster DJ, Gange S, Griswold ME, Mack W, Rubtsova A, Wang C, Weedon J, Anastos K, Adimora AA. Effects of Antiretroviral Therapy and Depressive Symptoms on All-Cause Mortality Among HIV-Infected Women. Am J Epidemiol. 2017 May 15;185(10):869-878. PMID: 28430844; PMCID: PMC5430940.

 

Todd JV, Cole SR, Wohl DA, Simpson RJ Jr, Jonsson Funk M, Brookhart MA, Cocohoba J, Merenstein D, Sharma A, Lazar J, Milam J, Cohen M, Gange S, Lewis TT, Burkholder G, Adimora AA. Underutilization of Statins When Indicated in HIV-Seropositive and Seronegative Women. AIDS Patient Care STDS. 2017 Nov;31(11):447-454. PMID: 29087746; PMCID: PMC5665094.

 

Trumble IM, Allmon AG, Archin NM, Rigdon J, Francis O, Baldoni PL, Hudgens MG. SLDAssay: A software package and web tool for analyzing limiting dilution assays. J Immunol Methods. 2017 Nov;450:10-16. PMID: 28733216; PMCID: PMC5595663.

 

Wohl DA, Allmon AG, Evon D, Hurt C, Reifeis SA, Thirumurthy H, Straub B, Edwards A, Mollan KR. Financial Incentives for Adherence to Hepatitis C Virus Clinical Care and Treatment: A Randomized Trial of Two Strategies. Open Forum Infect Dis. 2017 May 5;4(2):ofx095. PMID: 28695144; PMCID: PMC5499638.

 

2016

Chibwesha CJ, Ford CE, Mollan KR, Stringer JS. Point-of-Care Virologic Testing to Improve Outcomes of HIV-Infected Children in Zambia: A Clinical Trial Protocol. J Acquir Immune Defic Syndr. 2016 Aug 1;72 Suppl 2(Suppl 2):S197-201. PMID: 27355509; PMCID: PMC5113248.

 

Clutton G, Xu Y, Baldoni PL, Mollan KR, Kirchherr J, Newhard W, Cox K, Kuruc JD, Kashuba A, Barnard R, Archin N, Gay CL, Hudgens MG, Margolis DM, Goonetilleke N. The differential short- and long-term effects of HIV-1 latency-reversing agents on T cell function. Sci Rep. 2016 Aug 2;6:30749. Erratum in: Sci Rep. 2016 Oct 03;6:34430. PMID: 27480951; PMCID: PMC4969750.

 

Cottrell ML, Prince HM, Allmon A, Mollan KR, Hudgens MG, Sykes C, White N, Malone S, Dellon ES, Madanick RD, Shaheen NJ, Patterson KB, Kashuba AD. Cervicovaginal and Rectal Fluid as a Surrogate Marker of Antiretroviral Tissue Concentration: Implications for Clinical Trial Design. J Acquir Immune Defic Syndr. 2016 Aug 15;72(5):498-506. PMID: 26999532; PMCID: PMC4942408.

 

Cottrell ML, Yang KH, Prince HM, Sykes C, White N, Malone S, Dellon ES, Madanick RD, Shaheen NJ, Hudgens MG, Wulff J, Patterson KB, Nelson JA, Kashuba AD. A Translational Pharmacology Approach to Predicting Outcomes of Preexposure Prophylaxis Against HIV in Men and Women Using Tenofovir Disoproxil Fumarate With or Without Emtricitabine. J Infect Dis. 2016 Jul 1;214(1):55-64. PMID: 26917574; PMCID: PMC4907409.

 

Davis NL, Miller WC, Hudgens MG, Chasela CS, Sichali D, Kayira D, Nelson JA, Fiscus SA, Tegha G, Kamwendo DD, Rigdon J, Stringer JS, Juliano JJ, Ellington SR, Kourtis AP, Jamieson DJ, van der Horst C; BAN study team. Maternal and Breastmilk Viral Load: Impacts of Adherence on Peripartum HIV Infections Averted-The Breastfeeding, Antiretrovirals, and Nutrition Study. J Acquir Immune Defic Syndr. 2016 Dec 15;73(5):572-580. PMID: 27846071; PMCID: PMC5141681.

 

Dumond JB, Francis O, Cottrell M, Trezza C, Prince HM, Mollan K, Sykes C, Torrice C, White N, Malone S, Wang R, Van Dam C, Patterson KB, Hudgens MG, Sharpless NE, Forrest A. Tenofovir/emtricitabine metabolites and endogenous nucleotide exposures are associated with p16(INK4a) expression in subjects on combination therapy. Antivir Ther. 2016;21(5):441-5. PMID: 26731175; PMCID: PMC5266614.

 

Edwards JK, Cole SR, Lesko CR, Mathews WC, Moore RD, Mugavero MJ, Westreich D. An Illustration of Inverse Probability Weighting to Estimate Policy-Relevant Causal Effects. Am J Epidemiol. 2016 Aug 15;184(4):336-44. PMID: 27469514; PMCID: PMC4983650.

 

Floris-Moore MA, Mollan K, Wilkin AM, Johnson MA, Kashuba AD, Wohl DA, Patterson KB, Francis O, Kronk C, Eron JJ. Antiretroviral activity and safety of once-daily etravirine in treatment-naive HIV-infected adults: 48-week results. Antivir Ther. 2016;21(1):55-64. PMID: 26263403; PMCID: PMC5546302.

 

Howe CJ, Cole SR, Lau B, Napravnik S, Eron JJ Jr. Selection Bias Due to Loss to Follow Up in Cohort Studies. Epidemiology. 2016 Jan;27(1):91-7. PMID: 26484424; PMCID: PMC5008911.

 

Hudgens MG. Rejoinder to “Reader reaction: A note on the evaluation of group testing algorithms in the presence of misclassification”. Biometrics. 2016 Mar;72(1):304. PMID: 26355875.

 

Jensen K, Nabi R, Van Rompay KKA, Robichaux S, Lifson JD, Piatak M Jr, Jacobs WR Jr, Fennelly G, Canfield D, Mollan KR, Hudgens MG, Larsen MH, Amedee AM, Kozlowski PA, De Paris K. Vaccine-Elicited Mucosal and Systemic Antibody Responses Are Associated with Reduced Simian Immunodeficiency Viremia in Infant Rhesus Macaques. J Virol. 2016 Jul 27;90(16):7285-7302. PMID: 27252535; PMCID: PMC4984660.

 

Lee H, Hudgens MG, Cai J, Cole SR. Marginal Structural Cox Models with Case-Cohort Sampling. Stat Sin. 2016 Apr;26(2):509-526. PMID: 27057128; PMCID: PMC4820319.

 

Lesko CR, Cole SR, Hall HI, Westreich D, Miller WC, Eron JJ, Li J, Mugavero MJ; CNICS Investigators. The effect of antiretroviral therapy on all-cause mortality, generalized to persons diagnosed with HIV in the USA, 2009-11. Int J Epidemiol. 2016 Feb;45(1):140-50. Erratum in: Int J Epidemiol. 2021 Jul 9;50(3):1044. PMID: 26772869; PMCID: PMC5013889.

 

Liu C, Mao J, Wong T, Tang W, Tso LS, Tang S, Zhang Y, Zhang W, Qin Y, Chen Z, Ma W, Kang D, Li H, Liao M, Mollan K, Hudgens M, Bayus B, Huang S, Yang B, Wei C, Tucker JD. Comparing the effectiveness of a crowdsourced video and a social marketing video in promoting condom use among Chinese men who have sex with men: a study protocol. BMJ Open. 2016 Oct 3;6(10):e010755. PMID: 27697868; PMCID: PMC5073617.

 

Lodi S, Sharma S, Lundgren JD, Phillips AN, Cole SR, Logan R, Agan BK, Babiker A, Klinker H, Chu H, Law M, Neaton JD, Hernán MA; INSIGHT Strategic Timing of AntiRetroviral Treatment (START) study group. The per-protocol effect of immediate versus deferred antiretroviral therapy initiation. AIDS. 2016 Nov 13;30(17):2659-2663. PMID: 27782964; PMCID: PMC5339063.

 

Ludema C, Cole SR, Eron JJ Jr, Edmonds A, Holmes GM, Anastos K, Cocohoba J, Cohen M, Cooper HL, Golub ET, Kassaye S, Konkle-Parker D, Metsch L, Milam J, Wilson TE, Adimora AA. Impact of Health Insurance, ADAP, and Income on HIV Viral Suppression Among US Women in the Women’s Interagency HIV Study, 2006-2009. J Acquir Immune Defic Syndr. 2016 Nov 1;73(3):307-312. PMID: 27763995; PMCID: PMC5089078.

 

Maas BM, Francis O, Mollan KR, Lee C, Cottrell ML, Prince HM, Sykes C, Trezza C, Torrice C, White N, Malone S, Hudgens MG, Sharpless NE, Dumond JB. Concentrations of Pro-Inflammatory Cytokines Are Not Associated with Senescence Marker p16INK4a or Predictive of Intracellular Emtricitabine/Tenofovir Metabolite and Endogenous Nucleotide Exposures in Adults with HIV Infection. PLoS One. 2016 Dec 30;11(12):e0168709. PMID: 28036343; PMCID: PMC5201235.

 

Nelson CS, Pollara J, Kunz EL, Jeffries TL Jr, Duffy R, Beck C, Stamper L, Wang M, Shen X, Pickup DJ, Staats HF, Hudgens MG, Kepler TB, Montefiori DC, Moody MA, Tomaras GD, Liao HX, Haynes BF, Ferrari G, Fouda GGA, Permar SR. Combined HIV-1 Envelope Systemic and Mucosal Immunization of Lactating Rhesus Monkeys Induces a Robust Immunoglobulin A Isotype B Cell Response in Breast Milk. J Virol. 2016 Apr 29;90(10):4951-4965. PMID: 26937027; PMCID: PMC4859715.

 

O’Donnell JK, Gaynes BN, Cole SR, Edmonds A, Thielman NM, Quinlivan EB, Shirey K, Heine AD, Modi R, Pence BW. Ongoing life stressors and suicidal ideation among HIV-infected adults with depression. J Affect Disord. 2016 Jan 15;190:322-328. PMID: 26544615; PMCID: PMC4685465.

 

Olesen R, Swanson MD, Kovarova M, Nochi T, Chateau M, Honeycutt JB, Long JM, Denton PW, Hudgens MG, Richardson A, Tolstrup M, Østergaard L, Wahl A, Garcia JV. ART influences HIV persistence in the female reproductive tract and cervicovaginal secretions. J Clin Invest. 2016 Mar 1;126(3):892-904. PMID: 26854925; PMCID: PMC4767352.

 

Rosen DL, Wohl DA, Golin CE, Rigdon J, May J, White BL, Leone PA, Hudgens MG, Bowling JM. Comparing HIV Case Detection in Prison During Opt-In vs. Opt-Out Testing Policies. J Acquir Immune Defic Syndr. 2016 Mar 1;71(3):e85-8. PMID: 26536318; PMCID: PMC4752376.

 

Senkomago V, Backes DM, Hudgens MG, Poole C, Meshnick SR, Agot K, Moses S, Snijders PJ, Meijer CJ, Hesselink AT, Schlecht NF, Bailey RC, Smith JS. Higher HPV16 and HPV18 Penile Viral Loads Are Associated With Decreased Human Papillomavirus Clearance in Uncircumcised Kenyan Men. Sex Transm Dis. 2016 Sep;43(9):572-8. PMID: 27513384; PMCID: PMC4985051.

 

Shepherd BE, Liu Q, Mercaldo N, Jenkins CA, Lau B, Cole SR, Saag MS, Sterling TR. Comparing results from multiple imputation and dynamic marginal structural models for estimating when to start antiretroviral therapy. Stat Med. 2016 Oct 30;35(24):4335-4351. PMID: 27264354; PMCID: PMC5048599.

 

Tang W, Han L, Best J, Zhang Y, Mollan K, Kim J, Liu F, Hudgens M, Bayus B, Terris-Prestholt F, Galler S, Yang L, Peeling R, Volberding P, Ma B, Xu H, Yang B, Huang S, Fenton K, Wei C, Tucker JD. Crowdsourcing HIV Test Promotion Videos: A Noninferiority Randomized Controlled Trial in China. Clin Infect Dis. 2016 Jun 1;62(11):1436-1442. PMID: 27129465; PMCID: PMC4872295.

 

Yanik EL, Achenbach CJ, Gopal S, Coghill AE, Cole SR, Eron JJ, Moore RD, Mathews WC, Drozd DR, Hamdan A, Ballestas ME, Engels EA. Changes in Clinical Context for Kaposi’s Sarcoma and Non-Hodgkin Lymphoma Among People With HIV Infection in the United States. J Clin Oncol. 2016 Sep 20;34(27):3276-83. PMID: 27507879; PMCID: PMC5024548.

 

2015

Cole SR, Hudgens MG, Brookhart MA, Westreich D. Risk. Am J Epidemiol. 2015 Feb 15;181(4):246-50. PMID: 25660080; PMCID: PMC4325680.

Cole SR, Lau B, Eron JJ, Brookhart MA, Kitahata MM, Martin JN, Mathews WC, Mugavero MJ; CNICS Research Network. Estimation of the standardized risk difference and ratio in a competing risks framework: application to injection drug use and progression to AIDS after initiation of antiretroviral therapy. Am J Epidemiol. 2015 Feb 15;181(4):238-45. PMID: 24966220; PMCID: PMC4325676.

Davis NL, Barnett EJ, Miller WC, Dow A, Chasela CS, Hudgens MG, Kayira D, Tegha G, Ellington SR, Kourtis AP, van der Horst C, Jamieson DJ, Juliano JJ. Impact of daily cotrimoxazole on clinical malaria and asymptomatic parasitemias in HIV-exposed, uninfected infants. Clin Infect Dis. 2015 Aug 1;61(3):368-74. PMID: 25900173; PMCID: PMC4542924.

Dumond JB, Rigdon J, Mollan K, Tierney C, Kashuba AD, Aweeka F, Collier AC. Brief Report: Significant Decreases in Both Total and Unbound Lopinavir and Amprenavir Exposures During Coadministration: ACTG Protocol A5143/A5147s Results. J Acquir Immune Defic Syndr. 2015 Dec 15;70(5):510-4. PMID: 26230332; PMCID: PMC4648657.

Edwards JK, Cole SR, Adimora A, Fine J, Martin J, Eron J. Illustration of a measure to combine viral suppression and viral rebound in studies of HIV therapy. J Acquir Immune Defic Syndr. 2015 Feb 1;68(2):241-4. PMID: 25415292; PMCID: PMC4294958.

Edwards JK, Cole SR, Westreich D, Crane H, Eron JJ, Mathews WC, Moore R, Boswell SL, Lesko CR, Mugavero MJ; CNICS. Multiple Imputation to Account for Measurement Error in Marginal Structural Models. Epidemiology. 2015 Sep;26(5):645-52. PMID: 26214338; PMCID: PMC4638124.

Edwards JK, Cole SR, Martin JN, Moore R, Mathews WC, Kitahata M, Eron JJ, Saag M, Mugavero MJ; CNICS Investigators. Dynamic Visual Display of Treatment Response in HIV-Infected Adults. Clin Infect Dis. 2015 Jul 1;61(1):e1-4. PMID: 25838289; PMCID: PMC4481601.

Edwards JK, Cole SR, Westreich D, Mugavero MJ, Eron JJ, Moore RD, Mathews WC, Hunt P, Williams C; Centers for AIDS Research Network of Integrated Clinical Systems investigators. Age at Entry Into Care, Timing of Antiretroviral Therapy Initiation, and 10-Year Mortality Among HIV-Seropositive Adults in the United States. Clin Infect Dis. 2015 Oct 1;61(7):1189-95. PMID: 26082505; PMCID: PMC4560906.

Feinstein L, Edmonds A, Okitolonda V, Cole SR, Van Rie A, Chi BH, Ndjibu P, Lusiama J, Chalachala JL, Behets F. Implementation and Operational Research: Maternal Combination Antiretroviral Therapy Is Associated With Improved Retention of HIV-Exposed Infants in Kinshasa, Democratic Republic of Congo. J Acquir Immune Defic Syndr. 2015 Jul 1;69(3):e93-9. PMID: 25886922; PMCID: PMC4506694.

Firnhaber C, Mao L, Levin S, Faesen M, Lewis DA, Goeieman BJ, Swarts AJ, Rakhombe N, Michelow PM, Williams S, Smith JS. Evaluation of a cervicography-based program to ensure quality of visual inspection of the cervix in HIV-infected women in Johannesburg, South Africa. J Low Genit Tract Dis. 2015 Jan;19(1):7-11. PMID: 24914887; PMCID: PMC4272220.

Flax VL, Adair LS, Allen LH, Shahab-Ferdows S, Hampel D, Chasela CS, Tegha G, Daza EJ, Corbett A, Davis NL, Kamwendo D, Kourtis AP, van der Horst CM, Jamieson DJ, Bentley ME; BAN Study Team. Plasma Micronutrient Concentrations Are Altered by Antiretroviral Therapy and Lipid-Based Nutrient Supplements in Lactating HIV-Infected Malawian Women. J Nutr. 2015 Aug;145(8):1950-7. PMID: 26156797; PMCID: PMC4516772.

Geng Y, Zhang HH, Lu W. On optimal treatment regimes selection for mean survival time. Stat Med. 2015 Mar 30;34(7):1169-84. PMID: 25515005; PMCID: PMC4355217.

Herce ME, Kalanga N, Wroe EB, Keck JW, Chingoli F, Tengatenga L, Gopal S, Phiri A, Mailosi B, Bazile J, Beste JA, Elmore SN, Crocker JT, Rigodon J. Excellent clinical outcomes and retention in care for adults with HIV-associated Kaposi sarcoma treated with systemic chemotherapy and integrated antiretroviral therapy in rural Malawi. J Int AIDS Soc. 2015 May 29;18(1):19929. PMID: 26028156; PMCID: PMC4450240.

King CC, Kourtis AP, Persaud D, Nelson JA, Ziemniak C, Hudgens MG, Tegha G, Chasela CS, Jamieson DJ, van der Horst CM. Delayed HIV detection among infants exposed to postnatal antiretroviral prophylaxis during breastfeeding. AIDS. 2015 Sep 24;29(15):1953-61. PMID: 26153671; PMCID: PMC4665628.

Lesko CR, Cole SR, Miller WC, Westreich D, Eron JJ, Adimora AA, Moore RD, Mathews WC, Martin JN, Drozd DR, Kitahata MM, Edwards JK, Mugavero MJ. Ten-year Survival by Race/Ethnicity and Sex Among Treated, HIV-infected Adults in the United States. Clin Infect Dis. 2015 Jun 1;60(11):1700-7. PMID: 25767258; PMCID: PMC4447784.

Long DM, Hudgens MG, Wu CD. Surrogates of protection in repeated low-dose challenge experiments. Stat Med. 2015 May 10;34(10):1747-60. PMID: 25628249; PMCID: PMC4390486.

Nelson JA, Fokar A, Hudgens MG, Compliment KJ, Hawkins JT, Tegha G, Kamwendo DD, Kayira D, Mofolo IA, Kourtis AP, Jamieson DJ, Van Der Horst CM, Fiscus SA. Frequent nevirapine resistance in infants infected by HIV-1 via breastfeeding while on nevirapine prophylaxis. AIDS. 2015 Oct 23;29(16):2131-8. PMID: 26186128; PMCID: PMC4715989.

Nevo ON, Lesko CR, Colwell B, Ballard C, Cole SR, Mathews WC. Outcomes of pharmacist-assisted management of antiretroviral therapy in patients with HIV infection: A risk-adjusted analysis. Am J Health Syst Pharm. 2015 Sep 1;72(17):1463-70. PMID: 26294239; PMCID: PMC4877692.

Nolen TL, Hudgens MG, Senb PK, Koch GG. Analysis of repeated low-dose challenge studies. Stat Med. 2015 May 30;34(12):1981-92. PMID: 25752266; PMCID: PMC4420691.

Onsomu EO, Abuya BA, Okech IN, Rosen DL, Duren-Winfield V, Simmons AC. Association between domestic violence and HIV serostatus among married and formerly married women in Kenya. Health Care Women Int. 2015;36(2):205-28. PMID: 25127397; PMCID: PMC4312516.

Oxford KL, Dela Pena-Ponce MGA, Jensen K, Eberhardt MK, Spinner A, Van Rompay KK, Rigdon J, Mollan KR, Krishnan VV, Hudgens MG, Barry PA, De Paris K. The interplay between immune maturation, age, chronic viral infection and environment. Immun Ageing. 2015 May 9;12:3. PMID: 25991918; PMCID: PMC4436863.

Richardson DB, Kinlaw AC, MacLehose RF, Cole SR. Standardized binomial models for risk or prevalence ratios and differences. Int J Epidemiol. 2015 Oct;44(5):1660-72. PMID: 26228585; PMCID: PMC6372130.

Sellers CJ, Lee H, Chasela C, Kayira D, Soko A, Mofolo I, Ellington S, Hudgens MG, Kourtis AP, King CC, Jamieson DJ, van der Horst C; BAN Study Team. Reducing lost to follow-up in a large clinical trial of prevention of mother-to-child transmission of HIV: the Breastfeeding, Antiretrovirals and Nutrition study experience. Clin Trials. 2015 Apr;12(2):156-65. PMID: 25518956; PMCID: PMC4355163.

Senkomago V, Backes DM, Hudgens MG, Poole C, Agot K, Moses S, Snijders PJ, Meijer CJ, Hesselink AT, Schlecht NF, Bailey RC, Smith JS. Acquisition and persistence of human papillomavirus 16 (HPV-16) and HPV-18 among men with high-HPV viral load infections in a circumcision trial in Kisumu, Kenya. J Infect Dis. 2015 Mar 1;211(5):811-20. PMID: 25261492; PMCID: PMC4402376.

Soriano-Sarabia N, Archin NM, Bateson R, Dahl NP, Crooks AM, Kuruc JD, Garrido C, Margolis DM. Peripheral Vγ9Vδ2 T Cells Are a Novel Reservoir of Latent HIV Infection. PLoS Pathog. 2015 Oct 16;11(10):e1005201. PMID: 26473478; PMCID: PMC4608739.

Sung JA, Lam S, Garrido C, Archin N, Rooney CM, Bollard CM, Margolis DM. Expanded cytotoxic T-cell lymphocytes target the latent HIV reservoir. J Infect Dis. 2015 Jul 15;212(2):258-63. PMID: 25589335; PMCID: PMC4490234.

Tashima KT, Mollan KR, Na L, Gandhi RT, Klingman KL, Fichtenbaum CJ, Andrade A, Johnson VA, Eron JJ, Smeaton L, Haubrich RH. Regimen selection in the OPTIONS trial of HIV salvage therapy: drug resistance, prior therapy, and race-ethnicity determine the degree of regimen complexity. HIV Clin Trials. 2015 Aug;16(4):147-56.  PMID: 26212575; PMCID: PMC4640927.

Vardhanabhuti S, Taiwo B, Kuritzkes DR, Eron JJ Jr, Bosch RJ. Phylogenetic evidence of HIV-1 sequence evolution in subjects with persistent low-level viraemia. Antivir Ther. 2015;20(1):73-6. PMID: 24699164; PMCID: PMC4185268.

Vielot N, Hudgens MG, Mugo N, Chitwa M, Kimani J, Smith J. The Role of Chlamydia trachomatis in High-Risk Human Papillomavirus Persistence Among Female Sex Workers in Nairobi, Kenya. Sex Transm Dis. 2015 Jun;42(6):305-11. PMID: 25970306; PMCID: PMC4435827.

White BL, Golin CE, Grodensky CA, Kiziah CN, Richardson A, Hudgens MG, Wohl DA, Kaplan AH. Effect of directly observed antiretroviral therapy compared to self-administered antiretroviral therapy on adherence and virological outcomes among HIV-infected prisoners: a randomized controlled pilot study. AIDS Behav. 2015 Jan;19(1):128-36. PMID: 25055766; PMCID: PMC4303492.

Willoughby JF. BrdsNBz: Sexually Experienced Teens More Likely to Use Sexual Health Text Message Service. Health Educ Behav. 2015 Dec;42(6):752-8. PMID: 25889699.

Zhou S, Jones C, Mieczkowski P, Swanstrom R. Primer ID Validates Template Sampling Depth and Greatly Reduces the Error Rate of Next-Generation Sequencing of HIV-1 Genomic RNA Populations. J Virol. 2015 Aug;89(16):8540-55. PMID: 26041299; PMCID: PMC4524263.

 

Github

Visit the UNC CFAR Biostatistics GitHub at https://github.com/unc-cfar-bios.

Tools

R package for Serial Limiting Dilution Assay Statistics (SLDAssay)

Power Calculator for Repeated Low-Dose Challenge Studies

R Package for Rank-Sum Power Calculation (wmwpow)

 

Presentations

Mollan KR: An integrated intervention to engage HIV+ people who inject drugs in antiretroviral treatment and medication-assisted treatment: Extended follow-up of HPTN 074. 23rd International AIDS Conference, AIDS 2020: Virtual. Electronic Poster Presentation: PEC0707.

Shook-Sa, BE: Inverse probability weighting and outcome regression approaches in causal inference and survey sampling. UNC Department of Biostatistics Dissertation Defense, 2020. Oral Presentation.

Shook-Sa BE: Higher numbers of new and total sexual partners following periods of incarceration among women with or at risk for HIV. American Public Health Association (APHA), 2019. Philadelphia, PA. Poster Presentation.

Mollan KR: Precise and Accurate Power of the Rank-Sum Test for a Continuous Variable. Joint Statistical Meetings (JSM), 2019. Denver, CO. Oral Presentation & e-Poster.

Weideman AM: High Performance Computing on a Cluster with R: a Tutorial. Joint Statistical Meetings (JSM), 2019. Denver, CO. Poster Presentation.

Mollan KR: Transporting Outcomes from Randomized Trials to a Population of Interest: Suicidality among US Adults in Routine HIV Care. 2019 Triangle Comparative Effectiveness Research Symposium. RTI International, RTP, NC. Poster Presentation.

Hudgens MG: Causal Inference in HIV Prevention Trials. HPTN Annual Meetings, 2018. Oral Presentation.

Hudgens MG: Statistical Considerations for Repeated Low Dose Challenge Studies. HVTN Translational ESI Conference, 2018. Oral Presentation.

Hudgens MG: Counting Viruses – Measuring the Latent HIV-1 Reservoir. Emory CFAR Seminar, 2018. Oral Presentation.

Mollan KR: A World beyond p<0.05 – Synopsis and debate from the fall 2017 ASA Symposium. UNC CFAR Biostatistics Core Research Group, Nov 2017. Oral Presentation.
The P-value Statement – click here!

Love M: Analysis approaches for microarray and RNA sequencing data will be presented, with thoughts on how these approaches can apply to HIV research. UNC CFAR Biostatistics Core Research Group, June 2017. Oral Presentation.
Watch: http://unccfar.org/unccfarmain/wp-content/uploads/2017/09/zoom_0_shortened.mp4

Zadrozny S and Edwards JK: Stayin’ alive (and suppressed): a longitudinal HIV continuum in the Dominican Republic. UNC CFAR Biostatistics Core Research Group, April 2017. Oral Presentation.

Cole SR: Type 3 rationality is to optimize causally-expected utility, within reason. Examples from HIV will be discussed. UNC CFAR Biostatistics Core Research Group, Oct 2016. Oral Presentation.

Baldoni P and Lee SK: Statistical Methods for Viral Outgrowth Assays. UNC CFAR Biostatistics Core Research Group, June 2016. Oral Presentation.

Bobashev G: HIV modeling: using a combination of agent-modeling and survival analysis. UNC CFAR Biostatistics Core Research Group, Nov 2015. Oral Presentation.

Lu W: Doubly Robust Estimation of Optimal Treatment Regimes for Survival Data – with an Application to UNC AIDS Data. UNC CFAR Biostatistics Core Research Group, Sept 2015. Oral Presentation.

Powers K: Leveraging the HIV Cascade to Improve Public Health: Conceptual and Measurement Challenges. UNC CFAR Biostatistics Core Research Group, March 2015. Oral Presentation.

Buchanan AL, Westreich D and Lesko K: Generalizing Evidence from Randomized Trials and Observational Studies. UNC CFAR Biostatistics Core Research Group, Dec 2014. Oral Presentation.

Mollan KR and Hudgens MG: Power and Sample Size Boot Camp. UNC Friday Infectious Disease and CFAR Conference, 2014. Oral Presentation.

Rigdon J: Statistical Methods for Serial Limiting Dilution Assays. UNC CFAR Biostatistics Core Research Group, Sept 2014. Oral Presentation.

Edwards JK: A measure to combine viral suppression and viral rebound in studies of HIV therapy. UNC CFAR Biostatistics Core Research Group, June 2014. Oral Presentation.

Mollan KR: Hazard of Suicidality in Patients Randomly Assigned to Efavirenz for Initial Treatment of HIV-1. UNC CFAR Biostatistics Core Research Group, Feb 2014. Oral Presentation.

Chen PL and Taylor D: FHI 360 Biostatistics & Epidemiology Brown Bag Lunch Seminar. UNC CFAR Biostatistics Core Research Group, Oct 2013. Oral Presentation.

Hudgens MG and Mollan KR: An Overview of Biostatistics. UNC Friday Infectious Disease and CFAR Conference, 2013. Oral Presentation.

 

Brief Statistical Safety Checklist

Statistical Checklist

Purpose:

This checklist is designed to help review draft manuscripts, statistical reports, or analysis plans

Methods:

-Objective / hypotheses of the study are clearly stated

-Endpoints are defined, declare endpoints as primary, secondary, and exploratory as appropriate

-Exposures and covariates are defined

-Sample size calculation is explained (if applicable)

-If applicable, randomization and blinding process are explained

-If applicable, interim stopping guidelines are described

-All statistical methods are described (with references as needed)

-Methodological assumptions were reasonably met

-Reasonable considerations were made for:

-missing data or attrition (e.g. loss to follow-up)

-multiple testing or multiple comparisons

-correlation among observations (e.g. longitudinal or clustered data)

-small sample sizes (e.g. n<30)

-Statistical software and version used are stated (e.g. SAS version 9.3, Cary, North Carolina)

-Statistical type I error probability is declared (e.g. two-sided alpha of 0.05)

-Clinical trials: trial registration ID included (www.clinicaltrials.gov)

Results (including text, tables, figures):

-Number of decimal places reported appropriately reflects measurement precision

-Summaries of variability/spread are provided (e.g. SD, IQR)

-Sample sizes are provided (n=) and missing data are declared when applicable

-Each p-value is accompanied by a graphical display of data and descriptive statistics. Estimation with precision quantified (e.g., 95% confidence interval) is preferred.

-If reporting p-values, report specific p-values (p=0.027), rather than p<0.05

-Use of the word significant should be avoided

-Figures are clearly explained by a legend and all axes and symbols are appropriately labeled

-Distorted effect sizes (e.g. by truncation of y-axis) are clearly labeled and justified

-Units of measurement are stated

Discussion:

-Discussion conclusions are in agreement with results

-Limitations of the study design or analytic approach are appropriately stated

For more guidance, refer to standard reporting guidelines (e.g. CONSORT, STROBE, PRISMA, STARD) and the ASA p-value statement (and published updates thereof)

References:

This list was compiled with reference to ‘Instructions for Authors’ at  JAMA, Annals of Internal Medicine, Nature, and Science Magazine.

“To consult the statistician after an experiment is finished is often merely to ask them to conduct a post mortem examination. They can perhaps say what the experiment died of.” R.A. Fisher

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