Biostatistics Core- UNC Center for AIDS Research

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 Cole Dr. 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 the UNC Center for AIDS Research within the UNC-Chapel Hill School of Medicine, has 16 years of experience in quantitative research. Her areas of expertise include the design and analysis of clinical trials and observational cohorts. Mollan has provided statistical support for numerous HIV/AIDS grant proposals and research studies, including for the AIDS Clinical Trials Group (ACTG), the HIV Prevention Trials Network (HPTN), UNC-CH investigator-initiated studies, and industry collaborations with Ridgeback Biotherapeutics and Gilead Sciences. Ms. Mollan has co-authored >65 peer-reviewed articles in journals including Annals of Internal Medicine, The Lancet, American Journal of Epidemiology, Clinical Infectious Diseases, and the New England Journal of Medicine. She served gratis as Statistical Editor for the Open Forum of Infectious Diseases for 7 years. Her collaborative research background spans a breadth of topics, including antiretroviral treatment (ART), women’s health, mental health comorbidities, long-acting agents, HIV prevention and testing, HIV cure, and drug-resistant virus. She has worked with a wide variety of laboratory-based data, clinical data, and patient-reported outcomes and collaborated on research conducted in the United States, South Africa, Malawi, Zambia, China, Ukraine, Vietnam, and Indonesia. Her primary research interests include HIV, women’s health, mental health, COVID-19, epidemiologic methods, applied causal inference, and statistical power.

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 Headshot Ms. 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

Ann Marie Weideman is a PhD student in the Biostatistics Department at UNC. She received a B.S. and M.S. in Mathematics from the University of Maryland, Baltimore County. Before joining the CFAR, she worked as a post-baccalaureate fellow at the National Institutes of Health (NIH), where her research focused on developing mathematical and statistical models to predict disease progression in patients with multiple sclerosis. During her fellowship at the NIH, she worked as adjunct faculty at Capitol Technology University, where she taught engineering statistics and differential equations. Ann Marie has interests in high-performance computing, web-app design, and watercolor painting.

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 Headshot Taylor 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 white Kaitlyn 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 Richardson Brian 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 Young Amber 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-Lee Chanhwa 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-Mischell Melissa 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

(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]

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 Global Public Health, In press.

Boyce, R.M., Muhindo, E., Baguma, E., Muhindo, R., Shem, B., François, R., Hawke, S., Shook-Sa, B.E., Ntaro, M., Nalusaji, A. and Nyehangane, D., 2022. Permethrin-treated baby wraps for the prevention of malaria: results of a randomized controlled pilot study in rural Uganda. Malaria Journal, 21(1), pp.1-12. PMC8864600

Breger, T.L., Westreich, D., Edmonds, A., Edwards, J.K., Zalla, L.C., Cole, S.R., Ramirez, C., Ofotokun, I., Kassaye, S.G., Brown, T.T. and Konkle-Parker, D., 2022. A new smoking cessation ‘cascade’ among women with or at risk for HIV infection. AIDS, 36(1),

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, 2022. Household Transmission of Severe Acute Respiratory Syndrome Coronavirus 2 in the United States: Living Density, Viral Load, and Disproportionate Impact on Communities of Color. Clinical Infectious Diseases. 74(10), pp. 1776–1785, 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 (2022). A Randomized Trial of Point-of-Care Early Infant Human Immunodeficiency Virus (HIV) Diagnosis in Zambia. Clinical Infectious Diseases. 75(2), pp. 260–268. PMC9410723

Clutton GT, Weideman AMK, Goonetilleke NP and Maurer T (2022). An expanded population of CD8 dim T cells with features of mitochondrial dysfunction and senescence is associated with persistent HIV-associated Kaposi’s sarcoma under ART. Frontiers in. Cell and Developmental Biology. eCollection 2022. doi: 10.3389/fcell

Cole SR, Zivich PN, Edwards JK, Shook-Sa BE, Hudgens MG. “Sensitivity Analyses for Means or Proportions with Missing Outcome Data.” Epidemiology, In press.

Cole SR, Zivich PN, Edwards JK, Ross RK, Shook-Sa BE, Price JT, Stringer JS (2023). Missing Outcome Data in Epidemiologic Studies. American Journal of Epidemiology, 192(1), pp. 6-10. PMID: 36222655

Cole SR, Edwards JK, Breskin A, Rosin S, Zivich PN, Shook-Sa BE, Hudgens MG, 2022. Illustration of Two Fusion Designs and Estimators. American Journal of Epidemiology, 192(3), pp. 467-474, PMID: 35388406.

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, 3

Curtis, AD, 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 7, no. 1 (2022): e00839-21. PMC8865927

DeMonte, J., McCumber, M., Slye, N., Amico, K.R., Arnold, E.M., Comulada, W.S., Rezvan, P.H., Hightow-Weidman, L.B., Muessig, K.E., Nichols, S.L. Nielsen-Saines, K., Sanchez TH, Shook-Sa BE, Swendeman D, Valencia RK, Hudgens MG. 2023. Adolescents Living With or at Risk for HIV: A Pooled Descriptive Analysis of Studies From the Adolescent Medicine Trials Network for HIV/AIDS Interventions. Journal of Adolescent Health. In press. PMID36803999 NIHMSID1876882

Edwards JK, Cole SR, Breger TL, Filiatreau LM, Zalla L, Mulholland GE, Horberg MA, Silverberg MJ, Gill MJ, Rebeiro PF, Thorne JE, Kasaie P, Marconi VC, Sterling TR, Althoff KN, Moore RD, Eron JJ. Five-year mortality for adults entering HIV care under universal early treatment compared to the general US population. Clinical Infectious Diseases. 2022, 75(5):867-874. PMC9477443

Edwards JK, Cole SR, Shook-Sa BE, Zivich PN, Zhang N, Lesko CR (2022). When does differential outcome misclassification matter for estimating prevalence? Epidemiology. In press. DOI: 10.1097/EDE.0000000000001572 PMID: 36722801

Fischer WA, Eron JJ, 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. Science Translational Medicine. 2022, 14(628):eabl7430. doi: 10.1126/scitranslmed.abl7430. PMID: 34941423

Gao, X, MG Hudgens, F Zou. “Case-Cohort Studies with Time-Dependent Covariates and Interval-Censored Outcome.” In Emerging Topics in Modeling Interval-Censored Survival Data, pp. 221-234. Springer International Publishing, 2022.

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. Journal of Substance Use, 2022, 27(6), pp. 648-657. PMC9897261

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). Journal of Racial and Ethnic Health Disparities. 2023 Feb;10(1):64-82. doi: 10.1007/s40615-021-0

Jetsupphasuk M, MG Hudgens, H Lu, SR Cole, JK Edwards, AA Adimora, KN Althoff, MJ Silverberg, …, JJ Eron (2023). Optimizing Treatment for Human Immunodeficiency Virus to Improve Clinical Outcomes Using Precision Medicine. American Journal of Epidemiology,

Kandiyil, V.V.K., Curtis, A.D., Cross, K., Van Rompay, K.K., Pollara, J., Fox, C., Tomai, M., Hanke, T., Fouda, G., Hudgens, M. and Permar, S.R., 2022. Early post-vaccination gene signatures correlate with the magnitude and function of vaccine-induced HIV envelope-specific plasma antibodies in infant rhesus macaques. The Journal of Immunology, 208(1_Supplement), pp.126-40.

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. PMC8972014

LeMasters, K., Benson, A., Corsi, C., Krajewski, T., Seide, K., Brinkley-Rubinstein, L., Nowotny, K., 2023. Collateral consequences of COVID-19 for people on probation and parole. Health & Justice, In press.

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. 2022 Apr 2:1-6. PMC9530063

Li, F, AL Buchanan, SR Cole. Generalizing trial evidence to target populations in non-nested designs: Applications to AIDS clinical trials. Journal of the Royal Statistical Society: Series C, Applied Statistics. 2022 Jun;71(3):669-697. PMC9367209

Li, L., Lee, C., Cruz, D.F., Krovi, S.A., Hudgens, M.G., Cottrell, M.L., Johnson, L.M., 2022. Reservoir-Style Polymeric Drug Delivery Systems: Empirical and Predictive Models for Implant Design. Pharmaceuticals,15 (10), p.1226. PMC9610229

Li, X., May, S., Trumble, I.M., Archin, N.M. and Hudgens, M.G., 2022. Paired serial limiting dilution assays. Statistics in Medicine, 41(24), pp.4809-4821. PMC9588648

Lindsey, J.C., Hudgens, M., Gaur, A.H., Horvath, K.J., Dallas, R., Heckman, B., Johnson, M.M. and Amico, K.R., 2023. Electronic dose monitoring device patterns in youth living with HIV enrolled in an adherence intervention clinical trial. Journal of Acquired Immune Deficiency Syndromes, 92(3):p 231-241. DOI: 10.1097/QAI.0000000000003126.

Lu, H., Cole, S.R., Westreich, D., Hudgens, M.G., Adimora, A.A., Althoff, K.N., Silverberg, M.J., Buchacz, K., Li, J., Edwards, J.K., Rebeiro, P.F., Lima, V. , Marconi, V., Sterling, T., Horberg, M. , Gill, M., Kitahata, M., Eron, J., Moore, R. 2022. Virologic outcomes among adults with HIV using integrase inhibitor-based antiretroviral therapy. AIDS, 36(2), pp.277-286. PMC9048218

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. Corrigendum to: 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. Clinical Infectious Diseases. 2022 Mar 1;74(4):7

McNeil, C.J., Lee, J.S., Cole, S.R., Patel, S.A., Martin, J., Mathews, W.C., Moore, R.D., Mayer, K.H., Eron, J.J., Saag, M.S. and Kitahata, M.M., 2022. Anal cancer incidence in men with HIV who have sex with men: are black men at higher risk? AIDS, 36(5),

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. Science Translational Medicine. 2023 Mar;15(685):eadd6383. PMC9765459

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. Clinical Infectious Diseases. 75(1):e1028-e1036. PMC9402664

Nelson, A.N., 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. PMC9338948

Price JT, Sebastião YV, Vwalika B, Cole SR, Mbewe FM, Phiri WM, Freeman BL, Kasaro MP, Peterson M, Rouse DJ, Stringer EM. Risk of adverse birth outcomes in two cohorts of pregnant women with HIV in Zambia. Epidemiology. 2022, 33(3):422-430. PMC9516482

Pokaprakarn, T., Prieto, J.C., Price, J.T., Kasaro, M.P., Sindano, N., Shah, H.R., Peterson, M., Akapelwa, M.M., Kapilya, F.M., Sebastião, Y.V., Goodnight, W., Stringer EM, Freeman BL, Montoya LM, Chi BH, Rouse DJ, Cole SR, Vwalika B, Kosorok MR, and Stringer JSA. 2022. AI estimation of gestational age from blind ultrasound sweeps in low-resource settings. NEJM Evidence, 1(5), p.EVIDoa2100058, doi: 10.1056/EVIDoa2100058. PMC9980216

Rosenberg, NE, Shook-Sa BE, Liu M, Stranix-Chibanda L, Yotebieng M, Sam-Agudu NA, Hudgens MG, …, BH Chi. “Adult HIV-1 incidence across 15 high-burden countries in sub-Saharan Africa from 2015 to 2019: a pooled analysis of nationally representative data.” The Lancet HIV (2023). doi: 10.1016/S2352-3018(22)00328-9. Epub 2023 Jan 23. PMID: 36702151

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 Formative Research. 2022 Apr 19;6(4):e32899 PMC9066333

Sadinski, L.M., Westreich, D., Edmonds, A., Breger, T.L., Cole, S.R., Ramirez, C., Brown, T.T., Ofotokun, I., Konkle-Parker, D., Kassaye, S. and Jones, D.L., 2023. Hypertension and one-year risk of all-cause mortality among women with treated HIV in the United States. AIDS, 37(4), pp.679-688. PMC9974900

B Sanusi, J Cai, MG Hudgens. Nonparametric Estimation of Marked Survival Data in the Presence of Dependent Censoring. Stat in Med, In press.

Shook-Sa BE, Hudgens MG, Kavee AL, Rosen DL (2022). “Estimating the Number of Persons with HIV in Jails via Web Scraping and Record Linkage.” Journal of the Royal Statistical Society, Series A, 185(S2), S270-S287. PMC9970294

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.

Vijayan, K.K., Cross, K.A., Curtis, A.D., Van Rompay, K.K., Pollara, J., Fox, C.B., Tomai, M., Hanke, T., Fouda, G., Hudgens, M.G. and Permar, S.R., De Paris K, 2022. Early Post-Vaccination Gene Signatures Correlate With the Magnitude and Function of Vaccine-Induced HIV Envelope-Specific Plasma Antibodies in Infant Rhesus Macaques. Frontiers in Immunology, 13:840976. doi: 10.3389/fimmu.2022.840976 p.1790. 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. PMC8890628

Xu, Y., Weideman, A.M., Abad-Fernandez, M., Mollan, K.R., Kallon, S., Samir, S., Warren, J.A., Clutton, G., Roan, N., Adimora, A.A., Archin, N. Kuruc J, Gay C, Hudgens MG, Goonetilleke N, 2022. CD8 T Cell Virus Inhibition Assay Protocol. Bio-protocol, 12(

Zalla, L.C., Cole, S.R., Eron, J.J., Adimora, A.A., Vines, A.I., Althoff, K.N., Silverberg, M.J., Horberg, M.A., Marconi, V.C., Coburn, S.B. and Lang, R., 2023. Association of Race and Ethnicity with Initial Prescription of Antiretroviral Therapy among People With HIV in the US. JAMA, 329(1), pp.52-62. PMC9856806

Zhou, S, CS Hill, E Spielvogel, MU Clark, MG Hudgens, R Swanstrom. “Unique Molecular Identifiers and Multiplexing Amplicons Maximize the Utility of Deep Sequencing To Critically Assess Population Diversity in RNA Viruses.” ACS Infectious Diseases 2022, 8(12): 2505-2514. 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. PLo

Zivich PN, Cole SR, Edwards JK, Mulholland GE, Shook-Sa BE, Tchetgen Tchetgen E. “Introducing Proximal Causal Inference for Epidemiologists.” American Journal of Epidemiology, In press.

2022

Barzin A, Schmitz JL, Rosin S, Sirpal R, Almond M, Robinette C, Wells S, Hudgens M, Olshan A, Deen S, Krejci P. SARS-CoV-2 seroprevalence among a southern US population indicates limited asymptomatic spread under physical distancing measures. Mbio. 2020 O

Benkeser D, Horvath K, Reback C, Rusow J, Hudgens M. Design and analysis considerations for a sequentially randomized HIV prevention trial. Statistics in Biosciences, 2020, 12:446–467. PMC7986973

Boyce, R.M., Muhindo, E., Baguma, E., Muhindo, R., Shem, B., François, R., Hawke, S., Shook-Sa, B.E., Ntaro, M., Nalusaji, A. and Nyehangane, D., 2022. Permethrin-treated baby wraps for the prevention of malaria: results of a randomized controlled pilot study in rural Uganda. Malaria Journal, 21(1), pp.1-12. PMC8864600

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. Clinical Infectious Diseases. 2021 Nov;73(9):e3124-e3126. DOI: 10.1093/cid/ciaa1868. PMC7799336.

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. 2020a, 31(5):704-712. 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 2020b, 31(5), pp.695-703. PMC87250

Breskin A, Cole SR, Edwards JK, Brookmeyer R, Eron JJ, Adimora AA. Fusion designs and estimators for treatment effects. Statistics in Medicine. 2021 Jun 15;40(13):3124-37. PMC8237350

Breskin, A., Edmonds, A., Cole, S.R., Westreich, D., Cocohoba, J., Cohen, M.H., Kassaye, S.G., Metsch, L.R., Sharma, A., Williams, M.S. and Adimora, A.A., 2020. G-computation for policy-relevant effects of interventions on time-to-event outcomes. Internat

Ceriani, C., Streeter, G.S., Lemu, K.J., James, K.S., Ghofrani, S., Allard, B., Shook-Sa, B.E., Margolis, D.M. and Archin, N.M., 2021. Defining stable reference genes in HIV latency reversal experiments. Journal of Virology, 95(11), pp.e02305-20. PMC81397

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 HIV Diagnosis in Zambia. Clin Infect Dis. 2021

Cole, S.R., Edwards, J.K., Breskin, A., Hudgens, M.G., 2021. Comparing Parametric, Nonparametric, and Semiparametric Estimators: The Weibull Trials. American Journal of Epidemiology, 190(8), pp.1643-1651. PMC8484780

Cole SR, Edwards JK, Breskin A, Rosin S, Zivich PN, Shook-Sa BE, Hudgens MG, 2022. Illustration of Two Fusion Designs and Estimators. American Journal of Epidemiology, In press.

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 and Behavior. 2020 Jul;24(7):2033-44. PMC7319872

Curtis AD, 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. 2021 Oct 14;7(1):e00839-21. PMCID: PMC8865927

Davy-Mendez T, Napravnik S, Eron JJ, Cole SR, van Duin D, Wohl DA, Hogan BC, Althoff KN, Gebo KA, Moore RD, Silverberg MJ. Current and Past Immunodeficiency Are Associated With Higher Hospitalization Rates Among Persons on Virologically Suppressive Antiretroviral Therapy for up to 11 Years. The Journal of Infectious Diseases. 2021 Aug 15;224(4):657-66. PMC8366443

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 for the North American AIDS Cohort Collaboration on Research and Design 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):1229-39. PMC8172437

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 PPause: Results from the AIDS Clinical Trials Group A5345 Biomarker Study.AIDS Res Hum Retroviruses. 2021 Jun;37(6):489-501. doi: 10.1089/AID.2020.0222. Epub 2021 Feb 16. PMC8213012

Dumond JB, Bay CP, Nelson JA, Davalos A, Edmonds A, De Paris K, Sykes C, Anastos K, Sharma R, Kassaye S, Tamraz B. Intracellular tenofovir and emtricitabine concentrations in younger and older women with HIV receiving tenofovir disoproxil fumarate/fumarate/emtricitabine. Antimicrobial Agents and Chemotherapy. 2020 Sep 1;64(9):e00177-20. PMC7449168

Edmonds A, Breskin A, Cole SR, Westreich D, Ramirez C, Cocohoba J, Wingood G, Cohen MH, Golub ET, Kassaye SG, Metsch LR. Poverty, deprivation, and mortality risk among women with HIV in the United States. Epidemiology 32, no. 6 (2021): 877-885. PMC847881

Edwards JK, Cole SR, Breger TL, Filiatreau LM, Zalla L, Mulholland GE, Horberg MA, Silverberg MJ, Gill MJ, Rebeiro PF, Thorne JE, Kasaie P, Marconi VC, Sterling TR, Althoff KN, Moore RD, Eron JJ. Mortality for adults entering HIV care under universal early treatment compared to the general US population. Clinical Infectious Diseases. 2022, doi: 10.1093/cid/ciab1030. PMID34983066

Edwards JK, Cole SR, Breger TL, Rudolph JE, Filiatreau LM, Buchacz K, Humes E, Rebeiro PF, D’Souza G, Gill MJ, Silverberg MJ. Mortality among persons entering HIV care compared with the general US population: an observational study. Annals of Internal Medicine. 2021 Sep;174(9):1197-206. PMC8453103

Edwards JK, Cole SR, Fox MP. Flexibly accounting for exposure misclassification with external validation data. American Journal of Epidemiology. 2020 Aug;189(8):850-60 PMC7608057

Falcinelli, S.D., Kilpatrick, K.W., Read, J., Murtagh, R., Allard, B., Ghofrani, S., Kirchherr, J., James, K.S., Stuelke, E., Baker, C. and Kuruc, J.D., Eron JJ, Hudgens MG, Gay CL, Margolis DM, Archin NM. Longitudinal dynamics of intact HIV proviral DNA DNA and outgrowth virus frequencies in a cohort of individuals receiving antiretroviral therapy. The Journal of Infectious Diseases. 2021 Jul 1;224(1):92-100. PMC8253129

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. doi: 10.1093/infdis/jiaa298. PMC7653086

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. doi: 10.1126/scitranslmed.abl7430. PMID: 34941423; PMC pending

Garrido C, Curtis AD, 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. Science Immunology. 2021 Jun 5;6(60):eabj3684. PMC8774290

Gilbert P, Blette B, Shepherd B, Hudgens MG. Post-randomization Biomarker Effect Modification in an HIV Vaccine Clinical Trial. Journal of Causal Inference, vol. 8, no. 1, 2020, pp. 54-69. https://doi.org/10.1515/jci-2019-0022 PMC7996712

Gilliland, W.M., White, N.R., Yam, B.H., Mwangi, J.N., Prince, H.M.A., Weideman, A.M., Kahsuba, A.D.M., Rosen, E. (2020). “Influence of Hair Treatments on Detection of Antiretrovirals by Mass Spectrometry Imaging.” The Analyst, 145(13), 4540–4550. https://doi.org/10.1039/d0an00478b PMC8290328

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, Journal of Substance Use, 2022. DOI: 10.1080/14659891.2021.1989509. Epub ahead of print. PMC pending

Knittel AK, Rudolph JE, Shook-Sa BE, Edmonds A, Ramirez C, Cohen M, Taylor T, Adedimeji A, Michel KG, Milam J, Cohen J. Self-Reported Sexually Transmitted Infections After Incarceration in Women with or at Risk for HIV in the United States, 2007–2017.Journal of Women’s Health. 2021a Dec 30. PMID: 34967695

Knittel, A.K., Shook-Sa, B.E., Rudolph, J.E., Edmonds, A., Ramirez, C., Cohen, M.H., Adedimeji, A., Taylor, T.N., Michel, K.G., Milam, J. and Cohen, J., 2021b. Incidence and Prevalence of Incarceration in a Longitudinal Cohort of Women at Risk for Human Immunodeficiency Virus in the United States, 2007–2017. Journal of Women’s Health, 30(5), pp.694-704. 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. doi: 10.1093/ofid/ofab281. 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. doi: 10.1136/bmjopen-2020-047340. PMC8287623.

Lin JT, Mollan KR, Cerami C. The Consequences of Isolating at Home. Clin Infect Dis. 2021 Nov 2;73(9):e2823. doi: 10.1093/cid/ciaa1476. PMID: 32986803.

Lu, H., Cole, S.R., Westreich, D., Hudgens, M.G., Adimora, A.A., Althoff, K.N., Silverberg, M.J., Buchacz, K., Li, J., Edwards, J.K., Rebeiro, P.F., Lima, V. , Marconi, V., Sterling, T., Horberg, M. , Gill, M., Kitahata, M., Eron, J., Moore, R. 2022. Virologic outcomes among adults with HIV using integrase inhibitor-based antiretroviral therapy. AIDS, 36(2), pp.277-286. PMID: 34934020

Lu H, Cole SR, Westreich D, Hudgens MG, Adimora AA, Althoff KN, Silverberg MJ, Buchacz K, Li J, Edwards JK, Rebeiro PF, Lima VC, Marconi VC, Sterling TR, Horberg MS, Gill MJ, Kitahata MM, Eron JJ, Moore RD for the North American AIDS Cohort Collaboration on Research and Design of the International Epidemiologic Databases to Evaluate AIDS. 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. Clinical Infectious Diseases.

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. 2021 Nov 23:ciab968. doi: 10.1093/cid/ciab968. Epub ahead of print. PMID: 35022711.

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. doi: 10.1093/aje/kwab136. PMC8576379

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. doi: 10.1080/10543406.2020.1730866. PMC7316590.

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. doi: 10.1016/S2214-109X(21)00393-4. PMC8644317

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. The Journal of Infectious Diseases. 2020 Aug 17;222(6):903-9. PMC7337777

Price JT, Vwalika B, Edwards JK, Cole SR, Kasaro MP, Rittenhouse KJ, Kumwenda A, Lubeya MK, Stringer JS. Maternal HIV Infection and Spontaneous Versus Provider-Initiated Preterm Birth in an Urban Zambian Cohort. JAIDS Journal of Acquired Immune Deficiency Syndromes. 2021 Jun 1;87(2):860-8. PMC8131221

Price, J. T., Vwalika, B., Freeman, B. L., Cole, S. R., Saha, P. T., Mbewe, F. M., Phiri, W. M., Peterson, M., Muyangwa, D., Sindano, N., Mwape, H., Smithmyer, M. E., Kasaro, M. P., Rouse, D. J., Goldenberg, R. L., Chomba, E., Stringer, J. (2021). Weekly 17 alpha-hydroxyprogesterone caproate to prevent preterm birth among women living with HIV: a randomised, double-blind, placebo-controlled trial. The lancet. HIV, 8(10), e605–e613. https://doi.org/10.1016/S2352-3018(21)00150-8 PMC8476342

Rittenhouse KJ, Mwape H, Nelson JA, Mwale J, Chipili G, Price JT, Hudgens M, Stringer EM, De Paris K, Vwalika B, Stringer JS. Maternal HIV, antiretroviral timing, and spontaneous preterm birth in an urban Zambian cohort: the role of local and systemic inflammation. AIDS. 2021 Mar 15;35(4):555-65. PMC7944942

Rohner E, Edelman C, Sanusi B, Schmitt JW, Baker A, Chesko K, Faherty B, Gregory SM, Romocki LS, Sivaraman V, Nelson JA, Siobhan O’Connor, MG Hudgens, AK Knittel, L Rahangdale, JS Smith. Extended HPV Genotyping to Compare HPV Type Distribution in Self-and Provider-Collected Samples for Cervical Cancer Screening. Cancer Epidemiology and Prevention Biomarkers. 2020 Dec 1;29(12):2651-61. PMC7710587

Saidi F, Mutale W, Freeborn K, Rosenberg NE, Graybill LA, Maman S, Amico KR, Mollan KR, Phanga T, Milala B, Hill LM, Gottwalt AM, Phiri S, Kalua T, Chi BH. Combination adherence strategy to support HIV antiretroviral therapy and pre-exposure prophylaxis adherence during pregnancy and breastfeeding: protocol for a pair of pilot randomised trials. BMJ Open. 2021 Jun 30;11(6):e046032. doi: 10.1136/bmjopen-2020-

Smith, J.S., Backes, D.M., Hudgens, M.G., Mei, W., Chakraborty, H., Rohner, E., Moses, S., Agot, K., Meijer, C.J. and Bailey, R.C., 2021. Male Circumcision Reduces Penile HPV Incidence and Persistence: A Randomized Controlled Trial in Kenya. Cancer Epidemiology and Prevention Biomarkers, 30(6), pp.1139-1148. PMC8172477

Wahl A, Gralinski LE, Johnson CE, Yao W, Kovarova M, Dinnon KH, Liu H, Madden VJ, Krzystek HM, De C, White KK et al. SARS-CoV-2 infection is effectively treated and prevented by EIDD-2801. Nature. 2021 Mar;591(7850):451-7. PMC7979515

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. Reliable Estimation of CD8 T Cell Inhibition of In Vitro HIV-1 Replication. Front Immunol. 2021 Jun 30;12:666991. doi: 10.3389/fimmu.2021.666991. PMC8278574.

Yang, F, Zang TP, Tang, W, Ong JJ, Alexander M, Forastiere L, Kumar N, Li K, 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 ID 2020 Aug 1;20(8):976-82. DOI:https://doi.org/10.1016/S1473-3099(20)30172-9 PMID: 32530426

Zalla, L.C., Edwards, J.K., Cole, S.R., Rudolph, J.E., Breger, T.L., Virkud, A., Johnson, A.S. and Hall, H.I., 2021. Demographic Trends in US HIV Diagnoses, 2008-2017: Data Movies. American Journal of Public Health, 111(4), pp.529-532. PMC7958054

Zeziulin O*, Mollan KR*, Shook-Sa BE, Hanscom B, Lancaster KE, Dumchev K, Go VF, Chu VA, Kiriazova T, Syarif Z, Dvoryaka S. Depressive symptoms and use of HIV care and medication-assisted treatment among people living with HIV who inject drugs. AIDS. 2021 35(3), pp.495-501. PMC7855840 *co-first authors: Zeziulin (Ukraine), Mollan (UNC-CH)

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. PMCID: PMC8887971

2021

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,Journal of Substance Use, 2022. DOI: 10.1080/14659891.2021.1989509. Epub ahead of print. PMC pending

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. doi: 10.1126/scitranslmed.abl7430. PMC pending

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. doi: 10.1016/S2214-109X(21)00393-4. PMC8644317

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. 2021 Nov 23:ciab968. doi: 10.1093/cid/ciab968. Epub ahead of print. PMID: 35022711.

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. doi: 10.1093/ofid/ofab281. PMC8391093.

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 SARS-CoV-2 in the United States: living density, viral load, and disproportionate impact on communities of color. Clin Infect Dis. 2021 Aug 12:ciab701. doi: 10.1093/cid/ciab701. Epub ahead of print. PMC8436395.

Lin JT, Mollan KR, Cerami C. The Consequences of Isolating at Home. Clin Infect Dis. 2021 Nov 2;73(9):e2823. doi: 10.1093/cid/ciaa1476. PMID: 32986803.

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. Reliable Estimation of CD8 T Cell Inhibition of In Vitro HIV-1 Replication. Front Immunol. 2021 Jun 30;12:666991. doi: 10.3389/fimmu.2021.666991. PMC8278574.

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. doi: 10.1136/bmjopen-2020-047340. PMC8287623.

Saidi F, Mutale W, Freeborn K, Rosenberg NE, Graybill LA, Maman S, Amico KR, Mollan KR, Phanga T, Milala B, Hill LM, Gottwalt AM, Phiri S, Kalua T, Chi BH. Combination adherence strategy to support HIV antiretroviral therapy and pre-exposure prophylaxis adherence during pregnancy and breastfeeding: protocol for a pair of pilot randomised trials. BMJ Open. 2021 Jun 30;11(6):e046032. doi: 10.1136/bmjopen-2020-046032. PMC8246367.

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. doi: 10.1089/AID.2020.0222. Epub 2021 Feb 16. PMC8213012

Zeziulin O*, Mollan KR*, Shook-Sa BE, Hanscom B, Lancaster KE, Dumchev K, Go VF, Chu VA, Kiriazova T, Syarif Z, Dvoryaka S. Depressive symptoms and use of HIV care and medication-assisted treatment among people living with HIV who inject drugs. AIDS. 2020 Nov 26. PMC7855840 *co-first authors: Zeziulin (Ukraine), Mollan (UNC-CH)

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. doi: 10.1093/infdis/jiaa298. PMC7653086

2020

Barzin A, Schmitz J, 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 D, and Peden D. 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. doi: 10.1128/mBio.02426-20. PMID: 32994333; PMCID: PMC7527736.

Benkeser D, Horvath K, Reback CJ, Rusow J and Hudgens M. Design and Analysis Considerations for a Sequentially Randomized HIV Prevention Trial. Stat. Biosci. 2020 Dec;12(3):446-467. doi: 10.1007/s12561-020-09274-3. Epub 2020 Mar 25. 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. doi: 10.1097/EDE.0000000000001225. PMID: 32541609; PMCID: PMC7822729.

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 and Adimora AA. Neighborhood Poverty and Control of HIV, Hypertension, and Diabetes in the Women’s Interagency HIV Study. AIDS Behav. 2020.

Curtis AD, 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 and 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. 5(2). 2020.

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. doi: 10.1128/AAC.00177-20. PMID: 32631821; PMCID: PMC7449168.

Edwards JK, Cole SR and Fox MP. Flexibly Accounting For Exposure Misclassification with External Validation Data. Am. J. Epidemiol. 2020.

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 and Margolis DM. Assessing the impact of AGS-004, a dendritic cell-based immunotherapy, and vorinostat on persistent HIV-1 Infection. Sci. Rep. 10(1):5134. 2020.

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. doi: 10.1515/jci-2019-0022. Epub 2020 Jul 25. PMID: 33777613; PMCID: PMC7996712.

Graybill LA, Kasaro M, Freeborn K, Walker JS, Poole C, Powers KA, Mollan KR, Rosenberg NE, Vermund SH, Mutale W and Chi BH. Incident HIV among pregnant and breastfeeding women in sub-Saharan Africa: a systematic review and meta-analysis. AIDS. 2020.

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

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 and Adimora AA. Incarceration and Number of Sexual Partners After Incarceration Among Vulnerable US Women, 2007–2017. Am. J. Public Health. 110(S1):S100-S108. 2020.

Mollan KR, Trumble IM, Reifeis SA, Ferrer O, Bay CP, Baldoni PL and Hudgens MG. Precise and accurate power of the rank-sum test for a continuous outcome. J. Biopharm. Stat.:1-10. 2020.

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 and Adimora AA. Female genital tract shedding of HIV-1 is rare in women with suppressed HIV-1 in plasma. AIDS. 34(1):39-46. 2020.

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. doi: 10.1093/infdis/jiaa378. PMID: 32592581; PMCID: PMC7337777.

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 and Tucker JD. Pay-it-forward gonorrhoea and chlamydia testing among men who have sex with men in China: a randomised controlled trial. The Lancet Infectious Diseases. 2020.

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 and 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 Research Protocols. 8(3):e11416. 2019.

Bansi-Matharu L, Rodriguez Loria G, Cole SR, Mugerwa H, Vecino I, Lundgren J, Pulik P, Smith C and Phillips AN. Risk factors for antiretroviral therapy (ART) discontinuation in a large multinational trial of early ART initiators. AIDS. 33(8):1385-1390. 2019.

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

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

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

Cao B, Saha PT, Leuba SI, Lu H, Tang W, Wu D, Ong J, Liu C, Fu R, Wei C and 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. 23(5):1240-1249. 2019.

Clutton G, Mollan K, Hudgens M and Goonetilleke N. A Reproducible, Objective Method Using MitoTracker® Fluorescent Dyes to Assess Mitochondrial Mass in T Cells by Flow Cytometry. Cytometry Part A. 95(4):450-456. 2019.

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

Conserve DF, Bay C, Kilonzo MN, Makyao NE, Kajula L and 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. 31(2):169-176. 2019.

Davis NL, Corbett A, Kaullen J, Nelson JAE, Chasela CS, Sichali D, Hudgens MG, Miller WC, Jamieson DJ and 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. 80(4):467-473. 2019.

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

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 and Adimora AA. Prevalence and 1-year incidence of frailty among women with and without HIV in the Womenʼs Interagency HIV Study. AIDS. 33(2):357-359. 2019.

Fitzpatrick T, Tang W, Mollan K, Pan X, Chan PL, Zhou K, Cheng Y, Li L, Wong WC and 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. 16:64-73. 2019.

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

Horner MJ, Chasimpha S, Spoerri A, Edwards JK, Bohlius J, Tweya H, Tembo P, Nkhambule F, Phiri EM, Miller WC, Malisita K, Phiri S, Dzamalala C, Olshan AF and 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. 69(5):829-835. 2019.

Kay ES, Batey DS, Westfall AO, Christopoulos K, Cole SR, Geng EH, Mathews WC, Moore RD and Mugavero MJ. Compound Retention in Care and All-Cause Mortality Among Persons Living With Human Immunodeficiency Virus. Open Forum Infectious Diseases. 6(4). 2019.

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 Gimenez A, Jarrin I, Wittkop L, Meyer L, Perez-Hoyos S, Justice A, Neaton JD, Hernan 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. 188(8):1569-1577. 2019.

Lu H, Cole SR, Hall HI, Schisterman EF, Breger TL, J KE and Westreich D. Generalizing the per-protocol treatment effect: The case of ACTG A5095. Clin. Trials. 16(1):52-62. 2019.

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 and 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. 33(9):388-398. 2019.

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 and 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 Research Protocols. 8(4):e9898. 2019.

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 and 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. 93(15):e00168-00119, /jvi/00193/00115/JVI.00168-00119.atom. 2019.

Price JT, Vwalika B, Freeman BL, Cole SR, Mulenga HB, Winston J, Mbewe FM, Chomba E, Mofenson LM, Rouse DJ, Goldenberg RL and 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. 19(1):81. 2019.

Price JT, Winston J, Vwalika B, Cole SR, Stoner MCD, Lubeya MK, Kumwenda A and Stringer JSA. Quantifying bias between reported last menstrual period and ultrasonography estimates of gestational age in Lusaka, Zambia. International Journal of Gynecology & Obstetrics. 144(1):9-15. 2019.

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

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 and AIDS Clinical Trials Group. Human Immunodeficiency Virus-associated Neurocognitive Impairment in Diverse Resource-limited Settings. Clin. Infect. Dis. 2018.

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

Rudolph JE, Cole SR and 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. 19(1):58. 2019.

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

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

Xiao J and Hudgens MG. On nonparametric maximum likelihood estimation with double truncation. Biometrika. 106(4):989-996. 2019.

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 and Goonetilleke N. HIV-Specific T Cell Responses Are Highly Stable on Antiretroviral Therapy. Mol Ther Methods Clin Dev. 15:9-17. 2019.

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 and 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. 8(1):76. 2019.

2018

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. PMID number: 28383649. PMC number: PMC5850546.

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 number: 29227443. PMC number: PMC5728680.

Bengtson AM, Pence BW, Eaton EF, Edwards JK, Eron JJ, Mathews WC, Mollan K, MooreRD, 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 Feb 9. doi: 10.3851/IMP3223.[Epub ahead of print] PMID number: 29424697. PMC number pending.

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 number: 28749824. PMC number: PMC5659970

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.

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. Journal of the Royal Statistical Society: Series A. PMID: 30555215 PMCID: PMC6289264

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. Substance Abuse Treat Prev Policy. 2017 May 16;12(1):24. PMID number: 28511680. PMC number: PMC5433052

Chung Y, Ivanova A, Hudgens MG, Fine JP. Partial likelihood estimation of isotonic proportional hazards models. Biometrika. 105(1):133–148, 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. PMID number: 29403103. PMC number: PMC5791874

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. doi: 10.1093/cid/cix199. PMID: 28498892.

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. doi: 10.1002/bimj.201600140. PMID number: 29076182. PMC number: pending

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. 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. doi: 10.1093/cid/cix367. PMID number: 28444232. PMC number: 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 number: 28383402. PMC number: 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 number: 28682658. PMC number: PMC5733655.

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 number: 29112076. PMC number: 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 Feb 6. doi: 10.1093/aje/kwy028. [Epub ahead of print] PMID number: 29420696. PMC number: pending.

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). pii: e00505-17. PMID number: 29359183. PMC number: PMC5760748

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. doi: 10.1097/QAD.0000000000001641. PMID number: 28926409. PMC number: pending.

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 number: 28700693. PMC number: 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 myeloidonly mice during antiretroviral therapy. Nat Med. 2017 May;23(5):638-643. RPPR Page 460. PMID number: 28414330. PMC number: PMC5419854

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 number: 28992096. PMC number: PMC5860258.

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 number: 29308102. PMC number: 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. doi: 10.1016/j.celrep.2017.09.080. PMID number : 29045830. PMC number: 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 number: 28650383. PMC number: 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. PMID number: 28346267. PMC number: PMC5466356.

Lesko CR, Edwards JK, Cole SR, Moore RD, Lau B. When to Censor? Am J Epidemiol. 2018 Mar 1;187(3):623-632. doi: 10.1093/aje/kwx281. PMID number: 29020256. PMC number: pending

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. doi: 10.1016/j.annepidem.2017.08.021. Epub 2017 Sep 5. PMID number: 28939001. PMC number: 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 number: 28407044. PMC number: PMC5861569

Menezes P, Mollan K, Hoffman E, Xie Z, Wills J, Marcus C, Rublein J, Hudgens M, Eron JJ. 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 Apr 1. doi: 10.1089/AID.2016.0311. [Epub ahead of print] PMID number: 29607652. PMC number: PMC5994664.

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 number: 28931220. PMC number: 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. doi: 10.1080/09540121.2017.1307919. Epub 2017 Mar 28. PMID: 28351158.

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). pii: e00231-17. PMID number: 28814388. PMC number: 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 number: 28729911. PMC number: PMC5516378

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. doi: 10.1007/s10461-017-1824-4. PubMed PMID: 28620802. PMC number: PMC5971659

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. doi: 10.1186/s13063-017-2183-1. PMID number: 28969702. PMC number: 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 number: 28366730. PMC number pending

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. doi: 10.1097/EDE.0000000000000772. PMID number: 29045283. PMC number: PMC5792303

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. doi: 10.1016/S2352-3018(17)30046-2. PMID number: 28359444. PMC number: pending

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 number: 28803740. PMC number: 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. doi: 10.7448/IAS.20.1.21416. PMID number: 28361498. PMC number: 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 number: 28430844. PMC number: 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 number: 29087746. PMC number: 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 number: 28733216. PMC number: PMC5595663

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 number: 29183956. PMC number: 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 number: 29334550. PMC PMC6024258

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. doi: 10.1093/ofid/ofx095. eCollection 2017 Spring. PMID number: 28695144. PMC number: PMC5499638

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. PMC5850546 .

Cholera R, Pence BW, Bengtson AM, Crane HM, Christopoulos K, Cole SR, Fredericksen R, Gaynes BN, Heine A, Mathews WC, Mimiaga MJ, Moore R, Napravnik S, O’Clerigh C, Safren S, Mugavero MJ. Mind the Gap: Gaps in Antidepressant Treatment, Treatment Adjustments, and Outcomes among Patients in Routine HIV Care in a Multisite U.S. Clinical Cohort. PLoS One. 2017 Jan 26;12(1). PMC5268441.

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. 2017 Oct 27. [Epub ahead of print]. PMC pending. PMID: 29076182

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. PMC pending.

Dela Peña-Ponce MG, Rodriguez-Nieves J, Bernhardt J, Tuck R, Choudhary N, Mengual M, Mollan KR, Hudgens MG, Peter-Wohl S, De Paris K. Increasing JAK/STAT Signaling Function of Infant CD4(+) T Cells during the First Year of Life. Front Pediatr. 2017 Feb 21;5:15. PMC5318443.

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 Jul 6. [Epub ahead of print]. PMID: 28682658. 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 Sep 18. [Epub ahead of print]. PMID 28926409. PMC pending.

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. PMC5419854.

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. Evaluating the Population Impact of Intervening on Specific Targets to Reduce HIV Racial/Ethnic Disparities in Adulthood: a Conceptual and Methodological Framework. Am J Epidemiol. 2017 Jul 13. [Epub ahead of print]. PMID 28992096. PMC 5860258.

Jensen K, Dela Pena-Ponce MG, Piatak M Jr, Shoemaker R, Oswald K, Jacobs WR Jr, Fennelly G, Lucero C, Mollan KR, Hudgens MG, Amedee A, Kozlowski PA, Estes JD, Lifson JD, Van Rompay KK, Larsen M, De Paris K. Balancing Trained Immunity with Persistent Immune Activation and the Risk of Simian Immunodeficiency Virus Infection in Infant Macaques Vaccinated with Attenuated Mycobacterium tuberculosis or Mycobacterium bovis BCG Vaccine. Clin Vaccine Immunol. 2017 Jan 5;24(1). PMC5216431.

Lee SK, Zhou S, Baldoni PL, Speilvogel E, Archin NM, Hudgens MG, Margolis DM, Swanstrom R. Quantification of the Latent HIV-1 Reservoir Using Ultra Deep Sequencing and Primer ID in a Viral Outgrowth Assay. J Acquir Immune Defic Syndr. 2017 Feb 1;74(2):221-228. PMC5233602.

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. PMID 28346267. PMC5466356.

Lesko CR, Edwards JK, Cole SR, Moore RD, Lau B. When to Censor? Am J Epidemiol. 2017 Aug 11. [Epub ahead of print]. PMID 29020256. PMC pending.

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 Sep 5. pii: S1047-2797(16)30348-9. [Epub ahead of print]. PMID 28939001. PMC5714697.

Qin Y, Tang W, Nowacki A, Mollan K, Reifeis SA, Hudgens MG, Wong NS, Li H, Tucker JD, Wei C. Benefits and Potential Harms of Human Immunodeficiency Virus Self-Testing Among Men Who Have Sex With Men in China: An Implementation Perspective. Sex Transm Dis. 2017 Apr;44(4):233-238. PMC5347468.

Richardson A, Hudgens MG, Fine JP, Brookhart MA. Nonparametric binary instrumental variable analysis of competing risks data. Biostatistics. 2017 Jan;18(1):48-61. PMC6497235.

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. 2017 Jun 15. [Epub ahead of print]. PMID 28620802. PMC pending.

Saag MS, Westfall AO, Cole SR, Mathews WC, Drozd DR, Mayer KH, Burkholder GA, Kitahata M, Maiese EM; CFAR Network of Integrated Clinical Systems (CNICS). Brief Report: Factors Associated With the Selection of Initial Antiretroviral Therapy From 2009 to 2012. J Acquir Immune Defic Syndr. 2017 Jan 1;74(1):60-64. PMC5140679.

Smith ER, Hudgens M, Sheahan AD, Miller WC, Wheeler S, Nelson JA, Dube Q, Van Rie A. Timing of HIV Seroreversion Among HIV-Exposed, Breastfed Infants in Malawi: Type of HIV Rapid Test Matters. Matern Child Health J. 2017 Feb;21(2):248-252. PMC5290052.

Smith ER, Sheahan AD, Heyderman RS, Miller WC, Wheeler S, Hudgens M, Nelson JA, Dube Q, Van Rie A. Performance of HIV Rapid Tests Among Breastfeeding, Malawian Infants. Pediatr Infect Dis J. 2017 Apr;36(4):405-411. PMC pending.

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. 2017 Oct 16. [Epub ahead of print]. PMID 29045283. PMC pending.

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). PMID 28359444. PMC pending.

Wahl A, Ho PT, Denton PW, Garrett KL, Hudgens MG, Swartz G, O’Neill C, Veronese F, Kashuba AD, Garcia JV. Predicting HIV Pre-exposure Prophylaxis Efficacy for Women using a Preclinical Pharmacokinetic-Pharmacodynamic In Vivo Model. Sci Rep. 2017 Feb 1;7:41098. PMC5286499.

Wohl DA, Panter AT, Kirby C, Magnus BE, Hudgens MG, Allmon AG, Mollan KR. Estimating HIV Medication Adherence and Persistence: Two Instruments for Clinical and Research Use. AIDS Behav. 2017 Apr 26. [Epub ahead of print]. PMC pending.

Wohl DA, Golin CE, Knight K, Gould M, Carda-Auten J, Groves JS, Napravnik S, Cole SR, White BL, Fogel C, Rosen DL, Mugavaro MJ, Pence BW, Flynn PM. A Randomized Controlled Trial of an Intervention to Maintain Suppression of HIV Viremia Following Prison Release: The imPACT Trial. J Acquir Immune Defic Syndr. 2017 Mar 8. [Epub ahead of print]. PMC pending.

Zadrozny S, Westreich D, Hudgens MG, Chasela C, Jamieson DJ, Martinson F, Zimba C, Tegha G, Hoffman I, Miller WC, Pence BW, King CC, Kourtis AP, Msungama W, van der Horst C; BAN Study Team. Effect of Postnatal HIV Treatment on Clinical Mastitis and Breast Inflammation in HIV-Infected Breast-feeding Women. Paediatr Perinat Epidemiol. 2017 Feb 16. [Epub ahead of print]. PMC pending.

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:S197-201. 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. 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. 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 HIV Pre-Exposure Prophylaxis Outcomes in Men and Women Using Tenofovir Disoproxil Fumarate With or Without Emtricitabine. J Infect Dis. 2016 Jul 1;214(1):55-64. PMC4907409

Davis NL, Miller WC, Hudgens MG, Chasela CS, Sichali D, Kayira D, Nelson JA, Fiscus SA, Regha 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. 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. 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. PMC4983650.

Floris-Moore MA, Mollan K, Wilkin AM, Johnson MA, Kashuba ADM, 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.

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. 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.

Jensen K, Nabi R, Van Rompay KK, 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):7285-302. 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. 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. 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 socialmarketing video in promoting condom use among Chinese men who have sex with men: a study protocol. BMJ Open. 2016 Oct 3;6(10). 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. 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. JAcquir Immune Defic Syndr. 2016 Nov 1;73(3):307-312. 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 nucelotide exposures in adults with HIV infection. PLoS One. 2016 Dec 30; 11 (12). 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 GG, 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):4951-65. 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;190:322-8. 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. 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. 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. 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. 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):1436-42. 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.

2015

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

Cole SR, Lau B, Eron JJ, Brookhart MA, Kitahata MM, Martin JN, Mathews WC, Mugavero MJ; for the 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. 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. PMC4542924

Dumond JB, Rigdon J, Collier AC, Mollan K, Tierney C, Aweeka F, Kashuba ADM. Significant Decreases in both Total and Unbound Lopinavir and Amprenavir Exposures during Co-Administration: ACTG Protocol A5143/A5147s Results. J Acquir Immune Defic Syndr. 2015 Dec 15;70(5):510-4. 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. PMC4294958

Edwards JK, Cole SR, Westreich D, Crane H, Eron JJ, Mathews WC, Moore R, Boswell SL, Mugavero MJ. Multiple Imputation to Account for Measurement Error in Marginal Structural Models. Epidemiology 2015 Sep;26(5):645-52. 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 61:e1-4. 2015. PMC4481601.

Edwards JK, Cole SR, Westreich D, Mugavero MJ, Eron JJ, Moore RD, Mathews WC, Hunt P, Williams C, CNICS 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. PMC4560906.

Feinstein L, Edmonds A, Okitolonda V, Cole SR, Van Rie A, Chi BH, Ndjibu P, Lusiama J, Chalachala JL, Behets F. 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. 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. 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. 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. 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 18:19929. 2015. PMC4450240.

King CC, Kourtis AP, Persaud D, Nelson JAE, Ziemniak C, Hudgens MG, Tegha G, Chasela CS, Jamieson DJ, van der Horst CM. Delayed HIV Detection among Infants Exposed to Postnatal ARV Prophylaxis during Breastfeeding. AIDS 2015 Sep 24;29(15):1953-61. 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. 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. PMC4390486

Nelson JAE, 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: Results of the BAN Study. AIDS. 2015 Oct 23;29(16):2131-8. PMC4715989

Nevo ON, Lesko C, Colwell B, Ballard C, Cole SR, Mathews WC. Outcomes of Pharmacist Assisted Management of Antiretroviral Therapy in HIV Infected Patients: A Risk-Adjusted Analysis. American Journal of Health-Systems Pharmacy 2015 Sep 1;72(17):1463-70. 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. 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 Feb; 36(2): 205-228. PMC4312516.

Oxford KL, Dela Pena-Ponce MG, 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. 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. PMC Pending.

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. 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. 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. 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 212:258-263. 2015. 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 Clinical Trials. HIV Clinical Trials 2015 Aug;16(4):147-56. 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 20:73-76. 2015. 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.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. PMC4303492

Willoughby JF. BrdsNBz: Sexually Experienced Teens More Likely to use Sexual Health Text Message Service. Health Educ Behav 2015 Apr 17. 2015. PMC pending.

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. 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

Biostatistics Core

Mission

Michael Hudgens, Ph.D.

Core Director

Stephen R Cole, Ph.D.

Associate Core Director

Bonnie Shook-Sa, Dr.P.H.

Assistant Core Director

Katie Mollan, M.S.

Principal Biostatistician

Fei Zou, Ph.D.

Participating Faculty

Jessica Keys, Ph.D.

Research Analyst

Monika Caruso

Core Administrator

Ann Marie Weideman, M.S.

Research Assistant

Yen Chang, M.S.

Research Assistant

Taylor Krajewski, M.A.

Research Assistant

Kaitlyn Cross, M.S.

Research Assistant

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

Research Assistant

Amber Young, B.S.

Research Assistant

Chanhwa Lee, B.S.

Research Assistant

Mingwei Fei

Research Assistant

Melissa Mischell, B.A.

Research Assistant

Past Graduate Students (2012-Present)

UNC CFAR Biostatistics Summer Internship

CFAR Interns

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]

Matthew Dinwiddie (2021)

[UNC Class of 2022]

Gabrielle Streeter (2020)

[UNC Class of 2021]

Caroline Ha (2020)

[UNC Class of 2022]

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:

Publications

Github

Tools

Presentations

Brief Statistical Safety Checklist

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