Biostatistics Core

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.

 

Specific Aims The goal of the Biostatistics Core is to support and enhance AIDS research of the UNC CFAR. We will accomplish these goals with the following Aims.

 

Aim 1. Collaboration: Core F will provide a full spectrum of collaborative biostatistical services ranging from proposal development and study design to statistical analysis and manuscript writing.

 

Aim 2. Connection and growth: The Core will serve as a liaison between AIDS researchers and statistical scientists within the UNC CFAR research community and beyond.

 

Aim 3. Innovation and leadership: The Core will provide scientific innovation and leadership.

 

Aim 4. Training and mentoring: Core F will provide biostatistical training and education to the CFAR research community.

 

Aim 5. The Core will engage in evaluation and strategic planning, using input from user surveys, an Internal Advisory Board, and the CFAR External Advisory Board.

 

By accomplishing these Aims the Biostatistics Core will continue to provide key statistical support for the UNC CFAR, ensuring sound statistical design, conduct, and analysis of research leading to a deeper understanding of the HIV epidemic.

Michael Hudgens Ph.D.

Core Director

Dr. Hudgens is an Associate Professor in the Department of Biostatistics at the University of North Carolina at Chapel Hill and is Director of the Biostatistics Core of the UNC Center for AIDS Research. He has extensive experience in collaborative research and statistical methodology development related to studies of infectious diseases and vaccines, with an emphasis on HIV. Dr. Hudgens has co-authored 100 peer-reviewed papers in leading statistical journals such as Biometrika, Biometrics, JASA, and JRSS-B as well as top-tier biomedical journals such as the New England Journal of Medicine, Lancet, and Nature, and currently serves as an Associate Editor for Biometrics and JASA. He is an elected fellow of the American Statistical Association and has taught multiple graduate level biostatistics courses at UNC. Dr. Hudgens is the principal investigator or co-investigator on several NIH NIAID grants to develop novel statistical methodologies for application to infectious disease studies. He has served as lead statistician on multiple clinical trials sponsored by the NIH and CDC and currently serves on an advisory board to the FDA.

3107C McGavran-Greenberg
Chapel Hill, NC
Fax: 919.966.3804

Office Phone: 919.966.7253

Katie Mollan M.S.

Biostatistician

Katie Mollan is a biostatistician at the CFAR with over seven years of experience in HIV research.  Her prior research includes analysis of large randomized clinical trials, psychiatric complications, optimizing antiretroviral therapy, IRIS, adherence, and HIV treatment resistance.  She has experience providing statistical support for grant proposals, HIV network proposals, protocol development, case report forms, database structure, data safety monitoring board reviews, analysis programming, analysis report writing, and manuscript preparation. Ms. Mollan has co-authored articles in the Journal of Infectious Diseases, Annals of Internal Medicine, and the New England Journal of Medicine.

3126 McGavran-Greenberg Hall
Chapel Hill, NC

Office Phone: 919-966-8421

Stephen R Cole Ph.D.

Associate Core Director

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
Fax: 919-966-2089

Office Phone: 919-966-7415

Owen Francis M.S.

Research Assistant

Owen Francis is a Ph.D. student in the biostatistics department at UNC. He received his M.S. and B.S. in statistics from Brigham Young University. Before coming to UNC he worked for the University of Utah as a biostatistician analyzing observational studies and clinical trials.

Chapel Hill, NC

Joseph Rigdon M.S.

Research Assistant

Joseph Rigdon is a Ph.D. student in the biostatistics department at UNC.  He received his B.S. and M.S. in biostatistics from UNC.  His dissertation research focuses on developing statistical methods for evaluating vaccines and other modes of infectious disease prevention.

Chapel Hill, NC

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

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

2014

Denton PW, Long JM, Wietgrefe SW, Sykes C, Spagnuolo RA, Snyder OD, Perkey K, Archin NM, Choudhary SK, Yang K, Hudgens MG, Pastan I, Haase AT, Kashuba AD, Berger EA, Margolis DM, Garcia JV. Targeted Cytotoxic Therapy Kills Persisting HIV Infected Cells During ART. PLoS Pathog. 2014 Jan;10(1):e1003872. PMC3887103


Huang Y, Abler L, Pan S, Henderson GE, Wang X, Yao X, Parish WL. Population-based sexual behavior surveys in china: liuzhou compared with other prefectural cities. AIDS Behav. 2014 Feb;18 Suppl 2:118-25. PMC3943943


Corbett AH, Kayira D, White NR, Davis NL, Kourtis AP, Chasela C, Martinson F, Phiri G, Musisi B, Kamwendo D, Hudgens MG, Hosseinipour MC, Nelson JA, Ellington SR, Jamieson DJ, van der Horst C, Kashuba A; the BAN Study Team. Antiretroviral pharmacokinetics in mothers and breastfeeding infants from 6 to 24 weeks post partum: results of the BAN Study.  Antivir Ther. 2014 Jan 24 [Epub ahead of print].  PMC in process


Long DM, Hudgens MG. Sharpening bounds on principal effects with covariates. Biometrics. 2013 Dec;69(4):812-9. PMC in process


Hudgens MG, Li C, Fine JP. Parametric likelihood inference for interval censored competing risks data. Biometrics. 2014 Mar;70(1):1-9. PMC in process


Smith KY, Tierney C, Mollan K, Venuto CS, Budhathoki C, Ma Q, Morse GD, Sax P, Katzenstein D, Godfrey C, Fischl M, Daar ES, Collier AC; ACTG 5202 Study Team. Outcomes by Sex following Treatment Initiation with Atazanavir plus Ritonavir or Efavirenz with Abacavir/Lamivudine or Tenofovir/Emtricitabine. Clin Infect Dis. 2014 Feb;58(4):555-63. PMC3905755


Gouskova NA, Cole SR, Eron JJ, Fine JP. Viral suppression in HIV studies: Combining times to suppression and rebound. Biometrics. 2014 Jan 21 [Epub ahead of print]. PMC in process.


Yanik EL, Napravnik S, Cole SR, Achenbach CJ, Gopal S, Dittmer DP, Olshan AF, Kitahata MM, Mugavero MJ, Saag M, Moore RD, Mathews WC, Hunt P, Eron JJ. Relationship of immunologic response to antiretroviral therapy with non-AIDS defining cancer incidence. AIDS. 2014 Apr 24;28(7):979-87. PMC in process.


Nelson JA, Hawkins JT, Schanz M, Mollan K, Miller MB, Schmitz JL, Fiscus SA. Comparison of the Gen-Probe Aptima HIV-1 and Abbott HIV-1 qualitative assays with the Roche Amplicor HIV-1 DNA assay for early infant diagnosis using dried blood spots. J Clin Virol. 2014 Aug;60(4):418-21. PMC4077672


Mollan KR, Smurzynski M, Eron JJ, Daar ES, Campbell TB, Sax PE, Gulick RM, Na L, O'Keefe L, Robertson KR, Tierney C. Association Between Efavirenz as Initial Therapy for HIV-1 Infection and Increased Risk for Suicidal Ideation or Attempted or Completed Suicide: An Analysis of Trial Data. Ann Intern Med. 2014 Jul 1;161(1):1-10.


2013

Wohl DA, Dumond JB, Blevins S, Pittard D, Ragan D, Wang R, Massengale K, Walsh K, Floris-Moore M, Eron JJ Jr, Richardson A, Hudgens MG, Kashuba AD. Raltegravir pharmacokinetics in treatment-naive patients is not influenced by race: Results from the Raltegravir Early Therapy in African-Americans Living with HIV (REAL) study. Antimicrob Agents Chemother. 2013 Feb;57(2):784-8. PMC3553727


Hudgens MG, Taha TE, Omer SB, Jamieson DJ, Lee H, Mofenson LM, Chasela C, Kourtis AP, Kumwenda N, Ruff A, Bedri A, Jackson JB, Musoke P, Bollinger RC, Gupte N, Thigpen MC, Taylor A, van der Horst C. Pooled individual data analysis of 5 randomized trials of infant nevirapine prophylaxis to prevent breast-milk HIV-1 transmission. Clin Infect Dis. 2013 Jan;56(1):131-9. PMCID: PMC3518881.


Trott KA, Richardson A, Hudgens MA, Abel K. Immune Activation and Regulation in Simian Immunodeficiency Virus-Plasmodium fragile-Coinfected Rhesus Macaques. J Virol. 2013 Sep;87(17):9523-37. PMC3754117.


Patterson KB, Dumond JB, Prince HA, Jenkins A, Scarsi KK, Wang R, Malone S, Hudgens MG, Kashuba ADM. Protein binding of lopinavir and ritonavir during 4 phases of pregnancy: implications for treatment guidelines. J Acquir Immune Defic Syndr. 2013 May; 63(1):51-8. PMC3625477


May RC, Chu H, Ibrahim JG, Hudgens MG, Lees AC, Margolis DM. Change-point models to estimate the limit of detection. Stat Med. 2013 Dec 10;32(28):4995-5007. PMC3858526


Hoffman IF, Latkin CA, Kukhareva PV, Malov SV, Batluk JV, Shaboltas AV, Skochilov RV, Sokolov NV, Verevochkin SV, Hudgens MG, Kozlov AP. A Peer-Educator Network HIV Prevention Intervention Among Injection Drug Users: Results of a Randomized Controlled Trial in St. Petersburg, Russia. AIDS Behav. 2013 Sep;17(7):2510-20. PMC3950300


Flax VL, Bentley ME, Chasela CS, Kayira D, Hudgens MG, Kacheche KZ, Chavula C, Kourtis AP, Jamieson DJ, van der Horst CM, Adair LS. Lipid-based nutrient supplements are feasible as a breastmilk replacement for HIV-exposed infants from 24 to 48 weeks of age. J Nutr. 2013 May;143(5):701-7. PMC3738238.


Firnhaber CS, Mayisela N, Mao L, Williams S, Swarts A, Faesen M, Levin S, Michelow P, Omar T, Hudgens MG, Williamson AL, Allan B, Lewis D, Smith JS. Validation of cervical cancer screening methods in HIV positive women from Johannesburg, South Africa. PLoS ONE. 2013; 8(1):e53494. PMC3543403


Rositch AF, Mao L,  Hudgens MG, Moses S, Agot K, Backes DM, Nyagaya E, Snijders PJF, Meijer CJL, Bailey RC, Smith JS. Risk of HIV acquisition among circumcised and uncircumcised young men with penile HPV infection. AIDS.  2013 Oct 19 [Epub ahead of print].  PMC in process


Dow A, Kayira D, Hudgens MG, Van Rie A, King CC, Ellington S, Chome N, Kourtis A, Turner AN, Kacheche Z, Jamieson DJ, Chasela C, van der Horst C. The Effect of Cotrimoxazole Prophylactic Treatment on Malaria, Birth Outcomes, and Postpartum CD4 Count in HIV-Infected Women. Infect Dis Obstet Gynecol. 2013:340702. PMC3865641


Pages

2014

Buchanan AL, Hudgens MG.  Generalizing Evidence from Randomized Trials using Inverse Probability of Selection Weights.  Atlantic Causal Inference Conference, Providence, Rhode Island 2014.

Dumond JB, Trezza CR, Francis O, Prince HMA, Mollan K, Cottrell M, Sykes C, Torrice C, White N, Malone S, Wang R, Patterson KB, Forrest A, Hudgens MG, Sharpless NE, Kashuba ADM. Tenofovir (TFV), Emtricitabine (FTC), Intracellular Metabolite, and Endogenous Nucleotide (EN) Concentrations as a Function of Aging in HIV+ Subjects. 20th International AIDS Conference, Melbourne, Australia 2014. THPDB0105.

Cottrell ML, Prince HMA, Sykes C,  White N, Malone S, Dellon ES, Madanick RD, Shaheen NJ, Hudgens M, Wulff, J, Patterson KB, Kashuba ADM. Mucosal Tissues In Women Exhibit Different Concentrations of Endogenous Nucleotides and Intracellular and Extracellular Antiretroviral (ARV) Concentrations: Implications for Preexposure Prophylaxis (PrEP) Development. 20th International AIDS Conference, Melbourne, Australia 2014.

Davis NL, Miller WC, Hudgens MG, Chasela CS, Sichali DS, Kayira D, Kourtis AP, Ellington SR, Jamieson DJ, van der Horst CM. Antiretroviral Adherence Associated with Reduced Breastmilk HIV-1 Transmission: the BAN Study. 21st Conference on Retroviruses and Opportunistic Infections, Boston, Massachusetts, 2014, #880.

Cottrell ML, Prince HMA, Sykes C,  White N, Malone S, Dellon ES, Madanick RD, Shaheen NJ, Hudgens M, Wulff, J, Patterson KB, Kashuba ADM. Mucosal Tissue Pharmacokinetics of Maraviroc and Raltegravir in Women: Implications for Chemoprophylaxis. 15th HIV and Hepatitis PK workshop, Washington DC 2014.

2013

Van Rie A, Sawry S, Richardson A, DeLong S, Mahomed N, Murdoch D, Moultrie H.  Low Incidence of TB and Bacille Calmette Guerin Immune Reconstitution Inflammatory Syndrome in South African Children: Results of a Prospective Cohort Study. 20th Conference on Retroviruses and Opportunistic Infections, Atlanta, 2013, #942.

Van Rie A, Sawry S, Richardson A, DeLong S, Mahomed N, Murdoch D, Moultrie H.  Low Incidence of TB and Bacille Calmette Guerin Immune Reconstitution Inflammatory Syndrome in South African Children: Results of a Prospective Cohort Study. 20th Conference on Retroviruses and Opportunistic Infections, Atlanta, 2013, #942.

Denton PW, Long J., Archin N, Wietgrefe S, Choudhary S, Sykes C, Yang K, Hudgens M,  Pastan I, Berger E, Haase A, Kashuba A, Margolis D, Garcia JV. Destruction of the Residual Active HIV-1 Reservoir by Env-specific Immunotoxin. International AIDS Society Conference, Kuala Lumpur, Malaysia 2013, OA3-3.

Floris-Moore M, Mollan K, Wilkin A, Johnson M, Kashuba A, Wohl DA, Patterson K, Ragan D, Zelasky C, Currin D, Pittard D, Eron J. Antiretroviral Activity and Safety of Once-daily Etravirine in Treatment-naïve HIV-infected Adults. Infectious Disease Week, San Francisco, 2013, #170.

Mollan K, Smurzynski M, Na L, Robertson K, Campbell T, Sax P, Daar E, Eron J, Gulick R, O’Keefe L, Tierney C. Hazard of Suicidality in Patients Randomly Assigned to Efavirenz for Initial Treatment of HIV-1:  a Cross-Study Analysis Conducted by the AIDS Clinical Trials Group (ACTG). Infectious Disease Week, San Francisco, 2013.  Oral presentation #670.

2012

Wang C. The Epidemiology and Natural History of HIV and Hepatitis C Co-infection in Southern China. 14th International Symposium on Viral Hepatitis and Liver Disease (ISVHLD), Shanghai, June 2012.

Rahangdale L, Richardson A, Adams R, Grodensky C. Providers' attitudes toward discussing contraception and fertility intentions with HIV-infected women and serodiscordant couples in the U.S. Abstract submitted to CFAR Joint Symposium on HIV Research in Women, Providence, Rhode Island, 2012.

Long D, Hudgens MG. Estimating the effect of interventions to prevent postnatal mother-to-child transmission of HIV. Poster presentation TUPE178. International AIDS Conference, Washington DC, 2012.

Flax VL, Bentley ME, Chasela CS, Kayira D, Hudgens MG, Kacheche Z, Chavula C, Kourtis AP, Jamieson DJ, van der Horst CM, Adair LS for the BAN study group. The growth of HIV-exposed infants in the Breastfeeding, Antiretrovirals, and Nutrition (BAN) study during the first year of life. Nutrition Congress Africa, South Africa, 2012b.

Flax VL, Bentley ME, Chasela C, Kayira D, Hudgens MG, Kacheche Z, Chavula C, Jamieson DJ, van der Horst C, Adair LS. Patterns and predictors of growth in HIV exposed 24-48-week-old Malawians receiving lipid-based nutrient supplements as a breastmilk replacement: results of the BAN study. Experimental Biology, San Diego, 2012a.

Archin N, Liberty A, Kashuba A, Choudhary S, Kuruc J, Hudgens MG, Kearney M, Eron J, Hazuda D, Margolis D. Administration of vorinostat disrupts HIV-1 latency in patients on ART. 19th Conference on Retroviruses and Opportunistic Infections, Seattle, 2012, #157LB.

Feinstein L, Parikh M, Lapika Dimomfu B, Mupenda B, Duvall S, Hudgens MG, Edmonds A, Chalachala JL, Behets F. Should PMTCT programs take into account socioeconomic indicators related to antenatal care seeking behavior? Poster presentation THPE362. International AIDS Conference, Washington DC, 2012.

Adair LS, Jordan-Bell E, Chasela CS, Kayira D, Wiener J, Flax VL, Hudgens MG, Kacheche Z, Tembo M, Ellington SR, Patel KD, Chitsulo P, Jamieson DJ, van der Horst CM, and Bentley ME for the BAN Study Team. Weight status among HIV-infected women in the Breastfeeding, Antiretrovirals, and Nutrition Study. Nutrition Congress Africa, South Africa, 2012.

2011

Patterson K, Dumond J, Prince H, Jenkins A, Scarsi K, Wang R, Malone S, Hudgens M, Kashuba A, Pharmacokinetics of the LPV/r Tablet in HIV-infected Pregnant Women: A Longitudinal Investigation of Protein Bound and Unbound Drug Exposure with Empiric Dosage Adjustment. Poster #645,18th Conference on Retroviruses and Opportunistic Infections, Boston, 2011.

Hudgens MG, Taha T, Omer SB, Jamieson DJ, Lee H, Mofenson LM, Chasela C, Kourtis AP, Kumwenda N, Ruff A, Bedri Kelo A, Jackson B, Musoke P, Bollinger RC, Gupte N, Thigpen MC,Taylor A, Van der Horst C. Pooled analysis of five randomized trials of infant nevirapine prophylaxis to prevent breast-milk HIV-1 transmission. Oral Abstract WELBC03, International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention, Rome, Italy, 2011.

Dow A, Kayira D, Hudgens MG, Van Rie A, King CC, Ellington S, Kourtis A, Norris Turner A, Meshnick S, Kumwenda J, Kacheche Z, Jamieson DJ, Chasela C, van der Horst C. The effect of cotrimoxazole prophylaxis on adverse health outcomes in HIV-exposed, uninfected infants: results from the BAN study. Publication CDB212, International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention, Rome, Italy, 2011a.

Dow A, Kayira D, Hudgens MG, Van Rie A, King CC, Ellington S, Kourtis A, Norris Turner A, Meshnick S, Kacheche Z, Kumwenda J, Jamieson DJ, van der Horst C, Chasela C. Effect of cotrimoxazole prophylactic treatment on malaria, birth outcomes and CD4 cell count in HIV-infected pregnant women: results of the BAN study. Poster TUPE196, International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention, Rome, Italy, 2011b.

2010

Chasela C et al Prevalence of HCV Infection among HIV-1-infected Pregnant Women in Malawi. February 16 - 19, 2010, 17th Conference on Retroviruses and Opportunistic Infections (CROI).

Kayira D and the BAN Study Group. A High-energy, Micronutrient-fortified Supplement Is Effective for Reducing Nutritional Depletion among HIV-infected, Breastfeeding Women: The Breastfeeding, Antiretrovirals, and Nutrition Study. Paper # 838, 17th Conference on Retrovirus and Opportunistic Infections (CROI), San Francisco, CA, February 2010.

Pages