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 over 80 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, and is a member of the Biostatistics Core Internal Advisory Board. His current 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 Working Group at UNC.

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.

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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.

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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

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 Jun 20 [Epub ahead of print]. PMC in process


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. (PMC in process)


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


2012

Nelson JA, Krishnamurthy J, Menezes P, Liu Y, Hudgens MG, Sharpless NE, Eron JJ. Expression of p16INK4a as a biomarker of T-cell aging in HIV-infected patients prior to and during antiretroviral therapy. Aging Cell. 2012 Oct;11(5):916-8. PMC3697001


Jamieson DJ, Chasela CS, Hudgens MG, King CC, Kourtis AP, Kayira D, Hosseinipour MC, Kamwendo DD, Ellington SR, Wiener JB, Fiscus SA, Tegha G, Mofolo IA, Sichali DS, Adair LS, Knight RJ, Martinson F, Kacheche Z, Soko A, Hoffman I, van der Horst C; BAN study team. Maternal and infant antiretroviral regimens to prevent postnatal HIV-1 transmission: 48-week follow-up of the BAN randomised controlled trial. Lancet. 2012 Jun; 379(9835):2449-58. PMC3661206


Flax VL, Bentley ME, Chasela CS, Kayira D, Hudgens MG, Knight RJ, Soko A, Jamieson DJ, van der Horst CM, Adair LS. Use of lipid-based nutrient supplements by HIV-infected Malawian women during lactation has no effect on infant growth from 0 to 24 weeks. J Nutr. 2012 Jul;142(7):1350-6. PMC3374670.


Dow A, Kayira D, Hudgens M, Van Rie A, King CC, Ellington S, Kourtis A, Turner AN, Meshnick S, Kacheche Z, Jamieson DJ, Chasela C, van der Horst C. The effect of cotrimoxazole prophylaxis on adverse health outcomes in HIV-exposed, uninfected infants. The Pediatric Infectious Disease Journal. 31:842-847. 2012 PMID: 22581219


Chavula C, Long D, Mzembe E, Kayira D, Chasela C, Hudgens MG, Hosseinipour M, King CC, Ellington S, Chigwenembe M, Jamieson DJ, van der Horst C. Stopping the control arm in response to the DSMB: mother's choice of HIV prophylaxis during breastfeeding in the BAN Study. Contemporary Clinical Trials. 2012 Jan; 33(1):55-9. PMC3253884


Archin NM, Liberty AL, Kashuba AD, Choudhary SK, Kuruc JD, Crooks AM, Parker DC, Anderson EM, Kearney MF, Strain MC, Richman DD, Hudgens MG, Bosch RJ, Coffin JM, Eron JJ, Hazuda DJ, Margolis DM. Administration of vorinostat disrupts HIV-1 latency in patients on antiretroviral therapy, Nature. 2012 Jul; 487(7408):482-5. PMC3704185


Kourtis AP, Hudgens MG, Kayira, D. Neutrophil count in African mothers and newborns and HIV transmission risk. New Engl J Med. 2012 Dec 6; 367(23):2260-2.


2011

Gay CL, Mayo AJ, Mfalila CK, Chu H, Barry AC, Kuruc JD, McGee KS, Kerkau M, Sebastian J, Fiscus SA, Margolis DM, Hicks CB, Ferrari G, Eron JJ; Duke-UNC Acute HIV Infection Consortium.  Efficacy of NNRTI-based antiretroviral therapy initiated during acute HIV infection. AIDS. 25(7):941-9. 2011 PMID: 21487250


Wang Y, Li B, Pan J, Sengupta S, Emrick CB, Cohen MS, Henderson GE. Factors associated with utilization of a free HIV VCT clinic by female sex workers in Jinan City, Northern China. AIDS and Behavior. 15(4): 702–710. 2011 PMCID: PMC3140056


Ludema C, Cole SR, Poole C, Chu H, Eron JJ. Meta-analysis of randomized trials on the association of prophylactic acyclovir and HIV-1 viral load in individuals co-infected with HSV-2, AIDS. 25(10): 1265-9. 2011 PMID: 21666542


Trott KA, Chau JY, Hudgens MG, Fine J, Mfalila CK, Tarara RP, Collins WE, Sullivan J, Luckhart S, Abel K. Evidence for an increased risk of transmission of simian immunodeficiency virus and malaria in a rhesus macaque coinfection model. Journal of Virology. 85(22):11655-63. 2011 PMCID: PMC3209294


Pages

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.

Corbett A, Kayira D, Kashuba A, White N, Kourtis A, Chasela C, Martinson F, Phiri G, Musisi B, Kamwendo D, Hudgens MG, Hosseinipour M, van der Horst C. Pharmacokinetics (PK) of HAART in Mothers and Breastfeeding Infants from 6-24 wks Post Partum. Interscience Conference on Antimicrobial Agents and Chemotherapy, Boston, 2010.

2009

Stewart P, Cachafeiro A, Napravnik S, Eron J, Frank I, van der Horst C, Bosch R, Bettendorf D, Bohlin P, Fiscus S. Performance of the Cavidi ExaVir Load Assay and the Ultra-sensitive p24 Antigen Assays Relative to the Roche Monitor HIV-1 RNA Assay: ACTG New Works Concept Sheet 227. 16th Conference on Retroviruses and Opportunistic Infections, Montreal, Canada, February 8-11, 2009 [Abstract V-121].

Smith JS, Moses S, Parker CB, Hudgens M, Agot K, Maclean I, Ndinya-Achola JO, Snijders PJF, Meijer CJLM, Bailey RC. Risk of HIV acquisition among men with and without human papillomavirus infection in Kisumu, Kenya. 2009, ISSTDR conference, oral presentation, London, England, June 2009.

Hall NM, Jones Q, Ross C, Bates C. Sexual Schemas and Sexual Behavior among Young Heterosexual African American Association of Black Psychologists Annual Meeting, 2009, Atlanta, GA

Smith JS, Moses S, Hudgens M, Parker CB, Agot K, Maclean I, Ndinya-Achola JO, Snijders PJF, Meijer CJLM, Bailey RC. Risk of HIV acquisition among men with and without human papillomavirus infection in Kisumu, Kenya. 5th IAS Conference on HIV Pathogenesis and Treatment: Abstract no. WELBC104, July 2009.

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