Research

Recency Testing Approaches in HIV and Other Infectious Diseases

• Wang, Q., Duerr, A., and Gao., F. (2025+). "Addressing Population Heterogeneity for HIV Incidence Estimation Based on Recency Test".  Statistics in Medicine, 44(18-19), e70216. [Github code]

• Bannick, M., Donnell , D., Hayes , R., Laeyendecker, O., and Gao F. (2024). "An Enhanced Cross-Sectional HIV Incidence Estimator that Incorporates Prior HIV Test Results". Statistics in Medicine, 43(17), 3125–3139. [Github code]

• Shao, Y. and Gao., F. (2024). “Likelihood-based inferences for active arm trial with counterfactual incidence based on recency assay”. Statistical Communications in Infectious Diseases, 16(1), 20230004.

• Parkin, N., Gao, F., Grebe, E., Cutrell, A., Das, M., Donnell, D., Duerr, A., Glidden, D., Hughes, J. Murray, J., Robertson, M., Zinserling, J., Lau, J., and Miller, V., for the Forum for Collaborative Research Recency Assay Working Group. (2023). “Facilitating Next-generation Pre-exposure Prophylaxis Trials using HIV Recent Infection Assays: Forum HIV Prevention Trial Design Project Consensus”. Clinical Pharmacology & Therapeutics, 114(1), 29-40.

• Gao, F. and Bannick, M. (2022). “Statistical Considerations for Cross-Sectional HIV Incidence Estimation Based on Recency Test”. Statistics in Medicine, 41(8)v1446-1461. [Github code]

• Gao, F., Glidden, D., Hughes, J., and Donnell, D. (2021). “Sample Size Calculation for Active-Arm Trial with Counterfactual Incidence Based on Recency Assay”. Statistical Communications in Infectious Diseases, 13(1), 2020-0009.

Design and Analysis in Clinical Trial and Observational Studies

• Gao, F., Janes, H., Buchbinder, S., Donnell, D. (2025). “Active-Controlled Trial Design for HIV Prevention Trials with a Counterfactual Placebo”. Statistics in Medicine. 44, e70022. [Github code] [Presentation]

• He, Q., Gao, F.. Dukes, Q., Delany-Moretlwe, S., and Zhang, B. (2024). “Generalizing the Intention-to-Treat Effect of an Active Control from Historical Placebo-Controlled Trials to an Active-Controlled trial: A case Study of the Efficacy of Daily oral TDF/FTC in the HPTN 084 Study”. Journal of American Statistical Association, 119(548), 2478–2492.

• Zhu, Y., Gao, F., Glidden, D., Donnell, D. and Janes, H. (2024).“Estimating Counterfactual Placebo HIV Incidence in HIV Prevention Trials Without Placebo Arms Based on Markers of HIV Exposure”.  Clinical Trials, 21(1), 114-123.  [Github Code]

• Donnell, D., Kansiime, S., Glidden, D. V., Luedtke, A., Gilbert, P. B., Gao, F., and Janes, H. (2023). “Study Design Approaches for Future Active-Controlled HIV Prevention Trials”.  Statistical Communications in Infectious Diseases, 15(1), 20230002.

• Donnell, D., Gao, F., Hughes, J. P., Hanscom, B., Corey, L., Cohen, M. S., Edupuganti, S., Mgodi, N., Rees, H., Baeten, J., Gray, G., Bekker, L-G., Hosseinipour, M., and Delany-Moretlwe, S. (2023).“Counterfactual Estimation of Efficacy against Placebo for Novel PrEP Agents using External Trial Data: Example of Injectable Cabotegravir and Oral PrEP in Women”. Journal of the International AIDS Society, 26(6), e26118.

• Bannick, M., Gao, F., Brown, E. and Janes, H. (2023). “Retrospective, Observational Studies for Estimating Vaccine Effects on the Secondary Attack Rate of SARS-CoV-2”. American Journal of Epidemiology. 192(6), 1016–1028.

• Janes, H., Gao, F. and Luedtke, A. (2021).  “Discussion on “Estimating Vaccine Efficacy Over Time After a Randomized Study is Unblinded” by Anastasios A. Tsiatis and Marie Davidian”. Biometrics, 78(3), 841–843.

Semiparametric Regression in Survival Analysis

• Gao, F. and Chan, K. C. G (2024). “Efficient Estimation of Semiparametric Transformation Model With Interval-Censored Data in Two-Phase Cohort Studies”. Statistics in Biosciences, 16 (1), 203-220. [Github Code]

• Gao, F., Xia, F. and Chan, K. C. G (2023). “Defining and Estimating Subgroup Mediation Effects with Semi-Competing Risks Data”. Statistica Sinica, 33, 2495-2517. [Github Code]

• Gao, F. and Chan, K. C. G (2023). “Non-iterative Adjustment to Regression Estimators with Population-based Auxiliary Information for Semiparametric Models”. Biometrics, 79(1), 140-150.

• Gao, F., Wang, Y., and Zeng, D. (2023). “Semiparametric Regression Analysis of Bivariate Censored Events in a Family Study of Alzheimer’s Disease”. Biostatistics, 24(1), 32-51. [Github Code]

• Chan, K. C. G, Gao, F., and Xia, F. (2021).  “Discussion on “Causal Mediation of Semicompeting Risks” by Yen-Tsung Huang”. Biometrics, 77(4), 1155-1159.

• Gao, F. and Chan, K. C. G. (2019). "Semiparametric Regression Analysis of Length-Biased Interval-Censored Data". Biometrics, 75(1), 121-132.

• Gao, F., Zeng, D., Couper, D. and Lin, D. Y. (2018). "Semiparametric Regression for Multiple Right- and Interval-Censored Events". Journal of the American Statistical Association, 114(527), 1232–1240.

• Gao, F., Zeng, D., and Lin, D. Y. (2018). "Semiparametric Regression for Interval-Censored Data With Informative Dropout". Biometrics, 74(4), 1213-1222.

• Zeng, D., Gao, F., and Lin, D. Y. (2017). “Maximum Likelihood Estimation for Semiparametric Regression Models With Multivariate Interval-Censored Data”. Biometrika, 104(3), 505-525. 

• Gao, F., Zeng, D., and Lin, D. Y. (2017). "Semiparametric Estimation of the Accelerated Failure Time Model With Partly Interval-Censored Data". Biometrics, 73(4), 1161-1168. [R Package]

Collaborative Work

• Cardemil, CV., Cao, Y., Posavad, C., Badell, M., Bunge, K., Mulligan, M., Parameswaran, L., Olsen-Chen, C., Novak, R., Brady, R., DeFranco, E., Gerber, J., Pasetti, M., Shriver, M., Coler, R., Berube, B., Suthar, M., Moreno, A., Gao, F., Richardson, B., Beigi, R., Brown, E., Neuzil, K., Munoz, F. (2024). “Maternal COVID-19 Vaccination and Prevention of Symptomatic Infection in Infants”. Pediatrics, 153(3), e2023064252.

•  Wairimu, N., Malen, R. C., Reedy, A. M., Mogere, P., Njeru, I., Culquichic ́on, C., McGowan, M., Gao, F., Baeten, J. M., Ngure, K., and Ortblad, K. F. (2023).“Peer PrEP Referral + HIV Self-test Delivery for PrEP Initiation Among Young Kenyan Women: Study Protocol for a Hybrid Cluster-Randomized Controlled Trial”. Trials, 24, 705.

• Rashidi, A., Gao, F., Fredricks, D. N., Pergam, S. A., Mielcarek, M., Milano, F., Sandmaier, B. M., and Lee, S. J. (2023).“Analysis of Antibiotic Exposure and Development of Acute Graft-vs- Host Disease Following Allogeneic Hematopoietic Cell Transplantation”. JAMA Network Open, 6(6),  e2317188.

• Swan, D. A., Goyal, A., Bracis, C., Moore, M., Krantz, E., Brown, E., Cardozo-Ojeda, F., Reeves, D. B., Gao, F., Painter, I., Gilbert, P. B., Corey, L., Cohen, M. S., Janes, H., Dimitrov, D., and Schiffer, J. T. (2021). “Vaccines that Prevent SARS-CoV-2 Transmission may Prevent or Dampen a Spring Wave of COVID-19 Cases and Deaths in 2021”. Viruses, 13(10), 1921.