Scholars@Duke
Avi Kenny

Avi Kenny CV

Assistant Professor of Biostatistics & Bioinformatics
Biostatistics & Bioinformatics, Division of Biostatistics
Box 90519, Durham, NC 27708
310 Trent Drive, Durham, NC 27708
CV

Scholarly Works - Journal articles

A discrete-time survival model to handle interval-censored covariates, with applications to HIV cohort studies

Journal article Journal of the Royal Statistical Society Series C: Applied Statistics · August 4, 2026 AbstractMethods are lacking to handle the problem of survival analysis in the presence of an interval-censored covariate, specifically the case in which the conditional hazard of the primary event of inte ... Full text Cite

Early Implementation of Doxycycline Postexposure Prophylaxis at an Infectious Diseases Clinic in the Southern United States.

Journal article AIDS Patient Care STDS · July 2026 Doxycycline postexposure prophylaxis (DoxyPEP) is an emerging strategy to prevent bacterial sexually transmitted infections (STIs) among men who have sex with men (MSM) and transgender women (TGW). We evaluated early DoxyPEP implementation in a university- ... Full text Link to item Cite

Data sharing in stepped-wedge cluster randomized trials: suboptimal data availability despite "data available upon request".

Journal article J Clin Epidemiol · June 3, 2026 BACKGROUND AND OBJECTIVES: Data sharing enhances transparency, facilitates reproducibility, and promotes innovation in health research. For statisticians, access to data from real trials is essential to develop, validate, and refine statistical methods. Wi ... Full text Link to item Cite

Evaluating global health programmes targeting under-5 mortality: problems and recommendations.

Journal article BMJ Glob Health · June 2, 2026 Reducing the under-5 mortality rate (U5MR) is a key public health priority and remains a persistent challenge in low- and middle-income countries. Many interventions have been developed in attempts to lower U5MR through partnerships between governments, fu ... Full text Link to item Cite

TREATment of Lower Respiratory Tract Infection in Selected Hospitals in Southern Sri Lanka (TREAT-SL): study protocol for a stepped-wedge, cluster-randomized clinical trial.

Journal article Trials · March 18, 2026 BACKGROUND: Lower respiratory tract infection (LRTI) is a leading cause of hospitalization and antibacterial use globally. In low- and middle-income countries (LMICs), limited diagnostic resources contribute to inappropriate antibacterial use for LRTI. The ... Full text Link to item Cite

Perspectives from Sri Lankan physicians on current approaches to diagnosing and managing lower respiratory tract infections.

Journal article BMC Res Notes · February 21, 2026 OBJECTIVES: Lower respiratory tract infections (LRTIs) pose significant diagnostic challenges, especially in low- and middle-income countries (LMICs), where access to diagnostics and clinical tools is limited. This qualitative study explored Sri Lankan phy ... Full text Link to item Cite

Factors affecting power in stepped wedge trials when the treatment effect varies with time.

Journal article Trials · February 20, 2026 BACKGROUND: Stepped wedge cluster randomized trials (SW-CRTs) have historically been analyzed using immediate treatment (IT) models, which assume the effect of the treatment is immediate after treatment initiation and subsequently remains constant over tim ... Full text Link to item Cite

Nursing without borders: culturally tailoring a US SCD nursing excellence train-the-trainer bootcamp model for nurses in Nigeria and across Africa

Journal article Journal of Sickle Cell Disease · January 1, 2026 Objectives: To address the lack of structured sickle cell disease (SCD) training and missed opportunities for early identification, intervention, and improved patient outcomes in resource limited settings, the U.S. based SCD Nursing Excellence Train-the-Tr ... Full text Cite

Reducing Child Mortality in Togo With an Integrated Primary Care Program: A Cluster Randomized Clinical Trial.

Journal article Pediatrics · December 1, 2025 OBJECTIVE: The objective of this study was to evaluate the effectiveness and implementation of the Integrated Primary Care Program (IPCP) in reducing under-five mortality rate (U5M) in Togo when implemented at scale. METHODS: Using a stepped-wedge cluster ... Full text Link to item Cite

Inference on Controlled Effects for Assessing Immune Correlates of Protection Based on a Cox Model.

Journal article Stat Med · December 2025 In vaccine research, it is important to identify biomarkers that can reliably predict vaccine efficacy against a clinical endpoint. Such biomarkers are known as immune correlates of protection (CoP) and can serve as surrogate endpoints in vaccine efficacy ... Full text Link to item Cite

Immune correlates analysis of antibody responses against SARS-CoV-2 variants in the ENSEMBLE vaccine efficacy trial.

Journal article iScience · November 21, 2025 In Latin American sites of the ENSEMBLE trial of the Ad26.COV2.S vaccine vs. placebo, binding antibodies and neutralizing antibodies measured 4 weeks post-vaccination (∼peak) against circulating lineages (Ancestral, Gamma, Lambda, Mu, Zeta) were assessed a ... Full text Link to item Cite

Neutralizing and binding antibodies are a correlate of risk of COVID-19 in the CoVPN 3008 study in people with HIV.

Journal article Nat Commun · October 6, 2025 People with HIV (PWH) are understudied in COVID-19 vaccine trials, leaving knowledge gaps on whether the identified immune correlates of protection also hold in PWH. CoVPN 3008 (NCT05168813) enrolled predominantly PWH and reported lower COVID-19 incidence ... Full text Open Access Link to item Cite

Investigating Symptom Duration Using Current Status Data: A Case Study of Postacute COVID-19 Syndrome.

Journal article Epidemiology · September 1, 2025 BACKGROUND: For infectious diseases, characterizing symptom duration is of clinical and public health importance. Symptom duration may be assessed by surveying infected individuals and querying symptom status at the time of survey response. For example, in ... Full text Link to item Cite

Analysis of Stepped-Wedge Cluster Randomized Trials When Treatment Effects Vary by Exposure Time or Calendar Time.

Journal article Stat Med · September 2025 Stepped-wedge cluster randomized trials (SW-CRTs) are traditionally analyzed with models that assume an immediate and sustained treatment effect. Previous work has shown that making such an assumption in the analysis of SW-CRTs when the true underlying tre ... Full text Link to item Cite

Neutralizing antibody correlate of protection against severe-critical COVID-19 in the ENSEMBLE single-dose Ad26.COV2.S vaccine efficacy trial.

Journal article Nat Commun · November 12, 2024 Assessment of immune correlates of severe COVID-19 has been hampered by the low numbers of severe cases in COVID-19 vaccine efficacy (VE) trials. We assess neutralizing and binding antibody levels at 4 weeks post-Ad26.COV2.S vaccination as correlates of ri ... Full text Link to item Cite

Immune correlates analysis of the Imbokodo (HVTN 705/HPX2008) efficacy trial of a mosaic HIV-1 vaccine regimen evaluated in Southern African people assigned female sex at birth: a two-phase case-control study.

Journal article EBioMedicine · October 2024 BACKGROUND: The HVTN 705 Imbokodo trial of 2636 people without HIV and assigned female sex at birth, conducted in southern Africa, evaluated a heterologous HIV-1 vaccine regimen: mosaic adenovirus 26-based vaccine (Ad26.Mos4.HIV) at Months 0, 3, 6, 12 and ... Full text Open Access Link to item Cite

Omicron COVID-19 immune correlates analysis of a third dose of mRNA-1273 in the COVE trial.

Journal article Nat Commun · September 11, 2024 In the phase 3 Coronavirus Efficacy (COVE) trial (NCT04470427), post-dose two Ancestral Spike-specific binding (bAb) and neutralizing (nAb) antibodies were shown to be correlates of risk (CoR) and of protection against Ancestral-lineage COVID-19 in SARS-Co ... Full text Link to item Cite

Robust analysis of stepped wedge trials using composite likelihood models.

Journal article Stat Med · July 30, 2024 Stepped wedge trials (SWTs) are a type of cluster randomized trial that involve repeated measures on clusters and design-induced confounding between time and treatment. Although mixed models are commonly used to analyze SWTs, they are susceptible to misspe ... Full text Link to item Cite

Four statistical frameworks for assessing an immune correlate of protection (surrogate endpoint) from a randomized, controlled, vaccine efficacy trial.

Journal article Vaccine · April 2, 2024 A central goal of vaccine research is to characterize and validate immune correlates of protection (CoPs). In addition to helping elucidate immunological mechanisms, a CoP can serve as a valid surrogate endpoint for an infectious disease clinical outcome a ... Full text Link to item Cite

Under-five mortality before and after implementation of the Liberia National Community Health Assistant (NCHA) program: A study protocol.

Journal article PLoS One · 2024 Between 2018 and 2022 the Liberian Government implemented the National Community Health Assistant (NCHA) program to improve provision of maternal and child health care to underserved rural areas of the country. Whereas the contributions of this and similar ... Full text Link to item Cite

Retrospective review of compliance with guideline-directed germline testing in microsatellite instability-high colorectal cancer treated at the Veterans Health Administration

Journal article Journal of Clinical Oncology · January 1, 2024 Background: Lynch syndrome (LS) is an autosomal dominant inherited cancer syndrome that confers an increased risk of colorectal cancer (CRC). As clinical and history features under-recognize LS cases (3–5% of CRC), universal screening of CRCs for LS is rec ... Full text Cite

A controlled effects approach to assessing immune correlates of protection.

Journal article Biostatistics · October 18, 2023 An immune correlate of risk (CoR) is an immunologic biomarker in vaccine recipients associated with an infectious disease clinical endpoint. An immune correlate of protection (CoP) is a CoR that can be used to reliably predict vaccine efficacy (VE) against ... Full text Link to item Cite

Stochastic Interventional Vaccine Efficacy and Principal Surrogate Analyses of Antibody Markers as Correlates of Protection against Symptomatic COVID-19 in the COVE mRNA-1273 Trial.

Journal article Viruses · September 29, 2023 The COVE trial randomized participants to receive two doses of mRNA-1273 vaccine or placebo on Days 1 and 29 (D1, D29). Anti-SARS-CoV-2 Spike IgG binding antibodies (bAbs), anti-receptor binding domain IgG bAbs, 50% inhibitory dilution neutralizing antibod ... Full text Open Access Link to item Cite

Pharmacokinetic serum concentrations of VRC01 correlate with prevention of HIV-1 acquisition.

Journal article EBioMedicine · July 2023 BACKGROUND: The phase 2b proof-of-concept Antibody Mediated Prevention (AMP) trials showed that VRC01, an anti-HIV-1 broadly neutralising antibody (bnAb), prevented acquisition of HIV-1 sensitive to VRC01. To inform future study design and dosing regimen s ... Full text Link to item Cite

Comparing antibody assays as correlates of protection against COVID-19 in the COVE mRNA-1273 vaccine efficacy trial.

Journal article Sci Transl Med · April 19, 2023 The best assay or marker to define mRNA-1273 vaccine-induced antibodies as a correlate of protection (CoP) is unclear. In the COVE trial, participants received two doses of the mRNA-1273 COVID-19 vaccine or placebo. We previously assessed IgG binding antib ... Full text Link to item Cite

Immune correlates analysis of the ENSEMBLE single Ad26.COV2.S dose vaccine efficacy clinical trial.

Journal article Nat Microbiol · December 2022 Measuring immune correlates of disease acquisition and protection in the context of a clinical trial is a prerequisite for improved vaccine design. We analysed binding and neutralizing antibody measurements 4 weeks post vaccination as correlates of risk of ... Full text Link to item Cite

Analysis of stepped wedge cluster randomized trials in the presence of a time-varying treatment effect.

Journal article Stat Med · September 30, 2022 Stepped wedge cluster randomized controlled trials are typically analyzed using models that assume the full effect of the treatment is achieved instantaneously. We provide an analytical framework for scenarios in which the treatment effect varies as a func ... Full text Link to item Cite

Random effect misspecification in stepped wedge designs.

Journal article Clin Trials · August 2022 Stepped wedge cluster randomized trials are often analysed using linear mixed effects models that may include random effects for cluster, time and/or treatment. We investigate the impact of misspecification of the random effects structure of the model. Spe ... Full text Link to item Cite

Model misspecification in stepped wedge trials: Random effects for time or treatment.

Journal article Stat Med · May 10, 2022 Mixed models are commonly used to analyze stepped wedge trials (SWTs) to account for clustering and repeated measures on clusters. One critical issue researchers face is whether to include a random time effect or a random treatment effect. When the wrong m ... Full text Link to item Cite

Measuring Knowledge of Community Health Workers at the Last Mile in Liberia: Feasibility and Results of Clinical Vignette Assessments.

Journal article Glob Health Sci Pract · March 15, 2021 INTRODUCTION: Community health workers (CHWs) can provide lifesaving treatment for children in remote areas, but high-quality care is essential for effective delivery. Measuring the quality of community-based care in remote areas is logistically challengin ... Full text Link to item Cite

Design and implementation of a mobile health electronic data capture platform that functions in fully-disconnected settings: a pilot study in rural Liberia.

Journal article BMC Med Inform Decis Mak · February 22, 2020 BACKGROUND: Mobile phones and personal digital assistants have been used for data collection in developing world settings for over three decades, and have become increasingly common. However, the use of electronic data capture (EDC) through mobile phones i ... Full text Link to item Cite

Satellite images and machine learning can identify remote communities to facilitate access to health services.

Journal article J Am Med Inform Assoc · August 1, 2019 OBJECTIVE: Community health systems operating in remote areas require accurate information about where people live to efficiently provide services across large regions. We sought to determine whether a machine learning analyses of satellite imagery can be ... Full text Link to item Cite

A Community Health Worker Intervention to Increase Childhood Disease Treatment Coverage in Rural Liberia: A Controlled Before-and-After Evaluation.

Journal article Am J Public Health · September 2018 OBJECTIVES: To assess a community health worker (CHW) program's impact on childhood illness treatment in rural Liberia. METHODS: We deployed CHWs in half of Rivercess County in August 2015 with the other half constituting a comparison group until July 2016 ... Full text Link to item Cite

Validation Relaxation: A Quality Assurance Strategy for Electronic Data Collection.

Journal article J Med Internet Res · August 18, 2017 BACKGROUND: The use of mobile devices for data collection in developing world settings is becoming increasingly common and may offer advantages in data collection quality and efficiency relative to paper-based methods. However, mobile data collection syste ... Full text Link to item Cite

Implementation research on community health workers' provision of maternal and child health services in rural Liberia.

Journal article Bull World Health Organ · February 1, 2017 OBJECTIVE: To assess changes in the use of essential maternal and child health services in Konobo, Liberia, after implementation of an enhanced community health worker (CHW) programme. METHODS: The Liberian Ministry of Health partnered with Last Mile Healt ... Full text Link to item Cite

Charting health system reconstruction in post-war Liberia: a comparison of rural vs. remote healthcare utilization.

Journal article BMC Health Serv Res · September 7, 2016 BACKGROUND: Despite a growing global emphasis on universal healthcare, access to basic primary care for remote populations in post-conflict countries remains a challenge. To better understand health sector recovery in post-conflict Liberia, this paper seek ... Full text Link to item Cite

Facility-Based Delivery during the Ebola Virus Disease Epidemic in Rural Liberia: Analysis from a Cross-Sectional, Population-Based Household Survey.

Journal article PLoS Med · August 2016 BACKGROUND: The Ebola virus disease (EVD) epidemic has threatened access to basic health services through facility closures, resource diversion, and decreased demand due to community fear and distrust. While modeling studies have attempted to estimate the ... Full text Link to item Cite

Remoteness and maternal and child health service utilization in rural Liberia: A population-based survey.

Journal article J Glob Health · December 2015 BACKGROUND: This study seeks to understand distance from health facilities as a barrier to maternal and child health service uptake within a rural Liberian population. Better understanding the relationship between distance from health facilities and rural ... Full text Link to item Cite