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3. Targeted nonviral delivery of genome editors in vivo

Author

Tsuchida, Connor A, Wasko, Kevin M, Hamilton, Jennifer R, and Doudna, Jennifer A

Subjects
Medical Biotechnology, Biomedical and Clinical Sciences, Biotechnology, Gene Therapy, Genetics, Development of treatments and therapeutic interventions, 5.2 Cellular and gene therapies, Commerce, Gene Editing, Genetic Therapy, RNA, Messenger, Ribonucleoproteins, genome editing, CRISPR-Cas, in vivo delivery, nonviral delivery, targeted delivery
Abstract

Cell-type-specific in vivo delivery of genome editing molecules is the next breakthrough that will drive biological discovery and transform the field of cell and gene therapy. Here, we discuss recent advances in the delivery of CRISPR-Cas genome editors either as preassembled ribonucleoproteins or encoded in mRNA. Both strategies avoid pitfalls of viral vector-mediated delivery and offer advantages including transient editor lifetime and potentially streamlined manufacturing capability that are already proving valuable for clinical use. We review current applications and future opportunities of these emerging delivery approaches that could make genome editing more efficacious and accessible in the future.

Published
2024

5. In vivo human T cell engineering with enveloped delivery vehicles

Author

Hamilton, Jennifer R, Chen, Evelyn, Perez, Barbara S, Sandoval Espinoza, Cindy R, Kang, Min Hyung, Trinidad, Marena, Ngo, Wayne, and Doudna, Jennifer A

Subjects
Medical Biotechnology, Biomedical and Clinical Sciences, Immunology, Genetics, Bioengineering, Gene Therapy, Biotechnology, 1.1 Normal biological development and functioning, 5.2 Cellular and gene therapies, Generic health relevance
Abstract

Viruses and virally derived particles have the intrinsic capacity to deliver molecules to cells, but the difficulty of readily altering cell-type selectivity has hindered their use for therapeutic delivery. Here, we show that cell surface marker recognition by antibody fragments displayed on membrane-derived particles encapsulating CRISPR-Cas9 protein and guide RNA can deliver genome editing tools to specific cells. Compared to conventional vectors like adeno-associated virus that rely on evolved capsid tropisms to deliver virally encoded cargo, these Cas9-packaging enveloped delivery vehicles (Cas9-EDVs) leverage predictable antibody-antigen interactions to transiently deliver genome editing machinery selectively to cells of interest. Antibody-targeted Cas9-EDVs preferentially confer genome editing in cognate target cells over bystander cells in mixed populations, both ex vivo and in vivo. By using multiplexed targeting molecules to direct delivery to human T cells, Cas9-EDVs enable the generation of genome-edited chimeric antigen receptor T cells in humanized mice, establishing a programmable delivery modality with the potential for widespread therapeutic utility.

Published
2024

8. Monitoring SARS-CoV-2 incidence and seroconversion among university students and employees: a longitudinal cohort study in California, June–August 2020

Author

Hunter, Lauren A, Wyman, Stacia, Packel, Laura J, Facente, Shelley N, Li, Yi, Harte, Anna, Nicolette, Guy, Consortium, the IGI SARS-CoV-2 Testing, Di Germanio, Clara, Busch, Michael P, Reingold, Arthur L, Petersen, Maya L, Urnov, Fyodor, McDevitt, Shana, Hirsch, Ariana, Ehrenberg, Alexander, Doudna, Jennifer A, Amen, M, Barry, Kerrie W, Boyle, John M, Brook, Cara E, Choo, Seunga, Cornmesser, Dilworth, David J, Fedrigo, Indro, Friedline, Skyler E, Graham, Thomas GW, Green, Ralph, Hamilton, Jennifer R, Hochstrasser, Megan L, Hockemeyer, Dirk, Krishnappa, Netravathi, Lari, Azra, Li, Hanqin, Lin-Shiao, Enrique, Lu, Tianlin, Lyons, Elijah F, Mark, Kevin G, Martell, Lisa Argento, Martins, A Raquel O, Mitchell, Patrick S, Moehle, Erica A, Naca, Christine, Nandakumar, Divya, O’Brien, Elizabeth, Pappas, Derek J, Pestal, Kathleen, Quach, Diana L, Rubin, Benjamin E, Sachdeva, Rohan, Stahl, Elizabeth C, Syed, Abdullah Muhammad, Tan, I-Li, Tollner, Amy L, Tsuchida, Connor A, Tsui, C Kimberly, Turkalo, Timothy K, Warf, M Bryan, Whitney, Oscar N, and Witkowsky, Lea B

Subjects
Biodefense, Emerging Infectious Diseases, Infectious Diseases, Vaccine Related, Prevention, Clinical Research, Infection, Good Health and Well Being, Humans, SARS-CoV-2, COVID-19, Incidence, COVID-19 Testing, Longitudinal Studies, Universities, Seroconversion, Phylogeny, Prospective Studies, California, Cohort Studies, EPIDEMIOLOGY, Public health, Infection control, Epidemiology, PUBLIC HEALTH, IGI SARS-CoV-2 Testing Consortium, Clinical Sciences, Public Health and Health Services, Other Medical and Health Sciences
Abstract

ObjectivesTo identify incident SARS-CoV-2 infections and inform effective mitigation strategies in university settings, we piloted an integrated symptom and exposure monitoring and testing system among a cohort of university students and employees.DesignProspective cohort study.SettingA public university in California from June to August 2020.Participants2180 university students and 738 university employees.Primary outcome measuresAt baseline and endline, we tested participants for active SARS-CoV-2 infection via quantitative PCR (qPCR) test and collected blood samples for antibody testing. Participants received notifications to complete additional qPCR tests throughout the study if they reported symptoms or exposures in daily surveys or were selected for surveillance testing. Viral whole genome sequencing was performed on positive qPCR samples, and phylogenetic trees were constructed with these genomes and external genomes.ResultsOver the study period, 57 students (2.6%) and 3 employees (0.4%) were diagnosed with SARS-CoV-2 infection via qPCR test. Phylogenetic analyses revealed that a super-spreader event among undergraduates in congregate housing accounted for at least 48% of cases among study participants but did not spread beyond campus. Test positivity was higher among participants who self-reported symptoms (incidence rate ratio (IRR) 12.7; 95% CI 7.4 to 21.8) or had household exposures (IRR 10.3; 95% CI 4.8 to 22.0) that triggered notifications to test. Most (91%) participants with newly identified antibodies at endline had been diagnosed with incident infection via qPCR test during the study.ConclusionsOur findings suggest that integrated monitoring systems can successfully identify and link at-risk students to SARS-CoV-2 testing. As the study took place before the evolution of highly transmissible variants and widespread availability of vaccines and rapid antigen tests, further research is necessary to adapt and evaluate similar systems in the present context.

Published
2023

10. Potential immunomodulatory effects of CAS+IMD monoclonal antibody cocktail in hospitalized patients with COVID-19

Author

Wang, Bei, Golubov, Jacquelynn, Oswald, Erin M., Poon, Patrick, Wei, Qiaozhi, Lett, Clarissa, Shehadeh, Fadi, Kaczynski, Matthew, Felix, Lewis Oscar, Mishra, Biswajit, Mylona, Evangelia K., Wipperman, Matthew F., Chio, Erica, Hamon, Sara C., Hooper, Andrea T., Somersan-Karakaya, Selin, Musser, Bret J., Petro, Christopher D., Hamilton, Jennifer D., Sleeman, Matthew A., Kalliolias, George D., Mylonakis, Eleftherios, and Skokos, Dimitris

Published
2024
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13. CRISPR–Cas9-mediated nuclear transport and genomic integration of nanostructured genes in human primary cells

Author

Lin-Shiao, Enrique, Pfeifer, Wolfgang G, Shy, Brian R, Saffari Doost, Mohammad, Chen, Evelyn, Vykunta, Vivasvan S, Hamilton, Jennifer R, Stahl, Elizabeth C, Lopez, Diana M, Sandoval Espinoza, Cindy R, Deyanov, Alexander E, Lew, Rachel J, Poirer, Michael G, Marson, Alexander, Castro, Carlos E, and Doudna, Jennifer A

Subjects
Biological Sciences, Biotechnology, Genetics, Nanotechnology, Bioengineering, Human Genome, Gene Therapy, Underpinning research, 1.1 Normal biological development and functioning, Generic health relevance, Active Transport, Cell Nucleus, CRISPR-Cas Systems, DNA, Gene Editing, Gene Transfer Techniques, Genome, Humans, Nanostructures, Environmental Sciences, Information and Computing Sciences, Developmental Biology, Biological sciences, Chemical sciences, Environmental sciences
Abstract

DNA nanostructures are a promising tool to deliver molecular payloads to cells. DNA origami structures, where long single-stranded DNA is folded into a compact nanostructure, present an attractive approach to package genes; however, effective delivery of genetic material into cell nuclei has remained a critical challenge. Here, we describe the use of DNA nanostructures encoding an intact human gene and a fluorescent protein encoding gene as compact templates for gene integration by CRISPR-mediated homology-directed repair (HDR). Our design includes CRISPR-Cas9 ribonucleoprotein binding sites on DNA nanostructures to increase shuttling into the nucleus. We demonstrate efficient shuttling and genomic integration of DNA nanostructures using transfection and electroporation. These nanostructured templates display lower toxicity and higher insertion efficiency compared to unstructured double-stranded DNA templates in human primary cells. Furthermore, our study validates virus-like particles as an efficient method of DNA nanostructure delivery, opening the possibility of delivering nanostructures in vivo to specific cell types. Together, these results provide new approaches to gene delivery with DNA nanostructures and establish their use as HDR templates, exploiting both their design features and their ability to encode genetic information. This work also opens a door to translate other DNA nanodevice functions, such as biosensing, into cell nuclei.

Published
2022

14. Targeted delivery of CRISPR-Cas9 and transgenes enables complex immune cell engineering

Author

Hamilton, Jennifer R, Tsuchida, Connor A, Nguyen, David N, Shy, Brian R, McGarrigle, E Riley, Sandoval Espinoza, Cindy R, Carr, Daniel, Blaeschke, Franziska, Marson, Alexander, and Doudna, Jennifer A

Subjects
Biological Sciences, Biotechnology, Genetics, Transplantation, Gene Therapy, 5.2 Cellular and gene therapies, Development of treatments and therapeutic interventions, Quality Education, A549 Cells, CD4-Positive T-Lymphocytes, CRISPR-Associated Protein 9, CRISPR-Cas Systems, Cell Engineering, Gene Editing, Gene Transfer Techniques, HIV-1, Humans, Jurkat Cells, Lentivirus, Receptors, Chimeric Antigen, Ribonucleoproteins, Transgenes, Virion, env Gene Products, Human Immunodeficiency Virus, CAR-T cells, CRISPR delivery, CRISPR-Cas9, precision genome editing, viral engineering, virus-like particles, Biochemistry and Cell Biology, Medical Physiology, Biological sciences
Abstract

As genome engineering advances cell-based therapies, a versatile approach to introducing both CRISPR-Cas9 ribonucleoproteins (RNPs) and therapeutic transgenes into specific cells would be transformative. Autologous T cells expressing a chimeric antigen receptor (CAR) manufactured by viral transduction are approved to treat multiple blood cancers, but additional genetic modifications to alter cell programs will likely be required to treat solid tumors and for allogeneic cellular therapies. We have developed a one-step strategy using engineered lentiviral particles to introduce Cas9 RNPs and a CAR transgene into primary human T cells without electroporation. Furthermore, programming particle tropism allows us to target a specific cell type within a mixed cell population. As a proof-of-concept, we show that HIV-1 envelope targeted particles to edit CD4+ cells while sparing co-cultured CD8+ cells. This adaptable approach to immune cell engineering ex vivo provides a strategy applicable to the genetic modification of targeted somatic cells in vivo.

Published
2021

15. Efficacy and safety of a single dose of casirivimab and imdevimab for the prevention of COVID-19 over an 8-month period: a randomised, double-blind, placebo-controlled trial

Author

Chani, Achint, Adepoju, Adebiyi, Mahmood, Adnan, Mortagy, Aisha, Dupljak, Ajla, Baum, Alina, Brown, Alison, Froment, Amy, Hooper, Andrea, Margiotta, Andrea, Bombardier, Andrew, Islam, Anita, Smith, Anne, Dhillon, Arvinder, McMillian, Audra, Breazna, Aurora, Aslam, Ayesha, Carpentino, Barabara, Kowal, Bari, Siliverstein, Barry, Horel, Benjamin, Zhu, Bo, Musser, Bret, Bush, Brian, Head, Brian, Snow, Brian, Zhu, Bryan, Debray, Camille, Phillips, Careta, Simiele, Carmella, Lee, Carol, Nienstedt, Carolyn, Trbovic, Caryn, Chan, Casey (Kuo-Chen), Elliott, Catherine, Fish, Chad, Ni, Charlie, Polidori, Christa, Enciso, Christine, Caira, Christopher, Powell, Christopher, Kyratsous, Christos A., Baum, Cliff, McDonald, Colin, Leigh, Cynthia, Pan, Cynthia, Wolken, Dana, Manganello, Danielle, Liu, David, Stein, David, Weinreich, David M., Hassan, Dawlat, Gulabani, Daya, Fix, Deborah, Leonard, Deborah, Sarda, Deepshree, Bonhomme, Denise, Kennedy, Denise, Darcy, Devin, Barron, Dhanalakshmi, Hughes, Diana, Rofail, Diana, Kaur, Dipinder, Ramesh, Divya, Bianco, Dona, Cohen, Donna, Forleo-Neto, Eduardo, Jean-Baptiste, Edward, Bukhari, Ehsan, Doyle, Eileen, Bucknam, Elizabeth, Labriola-Tomkins, Emily, Nanna, Emily, Huffman O'Keefe, Esther, Gasparino, Evelyn, Fung, Evonne, Isa, Flonza, To, Fung-Yee, Herman, Gary, Yancopoulos, George D., Bellingham, Georgia, Sumner, Giane, Moggan, Grainne, Power, Grainne, Zeng, Haixia, Mariveles, Hazel, Gonzalez, Heath, Kang, Helen, Noor, Hibo, Minns, Ian, Heirman, Ingeborg, Peszek, Izabella, Donohue, James, Rusconi, Jamie, Austin, Janice, Parrino, Janie, Yo, Jeannie, McDonnell, Jenna, Hamilton, Jennifer D., Boarder, Jessica, Wei, Jianguo, Yu, Jingchun, Malia, Joanne, Tucciarone, Joanne, Tyler-Gale, Jodie, Davis, John D., Strein, John, Cohen, Jonathan, Meyer, Jonathan, Ursino, Jordan, Im, Joseph, Tramaglini, Joseph, Wolken, Joseph, Potter, Kaitlyn, Scacalossi, Kaitlyn, Naidu, Kamala, Browning, Karen, Rutkowski, Karen, Yau, Karen, Woloshin, Katherine, Lewis-Amezcua, Kelly, Turner, Kenneth, Dornheim, Kimberly, Chiu, Kit, Mohan, Kosalai, McGuire, Kristina, Macci, Kristy, Ringleben, Kurt, Mohammadi, Kusha, Foster, Kyle, Knighton, Latora, Lipsich, Leah, Darling, Lindsay, Boersma, Lisa, Cowen, Lisa, Hersh, Lisa, Jackson, Lisa, Purcell, Lisa, Sherpinsky, Lisa, Lai, Livia, Faria, Lori, Geissler, Lori, Boppert, Louise, Fiske, Lyra, Dickens, Marc, Mancini, Marco, Leigh, Maria C., O'Brien, Meagan P., Batchelder, Michael, Klinger, Michael, Partridge, Michael, Tarabocchia, Michel, Wong, Michelle, Rodriguez, Mivianisse, Albizem, Moetaz, O'Byrne, Muriel, Braunstein, Ned, Sarkar, Neena, Stahl, Neil, Deitz, Nicole, Memblatt, Nicole, Shah, Nirav, Kumar, Nitin, Herrera, Olga, Adedoyin, Oluchi, Yellin, Ori, Snodgrass, Pamela, Floody, Patrick, D'Ambrosio, Paul, Gao, Paul (Xiaobang), Hou, Peijie, Hearld, Philippa, Li, Qin, Kitchenoff, Rachel, Ali, Rakiyya, Iyer, Ramya, Chava, Ravikanth, Alaj, Rinol, Pedraza, Rita, Hamlin, Robert, Hosain, Romana, Gorawala, Ruchin, White, Ryan, Yu, Ryan, Fogarty, Rylee, Dass, S. Balachandra, Bollini, Sagarika, Ganguly, Samit, DeCicco, Sandra, Patel, Sanket, Cassimaty, Sarah, Somersan-Karakaya, Selin, McCarthy, Shane, Henkel, Sharon, Ali, Shazia, Geila Shapiro, Shelley, Kim, Somang, Nossoughi, Soraya, Bisulco, Stephanie, Elkin, Steven, Long, Steven, Sivapalasingam, Sumathi, Irvin, Susan, Wilt, Susan, Min, Tami, Constant, Tatiana, Devins, Theresa, DiCioccio, Thomas, Norton, Thomas, Bernardo, Travis, Chuang, Tzu-Chien, Wei, Victor (Jianguo), Nuce, Vinh, Battini, Vishnu, Caldwell, Wilson, Gao, Xiaobang, Chen, Xin, Tian, Yanmei, Khan, Yasmin, Zhao, Yuming, Kim, Yunji, Dye, Bonnie, Hurt, Christopher B., Burwen, Dale R., Barouch, Dan H., Burns, David, Brown, Elizabeth, Bar, Katharine J., Marovich, Mary, Clement, Meredith, Cohen, Myron S., Sista, Nirupama, Barnabas, Ruanne V., Zwerski, Sheryl, Herman, Gary A, O'Brien, Meagan P, Chan, Kuo-Chen, Bar, Katharine J, Barnabas, Ruanne V, Barouch, Dan H, Cohen, Myron S, Hurt, Christopher B, Burwen, Dale R, Marovich, Mary A, Musser, Bret J, Davis, John D, Turner, Kenneth C, Hooper, Andrea T, Hamilton, Jennifer D, Subramaniam, Danise, Kyratsous, Christos A, DiCioccio, A Thomas, Yancopoulos, George D, and Weinreich, David M

Published
2022
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16. "A Legacy of Woes": Internalized Racism and Political Accountability in Contemporary Kenya

Author

Hamilton, Jennifer Anne

Subjects
Political science, African politics, colonial mentality, internalized racism, Kenya, political accountability
Abstract

Why do voters tolerate poorly performing politicians? In African contexts, existing theory highlights lack of information, ethnic voting, and clientelistic equilibriums as potential explanations. Another explanation has remained overlooked: accountability is impaired by internalized racism, a psychological phenomenon wherein members of disadvantaged racial groups implicitly or explicitly adopt racist attitudes, ideologies, and behaviors instilled and perpetuated by dominant racial power structures. Notwithstanding its centrality in much African scholarship, political scientists have not investigated internalized racism as an explanation for impaired accountability, in large part because social scientists lack appropriate methodological tools to systematically document internalized racism and its effects. My research addresses this gap. In this dissertation, I outline internalized racism’s character, origins, and relevance in African contexts. I then leverage data from an original survey among 600 Kenyan respondents toward two ends. First, I use survey data to develop and validate new explicit measures of internalized racism. Second, I use survey data to test three hypotheses regarding internalized racism’s impact on contemporary political attitudes, beliefs, and behaviors: (1) internalized racism alters political evaluations via motivated reasoning, (2) internalized racism increases perceptions and expectations of ethnic discrimination, and (3) internalized racism alters patterns of political participation. While the survey included an embedded experiment with a new intervention to reduce internalized racism, this initial attempt at causal identification did not prove successful. I therefore turn to observational analyses to test the three research hypotheses. I do not find compelling evidence that internalized racism affects political evaluations via racial motivated reasoning. However, I do find that internalized racism significantly predicts reported experiences of ethnic discrimination. Contrary to expectations, I do not find evidence that internalized racism depresses political efficacy or adversarial participation. However, I find evidence that internalized racism significantly predicts acceptance of clientelistic norms. The findings raising the possibility that internalized racism increases tendencies toward ethnic voting and drives persistent clientelism, thus impairing accountability and producing a self-fulfilling prophecy of poor-quality governance. This research adds depth to existing political science theory by shifting emphasis to racial identities in a context where scholars have deemphasized race in recent decades.

Published
2024

17. Designing and delivering undergraduate law courses in the shadow of the UK consumer protection legislation

Author

Rose-Hamilton, Jennifer

Subjects
340.071
Abstract

Using both a survey of university law school web landing pages, and an in-depth study with a small number of academic and compliance professionals within seven English universities, this thesis explores the impact of consumer protection legislation on the design and delivery of undergraduate law courses. The legislation requires disclosure of particular information concerning aspects of the design and delivery of courses, including information on teaching and learning. This information, once disclosed, is binding on the university, and cannot be changed without student consent. This study examines the extent to which the implementation of the legislation might be leading to a more instrumental approach to aspects of design and delivery, its implications for understandings of the purpose of legal education, and what this might mean for the role of law academics. The findings suggest that the impact has been two fold, namely to slow down the pace of innovation and change within courses, to embed the role of centralised managerial professionals more firmly into centralised decision making processes that impact on the design and delivery of courses, in order to ensure legal compliance. This thesis argues that the interconnectedness of the managerial and academic processes around the design and delivery of undergraduate legal education has created the potential for reshaping the narratives, values and norms associated with legal education, and around the role of academics in the context of their teaching roles, in line with corporatist and consumerist values. Unless law schools are prepared to take a more proactive approach to publicly articulating the goals, norms and values of their undergraduate courses and the nature of their relationship with students, they risk these goals, values and norms and relationship expectations being shaped elsewhere, and their roles as law teachers becoming increasingly circumscribed. Ultimately the legislation, as a part of the broader marketisation policy agenda, has had a major impact not only on internal organisational arrangements but on academic life as well.

Published
2021

18. Efficacy and safety of dupilumab up to 52 weeks in adults and adolescents with eosinophilic oesophagitis (LIBERTY EoE TREET study): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial

Author

Rothenberg, Marc E, Dellon, Evan S, Collins, Margaret H, Hirano, Ikuo, Chehade, Mirna, Bredenoord, Albert J, Lucendo, Alfredo J, Spergel, Jonathan M, Sun, Xian, Hamilton, Jennifer D, Mortensen, Eric, Laws, Elizabeth, Maloney, Jennifer, Mannent, Leda P, McCann, Eilish, Liu, Xia, Glotfelty, Lila, and Shabbir, Arsalan

Published
2023
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19. Robotic RNA extraction for SARS-CoV-2 surveillance using saliva samples

Author

Hamilton, Jennifer R, Stahl, Elizabeth C, Tsuchida, Connor A, Lin-Shiao, Enrique, Tsui, C Kimberly, Pestal, Kathleen, Gildea, Holly K, Witkowsky, Lea B, Moehle, Erica A, McDevitt, Shana L, McElroy, Matthew, Keller, Amanda, Sylvain, Iman, Hirsh, Ariana, Ciling, Alison, Ehrenberg, Alexander J, Ringeisen, Bradley R, Huberty, Garth, Urnov, Fyodor D, Giannikopoulos, Petros, and Doudna, Jennifer A

Subjects
Clinical Research, Biotechnology, Prevention, Genetics, Emerging Infectious Diseases, Infectious Diseases, 4.2 Evaluation of markers and technologies, Detection, screening and diagnosis, Infection, Good Health and Well Being, Adult, COVID-19, COVID-19 Testing, Female, Humans, Male, Mass Screening, RNA, RNA, Viral, Real-Time Polymerase Chain Reaction, Robotics, SARS-CoV-2, Saliva, Specimen Handling, IGI SARS-CoV-2 Consortium, General Science & Technology
Abstract

Saliva is an attractive specimen type for asymptomatic surveillance of COVID-19 in large populations due to its ease of collection and its demonstrated utility for detecting RNA from SARS-CoV-2. Multiple saliva-based viral detection protocols use a direct-to-RT-qPCR approach that eliminates nucleic acid extraction but can reduce viral RNA detection sensitivity. To improve test sensitivity while maintaining speed, we developed a robotic nucleic acid extraction method for detecting SARS-CoV-2 RNA in saliva samples with high throughput. Using this assay, the Free Asymptomatic Saliva Testing (IGI FAST) research study on the UC Berkeley campus conducted 11,971 tests on supervised self-collected saliva samples and identified rare positive specimens containing SARS-CoV-2 RNA during a time of low infection prevalence. In an attempt to increase testing capacity, we further adapted our robotic extraction assay to process pooled saliva samples. We also benchmarked our assay against nasopharyngeal swab specimens and found saliva methods require further optimization to match this gold standard. Finally, we designed and validated a RT-qPCR test suitable for saliva self-collection. These results establish a robotic extraction-based procedure for rapid PCR-based saliva testing that is suitable for samples from both symptomatic and asymptomatic individuals.

Published
2021

20. LuNER: Multiplexed SARS-CoV-2 detection in clinical swab and wastewater samples

Author

Stahl, Elizabeth C, Gopez, Allan R, Tsuchida, Connor A, Fan, Vinson B, Moehle, Erica A, Witkowsky, Lea B, Hamilton, Jennifer R, Lin-Shiao, Enrique, McElroy, Matthew, McDevitt, Shana L, Ciling, Alison, Tsui, C Kimberly, Pestal, Kathleen, Gildea, Holly K, Keller, Amanda, Sylvain, Iman A, Williams, Clara, Hirsh, Ariana, Ehrenberg, Alexander J, Kantor, Rose, Metzger, Matthew, Nelson, Kara L, Urnov, Fyodor D, Ringeisen, Bradley R, Giannikopoulos, Petros, and Doudna, Jennifer A

Subjects
Genetic Testing, Vaccine Related, Biodefense, Genetics, Biotechnology, Prevention, Infectious Diseases, Lung, Emerging Infectious Diseases, Detection, screening and diagnosis, 4.2 Evaluation of markers and technologies, Infection, Good Health and Well Being, COVID-19, DNA Primers, Humans, RNA, Viral, Real-Time Polymerase Chain Reaction, Ribonuclease P, SARS-CoV-2, Sensitivity and Specificity, Specimen Handling, Wastewater, Wastewater-Based Epidemiological Monitoring, IGI Testing Consortium, General Science & Technology
Abstract

Clinical and surveillance testing for the SARS-CoV-2 virus relies overwhelmingly on RT-qPCR-based diagnostics, yet several popular assays require 2-3 separate reactions or rely on detection of a single viral target, which adds significant time, cost, and risk of false-negative results. Furthermore, multiplexed RT-qPCR tests that detect at least two SARS-CoV-2 genes in a single reaction are typically not affordable for large scale clinical surveillance or adaptable to multiple PCR machines and plate layouts. We developed a RT-qPCR assay using the Luna Probe Universal One-Step RT-qPCR master mix with publicly available primers and probes to detect SARS-CoV-2 N gene, E gene, and human RNase P (LuNER) to address these shortcomings and meet the testing demands of a university campus and the local community. This cost-effective test is compatible with BioRad or Applied Biosystems qPCR machines, in 96 and 384-well formats, with or without sample pooling, and has a detection sensitivity suitable for both clinical reporting and wastewater surveillance efforts.

Published
2021

21. Launching a saliva-based SARS-CoV-2 surveillance testing program on a university campus

Author

Ehrenberg, Alexander J, Moehle, Erica A, Brook, Cara E, Doudna Cate, Andrew H, Witkowsky, Lea B, Sachdeva, Rohan, Hirsh, Ariana, Barry, Kerrie, Hamilton, Jennifer R, Lin-Shiao, Enrique, McDevitt, Shana, Valentin-Alvarado, Luis, Letourneau, Kaitlyn N, Hunter, Lauren, Keller, Amanda, Pestal, Kathleen, Frankino, Phillip A, Murley, Andrew, Nandakumar, Divya, Stahl, Elizabeth C, Tsuchida, Connor A, Gildea, Holly K, Murdock, Andrew G, Hochstrasser, Megan L, O’Brien, Elizabeth, Ciling, Alison, Tsitsiklis, Alexandra, Worden, Kurtresha, Dugast-Darzacq, Claire, Hays, Stephanie G, Barber, Colin C, McGarrigle, Riley, Lam, Emily K, Ensminger, David C, Bardet, Lucie, Sherry, Carolyn, Harte, Anna, Nicolette, Guy, Giannikopoulos, Petros, Hockemeyer, Dirk, Petersen, Maya, Urnov, Fyodor D, Ringeisen, Bradley R, Boots, Mike, and Doudna, Jennifer A

Subjects
Infectious Diseases, Biodefense, Emerging Infectious Diseases, Clinical Research, Vaccine Related, Prevention, Good Health and Well Being, Adult, Aged, COVID-19, COVID-19 Testing, Female, Humans, Male, Middle Aged, Program Evaluation, RNA, Viral, Reverse Transcriptase Polymerase Chain Reaction, SARS-CoV-2, Saliva, Social Norms, Surveys and Questionnaires, Universities, Young Adult, IGI SARS-CoV-2 Testing Consortium, General Science & Technology
Abstract

Regular surveillance testing of asymptomatic individuals for SARS-CoV-2 has been center to SARS-CoV-2 outbreak prevention on college and university campuses. Here we describe the voluntary saliva testing program instituted at the University of California, Berkeley during an early period of the SARS-CoV-2 pandemic in 2020. The program was administered as a research study ahead of clinical implementation, enabling us to launch surveillance testing while continuing to optimize the assay. Results of both the testing protocol itself and the study participants' experience show how the program succeeded in providing routine, robust testing capable of contributing to outbreak prevention within a campus community and offer strategies for encouraging participation and a sense of civic responsibility.

Published
2021

22. This Contentious Storm: An Ecocritical and Performance History of King Lear

Author

Hamilton, Jennifer Mae

Subjects
Literary studies: plays and playwrights, Comparative literature, Literature: history and criticism, bic Book Industry Communication::D Literature & literary studies::DS Literature: history & criticism::DSG Literary studies: plays & playwrights::DSGS Shakespeare studies & criticism, bic Book Industry Communication::D Literature & literary studies::DS Literature: history & criticism::DSB Literary studies: general::DSBD Literary studies: c 1500 to c 1800, bic Book Industry Communication::D Literature & literary studies::DS Literature: history & criticism::DSA Literary theory
Abstract

This book is available as open access through the Bloomsbury Open Access programme and is available on www.bloomsburycollections.com. From providential apocalypticism to climate change, this ground-breaking ecocritical study traces the performance history of the storm scene in King Lear to explore our shifting, fraught and deeply ideological relationship with stormy weather across time. This Contentious Storm offers a new ecocritical reading of Shakespeare’s classic play, illustrating how the storm has been read as a sign of the providential, cosmological, meteorological, psychological, neurological, emotional, political, sublime, maternal, feminine, heroic and chaotic at different points in history. The big ecocritical history charted here reveals the unstable significance of the weather and mobilises details of the play’s dramatic narrative to figure the weather as a force within self, society and planet.

Published
2017
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23. Blueprint for a pop-up SARS-CoV-2 testing lab

Author

Amen, Alexandra M, Barry, Kerrie W, Boyle, John M, Brook, Cara E, Choo, Seunga, Cornmesser, LT, Dilworth, David J, Doudna, Jennifer A, Ehrenberg, Alexander J, Fedrigo, Indro, Friedline, Skyler E, Graham, Thomas GW, Green, Ralph, Hamilton, Jennifer R, Hirsh, Ariana, Hochstrasser, Megan L, Hockemeyer, Dirk, Krishnappa, Netravathi, Lari, Azra, Li, Hanqin, Lin-Shiao, Enrique, Lu, Tianlin, Lyons, Elijah F, Mark, Kevin G, Martell, Lisa Argento, Martins, A Raquel O, McDevitt, Shana L, Mitchell, Patrick S, Moehle, Erica A, Naca, Christine, Nandakumar, Divya, O'Brien, Elizabeth, Pappas, Derek J, Pestal, Kathleen, Quach, Diana L, Rubin, Benjamin E, Sachdeva, Rohan, Stahl, Elizabeth C, Syed, Abdullah Muhammad, Tan, I-Li, Tollner, Amy L, Tsuchida, Connor A, Tsui, C Kimberly, Turkalo, Timothy K, Urnov, Fyodor D, Warf, M Bryan, Whitney, Oscar N, and Witkowsky, Lea B

Subjects
Betacoronavirus, COVID-19 Testing, California, Clinical Laboratory Techniques, Coronavirus Infections, Humans, Mobile Health Units, SARS-CoV-2, Student Health Services, IGI Testing Consortium
Published
2020

24. Knocking out barriers to engineered cell activity

Author

Hamilton, Jennifer R and Doudna, Jennifer A

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Immunology, Rare Diseases, Biotechnology, Cancer, Genetics, Gene Therapy, Clinical Research, Stem Cell Research, Orphan Drug, Hematology, 5.2 Cellular and gene therapies, Evaluation of treatments and therapeutic interventions, 6.2 Cellular and gene therapies, Development of treatments and therapeutic interventions, Good Health and Well Being, Clustered Regularly Interspaced Short Palindromic Repeats, Humans, Neoplasms, T-Lymphocytes, General Science & Technology
Abstract

CRISPR-Cas9 gene-edited T cells show safety and long-term engraftment in humans

Published
2020

25. IL-4Rα Blockade by Dupilumab Decreases Staphylococcus aureus Colonization and Increases Microbial Diversity in Atopic Dermatitis.

Author

Callewaert, Chris, Nakatsuji, Teruaki, Knight, Rob, Kosciolek, Tomasz, Vrbanac, Alison, Kotol, Paul, Ardeleanu, Marius, Hultsch, Thomas, Guttman-Yassky, Emma, Bissonnette, Robert, Silverberg, Jonathan I, Krueger, James, Menter, Alan, Graham, Neil MH, Pirozzi, Gianluca, Hamilton, Jennifer D, and Gallo, Richard L

Subjects
Th2 Cells, Skin, Humans, Staphylococcus aureus, Staphylococcal Infections, Dermatitis, Atopic, Disease Progression, Receptors, Interleukin-4, RNA, Ribosomal, 16S, Cytokines, Placebos, Immunotherapy, Follow-Up Studies, Double-Blind Method, Female, Male, Antibodies, Monoclonal, Humanized, Infectious Diseases, Genetics, Clinical Research, Human Genome, Eczema / Atopic Dermatitis, Clinical Trials and Supportive Activities, Emerging Infectious Diseases, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Clinical Sciences, Oncology and Carcinogenesis, Dermatology & Venereal Diseases
Abstract

Dupilumab is a fully human antibody to interleukin-4 receptor α that improves the signs and symptoms of moderate to severe atopic dermatitis (AD). To determine the effects of dupilumab on Staphylococcus aureus colonization and microbial diversity on the skin, bacterial DNA was analyzed from swabs collected from lesional and nonlesional skin in a double-blind, placebo-controlled study of 54 patients with moderate to severe AD randomized (1:1) and treated with either dupilumab (200 mg weekly) or placebo for 16 weeks. Microbial diversity and relative abundance of Staphylococcus were assessed by DNA sequencing of 16S ribosomal RNA, and absolute S. aureus abundance was measured by quantitative PCR. Before treatment, lesional skin had lower microbial diversity and higher overall abundance of S. aureus than nonlesional skin. During dupilumab treatment, microbial diversity increased and the abundance of S. aureus decreased. Pronounced changes were seen in nonlesional and lesional skin. Decreased S. aureus abundance during dupilumab treatment correlated with clinical improvement of AD and biomarkers of type 2 immunity. We conclude that clinical improvement of AD that is mediated by interleukin-4 receptor α inhibition and the subsequent suppression of type 2 inflammation is correlated with increased microbial diversity and reduced abundance of S. aureus.

Published
2020

30. Repeat subcutaneous administration of casirivimab and imdevimab in adults is well-tolerated and prevents the occurrence of COVID-19

Author

Isa, Flonza, Forleo-Neto, Eduardo, Meyer, Jonathan, Zheng, Wenjun, Rasmussen, Scott, Armas, Danielle, Oshita, Masaru, Brinson, Cynthia, Folkerth, Steven, Faria, Lori, Heirman, Ingeborg, Sarkar, Neena, Musser, Bret J., Bansal, Shikha, O'Brien, Meagan P., Turner, Kenneth C., Ganguly, Samit, Mahmood, Adnan, Dupljak, Ajla, Hooper, Andrea T., Hamilton, Jennifer D., Kim, Yunji, Kowal, Bari, Soo, Yuhwen, Geba, Gregory P., Lipsich, Leah, Braunstein, Ned, Yancopoulos, George D., Weinreich, David M., and Herman, Gary A.

Published
2022
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33. A Very Secret Agent : an examination of James Brand Pinker and his circle of authors

Author

Hamilton, Jennifer

Subjects
070.50941
Abstract

This thesis examines the influence of the London-based literary agent James Brand Pinker, a former magazine editor who established his agency on Arundel Street in 1896. Working with archives in Britain and America, this investigation situates his career among the broader changes which were taking place within literary culture from the 1890s up to 1922: particularly, heightened commercialisation within the publishing industry and the increasing professionalisation of the author. Literary agents emerged in response – and as an antidote – to these changes. While there has been growing interest in J.B. Pinker for some time, there has been little concentrated study. Due to the impressive array of clients Pinker amassed over the course of his 26-year career, this thesis cannot be exhaustive; it is instead a consideration of selected writers with whom he developed sustained, intimate or unusual relationships. The chapters, organised by author, address Arnold Bennett, Henry James, Joseph Conrad, Ford Madox Ford and finally D.H. Lawrence and James Joyce, the latter two considered together. This structure seeks to reveal the different types of relationship Pinker fostered, enacting roles as diverse as business partner, patron, bank manager, friend and even cinematic collaborator. While these authors enjoyed varying degrees of popular and critical success, taken together they testify to Pinker’s particular interest in promoting and developing the careers of struggling, young literary talent. The agency continued for some years after J.B. Pinker’s death, but this study covers the period from 1896 to 1922, from the establishment of the agency until his death. This thesis aims to contribute to the expanding fields of publishing history and network studies, and to the early history of modernism, as well as to our understanding of the authors concerned.

Published
2018

34. A national postgraduate nurse practitioner and physician assistant fellowship in cystic fibrosis: An innovative approach to the provider shortage in complex and rare disease.

Author

Brady, Cynthia J., Looman, Wendy S., Hamilton, Jennifer L., Dunitz, Jordan, Gilard, Taylor, Sender, Abraham I., and George, Cynthia

Subjects
HEALTH services accessibility, CORPORATE culture, MEDICAL fellowships, ENDOWMENTS, RARE diseases, EVALUATION of human services programs, LEADERSHIP, GOAL (Psychology), LABOR demand, CLINICAL competence, CONCEPTUAL structures, ONLINE education, CURRICULUM planning, OUTCOME-based education, CYSTIC fibrosis
Abstract

The article introduces the Leadership and Education for Advanced Practice Provider (LEAPP) fellowship, an innovative postgraduate program designed to address the shortage of qualified cystic fibrosis (CF) providers by offering specialized training across various CF care centers. Topics include the program's unique blended learning approach, its focus on leadership and quality improvement, and its potential application to other complex conditions requiring specialized care.

Published
2024
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37. Digital wearable insole-based identification of knee arthropathies and gait signatures using machine learning

Author

Wipperman, Matthew F, primary, Lin, Allen Z, additional, Gayvert, Kaitlyn M, additional, Lahner, Benjamin, additional, Somersan-Karakaya, Selin, additional, Wu, Xuefang, additional, Im, Joseph, additional, Lee, Minji, additional, Koyani, Bharatkumar, additional, Setliff, Ian, additional, Thakur, Malika, additional, Duan, Daoyu, additional, Breazna, Aurora, additional, Wang, Fang, additional, Lim, Wei Keat, additional, Halasz, Gabor, additional, Urbanek, Jacek, additional, Patel, Yamini, additional, Atwal, Gurinder S, additional, Hamilton, Jennifer D, additional, Stuart, Samuel, additional, Levy, Oren, additional, Avbersek, Andreja, additional, Alaj, Rinol, additional, Hamon, Sara C, additional, and Harari, Olivier, additional

Published
2024
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39. The monoclonal antibody combination REGEN-COV protects against SARS-CoV-2 mutational escape in preclinical and human studies

Author

Copin, Richard, Baum, Alina, Wloga, Elzbieta, Pascal, Kristen E., Giordano, Stephanie, Fulton, Benjamin O., Zhou, Anbo, Negron, Nicole, Lanza, Kathryn, Chan, Newton, Coppola, Angel, Chiu, Joyce, Ni, Min, Wei, Yi, Atwal, Gurinder S., Hernandez, Annabel Romero, Saotome, Kei, Zhou, Yi, Franklin, Matthew C., Hooper, Andrea T., McCarthy, Shane, Hamon, Sara, Hamilton, Jennifer D., Staples, Hilary M., Alfson, Kendra, Carrion, Ricardo, Jr., Ali, Shazia, Norton, Thomas, Somersan-Karakaya, Selin, Sivapalasingam, Sumathi, Herman, Gary A., Weinreich, David M., Lipsich, Leah, Stahl, Neil, Murphy, Andrew J., Yancopoulos, George D., and Kyratsous, Christos A.

Published
2021
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40. Staff perceptions on the effectiveness of GRiP-S, a new approach to clinical supervision incorporating safewards: An interpretive phenomenological analysis

Author

Hamilton, Jennifer, Cole, Amanda, Bostwick, Richard, Ngune, Irene, Hamilton, Jennifer, Cole, Amanda, Bostwick, Richard, and Ngune, Irene

Abstract

This study explored the impact of an innovative approach to clinical supervision for mental health nurses which integrates Safewards, named Group Reflective integrated Practice with Safewards–GRiP-S. Qualitative data was collected through 10 individual semi-structured interviews with nursing staff who had participated within the clinical supervision approach. Interviews provided insights into the nursing staff’s perception and experience of the clinical supervision approach. Through interpretive phenomenological analysis six themes emerged (i) illuminating embodied practice of Safewards, (ii) building confidence through empowering connections, (iii) creating a culture of positive change, (iv) identifying internal motivation for and external barriers to supervision engagement, (v) navigating a global pandemic, and (vi) the transformative role of reflection. Findings demonstrated that the GRiP-S approach assisted mental health nurses’ adoption of Safewards interventions in practice, while supporting the development of a cohesive staff team. The impact of COVID-19 within the study setting was addressed and nurses identified how the Safewards model assisted in navigating challenges during this time. Findings further supported prior research on the role of the supervisor and supervisee relationship. This study supports the integration of Safewards within reflective clinical supervision for mental health nursing staff to assist in Safewards fidelity and nursing staff personal and professional development.

Published
2024

41. Dupilumab Normalized The Expression Of Genes Dysregulated In Eosinophilic Esophagitis (EoE) In Esophageal Biopsies From A Clinical Trial Of Children Aged 1–11 Years

Author

Rothenberg, Marc, primary, Lim, Wei Keat, additional, Wipperman, Matthew, additional, Chehade, Mirna, additional, Dellon, Evan, additional, Hundal, Navneet Virk, additional, Schroeder, Shauna, additional, Parrish, Christopher, additional, Liu, Ruiqi, additional, Laws, Elizabeth, additional, Mortensen, Eric, additional, Glotfelty, Lila, additional, Shabbir, Arsalan, additional, Hicks, Alexandra, additional, and Hamilton, Jennifer, additional

Published
2024
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42. Dupilumab Improves Histologic And Endoscopic Outcomes In Children Aged 1 To <12 Years With Eosinophilic Esophagitis (EoE): 52-Week Results From The Phase 3 EoE KIDS Trial

Author

Chehade, Mirna, primary, Dellon, Evan, additional, Spergel, Jonathan, additional, Rothenberg, Marc, additional, Pesek, Robert, additional, Collins, Margaret, additional, Hirano, Ikuo, additional, Liu, Ruiqi, additional, Laws, Elizabeth, additional, Mortensen, Eric, additional, Martincova, Renata, additional, Maloney, Jennifer, additional, McCann, Eilish, additional, Kosloski, Matthew, additional, Hamilton, Jennifer, additional, Samuely, Carin, additional, Glotfelty, Lila, additional, and Shabbir, Arsalan, additional

Published
2024
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43. Targeting Viral Proteostasis Limits Influenza Virus, HIV, and Dengue Virus Infection (vol 44, pg 46, 2016)

Author

Heaton, Nicholas S, Moshkina, Natasha, Fenouil, Romain, Gardner, Thomas J, Aguirre, Sebastian, Shah, Priya S, Zhao, Nan, Manganaro, Lara, Hultquist, Judd F, Noel, Justine, Sachs, David, Hamilton, Jennifer, Leon, Paul E, Chawdury, Amit, Tripathi, Shashank, Melegari, Camilla, Campisi, Laura, Hai, Rong, Metreveli, Giorgi, Gamarnik, Andrea V, Garcia-Sastre, Adolfo, Greenbaum, Benjamin, Simon, Viviana, Fernandez-Sesma, Ana, Krogan, Nevan J, Mulder, Lubbertus CF, van Bakel, Harm, Tortorella, Domenico, Taunton, Jack, Palese, Peter, and Marazzi, Ivan

Subjects
Immunology
Published
2016

44. Nasopharyngeal Viral Load Is the Major Driver of Incident Antibody Immune Response to SARS-CoV-2 Infection

Author

Xu, Meng, primary, O’Brien, Meagan P, additional, Hooper, Andrea T, additional, Forleo-Neto, Eduardo, additional, Isa, Flonza, additional, Hou, Peijie, additional, Chan, Kuo-Chen, additional, Cohen, Myron S, additional, Marovich, Mary A, additional, Hamilton, Jennifer D, additional, Hirshberg, Boaz, additional, Herman, Gary A, additional, and Musser, Bret J, additional

Published
2023
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46. Striving Readers Study: Targeted & Whole-School Interventions -- Year 5

Author

Westat, Inc., Department of Education (ED), Meisch, Allison, Hamilton, Jennifer, Chen, Eva, Quintanilla, Priscilla, Fong, Pauline, Gray-Adams, Karen, Petta, Ian, and Thornton, Nancy

Abstract

This report summarizes the results of the Newark, New Jersey, Striving Readers program for project Years 1, 2, 3, 4, and 5. This report updates one analysis (3 years); the remainder of the impacts and implementation findings are for Year 4. The Striving Readers Grant addresses the unmet needs of middle school students reading 2 or more years below grade level and provides professional development for teachers in all core content areas to help them learn about and use more effective literacy strategies. Nineteen middle schools in Newark are participating in the U.S. Department of Education Striving Readers study. Two components of the project are being evaluated: a targeted intervention and a whole-school intervention. [This report is the product of a collaborative effort involving numerous individuals at Westat and Newark Public Schools.]

Published
2011

48. Using Randomized Clinical Trials to Determine the Impact of Reading Intervention on Struggling Adolescent Readers: Reports of Research from Five Nationally Funded Striving Readers Grants

Author

Society for Research on Educational Effectiveness (SREE), Loadman, William, Sprague, Kim, Hamilton, Jennifer, Coffey, Deb, and Faddis, Bonnie

Abstract

In 2005, the U.S. Department of Education awarded eight Striving Readers grants to projects around the country. The goal of Striving Readers is to improve literacy skills and achievement for struggling readers in middle and high school and to increase the research base using randomized clinical research to address improvement in adolescent literacy instruction. This session will present results to date from the five Striving Readers sites that use READ 180. (Contains 2 exhibits.)

Published
2010

49. Five Randomized Trials to Assess the Effectiveness of Adolescent Literacy Interventions: Realities of Design and Implementation and Influences on Impact

Author

Society for Research on Educational Effectiveness (SREE), Sprague, Kim, Hamilton, Jennifer, Coffey, Deb, Loadman, William, and Faddis, Bonnie

Abstract

Rigorous research provides information that will allow other schools and districts to select interventions that have a scientifically based track record of effectiveness. All Striving Reader grants include the mandate to evaluate literacy intervention(s) targeted to adolescents who are reading significantly below grade level. Although all studies followed the same guidelines for evaluation, each was implemented in a different context, evaluated different interventions or curricula, and utilized different evaluation designs. This symposium will bring together five evaluations to share information about the challenges in both designing and implementing the designs of such studies after two years of implementation. In addition, the consideration of implementation context in the interpretation of the results and what should be done when planning to implement will also be discussed. As a result evaluators hope to provide important information to those planning similar studies in school districts and other complex social settings.

Published
2009

50. A Study of Classroom Literacy Interventions and Outcomes in Even Start. NCEE 2008-4028

Author

Institute of Education Sciences (ED), National Center for Education Evaluation and Regional Assistance, Judkins, David, St. Pierre, Robert, Gutmann, Babette, Goodson, Barbara, von Glatz, Adrienne, Hamilton, Jennifer, Webber, Ann, Troppe, Patricia, and Rimdzius, Tracy

Abstract

The Even Start Family Literacy Program was established in 1989 to help break the cycle of poverty and illiteracy for low-income families, by improving the literacy skills of parents and their young children. Even Start projects offer family literacy services, defined as four integrated instructional components: (1) Childhood Education (ECE); (2) Parenting Education (PE); (3) Parent-Child Literacy Activities (PC); and (4) Adult Education (AE). The Even Start Classroom Literacy Interventions and Outcomes (CLIO) Study presents 2-year impacts of the curricula on child language, literacy, and social competence; parenting skills; parent literacy; and instructional practices and participation in preschool and parenting classes. Prior studies have established that Even Start does not have statistically significant impacts on children's emergent literacy or on parent literacy. The CLIO study investigated whether the implementation of research-based, literacy-focused curricula would improve literacy outcomes for Even Start children and parents. Although there were positive impacts on some of the literacy supports in preschool classrooms, on time spent on child literacy in parenting education classes, on parenting skills, and on children's social competence, there were no statistically significant impacts on children's language and literacy. There was no evidence that the failure to find impacts on these core outcomes was due to a classrooms or cross-over in the control classrooms. Fifteen appendices are included: (1) Descriptive Comparison of the Five Groups; (2) Child and Parent Literacy Outcomes; (3) Construction of the Child Social Competence Scale; (4) Construction of Parenting Skills Scales; (5) Preschool Instructional Outcome Variables; (6) Parenting Instructional Outcome Variables; (7) Fidelity Measurement; (8) Final Multi-Level Outcome Models; (9) Effect Size Calculation; (10) Sample Sizes and Methods Used for Missing Data; (11) ITT Tables for Single Developer Contrasts; (12) Growth Analysis; (13) Interactions of Curriculum with Home Language and Ethnicity; (14) Simulation Study of Method for Exploring Fidelity-Adjusted Relationships; and (15) Participation and Participation-Adjusted Group Differences. (Contains 79 footnotes, 23 figures and 110 tables.)

Published
2008

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