EFFECTIVE GRANT WRITING - University of Washington



AFYA BORA CONSORTIUM GLOBAL HEALTH LEADERSHIP FELLOWSHIP PROGRAMEFFECTIVE GRANT WRITING AFYA BORA CONSORTIUM Table of Contents TOC \o "1-3" \h \z \u MODULE LEARNING OBJECTIVES PAGEREF _Toc9512535 \h 3EFFECTIVE PROPOSAL WRITING MODULE SCHEDULE PAGEREF _Toc9512536 \h 4EFFECTIVE PROPOSAL WRITING MODULE OBJECTIVES & READINGS FOR SPECIFIC SESSIONS PAGEREF _Toc9512537 \h 5Session 1: Introduction to Proposal Writing PAGEREF _Toc9512538 \h 6Session 2: Proposal Basics: Hypotheses & Specific Aims PAGEREF _Toc9512539 \h 6Session 3: Proposal Basics: Innovation & Significance PAGEREF _Toc9512540 \h 7Session 4: Proposal Basics: Analysis/Sample Size Plans PAGEREF _Toc9512541 \h 7 PAGEREF _Toc9512542 \h 8Session 5: Research with Human Subjects and Ethics Case Studies PAGEREF _Toc9512543 \h 8Session 6: Proposal Basics: Approach & Methods PAGEREF _Toc9512544 \h 8Session 7: Writing the Qualitative Research Methods Section PAGEREF _Toc9512545 \h 9Session 8: Sample Size Exercise PAGEREF _Toc9512546 \h 9Session 9: Proposal Basics: Supporting Materials and Career Development Awards PAGEREF _Toc9512547 \h 10Session 10: NIH Peer Review Process PAGEREF _Toc9512548 \h 10Session 11 : Expert Perspectives on Grant Submission PAGEREF _Toc9512549 \h 11Appendix 1. List of Instructors and Invited Speakers PAGEREF _Toc9512550 \h 12Appendix 2: Critique Template PAGEREF _Toc9512551 \h 13Appendix 3: Homework Exercises PAGEREF _Toc9512552 \h 16Exercise #1: Hypotheses and Specific Aims PAGEREF _Toc9512553 \h 16Exercise #2: Research Methods PAGEREF _Toc9512554 \h 17Exercise #3: Data Analysis and Sample Size PAGEREF _Toc9512555 \h 18Appendix 4: Literature Review Table PAGEREF _Toc9512556 \h 19Appendix 5: List of sources PAGEREF _Toc9512557 \h 20NOTES PAGEREF _Toc9512558 \h 21NOTES PAGEREF _Toc9512559 \h 21MODULE OVERVIEW This training module provides instruction in proposal writing, a critical first step in conducting a successful research project. Topics covered during the week include: effective writing, the components of a research proposal, quantitative and qualitative study design, and the peer review process. The module emphasizes skills required to write a proposal by having trainees spend at least one-third of the time in class and out of class developing their own proposals with feedback from each other and the course instructors. Ethical conduct and research with human subjects are two critical areas in the responsible conduct of research that have been covered elsewhere in the Fellowship (see Responsible Conduct of Research distance learning module). Principles will be reviewed and specific cases relevant to research proposal and grant writing will be discussed in this module.MODULE LEARNING OBJECTIVESOn course completion the student will be able to:Identify the key components of a successful grant proposal and discuss at least two “pearls” for writing each section.Demonstrate knowledge of the different qualitative and quantitative approaches and use these effectively in designing a study.Describe the grant application process and participate in reviewing a proposal using NIH criteria for peer review.Write a competitive research proposal with input from a mentor and more senior colleagues. EFFECTIVE PROPOSAL WRITING MODULE SCHEDULEDay 1 Day 2Day 3Day 49:00-10:00Session 1Introduction to Proposal WritingSession 3 Proposal Basics: Innovation & Significance Session 6Proposal Basics: Approach & MethodsSession 9Proposal Basics: Supporting Materials and Career Development Awards (HW #3 due)10:00-11:30Session 2Proposal Basics: Hypotheses & Specific AimsSession 4 Proposal Basics: Analysis/Sample Size Plans Session 7Sample Size ExerciseSession 10NIH Peer Review Process11:30-12:00BREAKBREAKBREAKBREAK12:00-1:00Group ExerciseWriting SkillsSession 5Research with Human Subjects and Ethics Case StudiesSession 8 Writing the Qualitative Research Methods SectionSession 11 (start at 11:30)Expert Perspectives on Grant Submission: Local Researchers Panel Discussion1:00-2:00LUNCHLUNCHLUNCHLUNCH2:00-3:00Introduction to Small Group DiscussionsSmall Group DiscussionSpecific Aims II(HW #1 due)Small Group DiscussionApproach & Methods I (HW #2 due)Final Presentations and Awards 3:00-4:00Small Group DiscussionSpecific Aims ISmall Group DiscussionsInnovation & Significance ISmall Group DiscussionApproach & Methods II4:00-4:30Wrap-up SessionEFFECTIVE PROPOSAL WRITING MODULE OBJECTIVES & READINGS FOR SPECIFIC SESSIONSOne of the best ways to learn how to write a grant is to read successful grants written by other researchers in the same field. We have identified 5 short proposals that will be used as the readings for the sessions below. Each session will specify which section of the grant is to be read. Trainees should read this section in all SIX grants and come to class prepared to discuss strengths and weaknesses of each section. The grants are as follows:Improving Uptake of Early Infant Diagnosis of HIV for PMTCT: RCT of a Text Messaging Intervention (PI Thomas Odeny)HIV Testing and Educating Male Partners to Improve Maternal and Infant Outcomes (PI Carey Farquhar)Human Herpesvirus-8 Replication and Kaposi Sarcoma Response to Treatment (PI Warren Phipps)Overcoming Barriers to HIV/AIDS Care and ART Initiation (PI Brandon Guthrie)Motivation matters! RCT of theory-based, 2-way SMS to support TASP in African FSW (PI Scott McClelland)Gender Specific Prevalence of Multiple Strain HSV-2 Infection: A Global View (PI Anna Wald)In addition to the above readings, journal articles may also be assigned or listed as optional reading. These have been carefully selected to complement material presented in class and will also be a topic of discussion (if required).Session 1: Introduction to Proposal WritingLearning Objectives:Prepare a realistic timeline for grant preparation Describe the optimal composition of a proposal writing committee Identify the different sections of a grant proposalName different types of funding sources and what is included in an RFAReadings:Review the overall format of the research grants provided and be prepared to identify similarities and differences in the organizational structure of these grants. Pay particular attention to headings, subheadings, use of figures and tables, and number of references.Garcia, P. J., & Curioso, W. H. (2008). Strategies for aspiring biomedical researchers in resource-limited environments.?PLoS Neglected Tropical Diseases,?2(8), e274. Session 2: Proposal Basics: Hypotheses & Specific AimsLearning Objectives:Describe the importance and rationale for including your research hypotheses Prepare a Specific Aims page following the recommended formatIdentify key elements in the introductory paragraph and Aims and incorporate these into your proposalsReadings:The Specific Aims pages for each of the research grants provided. Session 3: Proposal Basics: Innovation & Significance Learning Objectives:Identify domains of knowledge relevant to significance of a proposalDescribe components of well-written significance sectionUnderstand the concept of innovation in the setting of proposal writing Readings: The Significance sections and the Innovation sections of research grants provided.Session 4: Proposal Basics: Analysis/Sample Size PlansLearning Objectives:Identify the necessary elements of an analysis plan and a monitoring and evaluation plan.Understand how the analysis plan supports the rest of the proposal and how each specific aim is represented in the analysis plan.Describe common weaknesses in analysis and M&E plans.Explain how the scope of an analysis plans is directed by the nature of the proposal.Readings: Greenhalgh T. (1997). How to read a paper. Statistics for the non-statistician. I: Different types of data need different statistical tests. BMJ;315(7104):364-6.Greenhalgh T. (1997). How to read a paper. Statistics for the non-statistician. II: "Significant" relations and their pitfalls. BMJ;315(7105):422-5.Session 5: Research with Human Subjects and Ethics Case StudiesLearning Objectives:Discuss real-life issues that come up when conducting research in resource-limited settingsHighlight issues that are often beyond what is covered by IRB monitoringReadings: Bandewar S, Kimani J, Lavery J. (2010). The origins of a research community in the Majengo observational cohort study, Nairobi, Kenya. BMC Public Health. 10:630.Corneli A, Sorenson J, Bentley M, et al. (2012). Improving Participant Understanding of Informed Consent in an HIV-Prevention Clinical Trial: A Comparison of Methods. AIDS Behav. 16:412-421. Nama N, Swartz L. (2002). Ethical and Social Dilemmas in Community-based Controlled Trials in Situations of Poverty: A View from a South African Project. J. Community Appl. Soc. Psychol. 12:286-297.Reddy P, Buchanan D, Sifunda S, et al. (2010). The role of community advisory boards in health research: Divergent views in the South African experience. SAHARA J. 7(3):2-8.Vallely A, Lees S, Shagi C, et al. (2010). How informed is consent in vulnerable populations? Experience using a continuous consent process during the MDP301 vaginal microbicide trial in Mwanza, Tanzania. BMC Medical Ethics. 11:10.Session 6: Proposal Basics: Approach & MethodsLearning Objectives:Identify key components of research design to include in a grant proposal Describe strategies for outlining key aspects of research methods, including study design, eligibility criteria and study procedures.Readings:The Approach and Methods sections of the grants provided.Session 7: Writing the Qualitative Research Methods SectionLearning Objectives:Compose qualitative research questions and recognize appropriate questions to answer with qualitative methodsDescribe incorporation of qualitative research methods in grant writingReadings:Sandelowski M. (2000). Combining qualitative and quantitative sampling, data collection, and analysis techniques in mixed-method studies. Research in Nursing & Health. 23:246–255.Sandelowski M, Barroso J. (2003). Writing the proposal for a qualitative research methodology project. Qualitative Health Research. 13: 6: 781-820.Session 8: Sample Size ExerciseLearning Objectives:Explain why appropriate sample size/power calculations are important in the appropriate design of epidemiologic studies.Define elements required to conduct a sample size/power calculation.Identify the appropriate effect measure to be used in a sample size/power calculation. Explain how to choose an effect size to use in a sample size/power calculation.Conduct a sample size and power calculation for the comparison of a continuous and binary outcome between two groups and write an appropriate sample size/power justification appropriate for a research proposal. Readings: Moher D, Dulberg CS, Wells GA. Statistical power, sample size, and their reporting in randomized controlled trials. JAMA. 1994;272:122–124.Whitley E, Ball J. Statistics review 4: Sample size calculations Crit Care. 2002; 6(4): 335–341.Session 9: Proposal Basics: Supporting Materials and Career Development AwardsLearning Objectives:Identify supplemental components of grant proposalsRecognize time-sensitive elements of proposals and describe work-planning strategies to meet submission deadlinesExplain how each piece of supporting material complements the research portion of the proposal.Describe the characteristics of a strong letter of support.Outline the information that should be included in the “resources” section and how it is used by reviewers to evaluate your proposal.Readings:Review the letters, biosketches (especially the first paragraph), resources, and human subjects sections of the complete grant provided.Session 10: NIH Peer Review ProcessLearning Objectives:Describe the process of review that many peer-reviewed institutions employUnderstand the “scoring rubric” by which grants are scoredReadings:Benos DJ, Bashari E, Chaves JM, et al. (2007). The ups and downs of peer review. Advances in Physiology Education. 31: 145-152.Session 11 : Expert Perspectives on Grant SubmissionLearning Objectives:Identify specific characteristics of a successful grant proposal Provide examples of common pitfalls found in research proposalsGain an understanding of challenges faced by researchers from resource-limited settings in preparing successful research proposals and develop strategies to respond to these challenges Appendix 1. List of Instructors and Invited SpeakersChristine McGrath, PhD, MPHAssistant ProfessorDepartment of Global Health?University of Washingtonmcgrathc@uw.eduAliza Monroe-Wise, MD, MScActing Assistant Professor, Departments of Global Health & MedicineUniversity of Washingtonemail: alizamw@uw.edu Monisha Sharma, PhD, ScMActing Assistant ProfessorDepartment of Global HealthUniversity of Washingtonmsharma1@uw.edu Rose Bosire, MBChB, MPH, PhD.Senior Research Scientist, Kenya Medical Research Institute.bosirero@uw.eduCarey Farquhar, MD, MPHProfessorDepartments of Global Health, Medicine, and EpidemiologyUniversity of Washingtoncfarq@uw.edu Appendix 2: Critique TemplateApplication #Principal Investigator(s)Overall ImpactReviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five-scored review criteria, and additional review criteria. An application does not need to be strong in all categories to be judged likely to have major scientific impact.Overall ImpactStrengthsWeaknessesScored Review CriteriaReviewers will consider each of the five review criteria below in the determination of scientific and technical merit and give a separate score for each. 1. SignificanceStrengths Weaknesses2. Investigator(s)Strengths Weaknesses3. InnovationStrengths Weaknesses 4. ApproachStrengths Weaknesses 5. EnvironmentStrengthsWeaknesses Additional Review CriteriaAs applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit but will not give separate scores for these items. Responses for Protections for Human Subjects, Vertebrate Animals, and Biohazards are required for all applications. A response for Inclusion of Women, Minorities and Children is required for applications proposing Human Subjects Research.Appendix 3: Homework ExercisesThe following exercises are designed to help Fellows understand the grant writing process. Each exercise requires the Fellows to create a specific section that is required when submitting grants. The exercises build upon one another.Exercise 1: Hypotheses and specific aimsExercise 2: Research methods Exercise 3: Data analysis and sample sizeExercise #1: Hypotheses and Specific AimsWrite a short introductory paragraph followed by your specific aims and hypotheses as shown in the example below. HIV-1 exposed infants suffer from high levels of morbidity and mortality, even in the absence of HIV-1 infection, ADDIN EN.CITE <EndNote><Cite><Author>Brahmbhatt</Author><Year>2006</Year><RecNum>5</RecNum><record><rec-number>5</rec-number><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Brahmbhatt, H.</author><author>Kigozi, G.</author><author>Wabwire-Mangen, F.</author><author>Serwadda, D.</author><author>Lutalo, T.</author><author>Nalugoda, F.</author><author>Sewankambo, N.</author><author>Kiduggavu, M.</author><author>Wawer, M.</author><author>Gray, R.</author></authors></contributors><auth-address>Department of Population and Family Health Sciences, The Johns Hopkins University, Bloomberg School of Public Health, Baltimore, MD 21205, USA. hbrahmbh@jhsph.edu</auth-address><titles><title>Mortality in HIV-infected and uninfected children of HIV-infected and uninfected mothers in rural Uganda</title><secondary-title>J Acquir Immune Defic Syndr</secondary-title></titles><periodical><full-title>J Acquir Immune Defic Syndr</full-title></periodical><pages>504-8</pages><volume>41</volume><number>4</number><keywords><keyword>CD4 Lymphocyte Count</keyword><keyword>Female</keyword><keyword>HIV Infections/*mortality/virology</keyword><keyword>*HIV-1/physiology</keyword><keyword>Humans</keyword><keyword>Infant</keyword><keyword>*Infant Mortality</keyword><keyword>Infant, Newborn</keyword><keyword>Multivariate Analysis</keyword><keyword>Pregnancy</keyword><keyword>*Rural Population</keyword><keyword>Statistics as Topic</keyword><keyword>Survival Analysis</keyword><keyword>Uganda/epidemiology</keyword><keyword>Viral Load</keyword></keywords><dates><year>2006</year><pub-dates><date>Apr 1</date></pub-dates></dates><accession-num>16652060</accession-num><urls><related-urls><url> </url></related-urls></urls></record></Cite><Cite><Author>Kuhn</Author><Year>2005</Year><RecNum>4</RecNum><record><rec-number>4</rec-number><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Kuhn, L.</author><author>Kasonde, P.</author><author>Sinkala, M.</author><author>Kankasa, C.</author><author>Semrau, K.</author><author>Scott, N.</author><author>Tsai, W. Y.</author><author>Vermund, S. H.</author><author>Aldrovandi, G. M.</author><author>Thea, D. M.</author></authors></contributors><auth-address>Gertrude H. Sergievsky Center, Mailman School of Public Health, Columbia University, New York, NY, USA. lk24@columbia.edu</auth-address><titles><title>Does severity of HIV disease in HIV-infected mothers affect mortality and morbidity among their uninfected infants?</title><secondary-title>Clin Infect Dis</secondary-title></titles><periodical><full-title>Clin Infect Dis</full-title></periodical><pages>1654-61</pages><volume>41</volume><number>11</number><keywords><keyword>Aging</keyword><keyword>Birth Weight</keyword><keyword>CD4 Lymphocyte Count</keyword><keyword>Cohort Studies</keyword><keyword>Female</keyword><keyword>HIV Infections/*immunology/*physiopathology</keyword><keyword>Hospitalization</keyword><keyword>Humans</keyword><keyword>Immune Tolerance</keyword><keyword>Infant</keyword><keyword>*Infant Mortality</keyword><keyword>Infant, Newborn</keyword><keyword>*Mothers</keyword><keyword>Risk Factors</keyword><keyword>Zambia/epidemiology</keyword></keywords><dates><year>2005</year><pub-dates><date>Dec 1</date></pub-dates></dates><accession-num>16267740</accession-num><urls><related-urls><url> </url></related-urls></urls></record></Cite><Cite><Author>Marinda</Author><Year>2007</Year><RecNum>6</RecNum><record><rec-number>6</rec-number><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Marinda, E.</author><author>Humphrey, J. H.</author><author>Iliff, P. J.</author><author>Mutasa, K.</author><author>Nathoo, K. J.</author><author>Piwoz, E. G.</author><author>Moulton, L. H.</author><author>Salama, P.</author><author>Ward, B. J.</author></authors></contributors><auth-address>ZVITAMBO Project, Harare, Zimbabwe.</auth-address><titles><title>Child mortality according to maternal and infant HIV status in Zimbabwe</title><secondary-title>Pediatr Infect Dis J</secondary-title></titles><periodical><full-title>Pediatr Infect Dis J</full-title></periodical><pages>519-26</pages><volume>26</volume><number>6</number><keywords><keyword>Adolescent</keyword><keyword>Adult</keyword><keyword>Cause of Death</keyword><keyword>*Child Mortality</keyword><keyword>Child, Preschool</keyword><keyword>Disease Transmission, Vertical</keyword><keyword>Female</keyword><keyword>HIV Infections/complications/epidemiology/*mortality</keyword><keyword>Humans</keyword><keyword>Infant</keyword><keyword>*Infant Mortality</keyword><keyword>Infant, Newborn</keyword><keyword>Male</keyword><keyword>Pregnancy</keyword><keyword>Respiratory Tract Infections/complications/epidemiology/mortality</keyword><keyword>Risk Factors</keyword><keyword>Time Factors</keyword><keyword>Zimbabwe/epidemiology</keyword></keywords><dates><year>2007</year><pub-dates><date>Jun</date></pub-dates></dates><accession-num>17529870</accession-num><urls><related-urls><url> </url></related-urls></urls></record></Cite><Cite><Author>Mbori-Ngacha</Author><Year>2001</Year><RecNum>2</RecNum><record><rec-number>2</rec-number><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Mbori-Ngacha, D.</author><author>Nduati, R.</author><author>John, G.</author><author>Reilly, M.</author><author>Richardson, B.</author><author>Mwatha, A.</author><author>Ndinya-Achola, J.</author><author>Bwayo, J.</author><author>Kreiss, J.</author></authors></contributors><auth-address>Department of Paediatrics, University of Nairobi, Kenya.</auth-address><titles><title>Morbidity and mortality in breastfed and formula-fed infants of HIV-1-infected women: A randomized clinical trial</title><secondary-title>Jama</secondary-title></titles><periodical><full-title>Jama</full-title></periodical><pages>2413-20</pages><volume>286</volume><number>19</number><keywords><keyword>Adult</keyword><keyword>*Breast Feeding</keyword><keyword>Cause of Death</keyword><keyword>Developing Countries</keyword><keyword>Diarrhea, Infantile/epidemiology</keyword><keyword>Female</keyword><keyword>HIV Infections/epidemiology/*transmission</keyword><keyword>*Hiv-1</keyword><keyword>Humans</keyword><keyword>Infant</keyword><keyword>*Infant Food</keyword><keyword>*Infant Mortality</keyword><keyword>Infant, Newborn</keyword><keyword>Kenya</keyword><keyword>Male</keyword><keyword>Morbidity</keyword><keyword>Nutritional Status</keyword><keyword>Pneumonia/epidemiology</keyword><keyword>Proportional Hazards Models</keyword><keyword>Risk</keyword><keyword>Survival Analysis</keyword></keywords><dates><year>2001</year><pub-dates><date>Nov 21</date></pub-dates></dates><accession-num>11712936</accession-num><urls><related-urls><url> </url></related-urls></urls></record></Cite><Cite><Author>Nakiyingi</Author><Year>2003</Year><RecNum>3</RecNum><record><rec-number>3</rec-number><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Nakiyingi, J. S.</author><author>Bracher, M.</author><author>Whitworth, J. A.</author><author>Ruberantwari, A.</author><author>Busingye, J.</author><author>Mbulaiteye, S. M.</author><author>Zaba, B.</author></authors></contributors><auth-address>Medical Research Council Programme on AIDS in Uganda, Uganda Virus Research Institute PO Box 49, Entebbe, Uganda. jessica.nakiyingi@mrcuganda.</auth-address><titles><title>Child survival in relation to mother&apos;s HIV infection and survival: evidence from a Ugandan cohort study</title><secondary-title>Aids</secondary-title></titles><periodical><full-title>Aids</full-title></periodical><pages>1827-34</pages><volume>17</volume><number>12</number><keywords><keyword>Adolescent</keyword><keyword>Adult</keyword><keyword>Child, Preschool</keyword><keyword>Female</keyword><keyword>HIV Infections/*mortality</keyword><keyword>Humans</keyword><keyword>Infant</keyword><keyword>*Infant Mortality</keyword><keyword>Infant, Newborn</keyword><keyword>Longitudinal Studies</keyword><keyword>Male</keyword><keyword>Maternal Age</keyword><keyword>*Maternal Mortality</keyword><keyword>Pregnancy</keyword><keyword>Pregnancy, Multiple</keyword><keyword>Proportional Hazards Models</keyword><keyword>Uganda/epidemiology</keyword></keywords><dates><year>2003</year><pub-dates><date>Aug 15</date></pub-dates></dates><accession-num>12891069</accession-num><urls><related-urls><url> </url></related-urls></urls></record></Cite><Cite><Author>Shapiro</Author><Year>2007</Year><RecNum>1</RecNum><record><rec-number>1</rec-number><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Shapiro, R. L.</author><author>Lockman, S.</author><author>Kim, S.</author><author>Smeaton, L.</author><author>Rahkola, J. T.</author><author>Thior, I.</author><author>Wester, C.</author><author>Moffat, C.</author><author>Arimi, P.</author><author>Ndase, P.</author><author>Asmelash, A.</author><author>Stevens, L.</author><author>Montano, M.</author><author>Makhema, J.</author><author>Essex, M.</author><author>Janoff, E. N.</author></authors></contributors><auth-address>Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, MA 02215, USA. rshapiro@bidmc.harvard.edu</auth-address><titles><title>Infant morbidity, mortality, and breast milk immunologic profiles among breast-feeding HIV-infected and HIV-uninfected women in Botswana</title><secondary-title>J Infect Dis</secondary-title></titles><periodical><full-title>J Infect Dis</full-title></periodical><pages>562-9</pages><volume>196</volume><number>4</number><keywords><keyword>Antibodies, Bacterial/analysis/immunology</keyword><keyword>Antibody Specificity</keyword><keyword>Botswana/epidemiology</keyword><keyword>Breast Feeding</keyword><keyword>Campylobacter jejuni/immunology</keyword><keyword>Case-Control Studies</keyword><keyword>Child, Preschool</keyword><keyword>Female</keyword><keyword>HIV Infections/*epidemiology/*immunology</keyword><keyword>*Hiv-1</keyword><keyword>Haemophilus influenzae/immunology</keyword><keyword>Helicobacter pylori/immunology</keyword><keyword>Humans</keyword><keyword>Immunity, Natural</keyword><keyword>Immunoglobulin A/analysis</keyword><keyword>Immunoglobulin G/analysis</keyword><keyword>Immunoglobulin M/analysis</keyword><keyword>Infant</keyword><keyword>Milk, Human/*immunology/*microbiology</keyword><keyword>Pregnancy</keyword><keyword>Risk Factors</keyword><keyword>Streptococcus pneumoniae/immunology</keyword></keywords><dates><year>2007</year><pub-dates><date>Aug 15</date></pub-dates></dates><accession-num>17624842</accession-num><urls><related-urls><url> </url></related-urls></urls></record></Cite></EndNote>1-6 and this significantly attenuates the benefits of interventions to prevent mother-to-child HIV-1 transmission (MTCT). Common causes of death in HIV-1 exposed children are infectious diseases such as pneumonia, diarrhea, sepsis, and other invasive bacterial and viral infections, ADDIN EN.CITE <EndNote><Cite><Author>Mbori-Ngacha</Author><Year>2001</Year><RecNum>2</RecNum><record><rec-number>2</rec-number><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Mbori-Ngacha, D.</author><author>Nduati, R.</author><author>John, G.</author><author>Reilly, M.</author><author>Richardson, B.</author><author>Mwatha, A.</author><author>Ndinya-Achola, J.</author><author>Bwayo, J.</author><author>Kreiss, J.</author></authors></contributors><auth-address>Department of Paediatrics, University of Nairobi, Kenya.</auth-address><titles><title>Morbidity and mortality in breastfed and formula-fed infants of HIV-1-infected women: A randomized clinical trial</title><secondary-title>Jama</secondary-title></titles><periodical><full-title>Jama</full-title></periodical><pages>2413-20</pages><volume>286</volume><number>19</number><keywords><keyword>Adult</keyword><keyword>*Breast Feeding</keyword><keyword>Cause of Death</keyword><keyword>Developing Countries</keyword><keyword>Diarrhea, Infantile/epidemiology</keyword><keyword>Female</keyword><keyword>HIV Infections/epidemiology/*transmission</keyword><keyword>*Hiv-1</keyword><keyword>Humans</keyword><keyword>Infant</keyword><keyword>*Infant Food</keyword><keyword>*Infant Mortality</keyword><keyword>Infant, Newborn</keyword><keyword>Kenya</keyword><keyword>Male</keyword><keyword>Morbidity</keyword><keyword>Nutritional Status</keyword><keyword>Pneumonia/epidemiology</keyword><keyword>Proportional Hazards Models</keyword><keyword>Risk</keyword><keyword>Survival Analysis</keyword></keywords><dates><year>2001</year><pub-dates><date>Nov 21</date></pub-dates></dates><accession-num>11712936</accession-num><urls><related-urls><url> </url></related-urls></urls></record></Cite></EndNote>4 conditions for which a child may receive some protection from passive immunity obtained via placental and breast milk transfer of maternal antibodies. ADDIN EN.CITE <EndNote><Cite><Author>Hanson</Author><Year>2002</Year><RecNum>8</RecNum><record><rec-number>8</rec-number><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Hanson, L. A.</author><author>Korotkova, M.</author><author>Haversen, L.</author><author>Mattsby-Baltzer, I.</author><author>Hahn-Zoric, M.</author><author>Silfverdal, S. A.</author><author>Strandvik, B.</author><author>Telemo, E.</author></authors></contributors><auth-address>Department of Clinical Immunology, Goteborg University, Goteborg, Sweden. lars.a.hanson@immuno.gu.se</auth-address><titles><title>Breast-feeding, a complex support system for the offspring</title><secondary-title>Pediatr Int</secondary-title></titles><periodical><full-title>Pediatr Int</full-title></periodical><pages>347-52</pages><volume>44</volume><number>4</number><keywords><keyword>*Breast Feeding</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Infant, Newborn</keyword><keyword>Infant, Newborn, Diseases/*prevention &amp; control</keyword><keyword>Infection Control</keyword><keyword>Milk, Human/*immunology</keyword></keywords><dates><year>2002</year><pub-dates><date>Aug</date></pub-dates></dates><accession-num>12139555</accession-num><urls><related-urls><url> </url></related-urls></urls></record></Cite><Cite><Author>Hanson</Author><Year>2003</Year><RecNum>7</RecNum><record><rec-number>7</rec-number><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Hanson, L. A.</author><author>Korotkova, M.</author><author>Lundin, S.</author><author>Haversen, L.</author><author>Silfverdal, S. A.</author><author>Mattsby-Baltzer, I.</author><author>Strandvik, B.</author><author>Telemo, E.</author></authors></contributors><auth-address>Department of Clinical Immunology, Goteborg University, Goteborg, Sweden. lars.a.hanson@immuno.gu.se</auth-address><titles><title>The transfer of immunity from mother to child</title><secondary-title>Ann N Y Acad Sci</secondary-title></titles><periodical><full-title>Ann N Y Acad Sci</full-title></periodical><pages>199-206</pages><volume>987</volume><keywords><keyword>Female</keyword><keyword>Humans</keyword><keyword>Immune System Diseases/prevention &amp; control</keyword><keyword>*Immunity, Maternally-Acquired</keyword><keyword>Infant, Newborn</keyword><keyword>Milk, Human/immunology</keyword><keyword>Pregnancy</keyword></keywords><dates><year>2003</year><pub-dates><date>Apr</date></pub-dates></dates><accession-num>12727640</accession-num><urls><related-urls><url> </url></related-urls></urls></record></Cite></EndNote>7,8 However, if a woman’s immune system is compromised she may not be able to provide her infant with effective passive immunity. Several studies have demonstrated that low maternal CD4 count, high HIV-1 viral load, and symptomatic HIV-1 disease are associated with worse outcomes among infants. ADDIN EN.CITE <EndNote><Cite><Author>Blanche</Author><Year>1994</Year><RecNum>10</RecNum><record><rec-number>10</rec-number><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Blanche, S.</author><author>Mayaux, M. J.</author><author>Rouzioux, C.</author><author>Teglas, J. P.</author><author>Firtion, G.</author><author>Monpoux, F.</author><author>Ciraru-Vigneron, N.</author><author>Meier, F.</author><author>Tricoire, J.</author><author>Courpotin, C.</author><author>et al.,</author></authors></contributors><auth-address>Unite d&apos;Immunologie-Hematologie Pediatrique, INSERM Unite 132, Hopital Necker Enfants Malades, Paris, France.</auth-address><titles><title>Relation of the course of HIV infection in children to the severity of the disease in their mothers at delivery</title><secondary-title>N Engl J Med</secondary-title></titles><periodical><full-title>N Engl J Med</full-title></periodical><pages>308-12</pages><volume>330</volume><number>5</number><keywords><keyword>AIDS Dementia Complex/etiology</keyword><keyword>AIDS-Related Opportunistic Infections/etiology</keyword><keyword>CD4-Positive T-Lymphocytes</keyword><keyword>Confidence Intervals</keyword><keyword>*Delivery, Obstetric</keyword><keyword>Female</keyword><keyword>HIV Core Protein p24/analysis</keyword><keyword>HIV Infections/complications/*immunology/mortality</keyword><keyword>*HIV-1/immunology</keyword><keyword>Humans</keyword><keyword>Infant</keyword><keyword>Infant, Newborn</keyword><keyword>Leukocyte Count</keyword><keyword>Pregnancy</keyword><keyword>Pregnancy Complications, Infectious/*immunology</keyword><keyword>Prospective Studies</keyword><keyword>Risk</keyword></keywords><dates><year>1994</year><pub-dates><date>Feb 3</date></pub-dates></dates><accession-num>7904046</accession-num><urls><related-urls><url> </url></related-urls></urls></record></Cite><Cite><Author>Dabis</Author><Year>2001</Year><RecNum>11</RecNum><record><rec-number>11</rec-number><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Dabis, F.</author><author>Elenga, N.</author><author>Meda, N.</author><author>Leroy, V.</author><author>Viho, I.</author><author>Manigart, O.</author><author>Dequae-Merchadou, L.</author><author>Msellati, P.</author><author>Sombie, I.</author></authors></contributors><auth-address>Unite INSERM no. 330, ISPED, Universite Victor Segalen Bordeaux 2, Bordeaux, France. francois.dabis@isped.u-bordeaux2.fr</auth-address><titles><title>18-Month mortality and perinatal exposure to zidovudine in West Africa</title><secondary-title>Aids</secondary-title></titles><periodical><full-title>Aids</full-title></periodical><pages>771-9</pages><volume>15</volume><number>6</number><keywords><keyword>Adult</keyword><keyword>Africa, Western/epidemiology</keyword><keyword>CD4 Lymphocyte Count</keyword><keyword>Disease Transmission, Vertical</keyword><keyword>Female</keyword><keyword>HIV Infections/*drug therapy/mortality/transmission</keyword><keyword>*Hiv-1</keyword><keyword>Humans</keyword><keyword>*Infant Mortality</keyword><keyword>Infant, Newborn</keyword><keyword>Male</keyword><keyword>Multivariate Analysis</keyword><keyword>Odds Ratio</keyword><keyword>Pregnancy</keyword><keyword>Proportional Hazards Models</keyword><keyword>RNA, Viral/analysis</keyword><keyword>Risk</keyword><keyword>Risk Factors</keyword><keyword>Zidovudine/*adverse effects/therapeutic use</keyword></keywords><dates><year>2001</year><pub-dates><date>Apr 13</date></pub-dates></dates><accession-num>11371692</accession-num><urls><related-urls><url> </url></related-urls></urls></record></Cite><Cite><Author>Kuhn</Author><Year>2005</Year><RecNum>4</RecNum><record><rec-number>4</rec-number><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Kuhn, L.</author><author>Kasonde, P.</author><author>Sinkala, M.</author><author>Kankasa, C.</author><author>Semrau, K.</author><author>Scott, N.</author><author>Tsai, W. Y.</author><author>Vermund, S. H.</author><author>Aldrovandi, G. M.</author><author>Thea, D. M.</author></authors></contributors><auth-address>Gertrude H. Sergievsky Center, Mailman School of Public Health, Columbia University, New York, NY, USA. lk24@columbia.edu</auth-address><titles><title>Does severity of HIV disease in HIV-infected mothers affect mortality and morbidity among their uninfected infants?</title><secondary-title>Clin Infect Dis</secondary-title></titles><periodical><full-title>Clin Infect Dis</full-title></periodical><pages>1654-61</pages><volume>41</volume><number>11</number><keywords><keyword>Aging</keyword><keyword>Birth Weight</keyword><keyword>CD4 Lymphocyte Count</keyword><keyword>Cohort Studies</keyword><keyword>Female</keyword><keyword>HIV Infections/*immunology/*physiopathology</keyword><keyword>Hospitalization</keyword><keyword>Humans</keyword><keyword>Immune Tolerance</keyword><keyword>Infant</keyword><keyword>*Infant Mortality</keyword><keyword>Infant, Newborn</keyword><keyword>*Mothers</keyword><keyword>Risk Factors</keyword><keyword>Zambia/epidemiology</keyword></keywords><dates><year>2005</year><pub-dates><date>Dec 1</date></pub-dates></dates><accession-num>16267740</accession-num><urls><related-urls><url> </url></related-urls></urls></record></Cite><Cite><Author>Thea</Author><Year>1993</Year><RecNum>9</RecNum><record><rec-number>9</rec-number><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Thea, D. M.</author><author>St Louis, M. E.</author><author>Atido, U.</author><author>Kanjinga, K.</author><author>Kembo, B.</author><author>Matondo, M.</author><author>Tshiamala, T.</author><author>Kamenga, C.</author><author>Davachi, F.</author><author>Brown, C.</author><author>et al.,</author></authors></contributors><auth-address>Division of Geographic Medicine and Infectious Diseases, New England Medical Center, Boston, MA 02111.</auth-address><titles><title>A prospective study of diarrhea and HIV-1 infection among 429 Zairian infants</title><secondary-title>N Engl J Med</secondary-title></titles><periodical><full-title>N Engl J Med</full-title></periodical><pages>1696-702</pages><volume>329</volume><number>23</number><keywords><keyword>Acute Disease</keyword><keyword>CD4-CD8 Ratio</keyword><keyword>Confidence Intervals</keyword><keyword>Democratic Republic of the Congo/epidemiology</keyword><keyword>Diarrhea, Infantile/*etiology/mortality</keyword><keyword>Follow-Up Studies</keyword><keyword>HIV Infections/*complications/immunology/mortality</keyword><keyword>*Hiv-1</keyword><keyword>Humans</keyword><keyword>Incidence</keyword><keyword>Infant</keyword><keyword>Infant, Newborn</keyword><keyword>Proportional Hazards Models</keyword><keyword>Prospective Studies</keyword><keyword>Recurrence</keyword><keyword>Risk Factors</keyword></keywords><dates><year>1993</year><pub-dates><date>Dec 2</date></pub-dates></dates><accession-num>8232458</accession-num><urls><related-urls><url> </url></related-urls></urls></record></Cite></EndNote>2,9-11 The effect of restoring maternal immune function on transfer of passive immunity has not been investigated.Within a randomized clinical trial (RCT) conducted to assess the efficacy and safety of highly active antiretroviral therapy (HAART) versus short-course nevirapine (NVP)/zidovudine (ZDV) for the prevention of MTCT, we propose the following aims:Aim 1: To determine whether mothers randomized to HAART versus those randomized to short-course NVP/ZDV have increased plasma IgG antibody levels to measles virus and rotavirus and improved placental transfer of these antibodies to their infants. Aim 2: To determine whether mothers randomized to HAART versus those randomized to short-course NVP/ZDV have increased IgA antibody levels to measles virus and rotavirus in colostrum and breastmilk expressed at 2 and 6 weeks postpartum.We hypothesize that by restoring maternal immune function and reducing HIV-1 viral load through maternal HAART, systemic and breast milk antibody levels and placental antibody transfer will increase. Specifically, women randomized to HAART will have greater concentrations of anti-measles virus and anti-rotavirus antibodies in plasma (IgG) and breast milk (IgA) than women randomized to short-course NVP/ZDV. In addition, the ratio of infant cord blood IgG against these pathogens to the same in maternal plasma at delivery will be greater in women randomized to HAART.Exercise #2: Research MethodsThis exercise builds on exercise # 1. In the following exercise, you will create a research synopsis. We have included a list of the basic elements that should be included in a grant. Others are fine to include here if you have time/space. This should be 1-2 pages in length. Elements to include in your outline are as follows:TitleStudy design (e.g., cross-sectional, prospective cohort, case-control, randomized clinical trial, retrospective cohort, etc)Study population (include eligibility and exclusion criteria, where is it taking place?)Recruitment strategies and enrollment (discuss how you will perform consent or if no consent process is needed)Clinical procedures (follow-up schedule, what takes place at each visit?)Laboratory procedures (emphasize new procedures but mention all)Timeline (Data analysis plan and sample size will be included in exercise #3.)Exercise #3: Data Analysis and Sample SizeThis exercise is designed for you to create an outline of your proposed data analysis and same size. Data analysis:Restate each specific aim as one or more questionsFor each question:If it is a quantitative question:List outcome variables and exposure variables with definitions as neededDummy tables may be appropriateDefine comparisons and statistical tests needed to answer each question If it is a qualitative question, describe how you will evaluate each type of data you will be collecting. What will you do with the in-depth interviews, focus group data, etc?Sample size: Describe how you arrived at the sample size you will be using. Did you calculate the sample size? Did you use a statistical program? If so, which program and what were the assumptions? Author, yearArticle titleStudy design, locationFindingsAppendix 4: Literature Review TableRelevant Literature for Proposal (minimum 5 articles):Appendix 5: List of sources (Included on flashdrive)Articles Benos DJ, Bashari E, Chaves JM, et al. (2007). The ups and downs of peer review. Advances in Physiology Education. 31: 145-152Garcia, P. J., & Curioso, W. H. (2008). Strategies for aspiring biomedical researchers in resource-limited environments.?PLoS neglected tropical diseases,?2(8), e274.Greenhalgh T. (1997). How to read a paper. Statistics for the non-statistician. I: Different types of data need different statistical tests. BMJ;315(7104):364-6.Greenhalgh T. (1997). How to read a paper. Statistics for the non-statistician. II: "Significant" relations and their pitfalls. BMJ;315(7105):422-5.Haynes, Brian R. Forming research questions. Journal of Clinical Epidemiology 2006; 59: 881-886.Sandelowski M. (2000). Combining qualitative and quantitative sampling, data collection, and analysis techniques in mixed-method studies. Research in Nursing & Health, 23:246–255.Sandelowski M, Barroso J. (2003). Writing the proposal for a qualitative research methodology project. Qualitative Health Research. 13: 6: 781-820.Weinberg, J. M., & Kleinman, K. P. (2003). Good study design and analysis plans as features of ethical research with humans.?IRB: Ethics and Human Research,?25(5), 11-14.Yamey, Gavin, (2008). Read, reflect, respond: How to write a research paper and get it publishedGrant examplesImproving Uptake of Early Infant Diagnosis of HIV for PMTCT: RCT of a Text Messaging Intervention (PI Thomas Odeny)HIV Testing and Educating Male Partners to Improve Maternal and Infant Outcomes (PI Carey Farquhar)Human Herpesvirus-8 Replication and Kaposi Sarcoma Response to Treatment (PI Warren Phipps)Overcoming Barriers to HIV/AIDS Care and ART Initiation (PI Brandon Guthrie)Motivation matters! RCT of theory-based, 2-way SMS to support TASP in African FSW (PI Scott McClelland)Gender Specific Prevalence of Multiple Strain HSV-2 Infection: A Global View (PI Anna Wald)NOTES-4095752095500NOTES Acknowledgements Content created by:Carey Farquhar, Rose Bosire, Christine McGrath, Aliza Monroe-Wise, Monisha SharmaThis project was made possible by the Afya Bora Consortium Fellowship, which is supported by the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) through funding to the University of Washington’s International AIDS Education and Training Center (IAETC) under Cooperative Agreement U91 HA06801 from the Health Resources and Services Administration (HRSA) Global HIV/AIDS Bureau. ................
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