PI: Rebeiro, Peter F Title: The HIV Care Continuum and Health Policy: Changes through Context and 

Geography

Received: 01/05/2017 FOA: PA16-190 Council: 05/2017

Competition ID: FORMS-D FOA Title: MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD

(PARENT K01)

1 K01 AI131895-01A1 Dual: Accession Number: 4007925

IPF: 10040927 Organization: VANDERBILT UNIVERSITY MEDICAL CENTER

Former Number: Department: Medicine/Infectious Disease

IRG/SRG: AIDS AIDS: Y Expedited: Y

Subtotal Direct Costs Animals: N New Investigator: N

(excludes consortium F&A) Humans: N Early Stage Investigator: N

Year 1: Clinical Trial: N

Year 2: Current HS Code: 10

Year 3: HESC: N

Year 4:

Year 5:

Senior/Key Personnel: Organization: Role Category:

Peter Rebeiro Vanderbilt University Medical Center PD/PI 

Timothy Sterling Vanderbilt University Medical Center Other (Specify)-Mentor

John Graves Vanderbilt University Medical Center Other (Specify)-Co-Mentor

Richard Moore Johns Hopkins University Other (Specify)-Advisor

Stephen Gange Johns Hopkins Other (Specify)-Mentoring Committee

Catherine McGowan Vanderbilt University Medical Center Other (Specify)-Advisor

David Holtgrave Johns Hopkins University Other (Specify)-Mentoring Committee

William Schaffner Vanderbilt University Medical Center Other (Specify)-Mentoring Committee

Christopher Fonnesbeck Vanderbilt University Medical Center Other (Specify)-Advisor

Bryan Shepherd Vanderbilt University Medical Center Other (Specify)-Advisor

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Funding Opportunity Number: PA-16-190 . Received Date:

2017-01-05T17:21:11.000-05:00 Tracking Number: GRANT12315321

Page 1

OMB Number: 4040-0001

Expiration Date: 06/30/2016

APPLICATION FOR FEDERAL ASSISTANCE 3. DATE RECEIVED BY STATE State Application Identifier

SF 424 (R&R) TN: Tennessee

1. TYPE OF SUBMISSION* 4.a. Federal Identifier

❍Pre-application ❍Application ●Changed/Corrected b. Agency Routing Number

Application

2. DATE SUBMITTED Application Identifier c. Previous Grants.gov Tracking Number

2017-01-05 M0044399 GRANT12314772

5. APPLICANT INFORMATION Organizational DUNS*:

Legal Name*: Vanderbilt University MedicalCenter 

Department: Medicine/Infectious Disease 

Division:

Street1*: 

Street2: 

City*: 

County: 

State*:

Province: 

Country*:

ZIP / Postal Code*:

Person to be contacted on matters involving this application

Prefix: First Name*: Donald Middle Name: Clinton Last Name*: Brown Suffix: 

Position/Title: Director, Office of Sponsored Programs 

Street1*:

Street2: 

City*: 

County: 

State*:

Province: 

Country*:

ZIP / Postal Code*:

Phone Number*: Fax Number: Email:

6. EMPLOYER IDENTIFICATION NUMBER (EIN) or (TIN)* 

7. TYPE OF APPLICANT* M: Nonprofit with 501C3 IRS Status (Other than Institution of Higher 

Education)

Other (Specify):

Small Business Organization Type ❍Women Owned ❍Socially and Economically Disadvantaged

8. TYPE OF APPLICATION* If Revision, mark appropriate box(es).

❍New ●Resubmission ❍A. Increase Award ❍B. Decrease Award ❍C. Increase Duration

❍ ❍D. Decrease Duration ❍ E. Other (specify) : Renewal ❍Continuation ❍Revision

Is this application being submitted to other agencies?* ❍Yes ●No What other Agencies?

9. NAME OF FEDERAL AGENCY* 10. CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER

National Institute of Allergy and Infectious Diseases TITLE: Mentored Research Scientist Development Award (Parent K01)

11. DESCRIPTIVE TITLE OF APPLICANT'S PROJECT*

The HIV Care Continuum and Health Policy: Changes through Context and Geography

12. PROPOSED PROJECT 13. CONGRESSIONAL DISTRICTS OF APPLICANT

Start Date* Ending Date* TN-005

07/01/2017 06/30/2022
Funding Opportunity Number: PA-16-190 . Received Date:

2017-01-05T17:21:11.000-05:00 Tracking Number: GRANT12315321

Page 2

Contact PD/PI: Rebeiro, Peter F

SF 424 (R&R) APPLICATION FOR FEDERAL ASSISTANCE Page 2

14. PROJECT DIRECTOR/PRINCIPAL INVESTIGATOR CONTACT INFORMATION

Prefix: First Name*: Peter Middle Name: F Last Name*: Rebeiro Suffix: 

Position/Title: Research Asst Professor 

Organization Name*: Vanderbilt University Medical Center

Department: 

Division: 

Street1*: 

Street2: 

City*: 

County: 

State*:

Province: 

Country*:

ZIP / Postal Code*:

Phone Number*: Fax Number: Email*:

15. ESTIMATED PROJECT FUNDING 16.IS APPLICATION SUBJECT TO REVIEW BY STATE 

EXECUTIVE ORDER 12372 PROCESS?*

a. YES ❍ THIS PREAPPLICATION/APPLICATION WAS MADE 

a. Total Federal Funds Requested* AVAILABLE TO THE STATE EXECUTIVE ORDER 12372

b. Total Non-Federal Funds* PROCESS FOR REVIEW ON:

c. Total Federal & Non-Federal Funds* DATE: 

d. Estimated Program Income* b. NO ● PROGRAM IS NOT COVERED BY E.O. 12372; OR

❍ PROGRAM HAS NOT BEEN SELECTED BY STATE FOR 

REVIEW 

17. By signing this application, I certify (1) to the statements contained in the list of certifications* and (2) that the statements herein 

are true, complete and accurate to the best of my knowledge. I also provide the required assurances * and agree to comply with 

any resulting terms if I accept an award. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to 

criminal, civil, or administrative penalties. (U.S. Code, Title 18, Section 1001)

●I agree* * The list of certifications and assurances, or an Internet site where you may obtain this list, is contained in the announcement or agency specific instructions.

18. SFLLL or OTHER EXPLANATORY DOCUMENTATION File Name:

19. AUTHORIZED REPRESENTATIVE

Prefix: First Name*: Donald Middle Name: Clinton Last Name*: Brown Suffix: 

Position/Title*: Director, Office of Sponsored Programs 

Organization Name*: Vanderbilt University Medical Center

Department: 

Division: 

Street1*: 

Street2: 

City*: 

County: 

State*:

Province: 

Country*:

ZIP / Postal Code*:

Phone Number*: Fax Number: Email*:

Signature of Authorized Representative* Date Signed*

01/05/2017

20. PRE-APPLICATION File Name:

21. COVER LETTER ATTACHMENT File Name:M-22_RRSF424_Cover_Letter.pdf
Contact PD/PI: Rebeiro, Peter F OMB Number: 4040-0010

Expiration Date: 06/30/2016

Page 4

Tracking Number: GRANT12315321 Funding Opportunity Number: PA-16-190. Received Date: 

2017-01-05T17:21:11.000-05:00

Project/Performance Site Location(s)

Project/Performance Site Primary Location ❍I am submitting an application as an individual, and not on behalf of

a company, state, local or tribal government, academia, or other type of 

organization.

Organization Name: Vanderbilt University Medical Center

Duns Number: 

Street1*: 

Street2:

City*: 

County: 

State*: 

Province: 

Country*:

Zip / Postal Code*:

Project/Performance Site Congressional District*: TN-005

Additional Location(s) File Name:
Contact PD/PI: Rebeiro, Peter F

RESEARCH & RELATED Other ProjectInformation

OMB Number: 4040-0001

Expiration Date: 06/30/2016

Page 5

Tracking Number: GRANT12315321 Funding Opportunity Number: PA-16-190. Received Date: 

2017-01-05T17:21:11.000-05:00

1. Are Human Subjects Involved?* ● Yes ❍ No

1.a. If YES to Human Subjects

Is the Project Exempt from Federal regulations? ❍ Yes ● No

If YES, check appropriate exemption number: 1 2 3 4 5 6 If 

NO, is the IRB review Pending? ● Yes ❍ No

IRB Approval Date:

Human Subject Assurance Number

2. Are Vertebrate Animals Used?* ❍ Yes ● No

2.a. If YES to Vertebrate Animals

Is the IACUC review Pending? ❍ Yes ❍ No 

IACUC Approval Date:

Animal Welfare Assurance Number

3. Is proprietary/privileged information included in the application?* ❍ Yes ● No

4.a. Does this project have an actual or potential impact - positive or negative - on the environment?* ❍ Yes ● No

4.b. If yes, please explain:

4.c. If this project has an actual or potential impact on the environment, has an exemption been authorized or an ❍ Yes ❍ No

environmental assessment (EA) or environmental impact statement (EIS) been performed?

4.d. If yes, please explain:

5. Is the research performance site designated, or eligible to be designated, as a historic place?* ❍ Yes ● No

5.a. If yes, please explain:

6. Does this project involve activities outside the United States or partnership with international ❍ Yes ● No

collaborators?*

6.a. If yes, identify countries:

6.b. Optional Explanation:

Filename

7. Project Summary/Abstract* M-5_Project_Summary.pdf

8. Project Narrative* M-2_Narrative.pdf

9. Bibliography & References Cited M-4_Bibliography.pdf

10.Facilities & Other Resources M-1_Facilities.pdf

11.Equipment M-3_Equipment.pdf
Contact PD/PI: Rebeiro, Peter F

Project Summary/Abstract Page 6

PROJECT SUMMARY (ABSTRACT).

The HIV Care Continuum is a compelling epidemiologic framework describing the 

movement of people living with HIV/AIDS through care, including diagnosis, linkage and 

retention in care, use of antiretroviral therapy (ART), and ultimately, viral suppression. Health 

policies may profoundly influence outcomes along the Care Continuum, and these effects may 

be modified across regions and through individual contexts.

In observational cohorts, retention in clinical care, ART use, and viral suppression 

proportions have varied depending on available data and the population under study. The US 

National HIV/AIDS Strategy (updated to 2020) and the revised 2013 World Health Organization 

ART guidelines also reference milestones in the Care Continuum. Because the Patient 

Protection and Affordable Care Act (ACA) and other national health policies in North and Latin 

American countries aim to improve healthcare access and reduce health disparities, describing 

the effect of policy and contextual factors on Care Continuum outcomes in these settings is of 

great interest to epidemiologists, clinicians, and policy makers.

This research seeks to quantify health policy, sociodemographic, contextual, and 

geographic patterns and correlates of HIV Care Continuum outcomes among HIV-infected 

persons in the United States (US), Canada, and Mexico. Contextual factors include psychiatric 

illness, regional poverty, residential urbanicity, and other individual and environmental 

characteristics. The North American AIDS Cohort Collaboration on Research and Design (NAACCORD) and Caribbean, Central and South America network for HIV epidemiology 

(CCASAnet) provide rich data sources in which to conduct this work.

Aim 1 will quantify disparities in Care Continuum outcomes in North and Latin America, 

assessing health system, demographic, risk, contextual, and geographic differences. Because 

research into the influence of contextual factors and health system characteristics on Care 

Continuum outcomes in longitudinal cohorts with clinical care data have been sparse or 

geographically limited, this analysis will be novel and of significant importance.

Aims 2 and 3 will provide inferences about the ACA’s effects on improving healthcare 

among HIV-infected individuals in care in the US. The state-led expansion of Medicaid coverage 

under the ACA will be used as a quasi-experiment to assess effects on Care Continuum and 

other HIV disease outcomes, comparing pre-ACA (pre-2014) to ACA implementation periods.
Contact PD/PI: Rebeiro, Peter F

Project Narrative Page 7

PUBLIC HEALTH RELEVANCE STATEMENT (NARRATIVE).

HIV remains a massive public health challenge both domestically and internationally; the 

HIV Care Continuum is a widely used and powerful epidemiologic framework applicable to those 

suffering from HIV, and the influence of public health and health system policies across the 

Continuum may be profound. By assessing the dynamic process of the HIV Care Continuum in 

discrete stages, and examining disparities by health policy, geography, and individual context, 

transitions that demand improvement and specific targets for public health and clinical 

interventions can more easily be identified. The US National HIV/AIDS Strategy (updated to 

2020) and revised 2013 World Health Organization ART guidelines also reference milestones in 

the Care Continuum; because the Patient Protection and Affordable Care Act (ACA) and other 

national health policies implemented in North and Latin American countries aim to improve 

healthcare access and reduce health disparities in accord with these milestones, describing the 

effect of policy and individual contextual factors on Care Continuum outcomes, as this study 

aims to do, will be of great interest and utility to epidemiologists, clinicians, and policymakers.
Contact PD/PI: Rebeiro, Peter F

References Cited Page 8

BIBLIOGRAPHY AND WORKS CITED.

References including applicant as author include applicant’s name in bold font

1. Rebeiro P, Althoff K, Buchacz K,. for the North American AIDS Cohort Collaboration on Research and 

Design (NA-ACCORD). Retention Among North American HIV-infected Persons in ClinicalCare,

2000-2008. J Acquir Immune Defic Syndr. 2013 Mar 1;62(3):356-62. PMID: 23242158 PMCID: 

PMC3661708

2. Rebeiro P, Horberg MA, Gange SJ,.; for the North American AIDS Cohort Collaboration on Research 

and Design (NA-ACCORD). Strong agreement between nationally recommended retention 

measures from the Institute of Medicine and the Department of Health and Human Services. PLoS 

One. 2014 Nov 6;9(11):e111772. PMID: 25375099 PMCID: PMC4222946

3. Althoff KN, Rebeiro P, Brooks JT,.; for the North American AIDS Cohort Collaboration onResearch 

Design (NA-ACCORD). Disparities in the quality of HIV care when using US Department of Health 

and Human Services Indicators. Clin Infect Dis. 2014 Apr;58(8):1185-9. PMID: 24463281 PMCID: 

PMC3967825

4. Yehia BR, Rebeiro P, Althoff KN,.; for the North American AIDS Cohort Collaboration on Research 

Design (NA-ACCORD). The Impact of Age on Retention in Care and Viral Suppression. J Acquir 

Immune Defic Syndr. 2015 Apr 1;68(4):413-9. PMID: 25559604 PMCID: PMC4334738

5. Althoff KN, Buchacz K, Hall I, Zhang J, Hanna DB, Rebeiro P,. for The North American AIDS Cohort 

Collaboration on Research and Design. Trends in antiretroviral therapy use, HIV RNA plasma viral 

loads and CD4 T-lymphocyte counts among human immunodeficiency virus (HIV)-infected persons in 

care in the United States, 2000-2008. Ann Intern Med. 2012 Sep 4;157(5):325-35. PMID: 22944874 

PMCID: PMC3534765

6. Rebeiro P, Althoff KN, Lau B,. for the North American AIDS Cohort Collaboration on Research and 

Design (NA-ACCORD). Laboratory measures as proxies of primary care encounters: implications for 

quantifying clinical retention among HIV-infected adults in North America. Am J Epidemiol. 2015 Nov 

17. pii: kwv181. PMID: 26578717 PMCID: PMC4655744

7. Rebeiro P, Gange SJ, Sterling TR,. for the North American AIDS Cohort Collaboration on Research 

and Design (NA-ACCORD). Geographic Variations in Retention in Care among HIV-Infected Adults in 

the United States. PLoS One. 2016 Jan 11;11(1):e0146119. PMID: 26752637 PMCID: PMC4708981

8. Rebeiro P, Cesar C, Shepherd BE,. for the Caribbean, Central and South America network for HIV 

epidemiology (CCASAnet). Assessing the HIV Care Continuum in Latin America: progress in 

clinical retention, cART use, and viral suppression. J Int AIDS Soc. 2016 Apr 8;19(1):20636. PMID: 

27065108 PMCID: PMC4827101

9. Woodward B, Person AK, Rebeiro P,. Risk Prediction Tool for Medical Appointment Attendance 

Among HIV-Infected Persons with Unsuppressed Viremia. AIDS Patient Care STDS. 2015 

May;29(5):240-7. PMID: 25746288 PMCID: PMC4410547

11. Ford MA, and Spicer CM. Monitoring HIV care in the United States : indicators and data systems. 

Washington, D.C.: National Academies Press; 2012. PMID: 25144028

12. Gardner EM, McLees MP, Steiner JF,. The spectrum of engagement in HIV care and its relevance to 

test-and-treat strategies for prevention of HIV infection. Clin Infect Dis. United States;

2011;52(6):793-800. PMID: 21367734

13. Mayer KH. Introduction: Linkage, engagement, and retention in HIV care: essential for optimal 

individual- and community-level outcomes in the era of highly active antiretroviral therapy. Clin Infect 

Dis. United States; 2011. p. S205-7. PMID: 21342908
Contact PD/PI: Rebeiro, Peter F

References Cited Page 9

14. Williams CT, Kim S, Meyer J,. Gender differences in baseline health, needs at release, and 

predictors of care engagement among HIV-positive clients leaving jail. AIDS Behav. United States; 

2013;17 Suppl 2:S195-202. PMID: 23314801

15. Thompson MA, Mugavero MJ, Amico KR,. Guidelines for improving entry into and retention in care and 

antiretroviral adherence for persons with HIV: evidence-based recommendations from an International 

Association of Physicians in AIDS Care panel. Ann Intern Med. United States;

2012;156(11):817-33. PMID: 22393036

16. Cunningham WE, Sohler NL, Tobias C,. Health services utilization for people with HIV infection: 

comparison of a population targeted for outreach with the U.S. population in care. Med Care. United 

States; 2006;44(11):1038-47. PMID: 17063136

17. Stone VE. HIV/AIDS in Women and Racial/Ethnic Minorities in the U.S. Curr Infect Dis Rep. United 

States; 2012;14(1):53-60. PMID: 22139589

18. Andersen RM. Revisiting the behavioral model and access to medical care: does it matter? J Health 

Soc Behav. 1995 Mar;36(1):1-10. PMID: 7738325

19. Improving Outcomes: Accelerating Progress Along the HIV Care Continuum. White House Office of 

National AIDS Policy. Retrieved from: 

http://www.whitehouse.gov/sites/default/files/onap_nhas_improving_outcomes_dec_2013.pdf

20. Shadish WR, Cook TD, and Campbell DT. Experimental and quasi-experimentaldesigns for 

generalized causal inference. Wadsworth Cengage learning; 2002.

21. Abara W, and Heiman HJ. The Affordable Care Act and Low-Income People Living With HIV: Looking 

Forward in 2014 and Beyond. J Assoc Nurses AIDS Care. United States; 2014;25(6):476-82. PMID: 

24996850

22. Kates J. Implications of the Affordable Care Act for people with HIV infection and the Ryan White 

HIV/AIDS Program: what does the future hold? Top Antivir Med. United States; 2013;21(4):138-42. 

PMID: 24225080

23. Martin EG, and Schackman BR. What does U.S. health reform mean for HIV clinical care? J Acquir 

Immune Defic Syndr. United States; 2012;60(1):72-6. PMID: 22517415

24. Yehia BR, Fleishman JA, Agwu AL,. HIV Research Network. Health insurance coverage for 

persons in HIV care, 2006-2012. J Acquir Immune Defic Syndr. 2014 Sep 1;67(1):102-6. PMID: 

24977377

25. Hirnschall G, Harries AD, Easterbrook PJ, Doherty MC, and Ball A. The next generation of the World 

Health Organization's global antiretroviral guidance. J Int AIDS Soc. Switzerland; 2013;16:18757. 

PMID: 23819908

26. Frenk J, Gómez-Dantés O, and Knaul FM. The democratization of health in Mexico: financial 

innovations for universal coverage. Bulletin of the World Health Organization. SciELO Public Health; 

2009;87(7):542-548. PMID: 19649369

27. Elias PE, and Cohn A. Health reform in Brazil: lessons to consider. Am J Public Health. United States; 

2003;93(1):44-8. PMID: 12511382

28. Richards TB, Croner CM, Rushton G, Brown CK, and Fowler L. Information technology: Geographic 

information systems and public health: Mapping the future. Public Health Reports. Association of 

Schools of Public Health; 1999;114(4):359. PMID: 10501137

29. Gao S, Mioc D, Anton F, Yi X, and Coleman DJ. Online GIS services for mapping and sharing disease 

information. Int J Health Geogr. England; 2008;7:8. PMID: 18298859

30. Houle B, Holt J, Gillespie C, Freedman DS, and Reyes M. Use of density-equalizing cartograms to 

visualize trends and disparities in state-specific prevalence of obesity: 1996-2006. Am J Public Health. 

United States; 2009;99(2):308-12. PMID: 19059848
Contact PD/PI: Rebeiro, Peter F

References Cited Page 10

31. Koch T, and Denike K. Medical mapping: The revolution in teaching—and using—maps for the analysis 

of medical issues. Journal of Geography. Taylor & Francis; 2004;103(2):76-85.

32. Klassen AC, Kulldorff M, and Curriero F. Geographical clustering of prostate cancer grade and stage at 

diagnosis, before and after adjustment for risk factors. Int J Health Geogr. 2005;4(1):1. PMID: 

15649329

33. Wallace RG. AIDS in the HAART era: New York's heterogeneous geography. Soc Sci Med. England; 

2003;56(6):1155-71. PMID: 12600355

34. Eberhart MG, Yehia BR, Hillier A,. Behind the cascade: analyzing spatial patterns along the HIV 

care continuum. J Acquir Immune Defic Syndr. United States; 2013;64 Suppl 1:S42-51. PMID: 

24126447

35. Centers for Disease Control and Prevention (CDC). Geographic differences in HIV infection among 

Hispanics or Latinos--46 states and Puerto Rico, 2010. MMWR Morb Mortal Wkly Rep. United States; 

2012;61(40):805-10. PMID: 23051610

36. Hanna DB, Selik RM, Tang T, and Gange SJ. Disparities among US states in HIV-related mortality in 

persons with HIV infection, 2001-2007. AIDS. England; 2012;26(1):95-103. PMID: 22008659

37. Hanna DB, Buchacz K, Gebo KA,. and North American AIDS Cohort Collaboration on Research and 

Design (NA-ACCORD) of the International Epidemiologic Databases to Evaluate AIDS (IeDEA). 

Association between U.S. state AIDS Drug Assistance Program (ADAP) features and HIV antiretroviral 

therapy initiation, 2001-2009. PLoS One. United States; 2013;8(11):e78952. PMID: 24260137

38. Reif SS, Whetten K, Wilson ER, McAllaster C, Pence BW, Legrand S, and Gong W. HIV/AIDS in the 

Southern USA: A disproportionate epidemic. Taylor & Francis. England: Routledge; 2014;26(3):351-9. 

PMID: 23944833

39. Mugavero MJ, Amico KR, Horn T, and Thompson MA. The state of engagement in HIV care in the 

United States: from cascade to continuum to control. Clin Infect Dis. United States; 2013;57(8):1164- 

71. PMID: 23797289

40. Centers for Disease Control and Prevention (CDC). Vital signs: HIV prevention through care and 

treatment--United States. MMWR Morb Mortal Wkly Rep. United States; 2011;60(47):1618-23. PMID: 

22129997

41. Gange SJ, Kitahata MM, Saag MS,. Cohort profile: The North American AIDS cohort collaboration on 

research and design (NA-ACCORD). Int J Epidemiol. 2007 Apr;36(2):294-301. PMID: 17213214

42. McGowan CC, Cahn P, Gotuzzo E, Padgett D, Pape JW, Wolff M, Schechter M, Masys DR. Cohort 

Profile: Caribbean, Central and South America Network for HIV research (CCASAnet) collaboration 

within the International Epidemiologic Databases to Evaluate AIDS (IeDEA) programme. Int J 

Epidemiol. 2007 Oct;36(5):969-76. PMID: 17846055

43. Stuckler D, Feigl AB, Basu S, and McKee M. The political economy of universal health coverage. In 

Background paper for the global symposium on health systems research. Geneva: World Health 

Organization. 2010.

44. Valdiserri RO, Forsyth AD, Yakovchenko V, Koh HK. Measuring What Matters: The Development of 

Standard HIV Core Indicators across the U.S. Department of Health and Human Services. Public 

Health Rep 2013; 128(5): 354-359. PMID: 23997280

45. Berry SA, Fleishman JA, Yehia BR, Cheever LW, Hauck H, Korthuis PT, Mathews WC, Keruly J, 

Nijhawan AE, Agwu AL, Somboonwit C, Moore RD, Gebo KA, and HIV Research Network. Healthcare 

Coverage for HIV Provider Visits Before and After Implementation of the Affordable Care Act. Clin 

Infect Dis. United States; 2016;63(3):387-95. PMID: 27143660

46. Eaton EF, and Mugavero MJ. Editorial Commentary: Affordable Care Act, Medicaid Expansion ... or 

Not: Ryan White Care Act Remains Essential for Access and Equity. Clin Infect Dis. United States; 

2016. p. 404-6. PMID: 27143674
Contact PD/PI: Rebeiro, Peter F

References Cited Page 11

47. Liang K-Y, and Zeger SL. Regression analysis for correlated data. Annual review of public health. 

Annual Reviews 4139 El Camino Way, PO Box 10139, Palo Alto, CA 94303-0139, USA; 1993;14(1):43- 

68. PMID: 8323597

48. Harrell FE. Regression modeling strategies: with applications to linear models, logistic regression, and 

survival analysis. New York: Springer; 2001.

49. Kulldorff M. A spatial scan statistic. Communications in Statistics-Theory and methods. Taylor & 

Francis; 1997;26(6):1481-1496.

50. Kulldorff M. SaTScan user guide for version 9.3. SaTScan user guide for version 9.3. 2014.

51. The Kaiser Family Foundation’s State Health Facts: Current Status of State Medicaid

Expansion Decisions. Accessed Nov. 2014 from: http://kff.org/health-reform/slide/current-status-of-themedicaid-expansion-decision/

52. Moscoe E, Bor J, and Bärnighausen T. Regression discontinuity designs are underutilized in medicine, 

epidemiology, and public health: a review of current and best practice. J Clin Epidemiol. United States; 

2015;68(2):122-33. PMID: 25579639

53. Sommers BD, Baicker K, and Epstein AM. Mortality and access to care among adults after state 

Medicaid expansions. N Engl J Med. United States; 2012;367(11):1025-34. PMID: 22830435

54. Martin, Nussey, Wilson and Reale Submitted Measuring between-individual variation in reaction norms 

in field and experimental studies: a power analysis of random regression models. Methods in Ecology 

and Evolution. Online early.

55. Hsieh FY, Bloch DA, Larsen MD. A simple method of sample size calculation for linear and logistic 

regression. Stat Med. 1998 Jul 30;17(14):1623-34. PMID: 9699234

56. Waller LA, Hill EG, Rudd RA. The geography of power: statistical performance of tests of clusters and 

clustering in heterogeneous populations. Stat Med. 2006 Mar 15;25(5):853-65. PMID: 16453372

57. Tango T. Statistical Methods for Disease Clustering. Springer, New York, 2010. 208-9.

58. Bertrand M, Duflo E, and Mullainathan S. How Much Should We Trust Differences-In-Differences 

Estimates? The Quarterly Journal of Economics. 2004;119(1):249-275.

59. Greenland S. Basic methods for sensitivity analysis of biases. International Journal of Epidemiology. 

IEA; 1996;25(6):1107-1116. PMID: 9027513

60. Rubin DB. Multiple imputation after 18+ years. Journal of the American Statistical Association. Taylor & 

Francis; 1996;91(434):473-489.

61. Marshall BD, and Galea S. Formalizing the role of agent-based modeling in causal inference and 

epidemiology. Am J Epidemiol. United States; 2015;181(2):92-9. PMID: 25480821

62. Hernán MA. Invited commentary: Agent-based models for causal inference—reweighting data and 

theory in epidemiology. Am J Epidemiol. United States; 2015;181(2):103-5. PMID: 25480820

63. Lesko CR, Cole SR, Hall HI, Westreich D, Miller WC, Eron JJ, Li J, Mugavero MJ, and CNICS 

Investigators. The effect of antiretroviral therapy on all-cause mortality, generalized to persons 

diagnosed with HIV in the USA, 2009-11. Int J Epidemiol. England; 2016;45(1):140-50. PMID: 

26772869
Contact PD/PI: Rebeiro, Peter F

Facilities & Other Resources Page 12

FACILITIES AND OTHER RESOURCES.

The following research facilities and resources are available and will facilitate the success of proposed 

research project and training in epidemiologic research.

Institutional Descriptions:

Vanderbilt University: (Nicholas S. Zeppos, Chancellor)

Vanderbilt University is a private, non-sectarian university located in Nashville, Tennessee. It was founded in 

1873 as the result of a gift by shipping and rail magnate Cornelius Vanderbilt, who hoped his gift and the work 

of the new university would “contribute to strengthening the ties that should exist between all sections of our 

common country” and help to heal the sectional wounds of the Civil War. Today, Vanderbilt is an internationally 

renowned academic institution offering undergraduate programs in the liberal arts and sciences, engineering, 

music, education and human development, as well as a full range of graduate and professional degrees. The 

combination of cutting edge research, liberal arts education, and a distinguished medical center creates an 

invigorating atmosphere where students tailor their education to meet their goals and researchers collaborate 

to solve complex problems affecting our health, culture and society.

Vanderbilt University Medical Center: (Jeffrey R. Balser, M.D., Ph.D., Vice Chancellor for Health Affairs) 

Vanderbilt University Medical Center is a comprehensive health care facility dedicated to patient care, 

research, and the education of health care professionals. Its reputation for excellence in each of these areas 

has made Vanderbilt a major patient referral center for the South and Midwest. Vanderbilt University’s medical 

education has been held in high esteem among its peer institutions, and that legacy continues. Translational 

research into the pathophysiology and treatment of disease, as well as studying fundamental biological 

properties, is the primary focus of discovery at Vanderbilt. Vanderbilt University Medical Center is ranked 

among the nation's best hospitals. Vanderbilt has more than 450 research laboratories supported by $385 

million in extramural funds and approximately 545 graduate students and 400 postdoctoral fellows involved in 

research initiatives.

Vanderbilt University School of Medicine: (Jeffrey R. Balser, M.D., Ph.D., Dean)

The School of Medicine, originally part of the University of Nashville, was incorporated into Vanderbilt 

University in 1874 and awarded its first Vanderbilt medical degrees in 1875. Since the inception of the School 

of Medicine, a Vanderbilt medical education has been held in high esteem among its peer institutions, and that 

legacy continues today. Biomedical research at the School of Medicine has long been recognized for its 

contributions to the advancement of medicine. The School of Medicine currently has 2,147 faculty members 

and has more than 400 students. From 2000-2007, Vanderbilt University School of Medicine (VUSM) had the 

fastest growth in NIH funding among all academic medical centers (17.8%). Currently it ranks 10th in NIH 

funding among U.S. Medical Schools, with 586 NIH awards exceeding $240 million annually.

A. Clinical Research Facilities and Resources

1. Office Space and Logistical Support

Infectious Diseases Conference Room, The conference room is on

. It is a fully equipped multifunctional conference 

room that can be configured for meetings, training, luncheons or other needs for 35-40 people. It is 

equipped with wired and wireless internet connections, TV/VCR/DVD, dry erase board, projection 

screen, easels, and an overhead projector. The conference room has state-of-the-art videoconferencing 

capabilities, which can be utilized for videoconferencing with national and international collaborators (for 

example, collaborators at the North American AIDS Cohort Collaboration on Research and Design [NAACCORD] or external policymakers and policy symposia).

2. The Vanderbilt AIDS Center: The Vanderbilt AIDS Center is administratively based in the Division of 

Infectious Diseases of the Department of Medicine, and will provide research support during award period. 

The Vanderbilt AIDS Center coordinates all research related to HIV and AIDS at Vanderbilt, and promotes 

HIV care and education. Faculty is based in the Divisions of Infectious Diseases in the School of 

Medicine’s Departments of Medicine and Pediatrics, as well as the Department of Microbiology and
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Facilities & Other Resources Page 13

Immunology, and the Vanderbilt Institute for Global Health (VIGH). However, faculty from the Schools of 

Nursing, Education, Business, Divinity, Law, and Music also participate. A major goal of the Vanderbilt 

AIDS center is to foster collaborations between clinicians and investigators, and there is a long history of 

cutting-edge clinical outcomes research on HIV/AIDS by Vanderbilt faculty. The Vanderbilt AIDS Center will 

provide an enriched training environment, with broad exposure to an active clinical research and clinical 

trial program.

a. The Vanderbilt HIV Clinical Trials Unit includes clinical research sites for the NIAID AIDS Clinical 

Trials Group (the Vanderbilt Therapeutics Clinical Research Site) and the NIAID HIV Vaccine Trials 

Network (the Vanderbilt HIV Vaccine Clinical Research Site), for new medications and vaccines for 

HIV, respectively. Most of the clinical HIV research programs (including the Vanderbilt HIV Clinical 

Trials Unit’s Therapeutics Clinical Research Site) are integrated at the location of the HIV clinical care 

site, the Vanderbilt Comprehensive Care Clinic at Vanderbilt Health One Hundred Oaks.

b. The Epidemiology/Outcomes Unit conducts observational and translational research studies of HIV 

outcomes. Dr. Timothy Sterling is director of the unit which meets weekly to discuss ongoing projects 

and analyses. These meetings are directed by Dr. Sterling and are attended by David Haas, Bryan 

Shepherd (biostatistician), fellows, residents, and medical students. In addition to publishing work 

based on patients in the Vanderbilt Comprehensive Care Center, the Epidemiology/Outcomes Unit has 

collaborated with the Johns Hopkins University Adult HIV Clinic, the Case-Western Reserve University 

AIDS Clinical Trials Unit, the North American AIDS Cohort Collaboration on Research and Design (NAACCORD), the Antiretroviral Therapy Cohort, Collaboration (ART-CC), and the Caribbean, Central, and 

South America Network for HIV research (CCASAnet).

3. The Vanderbilt Comprehensive Care Center (VCCC) is the largest HIV/AIDS primary care clinic in the 

region, and the centralized medical home for almost all HIV-infected patients in Middle Tennessee. The 

Comprehensive Care Clinic (CCC), a non-profit entity now merged with Vanderbilt, started this clinic in 

1994 and has enrolled more than 7000 patients into care. In 2010, Vanderbilt assumed responsibility for 

the clinical practice and management of the clinic. Using a medical care management approach, the VCCC 

offers medical treatment, mental health services, nutrition services, medical case management, and 

laboratory services. Research on HIV care outcomes has always been integral to the VCCC’s mission.

The VCCC’s space has been specially designed for integrating clinical research into patient flow at its new 

facility at One Hundred Oaks in Nashville. All Vanderbilt medical records are electronic, and 

developed/maintained/improved by world-class Vanderbilt informatics experts. Outpatient and inpatient 

records are maintained in an electronic data warehouse that allows for access to data for research, as well 

as clinical care. An Informatics Working Group consisting of a Biomedical Informatics faculty member, Dr. 

Sterling, a database analyst based at the electronic data warehouse, and several research data managers 

and abstracters is supported by the Vanderbilt AIDS Center to meet research needs (as a core resource). 

This group meets weekly to address data needs in a timely manner.

The VCCC staff includes four Infectious Diseases Certified HIV primary care physicians, three nurse 

practitioners providing primary care, and 10 to 15 Vanderbilt Infectious Diseases Fellows at any one time. 

High risk obstetricians from Vanderbilt Maternal/Fetal Medicine provide obstetric and gynecological care. 

The VCCC also employs a pharmacist, psychiatrist, psychiatric mental health nurse practitioner, and 

dietitian. Additional personnel includes four social service medical case managers, two nurse medical case 

managers, one early intervention services specialist, and a pharmacy assistance program coordinator, 

ensuring a comprehensive continuum of care for VCCC patients. Approximately 85% of VCCC patients 

reside in the middle Tennessee region, with the remainder coming from more distant locations in 

Tennessee and surrounding states. The VCCC has three satellite clinics, located in Springfield, Columbia, 

and Cookeville, TN.

B. Career Development Facilities and Resources

1. Clinical and Translational Scientist Development (CTSD): In 2007, Vanderbilt University was awarded 

a $40 million Clinical and Translational Science Award (CTSA) from the National Center for Research 

Resources of the NIH to expedite the translation of laboratory discoveries to patients in the community. The 

CTSD is the educational component of Vanderbilt’s CTSA grant. The program provides an integrated 

career development program for all physician-scientists, regardless of their scope of research, and for
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Facilities & Other Resources Page 14

PhD-scientists engaged in translational or clinical research. The Office for CTSD will use endpoints such as 

publication rates, grant success (particularly K to R conversion), diversity among the faculty, retention of 

Newman Society members (see below) in academic medicine on the tenure track, and investment costs 

per faculty member to evaluate the success of its programs. Several resources available to young 

investigators are described below. Dr. Katherine Hartmann, M.D., Ph.D. serves as the Assistant Dean for 

Clinical and Translational Scientist Development.

a. Vanderbilt Institutional Funding Programs-The Vanderbilt Physician Scientist Development 

(VPSD) and Vanderbilt Clinical and Translational Research Scholars (VCTRS) Programs: These 

programs provide support to junior faculty and fellowship level trainees who are committed to a career 

in clinical or translational investigation, with a mentored research apprenticeship integrated with the 

didactic training. The programs provide salary support for trainees in clinical investigation, and 

additional funds for didactic coursework, research support and travel. The programs require awardees 

to work within the research space/program of the mentor, to ensure a close supervisory relationship 

while eliminating the need for the awardees to obtain their own supplies or equipment. The sponsoring 

clinical department chair must commit to provide 75% research time during the duration of the award. 

The clinical chair must also 1) provide support to the mentor's laboratory to support the activities of the 

applicant and 2) identify space and resources for the applicant's eventual emergence from the 

mentored setting as independent federal funding is secured. Candidates are selected on a competitive 

basis by a committee of Vanderbilt faculty who emphasize the quality of the mentor and his or her 

research environment, the training credentials of the applicant, and the quality of the research proposal. 

These programs are directed by Katherine Hartmann, M.D., Ph.D., Associate Dean for Clinical & 

Translational Scientist Development, who reports to the Dean of the School of Medicine, monitors the 

progress of all awardees, and engages departmental leadership if candidates require such support. 

These programs have been highly successful in bridging junior faculty physician-scientists into 

extramural career development awards.

b. The Elliot Newman Society is a professional organization for all physician-scientists and PhDscientists supported by the VPSD/VCTRS Programs, by other Vanderbilt K12 programs, or by 

individual K awards. All members meet every 6 months with the Associate Dean for Clinical and 

Translational Scientist Development, Dr. Katherine Hartmann, M.D., Ph.D. The purpose of this meeting 

is to review the candidate’s career plan and mentorship plan. As K awardees, all Newman Society 

Members are expected to have at least 75% protected time for research. Failure to meet this 

requirement for protected time will result in withdrawal of institutional salary support or K award. The 

Newman Society also sponsors an annual retreat for current and former students in the Masters of 

Public Health (MPH) or Masters of Clinical Science Investigation (MSCI), as well as any current holder 

of internal Vanderbilt grants to discuss their research projects. Invited speakers include established 

investigators in various fields of medicine.

c. Clinical Career Seminars are monthly one-hour seminars delivered by leading Vanderbilt faculty from 

diverse backgrounds on career development. Topics for the 2011-2012 academic year include: 

Mentoring Panel, Clinical and Translational Research Opportunities at Vanderbilt University, Time 

Management, Getting a Job in Academia: Preparing Yourself, Putting Your Promotion Packet Together, 

Managing Your Lab Finances, Managing Your Lab Team, Your Professional Portfolio, and Transition to 

Independence: Getting Your First R01.

d. Manuscript and Grant Writing Support is available from the CTSD through the availability of a 

repository of successfully funded grants, as well as an internal pre-review of grants by senior faculty.

2. Graduate Degree Programs

a. Master of Public Health (MPH): The Vanderbilt MPH program was developed in 1996 and provides a 

basic training program for fellows and junior faculty in an academic career in epidemiologic, behavioral, 

outcomes, and health services research. This encompasses Phase III clinical trials, cohort, and casecontrol studies to quantify the effects of patient, environmental, and behavioral factors on risk of 

disease, health services research, outcomes research, behavioral studies, and policy development. 

Since the program began in 1996, over 100 students have graduated and 89% of graduates remain in 

academic medicine or public health fields. Over 600 research articles have been published by program
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Facilities & Other Resources Page 15

alumni, including publications in JAMA, New England Journal of Medicine, Cancer Research and other 

high quality journals and over 150 research grants have been obtained by alumni, including K awards, 

R awards, and several grants from nongovernment sources.

b. Master of Public Health, Health Policy Track: The Vanderbilt MPH program includes Epidemiology, 

Global Health, and Health Policy Tracks. The Health Policy track is focused on analyzing how changes 

to public health policy and financing influence service delivery, health care spending, quality of care, 

and access to services. The Health Policy track prepares students for health policy leadership positions 

in the public and private sectors, potentially serving in a wide range of applied roles including as 

analysts, consultants, and policymakers. Relevant classes offered include: PUBH 5520 Introduction to 

Health Policy; PUBH 5538 Health Services Administration: Program and Policy Evaluation; PUBH 5525 

Health Economics; PUBH 5518 Research Ethics and Health Policy.

Brief course descriptions for select courses follow.

PUBH 5520 Introduction to Health Policy: This course addresses health policy from the perspectives of 

evidence development, analysis and economic impact within a socio-political context. There is a 

secondary focus on the role of regulation within the U.S. health care system.

PUBH 5538 Health Services Administration: Program and Policy Evaluation: The evaluation of changes 

in the health care delivery system, either through programs specifically implemented to achieve such 

changes or through changes in health care delivery/financing policies. The primary designs— 

before/after, concurrent/retrospective control, interrupted time-series—and their strengths and 

limitations. This course is taught by Wayne Ray, PhD. Dr. Ray is a Professor of Health Policy at 

Vanderbilt University School of Medicine. He founded the Vanderbilt Master of Public Health program 

and has been a Fellow of the International Society for Pharmacoepidemiology; he is the winner of 

Vanderbilt awards for innovative teaching (2004) and translational research (2015). Dr. Ray has 

research interests in population-based studies of therapeutic interventions and has published 200 

studies that use observational methods to assess safety and efficacy or seek to define and improve 

suboptimal use of therapeutic interventions.

PUBH 5525 Health Economics: Conceptual and empirical analysis of demand for health, medical 

services, and insurance; decisions by physicians and hospitals about price, quantity, and quality of 

services; technological change; and structure and performance of the pharmaceutical industry. This 

course is taught by Christopher Carpenter, PhD. Professor Carpenter is a health economist who 

studies the effects of public policy interventions on health behaviors, particularly in the areas of 

substance use and cancer screenings. He is also an expert on LGBT economic demography. His 

current research examines the effects of minimum legal drinking ages in the United States and other 

countries as well as the effects of federal funding for cancer screenings for low-income populations.

3. The Office of Biomedical Research and Training (BRET) was established in 1999 to support

and coordinate graduate education, postdoctoral training, minority affairs, and educational technology 

initiatives for the Vanderbilt biomedical research community. Under the guidance of Senior Associate Dean 

Dr. Roger Chalkley, the BRET staff handles applications and admissions to the Interdisciplinary Graduate 

Program (IGP) as well as Chemical and Physical Biology programs, coordinates the first-year IGP 

curriculum, provides educational technology support including web-based teaching and online distribution 

of course materials, organizes the Responsible Conduct of Research training, and maintains databases of 

research faculty involved in pre- and postdoctoral training. The Office of Career Development and 

Outcomes Analysis, based in BRET, holds a series of workshops and seminars periodically throughout the 

year. Topics for the 2011-2012 academic year include: Writing a Budget, Managing a Budget, and Get 

Clued into VICTR services and support (collaborative space, letters of support).

4. Vanderbilt University Library System

a. Eskind Biomedical Library (EBL): The Annette and Irwin Eskind Biomedical Library (EBL) is the hub 

of VUMC information services and resources. Opened in 1994, the EBL is prominently located at the 

center of campus. It is part of the Informatics Center, a federally designated Integrated Advances 

Information Management System (IAIMS) test site. EBL’s philosophy focuses on enabling information 

use at the point of need, providing extensive digital library of electronic journals, books, databases, and 

other resources, in addition to over 200,000 print volumes.
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Facilities & Other Resources Page 16

b. Jean and Alexander Heard Library, The Geographic Information Systems and Census 

Information services: The Geographic Information Systems and Census Information services of the 

Vanderbilt University Library are dedicated to providing the data, tools and training necessary to 

understand, analyze, and present geographic information. The service is designed to help Vanderbilt 

Students, Faculty, and staff as well as the community.

The Vanderbilt Library was chosen by the US Census Bureau as a designated Census Information 

Center (CIC) to assist the federal government in the dissemination of Census data to under-served 

communities, and to serve in partnerships with the international community, media, and nonprofit 

service providers in order to accomplish the goals set forth by the Census Bureau.

The Geographic Information Systems (GIS) service exists in conjunction with the CIC as many of 

our users wish to display their census information in the form of maps. The GIS service now includes, 

as well as reaches outside of, the use of census data to create maps and accomplish spatial analysis. 

The service offers practical software instruction, assists in the location, creation, and manipulation of 

data, and seeks to solve GIS related problems, as well as to produce maps for its users.

Hands-on GIS software, GIS concepts, and census information trainings are available to Vanderbilt 

students, faculty, and staff. GIS Services staff conduct occasional training for any member of the 

university community. Training services are listed through the University Calendar or the Scholarly 

Communication website.

Faculty can utilize the GIS Services staff to help plan and present GIS training and projects. ESRI 

online training courses are also available to students, faculty, and staff. The GIS office provides 

keycodes to access most of the training courses at no charge. Courses in GIS are available on campus 

through the Anthropology and Engineering departments, as are several GIS labs and public 

workstations.

C. Other Facilities and Resources

1. Research Funding and Growth: Vanderbilt University Medical Center (VUMC) has enjoyed a nearly 

decade-long expansion in NIH funding for biomedical research. For the period 2000-2005, VUMC became 

the fastest-growing academic medical center (AMC) research program in the nation on a percentage basis, 

with 17.3% compound annual growth. Since 2000, growth in NIH-sponsored research at VUMC has 

consistently outpaced the NIH budget annual percentage growth. This pattern has advanced VUMC quickly 

in the NIH rankings, from 24 in 2000 to 4 in 2011. Support for competitive research grants from all external 

sources was more than in 2011. In 2005, VUMC created a new research enterprise strategic 

plan that has driven institution growth. Its three major foci are: 1) personalized health and healthcare, 2) 

therapeutic discovery and translation, and 3) public health and healthcare. A key to VUMC’s success has 

been the ability to optimize research space productivity. Through strategic allocation of resources, VUMC 

has increased the financial productivity of research space in terms of direct revenue from all sponsorsto

/ sq. ft., near the top of the reported range of /sq. ft.

2. Vanderbilt Institute for Clinical and Translational Research (VICTR): The CTSA helped create a 

unique resource, the new Vanderbilt Institute for Clinical and Translational Research (VICTR), the purpose 

of which is to provide next-generation support to faculty working to translate fundamental scientific 

discoveries into clinical practice, with innovative training programs, and state-of-the-art informatics and 

biostatistical methods. Examples of programs to support translational investigators are describedbelow:

a. Synthetic Derivative (SD) is a database containing clinical information derived from Vanderbilt's 

electronic medical record (EMR), labeled with a unique research identification number derived from the 

clinical medical record, and stripped of personal identifiers. Thus, the SD is a set of records that is no 

longer linked to the identified medical record from which it is derived and has been altered to the point it 

no longer closely resembles the original record. The SD can be used as a stand-alone research 

resource, or can be used in conjunction with the Vanderbilt DNA Databank (see below) to identify 

patient sets for genome-phenome analysis. To data there are approximately 1.9 million records which 

include data from narratives (clinical notes, discharge summaries, history and physicals, problem lists, 

surgical reports, progress notes, letters), diagnostic codes (including TB and HIV), procedural codes, 

reports (ECGs, pathology, echocardiograms), laboratory values, vital signs, and medication orders

b. Vanderbilt DNA Databank (BioVU): In 2007, Vanderbilt investigators began extracting DNA from 

blood samples of adult patients at Vanderbilt that otherwise would be discarded, to create the
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Facilities & Other Resources Page 17

Vanderbilt DNA Databank (BioVU). To date it has acquired DNA samples from nearly 120,000 patients, 

linked to their matching electronic medical records. Both the samples and the records are “deidentified,” meaning that all personal information has been stripped away to guarantee patients’ 

anonymity. BioVU has been carefully reviewed to ensure it meets ethical standards for research. The 

“consent-to-treat” form for Vanderbilt patients includes a box that allows them to “opt out” of the 

databank. Only Vanderbilt researchers can apply as principal investigators to use BioVU, although their 

collaborators can be from other centers.

c. Database Management: Through resources provided through the CTSA and VICTR, a software 

application, REDCap (Research Electronic Data Capture), has been developed at Vanderbilt to collect 

and manage data for diverse clinical, epidemiologic, and translational research studies. The application 

was designed around the concept of giving research teams an easy method to specify project needs 

and rapidly develop secure, web based applications for collection, management, and sharing of 

research data. REDCap Survey was designed for studies where data are collected directly from the 

research participant. Both products include secure institutional data hosting and include full audit-trails 

in compliance with HIPAA security requirements. This program is available only to investigators from 

Vanderbilt and Meharry Medical College, but can be used by investigators at other institutions as long 

as they are part of a project/group from Vanderbilt that is utilizing REDCap or REDCap Survey. The 

International Epidemiologic Databases to Evaluate AIDS (IeDEA) network and Caribbean, Central and 

South America Network for HIV Epidemiology Research (CCASAnet), both funded by the NIH, utilize 

this distinctive Vanderbilt resource for their data coordination/management. See section C.6 (HIV 

Cohort Collaborations Associated with Vanderbilt University) below for more detail on CCASAnet.

d. Studios are a series of structured, dynamic sessions bringing together relevant Vanderbilt faculty 

research experts in a particular methodology to focus on a specific stage of research. VICTR offers 

studios for hypothesis generation, study design, implementation, analysis and interpretation, translation 

and manuscript development. These sessions are intended to enhance research quality, foster 

advances in clinical practice and improvements in patient health, increase publications, and generate 

new hypotheses. A studio consists of 2-6 experienced faculty selected to participate in a guidance 

session based on specific areas of research and needs identified by the investigator. Translation 

Studios are also available and are a structured guidance session to help researchers examine the 

broad community health implications of their research findings and identify opportunities for 

dissemination of relevant findings into practice.

e. StarBRITE (Biomedical Research Initiation, Translation, and Education) is a shared data 

infrastructure for the initiation and maintenance of human research programs that was developed to 

establish open channels for feedback and input from VICTR. It is an online central repository storing 

up-to-date study documents and project characteristics for Vanderbilt investigators. It also serves as a 

unified system for tracking research education, mentoring, conduct, collaboration, resource utilization, 

and productivity.

f. Pilot funding is available upon a minimal application process via expedited vouchers for up to $2000 

for acquiring or analyzing small amounts of data required for a grant submission or funding of final 

manuscript preparation. The application is reviewed within 48 hours following the request and the funds 

are immediately accessible upon approval. Request of funding in excess of $2000 requires a more-indepth application and committee review but the process is efficient and the funds can be made 

available in as little time as 2-4 weeks.

g. The Clinical Research Center (CRC): The purpose of the CRC is to provide the resources needed by 

clinical and translational investigators to carry out their research in an environment optimized for safety, 

comfort and convenience of the patient or volunteer, with the facilities and expertise to provide the most 

advantageous milieu in which to address the investigator's experimental requirements. This includes 

outpatient space, inpatient beds, laboratories, equipment and supplies for clinical research by the 

faculty of Vanderbilt University and their collaborating investigators. The CRC also serves as a 

resource for teaching medical, graduate, and other multidisciplinary students, a site for research on the 

methodology of patient care systems, and a unique environment for the apprenticeship of young clinical 

investigators. The CRC offers weekly workshops taught by Carlos Orozco, the Vanderbilt CRC 

Informatics Manager, and offering basic instruction and practical advice on a variety of issues and skills 

related to the conduct of clinical research. Sample topics include: how to use Microsoft Excel for
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Facilities & Other Resources Page 18

medical research; how to use queries in Microsoft Access; and how to use nQuery Advisor software to 

compute sample size estimates for common study designs. The class meets once a week and 

information is presented in an interactive format with computer demonstrations. A schedule of the CRC 

workshop series can be found at: http://www.mc.vanderbilt.edu/crc/workshop.html?value=archive.

3. Vanderbilt Institute for Global Health (VIGH)

The VIGH was inaugurated on July 1, 2005, when director Sten H. Vermund, M.D., Ph.D. came to 

Vanderbilt to become the first Amos Christie Chair in Global Health. The Institute for Global Health 

facilitates the expansion and coordination of global health research, service and training initiatives at 

Vanderbilt University, and reflects the university’s commitment to improve health services and outcomes in 

resource limited settings. Under Dr. Vermund’s guidance, its “center-without-walls” philosophy nurtures 

noncompetitive partnerships among and within departments and schools on campus, and with partner 

institutions around the globe. The Vanderbilt Institute for Global Health is expanding rapidly, having 

increased to more than 15 faculty members with appointments in Infectious Diseases, Pediatrics, 

Preventive Medicine, Obstetrics and Gynecology, Epidemiology, Biomedical Informatics, the School of 

Nursing, which work directly at the Institute, and numerous affiliated faculty members from across the 

institution. A global vision in health education is a core value of the Institute, and this is reflected in its 

strong commitment to training and research programs both at home and abroad. The extensive network 

and contacts that Dr. Vermund and his colleagues brought to Vanderbilt have facilitated the establishment 

of international training and research programs by Vanderbilt faculty, and broadened the range of 

opportunities available to students and fellows interested in these areas. Working with their colleagues at 

Vanderbilt and around the world, VIGH faculty members continually investigate new ways to develop 

innovative programs for addressing emerging global health challenges.

4. Vanderbilt Department of Health Policy

Vanderbilt University's new Department of Health Policy (Department Chair: Melinda Buntin, PhD) brings 

together a broad group of health policy scholars devoted to developing health policy solutions that can 

have a profound impact. The Department builds on a history of strong collaborative relationships with the 

Tennessee Department of Health, the Centers for Disease Control and Prevention, and several frontline 

policy makers to develop health policy solutions for our nation’s most pressing health care challenges. The 

combination of a major research university and preeminent medical center gives Department faculty 

incredible opportunities to build relationships with frontline care providers and policymakers which can lead 

to breakthrough discoveries. The Department fosters a deep belief that research and innovative thinking 

should guide health policy relationships and help policymakers understand implications. The Department 

offers weekly seminars in health policy topics and in Fall 2015 began offering a Health Policy Track for the

M.P.H. degree program.

a. Health Policy Methodology Group: Dr. John Graves maintains a standing regularly-scheduled 

meeting of health policy experts, econometricians, clinical researchers, epidemiologists, biostatisticians, 

and data managers to rigorously interrogate methods which may be applied to epidemiologic cohort 

data to derive valid inferences for the effects of health policy changes. As selection bias and 

confounding may be inferential barriers when translating internally valid estimates of effect from a study 

population to a larger, or more diverse, target population, techniques such as inverse probability of 

selection weighting, calibration, or propensity score matching may be required to derive unbiased 

population-appropriate estimates. This group therefore seeks to derive analytic techniques which may 

be applied to Dr. Graves’ ongoing research (e.g., and R01 examining the effects of health insurance 

coverage expansion on utilization and chronic disease outcomes in the Southern Community Cohort 

Study) and other, parallel projects, with similar methodologic barriers to overcome.

b. Institute for Medicine and Public Health: The Department of Health Policy is a member of this 

growing community of researchers, teachers and experts are working collaboratively to address 

important health care issues, generate innovative hypotheses, and expedite discovery and 

dissemination of new knowledge. The Institute serves to motivate, educate and support investigators 

and educators who will translate new evidence into health care practice, thereby improving personal 

and community health.

5. Vanderbilt Department of Biostatistics
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Facilities & Other Resources Page 19

The School of Medicine at Vanderbilt University created the Department of Biostatistics in September 

2003. The main goal of the Department of Biostatistics is to increase the quality and quantity of research in 

the School of Medicine with such mechanisms as developing study and experimental designs that 

maximize efficiency, interpretability, and generalizability of research, refining measurements to increase 

precision and sensitivity, and analyzing data in a powerful, robust, and reproducible fashion. Vanderbilt 

biostatisticians are available to assist in grant proposal development, specifically K award development, as 

well as manuscript writing to improve the chances of funding or publication. In addition to including 

biostatistician support in a grant budget, vouchers for biostatistics help are available through the VICTR 

funding mechanism. Relevant classes offered include: BIOS 8398 Special Topics: Spatial Analysis; BIOS 

8395: Causal Inference.

Brief course descriptions for select courses follow.

BIOS 8398 Special Topics: Spatial Analysis: The Special Topics course on spatial analysis, taught by Dr. 

Chris Fonnesbeck, will include but not be restricted to the following content: geostatistics, spatial cluster 

detection, spatial generalized linear models, methods for mapping, and methods for spatial data 

manipulation. The focus will be on appropriate analytic methods to derive valid inference for spatially and 

temporally variable exposures and outcomes. Dr. Fonnesbeck currently leads a project on optimal control 

of disease outbreaks and is particularly interested in the use of spatial statistics and Bayesian 

hierarchical/multilevel modeling strategies for inference and prediction in epidemiology. Moreover, as a 

biostatistical software developer, he is the creator and co-developer of PyMC, a popular software package 

for Bayesian statistical analysis.

BIOS 8395 Causal Inference: This course, currently under development, provides an introduction to the 

framework for causal modeling in observational data. Topics include propensity score adjustment, inverse 

probability weighting, instrumental variables, and sensitivity analysis. Methods are applied to a variety of 

biomedical examples. The course will be taught by Dr. Bryan Shepherd. Dr. Shepherd’s statistical methods 

research has a particular emphasis on causal inference and methods for epidemiological data. He has 

been involved in the development of causal inference methods important to HIV vaccine trials. Since he 

arrived at Vanderbilt, he has continued to develop and apply causal inference methods, and has branched 

into other areas including approaches for analyzing ordered categorical data, and measurement error 

methods.

a. Daily Biostatistics clinics are supported by the Vanderbilt CTSA grant and are available free of 

charge to Vanderbilt Investigators. These walk-in clinics are held in a group setting and cover a 

different biostatistics theme Monday through Friday (e.g. Monday – General: including Comparative 

Effectiveness Research, Prognosis, Diagnosis, Observational Research, Study Design, Analysis, 

Graphics and Thursday – Clinical Research).

b. The Biostatistics Collaboration Center at Vanderbilt (BCC) is a university sponsored core resource 

whose goal is to provide for, enhance, and/or facilitate statistical collaborations involving the design, 

conduct, analysis or publication of biomedical research at the university. The BCC is comprised of 

biostatisticians and computer systems analysts from the Department of Biostatistics who are available 

to work with faculty on a variety of projects. They offer a wide range of highly trained experts with 

unique expertise for almost any collaboration. The BCC has considerable expertise in the design, 

conduct, and analysis of large scale clinical trials and research design for basic biomedical research. 

Varying levels of expertise are available for consultation, from bachelor and master level trained 

biostatisticians and computer systems analysts to full professors. Services include, but not limited to, 

salaries, administrative costs, supplies, computing (software, hardware, and shared resources such as 

the Advanced Computing Center for Research and Education (ACCRE)), information technology 

support, and relevant professional development costs. ACCRE offers computing resources flexible 

enough to enable high performance computing applications in a wide variety of research and education 

areas, and also provides access to high performance storage resources.

The clinics are open to all members of the Vanderbilt and Meharry communities who have 

methodologic questions about their research projects or about published articles. Mentors should 

attend with post-docs and students. Attendees should select the appropriate clinic day according to the 

schedule. Biostatistics clinics are sponsored by the Department of Biostatistics and VICTR.
Contact PD/PI: Rebeiro, Peter F

Facilities & Other Resources Page 20

Investigators should email biostat-clinic@list.vanderbilt.edu by 9am of the day they wish to attend. 

More information including daily themes and notes may be found at 

http://biostat.mc.vanderbilt.edu/Clinics.

6. Mentorship

The Department of Medicine and Division of Infectious Diseases place a high importance on mentorship of 

young investigators. Dr. Rebeiro has a strong relationship with his primary mentor, Dr. Timothy Sterling, as 

well as with his co-mentor Dr. John Graves. He has maintained standing weekly meetings with Dr. Sterling 

over the past two years.

Dr. Rebeiro’s mentoring committee is composed of experienced and successful investigators who have 

collectively written numerous funded NIH grants and high-impact publications. The proposed study will 

benefit from the inclusion of health policy experts (Drs. Graves, Schaffner, and Holtgrave), epidemiologists 

(Drs. Sterling and Gange), biostatisticians (Drs. Fonnesbeck and Shepherd), and large cohort 

representatives (Drs. McGowan and Moore) who can provide expertise, mentoring, and advice in study 

design, health policy research, epidemiology, and biostatistics, specifically as they pertain to HIV quality of 

care, spatial statistics, and disease outcomes. His mentors’ complementary skills will improve his chances 

for success as his career develops as an independent investigator.

a. Primary mentor: Timothy R. Sterling, M.D. (Professor of Medicine, Vanderbilt University) is a skilled 

clinical investigator with expertise in HIV and TB outcomes research. He has directed the Epidemiology 

Outcomes Unit in the Vanderbilt AIDS Center as well as TB research at the Nashville Metro-Davidson 

Health Department since 2003. He also serves as a principal investigator of the Vanderbilt site in the 

Tuberculosis Trials Consortium of the Centers for Disease Control and Prevention, and the NA-ACCORD. 

Dr. Sterling has mentored 9 fellows that have gone on to receive K awards and 5 that have received R 

awards from the NIH. Importantly, Dr. Sterling has a K24 award from the National Institute of Allergy and 

Infectious Diseases to mentor young investigators in translational HIV and TB research.

b. Co-mentor: John A. Graves, Ph.D. (Assistant Professor of Health Policy and Medicine, Vanderbilt 

University) has an interdisciplinary research focus on the development, implementation and evaluation of 

health care reforms at the state and federal level. He also leads a Health Policy Methodology group 

dedicated to exploring methods for obtaining valid inferences for policy impact from epidemiologic cohort 

data. His research on the dynamics of health insurance has played a particularly important role in recent 

policy debates: his research was cited in the U.S. Supreme Court’s arguments over the Affordable Care 

Act in 2015 and was a key catalyst for regulatory changes affecting the way patients pay for insurance 

plans in the state insurance marketplaces created by the Affordable Care Act. His research portfolio 

includes NIH-funded research on the returns to health care spending and on the appropriate use of hospital 

quality measures to guide delivery system reforms. He has extensive experience in spatial econometrics. 

He is Principal Investigator on an R-01 assessing the impact of Medicaid expansion on chronic disease 

and mortality in the Southeastern United States. In addition, he was PI of a Robert Wood Johnson

Foundation-funded national initiative to identify local gaps in primary care capacity under the Affordable 

Care Act’s public and private coverage expansions. He has also mentored and continues to mentor other 

individuals successfully through T- and K-mechanisms.

c. Mentoring Committee Members:

(1) William Schaffner, M.D. (Professor of Health Policy, Professor of Medicine, Vanderbilt University) is an 

experienced researcher and mentor with more than 30 years of experience directly informing health policy 

at the state and federal level. Dr. Schaffner has served as the President of the Society for Healthcare 

Epidemiology of America and as chair of Preventive Medicine at Vanderbilt University. He is a consultant 

in public health policy for the World Health Organization, the Tennessee Department of Health, and the 

Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention. In 

those capacities, he has accumulated extensive first-hand experience in translating evidence to policy 

while working with policy makers. He has mentored dozens of scientists, many of whom have gone on to 

serve in distinguished capacities directing public health policy, including the current state epidemiologist for 

Tennessee.
Contact PD/PI: Rebeiro, Peter F

Facilities & Other Resources Page 21

(2) Christopher J. Fonnesbeck, Ph.D. (Assistant Professor of Biostatistics, Vanderbilt University) is an 

established statistical methods expert, with particular expertise in the fields of spatial analysis, Bayesian 

statistics, and hierarchical/multilevel modeling strategies for inference and prediction in epidemiology. He 

provides quantitative expertise to the Evidence-based Practice Center (Vanderbilt Institute for Medicine 

and Public Health), the Department of Pediatrics/Division of Infectious Diseases, and the Department of 

Orthopedic Surgery and Rehabilitation, as well as leading research on his own grant studying the optimal 

control of disease outbreaks through decision analysis, collaborating with Penn State University and the 

University of Warwick. He has taught courses on introductory and advanced statistical computing (BIOS 

6301; BIOS 8366) and takes mentoring responsibilities for biostatistics students seriously.

(3) Bryan E. Shepherd, Ph.D. (Associate Professor of Biostatistics, Vanderbilt University) is an 

established biostatistician and causal inference methodologist whose work can be broadly summarized as 

developing and applying novel statistical methods to medical studies, with an emphasis on studies of 

HIV/AIDS. For the past 10 years, he has been the lead statistician for the Caribbean, Central and South 

American network (CCASAnet) of the International epidemiologic Databases to Evaluate AIDS (IeDEA). He 

is also currently the Director of the Biostatistics and Biomedical Informatics Core of the Tennessee Center 

for AIDS Research (TN-CFAR). He has published over 130 peer-reviewed publications, and his statistical 

methods research has had a particular emphasis on causal inference and methods for epidemiological 

data. He has mentored several successful K-awardees.

(4) David R. Holtgrave, Ph.D. (Professor and Chair of Health, Behavior, and Society, Johns Hopkins 

University) is a researcher and policy maker who pursues the advancement of scientific understanding of 

the impact on health of behavior and the societal context. Prior to his positions in academia, Dr. Holtgrave 

oversaw HIV/AIDS services in the United States as director of the Division of HIV/AIDS Prevention: 

Intervention Research and Support in the National Center for HIV, STD and TB Prevention at the Centers 

for Disease Control and Prevention (CDC) from 1997 to 2001. Dr. Holtgrave’s research has focused on the 

effectiveness and cost-effectiveness of a variety of HIV prevention interventions, and the relation of the 

findings of these studies to HIV prevention policy making. He has also investigated the relationship 

between social capital measures, infectious disease rates, and risk behavior prevalence. He has also 

examined the cost-effectiveness of mass media approaches to the prevention of tobacco use. He also 

currently serves as the Vice-Chair of the Presidential Advisory Council on HIV/AIDS.

(5) Stephen J. Gange, Ph.D. (Executive Vice Provost for Academic Affairs, Professor of Epidemiology, 

Johns Hopkins University) is an accomplished biostatistician and epidemiologist, an international leader in 

the practice of HIV epidemiology who serves on the United States Department of Health and Human 

Services Antiretroviral Therapy Guidelines Committee. He has an interest in causal inference and 

application of advanced statistical methods in HIV epidemiology. He has mentored 7 faculty under 

individual K awards from the NIH, several of whom have advanced to their own R funding. Dr. Gange 

currently has a U01 award from the NIAID for the “WIHS Data Management and Analysis Center 

(WDMAC)” (AI-042590) and has previously held a P30 award entitled “Biostatistics and Epidemiology 

Methodology,” (AI-094189) also funded by NIAID. Additionally, he is Director of the 

Epidemiology/Biostatistics cores of both the NA-ACCORD and the Johns Hopkins University Center For 

AIDS Research (JHU CFAR).

d. Advisors for cohort utilization:

(1) Catherine C. McGowan, M.D. (Associate Professor of Medicine, Vanderbilt University) is a clinical 

researcher and educator who specializes in the management of adult HIV infection. She participates in the 

Epidemiology/Outcomes Unit of the Tennessee Center for AIDS Research, which utilizes patient data and 

specimen repositories from the Vanderbilt Comprehensive Care Clinic to examine HIV treatment 

outcomes. She is an expert in the international scale-up of HIV care, treatment, and research, and she is 

principal investigator of the Caribbean, Central, and South America network for HIV epidemiology 

(CCASAnet) of the NIH-funded International epidemiologic Databases to Evaluate AIDS (IeDEA).

(2) Richard D. Moore, M.D., M.H.S. (Professor of Medicine, Professor of Epidemiology, Johns Hopkins 

University) is recognized for mentorship of medical students, residents, fellows, and junior faculty in
Contact PD/PI: Rebeiro, Peter F

Facilities & Other Resources Page 22

HIV/AIDS Research. Winner of the David M. Levine Mentorship Award in the Johns Hopkins General 

Internal Medicine Department, he is an expert in pharmacoepidemiology, clinical epidemiology, and health 

services research, having authored over 450 publications. He is the Director of the Moore Clinic for HIV 

Care (begun in 1984), Director of the JHU CFAR Clinical Core, and Director of the Johns Hopkins Program 

for HIV Outcomes Research. He has been principal investigator of multiple NIH and HRSA grants 

(including both R and U mechanisms), and he is also principal investigator of the North American AIDS 

Cohort Collaboration on Research and Design (NA-ACCORD) of IeDEA.

7. HIV Cohort Collaborations Associated with Vanderbilt University

a. North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD): The 

NA-ACCORD is a regional collaboration of single-site and multi-site cohorts that includes over 

125,000 patients from 25 cohorts in the United States and Canada funded by the NIH (U01-AI069918). The NA-ACCORD is a collaboration of both academic medical centers and community 

based facilities that deliver HIV primary and specialty care, combines classical epidemiological 

and clinical HIV cohorts, and is complemented by specimen repositories for conducting 

translational research. It includes investigators who have a high level of scientific expertise and 

clinic experience and has an efficient structure for harmonization of data and the conduct of 

analyses. Their goals are: (1) To establish a collaboration of North American HIV/AIDS cohorts 

and a data center for compilation of data to address HIV/AIDS research questions that cannot be 

accomplished through smaller cohorts; (2) To address scientific aims that focus on the failure of 

HAART; (3) To address additional scientific aims related to events that cannot be as well studied 

in smaller cohorts (for example, those that require large sample sizes, such as TB disease in a 

low-incidence setting); (4) To develop and apply novel statistical and epidemiological 

methodology that is applicable to these scientific research initiatives, and; (5) To collaborate with 

other regional cohorts to compare results and address questions of inter-regional importance.

The work of NA-ACCORD is organized into three major cores: (1) The Administrative Core (AC) is

located at the Johns Hopkins University in Baltimore, MD. The AC staff is responsible for the 

administrative and operational functions of the NA-ACCORD; (2) The Data Management Core 

(DMC) is located at the University of Washington in Seattle, WA. The DMC provide expertise and 

experience in informatics that facilitate the merging of data from multiple heterogeneous sources 

and the ability to include additional sites over time. The NA-ACCORD does not maintain a 

centralized data base of all data collected by participating cohorts. For approved concept sheets 

inclusion criteria, variables, and time-lines are constructed for data collection and these data are 

abstracted from each cohort and transmitted to the DMC. Monitoring data quality includes 

systematic review of medical records, event driven audits, and verification of random samples of 

clinical events. Centralized data mapping was designed to specify how data are integrated into 

standard NA-ACCORD codes with known meanings; (3) The Epidemiology/Biostatistics Core 

(EBC) is located at Johns Hopkins and includes a network of leaders of HIV cohort studies who 

have developed innovative biostatistical and epidemiological methodologies. Databases 

generated by the DMC are transmitted to the EBC for statistical analyses.

A combination of topic-specific working groups and project-specific writing groups provides 

forums for communication among study investigators. Working groups have periodic conference 

calls and meetings to discuss ongoing projects and identify future projects. The following working 

groups are already established: (1) an antiretroviral therapy effectiveness working group, which 

oversees initiatives regarding major study outcomes (AIDS, death), therapies, and natural/treated 

history; (2) a toxicities and comorbidities working group which oversees initiatives regarding ARV 

toxicities and co-morbidities; (3) a specimen repository working group which advises the steering 

committee on use of specimens.

b. International Epidemiologic Databases to Evaluate AIDS (IeDEA): The IeDEA network 

(approximately 250,000 subjects) is an international research consortium established in 2005 and 

funded by the NIH to address the unique and evolving questions in HIV/AIDS research currently 

unanswerable by single cohorts. Seven regional centers including North America (NAACCORD), the Caribbean, Central, and South America (CCASAnet), Asia Pacific (TREATAsia),
Contact PD/PI: Rebeiro, Peter F

Facilities & Other Resources Page 23

West Africa, Central Africa, East Africa and Southern Africa, collaborate to collect and define key 

variables, harmonize data, and implement methodology to effectively pool data-thus providing a 

cost effective means of generating large datasets to address high priority research questions and 

streamline HIV/AIDS research. The Vanderbilt Institute for Global Health, utilizing REDCap, 

serves as the data coordinating/management center for this network. Dr. William Wester, M.D., 

M.P.H., Assistant Professor of Medicine, and Dr. Mary Lou Lindegren, Associate Professor of 

Pediatrics, serve as principal investigators of the IeDEA Network Coordinating Center (INCC).

c. Caribbean, Central and South America Network for HIV Epidemiology (CCASAnet): 

CCASAnet is a collaborative network of observational HIV cohorts in Latin America and the 

Caribbean (approximately 20,000 subjects) and a regional member of IeDEA. The goal of this 

network is to create a shared repository of HIV data and use the combined data to answer 

questions about the characteristics of the regional HIV epidemic. Dr. Catherine McGowan at 

Vanderbilt University is the Principal Investigator for this collaboration and Bryan Shepherd, is a 

co-investigator. Dr. Timothy Sterling is also a co-investigator in CCASAnet and oversees all TBrelated projects conducted in this collaboration. As with IeDEA, Vanderbilt University serves as 

the data coordinating/management center for this network through utilization of REDCap.
Contact PD/PI: Rebeiro, Peter F

Equipment Page 24

EQUIPMENT.

Please see section “FACILITIES AND OTHER RESOURCES” for additional information 

regarding support available for this project, including through the Vanderbilt University School of 

Medicine, within the Health Policy and Biostatistics Departments, and through the NA-ACCORD 

and CCASAnet Epidemiology/Biostatistics and Data Analysis Cores.

Dr. Rebeiro’s office, Dr. Rebeiro has private office space 

located within the Division of Infectious Diseases with 

a private phone, storage space, and desktop Dell computer.

He has administrative support for daily needs as well as 

grants management support from the main administrative office of the Division of Infectious 

Diseases. He has access to printers, copiers, fax machines, and other office support. He also 

has access to Adobe Acrobat, Microsoft Office, STATA, STAT Transfer, and Reference 

Manager software.

Infectious Diseases Conference Room, The conference room

It

is a fully equipped multifunctional conference room that can be configured for meetings, training, 

luncheons or other needs for 35-40 people. It is equipped with wired and wireless internet 

connections, TV/VCR/DVD, dry erase board, projection screen, easels, and overhead projector. 

The conference room has state-of-the-art videoconferencing capabilities, which can be utilized 

for videoconferencing with collaborators within NAACCORD.

North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD): The 

work of NA-ACCORD is organized into three major cores: (1) The Administrative Core (AC) is 

located at the Johns Hopkins University in Baltimore, MD; (2) The Data Management Core 

(DMC) is located at the University of Washington in Seattle, WA; (3) The 

Epidemiology/Biostatistics Core (EBC) is located at Johns Hopkins and includes a network of 

leaders of HIV cohort studies who have developed innovative biostatistical and epidemiological 

methodologies.

The EBC computing system is maintained autonomously by dedicated staff and 

includes:

• A dedicated Sun Microsystems Sun Fire E2900 server, used primarily for analytical tasksand 

intensive computational programming. It is an 8 RISC-based multiprocessor server with 1.2 

GHZ per CPU and 32 GBs of main memory. A SUN Unified Storage System 7210 is 

equipped with 2.0 TB of disk space.

• Four PC servers configured to separately serve as user file server support and database 

management.

• A dual socket Windows 7 64 bit PC with dual Intel Xeon X5680 CPUs (each up to 3.6 GHz) in 

which each processor has 12 physical cores with 2 logical cores per physical core (i.e. 12 

physical cores, 24 logical cores). This PC has 48 GB of RAM so that large data sets can be 

analyzed in parallel depending on the analysis. Solid-state drives with room for expansion 

provide fast data transfer from storage to RAM.

• Individual PCs and Mac Book Pro laptops running Windows or Mac OS. The EBC has all 

major computer packages installed, including current versions of SAS, R/Splus, and STATA. 

The center biostatisticians maintain an extensive collection of routines, primers, sample code, 

and validated sample code used for data analysis. The multiplatform configuration will 

adequately meet future demands for data management and complex statistical analysesand
Contact PD/PI: Rebeiro, Peter F

Equipment Page 25

modeling. PC database software of MS Access, and SQL Server 2005, in conjunction with 

ASP, XML, Visual Studio, and Java Script are primarily used to develop web-based data 

management systems. There are various printers, including color LaserJets, LaserJet8000s, 

LaserJet4100s, LaserJet 2420s, and a LaserJet5MX to support printing needs in TeX, 

Postscript, word processing and web browsing.

Dr. Richard Moore, M.D., M.H.S. (a collaborator on this project) is the PI for the NA-ACCORD 

and Professor of Medicine at Johns Hopkins University School of Medicine. Dr. Moore supports 

Dr. Rebeiro’s K award application (see attached letter) and will offer data management and 

analysis support from the NA-ACCORD Data Management and Epidemiology/Biostatistics 

Cores.

The Advanced Computing Center for Research and Education (ACCRE): The Vanderbilt 

University ACCRE High Performance Computing cluster has over 4,000 processor cores.

Processor cores each have 3 – 16 GB of memory. Compute nodes all run a 64-bit Linux OS and 

have a 250 GB – 1 TB hard drive and dual copper gigabit Ethernet ports. Forty-eight computing 

nodes are each equipped with 4X Nvidia GeForce GTX 480 GPU cards. Nodes are monitored 

via Nagios. Resource management, scheduling of jobs, and usage tracking are handled by an 

integrated scheduling system by Moab/Torque.

These utilities include an “advance reservation” system that allows a block of nodes to be 

reserved for prespecified periods of time (e.g., a class or lab session) for educational or 

research purposes. IBM’s General Parallel File System (GPFS) is used for user home and data 

directories and scratch space. The ACCRE filesystem provides over 325 TB of usable disk 

space and can sustain more than 100 Gb/s of I/O bandwidth to the cluster. The home 

directories of all users are backed up daily to tape. The disk arrays are attached to a SAN fabric 

along with the storage nodes that then exports the file system to the rest of the cluster using a 

fully redundant design with no single point of failure. The daily operation and maintenance of 

ACCRE is provided by ten support personnel, including eight system administrators, 

programmers and researchers with a combination of more than 60 years of computing 

experience. Support for system services is provided on a 24/7/365 basis for urgent issues, with 

on-call pager based support on nights and weekends. Cluster uptime has been better than 95% 

over the past three years. An online support ticket system is used to track and resolve problems 

and user questions. ACCRE staff are responsible for maintaining core system hardware, core 

system software, networking, user support, tape backup services, disk storage, logistical 

storage development work, education, and management/finance support. Dr. Rebeiro may 

utilize the ACCRE for data management and analysis as necessary.
Contact PD/PI: Rebeiro, Peter F OMB Number: 4040-0001

Page 26

Funding Opportunity Number: PA-16-190 . Received Date:

2017-01-05T17:21:11.000-05:00 Tracking Number: GRANT12315321

Expiration Date: 06/30/2016

RESEARCH & RELATED Senior/Key Person Profile(Expanded)

PROFILE - Project Director/Principal Investigator

Prefix: First Name*: Peter Middle Name F Last Name*: Rebeiro Suffix: 

Position/Title*: Research Asst Professor

Organization Name*: Vanderbilt University Medical Center

Department: 

Division: 

Street1*: 

Street2: 

City*: 

County: 

State*: 

Province:

Country*:

Zip / Postal Code*:

Phone Number*: Fax Number:

E-Mail*:

Credential, e.g., agency login:

Project Role*: PD/PI Other Project Role Category:

Degree Type: Doctor of Philosophy Degree Year: 2014

Attach Biographical Sketch*: File Name: ID-0039416_BN-1_BIOSKETCH.pdf

Attach Current & Pending Support: File Name:
Page 27

Funding Opportunity Number: PA-16-190 . Received Date:

2017-01-05T17:21:11.000-05:00 Tracking Number: GRANT12315321

Contact PD/PI: Rebeiro, Peter F

PROFILE - Senior/Key Person

Prefix: First Name*: Timothy Middle Name R Last Name*: Sterling Suffix: 

Position/Title*: Professor

Organization Name*: Vanderbilt University Medical Center

Department: 

Division: 

Street1*: 

Street2: 

City*: 

County: 

State*: 

Province:

Country*:

Zip / Postal Code*:

Phone Number*: Fax Number:

E-Mail*:

Credential, e.g., agency login:

Project Role*: Other (Specify) Other Project Role Category: Mentor

Degree Type: Medical Doctor Degree Year: 1989

Attach Biographical Sketch*: File Name: ID-0051371_BN-1_BIOSKETCH.pdf

Attach Current & Pending Support: File Name: ID-0051371_BN-2_CURRENTPENDING.pdf

PROFILE - Senior/Key Person

Prefix: First Name*: John Middle Name A Last Name*: Graves Suffix: 

Position/Title*: Asst Professor

Organization Name*: Vanderbilt University Medical Center

Department: 

Division: 

Street1*: 

Street2: 

City*: 

County: 

State*: 

Province:

Country*:

Zip / Postal Code*:

Phone Number*: Fax Number:

E-Mail*:

Credential, e.g., agency login:

Project Role*: Other (Specify) Other Project Role Category: Co-Mentor

Degree Type: Doctor of Philosophy Degree Year: 2011

Attach Biographical Sketch*: File Name: ID-0101157_BN-1_BIOSKETCH.pdf

Attach Current & Pending Support: File Name: ID-0101157_BN-2_CURRENTPENDING.pdf
Page 28

Funding Opportunity Number: PA-16-190 . Received Date:

2017-01-05T17:21:11.000-05:00 Tracking Number: GRANT12315321

Contact PD/PI: Rebeiro, Peter F

PROFILE - Senior/Key Person

Prefix: First Name*: Richard Middle Name D. Last Name*: Moore Suffix:

Position/Title*: Professor

Organization Name*: Johns Hopkins University

Department:

Division:

Street1*:

Street2:

City*:

County:

State*:

Province:

Country*:

Zip / Postal Code*:

Phone Number*: Fax Number:

E-Mail*:

Credential, e.g., agency login:

Project Role*: Other (Specify) Other Project Role Category: Advisor

Degree Type: Degree Year:

Attach Biographical Sketch*: File Name: ID-21644_BN-1_BIOSKETCH.pdf

Attach Current & Pending Support: File Name:

PROFILE - Senior/Key Person

Prefix: First Name*: Stephen Middle Name Last Name*: Gange Suffix:

Position/Title*: Sr. Assoc Dean for Academic Affairs

Organization Name*: Johns Hopkins

Department:

Division:

Street1*:

Street2:

City*:

County:

State*:

Province:

Country*:

Zip / Postal Code*:

Phone Number*: Fax Number:

E-Mail*:

Credential, e.g., agency login:

Project Role*: Other (Specify) Other Project Role Category: Mentoring Committee

Degree Type: Degree Year:

Attach Biographical Sketch*: File Name: ID-25353_BN-1_BIOSKETCH.pdf

Attach Current & Pending Support: File Name:
Page 29

Funding Opportunity Number: PA-16-190 . Received Date:

2017-01-05T17:21:11.000-05:00 Tracking Number: GRANT12315321

Contact PD/PI: Rebeiro, Peter F

PROFILE - Senior/Key Person

Prefix: First Name*: Catherine Middle Name C Last Name*: McGowan Suffix: 

Position/Title*: Assoc Professor

Organization Name*: Vanderbilt University Medical Center

Department: 

Division: 

Street1*: 

Street2: 

City*: 

County: 

State*: 

Province:

Country*:

Zip / Postal Code*:

Phone Number*: Fax Number:

E-Mail*:

Credential, e.g., agency login:

Project Role*: Other (Specify) Other Project Role Category: Advisor

Degree Type: Medical Doctor Degree Year: 1987

Attach Biographical Sketch*: File Name: ID-0006287_BN-1_BIOSKETCH.pdf

Attach Current & Pending Support: File Name:

PROFILE - Senior/Key Person

Prefix: First Name*: David Middle Name Last Name*: Holtgrave Suffix:

Position/Title*: Professor

Organization Name*: Johns Hopkins University

Department:

Division:

Street1*:

Street2:

City*:

County:

State*:

Province:

Country*:

Zip / Postal Code*:

Phone Number*: Fax Number:

E-Mail*:

Credential, e.g., agency login:

Project Role*: Other (Specify) Other Project Role Category: Mentoring Committee

Degree Type: Degree Year:

Attach Biographical Sketch*: File Name: ID-26286_BN-1_BIOSKETCH.pdf

Attach Current & Pending Support: File Name:
Page 30

Funding Opportunity Number: PA-16-190 . Received Date:

2017-01-05T17:21:11.000-05:00 Tracking Number: GRANT12315321

Contact PD/PI: Rebeiro, Peter F

PROFILE - Senior/Key Person

Prefix: First Name*: William Middle Name Last Name*: Schaffner Suffix: 

Position/Title*: Professor

Organization Name*: Vanderbilt University Medical Center

Department: 

Division: 

Street1*: 

Street2: 

City*: 

County: 

State*: 

Province:

Country*:

Zip / Postal Code*:

Phone Number*: Fax Number:

E-Mail*:

Credential, e.g., agency login:

Project Role*: Other (Specify) Other Project Role Category: Mentoring Committee

Degree Type: Degree Year:

Attach Biographical Sketch*: File Name: ID-0000414_BN-1_BIOSKETCH.pdf

Attach Current & Pending Support: File Name:

PROFILE - Senior/Key Person

Prefix: First Name*: Christopher Middle Name J Last Name*: Fonnesbeck Suffix: 

Position/Title*: Asst Professor

Organization Name*: Vanderbilt University Medical Center

Department: 

Division: 

Street1*: 

Street2: 

City*: 

County: 

State*: 

Province:

Country*:

Zip / Postal Code*:

Phone Number*: Fax Number:

E-Mail*:

Credential, e.g., agency login:

Project Role*: Other (Specify) Other Project Role Category: Advisor

Degree Type: Doctor of Philosophy Degree Year: 2005

Attach Biographical Sketch*: File Name: ID-0094542_BN-1_BIOSKETCH.pdf

Attach Current & Pending Support: File Name:
Page 31

Funding Opportunity Number: PA-16-190 . Received Date:

2017-01-05T17:21:11.000-05:00 Tracking Number: GRANT12315321

Contact PD/PI: Rebeiro, Peter F

PROFILE - Senior/Key Person

Prefix: First Name*: Bryan Middle Name E Last Name*: Shepherd Suffix: 

Position/Title*: Assoc Professor

Organization Name*: Vanderbilt University Medical Center

Department: 

Division: 

Street1*: 

Street2: 

City*: 

County: 

State*: 

Province:

Country*:

Zip / Postal Code*:

Phone Number*: Fax Number:

E-Mail*:

Credential, e.g., agency login:

Project Role*: Other (Specify) Other Project Role Category: Advisor

Degree Type: Doctor of Science Degree Year: 2005

Attach Biographical Sketch*: File Name: ID-0065337_BN-1_BIOSKETCH.pdf

Attach Current & Pending Support: File Name:
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 32

BIOGRAPHICAL SKETCH 

Provide the following information for the Senior/key personnel and other significant contributors.

Follow this format for each person. DO NOT EXCEED FIVE PAGES.

NAME: Rebeiro, Peter F.

eRA COMMONS USER NAME (agency login): 

POSITION TITLE: Research Assistant Professor

EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, 

include postdoctoral training and residency training if applicable.)

INSTITUTION AND LOCATION DEGREE Completion Date FIELD OF STUDY

(if applicable) MM/YYYY

Yale University, New Haven, CT BA 12/2005 Biology

Johns Hopkins University, Baltimore, MD ScM 05/2012 Epidemiology

Johns Hopkins University, Baltimore, MD MHS 08/2014 Biostatistics

Johns Hopkins University, Baltimore, MD PHD 08/2014 Epidemiology

A. Personal Statement

The execution of epidemiologic research to inform public health action is an incredibly complex and rewarding 

task that requires the input, collegial cooperation, and applied knowledge of several dedicated individuals.

Beyond my formal education, I have participated in HIV epidemiology and outcomes research in nearly every 

capacity: as a data abstractor, an IRB liaison, a data manager and quality control officer, a protocol analyst and 

editor, a statistical analyst, an abstract and manuscript editor and author, and others. I have also received 

extensive training in epidemiologic methods and biostatistics, making my skillset particularly well suited to the 

task of analyzing observational data while also providing me a solid foundation on which to build my 

understanding of policy evaluation and econometrics. Because of this varied experience, both in the 

development of questions and in the execution of the steps necessary to answer them scientifically and 

disseminate the results through publication, I believe that I have demonstrated my abilities as a competent 

researcher and epidemiologist. I believe I have also demonstrated my capacity for productive research 

collaborations on closely related topics, including through the use of uniquely rich data sources and by availing 

myself of the expertise of leaders in the field. I am currently working with both the North American AIDS Cohort 

Collaboration on Research and Design (NA-ACCORD) and the Caribbean, Central and South American 

network for HIV epidemiology (CCASAnet) of the NIH-funded International epidemiologic Databases to 

Evaluate AIDS (IeDEA), and am therefore also experienced in working with longitudinal data from large, 

geographically diverse HIV-infected populations. I therefore feel that I am well positioned to leverage these 

opportunities to answer significant questions in the arena of health policy and make a meaningful contribution 

to improve the lives of those with HIV.

1. Rebeiro PF, Cesar C, Shepherd BE, De Boni RB, Cortes CP, Rodriguez F, Belaunzarán-Zamudio P, 

Pape JW, Padgett D, Hoces D, McGowan CC, Cahn P for the Caribbean, Central and South America 

network for HIV epidemiology (CCASAnet). Assessing the HIV Care Continuum in Latin America: 

progress in clinical retention, cART use, and viral suppression. J Int AIDS Soc. 2016 Apr 

8;19(1):20636. Pubmed PMID: 27065108 PMCID: PMC4827101

2. Rebeiro PF, Althoff KN, Lau B, Gill J, Abraham AG, Horberg MA, Kitahata MM, Yehia BR, Samji H, 

Brooks JT, Buchacz K, Napravnik S, Silverberg MJ, Rachlis A, Gebo KA, Sterling TR, Moore RD, 

Gange SJ. Laboratory Measures as Proxies for Primary Care Encounters: Implications for Quantifying 

Clinical Retention Among HIV-Infected Adults in North America. Am J Epidemiol. 2015 Dec 

1;182(11):952-60. PubMed PMID: 26578717. PubMed Central PMCID: PMC4655744.

3. Rebeiro PF, Horberg MA, Gange SJ, Gebo KA, Yehia BR, Brooks JT, Buchacz K, Silverberg MJ, Gill J,

Moore RD, Althoff KN. Strong agreement of nationally recommended retention measures from the 

Institute of Medicine and Department of Health and Human Services. PLoS One. 2014;9(11):e111772. 

PubMed PMID: 25375099; PubMed Central PMCID: PMC4222946.
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 33

4. Rebeiro P, Althoff KN, Buchacz K, Gill J, Horberg M, Krentz H, Moore R, Sterling TR, Brooks JT, Gebo 

KA, Hogg R, Klein M, Martin J, Mugavero M, Rourke S, Silverberg MJ, Thorne J, Gange SJ. Retention 

among North American HIV-infected persons in clinical care, 2000-2008. J Acquir Immune Defic Syndr. 

2013 Mar 1;62(3):356-62. PubMed PMID: 23242158; PubMed Central PMCID: PMC3661708.

B. Positions and Honors

Positions and Employment

2001 - 2003 Research Assistant, Vanderbilt University, Medicine/Infectious Diseases, Nashville, TN

2004 - 2007 Research Analyst, Vanderbilt University, Medicine/Infectious Diseases, Nashville, TN

2007 - 2010 Research Coordinator, Vanderbilt University, Medicine/Infectious Diseases, Nashville, TN

2010 - 2014 Research Assistant, Johns Hopkins University, Epidemiology, Baltimore, MD

2011 - 2011 Teaching Assistant, Johns Hopkins University, Epidemiology, Baltimore, MD

2012 - 2012 Teaching Assistant, Johns Hopkins University, Epidemiology, Baltimore, MD

2012 - 2012 Lead Teaching Assistant, Johns Hopkins University, Epidemiology, Baltimore, MD

2014 - Research Assistant Professor, Vanderbilt University, Medicine/Infectious Diseases, Nashville, 

TN

Other Experience and Professional Memberships

2012 - Member, International AIDS Society

2013 - Member, Society for Epidemiologic Research

Honors

2011 Merit-based 75% tuition scholarship, Johns Hopkins University

2012 Merit-based 100% tuition scholarship (100%, 85%, and 85% in years I, II, and III), Johns 

Hopkins University

2012 Mary Meyer Scholarship (100% and 50% stipend for years I and II), Johns Hopkins University 

2013 Student Dissertation Workshop scholarship (competitive scholarship for conference attendance

and participation in the Student Dissertation Workshop), Society for Epidemiologic Research

2014 Gordis Fellowship (Competitive Teaching Award including Salary as an Undergraduate 

Instructor), Johns Hopkins University

2015 National Institutes of Health (NIH) Loan Repayment Program awardee

C. Contribution to Science

1. My work on HIV Continuum of Care outcomes, particularly the key stage of clinical retention and the 

"churn" of patient populations through clinical care in North America, has been highly cited among 

prominent scholars in the field. This work has also been used by Office of National AIDS Policy members 

to inform public health policy, including the US National HIV/AIDS Strategy. I continue to be engaged in 

productive collaborations with the NA-ACCORD and CCASAnet groups of IeDEA, examining topics related 

to the quality of HIV care, health services, and health policy in the United States, Canada, and Latin 

America.

a. Rebeiro PF, Cesar C, Shepherd BE, De Boni RB, Cortes CP, Rodriguez F, Belaunzarán-Zamudio P, 

Pape JW, Padgett D, Hoces D, McGowan CC, Cahn P for the Caribbean, Central and South America 

network for HIV epidemiology (CCASAnet). Assessing the HIV Care Continuum in Latin America: 

progress in clinical retention, cART use, and viral suppression. J Int AIDS Soc. 2016 Apr 

8;19(1):20636. Pubmed PMID: 27065108 PMCID: PMC4827101

b. Rebeiro PF, Althoff KN, Lau B, Gill J, Abraham AG, Horberg MA, Kitahata MM, Yehia BR, Samji H, 

Brooks JT, Buchacz K, Napravnik S, Silverberg MJ, Rachlis A, Gebo KA, Sterling TR, Moore RD, 

Gange SJ. Laboratory Measures as Proxies for Primary Care Encounters: Implications for Quantifying 

Clinical Retention Among HIV-Infected Adults in North America. Am J Epidemiol. 2015 Dec 

1;182(11):952-60. PubMed PMID: 26578717. PubMed Central PMCID: PMC4655744.
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 34

c. Rebeiro PF, Horberg MA, Gange SJ, Gebo KA, Yehia BR, Brooks JT, Buchacz K, Silverberg MJ, Gill 

J, Moore RD, Althoff KN. Strong agreement of nationally recommended retention measures from the 

Institute of Medicine and Department of Health and Human Services. PLoS One. 2014;9(11):e111772. 

PubMed PMID: 25375099; PubMed Central PMCID: PMC4222946.

d. Rebeiro P, Althoff KN, Buchacz K, Gill J, Horberg M, Krentz H, Moore R, Sterling TR, Brooks JT, Gebo 

KA, Hogg R, Klein M, Martin J, Mugavero M, Rourke S, Silverberg MJ, Thorne J, Gange SJ. Retention 

among North American HIV-infected persons in clinical care, 2000-2008. J Acquir Immune Defic Syndr. 

2013 Mar 1;62(3):356-62. PubMed PMID: 23242158; PubMed Central PMCID: PMC3661708.

2. While working as a research assistant with the Vanderbilt Adult AIDS Clinical Trials Group, I was fortunate 

to be allowed to contribute substantively to work on oxidant stress and pharmacogenomics related to early 

PI and NNRTI regimens. These studies have added considerably to the body of knowledge on metabolic 

processes during advanced HIV infection and its treatment with antiretroviral agents. The work on NNRTI 

hepatotoxicity mediation through CYP2B6, CYP3A4, and MDR1 variants has been particularly highly cited.

a. Hulgan T, Donahue JP, Hawkins C, Unutmaz D, D'Aquila RT, Raffanti S, Nicotera F, Rebeiro P, 

Erdem H, Rueff M, Haas DW. Implications of T-cell P-glycoprotein activity during HIV-1 infection and its 

therapy. J Acquir Immune Defic Syndr. 2003 Oct 1;34(2):119-26. PubMed PMID: 14526200.

b. Hulgan T, Morrow J, D'Aquila RT, Raffanti S, Morgan M, Rebeiro P, Haas DW. Oxidant stress is 

increased during treatment of human immunodeficiency virus infection. Clin Infect Dis. 2003 Dec 

15;37(12):1711-7. PubMed PMID: 14689356.

c. Ritchie MD, Haas DW, Motsinger AA, Donahue JP, Erdem H, Raffanti S, Rebeiro P, George AL, Kim 

RB, Haines JL, Sterling TR. Drug transporter and metabolizing enzyme gene variants and 

nonnucleoside reverse-transcriptase inhibitor hepatotoxicity. Clin Infect Dis. 2006 Sep 15;43(6):779-82. 

PubMed PMID: 16912956.

3. This work, performed while I was a research assistant with the Vanderbilt-Meharry Center For AIDS 

Research, contributed greatly to clinical awareness of the impact of laboratory processing procedures 

using PPT tubes on the spurious detectability of plasma HIV-1 RNA viral loads. The manuscript was later 

cited in the recommendations for ART from the International AIDS Society: "Antiretroviral Treatment of 

Adult HIV Infection: Recommendations of the International AIDS Society–USA Panel" (Thompson, Aberg, 

et al.; JAMA 2010).

a. Rebeiro PF, Kheshti A, Bebawy SS, Stinnette SE, Erdem H, Tang YW, Sterling TR, Raffanti SP, 

D'Aquila RT. Increased detectability of plasma HIV-1 RNA after introduction of a new assay and altered 

specimen-processing procedures. Clin Infect Dis. 2008 Nov 15;47(10):1354-7. PubMed PMID:

18922071; PubMed Central PMCID: PMC2605467.

4. As a research assistant with the Epidemiology/Outcomes unit of the Vanderbilt-Meharry Center For AIDS 

Research, I contributed to work examining the effect of pregnancy on various HIV clinical outcomes, and 

disparities in antiretroviral therapy use and mortality by sex. These studies enriched the body of literature 

related to outcome and treatment disparities in a vulnerable population of concern and addressed 

complications in the understudied population of pregnant HIV-infected women in resource-richsettings.

a. Tai JH, Udoji MA, Barkanic G, Byrne DW, Rebeiro PF, Byram BR, Kheshti A, Carter JD, Graves CR, 

Raffanti SP, Sterling TR. Pregnancy and HIV disease progression during the era of highly active 

antiretroviral therapy. J Infect Dis. 2007 Oct 1;196(7):1044-52. PubMed PMID: 17763327.

b. Lemly DC, Shepherd BE, Hulgan T, Rebeiro P, Stinnette S, Blackwell RB, Bebawy S, Kheshti A,

Sterling TR, Raffanti SP. Race and sex differences in antiretroviral therapy use and mortality among 

HIV-infected persons in care. J Infect Dis. 2009 Apr 1;199(7):991-8. PubMed PMID: 19220139.

c. Melekhin VV, Shepherd BE, Stinnette SE, Rebeiro PF, Barkanic G, Raffanti SP, Sterling TR. 

Antiretroviral therapy initiation before, during, or after pregnancy in HIV-1-infected women: maternal 

virologic, immunologic, and clinical response. PLoS One. 2009 Sep 9;4(9):e6961. PubMed PMID:

19742315; PubMed Central PMCID: PMC2734183.
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 35

d. Melekhin VV, Shepherd BE, Jenkins CA, Stinnette SE, Rebeiro PF, Bebawy SS, Rasbach DA, Hulgan 

T, Sterling TR. Postpartum discontinuation of antiretroviral therapy and risk of maternal AIDS-defining 

events, non-AIDS-defining events, and mortality among a cohort of HIV-1-infected women in the United 

States. AIDS Patient Care STDS. 2010 May;24(5):279-86. PubMed PMID: 20438375; PubMed Central 

PMCID: PMC2875979.

5. This work surrounding substance use and its impact on HIV clinical outcomes in a large Southeastern 

clinical cohort was completed while I was research coordinator at the Vanderbilt-Meharry Center For AIDS 

Research. The manuscripts contributed substantively to the literature exploring the relationship between 

substance use and HIV disease progression in clinical settings.

a. McGowan CC, Weinstein DD, Samenow CP, Stinnette SE, Barkanic G, Rebeiro PF, Sterling TR, 

Moore RD, Hulgan T. Drug use and receipt of highly active antiretroviral therapy among HIV-infected 

persons in two U.S. clinic cohorts. PLoS One. 2011 Apr 25;6(4):e18462. PubMed PMID: 21541016; 

PubMed Central PMCID: PMC3081810.

b. Qian HZ, Stinnette SE, Rebeiro PF, Kipp AM, Shepherd BE, Samenow CP, Jenkins CA, No P,

McGowan CC, Hulgan T, Sterling TR. The relationship between injection and noninjection drug use 

and HIV disease progression. J Subst Abuse Treat. 2011 Jul;41(1):14-20. PubMed PMID: 21349679; 

PubMed Central PMCID: PMC3110534.

Complete List of Published Work in MyBibliography 

http://www.ncbi.nlm.nih.gov/sites/myncbi/1f1ECwwJzoyAs/bibliography/40647706/public/?sort=date&direction=

ascending

D. Research Support

Ongoing Research Support

U01-AI069923-12, NIAID/NIH

Catherine C. McGowan (PI) 

07/01/16-06/30/21

Caribbean, Central and South American Network for HIV Epidemiology

This project aims to assess the epidemiology of HIV/AIDS as the Caribbean, Central and South American 

component of the International epidemiologic Databases to Evaluate AIDS (IeDEA) consortium

Role: KP

P30AI110527, NIAID/NIH

Simon A. Mallal (PI) 

04/01/15-03/31/20

Tennessee Center for AIDS Research (TN-CFAR)

The Tennessee CFAR (TN-CFAR) is an HIV/AIDS research collaboration between Vanderbilt University, 

Meharry Medical College, and the Tennessee State Department of Health. The TN- CFAR aims to enhance 

HIV/AIDS-related research by coordinating institutional and community resources, with the goal of reducing the 

burden of HIV/AIDS in our state and generalizing these benefits nationally and internationally.

Role: KP

Completed Research Support

F31 DA035713-01

Rebeiro, Peter F (PI) 

09/01/13-08/31/14

Epidemiology of Clinical Retention Among HIV-Infected Persons in North America 

Role: PI
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 36

U01-AI069918, NIAID/NIH

Richard D. Moore (PI) 

06/30/14-06/30/15

North American AIDS Cohort Collaboration on Research and Design (Mapping Supplement)

This project aims to assess the epidemiology of HIV/AIDS as the North American component of the 

International epidemiologic Databases to Evaluate AIDS (IeDEA) consortium. In particular, this supplement is 

concerned with geographic mapping of common HIV indicators in an informative and timely manner in a 

publically accessible forum

Role: KP

U01-AI042590, NIAID/NIH

Stephen J. Gange (PI) 

01/01/13-01/01/14

WIHS Data Management and Analysis Center (WDMAC)

This project addressed data cleaning and analytic dataset construction for studies conducted within the 

Women’s Interagency HIV Study (WIHS)

Role: GR

U01-AI069918, NIAID/NIH

Richard D. Moore (PI) 

01/01/10-01/01/13

North American AIDS Cohort Collaboration on Research and Design

This project addressed data cleaning and analytic dataset construction for studies conducted within the North 

American AIDS Cohort Collaboration on Research and Design (NA-ACCORD)

Role: GR

P30-AI54999, NIAID/NIH

David W. Haas (PI) 

01/01/04-01/01/10

Vanderbilt-Meharry Center for AIDS Research (CFAR)

This project addressed HIV basic science and epidemiologic research in a clinical cohort based in Nashville, 

TN.

Role: KP
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 37

BIOGRAPHICAL SKETCH

NAME: Sterling, Timothy R.

eRA COMMONS USER NAME:

POSITION TITLE: Professor of Medicine 

EDUCATION/TRAINING

Completion DEGREE Date FIELD OF STUDY INSTITUTION AND LOCATION (if applicable) MM/YYYY

Colgate University B.A. 05/1985 Chemistry, German

Hamilton, NY

Columbia University College of Physicians & Surgeons M.D. 05/1989 Medicine

New York, NY

Columbia Presbyterian Medical Center 06/1992 Internal Medicine

New York, NY

Johns Hopkins University School of Medicine 06/1998 Infectious Diseases

Baltimore, MD

A. Personal Statement

I am an infectious disease physician-scientist with expertise in the epidemiology and treatment of HIV and 

TB. I am the director of the Epidemiology and Outcomes Working Group of the Vanderbilt Comprehensive 

Care Clinic HIV Cohort. I established the Epi-Outcomes group in 2003 and have led it since its inception. I 

have been successful in mentoring young trainees and junior faculty for academic positions and NIH 

funding. Since 1998 I have mentored 58 investigators, including 10 who have obtained K23 or K08 

awards, and 6 who have R01 funding. My trainees have also benefited from three multi-center HIV cohort 

collaborations that I participate in: the North American ACCORD, the Caribbean Central America South 

America network (CCASAnet) (both in the International epidemiologic Databases to Evaluate AIDS 

(IeDEA) network, and the Antiretroviral Therapy Cohort Collaboration (ART-CC). I lead efforts for

the Regional Prospective Observational Research for TB (RePORT)-Brazil, and I have additional TB 

research collaborations in Peru and South Africa, as well as through the IeDEA network. I am well-suited to 

mentor Dr. Rebeiro. Of my 184 publications, the following are of interest for this application, including 

recent studies performed with Dr. Rebeiro: 

1. Rebeiro P, Althoff, KN, Buchacz K, Gill MJ, Horberg M, Krentz H, Moore R, Sterling TR, Brooks JT, Gebo 

KA, Hogg R, Klein M, Martin J, Mugavero M, Rourke S, Thorne J, Gange SJ for the North American AIDS 

Cohort Collaboration (NA-ACCORD). Retention Among North American HIV–infected Persons in Clinical 

Care, 2000-2008. J Acquir Immune Defic Syndr. 2013 Mar 1; 62(3): 356-362. PMCID: PMC3661708

2. Althoff KN, Rebeiro P, Brooks JT, Buchacz K, Gebo K, Martin J, Hogg R, Thorne JE, Klein M, Gill MJ, 

Sterling TR, Yehia B, Silverberg MJ, Crane H, Justice AC, Gange SJ, Moore R, Kitahata MM, Horberg MA; 

for the NA-ACCORD. Disparities in the quality of HIV care when using US Department of Health and Human 

Services indicators. Clin Infect Dis. 2014 Apr;58(8):1185-9. PMCID: PMC3967825

3. Rebeiro PF, Althoff KN, Lau B, Gill J, Abraham AG, Horberg MA, Kitahata MM, Yehia BR, Samji H, Brooks JT, 

Buchacz K, Napravnik S, Silverberg MJ, Rachlis A, Gebo KA, Sterling TR, Moore RD, Gange SJ for the NAACCORD. Laboratory measures are imperfect proxies of primary care encounters: implications for quantifying 

clinical retention among HIV-infected adults in North America. Am J Epidemiol 2015 Dec 1;182(11)952-60. 

PMCID: PMC4655744

4. Althoff KN, Rebeiro PF, Hanna DB, et al, Sterling TR, et al, Pape JW, Cahn P, McGowan C;NA-ACCORD) 

and the Caribbean, Central and the South America Network for HIV Epidemiology (CCASAnet). A picture is 

worth a thousand words: maps of HIV indicators to inform research, programs, and policy from NAACCORD and CCASAnet clinical cohorts. J Int AIDS Soc. 2016 Apr 4;19(1):20707. PMCID:PMC4821890
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 38

B. Positions and Honors

Positions and Employment

1992-1996 Staff Physician, U.S. Air Force Medical Center Keesler, Keesler AFB, MS.

1998-2002 Assistant Professor of Medicine & Epidemiology, Johns Hopkins University School of Medicine 

2002-2003 Associate Professor of Medicine & Epidemiology, Johns Hopkins University School of Medicine 

1998-2003 Medical Director, Baltimore City Tuberculosis Clinic

2003-2008 Associate Professor of Medicine, Vanderbilt University School of Medicine 

2003-present Director, Epidemiology Research, Division of Infectious Diseases

Director, Epi / Outcomes Working Group, Vanderbilt Comprehensive Care Clinic HIV Cohort 

Director, Tuberculosis Research, Metro-Davidson Health Department

2008-2011 Professor of Medicine, Vanderbilt University School of Medicine

2011-present David E. Rogers Professor of Medicine, Vanderbilt University School of Medicine

2012-present Visiting Scientist, KwaZulu Natal Research Institute for Tuberculosis and HIV (K-RITH).Durban 

2012-present Director, Vanderbilt Tuberculosis Center

Other Experience and Professional Memberships

• Centers for Disease Control and Prevention (CDC): Guidelines for the Use of Rifamycins for the Treatment 

of TB Among HIV-infected Patients Taking Protease Inhibitors or Nonnucleoside Reverse Transcriptase 

Inhibitors. January 2004. Updated September 2007, January 2012, July 2013.

• CDC: Adult/Adolescent HIV/AIDS Surveillance Case Definition and Clinical Staging Consultation. 2005.

• American Thoracic Society (ATS)/Infectious Diseases Society of America (IDSA)/Centers for Disease 

Control (CDC): Diagnostic Standards and Classification of Tuberculosis in Adults and Children. 2007-2011.

• CDC: Expert consultation:3 months of rifapentine+isoniazid for treatment of latent M. tuberculosis. 2011.

• Tuberculosis Trials Consortium: Chair, Core Science Group. May 2011-present

• ATS/IDSA/CDC. Guidelines for Treatment of Latent Tuberculosis Infection. Co-chair. 2011-present

• World Health Organization. Guidelines Development Group: Latent Tuberculosis. May 2014

• World Health Organization. Latent Tuberculosis Task Force. April 2015-present

• U.S. Dept of Health and Human Services Adult HIV OI Guidelines, TB section. October 2015-present

Honors (last 5 years)

2011 Robert Koch Award for TB Prevention Research—National TB Controller’s Association 

2011 Excellence in Public Health Impact Award—Centers for Disease Control and Prevention 

2012 Charles C. Shepard Science Award—Centers for Disease Control and Prevention

2014 Fellow, Infectious Diseases Society of America

C. Contributions to Science

1. Outcomes of HIV infection

I have led several observational studies of HIV outcomes that have provided insights into optimal management 

of HIV, as well as HIV pathogenesis. This has included studies of the sex difference in HIV-1 RNA, the 

association between pregnancy and improved HIV outcomes, the optimal timing of antiretroviral therapy 

initiation, and the relationship between body mass index and immune restoration on antiretroviral therapy.

a. Sterling TR, Vlahov D, Astemborski J, Hoover DR, Margolick JB, Quinn TC. Initial plasma HIV-1 RNA and 

progression to AIDS in women and men. N Engl J Med. 2001; 344:720-5. PMID: 11236775

b. Kitahata MM, Gange SJ, Abraham A, et al, Sterling TR, et al, Moore RD, for The North American AIDS 

Cohort Collaboration on Research and Design. Effect of early versus deferred antiretroviral therapy for HIV 

on survival. N Engl J Med. 2009; 360(18):1815-26. PMCID: PMC2854555

c. Koethe JR, Grome H, Jenkins CA, Kalams SA, Sterling TR. The metabolic and cardiovascular 

consequences of obesity in persons with HIV on long-term antiretroviral therapy. AIDS. 2015 Sep28. 

PMID: 26418084.

d. Castilho JL, Shepherd BE, Koethe J, Turner M, Bebawy S, Logan J, Rogers WB, Raffanti S, Sterling TR. 

CD4+/CD8+ ratio, age, and risk of serious non-communicable diseases in HIV-infected adults on 

antiretroviral therapy. AIDS 2016 Mar 27;30(6):899-908. PMCID: PMC4785819
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 39

2. Treatment of HIV-related TB

I have led a series of studies of HIV-related TB that have characterized risk factors for TB relapse, acquired 

rifamycin resistance, immune reconstitution inflammatory syndrome (IRIS), and mortality. These studies have 

helped inform the optimal timing of antiretroviral therapy initiation in TB patients, and the optimal duration of TB 

therapy in HIV-infected persons.

a. Pettit AC, Jenkins CA, Stinnette SE, Rebeiro PF, Blackwell RB, Raffanti SP, Shepherd BE, Sterling TR. 

Tuberculosis risk before and after highly active antiretroviral therapy initiation: does HAART increase the 

short-term TB risk in a low incidence TB setting? J Acquir Immune Defic Syndr. 2011;57(4):305-10.

PMCID: PMC3141096

b. Sterling TR, Lau B, Zhang J, et al, for the North American AIDS Cohort Collaboration on Research and 

Design (NA-ACCORD). Risk factors for tuberculosis after highly active antiretroviral therapy initiation in the 

United States and Canada: implications for tuberculosis screening. J Infect Dis. 2011; 204(6):893-901.

PMCID: PMC3156918

c. Cortes CP, Wehbe FH, McGowan CC, Shepherd BE, Duda SN, Jenkins CA, Gonzalez E, Carriquiry G, 

Schechter M, Padgett D, Cesar C, Madero JS, Pape JW, Masys DR, Sterling TR and the Caribbean, 

Central American, South American network for HIV research (CCASA-net) of the International 

Epidemiologic Databases to Evaluate AIDS (IeDEA). Duration of anti-tuberculosis therapy and timing of 

antiretroviral therapy initiation: association with mortality in HIV-related tuberculosis. PLoS ONE. 2013; 

8(9):e74057. PMCID: PMC3774609

d. Pettit AC, Mendes A, Jenkins C, Napravnik S, Freeman A, Shepherd BE, Dowdy D, Gill J, Rachlis A, 

Moore R, Sterling TR; North American AIDS Cohort Collaboration on Research and Design (NAACCORD). Timing of antiretroviral treatment, immunovirologic status and TB risk: implications for test and 

treat. J Acquir Immune Defic Syndr. 2016 Apr 5. [Epub ahead of print] PMCID: PMC4942351

3. Drug-resistant TB, with a focus on fluoroquinolone resistance

I have studied drug-resistant TB for more than 20 years. Recently, our focus has been on the role that 

fluoroquinolone exposure prior to TB diagnosis—for indications other than TB—plays on phenotypic and 

genotypic fluoroquinolone resistance. The identification of novel resistance mutations and mechanisms could 

improve the sensitivity of diagnostic tests for fluoroquinolone-resistant M. tuberculosis. 

a. Frieden TR, Sterling T, Pablos-Mendez A, Kilburn JO, Cauthen GM, Dooley SW. The emergence of drugresistant tuberculosis in New York City. N Engl J Med. 1993; 328:521-6. PMID: 8381207

b. Ginsburg AS, Woolwine SC, Hooper N, Benjamin WH, Dorman SE, Bishai WR, Sterling TR. The rapid 

development of fluoroquinolone resistance in M. tuberculosis. N Engl J Med. 2003; 349:1977-8. PMID: 

14614180

c. Devasia RA, Blackman A, Gebretsadik T, Griffin M, Shintani A, May C, Smith T, Hooper N, Maruri F, 

Warkentin J, Mitchel E, Sterling TR. Fluoroquinolone resistance in Mycobacterium tuberculosis: the effect 

of duration and timing of fluoroquinolone exposure. Am J Respir Crit Care Med. 2009; 180(4):365-70.

PMCID: PMC2731810

d. Eilertson B, Maruri F, Blackman A, Guo Y, Herrera M, van der Heijden Y, Shyr Y, Sterling TR. A novel 

resistance mutation in eccC5 of the ESX-5 secretion system confers ofloxacin resistance in Mycobaterium 

tuberculosis. J Antimicrob Chemother 2016 Jun 3. Epub ahead of print. PMID:27261264.

4. Immunogenetic factors associated with TB risk, particularly extrapulmonary disease

In a series of studies we have identified subtle immune defects among HIV-uninfected persons who have 

completed treatment for extrapulmonary TB. These abnormalities include decreased CD4+ counts, low 

unstimulated and stimulated cytokine production, increased regulatory T-cell frequency, and increased CD4+ 

activation. We also identified genetic polymorphisms associated with extrapulmonary TB. This suggests that an 

underlying host defect could predispose to extrapulmonary TB. This provides insight into TB pathogenesis, in 

which only a small sub-set of persons infected with M. tuberculosis progress to TB.

a. Sterling TR, Dorman SE, Chaisson RE, Ding L, Hackman J, Moore K, Holland SM. Human 

immunodeficiency virus-seronegative adults with extrapulmonary tuberculosis have abnormal innate 

immune responses. Clin Infect Dis. 2001; 33(7):976-82. PMID: 11528568
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 40

b. Antas PR, Ding L, Hackman J, Reeves-Hammock L, Shintani AK, Schiffer J, Holland SM, SterlingTR. 

Decreased CD4+ lymphocytes and innate immune responses in adults with previous extrapulmonary 

tuberculosis. J Allergy Clin Immunol. 2006;117(4):916-23. PMID: 16630952

c. Sterling TR, Martire T, de Almeida AS, Ding L, Greenberg DE, Moreira LA, Elloumi H, Torres AP, 

Sant'Anna CC, Calazans E, Paraguassu G, Gebretsadik T, Shintani A, Miller K, Kritski A, Lapa e Silva JR, 

Holland SM. Immune function in young children with previous pulmonary or miliary/meningeal tuberculosis 

and impact of BCG vaccination. Pediatrics. 2007; 120(4):e912-21. PMID: 17908747

d. Motsinger-Reif AA, Antas PR, Oki NO, Levy S, Holland SM, Sterling TR. Polymorphisms in IL-1beta, 

vitamin D receptor Fok1, and Toll-like receptor 2 are associated with extrapulmonary tuberculosis. BMC 

Med Genet. 2010;11:37. PMCID: PMC2837863

5. Short-course treatment of latent M. tuberculosis infection

I led a large multi-center clinical trial which demonstrated that a 3-month once-weekly regimen of isoniazid + 

rifapentine given under direct observation was as effective and well-tolerated as the gold-standard 9-month 

daily self-administered isoniazid regimen. The higher completion rate of the short-course regimen could 

improve the effectiveness of TB prevention efforts, and contribute to a decrease in the global TB burden.

a. Sterling TR, Villarino ME, Borisov AS, Shang N, Gordin F, Bliven-Sizemore E, Hackman J, Hamilton CD, 

Menzies D, Kerrigan A, Weis SE, Weiner M, Wing D, Conde MB, Bozeman L, Horsburgh CR, Chaisson 

RE, and the TB Trials Consortium. Three months of once-weekly rifapentine and isoniazid for the treatment 

of latent M. tuberculosis infection (PREVENT TB). N Engl J Med. 2011; 365:2155-66. PMID: 22150035.

b. Villarino ME, Scott NA, Weis SE, Weiner M, Conde MB, Jones B, Nachman S, Oliveira R, Moro RN, Shang 

N, Goldberg SV, Sterling TR; IMPAACT, TB Trials Consortium. Treatment for preventing tuberculosis in 

children and adolescents: a randomized clinical trial of a 3-month, 12-dose regimen of a combination of 

rifapentine and isoniazid. JAMA Pediatr. 2015; 169(3):247-55. PMID: 25580725

c. Sterling TR, Moro RN, Borisov AS, Phillips E, Shepherd G, Adkinson NF, Weis S, Ho C, Villarino ME; TB 

Trials Consortium. Flu-like and other systemic drug reactions among persons receiving weekly rifapentine 

plus isoniazid or daily isoniazid for treatment of latent tuberculosis infection in the PREVENT TB

Study. Clin Infect Dis. 2015 Aug 15;61(4):527-35. PMID: 25904367. PMCID: PMC4560029

d. Sterling TR, Scott NA, Miro JM, Calvet G, La Rosa A, Infante R, Chen MP, Benator DA, Gordin F, Benson 

CA, Chaisson RE, Villarino ME, the Tuberculosis Trials Consortium, and the AIDS Clinical Trials Group. 

Three months of weekly rifapentine and isoniazid for treatment of M. tuberculosis infection in HIV coinfected persons. AIDS 2016 June 19;30(10):1607-15. PMCID: PMC4899978

Complete List of Published Work in

MyBibliography: http://www.ncbi.nlm.nih.gov/sites/myncbi/timothy.sterling.1/bibliography/40632070/public/?so

rt=date&direction=descending

D. Research Support

Current

NIAID R56 AI118361 PI: Sterling TR 08/01/16-07/31/17

National Institutes of Health

Fluoroquinolones and efflux-mediated cross-resistance in HIV-related TB

This project studies novel fluoroquinolone resistance mutations and mechanisms in M. tuberculosis, their 

contribution to resistance to other drugs, and the role of HIV infection.

NIH R01 AI120790 PI: Sterling TR 08/12/16-07/31/20

Predictors of treatment toxicity, failure, and relapse in HIV-related tuberculosis

This project seeks to identify pharmacogenomic predictors of TB/HIV treatment toxicity and effectiveness in 

Brazil.

CDC10FED TB Trials Consortium, PI: Sterling TR; Peru PI: Gotuzzo E 09/30/09-09/29/19 

Universidad Cayetano Heredia, Lima, Peru

Centers for Disease Control and Prevention

This consortium conducts programmatically relevant studies of tuberculosis treatment and prevention.
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 41

NIAID 5 U01 AI069923 Project PI: Sterling TR 07/01/16-06/30/17 

National Institutes of Health

Regional Prospective Observational Research for TB (RePORT)-Brazil

Supplement to Caribbean, Central and South America network for HIV epidemiology (CCASAnet)

With joint funding from the NIH and the Brazilian Ministry of Health, this is a prospective, multi-center cohort of 

TB cases and close contacts in Rio de Janeiro, Salvador, and Manaus, Brazil. There is a biorepository of M. 

tuberculosis isolates, cells, DNA, and RNA. Studies will be performed of host and pathogen determinants of 

TB treatment response, recurrence, acquiring M. tuberculosis infection, and progressing to TB disease.

TB Epidemiologic Studies Consortium PI: Stout JE -Duke 09/30/11-09/29/21 

Centers for Disease Control and Prevention

This consortium conducts studies of the diagnosis and treatment of latent M. tuberculosis infection. 

Role: Vanderbilt PI

NIAID P30AI110527 PI: Mallal S 04/01/15 – 03/31/20

National Institutes of Health 

Tennessee Center for AIDS Research

Vanderbilt-Meharry-Tennessee Department of Health 

Role: Associate Director, Developmental Core

NIAID U01AI069918 PI: Moore RD -Johns Hopkins 07/01/16-06/30/21 

National Institutes of Health: Interntional Epi Databases to Evaluate AIDS

North America (NA-ACCORD) 

Role: Vanderbilt PI

NIAID U01AI069923 PI: McGowan C 07/01/16-06/30/21

National Institutes of Health: International Epi Databases to Evaluate AIDS 

South America and the Caribbean (CCASAnet)

Role: Co-investigator

Completed (past 3 years)

Biomarker Discovery for TB Infection and Disease PI: Sterling 04/01/15-06/30/16 

NIH / Brazilian Ministry of Health (CNPq)

Role: Vanderbilt PI

NIAID K24 AI65298 PI: Sterling TR 05/01/05-04/30/16

Mentoring In HIV and Tuberculosis Research 

National Institutes of Health

Dr. Sterling's research is focused on the following areas: 1) fluoroquinolone resistance in M. tuberculosis; 2) 

outcomes of HIV infection that influence timing of antiretroviral therapy initiation; 3) immunogenetic risk factors 

for tuberculosis infection and disease; 4) novel strategies to treat M. tuberculosis infection and disease; and 5) 

optimizing effectiveness of treatment of tuberculosis in HIV-infected persons. The K24 award allows Dr.

Sterling to mentor young investigators in these areas of HIV and tuberculosis research.

NIAID 5 U01 AI069924 PI: Sterling TR 1/1/2013-06/30/15

National Institutes of Health

Bringing K-RITH into IeDEA and the IeDEA TB Data Collection Form Project

Supplement to the International Epidemiologic Databases to Evaluate AIDS- Southern Africa (IeDEA-SA) 

study (M Egger- University of Bern, PI), to study TB epidemiology in Durban, South Africa.
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 42

BIOGRAPHICAL SKETCH

Provide the following information for the Senior/key personnel and other significant contributors.

Follow this format for each person. DO NOT EXCEED FIVE PAGES.

NAME: Graves, John Andrew

POSITION TITLE: Assistant Professor of Health Policy and Medicine

eRA COMMONS USER NAME (credential, e.g., agency login):

EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, 

include postdoctoral training and residency training if applicable. Add/delete rows as necessary.)

DEGREE Completion 

(if Date FIELD OF STUDY INSTITUTION AND LOCATION applicable) MM/YYYY

Sewanee: The University of the South BS 05/2003 Economics, English

Literature

Harvard University Ph.D. 05/2011 Health Policy

A. Personal Statement

My career in empirical health policy research spans over 13 years in academic and quasi-academic research 

at universities and think tanks throughout the U.S. The focus of my research is on the use of statistical, 

econometric and decision analytic methodologies to understand the impact of policy and clinical interventions 

on health care spending and patient health outcomes. For example, I currently serve as Principal Investigator 

on an NIH Common Fund Health Economics Program collaborative U01 research project on the economic, 

behavioral and patient health consequences of integrating genomic information into clinical practice and 

insurance design. In addition, I also lead an NCI-funded R01 that considers the utilization and health effects 

of insurance coverage expansions in the Southern United States. My research portfolio in health policy also 

includes an R01 from the National Institute on Aging to assess the patient health returns to medical spending, 

technology adoption and hospital quality in the United States. Based on these funded research programs I 

have published widely on insurance design, quality measurement and reporting, and the design of clinical and 

policy approaches to improving value in U.S. health care. This background ideally positions me to offer 

mentoring expertise to Dr. Rebeiro as he looks to become an expert in health policy evaluation, and in 

particular, to evaluate the impact of the Affordable Care Act on HIV outcomes across the UnitedStates.

B. Positions and Honors

Positions

2003-2009 Research Associate II and Research Consultant, The Urban Institute, Health Policy Center, 

Washington, D.C.

2011-present Assistant Professor, Vanderbilt University School of Medicine; Institute for Medicine and Public 

Health; Department of Health Policy; Department of Medicine, Nashville, Tennessee.

Honors

2006-2008 Pre-doctoral fellow in Health Services Research, Agency for Health Care Research and Quality, 

Cambridge, Massachusetts.

2008-2011 Pre-doctoral Fellow in Aging and Health Economics, National Institute on Aging, National 

Bureau of Economic Research, Cambridge, Massachusetts.

2011 Student Award, American Statistical Association, Section on Health Policy Statistics, Miami, 

Florida.

2012 Heinz Award (Honorable Mention), National Academy of Social Insurance
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 43

C. Contribution to Science

1. The Dynamics of Health Insurance Coverage in the U.S.

Over the last 25 years the number of uninsured in the U.S. has risen considerably, from 31 million in 1988 to 

nearly 50 million in 2013. Rising numbers of uninsured are symptomatic of growth in health care spending that 

has outpaced income growth and a fragmented insurance system characterized by frequent disruptions in 

coverage. Over the last 10 years I have published widely on the implications of these trends and what they 

portend for the design and future of the U.S. health insurance system. In previous research, for example, I 

demonstrated that coverage expansions in Massachusetts resulted in insurance gains mostly among adults 

with longer uninsured spell durations.1 My methodological contributions to small area estimation techniques, 

moreover, were critical in research that was able to demonstrate significant geographic variation in how often 

and for how long U.S. adults were going uninsured.2 This research, in turn, led to additional work on how 

these lessons could be used in the design of health policies to reduce the incidence and duration of 

uninsurance. For example, this research demonstrated that the dynamics affecting whether and how lowincome people obtain insurance coverage also play into how programs should be designed to account for 

fluctuations in income and family circumstances.3 My research also evaluated how, once programs results in 

large numbers of newly insured adults, additional policies could be implemented to mitigate the adverse effects 

of coverage losses due to dynamic changes in job status, income and family composition.4

a) “Health Insurance Dynamics: Methodological Considerations and a Comparison of Estimates from Two 

Surveys,” with Pranita Mishra. Health Services Research. 2016 Jan 1.

b) “Health Care Reform and the Dynamics of Insurance Coverage: Lessons from Massachusetts,” with 

Katherine Swartz. New England Journal of Medicine 2012, 367: 1181-1184.

c) “Understanding State Variation in Health Insurance Dynamics Can Help Tailor Enrollment Strategies for 

ACA Expansion,” Health Affairs (Millwood) 2013;32(10).

d) "Medicaid and Marketplace Eligibility Changes Will Occur Often In All States; Policy Options Can Ease 

Impact," with Benjamin Sommers, Katherine Swartz, and Sara Rosenbaum. Health Affairs 33.4 (2014): 

700-707.

2. The Impact of State and Federal Health Reform

Implementation health care reforms over the last 15 years has given rise to significant interest in understanding 

how coverage expansions impact insurance premiums and the financing of health care delivery. In this 

domain, I have conducted significant simulation-based and evaluation research as primary investigator that 

has helped inform policymakers’ understanding of design and impact of reforms at the state and federal level. 

This research has shown, for example, how coverage expansion in Massachusetts – which predated and 

informed the design of the Affordable Care Act – affected insurance premiums in private insurance markets.5

Moreover, using survey analyses and simulation techniques I was able to demonstrate how the design of open 

enrollment periods, premium payment mechanisms, and subsidy programs for health insurance could be 

redesigned to optimize enrollment.6,7 Finally, my research in this domain has also been influential in identifying 

the financial implications of coverage expansion – and non-expansion – for U.S. hospital financing of 

uncompensated care.8 In terms of impact, my research on the design of open enrollment and premium 

payment mechanisms under the ACA was instrumental in leading to federal policy shifts (allowing, for example, 

for alternative ACA health insurance premium payment mechanisms and a special enrollment period to be 

opened during the Spring of 2015), while my research on hospital uncompensated care financing has been 

featured in numerous state-level debates over the merits of Medicaid expansion under the ACA.

a) Richards MR, Nikpay SS, Graves JA. The Growing Integration of Physician Practices: With a Medicaid 

Side Effect. Medical Care. 2016 Apr.

b) 14. Graves JA, Mishra P, Dittus RS, Parikh R, Perloff J, Buerhaus PI. Role of Geography and Nurse 

Practitioner Scope-of-Practice in Efforts to Expand Primary Care System Capacity: Health Reform and the 

Primary Care Workforce. Medical care. 2016 Jan 1;54(1):81-9.

c) K Swartz and JA Graves, “Shifting the Timing of the Marketplaces’ Open Enrollment Period Could Increase 

Enrollment and Improve People’s Plan Choices ” Health Affairs, July 2014.
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 44

d) JA Graves, “Medicaid Expansion Opt-Outs and Uncompensated Care,” New England Journal of Medicine

2012 367:2365-2367.

3. Measuring Hospital Quality and the Returns to Health Care Spending

A key component of efforts to improve healthcare system delivery is the ability to measure hospital 

performance. It is often noted that if the payment system rewarded quality rather than volume, patient health 

could be improved at lower costs. To this end, I have been involved in significant research projects that aim to 

improve our scientific understanding on the returns to medical spending in the U.S. Using quasi-random 

assignment of patients to different local hospitals brought about my ambulance care, we demonstrated 

substantial returns to inpatient spending in the United States.9 Our estimates imply that a one standard 

deviation increase in Medicare reimbursement leads to a 4 percentage point (or 10 percent) reduction in 

mortality; the implied cost per at least one year of life saved is approximately $80,000. In follow-up work, we 

then demonstrated that positive returns to inpatient spending for acute care episodes are offset by negative 

returns to post-acute care spending.10 This significant finding not only reconciles our earlier work with that of 

the influential Dartmouth Atlas (which finds that areas that spend more do not achieve better outcomes) – but 

provides policymakers with more precise recommendations on where to find and measure wasteful spending in 

the U.S. health care system.

a) JJ Doyle, JA Graves, J Gruber and S Kleiner, “Estimating the Returns to Medical Spending: Evidence from

Journal of Political Economy 123 (1) 2015.

b) JJ Doyle, JA Graves and J Gruber, “Uncovering Waste in U.S. Health Care,” National Bureau of Economic 

Research Working Paper 2015.

Google Scholar Page: https://scholar.google.com/citations?hl=en&user=NXMBoRUAAAAJ

D. Research Support

Ongoing Research Support

U01HL122904 09/2013 – 09/2017

Common Fund Health Economics Program 

National Heart, Lung and Blood Institute 

Role: Principal Investigator (Multi-PI)

Rational Integration of Genomic Healthcare Testing (RIGHT)

A widely-held vision arising from the Human Genome Project is to guide therapeutic decision making with 

genetic data to improve the safety and efficacy of patient care, a promise that is fueled by extraordinary 

advances in the discovery of genomic variation that predicts drug response. For the RIGHT project, we are 

developing a Discrete Event Simulation (DES) to estimate the average clinical efficacy and cost-effectiveness 

of prospective pharmacogenetic testing across a diverse patient population. The RIGHT project will rigorously 

test hypotheses on the cost-effectiveness and factors that may affect cost-savings over time using different 

strategies for pharmacogenomic implementation.

R01 CA189152 07/2015-07/2020

National Cancer Institute

Role: Principal Investigator (Multi-PI)

Effects of Expanded Coverage on Access, Health Care and Health in the South

This project provides timely and rigorous analysis of the effect of health insurance coverage expansions on 

health care use and outcomes among a large cohort of low-income adults in 12 southeastern states. Using a 

quasi-experimental research design, we will quantify the effects of coverage expansion through Medicaid and 

private health insurance exchanges on access to care, cancer screening and use of preventive clinical 

services; self-reported health outcomes, mortality, cancer care, and use of emergent and inpatient care; and 

on access to care, utilization, and outcomes for adults with prior coverage whose access might be 

compromised by the expansions.

R01 AG041794 03/2016 – 02/2019
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 45

National Institute on Aging 

Role: Co-Investigator

Estimating the Returns to Medical Care Spending

The very high cost of health care in the U.S. relative to other nations, and in high cost areas of the U.S. relative 

to low cost areas, raises the question of whether health care spending in the U.S. is productive in terms of 

improving health. This question is difficult to answer because providers generally direct the greatest amount of 

resources towards individuals for whom the returns may be greatest – those in poor health. This project seeks 

to overcome the confounding influence of health on spending and outcomes by relying on essentially random 

variation in the hospital to which patients are admitted based on which ambulance company picked them up 

and which hospitals are most proximate to them during an emergency. By using multiple approaches and a 

variety of populations and outcome measures, we both produce a cross-validated set of findings and extend 

the previous literature on the returns to spending.

Completed Research Support

 

 

Center for Medicare and Medicaid Innovation 07/2012 – 07/2015 

Role: Co-Investigator

MyHealth Team: Regional Team-based and Closed-Loop Control Innovation Model for Ambulatory Chronic 

Care Delivery

The MHTAV pilot will focus on a group of patients followed by the Adult Primary Care Center. It is a population 

of about 11,000 patients all of whom have diabetes, hypertension and/or congestive heart failure. The project 

will be built in several phases, at first focusing on patients with comorbidities or having more severe single 

morbidity. Phase one (six months) involves design and proof of concept implementation in a small number of 

practices. Phase two involves implementation throughout the APCC with analysis that ensures that the system 

is in control and that outcome measures are improving. Phase three involves adding the single morbidity 

patients who are less severe and further optimizing the system. Finally, since the model design is not specific 

to primary care or to a particular set of conditions, we will analyze the feasibility of sustainability and spread of 

this model.

R01 DC011338 2012 – 2013
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 46

Role: Co-Investigator

National Institute on Deafness and Other Communication Disorders

Administrative Supplement for Collaborative Applied Research on Outcomes and Health Services in Deafness 

and Other Communication Disorders

The aim of this project is to study the feasibility of a cost-effectiveness approach to watchful waiting vs. medical 

intervention in the study of deafness and other communication disorders.

 

 
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 47

BIOGRAPHICAL SKETCH

Provide the following information for the Senior/key personnel and other significant contributors.

Follow this format for each person. DO NOT EXCEED FIVE PAGES.

NAME: Moore, Richard D.

eRA COMMONS USER NAME (credential, e.g., agency login):

POSITION TITLE: Professor of Medicine, Johns Hopkins University School of Medicine

EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency

training if applicable. Add/delete rows as necessary.)

DEGREE Completion Date FIELD OF STUDY INSTITUTION AND LOCATION (if applicable) MM/YYYY

University of Arkansas BA 05/1974 Chemistry

Vanderbilt University, Nashville, TN MD 05/1978 Medicine

Vanderbilt University, Nashville, TN 06/1981 Residency Int. Medicine

Johns Hopkins University, Baltimore, MD 06/1984 Postdoctoral Fellow

Johns Hopkins University, Baltimore, MD MHS 06/1988 Epidemiology

A. Personal Statement

I am an HIV specialist physician and epidemiologist with more than 25 years of experience conducting HIVassociated epidemiologic and clinical outcomes research at Johns Hopkins. I am well versed in the conduct of 

human subjects research, serving as the chairman of the Johns Hopkins IRB for the past 10 years. I am the 

Director of the Johns Hopkins Center for AIDS Research Clinical Core, and am the Director of the Johns 

Hopkins Program for HIV Outcomes Research, based in the School of Medicine, and affiliated with the 

Department of Epidemiology of the JH Bloomberg School of Public Health. The Program is the home of the 

NIH-supported Johns Hopkins HIV Clinical Cohort, AHRQ/HRSA-supported HIV Research Network, and most 

relevant to this proposal, the North American AIDS Cohorts Collaboration on Research and Design (NAACCORD), which will provide both data and support to Dr. Rebeiro for this proposal. The NA-ACCORD has 

been a resource for multiple K- and R- awards from junior investigators and has a well-established process for 

providing both data and support. Dr. Rebeiro has substantial experience working with the NA-ACCORD and 

has been highly productive in generating manuscripts and national and international presentations using these 

NA-ACCORD resources. As the PI of the NA-ACCORD, I am happy to continue to provide him with this access 

for this important proposal.

B. Positions and Honors

Positions and Employment

1981-1984 Postdoctoral Fellow, Division of General Internal Medicine, Johns Hopkins University School of

Medicine

1984-1996 Instructor, Johns Hopkins University School of Medicine

1984-1991 Assistant Professor of Medicine, Johns Hopkins University School of Medicine

1988- Joint appointment in Department of Epidemiology, Johns Hopkins Bloomberg School of Public

Health

1990- Director, Program for HIV Outcomes Research, Johns Hopkins University

1991-1998 Associate Professor of Medicine, Johns Hopkins University School of Medicine

1998- Professor of Medicine, Johns Hopkins University School of Medicine

2005- Director, Johns Hopkins HIV Clinic

2012- Director, Clinical Core, Johns Hopkins Center for AIDS Research

Other Experience and Professional Memberships

1991- International AIDS Society, 1991-current

1991- American Society for Microbiology, 1991-current

1997-2001 Executive Committee, National Association of HIV Care, Infectious Diseases Society of America

1998- Fellow, American College of Physicians, 1998-current
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 48

1999- Fellow, Infectious Diseases Society of America, 1999-current

2000- HIV Medicine Association, 2000-current

2001- American Academy of HIV Medicine, 2000-current

2010-13 HIV Medicine Association, Board of Directors 2010-2013

1995,1999 National Institutes of Diabetes and Digestive and Kidney Disease, Special Review Committee

2005-07 National Institutes on Drug Abuse, K-Award Review Committee (ad hoc reviewer)

2008-09 National Institutes on Drug Abuse Avant Garde Award Review Committee (ad hoc reviewer)

Honors

1989 American College of Preventive Medicine-Burroughs Wellcome Pharmacoepidemiology Scholar Award 

2007 Johns Hopkins Department of Medicine Mentoring Award, 2007

C. Contribution to Science

1. After training in medicine and epidemiology and early publications in antibiotic utilization and efficacy and in 

substance and alcohol abuse, my career focus coalesced on HIV/AIDS in the late-1990s, not long after the 

HIV epidemic began its rapid growth. My earliest work in this area specifically focused on the treatment 

and outcomes of HIV infection in substance users, a behavior associate with a high incidence of HIV 

infection in Baltimore, Maryland. I created an HIV cohort in 1991, the Johns Hopkins HIV Clinical Cohort, a 

longitudinal study of HIV-infected patients designed to better describe how HIV disease progression is 

affected by antiretroviral therapies and the risk factors associated with toxicity and effectiveness of these 

rapidly evolving therapies. This cohort has been funded by NIDA first as an R01 and now as a U01 for 

almost 20 years. It has been the source of over 250 publications which have documented how substance 

abuse interferes with HIV therapy, and results in worse clinical disease progression. However, it has also 

been used to document how the HIV epidemic has evolved over the past 25 as new antiretroviral and other 

therapies for HIV have become available that are more potent, have less toxicity and are easier to use. 

Over 100 investigators have used this resource. Representative publications that trace the evolution of HIV 

infection treatment and outcomes include.

a. Chaisson RE, Keruly JC, Moore RD. Race, sex, drug use and progression of HIV disease. N Engl 

J Med 1995;333:751-6.

b. Lucas GM, Chaisson RE, Moore RD. Highly active antiretroviral therapy in a large urban clinic: risk 

factors for virological failure and adverse drug reactions. Ann Intern Med 1999; 131:81-7.

c. Moore RD, Keruly JC, Gebo KA, Lucas GM. An improvement in virologic response to HAART in 

clinical practice from 1996-2002. J Acquir Immune Def Syndr 2005; 39:195-198.

d. Lucas GM, Griswold M, Gebo KA, Keruly JC, Chaisson RE, Moore RD. Illicit drug use and HIV-1 

disease progression: a longitudinal study in the era of highly active antiretroviral therapy. Am J 

Epidemiol 2006; 163:412-420.

2. Building upon my earlier work, I established two multisite longitudinal cohorts of HIV-infected persons for 

purposes of expanding sample size and sociodemographic heterogeneity to address to better study HIV 

treatment and disease progression in a much broader population. The first and largest of these is the 

North American AIDS Cohorts Collaboration on Research and Design (NA-ACCORD) supported by NIAID 

as part of the International epidemiologic Databases to Evaluate AIDS (IeDEA) initiative, and the subject of 

this current proposal. The NA-ACCORD, encompassing most of the NIH-supported HIV cohorts in North 

American has been particularly important for addressing questions requiring large sample sizes such as 

the optimal timing of ARV initiation, impact of aging with HIV, non-AIDS comorbidities affecting HIV 

progression and the HIV care continuum. In particular, both our size and demographic heterogeneity are 

allowing us to assess region-wide trends in the natural history of the HIV epidemic. Examplesinclude.

a. Kitahata MM, Gange SJ, Abraham AG, et al. Initiating rather than deferring antiretroviral therapy at 

a CD4+ count between 351-500 cells/mm3 and greater than 500 cells/mm3 is associated with 

improved survival. New Engl J Med 2009; 360:1815-26.

b. Althoff K, Buchacz K, Hall HI, et al. U.S. trends in antiretroviral therapy use, HIV RNA plasma viral 

loads, and CD4 T-lymphocyte counts among HIV-infected persons in care, 2000-2008. Ann Intern 

Med 2012; 157:325-35.
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 49

c. Rebeiro PF, Horberg MA, Gange SJ, Gebo KA, Yehia BR, Brooks JT, Buchacz K, Silverberg MJ, 

Gill MJ, Moore RD, Althoff KN for the North American AIDS Cohort Collaboration on Research and 

Design (NA-ACCORD). Strong agreement of nationally recommended retention measures from the 

Institute of Medicine and the Department of Health and Human Services. PLoS One. 2014 Nov 6; 

9(11):e111772.

d. Abraham AG, Althoff KN, Jing Y, Estrella MM, Kitahata M, Wester W, Bosch R, Crane H, Eron J, 

Gill MJ, Horberg M, Justice A, Klein M, Krishnasami Z, Mayor A, Moore RD, Palella F, Parikh CR, 

Silverberg MJ, Golub ET, Jacobson LP, McKaig R, Napravnik S, Rodriguez B, Lucas GR, for the 

NA-ACCORD of International Epidemiologic Databases to Evaluate AIDS (IeDEA). End stage renal 

disease among HIV-infected adults in North America. Clin Infect Dis 2015; 60:941-9.

3. The HIV Research Network has been important in describing how the costs of care have evolved and 

those factors that have impacted HIV health care utilization and outcomes. This multisite cohort was 

created with a specific focus on health care utilization and both the delivery and quality of care in HIV 

disease. The results have directly impacted policy decisions at HRSA (funder for the Ryan White CARE 

Act). Examples include.

a. Gebo KA, Fleishman JA, Conviser R, Hellinger J, Hellinger FJ, Josephs JX, Keiser P, Gaist P, 

Moore RD, HIV Research Network. Contemporary costs of HIV healthcare in the HAART era. AIDS 

2010; 13:2705-15.

b. Fleishman JA, Yehia BR, Moore RD, Korthuis PT, Gebo KA, for the HIVRN. Establishment, 

Retention, and Loss to Follow-Up in Outpatient HIV Care. J Acquir Immune Defic Synd 2012; 

60:249-59.

c. Schackman BR, Fleishman JA, Su AE, Berkowitz BK, Moore RD, Walensky RP, Becker JE, Voss 

C, Paltiel AD, Weinstein MC, Freedberg KA, Gebo KA, Losina E. The lifetime medical cost savings 

from preventing HIV in the United States. Med Care 2015; Feb 21 [Epub ahead of print]

d. Crowell TA, Gebo KA, Blankson JN, Korthuis PT, Yehia BR, Rutstein RM, Moore RD, Sharp V, 

Nijhawan AE, Mathews WC, Hanau LH, Corales RB, Beil R, Somboonwit C, Edelstein H, Allen SL, 

Berry SA, for the HIV Research Network. Elite controllers are hospitalized more often than persons 

with medically controlled HIV. J Infect Dis 2015; 211:1692-1702.

4. As HIV infection has evolved into a chronic illness and an aging population in the U.S., I have contributed 

to a better understanding of the non-AIDS comorbidities that appear to be occurring at a higher rate than 

might be expected in an HIV-uninfected population and the complex interactions among HIV infection, 

traditional disease risk factors and aging. This work, representing all of the cohorts for which I am PI, 

includes:

a. Engels EA, Brock MV, Chen J, Hooker CM, Gillison M, Moore RD. Elevated incidence of lung 

cancer among HIV-infected individuals. J Clin Oncology 2006; 24:1383-1388.

b. Long JL, Engels EA, Moore RD, Gebo KA. Incidence and outcomes of malignancy in the HAART 

era in an urban cohort of HIV-infected individuals. AIDS 2008; 22:489-96.

c. Lucas GM, Jing Y, Sulkowski M, Abraham AG, Estrella MM, Atta MG, Fine DM, Klein MB, 

Silverberg MJ, Gil MJ, Moore RD, Gebo KA, Sterling TR, But AA, for the NA-ACCORD of the 

IeDEA. Hepatitis C viremia and the risk of chronic kidney disease in HIV-infected individuals. J 

Infect Dis 2013; 208:1240-9.

d. Silverberg MJ, Lau B, Achenbach CJ, Jing Y, Althoff KN, D’Souza G, Engels EA, Hessol N, Brooks 

JT, Burchell AN, Gill MJ, Goedert JJ, Hogg R, Horberg MA, Kirk GD Kitahata MM, Korthuis PT, 

Mathews WC, Mayor A, Modur SP, Napravnik S, Novak RM, Patel P, Rachlis AR, Sterling TR, 

Willig JH, Justice MC, Moore RD, Dubrow R, Cumulative Incidence of Cancer among HIV-infected 

Individuals in North America. Ann Intern Med 2015; 163: 507-18.

5. Liver disease and hepatitis C are problems of particularly high incidence in North America, and I have 

teamed with investigators at Johns Hopkins to delineate that effect of HIV and its treatment antiretroviral 

therapies and on the progression of HIV and HCV infection on the HIV/HCV co-infected patient.
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 50

a. Sulkowski MS, Thomas DL, Chaisson RE, Moore RD. Hepatoxicity associated with 

antiretroviral therapy in HIV-infected adults: role of antiretroviral drugs and hepatitis C and B 

virus infection. JAMA 2000; 283:74-80.

b. Sulkowski MS, Mehta SH, Torbenson M, Afdhal NH, Mirel L, Moore RD, Thomas DL. Hepatic 

steatosis and antiretroviral drug use among adults coinfected with HIV and hepatitis C virus. 

AIDS 2005 19:585-592.

c. Mehta SH, Thomas DL, Torbenson M, Brinkley S, Mirel L, Chaisson RE, Moore RD, Sulkowski 

MS. The effect of antiretroviral therapy on liver disease among adults with HIV and hepatitis C 

coinfection. Hepatology 2005; 41:123-131.

d. Limketkai BN, Mehta SH, Sutcliffe CG, Higgins YM, Torbenson MS, Brinkley SC, Moore RD, 

Thomas DL, Sulkowski MS. Relationship of liver disease stage and antiviral therapy with liverrelated events and death in HIV/HCV coinfected adults. JAMA 2012; 308:370-8.

Complete List of Published Work in MyBibliography: 

http://www.ncbi.nlm.nih.gov/sites/myncbi/richard.moore.2/bibliography/40858943/public/?sort=date&direction=

ascending.

D. Research Support

ACTIVE

NIAID 2UO1AAI069918 (PI: Moore) 7/01/16 – 6/30/21

North American AIDS Cohorts Collaboration on Research and Design: Consortium HIV/AIDS databases from 

academic medical centers and community based facilities that deliver HIV care in the U.S. and Canada to 

identify and answer questions of intraregional and interregional importance

NIDA IU01-DA036935 (PI: Moore) 4/01/14 – 3/31/19

HIV Disease Outcomes in Drug Users in Clinical Practice: Project compares illicit drug users with non-drug 

users in regards to utilization of antiretroviral therapy, long-term effectiveness of antiretroviral therapy.

AHRQ HHSA290201100007C (PI: Moore) 10/01/06 – 9/30/16

HIV Research Network: Network of HIV care providers from across the U.S. who provide timely health 

services costs and utilization data linked to relevant clinical data on HIV-infected persons.

HRSA IHHSH250201400019C (PI: Moore) 9/27/14 – 9/26/16

Utilizing HIV Research Network Data to Examine HIV Care Continuum: Project to assess retention in HIV care, 

adherence to ART and costs of HIV care in the setting of insurance coverage change under the Affordable 

Care Act in states not expanding Medicaid vs. those instituting Medicaid expansion.

NIAID P30AI094189 (PI: Chaisson) 5/02/2012 – 4/30/2017

Center for AIDS Research (CFAR): Coordinate and mobilize the substantial scientific, clinical and public health 

resources at JHU to generate new knowledge to understand, respond to, and control the HIV pandemic.

NIAID R24AI1077039 University of Alabama (PI: Saag) 5/01/16 –8/31/17 

Subcontract

CFAR Network of Integrated Clinical Systems (CNICS): Goals of providing a resource for HIV research for the 

evolving HIV epidemic in the U.S.

Role: Co-Investigator

NIDA R01DA037601 (PI: Beach) 4/01/14 – 3/31/19

Maximizing respect and improving outcomes in HIV and substance abuse (MaRIPOHSA)

The aim of this project is to create a repository of audio-recorded patient-provider encounters that we will use 

to measure communication and its impact on patients with HIV and substance use.

COMPLETED

NIAID 2UO1AAI069918 (PI: Moore) 7/01/11 – 6/30/16
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 51

North American AIDS Cohorts Collaboration on Research and Design: Consortium HIV/AIDS databases from 

academic medical centers and community based facilities that deliver HIV care in the U.S. and Canada to 

identify and answer questions of intraregional and interregional importance

NIAAA 1U24AA020801 (PI: McCaul) 7/01/11 – 6/30/16

Alcohol Research Consortium in HIV – Administrative Core (ARCH-AC): This administrative core provides 

support to a consortium investigating the intersection of alcohol and HIV epidemiology and treatment.

R24AI1077039 University of Alabama (PI: Saag) 5/01/11 – 4/31/16 

Subcontract

CFAR Network of Integrated Clinical Systems (CNICS): Goals of providing a resource for HIV research for the 

evolving HIV epidemic in the U.S.

Role: Co-Investigator
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 52

BIOGRAPHICAL SKETCH

Provide the following information for the Senior/key personnel and other significant contributors.

Follow this format for each person. DO NOT EXCEED FIVE PAGES.

NAME: Gange, Stephen J.

eRA COMMONS USER NAME (credential, e.g., agency login):

POSITION TITLE: Executive Vice Provost for Academic Affairs & Professor

EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, 

include postdoctoral training and residency training if applicable. Add/delete rows as necessary.)

DEGREE Completion 

(if Date FIELD OF STUDY INSTITUTION AND LOCATION applicable) MM/YYYY

Animal Science/ Cornell University, Ithaca, NY B.S. 06/1989 Quantitative Genetics

University of Wisconsin, Madison, WI Ph.D 06/1994 Statistics

A. PERSONAL STATEMENT

I have substantial experience in mentoring and collaborating with numerous K12/K23/K01 scholars both at 

Johns Hopkins and other universities and have been a recipient of the School’s Advising, Mentoring, and 

Teaching Recognition Award. I have been working with Dr. Rebeiro since 2009 when he joined the department 

as a masters’ student as my advisee. I continued as a doctoral advisor and continue to work closely with him 

on a number of different initiatives.

Relevant to this proposal, I have been the Director of the Biostatistics and Epidemiology Core of the NAACCORD since its inception and have been involved with directing or advising on the design and analysis of all 

the major study initiatives. I have also been the Principal Investigator of the Women’s Interagency HIV Study 

(WIHS) Analysis Center since 2001, the largest US natural history study devoted to HIV-infected women. 

Lastly, I am a member of several editorial boards, and have participated with numerous review and oversight 

panels, including as a member of the DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents and 

co-chair of the Office of AIDS Research Planning Workshop for Natural History and Epidemiology.

Of my 225+ publications, the following are of interest for this application, including studies performed with Dr. 

Rebeiro:

1. Rebeiro P, Althoff KN, Buchacz K, Gill J, Horberg M, Krentz H, Moore R, Sterling TR, Brooks JT, Gebo KA, 

Hogg R, Klein M, Martin J, Mugavero M, Rourke S, Silverberg MJ, Thorne J, Gange SJ; North American 

AIDS Cohort Collaboration on Research and Design. Retention among North American HIV-infected 

persons in clinical care, 2000-2008. J Acquir Immune Defic Syndr. 2013 Mar 1;62(3):356-62. PubMed 

PMID: 23242158; PubMed Central PMCID: PMC3661708.

2. Althoff KN, Rebeiro P, Brooks JT, Buchacz K, Gebo K, Martin J, Hogg R, Thorne JE, Klein M, Gill MJ, 

Sterling TR, Yehia B, Silverberg MJ, Crane H, Justice AC, Gange SJ, Moore R, Kitahata MM, Horberg MA; 

North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD). Disparities in the 

quality of HIV care when using US Department of Health and Human Services indicators. Clin Infect Dis. 

2014 Apr;58(8):1185-9. Epub 2014 Jan 23. PubMed PMID: 24463281; PubMed Central PMCID: 

PMC3967825.

3. Rebeiro PF, Horberg MA, Gange SJ, Gebo KA, Yehia BR, Brooks JT, Buchacz K, Silverberg MJ, Gill J, 

Moore RD, Althoff KN; North American AIDS Cohort Collaboration on Research and Design (NAACCORD). Strong agreement of nationally recommended retention measures from the Institute of
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 53

Medicine and Department of Health and Human Services. PLoS One. 2014 Nov 6;9(11):e111772. 

eCollection 2014. PubMed PMID: 25375099; PubMed Central PMCID: PMC4222946.

4. Rebeiro PF, Althoff KN, Lau B, Gill J, Abraham AG, Horberg MA, Kitahata MM, Yehia BR, Samji H, Brooks 

JT, Buchacz K, Napravnik S, Silverberg MJ, Rachlis A, Gebo KA, Sterling TR, Moore RD, Gange SJ; North 

American AIDS Cohort Collaboration on Research and Design. Laboratory Measures as Proxies for 

Primary Care Encounters: Implications for Quantifying Clinical Retention Among HIV-Infected Adults in 

North America. Am J Epidemiol. 2015 Dec 1;182(11):952-60. Epub 2015 Nov 17. PubMed PMID: 

26578717; PubMed Central PMCID: PMC4655744.

5. Rebeiro PF, Gange SJ, Horberg MA, Abraham AG, Napravnik S, Samji H, Yehia BR, Althoff KN, Moore 

RD, Kitahata MM, Sterling TR, Curriero FC; North American AIDS Cohort Collaboration on Research and 

Design (NA-ACCORD). Geographic Variations in Retention in Care among HIV-Infected Adults in the 

United States. PLoS One. 2016 Jan 11;11(1):e0146119. doi: 10.1371/journal.pone.0146119. eCollection 

2016. PubMed PMID: 26752637; PubMed Central PMCID: PMC4708981.

B. POSITIONS AND HONORS:

Positions and Employment

1988 - 1989 Cornell Theory Center, National Supercomputer Facility, Ithaca, NY. Computer Analyst. 

2003 - 2004 Amgen Inc, Epidemiology Department, Thousand Oaks, CA. Associate Director.

1994 - Johns Hopkins Bloomberg School of Public Health, Dept. of Epidemiology, Baltimore, MD. 

1994-2007 Faculty positions from Research Associate to Associate Professor

2007-present Professor with Tenure 

2009-2012 Deputy Department Chair

2013-2015 Senior Associate Dean for Academic Affairs

2015 - Johns Hopkins University, Office of the Provost. Executive Vice Provost for Academic Affairs.

Selected Honors:

2002 Elected Member, Delta Omega Honorary Public Health Society, Alpha Chapter

2005 Advising, Mentoring, and Teaching Recognition Award from Student Assembly, JHSPH

2007 - 2010 Elected Faculty Senate President & Member of the School’s Advisory Board (3 yr term)

2010 Fellow, American College of Epidemiology

2012 Invited Member, American Epidemiological Society

2015 Ernest L. Stebbins Faculty Award Recognizing Excellence and Innovation in Education, JHSPH

Selected Federal Advisory Committees:

2001 - 2006 NIH AIDS Clinical Studies & Epidemiology Study Section

2001 - 2007 Office of AIDS Research, Natural History and Epidemiology Committee, [Co-Chair, 2005-7]

2006 - 2014 Chair, Data Safety & Monitoring Committee, LCA Trials of Gene Therapy (NEI)

2010 - 2012 Invited Member, NIH Center for Scientific Review, College of CSR Reviewers

2011 - 2015 Member, Data Safety & Monitoring Committee, Phase I/II HCV Vaccine Trial (NIAID/DMID)

2011 - 2015 Member, Data Safety & Monitoring Committee, Phase III Antimicrobial Trial (NIAID/DMID)

2011 - Member, DHHS Panel on Antiretroviral Guidelines for Adults & Adolescents

Other Selected Experience:

2005 - 2014 Editorial Board, AIDS Research and Therapy

2010 - Editorial Board, JAIDS: Journal of Acquired Immune Deficiency Syndromes

2010 - 2014 Chair, Safety Review Committee, Raltegravir post-licensure safety study (Merck)

C. CONTRIBUTION TO SCIENCE

1. Epidemiology of HIV/AIDS in US

Understanding the epidemiology of the HIV epidemic in the US has been, and will continue to be, a 

cornerstone for domestic public health efforts. For over 20 years, my research interests and experience has 

spanned basic, clinical, and policy-level domains in HIV/AIDS epidemiology. I believe my efforts have helped 

to better understand biomarkers for HIV disease progression, measured the use and impact of therapies in
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 54

observational settings, and characterize health disparities across the US. Much of my work has been in 

collaboration with mentored junior faculty (K. Althoff, B. Lau) and doctoral students (D. Hanna, P. Rebeiro, C. 

Wong). Selected relevant publications include:

a) Kitahata MM, Gange SJ, et al. Effect of early versus deferred antiretroviral therapy for HIV on survival.

N Eng J Med, 2009:360. [With Editorial Commentary]. PMC2854555

b) Hanna DB, Buchacz K, .., & Gange SJ. Trends and disparities in antiretroviral therapy initiation and 

virologic suppression among newly treatment-eligible HIV-infected individuals in North America, 2001- 

2009. Clin Infect Dis 2013 Apr;56(8):1174-82. PMC3657490

c) Rebeiro P, Althoff K, Buchacz K, ..., Gange S for the NA-ACCORD. Retention among North American 

HIV-infected persons in clinical care, 2000-2008. J Acquir Immune Defic Syndr. 2013 Mar 1;62(3):356- 

62. PMC3661708.

d) Rebeiro PF, Althoff K, Lau B, ..., & Gange SJ. Laboratory measures are imperfect proxies of primarycare encounters: Implications for quantifying clinical retention among HIV-infected adults in North 

America. Am J Epidemiol. 2015 Dec 1;182(11):952-60. Epub 2015 Nov 17. PMC4655744.

2. Leadership of HIV Cohort Studies

The data from NA-ACCORD and other cohort studies, collected using standardized procedures 

established by professional data centers, provide a basis for describing the full spectrum of the natural and 

‘treated’ history of HIV infection. All successful data centers and cores establish efficient operations to ensure 

the validity of study findings. Exceptional groups, however, complement operational methods with added 

scientific value by contributing as scientific partners and simultaneously integrating scientific knowledge with 

appropriate study designs, data management, and statistical methodology. I believe my leadership of NAACCORD Biostatistics & Epidemiology Core, the Women’s Interagency HIV Study Data Management and 

Analysis Center (since 1996), the JHU Center for AIDS Research Biostatistics & Epidemiology Core, and other 

similar activities has not only increase the breadth of initiatives that have been pursued but also their depth and 

quality. Selected relevant publications include:

a) Bacon MC, Von Wyl V, Alden C, et al. The Women’s Interagency HIV Study (WIHS): An Observational 

Cohort Brings Clinical Sciences to the Bench. Clinical and Diagnostic Laboratory Immunology. 

2005;12(9):1013-1019. PMC-Exempt

b) Gange SJ, Kitahata MM, Saag MS, ..., & Moore RD. The North American AIDS Cohort Collaboration 

on Research and Design (NA-ACCORD). Int J Epidemiology 2007:36(2):294-301. PMC-Exempt

c) Lau B, Gange SJ, Moore RD. Interval and clinical cohort studies: epidemiologic issues. AIDS Research 

and Human Retroviruses. 2007;6;769-776.

3. Statistical and Epidemiology Methodology

Appropriate and innovative statistical and epidemiological methodology is essential to high-quality 

science. I have lead or collaborated on the refinement of novel analytical methods and the adaptation and 

interpretation of modern methodological approaches in epidemiology. Further, I have worked to integrate these 

new methods into educational programs here at Johns Hopkins. I am the primary instructor for a spectrum of 

on-site and online methods courses in Epidemiology, and led the Department’s Gateway Sciences Initiative for 

innovation and modernization of introductory courses. Selected relevant publications include:

a) Gange SJ. Teaching Epidemiologic Methods. Epidemiology. 2008;19:353-6. [With Editorial 

Commentary]. PMC – Exempt

b) Lau B, Gange SJ, Kirk GD, and Moore RD. Evaluation of human immunodeficiency virus biomarkers: 

inferences from interval and clinical cohort studies. Epidemiology 2009 20(5):664-72.PMC2818534

c) Ishwaran H, Gerds TA, Kogalur UB, Moore RD, Gange SJ, Lau BM. Random survival forests for 

competing risks. Biostatistics. 2014 Oct;15(4):757-73. PMC4173102.

d) Gange SJ and Golub ET. From smallpox to big data: The next 100 years of epidemiological methods. 

Am J Epidemiol. 2016 Mar 1;183(5):423-6. PMC-Exempt.
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 55

D. SELECTED RESEARCH SUPPORT:

Active Research Support:

U01-AI-42590 (Stephen J. Gange & Elizabeth Golub, dual PI) Role: PI & Member of Executive Committee

WIHS Data Management and Analysis Center (WDMAC)

U01-AI-069918 (Richard D. Moore, PI) Role: Director of Epi/Biostat Core & Member of Exec Committee

North American AIDS Cohorts Collaboration on Research and Design (NA-ACCORD)

Selected Past Research Support:

U01-AI035043 (Lisa Jacobson, PI) Role: Co-Investigator

Center for the Analysis and Management of the Multicenter AIDS Cohort Study (CAMACS)

P30-AI094189 (Richard Chaisson, PI) Role: Inaugural Director and Senior Advisor, Biostatistics & 

Epidemiologic Methods Core

Johns Hopkins University Center for AIDS Research (JHU-CFAR)

Selected Active & Past Research Mentoring Projects (Mentee, Project Title):

Junior Faculty:

K01 AI-071754 (B. Lau, Biomarkers, Therapy, and Mortality in the Evolving HIV Epidemic)

K01 AI-071725 (M. Silverberg, HIV infection, Antiretroviral therapy, Cancer incidence and progression) 

K01 AI-093197 (K. Althoff, Challenging and Expanding Paradigms of Aging with HIV)

K23 DK-081317 (M. Estrella, Burden of Chronic Kidney Disease in HIV Infection)

K23 AI-084854 (S. Berry, Universal Screening of HIV-infected persons for gonorrhea and Chlamydia)

Doctoral Students:

R36 DA-021104 (A. Terzian, Physical Functioning in a Cohort of HIV-Infected Women) 

F31 MH-076656 (A. Boore, Trust, Conspiracy Beliefs, and the Use of HAART)

F31 DA-030254 (D. Hanna, Epidemiologic Evaluation of State ADAP Features in the US)

F31 DA-035713 (P. Rebeiro, Epidemiology of Clinical Retention Among HIV+ Persons in North America)

F31 DA-037788 (C. Wong, Multimorbidity among HIV-Infected Adults in North America from 2000-2010)
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 56

BIOGRAPHICAL SKETCH

Provide the following information for the Senior/key personnel and other significant contributors.

Follow this format for each person. DO NOT EXCEED FIVE PAGES.

NAME: McGowan, Catherine Carey

eRA COMMONS USER NAME (credential, e.g., agency login):

POSITION TITLE: Associate Professor of Medicine, Vanderbilt University Medical Center, Nashville, TN

EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, 

include postdoctoral training and residency training if applicable. Add/delete rows as necessary.)

DEGREE Completion FIELD OF STUDY INSTITUTION AND LOCATION (if Date

applicable) MM/YYYY

University of Kansas, Lawrence, KS BA 01/1983 Biochemistry

University of Kansas, Medical School, Kansas City, KS MD 05/1987 Medicine

Internship/ University of Arizona, Tucson, AZ 06/1990 Internal Medicine Residency

Vanderbilt University, Nashville, TN Fellowship 06/1995 Infectious Diseases

A. Personal Statement

My research interests focus on the use of observational cohort data to study clinical outcomes in HIVinfected individuals. I have over two decades’ experience in providing primary care for HIV-infected patients in 

a high-volume practice at the Vanderbilt Comprehensive Care Clinic (VCCC). I am also a member of the HIV 

Epidemiology and Outcomes Working Group of the Tennessee Center for AIDS Research (CFAR) and direct 

research activities at the VCCC. I have been closely involved with the NIH-funded Caribbean, Central and 

South America network (CCASAnet) of the International Epidemiologic Databases to Evaluate AIDS (IeDEA) 

since its inception in 2006, and participate in the Executive, Pediatric, Cancer, Clinical Outcomes, and 

Strategic Data Working Groups of IeDEA. In my current role as PI of CCASAnet and its regional Data 

Coordinating Center based at Vanderbilt, I lead efforts to develop large databases of HIV data from adult and 

pediatric clinical sites in Argentina, Brazil, Chile, Haiti, Honduras, Mexico, and Peru, direct the scientific 

program for CCASAnet, and oversee data quality activities.

As a member of the IeDEA Executive Committee and several IeDEA working groups, I have worked with 

Dr. Richard Moore, PI of the North American AIDS Cohort Collaboration on Research and Design (NAACCORD), to develop a cross-regional collaboration that spans the Americas.

The scientific aims of CCASAnet are closely aligned with those proposed by Dr. Peter Rebeiro in his K-01 

grant application. The collaborative projects he proposes within the Americas and globally will benefit the 

IeDEA consortium in many ways, including informing public health policy.

1. McGowan CC, Cahn P, Gotuzzo E, Padgett D, Pape JW, Wolff M, Schechter M, Masys DR. (2007). 

Cohort Profile: Caribbean, Central and South America Network for HIV research (CCASAnet) collaboration 

within the International Epidemiologic Databases to Evaluate AIDS (IeDEA) programme. Int J Epidemiol, 

35(5), 969-76. PMID: 17846055

2. Duda SN, Shepherd BE, Gadd CS, Masys DR, McGowan CC. (2012). Measuring the quality of 

observational study data in an international HIV research network. PLOS ONE, 7: e33908. PMCID: 

PMC332089.

3. Duda SN, Farr AM, Lindegren ML, Blevins M, Wester CW, Wools-Kaloustian K, Ekouevi DK, Egger M, 

Hemingway-Foday J, Cooper DA, Moore RD, McGowan CC, Nash D, and the International Epidemiologic 

Databases to Evaluate AIDS (IeDEA) Collaboration. (2014). Characteristics and comprehensiveness of 

adult HIV care and treatment programmes in Asia-Pacific, sub- Saharan Africa and the Americas: results of 

a site assessment conducted by the International epidemiologic Databases to Evaluate AIDS (IeDEA). J 

Intl AIDS Soc,17:19045. PMCID: PMC4268491.
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 57

4. Althoff K, Rebeiro PF, Hanna DB, Padgett D, Horberg MA, Grinsztejn B, Abraham A, Hogg R, Gill MJ, 

Wolff MJ, Mayor A, Rachlis A, Williams C, Sterling TR, Kitahata M, Buchacz K, Thorne J, Cesar C, Mejía 

Cordero F, Rourke SB, Sierra-Madero J, Pape JW, Cahn P, McGowan CC, for the North American AIDS 

Cohort Collaboration on Research and Design (NA-ACCORD) and the Caribbean, Central and the South 

America Network for HIV Epidemiology (CCASAnet). (2016). A picture is worth a thousand words: Maps of 

HIV clinical care indicators are essential tools for informing research, programs, and policy. J Int AIDS Soc, 

1:20707.doi:10.7448/ias.19.20707. PMCID: PMC4821890.

B. Positions and Honors

Positions and Employment

1987 Medical Volunteer, Hôpital Bon Samaritan, Limbe, Haiti, West Indies

1990 Physician Volunteer, Ministry of Primary Health Care, Belize, CentralAmerica 

1990-1992 Internist, Locum Tenens, CompHealth, Inc., Salt Lake City, UT

1995-1996 Instructor, Division of Infectious Diseases, Department of Medicine, Vanderbilt University, 

Nashville, TN

1996-2012 Assistant Professor of Medicine, Division of Infectious Diseases, Department of Medicine, 

Vanderbilt University, Nashville, TN

2012-present Associate Professor of Medicine, Division of Infectious Diseases, Department of Medicine, 

Vanderbilt University, Nashville, TN

1996-2000 Physician Volunteer, Siloam Family Health Center, Nashville, TN

1996-2001 Physician Volunteer, Christian Mission of Pignon, Pignon, Haiti, West Indies (intermittent basis) 

1996-2010 Assistant Medical Director, Comprehensive Care Center, Nashville, TN

1998-2002 Medical Director, Robertson County Comprehensive Care Center, Springfield, TN 

2001-2010 Research Director, Vanderbilt Comprehensive Care Center, Nashville, TN

Other Experience and Professional Memberships

1990-present American College of Physicians

1993-2000 Member, Helicobacter Study Group, VanderbiltUniversity 

1993-present Infectious Diseases Society of America

1993-2007 Infectious Diseases Society of Tennessee 

1994-2004 American Society for Microbiology

2002-2004 Member, Microbial:Host Interaction Study Group, Vanderbilt University

2002 Ministry of Public Health and Population, Haiti: Therapeutic antiretroviral strategies. Sharing of 

experiences and future perspectives for Haiti. Panel participant.

2004-present American Academy of HIV Medicine

2004-present HIV Epidemiology and Outcomes Working Group, Tennessee Center for AIDS Research, 

Faculty Member

2005 Ministry of Public Health and Population, Haiti: International workshop to develop guidelines for 

the prevention of mother-to-infant HIV transmission in Haïti. Panel participant.

2006-present International AIDS Society

2007 Ministry of Public Health and Population, Haiti: International workshop to revise national 

guidelines for management of HIV in adults and adolescents. Panel participant.

2010 Ministry of Public Health and Population, Haiti: International workshop to revise national 

guidelines for antiretroviral therapy. Panel participant.

2011-present Vanderbilt Institute for Global Health, Faculty Member 

2013-present Vanderbilt Tuberculosis Center, Faculty Member

Honors

1978 Presidential Freshman Scholarship, Drake University 

1993 National Foundation for Infectious Diseases Grant 

1995 Grant Liddle Scholar Award, Vanderbilt University 

2010 World AIDS Day Hero, Nashville, Tennessee

2013 Five Star Excellence Award, Vanderbilt MedicalGroup 

2014 Five Star Excellence Award, Vanderbilt MedicalGroup
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 58

C. Contribution to Science

1. HIV Continuum of Care in the Caribbean, Central and South America. This work assessed several 

important stages of the HIV Care Continuum in the context of health care delivery in Latin America and the 

Caribbean. Late diagnosis and late ART initiation were highly prevalent, and there was considerable 

heterogeneity across the region in long-term survival and loss to follow up rates. Regional HIV Care 

Continuum outcomes improved over time, though disparities for vulnerable groups remain.

a. Carriquiry G, Fink V, Koethe JR, Giganti MJ, Jayathilake K, Blevins M, Cahn P, Grinsztejn B, Wolff 

M, Pape JW, Padgett D, Madero JS, Gotuzzo E, McGowan CC, Shepherd BE. (2015). Mortality 

and loss to follow-up among HIV-infected persons on long-term antiretroviral therapy in Latin 

America and the Caribbean. J Int AIDS Soc,18:20016. PMCID: PMC4499577.

b. Crabtree-Ramírez B, Caro-Vega Y, Shepherd B, Cesar C, Wehbe F, Cortés C, Padgett D, Pape J, 

Gotuzzo E, McGowan C, Masys D, Sierra-Madero J. (2011). Cross-sectional analysis of late 

HAART initiation in Latin America and the Caribbean: late testers and late presenters. PLoS ONE, 

6: e20272. PMCID: PMC3102699.

c. Crabtree-Ramírez B, Neried Caro Vega Y, Shepherd BE, Turner M, Carriquiry G, Fink V, PM, 

Cortes CP, Rouzier V, Padgett D, Jayathilake K, McGowan CC, Person AK. (2015). Temporal 

trends in age at HIV diagnosis in cohorts in the United States, the Caribbean, and Central and 

South America. AIDS Behav, 15;19:1599-608. PMCID: PMC4512939.

d. Rebeiro P, Cesar C, Shepherd BE, De Boni RB, Cortés CP, Rodriguez F, Belaunzarán-Zamudio P, 

Pape JW, Padgett D, Hoces D, McGowan CC, Cahn P. (2016). Assessing the HIV care continuum 

in the Caribbean, Central and South American network for HIV epidemiology (CCASAnet): progress 

in clinical retention, cART use, and viral suppression. J Int AIDS 

Soc,19:20636.doi:10.7448/ias.19.1.20636. PMCID: PMC4827101.

2. Antiretroviral treatment outcomes in the Caribbean, Central and South America. This work 

documented important outcomes after ART initiation in the large multinational CCASAnet cohort including 

mortality, loss to follow up, rates of regimen change and failure, and need for third-line agents. These data 

were used by the Pan American Health Organization in its regional report on the HIV epidemic, and to 

forecast need for expensive third line agents.

a. Tuboi SH, Schechter M, McGowan CC, Cesar C, Krolewiecki A, Cahn P, Wolff M, Pape JW, 

Padgett D, Madero JS, Gotuzzo E, Masys DR, Shepherd BE. (2009). Mortality during the first year 

of potent antiretroviral therapy in HIV-1-infected patients in 7 sites throughout Latin America and the 

Caribbean. J Acquir Immun Def Syndr, 51:615-623. PMCID: PMC2780368.

b. Cesar C, Jenkins CA, Shepherd BE, Padgett D, Mejia F, Ribeiro SR, Cortes C, Pape JW, Madero 

JS, Fink V, Sued O, McGowan C, Cahn P. (2015). Incidence of virological failure and major 

regimen change of initial combination antiretroviral therapy in the Caribbean, Central, and South 

America: an observational cohort study. Lancet HIV, 2:e492-e500. PMCID: PMC4651009.

c. Wolff M, Shepherd BE, Cortés C, Rebeiro P, Cesar C, Wagner Cardoso S, Pape JW, Padgett D, 

Sierra-Madero J, Echevarria J, McGowan CC. (2015). Clinical and virologic outcomes after 

changes in first antiretroviral regimen at 7 sites in CCASAnet. J Acquir Immun Def Syndr, 71:102-

10. PMCID: PMC4712722.

d. Cesar C, Shepherd BE, Jenkins CA, Ghidinelli M, Castro JL, Veloso VG, Cortes CP, Padgett D, 

Crabtree-Ramirez B, Gotuzzo E, Fink V, Duran A, Sued O, McGowan CC, Cahn P, Caribbean, 

Central and South America Network for HIV Epidemiology (CCASAnet). (2014). Use of third line 

antiretroviral therapy in Latin America. PLOS ONE, 15;9(9):e106887. PMCID:PMC4164470.

3. Evolving epidemiology of clinical outcomes in HIV infection. These studies demonstrated the 

changing epidemiology of clinical outcomes in HIV-infected populations receiving combination ART, 

spanning low- and high-income settings and geographically diverse regions. The findings highlight the shift 

in the burden of cancer from AIDS-defining cancers to non AIDS-defining cancers, and the increased 

morbidity related to non-communicable diseases.

a. Wester CW, Koethe JR, Shepherd BE, Stinnette SE, Rebeiro PF, Kipp AM, Hong H, Bussmann H, 

Gaolathe T, McGowan CC, Sterling TR, Marlink RG. (2011). Non-AIDS defining events among HIV1 Infected adults receiving combination antiretroviral therapy in urban settings in Sub Saharan 

Africa and the United States. AIDS, 25(12). PMCID: PMC3188442.
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 59

b. Fink VI, Shepherd BE, Cesar C, Krolewiecki A, Wehbe F, Cortés CP, Crabtree-Ramírez B, Padgett 

D, Shafaee M, Schechter M, Gotuzzo E, Bacon M, McGowan C, Cahn P, Masys D. (2011). Cancer 

in HIV-infected persons from the Caribbean, Central and South America. J Acquir Immune Defic 

Syndr, 56:467–473. PMCID: PMC3293455.

c. Castilho JL, Luz PM, Shepherd BE, Turner M, Ribeiro SR, Bebawy SS, Netto JS, McGowan CC, 

Veloso VG, Engels EA, Sterling TR, Grinsztejn B. (2015). HIV and cancer: a comparative 

retrospective study of Brazilian and U.S. clinical cohorts. Infect Ag Cancer, 10:4. PMCID: 

PMC4477502.

d. Crabtree-Ramirez, B. Caro-Vega, Y. Shepherd, B. E. Grinsztejn, B. Wolff, M. Cortes, C. P.Padgett,

D. Carriquiry, G. Fink, V. Jayathilake, K. Person, A. K. McGowan, C. Sierra-Madero, J. (2016). 

Time to HAART initiation after diagnosis and treatment of opportunistic infections in patients with 

AIDS in Latin America. PLoS One, Jun 7;11(6):e0153921 doi: 10.1371/journal.pone.0153921. 

PMCID: PMC4896474.

4. Impact of non-injection drug use on HIV clinical outcomes. These studies evaluated non-injection drug 

use and its impact on clinical outcomes in HIV cohorts in the US and Latin America. The manuscripts 

contributed to the literature describing the relationship between substance use and HIV disease 

progression in varied clinical settings. The usefulness of a novel point-of-care rapid screening tool to 

assess substance use and ART adherence was demonstrated at high-volume HIV clinics in multinational 

settings.

a. McGowan CC, Weinstein DD, Samenow CP, Stinnette SE, Barkanic G, Rebeiro PF, Sterling TR, 

Moore RD, Hulgan T. (2011). Drug use and receipt of highly active antiretroviral therapy among 

HIV-infected persons in two U.S. clinic cohorts. PLOS ONE, 6(4):e18462. PMCID: PMC3081810.

b. Rasbach DA, Desruisseau AJ, Kipp AM, Stinnette S, Kheshti A, Shepherd BE, Sterling TR, Hulgan 

T, McGowan CC, Qian HZ. (2013) Active cocaine use is associated with lack of HIV-1 virologic 

suppression independent of non-adherence to antiretroviral therapy: use of a rapid screening tool 

during routine clinic visits. AIDS Care, 25(1):109-17. PMCID: PMC3443534.

c. Qian HZ, Mitchell VJ, Bebawy S, Cassell H, Perez G, McGowan CC, Sterling TR, Vermund SH, 

D'Aquila R, Hulgan T. (2014). Current drug use and lack of HIV virologic suppression: point-of-care 

urine drug screen versus self-report. BMC Infect Dis,14:508. PMCID: PMC4175271.

d. De Boni R, Shepherd BE, Grinsztejn B, Cesar C, Cortes C, Padgett D, Gotuzzo E, Belaunzaran 

Zamudio PF, Rebeiro PF, Duda SN, McGowan CC. (2016). Substance use and adherence among 

people living with HIV/AIDS receiving cART in Latin America. AIDS Behav, Apr 18. PMID: 

27091028. PMCID: pending.

Complete List of Published Work in MyBibliography:

http://www.ncbi.nlm.nih.gov/sites/myncbi/catherine.mcgowan.1/bibliograpahy/43431356/public/?sort=date&dire

ction=ascending

D. Research Support

Ongoing Research Support

2U01 AI069923-12 (NIH/NIAID) McGowan, Cahn (co-PIs) 07/01/2016 - 06/30/2021

CCASAnet: The Caribbean, Central and South America Network for HIV Epidemiology

This project creates and maintains a shared repository of HIV data from the Caribbean and Central and South 

America, and uses the combined data to answer questions about the characteristics of the regional HIV 

epidemic.

2U01 AI069923-12 (NIH/NIAID) McGowan (PI) 08/01/2013 – 06/30/2017

RePORT-Brazil (Administrative Supplement to CCASAnet)

This project creates a multicenter cohort of patients with well-defined tuberculosis infection and their contacts 

in three different regions in Brazil. Repositories for clinical data and biologic specimens will be established 

which will allow investigations on relevant epidemiologic, clinical, and pathogenesis questions in the region.
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 60

R24 AI124872-02 (NIH/NIAID) Duda, Harris (co-PIs) 04/06/2016 – 03/31/2021

Harmonist: A Scalable Toolkit for Standardizing and Coordinating Data Sharing Across International 

Research Networks

The goal of the Harmonist project is to develop the “Harmonist toolkit,” a software and standards package that 

will enable HIV observational research networks to coordinate large-scale research projects and apply data 

management best practices more effectively and efficiently.

Role: Co-investigator

1R03DA039743 (NIH/NIDA) Kipp (PI) 04/15/2015 - 03/31/2017

Characterizing non-medical prescription opioid use and pain in people living with HIV

The goal of this study is to identify the severity of non-medical opioid use among people with HIV and its 

association with pain and other substance use, and to inform ways to improve pain management while 

avoiding risks of non-medical opioid use.

Role: Co-Investigator

Completed Research Support

2U01 AI069923-06 (NIH/NIAID) McGowan, Cahn (co-PIs) 06/01/2011 - 06/30/2016

CCASAnet: The Caribbean, Central and South America Network for HIV Epidemiology

This project creates and maintains a shared repository of HIV data from the Caribbean and Central and South 

America, and uses the combined data to answer questions about the characteristics of the regional HIV 

epidemic.

5U01 AI069923-09 (NIH/NIAID) McGowan (PI) 07/01/2014 – 06/30/2016

Coorte Brasil: Validation and epidemiologic study of non-communicable diseases in HIV-infected 

persons receiving combination antiretroviral therapy in Brazil (Administrative Supplement to 

CCASAnet)

This project involves the collection, validation and analysis of data related to non-communicable diseases in a 

multicenter cohort of HIV-positive patients in Brazil.

5U01 AI069923-09/10 (NIH/NIAID) McGowan (PI) 04/01/2015 – 04/30/2016

Biomarker discovery for tuberculosis infection and disease (Administrative Supplement to CCASAnet) 

This project seeks to identify relevant biomarkers of key TB outcomes- acquisition of M. tuberculosis infection 

and progression from M. tuberculosis infection to TB disease in a well-characterized cohort of TB patients and 

their contacts in Rio de Janeiro.

5U01 AI069923-07 (NIH/NIAID) McGowan (PI) 07/01/2012 – 06/30/2013

Use of a rapid screening tool for substance use and adherence during routine clinic visits 

(Administrative Supplement to CCASAnet)

This project implemented a rapid clinical screening tool to prospectively collect point-of-care data on active 

drug use and antiretroviral adherence at CCASAnet sites multicenter cohort of patients with well-defined 

tuberculosis infection and their contacts in three different regions in Brazil. Repositories for clinical data and 

biologic specimens will be established which will allow investigations on relevant epidemiologic, clinical, and 

pathogenesis questions in the region.
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 61

OMB No. 0925-0001/0002 (Rev. 08/12 Approved Through 8/31/2015)

BIOGRAPHICAL SKETCH 

NAME: HOLTGRAVE, DAVID R

eRA COMMONS USER NAME (agency login): 

POSITION TITLE: Professor and Department Chair

EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, 

include postdoctoral training and residency training if applicable.)

INSTITUTION AND LOCATION DEGREE Completion FIELD OF STUDY

(if Date 

applicable) MM/YYYY

University of Missouri at St. BA 08/1983 Psychology

Louis

University of Illinois at PHD 01/1988 Quantitative Psychology

Urbana/Champaign

Harvard University School of OTH 07/1989 Post-doctoral Fellowship in Environmental Health and 

Public Health Public Policy (Interdisciplinary Programs in Health)

A. Personal Statement

Since August of 2005, Dr. Holtgrave has been Professor and Chair of the Department of Health, Behavior and 

Society at the Johns Hopkins Bloomberg School of Public Health. The Department was established in the 

summer of 2005 with a mission dedicated to research and training that advances scientific understanding of 

the impact on health of behavior and the societal context. Dr. Holtgrave’s research has focused on the 

effectiveness and cost-effectiveness of a variety of HIV prevention interventions (defined broadly), and the 

relation of the findings of these studies to HIV prevention policy making. He has also investigated the 

relationship between social capital measures, infectious disease rates, and risk behavior prevalence. He has 

also examined the cost-effectiveness of mass media approaches to the prevention of tobacco use. Dr.

Holtgrave teaches “Translating Research into Public Health Programs” (a two-term course in the Department 

of Health, Behavior and Society with a heavy emphasis on economic evaluation methods and applications) and 

has guest-lectured in numerous classes at the Johns Hopkins Bloomberg School of Public Health since joining 

the School in 2005 (primarily on cost-effectiveness and HIV prevention issues). He also recently served as the 

Vice-Chair of the Presidential Advisory Council on HIV/AIDS. He is therefore ideally suited to serve onDr.

Rebeiro’s mentoring committee, offering insight into how evidence informs policy and how health policy effects 

on HIV Care Continuum outcomes may be best assessed as part of his K01 Career Development Award.

1. Holtgrave DR, Hall HI, Wehrmeyer L, Maulsby C. Costs, consequences and feasibility of strategies for 

achieving the goals of the National HIV/AIDS strategy in the United States: a closing window for 

success?. AIDS Behav. 2012 Aug;16(6):1365-72. PubMed PMID: 22610372.

2. Hall HI, Frazier EL, Rhodes P, Holtgrave DR, Furlow-Parmley C, Tang T, Gray KM, Cohen SM, Mermin 

J, Skarbinski J. Differences in human immunodeficiency virus care and treatment among 

subpopulations in the United States. JAMA Intern Med. 2013 Jul 22;173(14):1337-44. PubMed PMID:

23780395.

3. Holtgrave DR, Kim JJ, Adkins C, Maulsby C, Lindsey KD, Johnson KM, Montoya DC, Kelley RT. Unmet 

HIV service needs among Black men who have sex with men in the United States. AIDS Behav. 2014 

Jan;18(1):36-40. PubMed PMID: 23892769.

4. Holtgrave DR. Development of year 2020 goals for the National HIV/AIDS Strategy for the United 

States. AIDS Behav. 2014 Apr;18(4):638-43. PubMed PMID: 23934340.

B. Positions and Honors

Positions and Employment

1989 - 1991 Assistant Professor, UNIVERSITY OF OKLAHOMA HEALTH SCIENCES CENTER

(Department of Family Medicine)

1991 - 1995 Behavioral Scientist, CENTERS FOR DISEASE CONTROL AND PREVENTION (National
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 62

Center for Prevention Services, and Office of the Associate Director of HIV/AIDS, CDC)

1995 - 1997 Associate Professor, MEDICAL COLLEGE OF WISCONSIN (Center for AIDS Research)

1997 - 2001 Director, CENTERS FOR DISEASE CONTROL AND PREVENTION (Division of HIV/AIDS

Prevention -- Intervention Research and Support)

2001 - 2005 Professor, EMORY UNIVERSITY (Rollins School of Public Health)

2005 - Professor and Department Chair, JOHNS HOPKINS UNIVERSITY (Bloomberg School of 

Public Health, Department of Health, Behavior & Society)

Other Experience and Professional Memberships

- Member, American Public Health Association

- Member, Society for Medical Decision Making

Honors

Appointed Member and Vice-Chair, Presidential Advisory Council on HIV/AIDS

The Golden Apple Award and The Johns Hopkins University Alumni Association Excellence in 

Teaching Award, Johns Hopkins Bloomberg School of Public Health

Positive Leadership Award, National Association of People with AIDS 

Partnership Award, National Alliance of State and Territorial AIDS Directors

C. Everett Koop National Health Award, The Health Project

C. Contribution to Science

1. I have conducted cost-effectiveness and cost-utility analyses of a number of public health interventions. 

This worked has focused most pointedly on HIV prevention and care programs, with a secondary emphasis 

on smoking-related interventions. The studies help inform program managers and policy makers about the 

cost and relative cost-effectiveness of a variety of public health services.

a. Holtgrave DR, Wunderink KA, Vallone DM, Healton CG. Cost-utility analysis of the National truth 

campaign to prevent youth smoking. Am J Prev Med. 2009 May;36(5):385-8. PubMed PMID:

19211214.

b. Holtgrave DR, Maulsby C, Kharfen M, Jia Y, Wu C, Opoku J, West T, Pappas G. Cost-utility analysis of 

a female condom promotion program in Washington, DC. AIDS Behav. 2012 Jul;16(5):1115-20. 

PubMed PMID: 22434283.

c. Villanti AC, Curry LE, Richardson A, Vallone DM, Holtgrave DR. Analysis of media campaign 

promoting smoking cessation suggests it was cost-effective in prompting quit attempts. Health Aff 

(Millwood). 2012 Dec;31(12):2708-16. PubMed PMID: 23213155.

d. Holtgrave DR, Wolitski RJ, Pals SL, Aidala A, Kidder DP, Vos D, Royal S, Iruka N, Briddell K, Stall R, 

Bendixen AV. Cost-utility analysis of the housing and health intervention for homeless and unstably 

housed persons living with HIV. AIDS Behav. 2013 Jun;17(5):1626-31. PubMed PMID: 22588529.

2. In partnership with key policy makers and program managers, I have conducted a number of resource 

allocation modeling projects which serve to provide guidance on how best to allocate resources across an 

array of available program options. These studies have been done on both very high and low HIV 

prevalence jurisdictions, and have served to directly inform the prioritization of uses of resources in these 

settings.

a. Holtgrave DR, Hall HI, Wehrmeyer L, Maulsby C. Costs, consequences and feasibility of strategies for 

achieving the goals of the National HIV/AIDS strategy in the United States: a closing window for 

success?. AIDS Behav. 2012 Aug;16(6):1365-72. PubMed PMID: 22610372.

b. Holtgrave DR, Young PA, Mayer RR, Maulsby C, Kim JJ. Employing resource allocation modeling to 

inform HIV prevention planning for the state of Iowa. AIDS Educ Prev. 2013 Oct;25(5):423-9. PubMed 

PMID: 24059879.
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 63

c. Holtgrave DR, Kim JJ, Adkins C, Maulsby C, Lindsey KD, Johnson KM, Montoya DC, Kelley RT. 

Unmet HIV service needs among Black men who have sex with men in the United States. AIDS Behav. 

2014 Jan;18(1):36-40. PubMed PMID: 23892769.

d. Holtgrave DR. Development of year 2020 goals for the National HIV/AIDS Strategy for the United 

States. AIDS Behav. 2014 Apr;18(4):638-43. PubMed PMID: 23934340.

3. Along with key colleagues specializing in HIV surveillance and epidemiology, I have contributed to studies 

which helped define the concept of HIV transmission rates for the U.S., and to estimate these transmission 

rates for a number of key populations (such as persons living with HIV who are aware and unaware of HIV 

seropositivity). Related to this work is research into trends in HIV testing and diagnoses in the U.S.

a. Hall HI, Holtgrave DR, Maulsby C. HIV transmission rates from persons living with HIV who are aware 

and unaware of their infection. AIDS. 2012 Apr 24;26(7):893-6. PubMed PMID: 22313960.

b. Hall HI, Holtgrave DR, Tang T, Rhodes P. HIV transmission in the United States: considerations of viral 

load, risk behavior, and health disparities. AIDS Behav. 2013 Jun;17(5):1632-6. PubMed PMID:

23456577.

c. Holtgrave DR, Hall HI, Des Jarlais DC, Mizuno Y, Purcell DW. Estimating number of diagnosed 

persons living with HIV in the United States engaged in unprotected serodiscordant risk behavior with 

unsuppressed viral load. J Acquir Immune Defic Syndr. 2014 Mar 1;65(3):e125-8. PubMed PMID:

23978998.

d. Johnson AS, Hall HI, Hu X, Lansky A, Holtgrave DR, Mermin J. Trends in diagnoses of HIV infection in 

the United States, 2002-2011. JAMA. 2014 Jul 23-30;312(4):432-4. PubMed PMID: 25038362.

D. Research Support

Ongoing Research Support

T28830 DOWDY (PI) 10/01/14-09/30/19

CDC: Emory University

Enhancing Models of HIV, Viral Hepatitis, STI’s and Tuberculosis to Inform and Improve Public Health Impact 

The goal of this five-year project is to assist the United States Centers for Disease Control and Prevention in 

their approach to modeling four key infectious diseases for U.S. disease control.

Role: Co-Investigator

 

 

2000 G QF123 HOLTGRAVE (PI) 06/07/12-03/31/17 

NIMH: UCLA

Implementing Eban II: An Evidence-Based Intervention for Sero-Discordant Couples
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 64

The implementation of Eban II is a 5-year study, an evidence-based risk reduction intervention for 

heterosexual, African American HIV serodiscordant couples, investigating the processes and determinants of 

implementation in 10 community-based organizations (CBOs) in California, and real-world cost-effectiveness of 

Eban II as it is delivered to 180 couples

Role: PI

P30AI094189 CHAISSON (PI) 09/01/12-04/30/17

The Johns Hopkins Center for AIDS Research (JHU CFAR)

CFAR will help coordinate, mobilize the substantial scientific, clinical and public health resources at JHU to 

generate new knowledge to understand, respond to, and control the HIV pandemic.

Role: Co-Investigator

 

 

 

 

 

 

 

Completed Research Support

 

 

 
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 65

 

 

 

 
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 66

BIOGRAPHICAL SKETCH

Provide the following information for the Senior/key personnel and other significant contributors.

Follow this format for each person. DO NOT EXCEED FIVE PAGES.

NAME: Schaffner, William

eRA COMMONS USER NAME (credential, e.g., agency login):

POSITION TITLE: Professor of Preventive Medicine, Department of HealthPolicy 

Professor of Medicine, Division of Infectious Diseases

EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, 

include postdoctoral training and residency training if applicable. Add/delete rows as necessary.)

DEGREE Completion 

(if Date FIELD OF STUDY INSTITUTION AND LOCATION applicable) MM/YYYY

Yale University, New Haven, CT BS 1957 Zoology

Cornell Univ. Med College, New York MD 1962 Medicine

Vanderbilt University Hospital, Nashville, Tn Residency 1963-64 Medicine

Vanderbilt University School of Medicine Fellow 1964-66 Infectious Diseases

Epidemic

Intelligence Public Health Centers for Disease Control, Atlanta, GA Service 1966-68 Epidemiology (EIS) Officer

Training

A. PERSONAL STATEMENT

I am Professor of Preventive Medicine in the Department of Health Policy and Professor of Medicine in 

the Division of Infectious Diseases at the Vanderbilt University School of Medicine. For 31 years (1982- 

2013) I chaired the Department of Preventive Medicine and for 7 years was Chief of the Division of 

Infectious Diseases (1982-1989). I am a staunch advocate for collaborative relationships between 

academic medical centers and governmental public health institutions. Members of my department and 

I have close working relationships with colleagues at the Tennessee Department of Health and the 

CDC on research, teaching and service activities. My research has been focused on, but not limited to, 

communicable diseases, creating new epidemiologic science and translating the science into 

progressive health policy. My trainees have included infectious disease fellows and CDC EIS officers 

who have gone on to have successful careers in academia and at CDC in senior policy positions. My 

primary current research is as Co-PI of the CDC-funded Emerging Infections Program Tennessee site 

which produces rigorous data that are the basis for national public health policy determinations. This 

background provides me the experience to mentor Dr. Rebeiro in the design and conduct of his 

investigations, and I am confident that our excellent mentorship teams will support Dr. Rebeiro fully as 

he accomplishes his proposed research tasks.

B. POSITIONS AND HONORS

Positions

1969-1973 Assistant Professor of Medicine, Vanderbilt

1969-1979 Director, Clinical Microbiology Laboratory,Vanderbilt 

1969-2006 Hospital Epidemiologist, Vanderbilt

1974-1979 Associate Professor of Medicine and Preventive Medicine, Vanderbilt
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 67

1979-Present Professor of Medicine and Preventive Medicine, Vanderbilt

1982-1989 Chief, Division of Infectious Diseases, Department of Medicine,Vanderbilt 

1982-2013 Chairman, Department of Preventive Medicine, Vanderbilt

Honors (selected)

1953-1957 Ford Foundation Scholar, Yale University

1957-1958 Fulbright Scholar, Freiburg, Germany

2009 James D. Bruce Award, American College of Physicians

2010 Ronald Davis Award, American College of Preventive Medicine

2010 Sedgwick Memorial Medal, American Public Health Association

2010 Harvie Branscomb Distinguished University Professor, Vanderbilt University

2010 Distinguished Alumnus Award, Vanderbilt University

2010 Alumni Award of Distinction, Weill Cornell Medical College

2011 Duncan Clark Award, Association for Prevention Teaching and Research

2011 Walter Stamm Mentor Award, Infectious Diseases Society of America

2012 Abraham Lilienfeld Award, American College of Epidemiology

2014 Laureate Award, Tennessee Chapter, American College of Physicians

2015 John Snow Award, Epidemiology Section, American Public Health Association

Federal Government Advisory Committee (selected)

1982-1986 Member, Advisory Committee on Immunization Practices, CDC

1986-Present Liaison representative, Advisory Committee on Immunization Practices

This committee establishes national immunization policy for both children and adults.

C. CONTRIBUTIONS TO SCIENCE

1. Immunization and Vaccine-Preventable Diseases

Several publications have had a specific influence on formulating national immunization policy. Among 

them are:

(a) The first demonstration that vaccine could eliminate measles from a large geographic area and that 

intensified surveillance could track the disease reliably. This paper gave proof of principle to the 

national goal of measles elimination.

(b) Research which persuaded the Advisory Committee on Immunization Practices (ACIP) to include 

asthma as an indication for pneumococcal vaccine.

(c) Demonstration that even the comprehensive deployment of vaccine could not contain an urban 

outbreak of hepatitis A, convincing the ACIP to change its recommendation and to make a new 

universal childhood recommendation.

a. Schaffner W, Schluederberg AE, Byrne EB. The clinical epidemiology of sporadic measles in a 

highly immunized population. New Engl J Med 1968;279:783-788.

b. Talbot TR, Hartert TV, Mitchel E, Halasa NB, Arbogast PG, Poehling KA, Schaffner W, Craig AS, 

Griffin MR. Asthma as a risk factor for invasive pneumococcal disease. N Engl J Med 

2005;353:2082-2090.

c. Craig AS, Sockwell DC, Schaffner W, Moore WL, Skinner JT, Williams IT, Shaw FE, Shapiro CN, 

Bell BP. Use of hepatitis A vaccine to control a community-wide outbreak of hepatitis A. Clin Infect 

Dis 1998;27:531-535.

2. Hospital-Associated Infections

(a) This investigation was an early demonstration that hospitals are not islands unto themselves and 

that healthcare-associated infections can originate in one institution and have transmissible
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 68

ramifications throughout an entire community’s medical care system. This, along with other studies, 

has led to the current regional approach to curtail antibiotic resistance.

(b) This was the first documentation that legionellosis could be spread from an air conditioning cooling 

towers. The results stimulated new recommendations specifying the need for regular cooling tower 

disinfection in order to prevent disease.

(c) Alert investigation of unusual infections in one hospital revealed a manufacturing problem in 

bronchoscopes that was brought to the attention of the FDA. A world-wide recall was undertaken, 

preventing perhaps hundreds of life-threatening infections.

a. Schaberg DR, Alford RH, Anderson R, Farmer JJ, Melly MA, Schaffner W. An outbreak of 

nosocomial infection due to multiply resistant Serratia marcescens: evidence of interhospital 

spread. J Infect Dis 1976;134:181-188.

b. Dondero TJ, Rendtorff RC, Mallison GF, Weeks RM, Levy J, Wong EW, Schaffner W. An 

outbreak of legionnaires’ disease associated with a contaminated air conditioning cooling tower. 

New Engl J Med 1980;302:365-370.

c. Kirschke DL, Jones, TF, Craig AS, Chu PS, Mayernick GG, Patel JA, Schaffner W. Pseudomonas 

aeruginosa and Serratia marcescens contamination associated with a manufacturing defect in 

bronchoscopes. N Engl J Med 2003;348:214-220.

3. Pharmacoepidemiology

(a) and (b) The results of these two studies prompted the FDA to remove liquid formulations of 

tetracycline from the market.

(c) and (d) Both of these papers were important in defining these drug-related hazards, now wellknown and accepted.

a. Ray WA, Federspiel CF, Schaffner W. The malprescribing of liquid tetracycline. Am J Pub Health 

1977;67:762-763.

b. Ray WA, Federspiel CF, Schaffner W. Prescribing of tetracycline to children less than 8 years old. 

A two-year old epidemiologic study among ambulatory Tennessee Medicaid recipients. JAMA 

1977;237:2069-2074.

c. Ray WA, Griffin MR, Schaffner W, Baugh DK, Melton LJ. Psychotropic drug use and the risk of 

hip fracture. New Engl J Med 1987;316:363-369.

d. Griffin MR, Ray WA, Schaffner W. Nonsteroidal anti-inflammatory drug use and death from peptic 

ulcer disease in elderly persons. Ann Int Med 1988;109:359-363.

(a) Public Health Investigation

The following are indicative of the broad variety of investigations that I have pursued in collaboration 

with public health colleagues.

(a) This investigation showed that the risk of ehrlichiosis increased in proportion to the golfer’s 

handicap (risk of hitting into the rough and encountering ticks). It is both elegant and fun – so is 

being used in schools of public health as a teaching exercise

(b) This was the first explicit documentation of the large role that child restraint devices (child car 

seats) have in preventing child injuries and death in motor vehicle crashes. Tennessee was the first 

state to require the use of such child restraints and this paper provided the stimulus for the passage 

of similar laws in the other 49 states.

(c) The first “look-back” investigation of a surgeon with AIDS. Performed during a socially-charged era, 

the investigation was led by Dr. Schaffner and conducted calmly. It provided the first direct
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 69

evidence that HIV-infected surgeons posed a low risk to their patients and had a direct influence on 

national recommendations by the CDC and the American College of Surgeons.

a. Standaert SM, Dawson JE, Schaffner W, Childs JE, Biggie KL, Singleton J, Gerhardt RR, Knight 

ML, Hutcheson RH. Ehrlichiosis in a golf-oriented retirement community. N ENgl J Med 

1995;333:420-425.

b. Decker MD, Dewey MJ, Hutcheson RH, Schaffner W. The use and efficacy of child restraint 

devices: the Tennessee experience, 1982 and 1983. JAMA 1984;252:2571-2575.

c. Mishu B, Schaffner W, Horan JM, Wood LH, Hutcheson RH, McNabb PC. A surgeon with AIDS: 

lack of evidence of transmission to patients. JAMA 1990;264:467-470.

D. RESEARCH SUPPORT

Ongoing Research Support

1U50CK000198-01 (Schaffner) 1/1/12-12/31/16

Agency: Centers for Disease Control and Prevention 

Title: Emerging Infections Program

Description: Emerging Infections Program is an umbrella collaboration of the CDC with 10 state health

departments and their academic partners. I am the PI of the Vanderbilt site. The goal of EIP is to 

conduct a broad portfolio of work of applied research to detect, prevent and control an array of 

emerging infectious diseases. The data are used directly by CDC to create public policy initiatives.

Completed Research Support

5R01CA092447-12 (Blot) 7/26/13-6/30/14

Agency: National Cancer Institute

Title: Southern Community Cohort Study

Description: The purpose of the SCCS is (1) to continue passive follow-up of the cohort via linkages 

with various national and state registries to identify deaths, incident cancers and other health 

outcomes, (2) to continue active follow-up of the cohort via re-contact with participants to directly 

update exposure and health information, and (3) to conduct multiple new cohort and nested casecontrol analyses utilizing the baseline and follow-up data and stored DNA and blood specimens for 

evaluation of lifestyle, genetic and other risk factors affecting the incidence of and disparities in the 

major cancers (lung, breast, prostate, and colon/rectum).

U50CCU41623-08 (Schaffner) 1/1/05-12/31/09

Agency: Centers for Disease Control and Prevention 

Title: Emerging Infections Program

Role: Co-Principal Investigator

1U011P000095-01 (Talbot) 9/30/07-9/29/08

Agency: Centers for Disease Control and Prevention

Title: The Impact of Pertussis Vaccination of Healthcare Workers 

Role: Investigator
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 70

BIOGRAPHICAL SKETCH

NAME: Fonnesbeck, Christopher J, PhD

eRA COMMONS USER NAME:

POSITION TITLE: Assistant Professor of Biostatistics 

EDUCATION/TRAINING

Completion INSTITUTION AND LOCATION DEGREE FIELD OF STUDY Date

University of British Columbia, Vancouver, BC BS 08/1996 Biology

University of British Columbia, Vancouver, BC MS 05/1998 Zoology

University of Georgia, Athens, GA MS 05/2002 Statistics

University of Georgia, Athens, GA PhD 07/2003 Quantitative Ecology

University of Georgia, Athens, GA Postdoc 10/2005 Quantitative Ecology

A. Personal Statement

I am an active collaborator at Vanderbilt University, providing quantitative expertise to the Evidence-based 

Practice Center (Vanderbilt Institute for Medicine and Public Health), the Department of Pediatrics/Division of 

Infectious Diseases, and the Department of Orthopedic Surgery and Rehabilitation, as well as leading research 

on my own grant studying the optimal control of disease outbreaks, collaborating with Penn State University 

and the University of Warwick. I am particularly interested in the use of spatial statistics and Bayesian 

hierarchical/multilevel modeling strategies for inference and prediction in epidemiology. Moreover, as a 

biostatistical software developer, I am able to provide efficient software implementations of state-of-the-art 

statistical methods, as required by the diverse needs of biomedical data analysis. Notably, I am the creator and 

co-developer of PyMC, a popular software package for Bayesian statistical analysis. I will provide mentorship 

to Dr. Peter Rebeiro as part of his K01 mechanism, discussing with and instructing him on topics in spatial 

analysis such as geostatistics, spatial cluster detection, spatial generalized linear models, and methods for 

mapping and spatial data manipulation, through an Independent Study course offered in the Vanderbilt 

Biostatistics Department. I will also consult on study design and data analysis addressing his scientific Aims, 

which seek to evaluate health policy and quality questions of serious import to improving outcomes in the HIV 

Care Continuum and informing future public health action.

B. Positions and Honors

Positions and Employment

2005-2008 Adjunct Assistant Professor, University of Georgia, Athens, GA

2005-2008 Associate Research Scientist, Florida Marine Research Institute, St. Petersburg, FL

2008-2010 Lecturer (Assistant Professor), Department of Mathematics and Statistics, University of Otago, 

Dunedin, New Zealand

2010-2012 Instructor in Biostatistics, Vanderbilt University School of Medicine, Nashville, TN

2012-Pres. Assistant Professor in Biostatistics, Vanderbilt University School of Medicine, Nashville, TN

Other Experience and Professional Memberships

2014-Pres. Associate Editor, Journal of Statistical Software

2009-2012 Associate Editor, Journal of Statistical Computation and Simulation 

2012-Pres. Member, International Society for Bayesian Analysis

2008-Pres. Member, American Statistical Association 

2008-Pres. Member, International Biometric Society

C. Contribution to Science

1. I employ Bayesian hierarchical modeling, including its integration in analyses with spatial components, as 

the primary tool for inference and prediction in my research. This is a powerful and flexible approach formodel- 
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 71

based inference in a variety of settings, from clinical trials to large observational epidemiological datasets. 

Bayesian methods typically require computationally-intensive algorithms to yield results. I implement cuttingedge statistical methods in software so that they may be used by a wider, non-technical audience in biomedical 

research. This work is critical given the advent of very large electronic databases and modern data collection 

procedures that collect gigantic quantities of data. My software is used by data scientists and statisticians in a 

wide variety of scientific fields.

a. Martin J, Edwards HH, Bled F, Fonnesbeck CJ, Dupuis JA, Gardner B, Koslovsky SM, Aven AM, 

Ward-Geiger LI, Carmichael RH, Fagan DE, Ross MA, Reinert TR. Estimating upper bounds for 

occupancy and number of manatees in areas potentially affected by oil from the Deepwater Horizon 

oil spill. PLoS One. 2014 Mar 26;9(3):e91683. [PMID: 24670971] [PMCID: PMC3966779]

b. Conroy MJ, Runge JP, Barker RJ, Schofield MR, Fonnesbeck CJ. Efficient estimation of 

abundance for patchily distributed populations via two-phase, adaptive sampling. Ecology. 2008 

Dec;89(12):3362-70. [PubMed PMID: 19137943]

c. Salvatier J, Wiecki TV, and Fonnesbeck C. Probabilistic programming in Python using PyMC3.

PeerJ Computer Science, 2016 Apr; 2:e55

d. Patil A, Huard D and Fonnesbeck CJ. PyMC 2.0: Bayesian Stochastic Modeling in Python. Journal 

of Statistical Software, Journal of Statistical Software, 2010; 35(4), 1-81. [PMID: 21603108] 

[PMCID: PMC3097064]

e. Fonnesbeck CJ, McPheeters ML, Krishnaswami S, Lindegren ML and Reimschisel T. 2012. 

Estimating the probability of IQ impairment from blood phenylalanine for phenylketonuria patients: A 

hierarchical meta-analysis. Journal of Inherited Metabolic Disease, 2013 Sep; 36(5): 757-766. 

[PMID: 23197105]

2. Going back to my own PhD research, my primary research focus is on structured decision analysis, which I 

currently apply to infectious disease research, specifically related to the optimal control of disease outbreaks 

through the evaluation of alternative policies/decisions over space and time. More generally, I am interested in 

the application of adaptive management for optimal control, whereby decisions are made with the best 

available information in the face of uncertainty, and this uncertainty is reduced over time via information 

derived from monitoring the outcomes of past decisions, with the aim of improved decision-making. This work 

can be applied widely in epidemiology wherever sequential decisions are made with the aim of satisfying some 

explicit objective. My contribution to this work is in the application of stochastic dynamic optimization models to 

derive optimal policies for making decisions.

a. Shea K, Tildesley M, Runge M, Fonnesbeck C, and Ferrari M. Adaptive Management andthe 

Value of Information: Learning via Intervention in Epidemiology. PLoS Biology 2014; 12(10): 

e1001970.

b. Probert WJM, Shea K, Fonnesbeck CJ, Runge MC, Carpenter TE, Du ̈rr S, Garner MG, Harvey N, 

Stevenson MA, Webb CT, Werkman M, Tildesley MJ, Ferrari MJ. Decision-making for foot-andmouth disease control: objectives matter. Epidemics. 2015; 15: 10-19.

c. Fonnesbeck CJ. 2005. Solving Dynamic Wildlife Resource Optimization Problems using 

Reinforcement Learning. Natural Resource Modeling, 18(1), 1-40.

3. I am a co-investigator for Vanderbilt University’s Evidence-based Practice Center (EPC), one of 14 centers 

contracted by the Agency for Healthcare Research and Quality (AHRQ) to review all relevant scientific 

literature on a variety of clinical and health services topics to produce evidence reports based on this 

synthesis. My role is to conduct quantitative meta-analyses to support the conclusions of the review. At 

Vanderbilt’s EPC, we employ sophisticated meta-analytic methods that allow complex medical interventions 

and multivariate outcomes to be modeled efficiently so that the current evidence and the associated residual 

uncertainty are adequately quantified. To date, my work has focused on the evaluation of pediatric and 

obstetric treatments.

a. Chinnadurai S, Fonnesbeck C, Snyder K, Sathe N, Morad A, Likis F, McPheeters M. 

Pharmacologic Interventions for Infantile Hemangioma: A Meta-Analysis. Pediatrics, 2016; 

137(2):1-10. [PMID: 26772662]

b. Epstein, RA, Fonnesbeck CJ, Potter S, Rizzone KH and McPheeters M. 2015. 

Psychosocial Interventions for Child Disruptive Behaviors: A Meta-Analysis. Pediatrics. 

doi:10.1542/peds.2015-2577
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 72

c. Likis FE, Velez-Edwards DR, Andrews JC, Woodworth AL, Jerome RN, Fonnesbeck CJ, McKoy 

JN, Hartmann KE. Progestogens for Preterm Birth Prevention: A Systematic Review and MetaAnalysis by Indication. Obstetrics and Gynecology, 2012; 120(4), 1-11. [PMID: 22955308]

d. Krishnaswami S, Fonnesbeck CJ, Penson D and McPheeters M. Magnetic Resonance Imaging 

for Locating Non-palpable Undescended Testicles: A Meta-Analysis. Pediatrics 2013; 

131(6):e1908-16. [PMID: 23690512] [PMCID: PMC4074662]

Complete List of Published Work in MyBibliography: http://bit.ly/fonnesbeck_ncbi_bibliography

D. Research Support

5 UL1 TR000445-09 (Bernard)

06/27/2012 – 05/31/2017

NIH/NCATS - “The Vanderbilt Institute for Clinical and Translational Research (VICTR)”

The specific aims of our renewal proposal are to: 1) Systematically remove impediments to research 

translation; 2) Create and make available novel, research-enabling infrastructure and resources; 3) Train the 

next generation of investigators; 4) Engage and involve the local community; and 5) Define and continuously 

measure success in meeting objectives.

R01 GM105247 (Fonnesbeck) 07/01/2012 – 06/30/2016

“Linking models and policy: Using active adaptive management for optimal control of disease outbreaks”

This work develops novel methods and training to combine decision theory and dynamic epidemic modeling to 

facilitate real-time implementation, evaluation, and adaptation of public health interventions.

Role: Site Principal Investigator

HHSA 290-2015-00003-I (McPheeters) 11/12/2014 – 11/11/2019

AHRQ Agency for Healthcare Research and Quality Evidence-based Practice Centers V The Evidence-based 

Practice Centers develop evidence reports and technology assessments on topics relevant to the clinical, 

social science/behavioral, economic, and health care organization and delivery arenas. Role: Co-investigator

Completed Research Support

HHSA 290-2007-10065-I (McPheeters) 11/01/2012 – 09/30/2013

Agency for Healthcare Research and Quality Evidence Based Practice Centers III (TO6)

Systematically reviews scientific literature on clinical, social, science/behavioral, and organization and 

financing topics to produce evidence reports and technology assessments. Role on the project:Co-Investigator

 

HHSA 290-2007-10065-I (Hartman) 01/01/2012 – 12/31/2012

“Agency for Healthcare Research and Quality Evidence Based Practice Centers III (TO5)”
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 73

Systematically reviews scientific literature on clinical, social, science/behavioral, and organization and 

financing topics to produce evidence reports and technology assessments 

Role on the project: Biostatistican

 

 
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 74

BIOGRAPHICAL SKETCH

Provide the following information for the Senior/key personnel and other significant contributors.

Follow this format for each person. DO NOT EXCEED FIVE PAGES.

NAME: Shepherd, Bryan Earl

eRA COMMONS USER NAME (credential, e.g., agency login):

POSITION TITLE: Associate Professor of Biostatistics

EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, 

include postdoctoral training and residency training if applicable. Add/delete rows as necessary.)

DEGREE Completion 

(if Date FIELD OF STUDY INSTITUTION AND LOCATION applicable) MM/YYYY

Brigham Young University, Provo, UT B.S. 08/1999 Statistics

University of Washington, Seattle, WA M.S. 12/2001 Biostatistics

University of Washington, Seattle, WA Ph.D. 08/2005 Biostatistics

A. Personal Statement

My primary research interests can be broadly summarized as developing and applying novel statistical 

methods to medical studies, with an emphasis on studies of HIV/AIDS. For the past 10 years, I have been the 

lead statistician for the Caribbean, Central and South American network (CCASAnet) of the International 

epidemiologic Databases to Evaluate AIDS (IeDEA). I am currently the Director of the Biostatistics and 

Biomedical Informatics Core of the Tennessee Center for AIDS Research (TN-CFAR); I served as the head 

statistician for the former Vanderbilt-Meharry CFAR from 2006-2013. I have also supervised biostatistical 

support for the Vanderbilt Institute for Global Health (VIGH) since 2006. In these contexts I have collaborated 

with many researchers on a wide variety of HIV/AIDS research topics, resulting in over 130 peer-reviewed 

publications, some of which are listed below. My statistical methods research has been motivated by problems 

I have encountered in my collaborative work, with a particular emphasis on causal inference and methods for 

epidemiological data. As a graduate student at the University of Washington, I developed causal inference 

methods important to HIV vaccine trials. Upon coming to Vanderbilt, I have continued to develop and apply 

causal inference methods, and have branched into other areas including approaches for analyzing ordered 

categorical data, and measurement error methods pertinent to this proposal. My statistical methods research 

has led to external funding: I was co-investigator and principal investigator (PI) of the Vanderbilt sub-contract of 

an R01 to investigate causal inference methods in partially randomized trials. I currently serve as PI of an R01 

developing statistical methods applicable to HIV/AIDS that leverage the order information in ordered 

categorical variables to increase statistical power.

With regards to the current proposal, I am interested in the application of causal inference methods to 

many problems in HIV epidemiology, and I will be happy to mentor Dr. Rebeiro as he applies his considerable 

skill in service of addressing urgent and important questions related to the implementation of Medicaid 

expansion under the ACA and its impact on HIV Continuum of Care outcomes. He has worked with me on 

several epidemiologic analyses since 2005 (we have co-authored 17 publications), and we have an excellent 

working relationship. We have collaborated extensively with the Epi/Outcomes group of the TN Center for 

AIDS Research (CFAR) at Vanderbilt (Dr. Rebeiro is a member of the TN-CFAR core that I direct), the NAACCORD, and CCASAnet. I have also mentored 3 other successful K-awardees regarding causal inference 

methods and biostatistics. My prior successful methods development and mentorship, and his expertise and 

prior successful collaborations, demonstrate the feasibility and likely success of his proposed research. Three 

publications most relevant for this proposal are (candidate’s name underlined):

1. Shepherd BE, Rebeiro PF; Caribbean, Central, South America network for HIV epidemiology 

(CCASAnet). Assessing and interpreting the association between continuous covariates andoutcomes
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 75

in observational studies of HIV using splines. J Acquir Immune Defic Syndr. 2016 Oct 27. PMID: 

27798430. [PMCID pending]

2. Rebeiro PF, Cesar C, Shepherd BE, De Boni RB, Cortés CP, Rodriguez F, Belaunzarán-Zamudio P, 

Pape JW, Padgett D, Hoces D, McGowan CC, Cahn P. Assessing the HIV Care Continuum in Latin 

America: progress in clinical retention, cART use and viral suppression. J Int AIDS Soc. 2016 Apr 

8;19(1):20636. PMCID: PMC4827101.

3. Shepherd BE, Jenkins CA, Rebeiro PF, Stinnette SE, Bebawy SS, McGowan CC, Hulgan T, Sterling 

TR. Estimating the optimal CD4 count for HIV-infected persons to start antiretroviral therapy. 

Epidemiology. 2010 Sep;21(5):698-705. PMCID: PMC3086582.

B. Positions and Honors

Positions and Employment

1998-1998 SAS Programmer, McBride Biostatistical Research, Morristown, NJ.

2000-2000 Research Assistant, Kenya Medical Research Institute and Univ. of Washington, Nairobi, Kenya. 

2000-2001 Teaching Assistant, Department of Biostatistics, University of Washington.

2001-2005 Research Assistant, Department of Biostatistics, University ofWashington.

2005–2011 Assistant Professor, Department of Biostatistics, School of Medicine, Vanderbilt University 

2011–pres. Associate Professor, Department of Biostatistics, School of Medicine, Vanderbilt University

Honors

1993 Trustees Scholarship, full tuition for four years, Brigham Young University (BYU) 

1998 Edwin Hinckley Scholarship, BYU

1998 Undergraduate Research Award, Office of Research and Creative Activities, BYU 

1999-2000 Graduate Merit Award, Department of Biostatistics, University of Washington 

2000-2005 NIH Cardiovascular Training Grant, University of Washington

2005 Senior Student Award, Department of Biostatistics, University of Washington

2016 Shayle Searle Fellow, School of Mathematics and Statistics, Victoria University of Wellington

C. Contribution to Science

1. Causal inference methods and applications. My early methods research was focused on developing 

statistical methods to compare clinical trial outcomes that only existed in subsets chosen after randomization. 

These methods were particularly motivated by HIV vaccine trials, where many outcomes (e.g., set point viral 

load, time from infection diagnosis to AIDS) only exist in participants who become infected; but they have also 

been applied to other settings (e.g., truncation by death and cancer studies). My work in this area focused on 

sensitivity analyses within the principal stratification framework – explicitly specifying assumptions to identify 

causal estimands and then relaxing assumptions through the use of sensitivity parameters elicited by subjectmatter experts. More recently, my causal inference research has dealt with time-varying confounding, 

particularly applications of marginal structural models and dynamic marginal structural models motivated by 

questions regarding optimal timing of antiretroviral therapy.

a. Shepherd BE, Gilbert PB, Jemiai Y, Rotnitzky A. Sensitivity analyses comparing outcomes only 

existing in a subset selected post-randomization, conditional on covariates, with application to HIV 

vaccine trials. Biometrics 2006; 62:332-342. PMID: 16918897.

b. Shepherd BE, Gilbert PB, Lumley T. Sensitivity analyses comparing time-to-event outcomes only 

existing in a subset selected post-randomization. Journal of the American Statistical Association 2007; 

102: 573-582. PMCID: PMC2613336.

c. Shepherd BE, Jenkins CA, Rebeiro PF, Stinnette SE, Bebawy SS, McGowan CC, Hulgan T, Sterling 

TR. Estimating the optimal CD4 count for HIV-infected patients to start antiretroviral therapy. 

Epidemiology 2010; 21: 698-705. PMCID: PMC3086582.

d. Shepherd BE, Liu Q, Mercaldo N, Jenkins CA, Lau B, Cole SR, Saag MS, Sterling TR. Comparing 

results from multiple imputation and dynamic marginal structural models for estimating when to start 

antiretroviral therapy. Statistics in Medicine 2016; 35: 4335-4351. PMID:27264354; PMCID: 

PMC5048599 [Available 10/30/2017].

2. Methods for ordinal data analysis. Motivated by a simple question we encountered in our collaborative 

research, my colleague, Chun Li and I developed a new statistical method to test for association between two
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 76

ordered categorical variables while adjusting for covariates. In the process, we developed a new residual for 

ordinal outcomes, which we have since discovered to be useful for many other outcome types. This work has 

opened up new directions for the analysis of ordinal data based on fewer assumptions than traditional 

approaches and is currently funded by an R01 from the National Institutes of Health.

a. Li C, Shepherd BE. Test of association between two ordinal variables while adjusting for covariates.

Journal of the American Statistical Association 2010; 105: 612-620. PMCID: PMC2946253

b. Li C, Shepherd BE. A new residual for ordinal outcomes. Biometrika 2012; 99: 473-480. PMCID:

PMC3635659

d. Dupont C, Horner J, Li C, Liu Q, Shepherd BE (2016) “PResiduals: probability-scale residuals and 

residual correlation” R package. URL: https://cran.r-project.org/web/packages/PResiduals/index.html

3. Collaborative HIV scientist. I have been involved in many team science studies of HIV/AIDS. In the 

majority of these studies I have been the head statistician, either performing the analyses myself or supervising 

the work of others. I have also taken the lead on several of these papers, serving as first or senior author. I 

take pride in our use of modern statistical methods (e.g., splines for continuous variables, multiple imputation 

for missing data, and appropriate applications of marginal structural models), the clarity and interpretability of 

our analyses, and our emphasis on reproducible research (e.g., analysis code is posted

at http://biostat.mc.vanderbilt.edu/ArchivedAnalyses). These studies, individually and collectively, have been 

important contributions to our understanding of HIV/AIDS and its management.

a. Tuboi SH, Schechter M, McGowan CC, Cesar C, Krolewiecki A, Cahn P, Wolff M, Pape JW, Padgett D, 

Madero JS, Gotuzzo E, Masys DR, Shepherd BE. Mortality during the first year of potent antiretroviral 

therapy in HIV-1-infected patients in 7 sites throughout Latin America and the Caribbean. Journal of 

Acquired Immune Deficiency Syndromes 2009; 51: 615-623. PMCID: PMC2780368.

b. Koethe JR, Jenkins CA, Shepherd BE, Stinnette SE, Sterling TR. An optimal body mass index range 

associated with improved immune reconstitution among HIV-infected adults initiating antiretroviral 

therapy. Clinical Infectious Diseases 2011; 53: 952-960. PMCID: PMC3189168.

c. Shepherd BE, Jenkins CA, Parrish DD, Glass TR, Cescon A, Masabeu A, Chene G, de Wolf F, Crane 

HM, Jarrin I, Gill J, del Amo J, Abgrall S, Khaykin P, Lehmann C, Ingle SM, May MT, Sterne JAC, 

Sterling TR; the Antiretroviral Therapy Cohort Collaboration. Higher rates of AIDS during the first year 

of antiretroviral therapy among migrants: the importance of tuberculosis. AIDS 2013; 27: 1321-1329. 

PMCID: PMC3992322.

d. Boulle A, Schomaker M, May MT, Shepherd BE, Monge S, Keiser O, Lampe F, Giddy J, Ndirangu J, 

Garone D, Fox M, Ingle SM, Reiss P, Dabis F, Costagliola D, Castagna A, Ehren K, Campbell C, Gill 

MJ, Saag M, Justice AC, Guest J, Crane HM, Egger M, Sterne JAC. Mortality in patients with HIV-1 

infection starting antiretroviral therapy in South Africa, Europe or North America: a collaborative 

analysis of prospective studies. PLoS Medicine 2014; 11: e1001718. PMCID: PMC4159124.

4. Other statistical/epidemiological research motivated by multi-cohort observational HIV studies. 

Given my involvement in many multi-cohort observational studies, I often encounter challenges or statistical 

problems that I feel deserve further study. Many are stand-alone studies – they have resulted in what I believe 

are interesting publications, but have not led to an extensive research agenda. The first two manuscripts listed 

below were motivated by a project building a predictive model for the VCCC. I asked (a) Does ignoring model 

fitting uncertainty caused by checking the proportional hazards assumption impact the validity of confidence 

intervals and p-values? (Answer: yes.) and (b) Why was our model poor at predicting when applied to a 

separate cohort? (Answer: substantial between-cohort heterogeneity). With the third paper listed below, we 

wondered what impact the various different definitions of loss to follow-up (LTFU) could have on study 

estimates. They had a huge impact: we applied 17 different definitions in the literature to data from the same 

cohort and found 2-year estimates of LTFU varying from 22% to 84%! The fourth paper listed was an 

investigation/tutorial into the many different ways one can account for between-cohort heterogeneity in Cox 

regression models, and their impact on results. Each of these studies increased our understanding and 

provided guidance for analyses of multi-cohort observational studies.

a. Shepherd BE. The cost of checking proportional hazards. Statistics in Medicine 2008; 27: 1248-1260.
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 77

b. Shepherd BE, Sterling TR, Moore RD, Raffanti SP, Hulgan T. Cross-cohort heterogeneity encountered 

while validating a model for HIV disease progression among antiretroviral initiators. Journal of Clinical 

Epidemiology 2009; 62: 729-737.

c. Shepherd BE, Blevins M, Vaz LME, Moon TD, Kipp AM, Jose E, Ferreira FG, Vermund SH. Impact of 

definitions of loss to follow-up on estimates of retention, disease progression, and mortality: Application 

to an HIV program in Mozambique. American Journal of Epidemiology 2013; 178: 819-828. PMCID: 

PMC3755641.

d. Giganti MJ, Luz PM, Caro-Vega Y, Cesar C, Padgett D, Koenig S, Echevarria J, McGowan CC, 

Shepherd BE. A comparison of seven Cox regression-based models to account for heterogeneity 

across multiple HIV treatment cohorts in Latin America and the Caribbean. AIDS Research and Human 

Retroviruses 2015; 31: 496-503.

Complete List of Published Work in

MyBibliography: http://www.ncbi.nlm.nih.gov/myncbi/browse/collection/45654384/?sort=date&direction=asce

nding

D. Research Support

Ongoing Research Support

6R01 AI093234-06 (Shepherd) 05/18/2011 - 04/30/2017

Statistical Methods for Ordinal Variables in HIV/AIDS Studies

The major goal of this project is to develop statistical methods that account for the ordered nature of ordinal 

variables without making linearity assumptions and then applying these methods to HIV studies.

2U01 AI069923-12 (McGowan) 07/25/2011 - 06/30/2021

Caribbean, Central and South America Network for HIV epidemiology (CCASAnet)

The major goals of this project are to create a shared database of HIV epidemiology data from six countries in 

the Caribbean, Central, and South America perform analyses of data to answer questions that cannot be 

answered by any single site, and develop novel analytical, informatic, and biostatistical methods for such 

pooled data.

5K08AI106420-04 (Van der Heijden) 08/01/2014 – 07/31/2019

Fluoroquinolone Resistance in Patients with Multidrug-Resistant Tuberculosis

Drug-resistant tuberculosis and HIV are devastating public health problems in South Africa. Fluoroquinolone 

antibiotics are critical for the treatment of tuberculosis that is resistant to the most important first-line drugs, but 

resistance to fluoroquinolones threatens their usefulness. The current study will examine the scope and impact 

of the problem of fluoroquinolone-resistant tuberculosis in a setting with high rates of HIV and provide new 

information that will help protect this vital class of medications for the treatment of tuberculosis.

6P30AI110527-02 (Mallal) 04/01/2015 - 03/31/2020

Tennessee Center for AIDS Research (TN-CFAR)

Reducing the overall burden of HIV/AIDS in Tennessee: By forging unique three-way partnership between VU, 

MMC, and TDH, the Tennessee CFAR (TN-CFAR) is building a research infrastructure toward having impact 

on the overall burden of HIV diseases in our state.

6R24AI124872-02 (Duda) 04/06/2016-03/31/2021

Harmonist: A Scalable Toolkit for Standardizing and Coordinating Data Sharing Across International Research 

Networks

The goal of the Harmonist project is to develop the “Harmonist toolkit,” a software and standards package that 

will enable HIV observational research networks to coordinate large-scale research projects and apply data 

management best practices more effectively and efficiently.

Completed Research Support (past 3 years)

5U01AI069918-08 (Moore) 1/01/2013 – 07/31/2015

National Institute of Allergy and Infectious Diseases – 

North American AIDS Cohorts Collaboration on Research & Design (NA-ACCORD)
Contact PD/PI: Rebeiro, Peter F

Biosketches Page 78

Supplement (Vanderbilt PI: Sterling)

This supplement supports a pair of analyses evaluating the effect of being overweight or obese on CD4+ T-cell 

recovery on antiretroviral therapy, and the role of angiotensin converting enzyme-inhibitors and angiotensin 

receptor blockers in the prevention of mortality and the development of card inflammation-related non-AIDS 

defining events among participants in the North American AIDS Cohort Collaboration on Research and Design 

(NA-ACCORD), one of the regional cohort groups supported by the International Epidemiologic Databases to 

Evaluate AIDS consortium (IeDEA) of the NIH.

5R01AI094562-04 (Vermund) 03/15/2011-03/31/2015

Multi-component HIV Intervention Packages for Chinese MSM

The major goal of this project is to develop and pilot test a multi-component prevention intervention package of 

Test and Link-to-Care strategy to reduce HIV transmission.

Role: Co-Investigator

3P30 AI054999-08S1 (Kalams) 09/01/2006-08/31/2014

Vanderbilt Meharry Center for AIDS Research

This application proposed a Developmental Center for AIDS Research at Vanderbilt and Meharry, including an 

administrative core, developmental core, clinical discovery core, molecular virology core, and an immunology 

core to build infrastructure and collaborations that will enhance HIV/AIDS research at both institutions.

Role: Co-Investigator

1R34AI091446-01A1 (Vermund) 08/01/2011-07/31/2014

Expanded Testing, Linkage, and Treatment for Aids Prevention Among MSM in China

Our goal in this one-year clinical trial planning (R34) grant is to prepare for a community-level randomized 

clinical trial (RCT) to test the efficacy of our multicomponent TLC intervention package to reduce HIV incidence 

among MSM in China.

R01HD075075-02 (Aliyu) 09/28/2012-06/30/2014

Optimizing integrated PMTCT services in rural North-Central Nigeria

The goal of this study is to implement and evaluate the impact of a familyfocused integrated PMTCT package 

comprising task shifting, point-of-care CD4 testing, and a prominent role for influential family members 

(particularly male partners) in rural primary health centers in Nigeria.

5R01DA26207-02 (Markham, PI) 09/01/2008-05/31/2013

Johns Hopkins University/NIDA/NIH

Effect of Cocaine & AN LTR Polymorphism-ON Campus

The major goal of this study was to evaluate whether the presence of certain variants of HIV-1 which carry 

genetic alterations might enable them to replicate more rapidly in cells exposed to cocaine therefore altering 

various parameters of disease progression in cocaine users.

Role on the Project: Co-Investigator
Contact PD/PI: Rebeiro, Peter F

Current and Pending Support Page 79

OTHER SUPPORT

STERLING, TIMOTHY

Active Support

R56AI118361-01A1 (Sterling) 08/03/16 – 6/30/2017 2.4 CM 

NIH/NIAID $566,475

Fluoroquinolones and Efflux Mediated Cross Resistance in HIV-related TB

This work will identify and characterize the efflux pumps involved in fluoroquinolone resistance in M. 

tuberculosis. It will also characterize the genes that may modify efflux pumps, including transcription factors 

and phosphate transporters. This work will determine whether HIV infection enables the acquisition of efflux 

pump-mediated fluoroquinolone resistance, and determine the role of efflux pumps in fluoroquinolone-resistant

M. tuberculosis in reducing susceptibility to other anti-tuberculosis drugs.

1 R01 AI20790-01A1 (Sterling/Rolla) 08/12/2016 – 06/30/2021 1.8 CM 

NIH/NIAID $522,654

Predictors of Treatment Toxicity, Failure, and Relapse in HIV-related Tuberculosis

The over-arching goal of this project is to optimize the treatment of HIV-related tuberculosis in a large, 

genetically diverse cohort in Brazil. These results will lay the groundwork for drug dosing and regimens that 

improve outcomes and treatment effectiveness of HIV-related tuberculosis.

2U01AI069923-12 (McGowan) 07/01/2016-06/30/2017 1.8 CM 

NIAID $700,874

CCASAnet Supplement—RePORT-Brazil Role: Project PI

The Regional Prospective Observational Research on Tuberculosis (RePORT)-Brazil TB Cohort will harmonize 

the clinical data and clinical specimens obtained from pulmonary TB cases and their close contacts in three 

different regions of Brazil: Southeast (Rio de Janeiro), Northeast (Salvador) and North (Manaus), to 

encompass different types of TB epidemiology in Brazil. The RePORT-Brazil cohort will lay the groundwork for 

subsequent studies of TB pathogenesis, including risk factors for progression from latent M. tuberculosis 

infection to active TB disease, and risk factors for TB.

1R21AI127129-01 (Kalams) 08/01/2016 - 07/31/2018 0.60 CM 

NIH/NIAID $150,000

Molecular analysis of the adaptive immune response to tuberculosis

The purpose of this R21 is to apply cutting edge molecular immunology techniques to determine the features of 

the adaptive immune response likely to protect against active tuberculosis infection.

CDC 10FED1007388 (Sterling) 10/01/2009- 9/30/2019 2.4 CM

Centers for Disease Control and Prevention $459,857 

TB Trials Consortium-Vanderbilt/Peru

This consortium conducts studies of tuberculosis treatment and prevention.

CDC RFS 200-2011-41276 (Stout, Duke, PI) 09/01/2011-09/29/2021 0.12 CM

Centers for Disease Control and Prevention $150,501 

TB Epidemiologic Studies Consortium-TN

This consortium conducts studies of the diagnosis and treatment of latent M. tuberculosis infection.

1P30AI110527-01A1 (Mallal) 04/01/15 - 03/31/2020 1.20 CM 

NIH/NIAID $1,049,280
Contact PD/PI: Rebeiro, Peter F

Current and Pending Support Page 80

Tennessee Center for AIDS Research (TN-CFAR)

Reducing the overall burden of HIV/AIDS in Tennessee: By forging ̀unique three-way partnership between VU, 

MMC, and TDH, the Tennessee CFAR (TN-CFAR) is building a research infrastructure toward having impact 

on the overall burden of HIV diseases in our state.

P30 AI110527 Suppl (Mallal, PI) 07/01/2016 – 03/31/2017 0.24 CM 

NIH/CFAR $199,162

Tennessee Center for AIDS Research: Characterizing HIV Phylodynamics in Middle Tennessee

Goal is to address the scientific area of interest tracking HIV transmission Phylodynamics. Using sequences 

and the patient characteristics in the VCCC database, our team will combine standard phylogeny-based 

approach as well as innovative statistic modeling to characterize the HIV-1 epidemic in Middle Tennessee.

Role: investigator

5U01AI069918-11 (Moore, JHU, PI) 07/01/2016 - 06/30/2021 0.12 CM 

NIH/NIAID $60,000

North American AIDS Cohorts on Collaboration and Design (NA-ACCORD) of the International Epidemiologic 

Databases to Evaluate AIDS (IeDEA) network. This collaboration conducts observational cohort studies of HIV 

outcomes.

U01AI069923-12 (McGowan) 07/01/2016 - 06/30/2021 0.6 CM 

NIAID $750,000

The Caribbean, Central American, and South American network for HIV epidemiology (CCASAnet) of the 

IeDEA network brings together the clinical and data expertise and resources of Vanderbilt University and 

clinical sites in Argentina, Brazil, Chile, Haiti, Honduras, Mexico and Peru. CCASAnet uses state of the art 

technologies to create a shared data repository and associated methods for data merging that brings together 

existing HIV-related clinical datasets available at the participating sites.

The project conducts and facilitates research using the shared data repository that enables answers to 

questions that cannot be answered by any single source, and develops and evaluates new biostatistical 

methods relevant to HIV epidemiology.

OVERLAP

There is no scientific or budgetary overlap. If all pending grants are funded, Dr. Sterling will reduce his active 

and pending effort as not to exceed 12 CM of support.
Contact PD/PI: Rebeiro, Peter F

Current and Pending Support Page 81

Current & Pending Support

Graves, John 

ACTIVE

1U01HL122904-03 (Peterson) 09/30/13 – 05/31/17 7.56 calendar months 

NHLBI $367,257

Rational Integration of Genomic Healthcare Testing (RIGHT)

The Rational Integration of Genomic Healthcare Technology (RIGHT) project will evaluate the feasibility and 

cost-effectiveness of three different pharmacogenomic implementation strategies. Capitalizing on the initial 

success of one of the largest pharmacogenomic testing programs in place within the Vanderbilt Health System, 

this project will measure the cost-effectiveness of prospective genotyping and determine factors that support 

successful genotype-tailored prescribing.

1R01CA189152-01A1 (Graves) 07/01/15-06/30/20 3.0 calendar months 

NCI $1,407,632

Effects of Expanded Coverage on Access, Health and Cancer Care in the South

This project will provide timely and rigorous analysis of the effect of health insurance coverage expansions on 

health care use and outcomes among a large cohort of low-income adults in 12 southeastern states (VA, WV, 

KY, TN, NC, SC, FL, GA, AL, MS, LA, AR). Using a quasi-experimental research design, we aim to quantify 

the effects of coverage expansion through Medicaid and private health insurance exchanges on access to 

care, cancer screening and use of preventive clinical services (Aim 1); on self-reported health outcomes, 

mortality and use of emergent and inpatient care (Aim 2); and on cancer stage at diagnosis and quality of 

cancer care (Aim 3).

PENDING
Contact PD/PI: Rebeiro, Peter F

Budget Justification Attachment Page 97

BUDGET JUSTIFICATION.

Personnel

Peter Rebeiro, MHS, PhD (candidate, calendar months with salary) will devote of his time to this 

project. He will be the principal investigator and will be responsible for acquiring the advanced skills in health 

policy analysis and causal inference methods necessary to complete all three aims of this proposal. This will 

include formal coursework as well as informal instruction and advice on data manipulation, management, and 

analysis. He will be responsible for overseeing or conducting analyses, interpretation of results, and 

manuscript preparation.

Timothy R. Sterling, MD (primary mentor, no salary support) will oversee the career development of the 

applicant to ensure that he is meeting his research and academic goals. He will meet with the candidate 

weekly as well as at semi-annual mentoring committee meetings. He will be available to review submitted 

meeting abstracts, manuscripts, and future grant applications. He is independently funded and not requesting 

salary support.

John A. Graves, PhD (co-mentor, no salary support) will oversee the methodological components of the 

proposal and serve as co-mentor for the candidate’s career development. He will meet with the candidate 

bi-weekly as well as at semi-annual mentoring committee meetings. He will guide the applicant in research

design and data analysis and will be available to review submitted meeting abstracts, manuscripts, and future 

grant applications. He is independently funded and not requesting salary support.

William Schaffner, MD (internal mentoring committee, no salary support) will serve as an internal mentoring 

committee member advising the applicant on career development. He will meet with the candidate quarterly as 

well as at semi-annual mentoring committee meetings. He will guide the applicant in communicating evidence 

for maximal impact with policy makers as part of his career development. He is independently funded and not 

requesting salary support.

David R. Holtgrave, PhD (external mentoring committee, no salary support) will serve as an external scientific 

advisory committee member, advising the applicant on the optimization of his analysis to best inform health 

policy. He will meet with the candidate at semi-annual mentoring committee meetings. He is independently 

funded and not requesting salary support.

Stephen J. Gange, PhD (external mentoring committee, no salary support) will serve as an external scientific 

advisory committee member, advising the applicant on use of appropriate biostatistical and epidemiologic 

methods to reach valid inferences regarding policy impact on HIV outcomes. He will meet with the candidate at 

semi-annual mentoring committee meetings and at monthly NA-ACCORD Epidemiology/Biostatistics Core 

meetings. He is independently funded and not requesting salary support.

Catherine C. McGowan, MD (internal advisor, no salary support) will serve as an internal advisor at 

Vanderbilt, advising the applicant on optimal use of CCASAnet data to meet the objectives of the proposed 

research. She will meet with the candidate quarterly as well as at weekly CCASAnet data 

management/analysis core meetings and at semi-annual mentoring committee meetings. She is independently 

funded and not requesting salary support.

Richard D. Moore, MD, MHS (external advisor, no salary support) will serve as an external advisor at Johns 

Hopkins, advising the applicant on appropriate use of NA-ACCORD data to best inform policy makers. He will 

meet with the candidate at semi-annual mentoring committee meetings and at monthly NA-ACCORD 

Epidemiology/Biostatistics Core meetings. He is independently funded and not requesting salary support.

Christopher J. Fonnesbeck, PhD (internal advisor, no salary support) will serve as an internal advisor at 

Vanderbilt, advising the applicant on appropriate spatial statistical methods to obtain valid inferences for the 

influence of geographically and temporally variable health policy changes on outcomes. He will also meet 

quarterly with the candidate as part of his internal advisory committee, in addition to teaching and consulting 

with the candidate during a “Special Topics” course on spatial analysis, which he will teach, offered with the 

approval of the Director of Graduate Studies for the Department of Biostatistics (see Letter of Support).

Bryan E. Shepherd, PhD (internal advisor, no salary support) will serve as an internal advisor at Vanderbilt, 

advising the applicant on the proper selection and use of causal inference methods germane to his research.
Contact PD/PI: Rebeiro, Peter F

Budget Justification Attachment Page 98

He will meet with the candidate on a weekly basis as part of regular research meetings (e.g., the Epi/Outcomes 

and CCASAnet research group meetings, see “Candidate Plan for Career Development/Training Activities”) 

and quarterly with the rest of his internal advisory committee.

Educational expenses

The candidate requests funding for tuition to enroll in formal coursework in Vanderbilt School of Medicine’s 

Health Policy track of the Master of Public Health program and in Special Topics coursework in the Department 

of Biostatistics during the first 1-2 years of the award. The Vanderbilt Graduate School charges $ per 

credit hour (2017-2018 rate), but the candidate will receive a 70% discount as a Vanderbilt facultymember

($ per credit hour after discount). Funds for textbooks and computer software mandated for coursework 

are also requested. The table below outlines formal coursework planned by semester (see “Candidate Plan for 

Career Development/Training Activities” and “Facilities and Other Resources” for further course descriptions):

Year 1 Year 2

1st Semester PUBH 5520 “Introduction to Health Policy” PUBH 5538 “Health Services Administration:

Program and Policy Evaluation”

2nd Semester BIOS 8398 “Special Topics: Spatial Analysis” PUBH 5525 “Health Economics”

The candidate may also require funding for seminars and short courses. For example, seminars on 

management of big data, simulation analyses for health policy, etc. are offered through membership in 

Academy Health, a premier Health Services Research organization which supports the production and use of 

evidence to inform policy and practice and also hosts the annual National Health Policy Conference. Similar 

Cost Effectiveness Analysis”), American Public Health Association (e.g., “Population Health in the context of 

the Affordable Care Act: The role and accountability of Hospitals and Health Systems”) and the International 

Conference on Health Policy Statistics (e.g., “Nonparametric Methods for Difference-in-Difference Estimation”). 

The fees required may include registration as a member with the organization or registration specific to the 

workshops. Short courses offered over 3-4 days by institutions such as the London School of Economics 

(“Health Economics”, SA4G2, http://tinyurl.com/kfjbl4k) and the University of California San Francisco (“Global 

Health Policy”, GHS 205, http://tinyurl.com/k92youo), may also be essential to the acquisition of new skills in 

health policy analysis. As an example of the associated fees for short courses, the London School of 

Economics would charge ( , exclusive of VAT) for 1 course; travel expenses would be 

required, as well.

Data Management, Computing, and Biostatistical Support

The candidate also requests funding for data validation, data management, and computing support through the 

Vanderbilt Epidemiology/Outcomes Group data validation and management team and through the Biostatistics 

Collaboration Center (BCC) at Vanderbilt.

The Epidemiology/Outcomes Group has extensive experience in validating, maintaining, and synthesizing 

demographic, socioeconomic, laboratory, prescription, and other clinical data from the Vanderbilt 

Comprehensive Care Center Cohort. Rates for the Epidemiology/Outcomes staff are based on a 5-10% 

percent effort for the data manager (Computer Systems Analyst II), data administrator (Research Coordinator), 

and data abstractor (Research Analyst I), as necessary for Aims 1-3 of this study.

The BCC is a revenue neutral university resource. Rates for the BCC are based on the complete cost of 

performing collaborative services including, but not limited to, salaries, administrative costs, supplies, 

computing (software, hardware, and shared resources such as the Advanced Computing Center for Research 

and Education (ACCRE)), information technology support, and relevant professional development costs. Rates 

have been calculated based on 1500 hour work year, explicitly excluding common professional activities not 

related to this specific project (e.g., seminars, meeting attendance etc.). Vanderbilt University annually reviews 

the BCC to ensure that it is in compliance with all applicable federal and state regulations, including OMB 

Circulars A-21, A-110 and A-133. Rates are adjusted annually to ensure that the BCC is operating on a strict 

non-profit cost recovery basis.

A Computer Systems Analyst will assist the candidate in the management of large datasets at the Advanced 

Computing Center for Research and Education (ACCRE). The current rate for a Computer Systems Analyst 

ranges from , and an estimate of 50 billable hours has been provided for this project (10 hours per 

year). This yields an estimated cost, excluding estimated inflationaryadjustments, of .
Contact PD/PI: Rebeiro, Peter F

Budget Justification Attachment Page 99

Beginning July 1, 2014 all biostatistics staff and faculty effort is billed directly to each project as a percentage 

of salary and fringe benefit expenses. In addition, a scientific resourcefee of per 100% annual FTE 

(faculty and staff combined) is billed to each project for allowable costs related to providing cutting-edge 

biostatistics support. The department utilizes robust computing technologies and innovative methodologies to 

manage complex analyses. This scientific resource fee covers costs necessary to perform the work of 

biostatisticians and computer systems analysts. These resources are directly related to the many technologies 

used and types of data generated across multiple disciplines that biostatisticians must competentlyhandle.

The scientific resource fee will be billed on a monthly basis via the Core Ordering and Reporting Enterprise 

System (CORES).

The School of Medicine has created a model described here that allows the costs to be recovered from the 

sources requesting the assistance. For example, with a faculty biostatistician at 5% annual effort and a staff 

biostatistician at 10% annual effort, the annual fee is will be 

billed monthly to the project. This scientific resource fee is in addition to the faculty and staff percent-effort 

salary and fringe benefit charges. These changes have been reviewed and approved by executive leadership 

of the School of Medicine and the fee schedule is implemented each year on August 1st.

The BCC has worked extensively with Dr. Sterling and others in the Division of Infectious Diseases.

Travel expenses

Funds to travel to 2-3 scientific meetings per year are requested. The candidate plans to submit a minimum of 

one abstract to at least three meetings per year: the Conference on Retroviruses and Opportunistic Infections 

(CROI), National Health Policy Conference (NHPC) of Academy Health, and either the Society for Medical 

Decision Making (SMDM) or the Society for Epidemiologic Research (SER) meetings. Additionally, the annual 

meeting of the NA-ACCORD Steering Committee is held during CROI and the annual scientific meeting of 

CCASAnet is typically held in one of the 7 member countries during the fall. Funds to travel to one workshop or 

short course on marginal structural methodology per year are requested during the first three years of the 

award. Funds to travel to HRSA/HAB meetings with Dr. Cheever and HRSA partners in Rockville, MD; NIHsponsored HIV-related health policy symposia in Bethesda, MD; or meetings with the 

Epidemiology/Biostatistics Core (EBC) of NA-ACCORD in Baltimore, MD for 2-3 days, 1-2 times per year are 

also requested. Based on searches using Google’s ITA Matrix, flights would be per round-trip.

Hotel accommodations may cost between per night.

Additional expenses

The candidate asks for funding to purchase a laptop and printer during the first year of the award and a 

desktop computer during the fourth year of the award for data analysis and manuscript and grant application 

preparation. The candidate also asks for funding to purchase updated versions of Adobe Acrobat, ArcGIS, 

SAS and/or Stata, Microsoft Office, Stat Transfer, and Reference Manager or Sente as necessary for the new 

hardware.

The natural aging of hardware, accumulation of memory leaks in operating systems, interoperability 

requirements for updated software packages, and ability of processing power to keep pace with increasingly 

complex models (potentially including simulation models) using large datasets (millions of observations across 

dozens of variables, due to the data’s longitudinal nature) would require periodic updating/replacement of 

hardware. This would include a laptop, required for work when away from the office (including time spent in 

classes, at conferences, during visits to HRSA/Johns Hopkins in MD, and during time at home in the 

evenings).

This may also include a desktop if much more robust processing power (beyond the standards available in 

laptops) would be required for complex computational issues in the analysis phase; this may also be required if 

the computation will be required to run for days or weeks and consume most of the CPUs resources, rendering 

other critical software such as word processing programs unusable during computation- this would be the case 

for certain multilevel/mixed effects models, bootstrapping procedures, or simulation models.

A printer is being requested to facilitate the production of reports for collaborators, printing journal articles for 

consultation with other analysts/colleagues during the course of the project, and printing handouts for 

conferences.

Publication costs and office supplies are requested for the final three years of the award.
Contact PD/PI: Rebeiro, Peter F

PHS 398 Cover Page Supplement

OMB Number: 0925-0001

Expiration Date: 10/31/2018

1. Human Subjects Section

Clinical Trial? ❍ Yes ● No

*Agency-Defined Phase III Clinical Trial? ❍ Yes ❍ No

2. Vertebrate Animals Section

Are vertebrate animals euthanized? ❍ Yes ● No 

If "Yes" to euthanasia

Is the method consistent with American Veterinary Medical Association (AVMA) guidelines?

❍ Yes ❍ No

If "No" to AVMA guidelines, describe method and proved scientific justification

3. *Program Income Section

*Is program income anticipated during the periods for which the grant support is requested?

❍ Yes ● No

If you checked "yes" above (indicating that program income is anticipated), then use the format below to reflect the amount and 

source(s). Otherwise, leave this section blank.

*Budget Period *Anticipated Amount ($) *Source(s)

Page 101

Funding Opportunity Number: PA-16-190 . Received Date:

2017-01-05T17:21:11.000-05:00 Tracking Number: GRANT12315321
Contact PD/PI: Rebeiro, Peter F

PHS 398 Cover Page Supplement

4. Human Embryonic Stem Cells Section

*Does the proposed project involve human embryonicstem cells? ❍ Yes ● No

If the proposed project involves human embryonic stem cells, list below the registration number of the specific cell line(s) from the 

following list: http://grants.nih.gov/stem_cells/registry/current.htm. Or, if a specific stem cell line cannot be referenced at this time, 

please check the box indicating that one from the registry will be used:

Specific stem cell line cannot be referenced at this time. One from the registry will be used.

Cell Line(s) (Example: 0004):

5. Inventions and Patents Section (RENEWAL)

*Inventions and Patents: ❍ Yes ❍ No 

If the answer is "Yes" then please answer the following:

*Previously Reported: ❍ Yes ❍ No

6. Change of Investigator / Change of Institution Section

❑ Change of Project Director / Principal Investigator 

Name of former Project Director / PrincipalInvestigator

Prefix: 

*First Name:

Middle Name:

*Last Name:

Suffix:

❑ Change of Grantee Institution

*Name of former institution:

Page 102

Funding Opportunity Number: PA-16-190 . Received Date:

2017-01-05T17:21:11.000-05:00 Tracking Number: GRANT12315321
Page 103

Funding Opportunity Number: PA-16-190 . Received Date:

2017-01-05T17:21:11.000-05:00 Tracking Number: GRANT12315321

Contact PD/PI: Rebeiro, Peter F

PHS 398 Career Development Award Supplemental Form

OMB Number: 0925-0001

Expiration Date: 10/31/2018

Introduction

1. Introduction to Application M-23_PHS_Career_IntroductionToApplication.pdf

(RESUBMISSION)

Candidate Section

2. Candidate Information and Goals for Career M-15_PHS_Career_Candidate_Info_Goals.pdf Development

Research Plan Section

3. Specific Aims M-11_PHS_Career_SpecificAims.pdf

4. Research Strategy* M-19_PHS_Career_Res_Strategy.pdf

5. Progress Report Publication List

(for RENEWAL applications only)

6. Training in the Responsible Conduct of Research M-6_PHS_Career_Training_Resp_Conduct_Research.pdf

Other Candidate Information Section

7. Candidate's Plan to Provide Mentoring

Mentor, Co-Mentor, Consultant, Collaborators Section

8. Plans and Statements of Mentor and M-20_PHS_Career_Mentor_Statements_Letters.pdf Co-Mentor(s)

9. Letters of Support from Collaborators, M-14_PHS_Career_SupportLtrs.pdf Contributors, and Consultants

Environment and Institutional Commitment to Candidate Section

10. Description of Institutional Environment M-10_PHS_Career_Inst_Environment.pdf

11. Institutional Commitment to Candidate's M-21_PHS_Career_Inst_Commitment.pdf Research Career Development

Human Subject Section

12. Protection of Human Subjects M-7_PHS_Career_ProtectionOfHumanSubjects.pdf

13. Data Safety Monitoring Plan

14. Inclusion of Women and Minorities M-8_PHS_Career_InclusionOfWomenAndMinorities.pdf 

15. Inclusion of Children M-9_PHS_Career_InclusionOfChildren.pdf

Other Research Plan Section

16. Vertebrate Animals

17. Select Agent Research M-17_PHS_Career_SelectAgentResearch.pdf

19. Consortium/Contractual Arrangements

19. Resource Sharing M-18_PHS_Career_Resource_Sharing_Plan.pdf

20. Authentication of Key Biologicaland/or M-16_PHS_Career_Auth_KeyBioChem_Resources.pdf Chemical Resources

Appendix

21. Appendix M-12_PHS_Career_Appendix.pdf
Page 104

Funding Opportunity Number: PA-16-190 . Received Date:

2017-01-05T17:21:11.000-05:00 Tracking Number: GRANT12315321

Contact PD/PI: Rebeiro, Peter F

PHS 398 Career Development Award Supplemental Form

Citizenship*:

U.S. Citizen or Non-Citizen National?* ✔❏ Yes ❏ No

If no, select most appropriate Non-U.S. Citizen option

❑ With a Permanent U.S. Resident Visa 

❑ With a Temporary U.S. Visa

❑ Not Residing in the U.S.

If with a temporary U.S. visa who has applied for permanent resident status and expect to hold a permanent resident

visa by the earliest possible start date of the award, also check here: ❏
Contact PD/PI: Rebeiro, Peter F

Introduction to Application Page 105

INTRODUCTION TO APPLICATION. 

I greatly appreciate the Study Section comments on my application. In response, I have made substantive 

changes in the “Career Development Plan” and “Research Strategy”, which address all major concerns raised. 

Revisions are denoted by vertical black lines in the left-hand margin of the submitted documents (see this line).

Career Development Plan: The résumé noted that “It is not clear how many of the courses in the budget 

justification section will be taken.” I have therefore emphasized that there are 4 planned courses in the “Career 

Development Plan” (following Table 2) and outlined them in the “Budget Justification”: PUBH 5520 

“Introduction to Health Policy”, PUBH 5538 “Health Services Administration: Program and Policy Evaluation”, 

BIOS 8398 “Special Topics: Spatial Analysis”, and PUBH 5525 “Health Economics”. These are most critical, 

though additional courses available are described in “Facilities and Other Resources”. I will also attend short 

courses and symposia at health policy conferences (e.g., National Health Policy Conference).

Reviewer 2 specifically noted that “advanced biostatistics courses” in “spatial and temporal data analysis” 

would be needed, and that more effort for “training or closer interactions with local biostatisticians” would be 

desirable. Though I studied spatial statistics under Frank Curriero as part of my master’s coursework in 

biostatistics at Johns Hopkins, I fully recognize the value in further study and continued mentorship during this 

research. I have therefore revised my proposed effort in the first 2 years to allocate more effort (now 5%, Table

1) to formal coursework, in addition to identifying two biostatistics mentors (with expertise in spatial statistics 

and causal inference) and formal coursework in spatial analysis in the Vanderbilt Department of Biostatistics 

(Table 2, and descriptions of mentorship team in the “Career Development Plan” and “Facilities and Other 

Resources”). The additions to my internal mentoring committee from the Vanderbilt Department of Biostatistics 

are Drs. Chris Fonnesbeck (Asst. Prof. with an extensive background in spatial statistics, teaching the BIOS 

8398 course in spatial analysis) and Bryan Shepherd (Assoc. Prof. with expertise in causal inference, and with 

whom I have had successful prior collaborations, resulting in 17 co-authored manuscripts). I will meet with both 

regularly and will take a formal class with Dr. Fonnesbeck.

My co-mentor, Dr. John Graves, also has extensive experience in spatial econometrics, which is germane 

to this critique and is now mentioned under the “Co-mentor” description of the “Career Development Plan”.

Dr. Sten Vermund, an expert in policy and implementation science, will no longer be a formal member of 

my internal mentoring committee, as he has accepted a position as Dean of the Yale School of Public Health 

(effective Feb. 1, 2017). However, he has kindly offered to remain an informal resource for advice in this and 

other HIV epidemiology research. All new committee-member biosketches are included.

Research Strategy: Reviewer 1 noted the lack of description for including Canadian and Mexican populations 

in the analysis plan. Though this omission was made merely to save space, I have now described the addition 

of these populations as a comparator group (a true “universal access” comparator), with which non-expansion, 

and even expansion, states might be contrasted. This would provide greater depth to our inferences with 

respect to the merits of Medicaid expansion as either mimicking or still falling short of the promise of universal 

access and/or coverage.

Reviewer 2 was concerned that the methods may have “limited” novelty. Though the proposed methods 

are standard for health policy analysis, they have been used in the literature to assess changes in various 

health outcomes across varying levels of policy implementation (e.g., counties, states, and even countries in a 

region). However, I have now noted the inclusion of alternate methods which may be explored and used to 

accomplish the Aims under “Statistical Refinements.” These are not meant to be primary methods for 

addressing the Aims, but they are intended to demonstrate that I will explore multiple methods (either existing 

or in development) to execute this research. In particular, I will explore spatial methods with Dr. Fonnesbeck in 

addition to the proposed agent-based models (exploring future outcome trajectories under proposed policy 

changes, conditional on data-driven assumptions from observational data), regression discontinuity analyses, 

and methods to improve generalizability of quasi-experimental evidence from epidemiologic cohorts.

Reviewer 2 wondered about the random error term in the proposed generalized linear mixed model. I 

have now removed the epsilon notation and clarified that the random error may be decomposed as the random 

effects for the intercepts and slopes, each normally distributed: b~N(0,σ2).

Mentors, Co-Mentors, Collaborators: Reviewer 2 noted it “may be better to have a local biostatistical mentor.” 

I now have Drs. Fonnesbeck and Shepherd (mentioned above) as part of my internal mentorship team.

Since the prior submission in September 2016, I have published 5 manuscripts, had 2 manuscripts 

provisionally accepted (under revision), and submitted an additional 4 manuscripts for publication. In addition, I 

will present work on the HIV Care Continuum related to health literacy as an abstract at the 2017 Conference 

on Retroviruses and Opportunistic Infections (CROI) in Seattle, WA (Feb. 2017).
Contact PD/PI: Rebeiro, Peter F

Candidate Information and Goals for Career Development Page 106

CANDIDATE BACKGROUND.

My passion for research and belief in the power of science to improve the welfare of those suffering the 

scourge of HIV infection have been evident since, as a high school student, I took my first job in the field: an 

assistant obtaining informed consents for clinical trials at the Vanderbilt branch of the Adult AIDS Clinical Trials 

Group (AACTG). As I progressed through my undergraduate studies, I maintained my working life in HIV 

research under the supervision of Drs. David Haas and Timothy Sterling, next as a research analyst, then as a 

research coordinator, with the Center For AIDS Research (CFAR) at Vanderbilt University. Throughout, I was 

immersed in the day-to-day workings of the research enterprise, from data mapping, data abstraction, and 

validation, to analysis, scientific writing, IRB documentation, and data submissions for intra- and extramural 

collaborators. After working with a productive group for nearly seven years, I embarked on the next phase of 

my education at one of the premier institutions of higher learning in my chosen field, Johns Hopkins Bloomberg 

School of Public Health.

First as a master’s student in epidemiology in 2010, then as a doctoral student and Meyer Scholar in 

epidemiology and master’s student in biostatistics in 2012, I progressed in my understanding and practice of 

modern epidemiologic and biostatistical methods under the mentorship of Dr. Stephen Gange. During my 

schooling, I pursued my goal of becoming an independent investigator through the execution of a rigorous 

research program alongside my classroom instruction, collaborating with preeminent scholars in the field as a 

member of the Epidemiology/Biostatistics core of the North American AIDS Cohort Collaboration on Research 

and Design (NA-ACCORD) of the International epidemiologic Databases to Evaluate AIDS (IeDEA). During 

this period, I also participated in the NA-ACCORD Quality of Care Working Group, collaborating with national 

leaders in HIV research such as Dr. Richard Moore (PI of the NA-ACCORD), Dr. Kelly Gebo (PI of the HIV 

Research Network), Dr. Michael Horberg (past member of the Presidential Advisory Council on HIV/AIDS), and 

Dr. John Gill (originator of the literature on “churn” in HIV epidemiology), among many others. Through work on 

the clinically important and methodologically challenging topics of “churn” (the movement of patients into and 

out of care over time) and clinical retention in HIV care, central components of the HIV Care Continuum, I 

completed my multiple thesis requirements and presented novel research at national and international 

meetings: the 20th Conference on Retroviruses and Opportunistic Infections (CROI 2013), the 15th, 16th, and 

18th International Workshop on HIV Observational Databases (IWHOD 2011, 2012, and 2014), the XIX 

International AIDS Society Conference (IAS 2012), and the 45th and 46th Society for Epidemiologic Research 

Meeting (SER 2012, and 2013). My work on these topics during the program also resulted in two first-author 

publications (Rebeiro P, et al. J Acquir Immune Defic Syndr. 2013; Rebeiro P, et al., PLoS One. 2014)(1,2) and 

two second-authored publications (Althoff KN, Rebeiro P, et al., Clin Infect Dis. 2014; Yehia BR, Rebeiro P, et 

al., J Acquir Immune Defic Syndr. 2014).(3,4) Beyond producing publications in areas of my own interest, I 

contributed to the ongoing work of colleagues in the Epidemiology/Biostatistics core including Dr. Keri Althoff, 

resulting in co-authorship on a manuscript concerning temporal trends in HIV disease markers in the North 

American population (Althoff KN, et al. Ann Intern Med. 2012).(5) I also improved my didactic skills by working 

as teaching assistant for 4 courses and lead teaching assistant for the primary epidemiologic methods course, 

completing a certificate in the Preparing Future Faculty Teaching Academy program, and competing for and 

winning a Gordis Teaching Fellowship. As a teaching fellow, I served as primary instructor for a self-designed 

undergraduate seminar on the epidemiology of HIV.

Upon completion of my degrees in epidemiology and biostatistics in August 2014, I was recruited as a 

Research Assistant Professor by the working group I had previously been a part of at Vanderbilt University 

School of Medicine. I continued my working relationship with the Epidemiology/Biostatistics core of NAACCORD at Johns Hopkins while forging new connections with another of the IeDEA’s regional collaborations: 

the Caribbean, Central and South America network for HIV epidemiology (CCASAnet), whose data 

management and analysis cores reside at Vanderbilt. In my capacity as a study epidemiologist for CCASAnet, 

I have had the good fortune to participate in important HIV outcomes research using advanced epidemiologic 

and causal inference methods, including the description of HIVCC trends over time, exploration of CD4 

recovery after properly accounting for mortality and loss to follow-up during the study period, and the influence 

of ART regimen transitions and their reasons on subsequent mortality or regimen failure in Latin America and 

the Caribbean; this work has been executed in collaboration with and under the expert guidance of Drs.

Timothy Sterling and Catherine McGowan. My choice of this working environment as an ideal location to 

pursue my early career development as an epidemiologist was compelled not only by the possibility of joint 

mentorship by leaders in the field (Drs. Timothy Sterling and John Graves), but by continued involvement in
Contact PD/PI: Rebeiro, Peter F

Candidate Information and Goals for Career Development Page 107

two remarkably productive research groups with records of outstanding contributions to HIV epidemiology and 

access to the rich resources of large, long-established HIV research consortia.

Since joining the faculty at Vanderbilt, I have taken full advantage of these opportunities and extended my 

rigorous research program surrounding the HIV Care Continuum, whether on work completed with the NAACCORD (Rebeiro P, et al., Am. J. Epidemiol. 2015; Rebeiro P, et al., PLoS ONE 2016), novel work 

undertaken with CCASAnet (Rebeiro P, et al., J. Int. AIDS Soc. 2016), work published in collaboration with the 

Vanderbilt cohort itself (Woodward B, Person A, Rebeiro P, et al., AIDS Patient Care STDs 2015), or work with 

the Tennessee State Department of Health (TN DOH) Division of HIV/AIDS/STDs

Through these experiences as a member of two major international HIV cohort groups, I have gained 

knowledge and facility in using advanced epidemiologic methods, collaborating with researchers across 

disciplines and geographic regions, and in using data from large longitudinal cohorts of HIV-infected individuals 

in North, Central, and South America (the NA-ACCORD and CCASAnet), which I will use in the proposed 

research. This work will form the bulk of my research proposal, and it is detailed below in the Research 

Strategy section of this application.

If this career development award is successfully funded, I will be able to make great strides toward my goal 

of becoming a recognized authority in the fields of HIV health policy and HIV epidemiology. The award will 

cultivate my capacity to be an independent investigator by enabling my research, career development through 

targeted individual meetings with relevant policy makers, education in the application of epidemiologic methods 

to health policy questions, and continued mentoring in research, grant writing, and future proposal 

development. My progress will be facilitated through access to internationally renowned experts in exemplary 

scholarly environments, and my transition from a junior investigator to a senior scientist making major 

contributions to the field will be greatly enhanced and accelerated. This award will provide evidence for health 

policy changes, positively impacting millions of lives.

CAREER GOALS AND OBJECTIVES.

My primary career goal is to become a recognized leader in the fields of HIV health policy and HIV 

epidemiology, specifically focused on the impact of policy interventions on HIV Care Continuum and other HIV 

disease outcomes, assessing the influence of contextual factors such as psychiatric health, poverty, and 

geographic location, alongside health policy implementation factors. This work holds the real potential to 

positively impact public health on massive scales by informing policy interventions that reach large populations. 

I hope to pursue this research as an independently funded investigator and tenure-track faculty member in 

medicine and/or epidemiology at a leading academic research institution. I believe that the education and 

extension of my research experience gained through my training plan would make me a competitive candidate 

for future funding and substantially augment my expertise in the practice of health policy evaluation and 

epidemiology. In tandem, I hope to advance my understanding of the methodology central to policy evaluation 

and of the workings of healthcare systems in general through additional training.

Over the next five years, I will investigate the confluence of health policy, socioeconomics, psychiatric 

illness, geography, demography, healthcare, and HIV outcomes through the lens of the HIV Care Continuum, 

contributing in a meaningful and unique way to the body of knowledge surrounding this topic. In focusing on a 

well-defined epidemiologic construct (the HIV Care Continuum) and leveraging the resources of established, 

large HIV consortia to answer questions that require large populations distributed broadly geographically and 

longitudinally over time, I will enrich the body of scientific knowledge and inform public health policy and clinical 

practice by highlighting points of possible intervention to improve HIV outcomes. I will also endeavor to create 

compelling visual displays of the relevant research findings, maximizing the utility and reach of generated 

evidence for policy makers and other researchers in extending my work to positively influence public health.

Importantly, this award will also give me the opportunity to retain protected time in which to gain a more 

advanced understanding of statistical and analytic methods pertinent to health policy analyses while attaining 

proficiency in the application of these methods. This unencumbered time will also be key to my ability to 

produce high quality research that has the potential to sway policy makers and substantively contribute to the 

field: namely, by elucidating the influence of contextual factors on HIV Care Continuum outcomes across two 

continents, and understanding the changes in HIV care in the US wrought by the expansion of Medicaid under 

the Patient Protection and Affordable Care Act. The Vanderbilt University School of Medicine is an outstanding 

environment in which I may pursue these goals and this work. The Divisions of Infectious Diseases and 

Epidemiology, housed within the Department of Medicine, are among the best in the country and offer multiple
Contact PD/PI: Rebeiro, Peter F

Candidate Information and Goals for Career Development Page 108

resources for junior faculty (these are detailed in the Facilities and Other Resources section). Further, the 

broad array of educational programs and expertise available through the Department of Health Policy, Division 

of Epidemiology, and the Center for Health Services Research (HSR) at Vanderbilt are noteworthy. These 

centers house established practitioners of the very disciplines in which I am most interested in honing my skills. 

Because I intend to continue participating in multiple research groups, indeed across institutions, I will also be 

able to take advantage of knowledge, programs, and other resources that will afford me fairly rarefied 

opportunities. I will take advantage of these resources, including collaborative and consultative relationships 

with others across these divisions through regular meetings and coursework, to advance my understanding 

and ultimately to improve the quality and impact of my research. Details of these resources are contained in 

the Career Development/Training Activities section below.

Future Directions and Conversion to R: By the conclusion of the award period, I hope to have advanced 

significantly in my abilities through research and educational activities in a vibrant intellectual environment with 

mentorship at Vanderbilt and Johns Hopkins Universities. This progress should sufficiently prepare me to 

successfully compete for R-01 funding to address and intervene on some of the identified contextual factors 

related to quality of HIV care, access to care, and HIV Care Continuum outcomes. In particular, results from 

the specific aims of this study may lead directly to applications involving interventions for identified modifiable 

risks which are mediators of the policy-HIV outcome relationship (e.g., treatment of psychiatric illness). Further, 

extensions of methods developed to probe the impact of policy using epidemiologic cohort data as part and 

parcel of this award may contribute to high priority research on the disparate impact of expanded testingor

pre-exposure prophylaxis (PrEP) policies/programs in the United States. Because of the difficulties in linking 

large surveillance data sources with prescription databases, and because of the limitations of ecologic studies 

to control for confounding, the utilization of longitudinal cohorts with detailed clinical data to assess such policy 

changes is highly desirable. Multiple R-01 applications addressing these topics both in North and Latin 

American cohorts, making use of collaborations that will be developed and enriched through this award, would 

be compelling and highly desirable. These applications would make efficient use of studies that have already 

garnered millions of dollars of investment and potentially obviate the need for costly investments in other data 

sources which may be subject to significant inferential barriers.

Critical to my development and success as an independent investigator, this award would also allow me 

protected time to write and publish high-impact, first-author manuscripts, which would seed and help establish 

my reputation as a leader within the field. My immediate goals as part of my career plan are to publish at least 

two first-author peer-reviewed manuscripts per year (related either to the primary outcomes or methodologic 

details of these analyses). My intermediate goal will be to prepare and submit a compelling R-01 application 

by the conclusion of the 3rd K-01 award year. My long-term goal is to demonstrate my bona fides as an 

independent researcher, validated by my promotion to Associate Professor within 7-years of the K-01 award 

commencing.

CANDIDATE PLAN FOR CAREER DEVELOPMENT / TRAINING ACTIVITIES DURING AWARD PERIOD.

I will optimally utilize the resources and opportunities available to me in service of advancing my research 

experience and leadership abilities by: 1) attending and participating in regular mentorship meetings with a 

team of distinguished researchers; 2) accessing continuing education opportunities in the form of meetings and 

symposia; 3) engaging in formal education through health policy, econometrics, and biostatistics classwork 

offered at Vanderbilt

(4 courses); 4) 

attending and 

participating in 

national and 

international policy 

symposia and 

scientific 

conferences. Table 

1 displays the

relative effort I will 

contribute toward 

these critical training 

plan components.

Table 1. Distribution of effort: educational, research, & professional activities, by year

Activity Year 1 Year 2 Year 3 Year 4 Year 5

Mentor/policy meetings, cont. learning, symposia 5% 5% 5% 5% 5%

Formal education (coursework) 5% 5% 2.5% 2.5% 2.5%

Conferences and scientific meetings 2.5% 2.5% 2.5% 2.5% 2.5%

Data collection, analysis, & manuscript submission 71.5% 71.5% 68% 64% 60%

Novel & related project development, grant writing 0% 0% 6% 10% 14%

Total % effort for K-01 award 84% 84% 84% 84% 84%

Education (teaching) 11% 11% 11% 11% 11%

Service (academic committee assignments) 5% 5% 5% 5% 5%

Total % effort for professional responsibilities 16% 16% 16% 16% 16%
Contact PD/PI: Rebeiro, Peter F

Candidate Information and Goals for Career Development Page 109

The heart of my career development plan may be found in the multidisciplinary mentorship team I will be 

engaged with. I have collaborated extensively with some members (e.g., Drs. Sterling, Shepherd, Gange, and 

Moore), enhancing my ability for continued productive research; however, the addition of experts in health 

policy with whom I have no prior collaborative relationship (e.g., Drs. Graves, Schaffner, Fonnesbeck, and 

Holtgrave) will add complementary training to my current repertoire for an optimal combination of mentorship. 

This team will be housed within institutions with myriad resources well suited to extending my epidemiologic 

research to inform health policy in the context of multi-cohort collaborations. Interacting with investigators in 

health policy, epidemiology, biostatistics, and health services research will allow me to participate in the 

conduct of high-quality research in a “big data” setting, gaining an understanding of the flow of information and 

interaction between researchers and staff that is critical to the success of such endeavors.

Mentor and Co-Mentor: My primary mentor, Dr. Timothy Sterling, has decades of experience conducting 

high-impact clinical infectious disease research using multi-site cohorts around the world. As I am fluent in 

methodology but not clinical language or practice, his expertise is necessary in translating my analysis into 

usable science- the evidence which evidence-based policy demands. He has extensive experience leading 

research collaborations within Vanderbilt University (VU) as well as nationally and internationally. He has been 

the PI of multiple NIH-funded studies and has a track record of successfully mentoring several young 

investigators through K mechanisms. He has agreed to continue serving as my faculty mentor and 

shepherding me through career milestones. Our weekly meetings to discuss research and career progress will 

continue during the award period. My co-mentor, Dr. John Graves is an R-funded Assistant Professor of 

Health Policy at VU and a nationally renowned expert in spatial econometrics and health policy evaluation. He 

modeled the Patient Protection and Affordable Care Act’s (ACA) budgetary impact for the White House Office 

of Health Reform during the ACA’s development; his R01 evaluates the ACA’s impact on utilization and chronic 

disease outcomes in the Southern U.S. His R01 parallels this proposal, and I will collaborate in addressing its 

aims as part of my career development: honing newly acquired policy analysis skills in non-HIV cohorts under 

his guidance. He also leads a methodology development group (described in Table 2) that will be a source of 

alternative analytic approaches for the proposed research. I will meet with him in person on a bi-weekly basis 

to discuss progress in my proposed research and optimal career development in health policy research.

Mentoring Committees & Advisors: I will engage the expertise of leaders in health policy, program 

implementation, and methodology at VU through an internal career advisory committee and at Johns Hopkins 

(JHU) through an external scientific advisory committee. I will meet quarterly in person with internal committee 

members, easily assembled due to proximity, and semi-annually with external committee members (via 

teleconference or in person) to assess: 1) progress of analyses and how well they mesh with both proposal 

and career development goals; 2) educational progress in health policy, econometric, and epidemiologic 

methods; 3) quality and continued impact of research products in the fields of HIV health policy and HIV 

epidemiology. The internal committee will include Drs. William Schaffner, Christopher Fonnesbeck, and 

Bryan Shepherd. Dr. Schaffner is a former chair of Preventive Medicine and current professor of Health Policy 

and of Medicine with decades of experience, including in leadership roles formulating vaccination policy with 

federal and state policy-making agencies such as the Centers for Disease Control and Prevention (CDC) and 

the TN DOH. Drs. Fonnesbeck and Shepherd are Assistant and Associate Professors, respectively, in the 

Department of Biostatistics with expertise and extensive publication records in spatial analysis, Bayesian 

analysis, and the application of causal inference methods in HIV epidemiology. The external committee will 

include Drs. David Holtgrave and Stephen Gange. Dr. Holtgrave is Vice-Chair of the US Presidential 

Advisory Council on HIV/AIDS (PACHA), Chair and Professor in the Department of Health Behavior and 

Society at JHU, and a recognized leader in HIV health policy, cost effectiveness, and surveillance research. Dr. 

Gange is Executive Vice Provost of JHU and Professor of Epidemiology, and he is an expert in the use of 

biostatistical and epidemiologic methods for observational data; he is also Director of the 

Epidemiology/Biostatistics Core of NA-ACCORD and a member of several federal health policy and guidelines 

panels. Each member of these committees has received multiple NIH-funded grants and engaged in 

mentorship activities. The committees also possesses a unique combination of experience and skills in fields 

directly related to the proposed work, as well as track records of productivity, perfectly suited to my research 

interests and long-term career goals. Further, Drs. Catherine McGowan and Richard Moore will act as 

advisors in the appropriate use of their cohort data. Dr. McGowan is an Associate Professor of Medicine and 

an HIV epidemiologist who is the principal investigator of the CCASAnet cohort. Dr. Moore is a Professor of 

Medicine and principal investigator of the NA-ACCORD; he is also Director of the JHU Center for AIDS 

Research Clinical Core. All meetings will be in-person or via teleconference (e.g., Skype).
Contact PD/PI: Rebeiro, Peter F

Candidate Information and Goals for Career Development Page 110

In addition, I will leverage the many opportunities for direct contact with policy-makers and continued learning 

available to me by attending meetings with federal policy-makers and symposia regularly. I will attend quarterly 

meetings with the Administrator of the Health Resources and Services Administration’s (HRSA) HIV/AIDS 

Bureau (Dr. Laura Cheever) and HRSA partners either in-person in Rockville, MD or via teleconference, and 

maintain contact with epidemiologists in the CDC’s Division of HIV/AIDS Prevention (Drs. John Brooks and 

Kate Buchacz) through the NA-ACCORD Quality of Care Working Group (see invitation letter in Appendix). As 

a Scholar in Vanderbilt’s Health Services Research group, I will have access to weekly meetings covering 

current research and advances in diverse fields such as implementation science, clinical economics, health 

promotion, behavioral health, and health policy (see appointment letter in Appendix). Seminars in methodology 

and health policy at the Vanderbilt University School of Medicine across the Division of Epidemiology and 

Departments of Health Policy and Biostatistics, may also serve as fertile ground for advancing my 

understanding and skills. In addition, I will continue to attend regular meetings of the various research groups I 

have been involved in, central to the research I will engage in with this award. These groups, their missions, 

and the regular time commitment I will make to them are outlined in Table 2.

Meeting/Group Frequency Description and Goals

(Duration)

Weekly Individual meetings with mentor, co-mentor, and mentoring Mentor meeting: Dr. Sterling (60 minutes) committees to guide and assess progress toward career 

Bi-Weekly development, educational, and research goals. Includes intensive Co-Mentor meeting: Dr. Graves (60 minutes) discussion and feedback from senior faculty and elite researchers 

Internal Advisory Committee: in health policy, epidemiology, and biostatistics at both Vanderbilt Quarterly Drs. Schaffner, Fonnesbeck, and (internal advisory committee) and Johns Hopkins (external 

(90 minutes) Shepherd advisory committee). Meetings with faculty at JHU will be held via 

External Advisory Committee: Semi-Annual teleconference/videoconference, except for semi-annual visits to 

Drs. Holtgrave and Gange (90 minutes) Baltimore, MD.

In-person/teleconference meeting with federal policy makers with 

Policy meetings: Dr. Cheever, Quarterly implementation of evidence-based policy specific to vulnerable 

Administrator of HRSA HIV/AIDS (90 minutes) HIV populations in their purview; will focus on practical implications 

Bureau (and HRSA partners) and priorities of research for policy/programmatic changes.

Dr. Sterling leads this meeting of data abstractors, data managers, 

biostatisticians (including Dr. Shepherd), and epidemiologists Epidemiology/Outcomes Group Weekly involving discussion of ongoing research using the Vanderbilt (Vanderbilt) (60 minutes) Comprehensive Care Clinic cohort, and collaborations with various

outside groups (e.g., NA-ACCORD, CCASAnet, TN DOH, et al.).

Dr. Graves leads this meeting of health policy analysts, 

epidemiologists, and biostatisticians to explore solutions to 

methodologic issues in the use of epidemiologic cohort data to Health Policy Methodology Monthly answer policy-oriented questions. As cohort data may not allow (Vanderbilt) (continued) (90 minutes) inference to the appropriate policy-impacted target population, 

weighting or calibration techniques may be developed to derive

externally valid inferences.

Drs. Moore and Gange lead this meeting of data managers, 

NA-ACCORD analysts, investigators, epidemiologists, and coordinators of NA- Monthly Epidemiology/Biostatistics Core ACCORD. Epidemiologic/biostatistical challenges are discussed (90 minutes) (Johns Hopkins) and solutions are proposed. Meetings at JHU will be held via

teleconference/videoconference.

Dr. McGowan leads this meeting of bioinformaticists, CCASAnet Data Weekly biostatisticians (including Dr. Shepherd), epidemiologists, and data Management/Analysis Core (90 minutes) coordinators of CCASAnet. It consists of discussion of ongoing (Vanderbilt) CCASAnet projects, data collection, and data management issues.

Drs. Keri Althoff and Kelly Gebo lead this meeting of NA-ACCORD NA-ACCORD Quality of Care Semi-Annual collaborators including investigators, epidemiologists, and Working Group Teleconferences (60 minutes) biostatisticians. It addresses research on healthcare access, (Johns Hopkins) health policy, and process measures of care for HIV+ individuals.

By working with these mentors, I will be able to expand my understanding of the methods and statistical 

techniques capable of overcoming impediments to valid inferences in epidemiologic research, while placing 

these analyses and inferences in a larger public health and policy context. Furthermore, in collaborating with 

other investigators within and without VU and JHU, I will be working alongside researchers in international
Contact PD/PI: Rebeiro, Peter F

Candidate Information and Goals for Career Development Page 111

consortia who have provided a foundation for the success of several large ongoing observational studies and 

have contributed to the body of knowledge on HIV in seminal and significant ways, including through the 

implementation of novel epidemiologic methods. I will also maintain access to experts in HIV medicine, health 

disparities, health policy, and health services research that will be vital for ensuring my work’s rigor and 

practical application to the most important and current research questions.

Though I am an experienced epidemiologist, I lack specific training in the advanced methodology required 

for health policy evaluation, and have therefore identified coursework in the Vanderbilt School of Medicine’s 

Master of Public Health Program, Division of Health Policy, and in the Department of Biostatistics, that will 

enrich my understanding of health services, health policy, and appropriate methods for analyzing policy impact 

with spatial data. I have received permission to attend courses of interest and engage in all learning activities, 

so that I may make full use of these opportunities. Pertinent courses include BIOS 8398 “Special Topics: 

Spatial Analysis”, PUBH 5525 “Health Economics”, and PUBH 5538 “Health Services Administration: Program 

and Policy Evaluation”. Course descriptions and faculty are in the Facilities and Other Resources section.

Throughout my training, I will continue to develop my scientific writing and presentation skills and will use 

these to share the results of my research with the broader epidemiology and public health communities. By 

continuing to present results at scientific conferences I will be able to disseminate my findings to others and 

learn about new opportunities for collaboration. I will plan to attend two of the following conferences each year:

1) the Conference on Retroviruses and Opportunistic Infections (CROI); 2) the National Health Policy 

Conference (NHPC) of Academy Health; 3) the Society for Medical Decision Making (SMDM); or 4) the Society 

for Epidemiologic Research (SER) meeting. I will attempt to attend CROI and NHPC preferentially, as they 

align most closely with my interests and would likely offer me the greatest benefit based on the mix of scientific 

results, methods, and policy issues raised there. Conference preparation and attendance will not consume 

more than 9 days per year (2.5% effort).

As a faculty member in the Vanderbilt University School of Medicine’s Department of Medicine, I will 

dedicate 16% effort toward Professional/Educational responsibilities, including teaching and service on 

academic committees (including student thesis and oral examination committees). I currently teach/co-teach 

two courses in the Epidemiology doctoral program at Vanderbilt: EPID 8310 “Causal Inference” and EPID 8321 

“Applied Epi Methods: Logistic Regression”. Finally, I will also continue to propose and conduct research 

related to changes in HIVCC outcomes and HIV epidemiology as influenced by contextual factors and policy 

through collaborations with NA-ACCORD, CCASAnet, and other groups, insofar as such work aligns with my 

overall research interests. All of these groups have prioritized research in this domain, providing numerous 

opportunities for continued productivity regarding these topics in collaboration with the highest caliber of 

epidemiological researchers. As the primary responsibilities of promotable, independent faculty investigators 

are education, service, and research, I intend to continue advancing my proficiency in each of these throughout 

the award period.

My progress will be monitored through multiple mechanisms: 1) regular meetings with my mentor and comentor (≥bi-weekly); 2) ≥semi-annual reviews with my mentor, co-mentor, and mentoring committees through 

in-person and teleconference meetings; and 3) a shared electronic document tracking my educational 

progress, continued learning activities, scientific meeting/symposium attendance, and progress toward meeting 

my proposed research aims. At the outset, I will formulate a series of measurable goals for the initial award 

year through meetings with my mentor and co-mentor. These goals will include 1) at least one oral 

presentation at a national or international scientific meeting; 2) at least three presentations at Divisional (either 

Infectious Diseases or Epidemiology) or Center for Health Services Research-based meetings annually; and 3) 

at least two peer-reviewed primary-author publications per year. My attainment of these goals will be assessed 

at regular review meetings with my mentor and co-mentor. I will also maintain and share a regularly-updated 

electronic record of my progress toward my research and educational goals, to be discussed at the review, as 

well as during my ongoing bi-weekly meetings with my mentor and co-mentor, respectively. Because I will have 

such regular contact with both my mentor and co-mentor, I expect that I will benefit greatly from heightened 

scrutiny of my overall progress and ongoing in-depth discussions of solutions to methodologic impediments 

and approaches to maximize the public health impact of my research. Meetings with my mentoring 

committees on a ≥semi-annual basis will further guide my application of advanced methods to answering 

health policy and quality of care questions in the context of HIV care, while providing me valuable feedback on 

the most meaningful ways to address these questions for consumption even beyond the field of HIV 

epidemiology (i.e., for health policy analysts, policy makers, program funders, and public health officials).
Contact PD/PI: Rebeiro, Peter F

Candidate Information and Goals for Career Development Page 112

With the implementation of this highly structured mentoring plan, the K-01 award would allow me to 

advance my career with an optimal combination of education in advanced epidemiologic methods appropriate 

for health policy assessment and research in a rich and supportive educational environment regarding 

questions that lend themselves to the application of these advanced methods. This award will facilitate the 

development of my skills and, with the collaboration of my sponsor; CCASAnet, NA-ACCORD, and VCCC 

researchers; and the faculty and staff at VU and JHU, will advance my research career in the fields of HIV 

public health policy and HIV epidemiology.

Training in the Responsible Conduct of Research: As a graduate student at Johns Hopkins Bloomberg 

School of Public Health, I attended and completed two, face-to-face courses regarding the responsible conduct 

of research: Responsible Conduct of Research (taught by Dr. Sharon Krag, former Associate Dean for 

Graduate Education and Research, including eight hours of in-class time over the course of an eight week 

term, completed in 2010 and again in 2012). In addition, I have completed the following Research Compliance 

Training courses: Human Subjects Research, Conflict of Interest and Commitment, and HIPAA Compliance.

As a junior faculty member, I will enroll in the “Responsible Conduct of Research” training session offered in 

2016-2017 through the Vanderbilt University School of Medicine’s Office of Biomedical Research Education 

and Training (BRET). This course covers the responsible conduct of research, including ethics, data 

management, research fraud, academic misconduct, and conflict of interest.

In addition to formal training, I will attend symposia and seminars as available on relevant ethical issues in 

the conduct of health policy research and biomedical research. The Center for Biomedical Ethics and Society 

at Vanderbilt University School of Medicine’s Institute for Medicine and Public Health conducts “Ethics Grand 

Rounds” on the first Tuesday of the month every April and November, as well as hosting coursework, research, 

and symposia related to biomedical research ethics. There is also a formal course offered through the 

Vanderbilt University School of Medicine’s Master of Public Health program (PUBH 5518 “Research Ethics in 

Health Policy”) that I may attend as topics of interest arise in the syllabus. Further, my mentorship team 

members are eminent human subjects researchers involved in observational research with extensive 

knowledge in these issues related to data collection, management, security, and sharing; responsible 

authorship and publication; intra- and inter-institutional collaborations; and peer review.
Contact PD/PI: Rebeiro, Peter F

Specific Aims Page 113

SPECIFIC AIMS & HYPOTHESES.

The HIV Care Continuum has become established as a compelling framework to describe the current 

clinical goals for managing HIV infection; it tracks the progression of individuals from diagnosis, through 

linkage, clinical retention, ART use, and ultimately to the goal of viral suppression. Health policy differences 

over time may profoundly influence Care Continuum outcomes, both domestically and internationally, 

augmented by differences in patient contexts.

Because improvements in the proportion of patients conforming to each stage of the Care Continuum 

should lead to improved individual- and population-level disease and transmission outcomes, the work 

proposed below will harness this lens to provide valuable insight into health policy impact, persistent health 

disparities in vulnerable populations by geography and context, highlighting possible points of intervention 

along the Care Continuum.

Not only does the Care Continuum provide a clinical benchmark as reflected in the milestones of the US 

National HIV/AIDS Strategy (NHAS), the revised World Health Organization ART guidelines, and statements 

from the Pan American Health Organization (PAHO), it also provides a framework to focus epidemiological 

investigations on the relevant questions in contemporaneous HIV research. Because the Patient Protection 

and Affordable Care Act (ACA) and other national health policies implemented in the US, Canada, and Mexico 

aim to improve healthcare access and reduce health disparities, studies of the effect of policy and contextual 

factors on the trajectory of Care Continuum outcomes is of great interest and relevance for epidemiologists, 

clinicians, and policy makers.

Here I will pursue aims relevant to this framework using data from two sources: the Caribbean, Central and 

South America network for HIV epidemiology (CCASAnet), and the North American AIDS Cohort Collaboration 

on Research and Design (NA-ACCORD), which has been designated by the Institute of Medicine (IOM) as one 

of 12 data systems ideally suited to assess Care Continuum measures and benchmarks for progress in the 

NHAS and ACA. The study aims are both descriptive (Aim 1) and inferential (Aims 2 and 3).

The Specific Aims and Hypotheses of this study are as follows:

Aim 1a: To describe disparities in three NHAS-specified HIVCC outcomes across North America: proportion of 

population clinically retained, using antiretroviral therapy (ART), or virally suppressed. Disparities by 

demography, geography, patient context (i.e., psychiatric diagnosis and regional poverty level), and 

health system characteristics (i.e., universal ART access in Canada vs. changing payer structures in 

the United States and Mexico) will be highlighted.

Aim 1b: To describe temporal trends in these three outcomes, accounting for geographic, contextual, and 

health policy differences, from 2000 beyond 2014

Hypotheses, Aim 1: The proportion with successful HIVCC outcomes will increase over time, though disparities 

by demographic, socioeconomic, psychiatric, geographic, and health system characteristics may persist 

(contrasting the US, Canada, and Mexico).

Aim 2: To measure the effect of ACA implementation on HIVCC outcomes (e.g., clinical retention, ART use, 

virologic suppression) using data from NA-ACCORD clinical cohorts. Cohorts that provide uniform 

access to care (e.g., Canadian cohorts) and states opting not to expand Medicaid will be used as 

comparators.

Aim 3: To measure the effect of ACA implementation on HIV disease status at entry and clinical endpoints 

(e.g., CD4+ count at enrollment, all-cause mortality incidence, etc.) related to competent HIV care in 

the NA-ACCORD. Outcomes that are not process measures will be assessed using both interval and 

clinical cohorts (e.g., all-cause mortality).

Hypotheses, Aims 2, 3: HIVCC and HIV clinical outcomes (e.g., proportion on ART, or incidence of mortality) 

will improve at a faster rate, comparing the ACA period to the pre-ACA period, among residents of US 

states fully implementing the law compared to residents of other states.
Contact PD/PI: Rebeiro, Peter F

Research Strategy Page 114

RESEARCH STRATEGY.

Specific Aims and Hypotheses:

The HIV Care Continuum (HIVCC) is a powerful framework to describe the epidemiology of HIV; it tracks 

the progression of individuals from diagnosis, through linkage, clinical retention, ART use, and ultimately to the 

goal of viral suppression. The work proposed below will harness this lens to provide valuable insight into health 

policy impact, persistent health disparities in vulnerable populations by geography and context, highlighting 

possible points of intervention along the Care Continuum.

The National HIV/AIDS Strategy (NHAS) formulated in 2010 and the revised 2013 WHO ART guidelines 

reference milestones in the HIVCC, and because the ACA and other national health policies implemented in 

various North, Central, and South American countries aim to improve healthcare access and reduce health 

disparities, describing the effect of policy and contextual factors on the trajectory of HIVCC outcomes is of 

great interest to epidemiologists, clinicians, and policy makers. This study will use well-characterized data from 

the Caribbean, Central and South America network for HIV epidemiology (CCASAnet), and the North American 

AIDS Cohort Collaboration on Research and Design (NA-ACCORD), which has been designated by the 

Institute of Medicine (IOM) as one of 12 data systems ideally suited to assess HIVCC measures and 

benchmarks for progress in the NHAS and ACA.(11) The study aims are both descriptive (Aim 1) and inferential 

(Aims 2 and 3).

The Specific Aims and Hypotheses of this study are as follows:

Aim 1a: To describe disparities in three NHAS-specified HIVCC outcomes across North America: proportion of 

population clinically retained, using antiretroviral therapy (ART), or virally suppressed. Disparities by 

demography, geography, patient context (i.e., psychiatric diagnosis and regional poverty level), and 

health system characteristics (i.e., universal ART access in Canada vs. changing payer structures in 

the United States and Mexico) will be highlighted.

Aim 1b: To describe temporal trends in these three outcomes, accounting for geographic, contextual, and 

health policy differences, from 2000 beyond 2014

Hypotheses, Aim 1: The proportion with successful HIVCC outcomes will increase over time, though disparities 

by demographic, socioeconomic, psychiatric, geographic, and health system characteristics may persist 

(contrasting the US, Canada, and Mexico).

Aim 2: To measure the effect of ACA implementation on HIVCC outcomes (e.g., clinical retention, ART use, 

virologic suppression) using data from NA-ACCORD clinical cohorts. Cohorts that provide uniform 

access to care (e.g., Canadian cohorts) and states opting not to expand Medicaid will be used as 

comparators.

Aim 3: To measure the effect of ACA implementation on HIV disease status at entry and clinical endpoints 

(e.g., CD4+ count at enrollment, all-cause mortality incidence, etc.) related to competent HIV care in 

the NA-ACCORD. Outcomes that are not process measures will be assessed using both interval and 

clinical cohorts (e.g., all-cause mortality).

Hypotheses, Aims 2, 3: HIVCC and HIV clinical outcomes (e.g., proportion on ART, or incidence of mortality) 

will improve at a faster rate, comparing the ACA period to the pre-ACA period, among residents of US 

states fully implementing the law compared to residents of other states.

Background and Significance:

The HIVCC describes the path of progress toward improved individual- and population-level HIV outcomes: 

from testing, to diagnosis, to linkage, retention, ART use, and viral suppression (Figure 0). Interventions 

minimizing disparities and losses at each stage throughout the HIVCC must be sought.(11-14) Disparities in 

HIVCC and HIV outcomes by demographic, SES, geographic, and structural factors (e.g., health insurance 

status) have been noted.(15-20) Though improved public health infrastructure, scale-up in ART access programs, 

and expansion of Medicaid by the ACA holds promise for improved HIV care and diminished disparities 

(because a plurality of HIV+ patients use Medicaid in the US), careful analysis of high quality data in a large, 

geographically diverse network is required to render an evidence-based verdict.(21-27) Identifying spatial 

patterns of disease distribution and health disparities has also provided evidence in health policy decisionmaking, directing funding and interventions to locales of greatest need, even in HIV epidemiology.(17,28-39) By 

leveraging high quality longitudinal data on HIVCC and other clinical and process outcomes along with 

geographic, demographic, and structural data from CCASAnet, the NA-ACCORD, and the VCCC this study is
Contact PD/PI: Rebeiro, Peter F

Research Strategy Page 115

uniquely positioned to alert policy makers, public health officials, and epidemiologists to persistent disparities in 

HIVCC outcomes and the real effects of the healthy policies, including the ACA.(15,19,40)

Evaluation using data from CCASAnet 

and the NA-ACCORD: We propose to 

use data from the largest cohort 

collaborations including HIV-infected 

individuals in the US and Canada (the NAACCORD) and in Latin America 

(CCASAnet). The NA-ACCORD, an NIHsponsored collaboration that is one of 

seven regional members of the 

International epidemiologic Databases to 

Evaluate AIDS (IeDEA), began collecting 

data from multi- and single-site interval 

and clinical cohorts in 2006.(41) Currently, 

25 cohorts comprised of patients residing 

in all 50 US states, Washington, D.C., 

Puerto Rico, and 9 of 13 Canadian 

provinces/territories participate; more than 

125,000 patients are currently included.

Clinical and demographic data (e.g., 

laboratory values and collection dates, 

ART medications and prescription dates, 

clinic visit information) are transmitted to a

centrally-administered Data Management Core semi-annually. CCASAnet, another regional member of IeDEA, 

consists of multi-site clinical cohorts based in Argentina, Brazil, Chile, Haiti, Honduras, Mexico, and Peru; more 

than 25,000 patients are currently included.(42) Within NA-ACCORD and CCASAnet, census-derived data for 

geographic regions within countries, states/provinces, and smaller jurisdictions will be obtained from publicallyavailable sources and used to provide inference for the influence of contextual factors on patient experiences 

and outcomes of HIV care. In particular, comparisons within the US and between the US and its neighbors 

Canada and Mexico (where there has been long-standing universal access and progress toward universal 

access to healthcare, respectively) will lend strength to any inferences drawn.(43)

If the data collection capacities of NA-ACCORD and/or CCASAnet are altered after the award period 

commences, changes in HIVCC outcomes due to state-level policy changes in the years preceding 2014, 

short-term changes immediately after ACA implementation, and the influence of contextual factors in North, 

Central, and South America will still be able to be examined using legacy data from these cohorts. Medicaid 

expansion is still expected to proceed with 100% federal funding for the period of 2014-2017, phasing down to 

90% federal funding by 2020. Even so, if the Medicaid expansion provisions of the ACA underwent significant 

changes, analyses concerning shifts in HIVCC outcomes due to policy changes would still be able to be

conducted within the NA-ACCORD, and in fact, might have greater meaning (as negative changes in outcomes 

following contraction of a program may provide impetus for its restoration).

Innovation: The vast scope (both breadth and depth) of data related to HIV Care Continuum outcomes and 

the geographic heterogeneity of the clinical populations involved in both the NA-ACCORD and CCASAnet 

indicate a unique contribution to monitoring clinical care and health services outcomes, particularly in the 

impact of far-reaching health policy changes, for which few (if any) other cohorts may be well suited to provide 

evidence.(11,43) Applying a focus on health policy and contextual determinants of health to the realm of HIV 

Care Continuum research in these settings will involve the synthesis of publically-available data on policy 

implementation, census-derived characteristics in North and Latin American countries, which should be 

particularly germane and informative for health policymakers at a time when the healthcare systems in the 

United States are undergoing dramatic changes. Even the execution of a primarily descriptive Aim 1, in 

contrast to the more methodologically sophisticated inferential Aims 2 and 3, would provide useful information 

not otherwise available to policy makers, funders, and epidemiologists on the state of HIVCC outcomes and 

potential disparities across demographic and intervenable factors (e.g., psychiatric diagnosis) among a wide 

swath of the HIV-infected population of North America.

Figure 0. Conceptual framework of HIV Care Continuum, “Testing” to “Viral Suppression”
Contact PD/PI: Rebeiro, Peter F

Research Strategy Page 116

Further, the use of a pseudo-experimental design, applicable to the state-determined expansion of 

Medicaid accompanying implementation of the Affordable Care Act, to assess the influence of policy and 

context on HIV Care Continuum outcomes has not been executed elsewhere.(20) Taken together, this 

combination of rich data in a study population covering a geographically expansive area, cultivated in an 

environment replete with competent expertise in their analysis, and their utility in service of a topic of 

immediate and great importance to epidemiologists, public health policy makers, and program funders, make 

the proposed research an obvious candidate for funding and execution in a timely fashion.

Preliminary Studies: Analyses of 

NA-ACCORD data from 2000-2012 

have shown a steady, significant 

improvement in the HIVCC outcome 

of clinical retention (measured using

the IOM indicator). Adjusted predicted 

probabilities of retention tracked 

closely with observed patterns 

(stratified by region) (Figure 1).

Multiple HIVCC outcomes have also 

been noted to improve over time 

within the CCASAnet countries 

(Figure 2).(7,8) Publications noting 

disparities in the quality of HIV care 

using the NHAS and US Department 

of Health and Human Services 

(DHHS) indicators have also been 

produced in the NA-ACCORD 

cohort.(1-4,44) Aims 1, 2, and 3 will seek 

to capitalize on these data by 

supplementing current data in the 

post-2014 period and expanding 

these analyses to include 

assessments of intervention 

effectiveness, influences of 

psychiatric illness, and geographic 

clustering for other HIVCC and HIV 

clinical outcomes. These may serve 

as baseline, or “placebo”, data in 

2014 to gauge ACA or other policy 

effectiveness as a “treatment” in the 

ACA period (post-implementation) for 

Aims 2 and 3.

Research Design and Methods:

Data collection: The NA-ACCORD’s 

latest wave of data collection was in 

2014 (data updated through 

December 31, 2013). CCASAnet 

most recently received updated data 

from its cohorts in January 2015 (data 

updated through December 31, 

2014). This retrospective study will

begin with a baseline assessment and will continue until ≥2 full years of data following 2014 have been 

collected. The study population for all Aims will be adults contributing geographic data and either laboratory 

(CD4 count or HIV-1 viral load) or visit data at least once between January 1, 2000 and the study close.

Aligning data collected at the individual level with state/region-level data derived from publicly-available 

sources over time and across countries (i.e., the US, Canada, and Mexico) will require extensive data cleaning 

and codification. Rigorous interrogation of the data, their linkages, and derivation of an analytic dataset from
Contact PD/PI: Rebeiro, Peter F

Research Strategy Page 117

the source data will require collaboration with data management personnel and bioinformaticians across 

cohorts. This process will be time-consuming and iterative; as new data are collected in these cohorts, and 

data are accumulated in the post-ACA implementation period (from 2014 onward), new challenges in collating 

and integrating these longitudinal data may arise. Fortunately, resources germane to these obstacles are 

available within the research groups and mentoring committee described above. However, data preparation for 

analyses spanning time, multiple comparator groups, and multiple outcomes will consume a significant portion 

of the award period.

Outcomes: The outcomes will be clinical retention, ART use, viral suppression (Aims 1 and 2), CD4+ count at 

enrollment (or at ART start), incident AIDS, all-cause mortality, and cause-specific mortality (due to HIV/AIDS) 

(Aims 1 and 3). Retention will be assigned each year by the IOM/NHAS indicator between entry to the study 

and the closing year or year of death: ≥2 HIV primary care visits within 12 months, >90 days apart.(11,19) Death 

during the study period will be treated as a competing event or “absorbent state”. ART use and viral 

suppression will be assigned by the DHHS indicators: ART use during the year, of those with ≥1 visit in that 

year; HIV-1 viral load <200 copies/mL at last measurement in the year, of those with ≥1 visit and a 

measurement in that year.(44) CD4+ count at enrollment (or at ART start) will be defined as the first available 

CD4+ count within 6 months of enrollment date. Missing CD4+ counts may be multiply imputed.

Risk factors of interest: Factors such as age, race, sex, history of injection drug use, state/jurisdiction of 

residence, laboratory measures (e.g., lipid levels, HbA1C, etc.), diagnoses (e.g., psychiatric diagnoses, 

hypertension, hyperlipidemia, etc.), and clinic encounters are already regularly collected and may be analyzed 

as risk factors, mediators, or confounders of the relationship between various exposures and HIVCC or clinical 

outcomes. ART will be multidrug regimens including ≥3 antiretroviral agents, excluding triple-nucleoside 

regimens abacavir+tenofovir+lamivudine and didanosine+tenofovir+lamivudine.

These variables are part of standard data already collected by NA-ACCORD and CCASAnet. Additional 

factors related to geographic location of patient residence may also be collected, either at the site level, or else 

using publically available data through government or non-profit organizations (e.g., Kaiser Family Foundation) 

databases (e.g., census-derived poverty levels, jobless rates, urbanicity, Ryan White income eligibility 

threshold, etc.); these data will be obtained, geocoded, and cleaned during a pre-award timeline. In particular, 

Ryan White eligibility thresholds will be treated as a potential confounder, as more generous thresholds may 

be associated with Medicaid expansion decisions and with HIVCC outcomes (i.e., changes in access to care 

through Ryan White may alter the measured effect of Medicaid expansion at the populationlevel).(45,46)

Statistical Analysis Plan:

Aim 1. Regression methods using Generalized Estimating Equations (GEE) and restricted cubic splines will be 

used to assess temporal trends in outcomes, accounting for within-individual clustering of outcomes.(47)

Categorical indicator variables will be used to denote health system differences, and restricted cubic splines 

may be used to model continuous factors (e.g., age, CD4+ count, etc.).(48) Spatial analyses using regression or 

cluster detection techniques, identifying locations as clusters by likelihood ratio testing, will be used.(34,49,50)

These analyses will be primarily descriptive, focusing on trends and disparities in HIVCC outcomes by 

demographic, geographic, psychiatric, and socioeconomic characteristics. For example, the adjusted 

difference in viral suppression by sex, across states and over time, will be estimated.

Aims 2 and 3. Currently, 27 states and the 

District of Columbia are expanding Medicaid 

under the ACA, 2 are debating expansion, 

and 21 are not expanding Medicaid (Figure 

3).(51) The expansion of Medicaid by state 

enactments of the ACA may be treated as a 

quasi-experimental, pre-post study design, 

entailing a difference-in-difference analysis or 

else a piecewise generalized linear mixed 

model.(20,51,52) An indicator for states 

implementing ACA provisions vs. not, an 

indicator for pre-ACA vs. post-ACA period, 

and an interaction term for the two to observe 

effect modification from the pre- to post-ACA 

periods by state of residence will be used.
Contact PD/PI: Rebeiro, Peter F

Research Strategy Page 118

Alternatively, a piecewise generalized linear mixed model with random intercepts and slopes by state and 

separate intercepts in the post-ACA period may be utilized.(52) Due to the distribution of states by expansion 

status, an analysis of neighboring states with different statuses (minimizing confounding) will be possible.(53)

These states have large patient populations in the NA-ACCORD. Mexican and Canadian populations (with 

universal access) in CCASAnet and NA-ACCORD may be a second comparator group, contrasting outcomes 

in non-expansion, expansion, and true universal-access “states.” Aims 2 and 3 are inferential, involving 

multiple methodologies to assess ACA implementation impact on HIVCC outcomes. Novel methods, which 

may be developed with the Health Policy Methodology group and Department of Biostatistics (described 

below), may be applied to improve external validity of inferences derived using these cohorts. Analyses may be 

conducted in SaTScan v 9.1.1 or R v 3.0.3 software.

Sample Size Calculations:

Aim 1. With >40,000 patients in each year (using the current NA-ACCORD and CCASAnet samples) clustered 

by cohort, under variance-covariance structure constraints, the power to detect an odds ratio of 0.95 (or 1.05) 

for an outcome by an individual factor would be >0.90 at α=0.05.(54) Power for a logistic marginal structural 

model calculated by simulation allows a similar range of effects at >0.90 power and α=0.05 with the same 

sample.(55) Power for geographic clustering depends on background population, outcome incidence, and 

relative spatial location of events.(50,56) Tango’s statistic (similar to Kulldorff’s statistic) has a power of ~0.95 at 

α=0.05, with relative risk of 4 and sample size of 200.(57) Because sample size per calendar year is 

exponentially larger here (~2002), the risk difference required for power of 0.9 at α=0.05 is factors smaller.

Aims 2 and 3. A difference-in-differences analysis for a quasi-experimental design may use a regression 

model: Yi = β0 + β1Si + β2Ti + β3SiTi with β3 as the estimated effect of Medicaid expansion (S) on the outcome 

(Y), comparing the pre- to post-ACA time periods (T). Using arbitrary autocorrelation, detection of an effect size 

of 2% with sufficient power (>0.8) requires observations of >10 states and >1 year in the pre- and postintervention periods. These sample sizes are available within the NA-ACCORD (patients residing in all 50 

states and Washington, D.C. across >2 years).(41,58). In a piecewise generalized linear mixed model, the model 

could be specified: Logit(πij) = (β0+b0i) + (β00+b00i)*post-ACA + (β1+b1i)*tij*pre-ACA + (β2+b2i)*tij*post-ACA + 

βx*X with b0i, b00i as random effects for intercepts, b1i, b2i as random effects for slopes, and each b~N(0,σ2).

Power would be similar to that for Aim 1.(52)

For all Aims, the number of events in each exposure category should be sufficiently large to accommodate 

inferences with adequate power, as 71% were retained in care, 82% were prescribed treatment, and 78% had 

HIV RNA ≤200 copies/mL from 2009 to 2010 in the NA-ACCORD.(3)

Statistical Refinements: Sensitivity analyses will be conducted for inclusion of unmeasured confounding 

(using methods of Cornfield)(59), due to multiple influences on receipt of HIV care, some of which may be 

unavailable. Data missingness will also be explored (e.g., for CD4+ counts at entry), and some data cleaning 

will be conducted, though the source data are already cleaned and validated at multiple stages during and after 

extraction and collection. If data are missing within sites, multiple imputation techniques will be used.(60)

Additional “cutting-edge” techniques such as agent-based modeling may be employed to explore the range 

of plausible effects under different policy decisions and individual behaviors, with input parameters derived 

from our observational research.(61,62) Dr. Fonnesbeck will help Dr. Rebeiro develop this, and apply appropriate 

spatial statistical techniques to tackle inferential hurdles posed by spatial and temporal variability in both the 

exposure and outcomes. Dr. Graves’ Health Policy Methodology group may also develop alternative methods 

pertinent to both this research (Aims 2 and 3) and to his funded R01, assessing ACA impact on outcomes. In 

extracting data from epidemiologic cohorts outside of a quasi-experimental design, the translation of inferences 

to a target population is not methodologically trivial. Assuming control for confounding, selection bias and other 

impediments to generalizability or transportability may remain. Inverse probability of selection weighting may 

be of use, but research on the application of these methods to program/policy-specific questions is required.(63)

Timeline and Milestones: I will serve as the primary investigator, analyst, and author for all analyses involved 

in this research, though it will be conducted in collaboration. Working closely with my mentor, Dr. Sterling, my 

co-mentor Dr. Graves, and others in the Epi/Outcomes, CCASAnet, and NA-ACCORD working groups, I will 

conduct data cleaning and analyses during the first through fifth years of research (see table below), assuming 

a 1-2 year lag in updated data submissions from NA-ACCORD cohorts. Deliverables for each Aim will include 

conference presentations and manuscript publication (following protocols for collaboration and authorship 

within NA-ACCORD and CCASAnet); data visualizations and maps may be hosted online by NA-ACCORD as 

available. A detailed timeline is depicted in the table below:
Contact PD/PI: Rebeiro, Peter F

Research Strategy Page 119

2017 2018 2019 2020 2021

Requested start date: July 2017 (Year 1) (Year 2) (Year 3) (Year 4) (Year 5)

Preparatory to Research 

Acquire concept sheet and IRB approvals from all groups

Aim 1

Clean & aggregate data; perform longitudinal analyses

Abstract submission (Fall, 2018)

Internal peer-review and manuscript submission/revision

Perform spatial analyses and map adjusted outcomes

Internal peer-review and manuscript submission/revision

Aim 2

Clean data; perform difference-in-difference analyses 

Abstract submission (Fall, 2019)

Internal peer-review and manuscript submission/revision

Aim 3

Clean data; perform difference-in-difference analyses 

Abstract submission (Fall, 2020)

Internal peer-review and manuscript submission/revision

Additional analyses, agent-based models, & publications

R-01 grant writing/submission

Initial submission in Sept. 2019 (allows for resubmission) 
Contact PD/PI: Rebeiro, Peter F

Training in the Responsible Conduct of Research Page 120

TRAINING IN THE RESPONSIBLE CONDUCT OF RESEARCH.

Training in the responsible conduct of research is required for all faculty engaged in human subjects 

research both at Vanderbilt University School of Medicine (VUSM) and at the Johns Hopkins Bloomberg 

School of Public Health (JHSPH). In 2017, I will enroll in the “Responsible Conduct of Research” training 

session offered through the VUSM Office of Biomedical Research Education and Training (BRET). This course 

presents issues in the responsible conduct of research, including ethics, data management, research fraud, 

academic misconduct, and conflict of interest. The course covers federal and institutional guidelines regarding 

research in human and animal subjects. Topics include vulnerable populations in research, confidentiality, and 

the Institutional Review Board (IRB). The course is a full-day face-to-face training session, and attendance and 

completion are tracked and recorded by the BRET office.

The VUSM Master of Public Health program also offers a course (PUBH 5518 “Research Ethics in 

Health Policy”) that I will attend. This face-to-face course will meet weekly during the semester it is offered. 

Course topics include: conflict of interest – personal, professional, and financial; policies regarding human 

subjects; mentor/mentee responsibilities and relationships; collaborative research including collaborations with 

industry; peer review; data acquisition and laboratory tools – management, sharing and ownership; research 

misconduct and policies for handling misconduct; responsible authorship and publication; the scientist as a 

responsible member of society, contemporary ethical issues in biomedical research, and the environmental 

and societal impacts of scientific research.

Further, my mentor, co-mentor, mentoring committee members, and collaborators are eminent human 

subjects researchers involved in observational research with extensive knowledge in these issues related to 

data collection, management, security, and sharing; honest and responsible authorship and publication; intraand inter-institutional collaborations; and peer review.

My mentor and co-mentor, Drs. Sterling and Graves, serve on multiple data safety monitoring boards 

and clinical trial endpoint committees. My external advisor, Dr. Richard Moore (Professor of Medicine, 

Johns Hopkins School of Medicine) also chairs the Johns Hopkins School of Medicine IRB. The 

combination of formal and informal resources to guide me in conducting my own research in a responsible 

manner will ensure a rigorously ethical environment, which will complement my prior coursework in this topic 

(the “Responsible Conduct of Research” (550.600) course taught by Sharon Krag, PhD, professor emeritus 

and Associate Dean for Graduate Education and Research at JHSPH).

In addition to taking the courses noted above, I have completed and passed the online “Human Research” 

Collaborative Institutional Training Initiative (CITI) module as a requirement of the VUSM and JHSPH 

Institutional Review Boards. The basic course contained the following sections: Belmont Report and CITI 

Course Introduction; History and Ethical Principles; Basic Institutional Review Board (IRB) Regulations and 

Review Process; Informed Consent; Research with Protected Populations - Vulnerable Subjects: An Overview. 

Certification for my CITI coursework is included in the Appendix to my application.

In addition to formal training, I will attend symposia and seminars as available on relevant ethical 

issues in the conduct of health policy research and biomedical research. The Center for Biomedical 

Ethics and Society at VUSM’s Institute for Medicine and Public Health conducts “Ethics Grand Rounds” on the 

first Tuesday of the month every April and November, as well as hosting coursework, research, and symposia 

related to biomedical research ethics. The mission of the Center is to provide leadership in education, 

research, and clinical service at Vanderbilt University Medical Center concerning the ethical, legal, and social 

dimensions of medicine, health care, and health policy. The Center is committed to multi-disciplinary 

exploration of the individual and social values, cultural dynamics, and legal and professional standards that 

characterize and influence clinical practice and biomedical research. The Center aims to be a catalyst for 

collaboration in teaching, research, and practice at Vanderbilt and to contribute to scholarship and policy 

making from the local to the international level. The Center for Biomedical Ethics and Society is therefore a 

rich source for ethics training within Vanderbilt University, and I will make use of the resources they offer. I will 

also incorporate discussions of the Responsible Conduct of Research into my presentations and talks, 

relating the challenges and rewards of ethical human subjects research, issues of consent and secure data 

management, and IRB guidance and interactions that I encounter through the proposed work.

The VUSM and JHSPH IRBs will also be a resource. Guidance documents and policies for researchers are 

easily accessible through their websites: https://www4.vanderbilt.edu/irb/, https://phirst.jhsph.edu. Finally, the 

VUSM and JHSPH IRB offices have staff available to answer questions on an as-needed basis.
Contact PD/PI: Rebeiro, Peter F

Description of Institutional Environment Page 133

INSTITUTIONAL ENVIRONMENT.

Description of Institutional Environment: Vanderbilt University includes one of the largest academic medical 

centers in the Southeast with more than 450 research laboratories supported by over $587 million in 

extramural funds. Vanderbilt is among the top 15 NIH funded institutions and one of the fastest growing 

research institutions in the US as measured by annual increases in extramural support.

• The Department of Medicine has a diverse research portfolio currently supported by more than $150 million 

of annual external funding. In 2012, it was ranked 4th in NIH funding for research among all Departments of 

Medicine in US medical schools.

• The Division of Infectious Diseases is a national leader in academic research and houses the Vanderbilt 

AIDS Center, which coordinates all research and care related to HIV/AIDS at Vanderbilt. The 

Epidemiology/Outcomes Unit of the Vanderbilt AIDS Center conducts observational research studies of HIV 

outcomes and has collaborations with the Johns Hopkins University Adult HIV Clinic, the Case-Western 

Reserve University AIDS Clinical Trials Unit, the North American AIDS Cohort Collaboration on Research 

and Design (NA-ACCORD), the Antiretroviral Therapy Cohort Collaboration (ART-CC), and the Caribbean, 

Central, and South America Network for HIV research (CCASAnet). The AIDS Center also oversees the HIV 

Clinical Trials Unit (including HVTN and ACTG sites), and the TN Center for AIDS Research.

• The Vanderbilt Comprehensive Care Clinic (VCCC) of the Vanderbilt AIDS Center and the Vanderbilt 

Medical Group, is the largest HIV provider in central Tennessee. VCCC has enrolled over 7,000 patients 

since 1994 and provides a full spectrum of HIV primary care services. The preliminary data (found in the 

Research Strategy section of this K application) were generated through data collected from patients 

enrolled in care in this clinic in which observational research and clinical trials are tightlyintegrated.

Description of Institutional Scientific Environment:

• Vanderbilt Institute for Clinical and Translational Research (VICTR): VICTR is supported by the NIH via a 

Clinical and Translational Science Award (CTSA) to support faculty working to translate fundamental 

scientific discoveries into clinical practice. Examples of programs include: (1) StarBRITE (Biomedical 

Research Initiation, Translation, and Education) is a shared online data infrastructure storing up-to-date 

study documents and project characteristics; tracking research education, mentoring, conduct, collaboration, 

resource utilization, and productivity; and linking investigators to VICTR; (2) Pilot funding is available for up 

to $100,000 to support promising early-stage research; (3) Research Electronic Data Capture (REDCap) 

was developed at Vanderbilt with the goal to rapidly collect and manage clinical or translational research 

data using a secure web-based application; (4) Studios are structured sessions bringing together research 

experts to focus on a specific stage of research including hypothesis generation, study design, 

implementation, analysis and interpretation, translation and manuscript development. Dr. Rebeiro may make 

use of these resources for future grant applications and manuscript development.

Description of Institutional Educational and Career Development Environment:

• The Clinical and Translational Scientist Development (CTSD) is the educational component of Vanderbilt’s 

CTSA grant. Resources available include: (1) The Elliot Newman Society is a professional organization for 

all investigators supported by individual K awards. Members attend semi-annual meetings with the 

Associate Dean to review career development and mentorship; a monthly Clinical Career Seminar on 

research resources, career advancement, and grant writing; and a yearly workshop retreat on successful 

transitioning to independence; (2) Manuscript and Grant Writing Support is available through a repository of 

successfully funded grants and an internal grant pre-review by senior faculty.

• Vanderbilt Department of Biostatistics: Resources available include: (1) Daily Biostatistics clinics supported 

by the Vanderbilt CTSA grant and available free of charge to Vanderbilt investigators; (2) The Biostatistics 

Collaboration Center at Vanderbilt (BCC), is a university sponsored core resource, whose services include 

computing software, hardware, and shared resources such as the Advanced Computing Center for 

Research and Education (ACCRE). Dr. Rebeiro will also enroll in biostatistics coursework under the 

mentorship of Drs. Chris Fonnesbeck and Bryan Shepherd (approved by DGS Dr. Jeffrey Blume).

• The Vanderbilt Department of Health Policy brings together a broad group of health policy scholars devoted 

to developing solutions that can have a profound impact. The Department builds on a history of strong 

collaborative relationships with the Tennessee Department of Health, the CDC, and several frontline policy 

makers to develop health policy solutions for our nation’s most pressing health care challenges. The 

Department offers weekly seminars, a Health Policy Track for the M.P.H. degree program, and hosts a 

Health Policy Methodology group. Dr. Rebeiro will enroll in coursework, attend symposia, and attend Health 

Policy Methodology group meetings under the mentorship of Dr. John Graves.
Contact PD/PI: Rebeiro, Peter F

Protection of Human Subjects Page 135

PROTECTION OF HUMAN SUBJECTS.

Risks to human subjects

Human subjects involvement and characteristics

Existent data currently collected by clinical cohorts participating in the North American AIDS 

Cohort Collaboration on Research and Design (NA-ACCORD) and the Caribbean, Central and 

South America network for HIV epidemiology (CCASAnet) will be used for the proposed 

research. No additional information is required from individual subjects to complete analyses.

The NA-ACCORD has data on >120,000 individuals and CCASAnet has data on >23,000 

individuals. The study population for this research project will be comprised of approximately 

140,000 individuals >18 years of age who had at least one CD4 count or HIV-1 viral load 

measured or at least one clinic visit recorded between January 1, 2000 and December 31, 2014 

(or beyond, for Aims 2 and 3). For Aims 2 and 3, the additional inclusion criteria of participation 

in an NA-ACCORD clinical cohort may be applied, bringing the total number for that analysis 

closer to 80,000. Based on age at study entry in data through December 31, 2012, the age 

distribution among individuals eligible for Aim 1 of this study is as follows: age 18-24, 5.2%; age 

25-34, 21.6%; age 35-44, 35.1%; age 45-54, 26.8%; age 55-64, 8.8%; age 65+, 2.6%.

Inclusion criteria of individuals enrolled in clinical cohorts within the NA-ACCORD and 

CCASAnet, and with at least one laboratory measurement and/or one clinic encounter render 

this patient population likely healthier than the HIV-infected population at large, since these are 

individuals who have been successfully diagnosed and linked to care, though some engage in 

care at later stages of their HIV disease than others.

As stated in the “Research Strategy”, individuals excluded will be pediatric patients, those with 

no clinic encounter data (records of actual clinic visits and/or appointments) for retention 

outcomes, and for Aims 2 and 3, those patients not in NA-ACCORD clinical cohorts (unless the 

outcomes are not health service related in Aim 3). These variables either define the outcome or 

the exposure group of interest for their respective analyses, and so cannot be missing.

Vulnerable populations are not specifically targeted in the proposed research.

Clinical cohorts will contribute patient information for the proposed research, however no direct 

patient contact will occur as a result. The data that will be used are collected on an ongoing 

basis as part of standard clinical activities at the cohort-level. Investigators representing these 

clinical cohorts within the NA-ACCORD and CCASAnet will have the choice of opting in to the 

proposed research, contributing to the analysis plan, preparation of results, and writing. The 

clinical cohorts with patients currently meeting inclusion criteria are as follows:

In the NA-ACCORD

• Case Western Reserve University Immunology Unit Patient Care and Research 

Database: Cleveland, OH

• Fenway Community Health Center: Boston, MA

• HIV Research Network: Baltimore, MD; Boston, MA; Dallas, TX; Detroit, MI; Kansas 

City, MO; La Jolla, CA; Memphis, TN; New York, NY; Oakland, CA; Philadelphia, PA; 

Portland, OR; Rochester, NY; San Diego, CA; Tampa, FL

• HAART Observational Medical Evaluation and Research: Vancouver, BC, Canada
Contact PD/PI: Rebeiro, Peter F

Protection of Human Subjects Page 136

• HIV Outpatient Study: Chicago, IL; Denver, CO; Philadelphia, PA; San Leandro, CA; 

Stony Brook, NY; Tampa, FL; Vienna, VA; Washington, DC

• Johns Hopkins HIV Clinical Cohort: Baltimore, MD

• Kaiser Permanente, Northern California: Oakland, CA

• Kaiser Permanente, Mid-Atlantic States: Rockville, MD

• Montreal Chest Institute Immunodeficiency Service Cohort: Montreal, QC, Canada

• Ontario HIV Treatment Network Cohort Study: Toronto, ON, Canada

• Southern Alberta Clinic Cohort: Calgary, AB, Canada

• University of Alabama at Birmingham 1917 Clinic Cohort: Birmingham, AL

• University of North Carolina, Chapel Hill HIV Clinic: Chapel Hill, NC

• University of Washington HIV Cohort: Seattle, WA

• Veterans Aging Cohort Study and Virtual Cohort: Clinical sites in all 50 US States, 

Washington, DC, and 2 Territories

• Vanderbilt-Meharry CFAR Cohort / VCCC: Nashville,TN

In CCASAnet

• Hospital Fernandez: Buenos Aires, Argentina

• Centro Médico Huésped: Buenos Aires, Argentina

• Instituto de Pesquisa Clinica Evandro Chagas: Rio de Janeiro, Brazil

• Fundação Oswaldo Cruz: Rio de Janeiro, Brazil

• Fundación Arriarán: Santiago, Chile

• Le Groupe Haïtien d'Etude du Sarcome de Kaposi et desInfections Opportunistes 

(GHESKIO): Port-au-Prince, Haiti

• Instituto Hondureño de Seguridad Social: Tegucigalpa, Honduras

• Hospital Escuela: Tegucigalpa, Honduras

• Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán: MexicoCity, 

México

• Instituto de Medicina Tropical Alexander von Humboldt: Lima,Perú

Sources of materials

Existent “on the shelf” electronic data from participating clinical cohorts will be used for the 

proposed research. Individual cohorts transmit all data elements, as prescribed in a centrally 

assembled data submissions document based on approved concept sheets and protocols, to 

the Data Management Cores of NA-ACCORD (located at the University of Washington) and 

CCASAnet (located at Vanderbilt University). The Data Management Cores use established 

methods for data assembly and harmonization to integrate transmitted data and maintain 

comparability across cohorts. Only those data elements which are required for analyses in 

Steering-Committee-approved protocols are maintained. These data comprise variables related 

to basic demographic information (e.g., age, sex, race/ethnicity, HIV-transmission risk factors), 

clinic encounter information (e.g., types of clinical encounters, status of appointment as kept or 

missed, etc.), insurance status (e.g., publicly insured vs. privately insured), geographic 

information (e.g., city of residence, state of residence, 3-digit ZIP code of residence, etc.),

clinical diagnoses (e.g., AIDS-defining illnesses, psychiatric illnesses, cardiac/vascular diseases, 

liver diseases, renal diseases, endocrine/metabolic disorders, substance abuse disorders, etc.), 

medications (e.g., antiretroviral therapy, opportunistic infection prophylaxis medications, 

antihypertensive medications, psychotropic medications, etc.), laboratory measurement values 

(e.g., CD4+ lymphocyte counts, HIV-1 viral load measures, serum cholesterol measures, etc.),
Contact PD/PI: Rebeiro, Peter F

Protection of Human Subjects Page 137

and vital status. Also, elements of dates associated with these variables (e.g., date of 

medication prescription or laboratory measure collection, etc.) are transmitted and maintained in 

accordance with the HIPAA guidelines for de-identified datasets. For geographic data, 

individuals residing in 3-digit ZIP code areas with resident populations <20,000 have their ZIP 

code entered as “000” before transmission to the Data Management Core (in accordance with 

HIPAA guidelines). The Data Management Cores are responsible for the integration of data 

obtained from cohorts’ individual electronic or paper-based data systems. Census-derived 

contextual data on regions of patient residence (e.g., regional poverty levels, urbanicity, etc.) 

may be extracted from publically available data sources and merged with individual-level cohort 

data for analysis.

Because the population of interest for this research is comprised of those patients accessing 

regular clinical care in North and Latin America, patients enrolled in interval cohorts (or classic 

cohort studies) will not be included in Aims 1 or 2; they may potentially be included in Aim 3 if 

the HIV disease outcome is not a health service indicator (e.g., incidence of AIDS). Therefore, 

the bulk of the data being utilized are largely obtained from medical records (both electronic and 

paper) that are part of routine clinical HIV care at academic centers and community-based 

facilities where primary and specialty care are available. Nevertheless, routine data audits to 

control data quality are conducted within cohorts to verify how data are collected, maintained, 

and captured from individual sites’ electronic or paper records. Data mapping processes are 

conducted at the cohort-level and cohort-specific data maps applying standardized labels are 

generated through an iterative process. Data quality issues associated with specific data 

elements are documented. The generated databases are transmitted to the NA-ACCORD 

Epidemiology/Biostatistics Core and the CCASAnet Data Analysis Core for statistical analyses, 

and these are the databases which will be used in the proposed research.

For this study, additional granular geographic information on individual participants that may be 

pertinent to the study of contextual factors in Latin American settings will be obtained through a 

uniform survey at the cohort-level, and there will be no involvement of individual subjects. This 

information will be transmitted to the Data Management Core of CCASAnet where it will be 

maintained.

All information maintained within the Data Management Cores and transmitted to the 

Epidemiology/Biostatistics Core (NA-ACCORD) or Data Analysis Core (CCASAnet) will be deidentified in accordance with HIPAA guidelines and no NA-ACCORD or CCASAnet staff, 

including myself, will have access to individually identifiable private information about human 

subjects.

Potential risks

There are no perceived potential risks to human subjects because the data used in these 

analyses is routinely collected, on-the-shelf data, which are completely de-identified prior to 

analysis. No individually identifiable information on any subject will be shared with NAACCORD or CCASAnet staff, including myself.

Adequacy of protection against risks

Recruitment and informed consent

There is no additional recruitment of subjects for this study, since all participants are already 

enrolled in their parent cohorts, which then contribute to the NA-ACCORD and CCASAnet. The
Contact PD/PI: Rebeiro, Peter F

Protection of Human Subjects Page 138

NA-ACCORD and CCASAnet maintain their current Institutional Review Board (IRB) approvals 

from the Johns Hopkins School of Medicine and Vanderbilt University School of Medicine IRBs 

(respectively), and each contributing cohort must maintain their current approvals from their own 

institutional IRBs. A waiver of informed consent will be requested from the IRB for the 

Vanderbilt University School of Medicine for this project prior to the start of the fundingperiod.

Protections against risk

All data used in these analyses will be completely stripped of individually identifiable private 

information before maintenance in the Data Management Cores (either at the University of 

Washington or Vanderbilt University) as part of this study, and there are therefore no potential 

perceived risks to individual subjects. Each subject is given a unique study identifier distinct 

from any identifiers they may use in their parent cohort. Geographic information on areas of 

residence will be de-identified in accordance with HIPAA guidelines; 3-digit ZIP codes will be 

entered as “000” for individuals residing in areas with fewer than 20,000 total residents.

All data are transmitted from the Data Management Cores to the Epidemiology/Biostatistics 

Core or Data Analysis Core computer systems, which function in line with university-wide 

systems and network security guidelines and recommendations for both Johns Hopkins and 

Vanderbilt Universities. The five levels of security monitored are: user access, data access, 

Network File System (NFS) export access, tape security, and monitoring for damaging software 

(viruses). Study staff maintain the computer systems and therefore completely control access 

to the system. All computer equipment used for analyses is located behind the tightly controlled 

security firewall of Vanderbilt University School of Medicine.

An analytic dataset domain has been configured with a domain controller to manage user IDs, 

access privileges, computer membership, and file and printer sharing within the domain at both 

Johns Hopkins and Vanderbilt Universities. Access to Windows servers and workstations, as 

well as UNIX-shared directories, is restricted to legitimate user IDs and passwords within the 

domain.

All study administrative webpages, fora, and web-based data management tasks are further 

restricted by user and group access control settings. Local access to SQL Server and MySQL 

is limited to domain-wide administrators only. Secure Shell Client (SSL) is used to enable 

secure transfer of data between external sites and central databases. The UNIX server 

provides shell access for external users to transfer documents, distribute data, communicate, 

and program in SAS/S-PLUS using certain summarized data sets. SSL (as opposed to clear 

text, telnet, or ftp) is required to access the UNIX server’s director and shell operations; access 

via all other protocols is disabled.

Potential benefits of proposed research to human subjects and others

There will be no direct benefit to subjects included in this study. However, living NA-ACCORD 

and CCASAnet participants who access clinical HIV care may indirectly benefit from more 

appropriately targeted policies and funding and implementation of more effective strategies to 

improve patient retention in clinical care, access to ART, and viral suppression rates, based on 

the findings of these analyses. Other HIV-infected patients in North and Latin America may 

benefit from increased emphasis on health policy or healthcare system strengthening to improve 

HIV outcomes, and HIV-uninfected individuals may benefit from the reduction in disease 

transmission associated with improved clinical retention, ART use, and HIV virologic control.
Contact PD/PI: Rebeiro, Peter F

Protection of Human Subjects Page 139

Subjects will not be re-contacted for this study. Additional information collected for the purposes 

of this study (i.e., granular geographic information in Latin American settings) will be obtained 

from cohort representatives and not from subjects directly. Therefore, the risks to subjects are 

minimal and are reasonable in relation to the anticipated benefits for research participants and 

others.

Importance of knowledge to be gained

Because many large, cross-sectional studies assessing HIV Care Continuum outcomes do not 

have access to high quality, longitudinal clinical care data from a geographically heterogeneous 

population, a quantification of trends in these outcomes, as well as assessments of disparities 

and health policy influences from a large, diverse population in which the necessary data are 

available, would be quite valuable. Such quantification could be used to guide future 

interventions in different geographic regions and inform health policy.

Because no large, geographically diverse study has yet assessed the influence of ACA reforms 

on HIV Care Continuum or other HIV disease outcomes among people living with HIV/AIDS in 

the United States, analyses demonstrating relative effectiveness of implemented interventions 

at the state-level would be valuable to direct future research, interventions, and ultimately, 

further health policy reforms.

Finally, because funding may be directed to geographic regions or high-risk demographic 

groups differentially, comparisons of which groups (regionally, demographically, clinically, and 

socioeconomically) may be at higher risk for suboptimal HIV Care Continuum outcomes using 

methodologically appropriate and sophisticated techniques may help redirect funding priorities. 

Further, the evaluation of these risk factors for suboptimal Care Continuum outcomes could 

provide future researchers with a template for assessing progress in National HIV/AIDS 

Strategy goals and ACA benchmarks.

As mentioned above, subjects will not be re-contacted for this study. Additional information 

collected for this study (i.e., types of cohort-level intervention strategies to improve retention in 

clinical care, and dates of their implementation) will be obtained from cohort representatives and 

not from subjects directly. Therefore, the risks to subjects are minimal and reasonable in relation 

to the importance of knowledge that may reasonably be expected to result from this research.
Contact PD/PI: Rebeiro, Peter F

Inclusion of Women and Minorities Page 140

INCLUSION OF WOMEN AND MINORITIES

There will be no exclusions based on sex or race/ethnicity. Preliminary estimates of potential 

participants indicate that 19% are women, 34% are black or African-American, 34% are white, 

0.01% are Asian or Pacific Islander, 0.01% are American Indian or Alaskan Native, and 0.002% 

are Multiracial; 24% are of Hispanic ethnicity (of any race), and 0.04% are of unknown or other 

race/ethnicity.

More detailed descriptions of the racial composition of potential participants for Aims 1, 2, and 3 

are presented in the Targeted/Planned Enrollment Tables in the next section 

(TARGETED/PLANNED ENROLLMENT).
Contact PD/PI: Rebeiro, Peter F

PHS Inclusion Enrollment Report

This report format should NOT be used for collecting data from study participants.

OMB Number:0925-0001 and 0925-0002

Expiration Date: 10/31/2018

Report 1 of 2

Page 141

Tracking Number: GRANT12315321 Funding Opportunity Number: PA-16-190. Received Date: 2017-01-05T17:21:11.000-05:00

*Study Title: The HIV Care Continuum and Health Policy: Changes through Context and Geography (Aim 1)

*Delayed Onset Study? ❏ Yes ❏✔ No

If study is not delayed onset, the following selections are required:

Enrollment Type ❏✔ Planned ❏ Cumulative (Actual) 

Using an Existing Dataset ❑ Yes ❏✔ No or Resource

Enrollment Location ❏✔ Domestic ❏ Foreign

Clinical Trial ❏ Yes ✔❏ No

NIH-Defined Phase III ❑ Yes ❏✔ No

Clinical Trial

By assessing the dynamic process of the HIV Care Continuum in discrete stages, and examining disparities by health policy, geography, and individual 

context, transitions that demand improvement and specific targets for public health and clinical interventions can more easily be identified. Comments:

Racial Categories

Ethnic Categories

Not Hispanic or Latino Hispanic or Latino Total

Unknown/Not 

Reported Ethnicity

Female Male Unknown/ 

Not Reported Female Male Unknown/ Not Reported Female Male Unknown/ Not Reported

American Indian/Alaska Native 418 905 0 0 1323

Asian 191 1270 0 0 1461

Native Hawaiian or 

Other Pacific Islander 7 116 0 0 123

Black or African American 11649 38324 0 0 49973

White 4109 46423 0 0 50532

More than One Race 11376 232 0 0 11608

Unknown or Not Reported

Total 27750 87270 0 0 115020
Contact PD/PI: Rebeiro, Peter F

PHS Inclusion Enrollment Report

This report format should NOT be used for collecting data from study participants.

OMB Number:0925-0001 and 0925-0002

Expiration Date: 10/31/2018

Report 2 of 2

Page 142

Tracking Number: GRANT12315321 Funding Opportunity Number: PA-16-190. Received Date: 2017-01-05T17:21:11.000-05:00

*Study Title: The HIV Care Continuum and Health Policy: Changes through Contect and Geography (Aims 2 &3)

*Delayed Onset Study? ❏ Yes ✔❏ No

If study is not delayed onset, the following selections are required:

Enrollment Type ❏✔ Planned ❏ Cumulative (Actual) 

Using an Existing Dataset ❑ Yes ✔❏ No or Resource

Enrollment Location ❏✔ Domestic ❏ Foreign

Clinical Trial ❏ Yes ✔❏ No

NIH-Defined Phase III ❑ Yes ❏✔ No

Clinical Trial

By assessing the dynamic process of the HIV Care Continuum in discrete stages, and examining dispartities by health policy, geography, and individual Comments: context, transitions that demand improvement and specific targets for public health and clinical interventions can more easily be identified.

Racial Categories

Ethnic Categories

Not Hispanic or Latino Hispanic or Latino Total

Unknown/Not 

Reported Ethnicity

Female Male Unknown/ 

Not Reported Female Male Unknown/ Not Reported Female Male Unknown/ Not Reported

American Indian/Alaska Native 418 905 0 0 1323

Asian 191 1270 0 0 1461

Native Hawaiian or 

Other Pacific Islander 7 116 0 0 123

Black or African American 11649 38324 0 0 49973

White 4109 46423 0 0 50532

More than One Race 89 232 0 0 321

Unknown or Not Reported

Total 16463 87270 0 0 103733
Contact PD/PI: Rebeiro, Peter F

Inclusion of Children Page 143

INCLUSION OF CHILDREN.

The National Institutes of Health (NIH) defines “children” as those individuals who are under the 

age of 18 years. Cohorts participating in the NA-ACCORD pre-enroll only individuals at least 18 

years of age. There are therefore no children under age 18 included in the NA-ACCORD, per 

its design. In CCASAnet, there are indeed pediatric cohorts, though these will not be included 

in this study as they are limited in their geographic extent (i.e., they are not present across 

areas with great heterogeneity in health system structures or geographic location), and may 

therefore be insufficient to address Aim 1. This fulfills the exclusionary circumstance noted in 

the NIH policy on the Inclusion of Children:

• Study designs are aimed at collecting additional data on pre-enrolled adult study 

subjects (e.g., longitudinal follow-up studies that did not include data on children).

The research questions in this proposal may be relevant to children infected with HIV as to 

adults. Because the proposed research focuses on HIV Care Continuum outcomes and health 

policy, demographic, clinical, and geographic characteristics associated with these outcomes, 

and because the factors associated with these outcomes among children may differ from those 

among adults due to adult parents, relatives, or caregivers being responsible for maintaining 

their clinical care or different policies applying specifically to children, the policies or strategies 

this research may inform may not apply to children.
Contact PD/PI: Rebeiro, Peter F

Select Agent Research Page 144

SELECT AGENT RESEARCH.

NOT APPLICABLE
Contact PD/PI: Rebeiro, Peter F

RESOURCE SHARING PLAN.

All data acquired through NIH funds and the conduct of the proposed research will be shared 

and made publicly available through publication in the peer-reviewed literature.

However, this application does not request direct costs of $500,000.00 or greater in any single 

year. Further, it does not involve the development of model organisms, nor is funding being 

sought for a genome-wide association study.

Resource Sharing Page 145
Contact PD/PI: Rebeiro, Peter F

AUTHENTICATION OF KEY BIOLOGICAL AND/OR CHEMICAL RESOURCES.

Our proposal does not utilize key biological and/or chemical resources; there are 

therefore no biological and/or chemical resources to be fully authenticated and/or 

validated prior to embarking upon work within the proposed Aims.

Authentication of Key Biological and/or Chemical Resources Page 146