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OMB No. 0925-0001/0002 (Rev. 08/12 Approved Through 8/31/2015) 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: Richard S. Garfein eRA COMMONS USER NAME (credential, e.g., agency login): RGARFEIN POSITION TITLE: Professor 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.) INSTITUTION AND LOCATION University of California, Santa Barbara, CA San Diego State University, San Diego, CA Johns Hopkins University, Baltimore, MD US Public Health Service, CDC, Atlanta, GA DEGREE (if applicable) B.A. M.P.H. Ph.D. Fellowship Completion Date MM/YYYY 06/85 12/89 05/97 09/97-06/99 FIELD OF STUDY Biology Epidemiology Epidemiology Epidemic Intellig. Service A. Personal Statement As an infectious disease epidemiologist, I have dedicated over 26 years to conducting public health research involving infectious diseases and vulnerable populations. My research focuses primarily on diseases associated with substance abuse, including HIV, viral hepatitis (HBV, HCV) and tuberculosis (TB) in the U.S. and abroad. I have extensive experience designing and implementing observational research studies to describe the epidemiology of these diseases among persons who inject drugs (PWID) and other high-risk populations, and for evaluating interventions to prevent their transmission. I was the principal investigator (PI) for a five-city randomized controlled trial of a behavioral intervention to prevent HIV and HCV transmission among 15-30 year-old PWID called “DUIT” that was included in the CDC’s Compendium of Evidence-Based HIV Behavioral Interventions. The impact of my work is also evidenced by publication of positive findings from a conditional cash transfer intervention for school-age girls in Malawi to prevent HIV infection that was published in The Lancet. I was also the PI for a recently completed CDC-funded study of HIV and HCV infection among young adult PWID in San Diego (STAHR), which provided preliminary data for a subsequent NIDA-funded study (STAHR II) to assess the impact of changes in drug possession laws in Mexico on the behavior of PWID in the U.S. (R01-DA031074). Since 2009, I have been conducting research on the use of mobile technology to improve adherence and of monitoring anti-TB treatment (R21-AI088326, U01-AI116392, Verizon Foundation, California HealthCare Foundation). In addition, I served as the lead epidemiologist on a NIAID-funded multi-site study (Moldova, the Philippines, South Africa and India) to evaluate rapid molecular- and culture-based assays for detection of XDR-TB, to identify the genetic basis of discordant results, and to characterize XDR-TB strains globally (U01 AI082229-01). The productivity of my research is exemplified by authorship of >150 peer-reviewed publications and >160 conference abstracts. These studies also provide learning opportunities for undergraduate, graduate and post-doctoral levels mentees. B. Positions and Honors Positions and Employment 1989-1991 Health Care Statistician, Naval Health Research Center, United States Naval Hospital 1990-1992 Study Coordinator, San Diego State University, School of Public Health, San Diego CA 1993-1997 Study Coordinator, Johns Hopkins University, School of Public Health, Baltimore, MD 1997-1999 Epidemic Intelligence Service Officer, Division of Viral Hepatitis, CDC, Atlanta, GA 1999-2005 Senior Staff Epidemiologist, Division of HIV/AIDS Prevention, Atlanta, GA 2005-2008 Associate Professor, Div. Int. Health and Cross Cultural Med., Dep. Fam. Prev. Med., UCSD 2009-2011 Associate Professor, Division of Global Public Health, Department of Medicine, UCSD 2009-pres. Adjunct Associate Professor, School of Social Work, San Diego State University 2011-pres. Professor, Division of Global Public Health, Department of Medicine, UCSD 2012-pres. Adjunct Professor, Graduate School of Public Health, San Diego State University Other Experience and Professional Memberships 1986-pres Member – American Public Health Association, Epidemiology Section 1997-pres 2007-pres 2010-pres Member – CDC-Epidemic Intelligence Service Alumni Association Member – International Urban Health Society Member – International Union against Tuberculosis and Lung Disease Honors 1999 2001 2001 2003 2008&2010 2011 2015 DHHS Secretary’s Award for Distinguished Service, National Hepatitis C Recommendations CDC - Honor Award, Hepatitis C Inter-Center Working Group Unit Commendation for comprehensive response to an emerging HIV epidemic in Orel, Russia Unit Commendation for the rapid response to an outbreak of fulminant hepatitis B among IDUs Nominee, Outstanding Scientific Contribution to Public Health, Charles C. Shepard Award, CDC UCSD Equal Opportunity/Affirmative Action and Diversity Award, Division of Global Public Health Public Health Champion Award, San Diego County Health and Human Services Agency C. Contributions to Science 1. Diagnostic Assays. In the first decade of the AIDS pandemic, I trained as an epidemiologist studying quality control for the early HIV antibody tests. These CDC-funded studies identified where errors could occur during the HIV testing process, which helped guide laboratory quality assurance practices. My experience in laboratory testing procedures was subsequently applied to evaluating point-of-care rapid antibody assays for hepatitis C virus (HCV) infection among a cohort of persons who inject drugs (PWID)—the highest risk group for HCV infection. These assays are now recommended by the CDC for screening high-risk groups nationwide. My research in diagnostic assay development currently involves identifying genomic mutations associated with resistance to anti-TB drugs. I am a co-investigator on the NIH-funded Global Consortium for Drug-resistant Tuberculosis Diagnostics, which produced one of the world’s largest well-described, multi-site collections of M. tuberculosis isolates. This study’s findings are informing the next generation of rapid, genetic-based assays that will allow providers to detect drug resistance within days versus weeks to months, so that TB patients may begin effective treatment sooner. a. Peddecord KM, Benenson AS, Hofherr LK, Garfein RS, Francis DP, Hewitt DJ, Ferran KL, Schalla WO, Hearn TL. Identification of non-analytic quality issues in human immunodeficiency virus type 1 antibody testing using blind proficiency testing. Clinical Laboratory Science, 1992;5:172-176. PMID: 10147725 b. Jewett A, Smith BD, Garfein RS, Cuevas-Mota J, Teshale EH, Weinbaum CM. Field-based performance of three pre-market rapid hepatitis C virus antibody assays in STAHR (Study to Assess Hepatitis C Risk) among young adults who inject drugs in San Diego, CA. Journal of Clinical Virology, 2012;54(3):213-217. c. Garfein RS, Catanzaro DG, Rodwell TC, Avalos E, Jackson RL, Kaping J, Evasco H, Rodrigues C, Crudu V, Lin SY, Groessl E, Hillery N, Trollip A, Ganiats T, Victor TC, Eisenach K, Valafar F, Channick J, Qian L0, Catanzaro A. Phenotypic and genotypic diversity in a multinational sample of drug-resistant Mycobacterium tuberculosis isolates. International Journal of Tuberculosis and Lung Disease. 2015;19(4):420-7. PMCID: PMC4494864 d. Catanzaro A, Rodwell TC, Catanzaro DG, Garfein RS, Jackson RL, Seifert M, Georghiou SB, Trollip A, Groessl E, Hillery N, Crudu V, Victor TC, Rodrigues C, Lin GS, Valafar F, Desmond E, Eisenach K. Performance comparison of three rapid tests for the diagnosis of drug-resistant tuberculosis. PLoS ONE. 2015;10(8):e0136861. PMCID: PMC4556461 2. Substance Use and Infectious Disease Outcomes. My career in substance use research began with the publication of a seminal study (2.a) showing that most HCV infections among PWID occur shortly after beginning to inject drugs. These findings prompted a number of observational studies to identify risk factors for HCV and HIV infection, particularly among young, recently-initiated PWID. Over the past two decades, my research described the epidemiology and identified risk factors for the infectious diseases associated with substance use domestically and internationally. This body of work contributed to the development and evaluation of interventions designed to reduce the risk of these infections (see Section 4 below). I served as principal or co-investigator on these studies. a. Garfein RS, Vlahov D, Galai N, Doherty MC, Nelson KE. Viral infections among short-term injection drug users: The prevalence of hepatitis C, hepatitis B, human immunodeficiency, and human T-lymphotrophic viruses. American Journal of Public Health, 1996;86:655-661. PMCID: PMC1380472 b. Garfein RS, Vlahov D, Doherty MC, Thomas D, Monterroso E, Nelson KE. Prevalence and incidence of hepatitis C virus infection among young adult injection drug users. Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology, 1998;18 Suppl. 1:S11-S19. PMID: 9663618 c. Garfein RS, Lozada R, Liu L, Laniado-Laborin R, Rodwell TC, Deiss R, Alvelais J, Catanzaro A, Chiles PG, Strathdee SA. High prevalence of latent tuberculosis infection among injection drug users in Tijuana, Mexico. International Journal of Tuberculosis and Lung Disease, 2009;13:626-632. PMCID: PMC2744313 d. Garfein RS, Rondinelli A, Barnes RF, Cuevas J, Metzner M, Velasquez M, Rodriguez D, Reilly M, Xing J, Teshale EH. HCV infection prevalence lower than expected among 18-40-year-old injection drug users in San Diego, California. Journal of Urban Health, 2013;(90)3:516-528. PMCID: PMC3665980 3. Health Policy & Prevention. Empirical evidence is crucial for guiding health policy. Throughout my research career, I have led or collaborated on studies designed to enhance our understanding of the individual, social and structural factors that increase the risk for infectious disease transmission to inform policies that reduce these risks. Legalization of non-prescription syringe sales and syringe exchange programs are evidence-based interventions that research conducted by me and my colleagues have been shown to reduce the risk of HIV, HCV and other blood borne viral infections among PWID and not increase the risk to community from discarded syringes. Based on these studies, California legalized non-prescription syringe sales to prevent syringe sharing among PWID. These studies have been cited as evidence for changing policy elsewhere in the U.S. and abroad. Research is currently underway to assess the binational impact of decriminalizing possession of drugs for personal use in Mexico (R01-DA031074). a. Doherty MC, Garfein RS, Vlahov D, Junge B, Rathouz PH, Galai N, Anthony JC, Beilenson P. Discarded needles do not increase soon after the opening of a needle exchange program. American Journal of Epidemiology, 1997;145:730-737. PMID: 9125999 b. McKnight CA, DesJaralais DC, Perlis T, Eigo K, Krim M, Auerbach J, Purchase D, Solberg A, Jones TS, Garfein RS. Update: Syringe exchange programs-United States. JAMA, 2005;294:1892-1894 c. Stopka TS, Garfein RS, Riley E, Rose V, Kral A, Ross A, Bluthenthal R. California Senate Bill 1159 Report: An evaluation of over-the-counter sale of sterile syringes in California. July 2010. http://www.cdph.ca.gov/programs/Documents/SB1159StateReportFinal.pdf. d. Robertson A, Garfein RS, Wagner KD, Mehta SR, Magis-Rodriguez C, Cuevas-Mota J, G, Gonzalez MoenoZuniga P, Strathdee SA. Evaluating the impact of Mexico’s drug policy reforms on people who inject drugs in Tijuana, B.C., Mexico, and San Diego, CA United States: A binational mixed methods research agenda. Harm Reduction Journal, 2014;11:4. PMCID: PMC3944401 4. Behavioral Intervention Research. Once the risk factors and target populations were identified for HIV, HCV and other behaviorally-transmitted infectious diseases were elucidated, interventions were conceived to minimize these risks. Based on prior research of my own and others, I led the development of a behavioral intervention to prevent HIV and HCV infection among young adult PWID and evaluated its efficacy in a multisite randomized controlled trial. I also collaborated on a parallel intervention trial to prevent transmission of HCV from young adult PWID infected with HCV. Both of these interventions were found to be efficacious and included in the CDC’s Compendium of Evidence-Based HIV Behavioral Interventions and the former intervention has been packaged for dissemination (http://www.socio.com/srch/summary/happa/hap18full.html). I also collaborated on a study published in the Lancet that showed conditional cash transfers could reduce the risk of HIV among Malawian school-age girls. a. Garfein RS, Golub ET, Greenberg A, Hagan H, Hanson DL, Hudson S, Kapadia F, Latka MH, Ouellet LJ, Purcell DW, Strathdee SA, Thiede H, for the DUIT Study Team. A peer-education intervention to reduce injection risk behaviors for HIV and HCV infection in young injection drug users. AIDS, 2007;21(14):19231932. PMID: 17721100 b. Latka MH, Hagan H, Kapadia F, Golub ET, Bonner S, Campbell JV, Coady MH, Garfein RS, Pu M, Thomas DL, Thiel TK, Strathdee SA. A randomized intervention trial to reduce the lending of used injection equipment among injection drug users infected with Hepatitis C. American Journal of Public Health, 2008;98:853-861. PMCID: PMC2374802 c. Garfein RS, Metzner M, Cuevas J, Bousman CA, Patterson T. Formative assessment of ARM-U: a modular intervention for decreasing risk behaviors among HIV-positive and HIV-negative methamphetamine-using MSM. The Open AIDS Journal, 2010;4:105-115. PMCID: PMC2905777 d. Baird SJ, Garfein RS, McIntosh CT, Ozler B. Effect of a cash transfer programme for schooling on prevalence of HIV and herpes simplex type 2 in Malawi: a cluster randomised trial. Lancet, 2012;7:379(9823):1320-1329. PMID: 22341825 5. mHealth and Medication Adherence. While describing the epidemiology of infectious diseases has been a major focus of my research, my ultimate goal is to translate this research into prevention. Recognizing the growing worldwide incidence of drug resistant TB that is caused by poor adherence to long antibiotic regimens, my interests turned to developing tools for monitoring and improving medication adherence. In 2010, I received an NIH grant to develop and evaluate a smartphone application called Video Directly Observed Therapy (VDOT) that allows health workers to observe TB patients ingesting each dose of medication through videos made and sent by the patient. This was the first study to show that asynchronous VDOT was feasible and acceptable in both high and low resource settings (5.a). Great interest from TB control programs led to my being awarded grants from the NIH, Verizon Foundation, California HealthCare Foundation, and several health departments to further enhance and evaluate VDOT for monitoring TB medication adherence. Our technology has been used in four countries and eight U.S. county health departments. The application developed at UCSD was licensed to a start-up company (www.sureadhere.com) to disseminate VDOT globally as a technology solution to the epidemic of drug resistant TB. In 2015, the NIH funded a randomized controlled trial of VDOT for monitoring patients on short-course treatment for latent TB infection (U01-AI116392). a. Garfein RS, Collins K, Muñoz F, Moser K, Cerecer-Callu P, Raab F, Rios P, Flick A, Zúñiga ML, CuevasMota J, Liang K, Rangel G, Burgos JL, Rodwell TR, Patrick K. Feasibility of Tuberculosis Treatment Monitoring by Video Directly Observed Therapy: A Binational Pilot Study. International Journal of Tuberculosis and Lung Disease. 2015;19(9):1057-64. PMID: 26260824 [PubMed - in process] b. Falzon D, Timimi H, Kurosinski P, Migliori GB, Van Gemert W, Denkinger C, Isaacs C, Story A, Garfein RS, do Valle Bastos LG, Yassin MA, Rusovich V, Skrahina A, Van Hoi Le, Broger T, Abubakar I, Hayward A, Thomas BV, Temesgen Z, Quraishi S, von Delft D, Jaramillo E, Weyer K, Raviglione MC. Digital health for the End TB Strategy: developing priority products and making them work. The European Respiratory Journal. 2016;48(1):29-45. c. Story A, Garfein RS, Hayward A, Rusovich V, Dadu A, Soltan V, Oprunenco A, Collins K, Sarin R, Quraishi S, Sharma M, Migliori GB, Varadarajan M, Falzon D. Monitoring therapy compliance of tuberculosis patients by using video-enabled electronic devices. Emerging Infectious Diseases 2016;22(3):538-540. Complete List of Published Work in MyBibliography: http://www.ncbi.nlm.nih.gov/pubmed/?term=Garfein%20RS[Author]&cauthor=true&cauthor_uid=26382653 D. Research Support Ongoing Research Support NIAID U01 AI116392 Garfein (PI) 03/16/15-02/28/20 Cell Phone Video Directly Observed Therapy to Monitor Short Course LTBI Treatment This randomized controlled trial will compare the efficacy of Video DOT to standard in-person DOT for monitoring adherence to weekly Isoniazid and Rifapentine for treating latent tuberculosis infection. California HealthCare Foundation Garfein (PI) 11/01/14-10/31/16 Video Directly Observed Therapy The goal of this study is to determine the efficacy of Video DOT for monitoring adherence to TB treatment compared with in-person DOT in urban and rural California counties, and to inform MediCal reimbursement policy for Telehealth. CA Dept. Public Health Garfein (PI) 09/15/11-09/14/21 CDC – Tuberculosis Epidemiologic Studies Consortium: Task Order 1 This multisite, prospective cohort study will compare performance and cost of 3 diagnostic tests for LTBI (TST, QFT, and T-Spot), and measure their predictive ability to identify persons at risk for progression to active TB. Role: Site PI Royal Free Hospital, UK Garfein (PI) 04/01/13-12/31/16 VDOT for Hard-to-Reach TB Patients – UK The goal of this randomized controlled trial is to determine the efficacy of VDOT compared to in-person DOT for monitoring anti-TB treatment adherence among homeless and substance using patients. Completed Research Support NIDA 1R01DA031074-01A1 Garfein (PI) 08/01/11-05/31/16 Drug Tourism to Mexico: Impact of Mexico’s New Drug Law on HIV-HCV-TB in US IDUs This longitudinal cohort study examines the impact that a 2010 Mexican law reducing drug possession penalties will have on behaviors and HIV/HCV/TB risks among IDUs in San Diego who cross the border into Mexico to buy and use drugs. NIDA R01 DA019829-05 Strathdee (PI) 04/01/05-06/30/15 Impact of Drug Policy Reform on the HIV Risk Environment among IDUs in Tijuana The goal of this study is to assess the impact of recent Mexican drug policy reform on HIV-associated risk factors and protective factors among IDUs in Tijuana, Mexico, which has the largest number of drug users per capita in Mexico. Role: Co-investigator NIAID U01 AI082229-01 Catanzaro (PI) 09/27/09-12/31/14 Cooperative Research Partnerships for Biodefense and Emerging Infectious Diseases Aims: Reduce average XDR-TB detection time from months to a week; Determine agreement between rapid and standard drug sensitivity testing; Identify genetic basis of discordant results from Aim 2; describe XDR-TB strains globally. Role: Co-investigator NIAID P01 AI074621-01A1 Little (PI) 03/15/08-02/28/13 Determinants of HIV Transmission To elucidate and quantify epidemiologic, behavioral, biologic, virologic, and host factors that contribute to transmission among individuals who have been recently infected with HIV and the sexual partners who transmitted HIV to them. Role: Project PI NIAID R21 AI088326 Garfein (PI) 04/01/10-03/31/12 Mobile Phone-Based Video Directly Observed Therapy for Tuberculosis To develop and pilot test a methodology to provide directly observed anti-TB therapy using video-enabled cellular phones in San Diego, CA and Tijuana, B.C., Mexico. NIAID 1R56AI081321-01 Garfein (PI) 09/27/09-08/31/11 Cross-Border Dynamics of MDR/XDR-TB Epidemiology by HIV Status in Tijuana, Mexico The goal of this study is to describe the epidemiology and transmission dynamics of MDR/XDR-TB in Tijuana with relation to HIV and the US/Mexico border region. CDC 2007-N-09566 Garfein (PI) 10/01/07-09/30/10 Pilot Study for National HCV Surveillance, San Diego, CA (STAHR) The goal of this study is to develop and pilot test sampling methods for recruiting young adult IDUs for HCV testing. Results will be used to inform the development of a national HCV surveillance system among IDUs. CA Dept. of Public Health 05-46118 Garfein (PI) 01/01/07-01/31/09 Informing the Opt-Out Option: Formative Research on Client Perspectives and Characteristics of Repeat HIV Testers in California HIV Counseling and Testing Sites. Since mandatory HIV prevention counseling deterred some high risk clients from regular testing, this study will assess the potential impact of offering repeat testers the option to opt-out of counseling. Data will be used to inform state policy. Cal State Univ. Dominguez Hills Bluthenthal (PI) 09/01/06-06/30/09 Influence of Pharmacy-Based Syringe Disposal on Unsafe Syringe Discard among IDUs in CA. The goal of this study is to determine whether Senate Bill 1159 allowing pharmacies in CA to legally sell syringes without a prescription had a negative impact on unsafe syringe discard practices. Role: Co-Investigator CDC IUR6PS 000306 Garfein (PI) 09/30/06-08/29/09 Reducing Sexual Risk for HIV Acquisition and Transmission among Methamphetamine-Using Men who have Sex with Men who are Not Currently in Substance Abuse Treatment. This is a phase I behavioral intervention trial to develop and pilot test a novel intervention to decrease high risk sexual practices among methamphetamine-using men who have sex with men. NIDA R01 DA019829 Strathdee (PI) 07/01/05-07/01/09 Epidemiology of HIV and Bloodborne Pathogens among IDUs in Tijuana. The goal of this study was to characterize the epidemiology of HIV, syphilis, TB and associated risk factors among IDUs in Tijuana, Mexico and to identify timely and culturally-sensitive interventions. Role: Co-investigator USAID GSM-025 Garfein (PI) 09/01/06-12/31/08 PreveTB: A Mobile TB Screening and Diagnostic Project for High Risk Populations in Tijuana. The goal of this study was to estimate the prevalence and identify correlates of M. tuberculosis (TB) and HIV infections among high risk populations for HIV infection in Tijuana, Mexico.