HIV in women, prevention of mother-to-child transmission of HIV, clinical care of HIV in resource-poor settings, sexually transmitted infections

The world has seen a dramatic scale-up in the care and treatment of people living with HIV since 2002. The establishment of the President's Emergency Plan For AIDS Relief (PEPFAR) and the Global Fund for HIV, tuberculosis and malaria during this time has created funding mechanisms that have financed the bulk of this scale-up. Since 2005 I have been working with the Clinton Health Access Initiative (CHAI) to help national governments develop and strengthen HIV treatment programs, improve access to medicines and diagnostic services and to help them run more efficiently and effectively. My work for CHAI began in Asia, where I served as the Regional Clinical Officer for the CHAI country programs in Cambodia, China, Indonesia, Lao PDR, Myanmar, Papua New Guinea, and Vietnam. These programs have had particular emphases on children and rural areas, where the economic, structural, and technical barriers to care and treatment are considerable. Since 2014 I have served as the Director of the CHAI Clinical Sciences Team, supporting country and Global Team programs in more than 30 countries where we work, most of which is in sub-Saharan Africa. CHAI has expanded programmatic focus to include tuberculosis, malaria, nutrition, sexual and reproductive health and non-communicable diseases like cervical cancer.

1. Fogarty AIDS International Training and Research Program (NIAID TW000237). Co coordinator of Cambodian programs. Co-investigator.
2. HIV Prevention Trials Network (NIAID). Site representative for STD working group. Involved in microbicide trials and perinatal working group. Co-investigator.
3. "Pilot study of genital tract and blood plasma virology and pharmacology in HIV-1 infected women" (Rhode Island Foundation 20020737). Principal Investigator.
4. "Clinical evaluation of Vironostika HIV-1 plus o microelisa system" (Biomerieux 226034). Principal investigator. $21250.00.
5. "Sexual risk and HIV/STD in vulnerable Cambodian females" (NIAID). Co-investigator.
6. "HIV, abuse, and psychiatric disorders among youth" (NIMH 1R01MH061149-01). Co-investigator. 30 September 2000 – 21 January 2003.
7. Scholar in the "Building Interdisciplinary Research Careers in Women's Health (BIRCWH Scholars) Program," NIH Grant K12 HD043447, (Coustan) to Women & Infants. 1 January 2003 – 31 December 2005.
8. Establishing a Women's HIV Clinic in Phnom Penh, Cambodia: Clinical and Research Training and Development (World AIDS Foundation 320 (03-038), Harwell). 1 September 2003 – 31 December 2005.
9. Genital Tract HIV Shedding in Cambodian Women (1 R03 TW006981-01, Harwell). 1 April 2004 – 31 March 2007.
10. "Clinical Training in Pediatric HIV Care in Clinton Foundation Partner Countries" (Clinton HIV/AIDS Initiative). 1 January 2006-31 December 2006.
11. "Supplement for RCR Training in Cambodia" (5D43TW000237, Cu-Uvin). Co-investigator. $50,000. 1 September 2011 - 31 August 2012.
12. "A randomized controlled trial to assess the effect of peer support to children with HIV in relation to adherence, virological treatment failure as well as physical and cognitive development" Government of Sweden (Larson). Co-investigator. $387,000. 1 November 2011 – 31 October 2014.

13. Risk factors for infection by Neisseria gonorrhoeae harbouring reduced susceptibility to cephalosporins in Hong Kong. (Research Fund for Control of Infectious Diseases, Hong Kong Food and Health Bureau) (Hui) $250,000 HKD. 4 October 2013 – 3 October 2014.

14. Molecular epidemiology and evolutionary genetics study of Neisseria gonorrhoeae with decreased susceptibility to cephalosporins between Hong Kong and Guangdong. (Direct Grant for Research 2013/2014 (Round 1), CUHK Research Committee) (Harwell) Principal Investigator. $80,000 HKD.

15. Molecular screening for community-based cephalosporin-resistant Neisseria gonorrhoeae in key populations in Hong Kong. (Hong Kong Health and Medicine Research Fund (Research Grant 14130102)) (Harwell) Principal Investigator. $992,171 HKD.

16. “Darunavir/ritonavir and dolutegravir combination as a backbone for third line antiretroviral regimen in Cambodia.” (ANRS ECTZ46920)(Ly) Co-Investigator. €173,194 euros.

17. “Acceptability of Dolutegravir-Based Regimens for First-line Antiretroviral Treatment in Uganda.” and “Acceptability of Dolutegravir-Based Regimens in Alternate First-Line HIV Antiretroviral Therapy for Adult and Adolescent Patients in Nigeria.” (Unitaid)(Amole) Co-Investigator. 2017-2018.

1. Harwell JI, Fisher D. Fever, cough and rash in a 12-year-old traveler. Pediatr Infect Dis J  19(1):81,87-88, 2000
2. Morris AB, Cu-Uvin S, Harwell JI. et al.  A Multicenter Review of Protease Inhibitors in 89 Pregnancies. J AIDS 2000;25:306-311
3. Harwell JI, Fisher D.  Pediatric Septic Bursitis: Case Report of Retrocalcaneal Infection and Review of the Literature. Clin Infect Dis 2001;32:e102-4
4. Cu-Uvin S, Hogan JW, Caliendo AM, Harwell JI, Mayer KH, Carpenter CCJ. Association between bacterial vaginosis and expression of HIV-1 RNA in the female genital tract. Clin Infect Dis 2001; 33:894-6
5. Lally MA, Alvarez S, MacNevin R, Cenedella C, Dispigno M, Harwell JI, Pugatch D, Flanigan, TE.  Acceptability of Sexually Transmitted Infection Screening among Women in Short-Term Substance Abuse Treatment.  Sexually Transmitted Diseases, Vol. 29, No.12;752-755, December 2002.
6. Tashima KT, Alt DN, Harwell JI, Fiebich-Perez DK, Flanigan TP.  Internet Sex Seeking Leads to Acute HIV Infection: A Report of Two Cases.  International Journal of STD and AIDS 2003;14(4); 285-
7. Senya C, Mehta A, Harwell JI, Pugatch D, Flanigan T, Mayer KH.  Spectrum of Opportunistic Infections in Hospitalised HIV-Infected Patients in Phnom Penh, Cambodia.  International Journal of STD & AIDS 2002;14:411-6.
8. Harwell JI, Moench T, Mayer KH, Chapman S, Rodriguez I, Cu-Uvin S.  A Pilot Study of Treatment of Bacterial Vaginosis with a Buffering Vaginal Microbicide.  Women's Health and Gender Based Medicine 2003;12:255-9.
9. Chhin S, Rozycki G, Pugatch D, Harwell JI.  Etiology of Meningitis in HIV-Infected Patients in a Referral Hospital in Phnom Penh, Cambodia.  International Journal of STD & AIDS 2004;15:48-50.
10. Harwell JI, Flanigan TP, Mitty JA, Macalino GE, Stenzel MA, Carpenter CCJ, Cu-Uvin S. Directly observed therapy to reduce genital tract and plasma HIV-1 RNA in women with poor adherence. AIDS 2003;17:1190-3.
11. Mitty JA, Macalino G, Taylor L, Harwell JI, Flanigan TP. Directly observed therapy (DOT) for individuals with HIV: successes and challenges. MedGenMed 2003;5:30
12. Madhivanan P, Cu-Uvin S, Govindarajan M, Mayer K,.Wilson K, Harwell J, Hemalatha R, Solomon S. Prevalence of cervical dysplasia among women attending an HIV care center in Chennai, South India. J Obstet Gynecol India 2003;53 (4) July/August:367-70.
13. Theng T, Sok P, Pugatch D,  Harwell JI, Ruffner, KM, Chhi Mean V, Mayer KH,  Cu-Uvin S,. HIV prevalence among parturient women in Sihanoukville, Cambodia. International Journal of STD & AIDS 2004;15:419-21.
14. Sheth AA, Harwell JI, Tashima KT. Guillain-Barré syndrome and acute HIV seroconversion. Infect Med 2003 ;20:559-61
15. Obaro SK, Losikoff P, Harwell J, Pugatch D. Failure of serial DNA polymerase chain reaction tests to identify HIV-1 clade A/G. Pediatr Infect Dis J  2005;24:183-4.
16. Morris AB, Dobles AR, Cu-Uvin S, Zorilla C, Anderson J, Harwell JI, Keller J, Garb J. Protease inhibitor use in 233 pregnancies. J Acquir Immun Defic Syndr 2005;40:30-33.
17. Bun Navy K, Prem Prey S, Lynen L, Sovanna P, Bell, J, Harwell JI. The first reported case of disseminated histoplasmosis in Cambodia, complicated by multiple opportunistic infections. Southeast Asian J Trop Med Public Health 2005;36:1-3
18. Sok P, Harwell JI, McGarvey ST, Lurie M, Lynen L, Flanigan T, Mayer KH. Demographic and clinical characteristics among HIV-infected patients in Cambodia. AIDS Pat Care STD 2006;20:59-68.
19. Cu-Uvin S, Snyder B, Harwell JI, Hogan J, Chibwesha C, Hanley D,  Ingersoll J, Kurpewski J, Mayer KH, Caliendo AM. Association between paired plasma and cervicovaginal lavage fluid HIV-1 RNA levels during 36 months. J Acquir Immun Defic Syndr 2006;42:584-7
20. Chhin S, Harwell JI, Bell JD, Rozycki G, Ellman T, Barnett JM, Ward H, Reinert SE, Pugatch D. Etiology of Chronic Diarrhea in Antiretroviral-Naїve AIDS Patients Admitted to Norodom Sihanouk Hospital, Phnom Penh, Cambodia. Clin Infect Dis 2006;43:925-32.
21. Myung P, Pugatch D, Brady MF, Many P, Harwell JI, Lurie M, Tucker J. Directly-Observed HAART for HIV Infected Children in Cambodia. Am J Public Health 2007;97:974-7.
22. Kong BN, Harwell JI, Suos P, Lynen L, Mohiuddin S, Reinert S, Pugatch D. Opportunistic infections and HIV clinical disease stage among patients presenting for care in Phnom Penh, Cambodia. Southeast Asian J Trop Med Public Health 2007;38:62-8.
23. Losikoff P, Fichorova R, Snyder B, Rodriguez I, Cu-Uvin S, Harwell J, Mayer KH. Genital tract interleukin-8 but not interleukin-1beta or interleukin-6 concentration is associated with bacterial vaginosis and its clearance in HIV-infected and HIV-uninfected women. Infect Dis Obstet Gynecol. 2007;2007:92307.
24. Lynen L, Sok P, Suos PP, Thai S, Harwell J, Boelaert M, Koole O, Colebunders R. Does Hyponatremia have a Value in the Diagnosis of Extrapulmonary Tuberculosis in HIV-1 Infected Patients in Cambodia? Open Infectious Disease Journal 2008;1:1-3.
25. Sok P, Harwell JI, Dansereau L, McGarvey ST, Lurie M, Flanigan T, Mayer KH. Patterns of sexual behaviors of male patients prior to testing HIV+M in a Cambodian hospital, Phnom Penh. Sexual Health 2008;5:353-8.
26. Sam S, Chhour YM, Polidy P, Harwell J, Hutton E, Trzmielina S, Somasundaran M, Luzuriaga K, Pugatch D. Virologic and immunologic outcomes in HIV-infected Cambodian children after 18 months of highly active antiretroviral therapy (HAART). Southeast Asian J Trop Med Public Health 2010;41:126-37.
27. Vinson AE, Dufort EM, Willis MD, Eberson CP, Harwell JI. Drug rash, eosinophilia, and systemic symptoms syndrome: Two pediatric cases demonstrating the range of severity in presentation--A case of vancomycin-induced drug hypersensitivity mimicking toxic shock syndrome and a milder case induced by minocycline. Pediatr Crit Care Med. 2010;11:e38-43.
28. Venkatesh KK, Lurie MN, Triche EW, De Bruyn G, Harwell JI, McGarvey ST, Gray GE. Growth in infants born to HIV-infected women in South Africa according to maternal and infant characteristics. Tropical Medicine & International Health 2010;15:1364-74.
29. Lim K, Davidson A, Harwell JI, Thay S, Boardman LA, Feller E, Cu-Uvin S. Comparing Visual Inspection with Acetic Acid to Cytology in Detection of Precancerous Lesions of the Cervix in HIV-Infected Cambodian Women. J Int Assoc Physicians AIDS Care 2011;10:283-6
30. Simonsen K, Harwell J, Lainwala S. Clinical Presentation and Treatment of Transfusion Associated Babesiosis in Premature Infants. Pediatrics 2011;128:e1019-24.
31. Zhao Y, Mu W, Harwell J, Zhou H, Sun X, Cheng Y, Li C, Zhang F. Drug Resistance Profiles among HIV-1 Infected Children Experiencing Delayed Switch and 12-months Efficacy after Using Second-line Antiretroviral Therapy: An Observational Cohort Study in Rural China. J Acquir Immune Defic Syndr 2011;58:47-53.
32. Westley BP, DeLong AK, Tray CS, Sophearin D, Dufort EM, Nerrienet E, Schreier L, Harwell JI, Kantor R. Prediction of Treatment Failure using 2010 WHO Guidelines is Associated with High Misclassification Rates and Drug Resistance among HIV-Infected Cambodian Children. Clin Infect Dis 2012;55:432-40
33. Chen J, Yu B, Wang Y, Tang M, Hu Y, Cai T, Zhang F, von Zinkernagel D,  Harwell JI, Huang ZJ. Expansion of HIV care and treatment in Yunnan Province, China: Treatment outcomes with scale up of combination antiretroviral therapy. AIDS Care 2014;26:633-41
34. Wei X, Yin J, Zou G, Zhang Z, Walley J, Harwell J, Li H, Li R, Wang L, Sun Q, Zhang X, Treatment interruptions and provision of directly observed treatment of multidrug resistant tuberculosis patients in China. Int J Tuberc Lung Dis 2015;19(4):413-9. doi: 10.5588/ijtld.14.0485.
35. Sau MS, Balamane M, Lurie M, Harwell J, Welle E, Mean C, Cu-Uvin S. Assessment of Prevention of Mother-to-Child Transmission HIV Services in the Bantey Meanchey Province in Cambodia. J Int Assoc Provid AIDS Care. 2016 Jul;15(4):345-9. doi: 10.1177/2325957415599208. 
36. Hu Y, Walley J, Chou R, Tucker JD, Harwell JI, Wu X, Yin J, Zou G, Wei X. Interventions to reduce childhood antibiotic prescribing for upper respiratory infections: systematic review and meta-analysis. J Epidemiol Community Health. 2016 Jun 20. pii: jech-2015-206543. doi: 10.1136/jech-2015-206543
37. Mohammed BH, Johnston JM, Harwell JI, Yi H, Tsang KW, Haidar JA. Intimate partner violence and utilization of maternal health care services in Addis Ababa, Ethiopia. BMC Health Serv Res 2017;17:178. Doi 10.1186/s12913-017-2121-7
38. Wang S, Hu YJ, Little P, Wang Y, Chan Q, Zhou X, Moore M, Harwell JI. The impact of the National Action Plan on the epidemiology of antibiotic resistance among 352,238 isolates in a tertiary teaching hospital in China from 2015-2018. Antimicrob Resist Infect Control 2019;8(22): https://doi.org/10.1186/s13756-019-0473-y
39. Prabhu S, Harwell JI, Kumarasamy N. Advanced HIV: Diagnosis, treatment and prevention. Lancet HIV 2019 http://dx.doi.org/10.1016/S2352-3018(19)30189-4
40. Nabitaka VM, Nawaggi P, Campbell J, Conroy J, Harwell J, Magambo K, Middlecote C, Caldwell B, Katureebe C, Namuwenge N, Atugonza R, Musoke A, Musinguzi J. High acceptability and viral suppression of patients on Dolutegravir-based first-line regimens in pilot sites in Uganda: A mixed-methods prospective cohort study. PLoS One. 2020 May 27;15(5):e0232419. doi: 10.1371/journal.pone.0232419.
41. CE Boeke, S Khan, F Walsh, A Hettema, C Lejeune, D Spiegelman, V Okello, J Harwell, S Mazibuko, T Bärnighausen. Universal test and treat in relation to HIV disease progression: Results from a stepped-wedge trial in Eswatini. HIV Med 2020 (in press).

1998 "Outstanding Fellow of the Year" as selected by the internal medicine housestaff, Baystate Medical Center
2002 "Dean's Teaching Excellence Award," Brown Medical School Bio 282 Pathophysiology – Infectious Disease
2002 "Vision Award" New Visions for Newport County Inc. Jean E. Hicks Community Health Center for community service and support
2004 "Dean's Teaching Excellence Award," Brown Medical School Bio 282 Pathophysiology – Infectious Disease
2005 "Dean's Teaching Excellence Award," Brown Medical School Bio 282 Pathophysiology – Infectious Disease

1999- Staff Physician, Rhode Island Hospital, Providence, RI
1999- Staff Physician, The Miriam Hospital, Providence, RI