In 2005-06, the College of Physicians and Surgeons (P&S) supported a Duke Fellow who spent the year in Durban, South Africa conducting mentored clinical HIV/AIDS research. In 2006-07, two Fellows similarly spent their fellowship year. For 2007-08,, Columbia University was awarded a 1-year grant from the Doris Duke Charitable Foundation (DDCF) to support 3 additional Fellows to conduct mentored clinical research on HIV/AIDS and related diseases in Africa. Since 2008-09, Columbia University has received additional funding from the DDCF to support 2 Fellows per year involved in a broad range of clinical global health research projects. These programs are a collaborative effort between a number of P&S faculty and their international colleagues. In addition to South Africa, Fellows have spent their year in the Dominican Republic, Mozambique, Nicaragua, Peru, and Thailand. It should be noted that Fellows in the "domestic" program may also be involved in international projects; albeit for shorted periods of time.

Examples of Clinical Research Opportunities

Department of Medicine/Division of Infectious Diseases
College of Physicians and Surgeons mentors:
Dr. Scott Hammer (Division Chief)
Dr. Magdalena Sobieszczyk

Examples of clinical research opportunities with faculty from the Division of Infectious Diseases/Department of Medicine, the Department of Epidemiology, Mailman School of Public Health, Harlem Hospital Center, and medical and scientific collaborators in South Africa include:

(1) The Centre for the AIDS Program of Research in South Africa (CAPRISA) in Durban, South Africa was founded by the Universities of Natal, Cape Town, and the Western Cape, Columbia University, and the National Institute for Communicable Diseases. It is currently supported by the National Institutes of Health's National Institute of Allergy and Infectious Diseases. CAPRISA's goal is to develop and undertake research that contributes to the understanding of HIV pathogenesis and epidemiology, as well as to build a local research infrastructure and to provide training opportunities through research fellowships to young investigators from South Africa and the United States. One of the projects initiated by the CAPRISA research team is an Acute Infection (AI) study based at the Doris Duke Medical Research Institute at the Nelson R. Mandela School of Medicine. The primary objectives of this observational study include evaluating the immunological and viral factors during acute and early HIV-1 subtype C infection, describing clinical features of acute HIV-1 infection (i.e., acute retroviral syndrome), and describing the nutritional and metabolic derangements during acute and early infection. Other activities revolve around delivery of care to over 350 HIV-1 infected individuals through the CAPRISA Antiretroviral Treatment program (CAT). Current and future projects include cross-sectional studies of (a) prevalence of insulin resistance in women receiving antiretroviral agents; (b) prevalence of renal-, hepatic, and metabolic toxicities in individuals initiating therapy; and (c) determinants of adherence to antiretroviral regimen.

(2) The International AIDS Clinical Trials Unit (IACTU) in Durban, South Africa is a clinical trials unit located at the University of Kwazulu-Natal/King Edward VIII Hospital. One of the active protocols, AIDS Clinical Trials Group (ACTG) 5175, is a prospective study evaluating the non-inferiority of once-daily protease inhibitor (PI) and non-nucleoside reverse transcriptase inhibitor (NNRTI)-containing regimens in resource poor settings. Other ACTG trials are currently being activated at the site, including ACTG 5221 which will investigate the relative timing of antiretroviral and antituberculous treatments in patients who are HIV and TB co-infected. The site serves as a resource for medical students and fellows interested in developing investigational and clinical expertise necessary for future work in clinical trials.

Department of Otolaryngology/Head and Neck Surgery
College of Physicians and Surgeons mentor: Dr. Joseph Haddad Jr.
Vice Chairman of Clinical Otolaryngology and Director of Pediatric Otolaryngology
Host Country Institution: Hospital Escuelas, UNAH (Honduras University), Honduras
Host Country Mentor: Dr. Carlos Flores
Project: The Genetics of Non-Syndromic Cleft Lip and Palate

(1) Honduras has among the highest incidence of cleft lip and cleft palate in the world. Each year, hundreds of children are born with this problem. The Honduran Medical Institute is a private initiative founded to provide medical and surgical care to children with cleft lip, cleft palate and other congenital or aquired deformities. Cleft lip and cleft palate can be related to nutritional issues and potentially has a genetic basis as well, although this is not yet fully defined. The Honduran Medical Institute has initiated a research effort to elucidate the genetic basis of non-syndromic cleft lip and cleft palate in the Honduran population. In collaboration with the Doris Duke Clinical Research Fellowship Program, a study is being conducted with families with more than one affected member. This research effort is coordinated by Dr. Joseph Haddad Jr., in collaboration with Dr. Gloria Su, a molecular biologist in the Department of Otolaryngology/Head and Neck Surgery and Dr. Joseph Lee, an epidemiologist in the Department of Epidemiology, Mailman School of Public Health.

Didactic Component of Program

The didactic component of the International Clinical Research Fellowship includes: 1) One or two courses in the Mailman School of Public Health summer session, ranging from Biostatistics to Multivariate Analysis. The selection of courses is made by the Fellow in consultation with the mentor and is designed to provide tools, not only for the research planned for the coming year, but also for the Fellow's anticipated clinical research career. 2) A two-week mandatory rotation at the Irving Institute for Clinical and Translational Research (the Medical Center's CTSA) that allows Fellows to meet with clinical investigators, become familiar with clinical research core facilities, and write an IRB protocol with the assistance of biostatistics support, which is submitted for critical evaluation before a mock IRB. Fellows also attend IRB meetings. 3) Training in the Responsible Conduct of Research; 4) Web-based training in the Protection of Human Research Participants; and 5) Web-based training in the Health Insurance Portability & Accountability Act (HIPAA).

Application Process

Potential applicants may wish to speak to Drs. Donald W. Landry (Duke Program Leader) or Jaime S. Rubin (Duke Program Advisor) to learn more about the International Clinical Research Fellowship Program. For specific questions on the Infectious Disease projects please contact Drs. Scott Hammer, or Magdalena Sobieszczyk. For specific questions on the Honduran cleft lip/palate project, please contact Dr. Joseph Haddad Jr.

Those that decide to apply should complete the same common online application form as applicants to the domestic program. The same supporting documentation (e.g. letters of reference, transcripts) is also required. Applicants should describe in the "Personal Statement" section, their interest in the International Clinical Research Fellowship, the basis for this interest, any relevant experiences, and if you've had any discussions with Drs. Landry, Rubin, Hammer, or Sobieszczyk in this regard.