Clinical Research

International Health Track

Fellows interested in international medicine can apply to participate in the International Health Track. Selected fellows can spend 1-2 years in Moshi, Tanzania performing research on HIV infection and HIV-associated co-infections. The Division and its Tanzanian partners at Kilimanjaro Christian Medical Centre (KCMC), Kibongoto National Tuberculosis Hospital (KNTH) and the community-based organization KIWAKKUKI share scientific expertise, the ability to perform research and deliver care in a region with extraordinary need, a commitment to training, and a 19-year record of collaboration.

With significant expertise in AIDS-associated co-infections including bacterial, mycobacterial, fungal, malarial, other parasitic, and female genital tract infections, and expertise in HIV immunopathogenesis, epidemiology, and pediatrics, the investigators involved in International Health are poised to make major contributions. A full-time faculty member, John Crump, resides in Moshi and is responsible for the local administration of the clinical studies.

Interested applicants are encouraged to contact Drs. Hamilton, Bartlett, Crump, or Thielman for more information.

Examples of projects completed or underway in Moshi:

Tuberculosis and HIV Immune Reconstitution Syndrome Trial (THIRST)
A pilot study of fixed dose combination zidovudine/lamivudine/abacavir in HIV infected persons with tuberculosis in Moshi, Tanzania. This study which we believe is the first controlled trial of antiretroviral therapy for HIV infected individuals in Tanzania randomizes patients co-infected with HIV and Tuberculosis to receive their antiretroviral therapy either two weeks after or eight weeks after initiating antituberculosis therapy. Forty subjects have enrolled in this study to date. Planned accrual is for seventy study subjects. This study should be fully accrued within the next two months.
Evaluation of Introduction of Trimethoprim-Sulfamethoxazole Prophylaxis for Persons with HIV/AIDS in Sub-Saharan Africa on Antimicrobial Resistant Infections in Clinical Diseases (Cotrimoxazole study).
Two of three arms for this study are fully accrued, and the third arm is lacking twenty-five subjects before we will close this study all together. Once the study is fully accrued and E. coli samples have been obtained from study subjects at one month on Cotrimoxazole therapy, we plan to ship specimens to DUMC Microbiology Laboratory for further testing.
Evaluation of Clinical Staging Criteria of HIV Infection in the Kilimanjaro Region of Tanzania (Fulbright/Clinical Staging Study)
This study which seeks to evaluate the WHO clinical staging criteria and develop more regionally relevant criteria for staging HIV infection has accrued one hundred and seventy patients out of a planned two hundred to date. Susan Morpeth presented preliminary analysis of this study at the 12^th Conference on Retroviruses and Opportunistic Infections in Boston in February 2005.
KIWAKKUKI Voluntary Counseling and Testing Project (KIWAKKUKI VCT)
Well over three thousand clients have been tested to date. Helen Chu’s paper will be forthcoming in the International Journal of STDS and AIDS. This paper describes the sociodemographic characteristics of clients presenting for VCT at KIWAKKUKI as well as risk factors for HIV infection through multivariable logistic regression analysis. An additional paper describing the cost effectiveness of a brief free VCT campaign and sustained free VCT has been accepted by the American Journal of Public Health. Further revisions to our survey have been made and these will be piloted in the next few weeks with the assistance of Keren Landman, third year medical student. Keren Landman has had an abstract accepted at the International AIDS Society meeting in Rio describing risk factors for low HIV treatment literacy among clients presenting for VCT.
Diagnosis of Tuberculosis in Patients Co-infected with HIV
This study, which was performed by Duke Internal Medicine resident Chetan Seshadri, was completed about one year ago. An abstract submitted to the International AIDS Society meeting in Rio in July 2006 was accepted and Chetan hopes to be able to take time off from his Fellowship at Mass General to be able to present these data.
Clinical Characteristics of HIV Home Based Care Clients in the Kilimanjaro Region of Tanzania (HBC study)
This study which seeks to build upon a past quality improvement survey done at KIWAKKUKI for home-based care clients eighteen months ago will describe HIV progression among this cohort. Thus far eight-five out of about three hundred planned surveys have been returned.
Kilimanjaro Christian Medical Centre (KCMC) HIV Clinic Databases
Tereza Martinu, a Duke Internal Medicine Resident, has worked to refine out survey instrument which will capture clinical data among patients being treated in the KCMC Infectious Diseases Clinic (IDC). Keren Landman has been working on a similar form for a pediatric clinic database.
Antiretroviral Drug Adherence and Resistance Study (ADAR)
This study has been approved by Duke IRB, KCMC Ethics Committee, and should be approved very soon by the National Institute of Medical Research. Funding is anticipated from the CFAR for this study which will evaluate one hundred and fifty patients who have taken Trimune for the past six months in the KCMC IDC. Feng Gao will assist with measuring plasma HIV RNA levels, resistance mutations and clade subtyping. A detailed questionnaire will address potential psychosocial and economic factors associated with maladherence. Adherence will be assessed with an instrument previously validated in sub-Saharan Africa.

Studies that will be opening soon:

AIDS orphans and social support
Optimizing therapy for the diagnosis and treatment of cryptococcal meningitis
Etiology of co-infections in HIV-infected children
Enteric pathogens in HIV
Relationships between HIV and malaria infection