Update On Studies in Moshi, Tanzania April 28 2005
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 antiretroviral therapy either two weeks or eight weeks after initiating antituberculosis therapy. 40 subjects have enrolled in this study to date. With total accrual planned for 70 subjects, this study is projected to be fully enrolled by July 2005. A 24 week analysis should be completed in the Fall 2006.
Cotrimoxazole Study
Evaluation of Introduction of Trimethoprim-Sulfamethoxazole Prophylaxis for Persons with HIV/AIDS in Sub-Saharan Africa on Antimicrobial Resistant Infections in Clinical Diseases
Two of three arms for this study (each with 50 subjects) are fully accrued. The third arm needs twenty-five more subjects to complete enrollment. Once the study is fully accrued and E. coli samples have been obtained from study subjects at baseline and at one month on trimethoprim-sulfamethoxazole therapy, paired isolates will be sent to the to DUMC Microbiology Laboratory for further resistance testing.
Fulbright Clinical Staging Study
Evaluation of Clinical Staging Criteria of HIV Infection in the Kilimanjaro Region of Tanzania
This study seeks to evaluate the WHO clinical staging criteria and to develop more regionally relevant criteria for staging HIV infection based on simple laboratory tests and clinical examination. To date, 170 subjects have enrolled, with plans to begin final data analysis after enrolling 200. Dr. Susan Morpeth (Duke Infectious Diseases Fellow) presented preliminary analysis of this study at the 12 th Conference on Retroviruses and Opportunistic Infections in Boston in February 2005.
KCMC IDC Databases
Kilimanjaro Christian Medical Centre (KCMC) Adult and Pediatric HIV Clinic Databases
With the assistance of Tereza Martinu, a Duke Internal Medicine Resident, the Adult IDC survey instrument has recently been refined. This will now capture sociodemographic and clinical data among patients being treated in the KCMC Infectious Diseases Clinic (IDC). Keren Landman has developed a similar instrument for use in the Pediatric IDC.
Antiretroviral Drug Adherence and Resistance Study (ADAR)
Predictors of Emerging Virologic Failure and Resistance among HIV-Infected Patients Treated With Fixed Dose Combination Stavudine/ Lamivudine/Nevirapine in Northern Tanzania
This study has just been approved by Duke IRB, KCMC Ethics Committee, and should be approved very soon by the Tanzanian National Institute of Medical Research. Funding is anticipated from the Duke Center for AIDS Research for this study which will evaluate 150 HIV-infected patients who have taken fixed dose combination stavudine/lamivudine/nevirapine (e.g. Triomune) for at least six months. Dr. Feng Gao, in the Human Vaccine Institute, will assist with the molecular work required to measure plasma HIV RNA levels, identify resistance mutations, and subtype HIV virus. Adherence will be assessed with an instrument previously validated in sub-Saharan Africa, and a detailed questionnaire will address potential psychosocial and economic factors associated with maladherence.
KIWAKKUKI VCT
KIWAKKUKI HIV Voluntary Counseling and Testing Project
Since its inception, over 3,000 clients have received HIV testing at the Moshi AIDS Information Centre at KIWAKKUKI (a community-based AIDS service organization serving the Kilimanjaro Region). Approximately 250 new clients present for testing each month. The sociodemographic and HIV risk behavior characteristics of the first 811 clients presenting to this program are described in a forthcoming issue of the International Journal of STDS and AIDS authored by Duke medical student, Helen Chu. An additional paper describing the cost effectiveness of a brief free VCT campaign and of sustained free VCT has been accepted for publication by the American Journal of Public Health . Keren Landman, a third year medical student, will be presenting data describing risk factors for the low HIV treatment literacy (11%) observed among these clients at the 3rd International AIDS Society Conference on HIV Pathogenesis and Treatment in Rio de Janeiro, Brazil in July 2005. Duke Internal Medicine Resident, Holly Rawizza, recently assisted with implementing a new unique identification system at KIWAKKUKI to enable more efficient tracking for repeat testers. Further revisions to the survey instrument will begin to assess partner relationships, including sexual concurrency and domestic violence, as potential risk factors for HIV infection.
KIWAKKUKI QuantiFERON Study
Evaluation of an ESAT-6 and CFP-10 Based Whole Blood IFN-? Assay
(QuantiFERON-TB GOLD) for the Diagnosis of Tuberculosis Among Tanzanian Patients Co-Infected with HIV
This study, which was performed by Duke Internal Medicine resident Chetan Seshadri, was completed one year ago. An abstract describing the diagnostic utility of QuantiFERON-TB GOLD in this setting has been accepted for presentation at the International AIDSSociety meeting in Rio in July 2006.
KIWAKKUKI HBC Study
Clinical Characteristics of HIV Home Based Care Clients in the Kilimanjaro Region of Tanzania
This study, which builds upon a past quality improvement survey done at KIWAKKUKI for their home-based care program 18 months ago, is now systematically resurveying HIV-infected clients to assess for disease progression and interim interactions with the health care system. 85 out of around 300 planned surveys have been returned by KIWAKKUKI home-based carers.
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