South Africa has the highest burden of HIV worldwide and has a rapidly growing MDR TB epidemic which threatens recent gains in TB and HIV care and treatment. Until recently, MDR TB was treated at centralized TB referral hospitals, with patients admitted for the full 6-month intensive phase. However, with growing numbers of MDR TB patients and limited healthcare infrastructure, the centralized MDR TB program is no longer a sustainable approach for providing treatment. Our research group recently designed and implemented an integrated home-based treatment program for MDR TB and HIV in a rural area of KwaZulu-Natal province, South Africa. Patients receive concomitant treatment for MDR TB and HIV at home by a visiting nurse who provides daily injections and observes administration of oral TB and antiretroviral medications. Intensive adverse event monitoring, patient treatment literacy education and adherence support are essential components. Although this program has recently been implemented, it has not been formally evaluated. In this application, we propose a prospective observational cohort study to examine the feasibility, effectiveness, and safety of the integrated home-based treatment program for MDR TB and HIV. We will enroll 100 MDR TB and HIV co-infected patients receiving care in the program. Our study involves: (1) a quantitative assessment of feasibility (including completion of home-visits, injections, adverse event monitoring, and laboratory testing), (2) comparison of mortality and treatment outcomes to patients treated in an inpatient program, (3) characterization of adverse events, and (4) identification of predictors of survival. The candidate is an Assistant Professor of Medicine at Albert Einstein College of Medicine and Montefiore Medical Center, whose long-term goal is to become an independent investigator studying drug- resistant TB and HIV in international, resource-limited settings. His short-term goals are to broaden his expertise in international clinical research, expand his proficiency in epidemiologic and biostatistical research methods, and further his understanding of clinical TB management and diagnostics. He has substantial experience in conducting clinical research in HIV and TB in South Africa. This project will take place at the Church of Scotland Hospital in Tugela Ferry, South Africa, with the support of Dr. Gerald Friedland, an internationally recognized HIV/TB investigator, and a team of highly experienced co-mentors and collaborators from both the US and South Africa.

Public Health Relevance

As the first prospective evaluation of integrated, home-based treatment for MDR TB and HIV in a high-HIV prevalence area of the world, our study has the potential to provide evidence for a new model of treatment for other resource-limited settings.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Mentored Patient-Oriented Research Career Development Award (K23)
Project #
5K23AI083088-04
Application #
8454557
Study Section
Acquired Immunodeficiency Syndrome Research Review Committee (AIDS)
Program Officer
Decarlo, Ellen S
Project Start
2010-05-01
Project End
2015-04-30
Budget Start
2013-05-01
Budget End
2014-04-30
Support Year
4
Fiscal Year
2013
Total Cost
$132,952
Indirect Cost
$9,552
Name
Albert Einstein College of Medicine
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
110521739
City
Bronx
State
NY
Country
United States
Zip Code
10461
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Brust, James C M; Shah, N Sarita; van der Merwe, Theo L et al. (2013) Adverse events in an integrated home-based treatment program for MDR-TB and HIV in KwaZulu-Natal, South Africa. J Acquir Immune Defic Syndr 62:436-40

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