Mycobacterium tuberculosis (TB) remains the leading cause of death among persons living with human immunodeficiency virus and acquired immunodeficiency syndrome (HIV/AIDS) in southern Africa. This syndemic has resulted in an overwhelming burden for healthcare workers and the healthcare system. Drug- resistant TB remains a growing threat to public health despite advances in treatment and diagnosis over the past decade. South Africa has the world highest rate of TB/HIV co-infection and ranks fourth worldwide for multi-drug resistant (MDR) TB incidence and HIV prevalence. Treatment of MDR-TB, defined as resistance to isoniazid and rifampin, remains challenging and complex and success of second line treatment regimens is considerably less likely. Prospective cohort studies from South Africa report less than 50% treatment success (i.e. cure/completion) and marked differences between patients with and without HIV. International and South Africa specific MDR-TB guidelines recommend integration with HIV treatment programs and movement toward community-based programs within the primary care system. Although heralded as a major success by the HIV and TB treatment communities, implementation of TB/HIV integration in a community-based platform is much more challenging, requiring clinicians to navigate both HIV and MDR-TB treatment guidelines, overlapping drug toxicities and parallel care systems potentially leading to greater fragmentation of care. Nurse case management (NCM) models in which a registered nurse coordinates treatment plans to ensure that appropriate and timely care is given have been shown to improve treatment outcomes. There is little evidence to describe NCM of MDR-TB/HIV co-infected patients by registered nurses globally, and specifically MDR- TB/HIV in sub-Saharan Africa. The proposed 5-year interdisciplinary cluster randomized study will determine the impact and cost-effectiveness of a NCM intervention on MDR-TB treatment outcomes in South Africa, the epicenter of the MDR-TB/HIV epidemics. We hypothesize that the NCM intervention sites will report increased cure/completion rates of MDR-TB among patients with and without HIV compared to control sites. Sampling 10 clusters with 300 subjects each (1500 per group), achieves 88% power to detect a difference between the groups of 0.18; a clinically meaningful difference in MDR-TB treatment outcomes. The Chronic Care Model (CCM) identifies essential elements of a health care system that encourage high-quality chronic disease care in a bundled approach. These elements provided the conceptual framework for the proposed NCM intervention, a multi-faceted systems level intervention bundle to improve MDR-TB/HIV treatment outcomes. The proposed study is innovative and significant as it will translate a NCM intervention within the proven CCM framework in a low resource setting with a robust cost-effectiveness analysis. The study is globally relevant as it addresses the essential question of how can the implementation of TB/HIV integration occur in an evidence- based and sustainable manner.

Public Health Relevance

Tuberculosis (TB) remains the leading cause of death among persons living with HIV and AIDS. Drug resistant forms of the bacteria are growing among this population and a considerable disparity exists in treatment outcomes between those with and without HIV. This study will evaluate a nurse case management intervention to determine the impact on drug-resistant TB treatment outcomes in South Africa.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project (R01)
Project #
5R01AI104488-02
Application #
8770022
Study Section
AIDS Clinical Studies and Epidemiology Study Section (ACE)
Program Officer
Huebner, Robin E
Project Start
2013-12-01
Project End
2018-11-30
Budget Start
2014-12-01
Budget End
2015-11-30
Support Year
2
Fiscal Year
2015
Total Cost
Indirect Cost
Name
Johns Hopkins University
Department
Other Health Professions
Type
Schools of Nursing
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21205
Hong, Hyejeong; Budhathoki, Chakra; Farley, Jason E (2018) Effectiveness of macronutrient supplementation on nutritional status and HIV/AIDS progression: A systematic review and meta-analysis. Clin Nutr ESPEN 27:66-74
Hong, H; Budhathoki, C; Farley, J E (2018) Increased risk of aminoglycoside-induced hearing loss in MDR-TB patients with HIV coinfection. Int J Tuberc Lung Dis 22:667-674
Whitehouse, E; Lai, J; Golub, J E et al. (2018) A systematic review of the effectiveness of smoking cessation interventions among patients with tuberculosis. Public Health Action 8:37-49
van de Water, Brittney J; Prvu Bettger, Janet; Silva, Susan et al. (2017) Time to Drug-Resistant Tuberculosis Treatment in a Prospective South African Cohort. Glob Pediatr Health 4:2333794X17744140
Kelly, A M; Smith, B; Luo, Z et al. (2016) Discordance between patient and clinician reports of adverse reactions to MDR-TB treatment. Int J Tuberc Lung Dis 20:442-7
Farley, Jason E; Hayat, Matthew J; Sacamano, Paul L et al. (2015) Prevalence and risk factors for methicillin-resistant Staphylococcus aureus in an HIV-positive cohort. Am J Infect Control 43:329-35
Farley, Jason E; Kelly, Ana M; Reiser, Katrina et al. (2014) Development and evaluation of a pilot nurse case management model to address multidrug-resistant tuberculosis (MDR-TB) and HIV in South Africa. PLoS One 9:e111702