A Nurse Case Management Intervention to Improve MDR-TB/HIV Co-Infection Outcomes
NCT ID: NCT02129244
Last Updated: 2026-01-07
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
NA
Total Enrollment
3600 participants
Study Classification
INTERVENTIONAL
Study Start Date
2014-10-31
Study Completion Date
2026-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The researchers of this study are observing the treatment of multi-drug resistant Mycobacterium tuberculosis (MDR-TB) in South Africa. MDR-TB can not be treated with the usual TB drugs and needs to be treated with special drugs. The patients need to take these drugs for up to two years. Certain hospitals have already agreed to participate in this research project, half of the hospitals will be assigned a nurse case manager and the other half will not. The researchers are studying the benefits of having a nurse case manager to improve treatment response for patients with drug resistant TB. The researchers believe that nurse case management (NCM) in the intervention sites will increase MDR-TB cure and completion rates (i.e. treatment success) in comparison to usual care (UC), i.e. standardized programmatic management alone, in patients with and without HIV co-infection. To do this, the researchers will review the medical information collected at the hospital as part of the patient's treatment after obtaining the patient's permission.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Tuberculosis Prevention for HIV Infected Adults
NCT00057122
HIV Infections
Tuberculosis
COMPLETED
PHASE3
The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB
NCT02409290
MDR-TB
COMPLETED
PHASE3
Bring BPaL2Me Trial Comparing Nurse-Led RR-TB Treatment to Physician-Led RR-TB Treatment
NCT05671718
Drug Resistant Tuberculosis
RECRUITING
NA
The Individualized M(X) Drug-resistant TB Treatment Strategy Study
NCT03237182
Tuberculosis, Multidrug-Resistant
TERMINATED
PHASE4
Comparative Effectiveness/Implementation of TB Case Finding in Rural South Africa
NCT02808507
Tuberculosis
COMPLETED
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Mycobacterium tuberculosis (TB) remains the leading cause of death among persons living with Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS) in southern Africa. This syndemic places an overwhelming burden on healthcare workers and the health 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's highest rate of TB/HIV co-infection and ranks fourth worldwide for both multi-drug resistant (MDR) TB incidence and HIV prevalence. Treatment of MDR-TB, defined as resistance to isoniazid and rifampin, remains challenging and its treatment course complex. Success of second line treatment regimens is considerably less likely than first line treatment with significantly more adverse drug reactions (ADRs). Prospective cohort studies from South Africa report less than 50% treatment success (i.e. cure or completion) and significant differences in patients with and without HIV are noted. Differences in sex and gender as well as age are rarely evaluated. In addition to the management complexity and length of treatment, systems level factors such as access to care and healthcare capacity contribute to poorer treatment outcomes. Insufficient numbers of trained physicians capable and clinically competent to manage the challenges of integrated MDR-TB/HIV care are commonplace. These circumstances place a heavy burden on the most abundant healthcare resource in South Africa, the nurse. Nurses with proficiency in care models for both diseases are essential to improve treatment outcomes. The investigators experience dictates, however, that patients endure lengthy treatment with little assessment, support or guidance from nursing professionals due to a lack of training as well as lack of evidence-based interventions and delineated models of care for MDR-TB patients.
Nurse case management (NCM) models in which a registered nurse facilitates and coordinates treatment plans to ensure that timely, evidence-based care is given improves treatment outcomes. Presently, there is little evidence to describe such models in TB/HIV co-infected patients globally, and specifically less evidence for MDR-TB/HIV in sub-Saharan Africa. Many studies, however, have demonstrated substantial improvements in disease outcomes utilizing nurse case managers. Complex diseases such as heart failure, diabetes, HIV and drug susceptible TB are among these. Substantial gaps remain, however, in the investigators understanding of the impact of such interventions among co-infected patients, the influence of such models among different age groups or the cost-benefit in under resourced settings. Prior studies provide strong evidence that interventions must be multi-faceted and foster system level approaches to improve treatment outcomes (i.e. NCM patient-centered care services coupled with systems level approaches to care coordination). The Chronic Care Model identifies essential elements of a health care system that encourage high-quality chronic disease care in such a systems approach. These elements provide the conceptual model and implementation structure for the proposed NCM plus health systems strengthening (i.e. NCM-plus) intervention, a multi-faceted health systems and patient-centered intervention to improve MDR-TB/HIV treatment outcomes. The proposed 5-year cluster randomized trial, will evaluate the NCM-plus intervention on MDR-TB treatment outcomes in South Africa, the epicenter of the MDR-TB/HIV epidemic.
Primary Aim:
To determine the impact of a NCM model (i.e. NCM-Plus) on MDR-TB outcomes in patients with and without HIV co-infection in South Africa through a cluster randomized trial.
Hypothesis:
Nurse case management (NCM) in intervention sites will increase MDR-TB cure and completion rates (i.e. treatment success) in comparison to usual care (UC), i.e. standardized programmatic management alone, in patients with and without HIV co-infection.
Secondary Aims:
1. To conduct sub-group analysis by a) HIV co-infection; b) sex and gender; and c) age
2. To compare the frequency and time to identification of adverse drug events between intervention and control sites.
3. To conduct a costing analysis and a cost-effectiveness evaluation of the intervention.
Nurse case management (NCM) models in which a registered nurse facilitates and coordinates treatment plans to ensure that timely, evidence-based care is given improves treatment outcomes. Presently, there is little evidence to describe such models in TB/HIV co-infected patients globally, and specifically less evidence for MDR-TB/HIV in sub-Saharan Africa. Many studies, however, have demonstrated substantial improvements in disease outcomes utilizing nurse case managers. Complex diseases such as heart failure, diabetes, HIV and drug susceptible TB are among these. Substantial gaps remain, however, in the investigators understanding of the impact of such interventions among co-infected patients, the influence of such models among different age groups or the cost-benefit in under resourced settings. Prior studies provide strong evidence that interventions must be multi-faceted and foster system level approaches to improve treatment outcomes (i.e. NCM patient-centered care services coupled with systems level approaches to care coordination). The Chronic Care Model identifies essential elements of a health care system that encourage high-quality chronic disease care in such a systems approach. These elements provide the conceptual model and implementation structure for the proposed NCM plus health systems strengthening (i.e. NCM-plus) intervention, a multi-faceted health systems and patient-centered intervention to improve MDR-TB/HIV treatment outcomes. The proposed 5-year cluster randomized trial, will evaluate the NCM-plus intervention on MDR-TB treatment outcomes in South Africa, the epicenter of the MDR-TB/HIV epidemic.
Primary Aim:
To determine the impact of a NCM model (i.e. NCM-Plus) on MDR-TB outcomes in patients with and without HIV co-infection in South Africa through a cluster randomized trial.
Hypothesis:
Nurse case management (NCM) in intervention sites will increase MDR-TB cure and completion rates (i.e. treatment success) in comparison to usual care (UC), i.e. standardized programmatic management alone, in patients with and without HIV co-infection.
Secondary Aims:
1. To conduct sub-group analysis by a) HIV co-infection; b) sex and gender; and c) age
2. To compare the frequency and time to identification of adverse drug events between intervention and control sites.
3. To conduct a costing analysis and a cost-effectiveness evaluation of the intervention.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
MDR-TB
HIV
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
NCM Plus Intervention
The researchers designed the NCM-Plus intervention by integrating the domains of the Chronic Care Model with added attention to linkage to care, building on evidence-based guidelines and the team's pilot findings. In the NCM bundle, the researchers provide extensive details on both proximal and distal outcome variables. Nurse case managers will be hired and trained to improve disease management for patients with MDR-TB and HIV. Specific measurable responsibilities will be implemented by each NCM at sites randomized to receive the intervention. The NCM-patient interaction will occur at the MDR-TB treatment inpatient or outpatient facility.
Group Type
ACTIVE_COMPARATOR
NCM-Plus
Intervention Type
OTHER
The NCM will follow the domains of the chronic care model by:
1. Assuring effective, efficient clinical care and self-management support
2. Promoting clinical care consistent with scientific evidence and patient preferences
3. Organizing data to facilitate efficient, effective care
4. Empowering and preparing patients to manage their health and health-care needs
5. Mobilizing community resources to meet the needs of patients
Standard/Usual Care
Usual care is defined as standardized programmatic management of MDR-TB/HIV without care coordination. Nurses are present as part of the team, but with no special coordination role, leaving the MDR-TB physician solely responsible for treatment outcomes with little support. Physicians see patients weekly during the intensive phase and the patient receives basic daily nursing care without coordination of care, active monitoring of Adverse Drug Reactions (ADR)s or HIV care integration. This care transitions to monthly visits with the physician in the continuation phase, again with very little nursing involvement in care coordination.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
NCM-Plus
The NCM will follow the domains of the chronic care model by:
1. Assuring effective, efficient clinical care and self-management support
2. Promoting clinical care consistent with scientific evidence and patient preferences
3. Organizing data to facilitate efficient, effective care
4. Empowering and preparing patients to manage their health and health-care needs
5. Mobilizing community resources to meet the needs of patients
Intervention Type
OTHER
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Center (Cluster Level)
1. MDR-TB Centers in KwaZulu-Natal (KZN) or Eastern Cape (EC), South Africa providing standardized
2. MDR-TB regimen according to National Department of Health guidelines
3. Facility has provided MDR-TB care for a minimum of 6 months at study initiation
4. MDR-TB Centers with facility-based access to anti-retroviral therapy
5. Facility willingness to participate in the study
* Individual (Patient Level)
1. Patients 18 years of age and older, with microbiologically confirmed MDR- TB, admitted to receive inpatient care at a participating hospital who signs informed consent within 7 days of admission.
2. Patients 13 - 17 years of age, with microbiologically confirmed MDR- TB, who provide consent for study team to contact parent or legal guardian and when patient is willing and parent or legal guardian provides approval for study participation within 7 days of admission.
1. MDR-TB Centers in KwaZulu-Natal (KZN) or Eastern Cape (EC), South Africa providing standardized
2. MDR-TB regimen according to National Department of Health guidelines
3. Facility has provided MDR-TB care for a minimum of 6 months at study initiation
4. MDR-TB Centers with facility-based access to anti-retroviral therapy
5. Facility willingness to participate in the study
* Individual (Patient Level)
1. Patients 18 years of age and older, with microbiologically confirmed MDR- TB, admitted to receive inpatient care at a participating hospital who signs informed consent within 7 days of admission.
2. Patients 13 - 17 years of age, with microbiologically confirmed MDR- TB, who provide consent for study team to contact parent or legal guardian and when patient is willing and parent or legal guardian provides approval for study participation within 7 days of admission.
Exclusion Criteria
* Persons who present to the MDR-TB ward who have started MDR-TB treatment prior to admission.
* Children, less than 13 years of age; only one participating center has an MDR-TB wards for children under 13.
* Persons who are unable or unwilling to provide informed consent for participation
* Any patient enrolled in another clinical trial that changes standard MDR- TB or HIV care.
* Children, less than 13 years of age; only one participating center has an MDR-TB wards for children under 13.
* Persons who are unable or unwilling to provide informed consent for participation
* Any patient enrolled in another clinical trial that changes standard MDR- TB or HIV care.
Minimum Eligible Age
13 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institutes of Health (NIH)
NIH
Sponsor Role
collaborator
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Sponsor Role
collaborator
Medical Research Council, South Africa
OTHER
Sponsor Role
collaborator
Johns Hopkins University
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jason E Farley, PhD, MPH, NP
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Regus Primary Office
Westville, Durban, South Africa
Site Status
Catherine Booth Hospital
aMatikulu, KwaZulu-Natal, South Africa
Site Status
Don McKenzie
Durban, , South Africa
Site Status
King George V Hospital
Durban, , South Africa
Site Status
Fort Gray Hospital
East London, , South Africa
Site Status
Dunstan Farrell Hospital
Hibberdene, , South Africa
Site Status
Hlabisa Hospital
Hlabisa, , South Africa
Site Status
Manguzi
Manguzi, , South Africa
Site Status
Nkqubela
Mdantsane, , South Africa
Site Status
Fosa Hospital
Newlands West, , South Africa
Site Status
Doris Goodwin Hospital
Pietermaritzburg, , South Africa
Site Status
Marjorie Parrish Hospital
Port Alfred, , South Africa
Site Status
Jose Pearson Hospital
Port Elizabeth, , South Africa
Site Status
Murchison Hospital
Port Shepstone, , South Africa
Site Status
St Margaret's MDR-TB Hopsital
Umzimkulu, , South Africa
Site Status
Countries
Review the countries where the study has at least one active or historical site.
South Africa
References
Explore related publications, articles, or registry entries linked to this study.
World Health Organization. Global Tuberculosis Control. WHO/HTM/TB/2010.7. 2010. Geneva, Switzerland.
Reference Type
BACKGROUND
Zeger SL, Liang KY. Longitudinal data analysis for discrete and continuous outcomes. Biometrics. 1986 Mar;42(1):121-30.
Reference Type
BACKGROUND
Gallop R, Small DS, Lin JY, Elliott MR, Joffe M, Ten Have TR. Mediation analysis with principal stratification. Stat Med. 2009 Mar 30;28(7):1108-30. doi: 10.1002/sim.3533.
Reference Type
BACKGROUND
World Health Organization. Multidrug and extensively drug-resistant TB (M/XDR-TB): 2010 global report on surveillance and response. [WHO/HTM/TB/2010.3]. 2010. World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland, WHO Press.
Reference Type
BACKGROUND
Orenstein EW, Basu S, Shah NS, Andrews JR, Friedland GH, Moll AP, Gandhi NR, Galvani AP. Treatment outcomes among patients with multidrug-resistant tuberculosis: systematic review and meta-analysis. Lancet Infect Dis. 2009 Mar;9(3):153-61. doi: 10.1016/S1473-3099(09)70041-6.
Reference Type
BACKGROUND
Johnston JC, Shahidi NC, Sadatsafavi M, Fitzgerald JM. Treatment outcomes of multidrug-resistant tuberculosis: a systematic review and meta-analysis. PLoS One. 2009 Sep 9;4(9):e6914. doi: 10.1371/journal.pone.0006914.
Reference Type
BACKGROUND
Farley JE, Ram M, Pan W, Waldman S, Cassell GH, Chaisson RE, Weyer K, Lancaster J, Van der Walt M. Outcomes of multi-drug resistant tuberculosis (MDR-TB) among a cohort of South African patients with high HIV prevalence. PLoS One. 2011;6(7):e20436. doi: 10.1371/journal.pone.0020436. Epub 2011 Jul 22.
Reference Type
BACKGROUND
Shean KP, Willcox PA, Siwendu SN, Laserson KF, Gross L, Kammerer S, Wells CD, Holtz TH. Treatment outcome and follow-up of multidrug-resistant tuberculosis patients, West Coast/Winelands, South Africa, 1992-2002. Int J Tuberc Lung Dis. 2008 Oct;12(10):1182-9.
Reference Type
BACKGROUND
Gandhi NR, Shah NS, Andrews JR, Vella V, Moll AP, Scott M, Weissman D, Marra C, Lalloo UG, Friedland GH; Tugela Ferry Care and Research (TF CARES) Collaboration. HIV coinfection in multidrug- and extensively drug-resistant tuberculosis results in high early mortality. Am J Respir Crit Care Med. 2010 Jan 1;181(1):80-6. doi: 10.1164/rccm.200907-0989OC. Epub 2009 Oct 15.
Reference Type
BACKGROUND
Somma D, Thomas BE, Karim F, Kemp J, Arias N, Auer C, Gosoniu GD, Abouihia A, Weiss MG. Gender and socio-cultural determinants of TB-related stigma in Bangladesh, India, Malawi and Colombia. Int J Tuberc Lung Dis. 2008 Jul;12(7):856-66.
Reference Type
BACKGROUND
O'Donnell MR, Zelnick J, Werner L, Master I, Loveday M, Horsburgh CR, Padayatchi N. Extensively drug-resistant tuberculosis in women, KwaZulu-Natal, South Africa. Emerg Infect Dis. 2011 Oct;17(10):1942-5. doi: 10.3201/eid1710.110105.
Reference Type
BACKGROUND
Vella V, Racalbuto V, Guerra R, Marra C, Moll A, Mhlanga Z, Maluleke M, Mhlope H, Margot B, Friedland G, Shah NS, Gandhi NR. Household contact investigation of multidrug-resistant and extensively drug-resistant tuberculosis in a high HIV prevalence setting. Int J Tuberc Lung Dis. 2011 Sep;15(9):1170-5, i. doi: 10.5588/ijtld.10.0781.
Reference Type
BACKGROUND
National Department of Health, South Africa. Decentralized Management of Multi-Drug Resistant Tuberculosis: A Policy Framework for South Africa. 2011.
Reference Type
BACKGROUND
Welch G, Garb J, Zagarins S, Lendel I, Gabbay RA. Nurse diabetes case management interventions and blood glucose control: results of a meta-analysis. Diabetes Res Clin Pract. 2010 Apr;88(1):1-6. doi: 10.1016/j.diabres.2009.12.026. Epub 2010 Feb 8.
Reference Type
BACKGROUND
Nyamathi A, Nahid P, Berg J, Burrage J, Christiani A, Aqtash S, Morisky D, Leake B. Efficacy of nurse case-managed intervention for latent tuberculosis among homeless subsamples. Nurs Res. 2008 Jan-Feb;57(1):33-9. doi: 10.1097/01.NNR.0000280660.26879.38.
Reference Type
BACKGROUND
Del Sindaco D, Pulignano G, Minardi G, Apostoli A, Guerrieri L, Rotoloni M, Petri G, Fabrizi L, Caroselli A, Venusti R, Chiantera A, Giulivi A, Giovannini E, Leggio F. Two-year outcome of a prospective, controlled study of a disease management programme for elderly patients with heart failure. J Cardiovasc Med (Hagerstown). 2007 May;8(5):324-9. doi: 10.2459/JCM.0b013e32801164cb.
Reference Type
BACKGROUND
Anaya HD, Hoang T, Golden JF, Goetz MB, Gifford A, Bowman C, Osborn T, Owens DK, Sanders GD, Asch SM. Improving HIV screening and receipt of results by nurse-initiated streamlined counseling and rapid testing. J Gen Intern Med. 2008 Jun;23(6):800-7. doi: 10.1007/s11606-008-0617-x. Epub 2008 Apr 18.
Reference Type
BACKGROUND
Andersen MD, Smereck GA, Hockman EM, Ross DJ, Ground KJ. Nurses decrease barriers to health care by "hyperlinking" multiple-diagnosed women living with HIV/AIDS into care. J Assoc Nurses AIDS Care. 1999 Mar-Apr;10(2):55-65. doi: 10.1016/S1055-3290(06)60299-9.
Reference Type
BACKGROUND
Schumann A, Nyamathi A, Stein JA. HIV risk reduction in a nurse case-managed TB and HIV intervention among homeless adults. J Health Psychol. 2007 Sep;12(5):833-43. doi: 10.1177/1359105307080618.
Reference Type
BACKGROUND
Nyamathi AM, Christiani A, Nahid P, Gregerson P, Leake B. A randomized controlled trial of two treatment programs for homeless adults with latent tuberculosis infection. Int J Tuberc Lung Dis. 2006 Jul;10(7):775-82.
Reference Type
BACKGROUND
Hsieh CJ, Lin LC, Kuo BI, Chiang CH, Su WJ, Shih JF. Exploring the efficacy of a case management model using DOTS in the adherence of patients with pulmonary tuberculosis. J Clin Nurs. 2008 Apr;17(7):869-75. doi: 10.1111/j.1365-2702.2006.01924.x.
Reference Type
BACKGROUND
Wagner EH, Glasgow RE, Davis C, Bonomi AE, Provost L, McCulloch D, Carver P, Sixta C. Quality improvement in chronic illness care: a collaborative approach. Jt Comm J Qual Improv. 2001 Feb;27(2):63-80. doi: 10.1016/s1070-3241(01)27007-2.
Reference Type
BACKGROUND
Wagner EH, Bennett SM, Austin BT, Greene SM, Schaefer JK, Vonkorff M. Finding common ground: patient-centeredness and evidence-based chronic illness care. J Altern Complement Med. 2005;11 Suppl 1:S7-15. doi: 10.1089/acm.2005.11.s-7.
Reference Type
BACKGROUND
Institute of Medicine (US) Committee on Envisioning a Strategy for the Long-Term Burden of HIV/AIDS: African Needs and U.S. Interests. Preparing for the Future of HIV/AIDS in Africa: A Shared Responsibility. Washington (DC): National Academies Press (US); 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK209740/
Reference Type
BACKGROUND
Joint United Nations Programme on HIV/AIDS (UNAIDS). Global Report: UNAIDS Report on the Global AIDS Epidemic, 2010. UNAIDS/10.11E | JC1958E. 2010.
Reference Type
BACKGROUND
National Department of Health, South Africa. Decentalized Management of Multi-Drug Resistant Tuberculosis: A Policy Framework for South Africa. 2010.
Reference Type
BACKGROUND
Department of Labour. The shortage of Medical Doctors in South Africa: Scarce and critical skills research project. 1-30-2009.
Reference Type
BACKGROUND
National Department of Health, South Africa. Programmatic Management of Multi-Drug Resistant Tuberculosis: Emergency Update. 2008.
Reference Type
BACKGROUND
Campbell MK, Mollison J, Grimshaw JM. Cluster trials in implementation research: estimation of intracluster correlation coefficients and sample size. Stat Med. 2001 Feb 15;20(3):391-9. doi: 10.1002/1097-0258(20010215)20:33.0.co;2-z.
Reference Type
BACKGROUND
Laserson KF, Thorpe LE, Leimane V, Weyer K, Mitnick CD, Riekstina V, Zarovska E, Rich ML, Fraser HS, Alarcon E, Cegielski JP, Grzemska M, Gupta R, Espinal M. Speaking the same language: treatment outcome definitions for multidrug-resistant tuberculosis. Int J Tuberc Lung Dis. 2005 Jun;9(6):640-5.
Reference Type
BACKGROUND
Brust JC, Gandhi NR, Carrara H, Osburn G, Padayatchi N. High treatment failure and default rates for patients with multidrug-resistant tuberculosis in KwaZulu-Natal, South Africa, 2000-2003. Int J Tuberc Lung Dis. 2010 Apr;14(4):413-9.
Reference Type
BACKGROUND
Lin RL, Lin FJ, Wu CL, Peng MJ, Chen PJ, Kuo HT. Effect of a hospital-based case management approach on treatment outcome of patients with tuberculosis. J Formos Med Assoc. 2006 Aug;105(8):636-44. doi: 10.1016/S0929-6646(09)60162-5.
Reference Type
BACKGROUND
Nathanson E, Nunn P, Uplekar M, Floyd K, Jaramillo E, Lonnroth K, Weil D, Raviglione M. MDR tuberculosis--critical steps for prevention and control. N Engl J Med. 2010 Sep 9;363(11):1050-8. doi: 10.1056/NEJMra0908076. No abstract available.
Reference Type
BACKGROUND
Department of Health. Management of Drug Resistant Tuberculosis: Policy Guidelines. i-151. 8-1-2012.
Reference Type
BACKGROUND
Department of Health. National Strategic Plan on HIV, STIs and TB (2012-2016). 1-78. 12-1-2012.
Reference Type
BACKGROUND
Boulle A, Clayden P, Cohen K, Cohen T, Conradie F, Dong K, Geffen N, Grimwood A, Hurtado R, Kenyon C, Lawn S, Maartens G, Meintjes G, Mendelson M, Murray M, Rangaka M, Sanne I, Spencer D, Taljaard J, Variava E, Venter WD, Wilson D. Prolonged deferral of antiretroviral therapy in the SAPIT trial: did we need a clinical trial to tell us that this would increase mortality? S Afr Med J. 2010 Sep 7;100(9):566, 568, 570-1. doi: 10.7196/samj.4434. No abstract available.
Reference Type
BACKGROUND
Dheda K, Lampe FC, Johnson MA, Lipman MC. Outcome of HIV-associated tuberculosis in the era of highly active antiretroviral therapy. J Infect Dis. 2004 Nov 1;190(9):1670-6. doi: 10.1086/424676. Epub 2004 Sep 29.
Reference Type
BACKGROUND
National Department of Health, South Africa. The South African Antiretroviral Treatement Guidelines 2010. 2010. 2010.
Reference Type
BACKGROUND
Iseman MD. Treatment and implications of multidrug-resistant tuberculosis for the 21st century. Chemotherapy. 1999;45 Suppl 2:34-40. doi: 10.1159/000048480.
Reference Type
BACKGROUND
Weyer K, Brand J, Lancaster J, Levin J, van der Walt M. Determinants of multidrug-resistant tuberculosis in South Africa: results from a national survey. S Afr Med J. 2007 Nov;97(11 Pt 3):1120-8. No abstract available.
Reference Type
BACKGROUND
Amuha MG, Kutyabami P, Kitutu FE, Odoi-Adome R, Kalyango JN. Non-adherence to anti-TB drugs among TB/HIV co-infected patients in Mbarara Hospital Uganda: prevalence and associated factors. Afr Health Sci. 2009 Aug 1;9 Suppl 1(Suppl 1):S8-15.
Reference Type
BACKGROUND
Swaminathan S, Narendran G, Venkatesan P, Iliayas S, Santhanakrishnan R, Menon PA, Padmapriyadarsini C, Ramachandran R, Chinnaiyan P, Suhadev M, Sakthivel R, Narayanan PR. Efficacy of a 6-month versus 9-month intermittent treatment regimen in HIV-infected patients with tuberculosis: a randomized clinical trial. Am J Respir Crit Care Med. 2010 Apr 1;181(7):743-51. doi: 10.1164/rccm.200903-0439OC. Epub 2009 Dec 3.
Reference Type
BACKGROUND
Cramm JM, Finkenflugel HJ, Moller V, Nieboer AP. TB treatment initiation and adherence in a South African community influenced more by perceptions than by knowledge of tuberculosis. BMC Public Health. 2010 Feb 17;10:72. doi: 10.1186/1471-2458-10-72.
Reference Type
BACKGROUND
Kliiman K, Altraja A. Predictors and mortality associated with treatment default in pulmonary tuberculosis. Int J Tuberc Lung Dis. 2010 Apr;14(4):454-63.
Reference Type
BACKGROUND
Holtz TH, Lancaster J, Laserson KF, Wells CD, Thorpe L, Weyer K. Risk factors associated with default from multidrug-resistant tuberculosis treatment, South Africa, 1999-2001. Int J Tuberc Lung Dis. 2006 Jun;10(6):649-55.
Reference Type
BACKGROUND
Gardam M, Verma G, Campbell A, Wang J, Khan K. Impact of the patient-provider relationship on the survival of foreign born outpatients with tuberculosis. J Immigr Minor Health. 2009 Dec;11(6):437-45. doi: 10.1007/s10903-008-9221-8. Epub 2009 Jan 6.
Reference Type
BACKGROUND
Bloss E, Kuksa L, Holtz TH, Riekstina V, Skripconoka V, Kammerer S, Leimane V. Adverse events related to multidrug-resistant tuberculosis treatment, Latvia, 2000-2004. Int J Tuberc Lung Dis. 2010 Mar;14(3):275-81.
Reference Type
BACKGROUND
National Department of Health, South Africa. Decentralized Management of Multi-Drug Resistant Tuberculosis: A Policy Framework for South Africa (Draft). 2010.
Reference Type
BACKGROUND
Guidelines for the Programmatic Management of Drug-Resistant Tuberculosis: 2011 Update. Geneva: World Health Organization; 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK148644/
Reference Type
BACKGROUND
Wagner EH, Austin BT, Davis C, Hindmarsh M, Schaefer J, Bonomi A. Improving chronic illness care: translating evidence into action. Health Aff (Millwood). 2001 Nov-Dec;20(6):64-78. doi: 10.1377/hlthaff.20.6.64.
Reference Type
BACKGROUND
Moulton LH. Covariate-based constrained randomization of group-randomized trials. Clin Trials. 2004;1(3):297-305. doi: 10.1191/1740774504cn024oa.
Reference Type
BACKGROUND
Institute of Healthcare Improvement. Improving HIV Care: A Modular Quality Improvement Curriculum. Institue of Healthcare Improvemnet . 6-15-2011.
Reference Type
BACKGROUND
Farley JE, Alwood K, Davis JG, Stellenberg E, and van der Walt M. Development and Pilot Testing of MDR-TB/HIV In-Service Training in Rural KwaZulu Natal. National Education Association and Foundation of Nursing University Deans of South Africa Annual Conference . 10-15-2010.
Reference Type
BACKGROUND
Farley JE, Tudor C, Mphahlele M, Franz K, Perrin NA, Dorman S, Van der Walt M. A national infection control evaluation of drug-resistant tuberculosis hospitals in South Africa. Int J Tuberc Lung Dis. 2012 Jan;16(1):82-9. doi: 10.5588/ijtld.10.0791.
Reference Type
BACKGROUND
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
Reference Type
BACKGROUND
Roberts C, Roberts SA. Design and analysis of clinical trials with clustering effects due to treatment. Clin Trials. 2005;2(2):152-62. doi: 10.1191/1740774505cn076oa.
Reference Type
BACKGROUND
Campbell MK, Fayers PM, Grimshaw JM. Determinants of the intracluster correlation coefficient in cluster randomized trials: the case of implementation research. Clin Trials. 2005;2(2):99-107. doi: 10.1191/1740774505cn071oa.
Reference Type
BACKGROUND
Dumas JE, Lynch AM, Laughlin JE, Phillips Smith E, Prinz RJ. Promoting intervention fidelity. Conceptual issues, methods, and preliminary results from the EARLY ALLIANCE prevention trial. Am J Prev Med. 2001 Jan;20(1 Suppl):38-47. doi: 10.1016/s0749-3797(00)00272-5.
Reference Type
BACKGROUND
McNabb KC, Bergman AJ, Patil A, Lowensen K, Mthimkhulu N, Budhathoki C, Perrin N, Farley JE. Travel distance to rifampicin-resistant tuberculosis treatment and its impact on loss to follow-up: the importance of continued RR-TB treatment decentralization in South Africa. BMC Public Health. 2024 Feb 23;24(1):578. doi: 10.1186/s12889-024-17924-0.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RO1 104488-01A1
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
NA_00078899
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
The Utility of Intensified Case Finding Combined With a Package of Novel TB Diagnostics Using a Mobile Clinic in Africa
NCT01990274
COMPLETED
NA
Improving Retreatment Success (IMPRESS)
NCT02114684
COMPLETED
PHASE1/PHASE2
Effects of Interferon-Gamma on Cavitary Pulmonary Tuberculosis in the Lungs
NCT00201123
COMPLETED
PHASE2
Short-Course Anti-tuberculosis Regimens for Mild Spinal Tuberculosis
NCT06917495
NOT_YET_RECRUITING
PHASE2
Brief Bactericidal Activity of Anti-Tuberculosis Drugs
NCT02236078
COMPLETED
PHASE1
A Multiple Ascending Dose Study With a Dose Formulation Comparison Cohort to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBA-354 in Healthy Adult Subjects
NCT02606214
TERMINATED
PHASE1
Test to Treat TB: Impact of Sputum Sequencing-guided Individualised Therapy on Outcomes in Drug-resistant Tuberculosis
NCT05007795
NOT_YET_RECRUITING
NA
Strengthening Evidence on Optimal Multidrug-resistant Tuberculosis Treatment Regimens
NCT05871489
ACTIVE_NOT_RECRUITING
Interferon Gamma for Drug Resistant Tuberculosis
NCT00001407
COMPLETED
PHASE2
Diagnosis of Tuberculosis Infection in HIV Co-infected Children
NCT00541294
COMPLETED
PA-824-CL-007: Phase IIa Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis
NCT00567840
COMPLETED
PHASE2
Study to Evaluate H56:IC31 in Preventing Rate of TB Recurrence
NCT03512249
ACTIVE_NOT_RECRUITING
PHASE2
Post-Trial Tuberculosis Case Finding: A Substudy of CoVPN 3008
NCT06585683
COMPLETED
Improving the Diagnostic of Tuberculosis
NCT02861768
COMPLETED
NA
Faster Identification of TB and Evaluation of Drug Resistance in HIV-infected People
NCT00959088
COMPLETED
Xpert Active Case-finding Trial 2: Community-based Active Case-finding for Tuberculosis in South Africa
NCT03168945
COMPLETED
NA
Evaluation of Three Regimens of Chemoprophylaxis for Tuberculosis in Patients co-Infected by HIV and Mycobacterium Tuberculosis
NCT00402454
COMPLETED
PHASE4
Evaluation of a Rapid Point-of-Care Serological Triage Test for Active TB
NCT04752592
COMPLETED
NA
Safety, Tolerability, Extended Early Bactericidal Activity and PK of Higher Doses Rifampicin in Adults With Pulmonary TB
NCT01392911
COMPLETED
PHASE2
Short Course Regimen in Low Risk Active Tuberculosis- a Multicenter, Randomized, Active-controlled, Trial
NCT06727864
RECRUITING
PHASE3
Same Day Diagnosis of Extrapulmonary TB (TB Serositis and TB Meningitis).
NCT06135818
RECRUITING
NA
Testing New Strategies for Patients Hospitalised With HIV-associated Disseminated Tuberculosis
NCT04951986
ACTIVE_NOT_RECRUITING
PHASE3
Tuberculosis Treatment Shortening Trial
NCT00130247
COMPLETED
PHASE3
Point-of-care Triage Test for Active Tuberculosis
NCT04232618
UNKNOWN