Addressing challenges in scaling up TB and HIV treatment integration in public health settings in South Africa

Lead Research Organisation: Centre for the AIDS Programme of Research in South Africa
Department Name: UNLISTED

Abstract

Tuberculosis is the most common cause of death in people who are HIV-infected. Research has shown that when TB and HIV treatment and services are offered together there is a decrease in deaths for patients who have both these diseases. However, health care facilities in poor and developing countries struggle to efficiently provide both TB and HIV services to patients. We are testing whether an intervention for clinic staff, called ‘Quality Improvement’, will assist the staff to work in a more planned and structured manner to incorporate both TB and HIV services in their clinic and provide excellent quality of services. Our study will select 40 clinics from 2 rural districts in KwaZulu, South Africa and at random assign 20 clinics to receive the Quality Improvement intervention and 20 clinics to receive the standard support for delivering both TB and HIV services. We anticipate that clinics receiving the Quality Improvement intervention will have lower numbers of patient deaths from TB and HIV than those clinics receiving the standard support. Our study will inform how we can make combined TB and HIV services more manageable for clinics in poor and developing countries and so reduce deaths in TB and HIV patients.

Technical Summary

Tuberculosis (TB) and HIV prevalence is highest in sub-Saharan Africa, a region with limited health budgets, infrastructure, human resources, and suboptimal TB infection control practices. Persistently high rates of mortality and morbidity associated with HIV and TB continues to devastate families and overwhelm heath systems in South Africa. A large and compelling clinical evidence base suggests that integrating HIV and TB services improves survival in co-infected patients and presents a more effective & efficient use of limited health resources. Global policy makers have been responsive in translating research findings into TB HIV integration policy and recommendations, however there is a growing concern that the gains made in the field of TB HIV research will not be realized if not effectively translated into practice at the point-of-care. Implementing the full integrated TB HIV service ‘package’ at a health care facility level is not simple as very little is known about the best ‘scale up’ model for integrated TB HIV service delivery. This study is a cluster randomized controlled trial, which evaluates the effectiveness of implementing a quality improvement model to integrate TB HIV service delivery in primary health care clinics. The study will be conducted in 2 rural districts in KwaZulu-Natal, South Africa, namely the Ugu & uThungulu districts. Our hypothesis is that survival rates in TB and HIV infected patients accessing services in clinics using Quality Improvement methods to deliver comprehensive and reliable processes in implementing integrated TB HIV care, will be better than in patients accessing services in clinics provided with standard support for implementing TB HIV clinical guidelines. The anticipated eventual product arising from this study is a set of principles/model on how integrated TB HIV services maybe embedded in primary health care clinics in resource constrained settings. This study has the potential to elucidate which resources (inputs), processes (steps) and outputs lead to fully integrated TB HIV services hence impacting on improving the survival of co-infected patients.

People

ORCID iD

Publications

10 25 50
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Gengiah S (2021) A cluster-randomized controlled trial to improve the quality of integrated HIV-Tuberculosis services in Journal of the International AIDS Society (JIAS)

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Naidoo K (2019) Quality of TB care among people living with HIV: Gaps and solutions. in Journal of clinical tuberculosis and other mycobacterial diseases

 
Description Research in context Evidence before this study: Initially in 2013, Medline via PubMed was searched for articles published between 2003 and 2013 reporting on search terms: "epidemiology of HIV-TB co-infection"; "integrated HIV-TB care, TB case finding among people living with Human Immunodeficiency Virus HIV)/acquired immunodeficiency syndrome (AIDS) (PLWHA)"; "isoniazid preventive therapy (IPT) and antiretroviral therapy (ART) uptake"; and "strategies for improving TB outcomes among patients HIV-TB in resource limited settings", yielding 288 relevant published articles that suggested that co-location of TB and HIV services was alone insufficient to substantially improve integrated services, recommending additional interventions such as quality improvement (QI) targeting health systems performance improvements for evaluation. In 2015, an expanded search for articles published between 2003 and 2015, evaluating impact of QI mediated integrated TB and HIV services on improved patient outcomes, using the terms 'Quality Improvement' AND 'resource constrained' AND 'HIV' AND tuberculosis, OR TB yielded zero findings. Since our search, two new trials have been published: the Merge trial found no patient outcome improvement with placement of additional staff supporting integrated HIV-TB care, and the TB-Fast Track trial found no short-term mortality reduction among PLWHA despite substantial increases in TB diagnosis and treatment coverage. Evidence guiding "how to" effectively implement integrated services at the frontline will optimize implementation of integrated services and help address persistently high mortality rates among HIV-TB coinfected individuals in resource limited settings. Added value of this study This is the first randomized trial to test a scalable HIV-TB integration strategy using QI methods. Despite the intervention, similarly high mortality rates among HIVTB co-infected patients were found. Demonstrating mortality benefit from health systems process improvements in real-world operational settings remains challenging, with this study highlighting the high level of health systems planning and organization required for delivery of complex QI supported HIV-TB integration interventions. Having rural clinics with their existing facility staff participate in this research enabled a better understanding of whether the QI intervention could be translated irrespective of resources or setting. Despite failing to show an impact on HIV-TB mortality rates the study found the health system to be responsive to strategic implementation support, showing overall improvements in performance. Implications of all the available evidence Growing evidence shows that affordable and sustainable QI strategies offer strengthened integrated HIV-TB service delivery through establishment of clear guidelines that address weaknesses in PHC clinic systems. This trial evaluated the effect of QI intervention to optimise delivery of integrated TB and HIV services and improve patient health outcomes. Incorporation of QI strategies into routine support for PHC clinics to sustain improved patient health outcomes yielded no added benefit to patient outcomes.
First Year Of Impact 2016
Sector Healthcare
Impact Types Policy & public services

 
Description Advanced Clinical Care National Training Curriculum
Geographic Reach National 
Policy Influence Type Influenced training of practitioners or researchers
Impact The goal of ACC curriculum was to strengthen the South African governments' capacity in delivering high quality care to patients with complicated HIV and HIV/TB including those failing ART. Enhanced capacity through specialized clinical training, specialized clinical support, pharmaceutical services, laboratory services, strengthen referral pathways and collecting strategic information. This evolved into two streams : training around quality and case based approach . A national training ACC Curriculum was developed to provide health care professionals with the core knowledge and skills required to diagnose and manage unstable HIV patients with commonly observed opportunistic infections and other co-morbidities in addition to those failing antiretroviral therapy (ART). The curriculum consists of 4 main modules and 25 sub-modules (five of which are autodidactic pre-reading modules). 1. Module 1 - Core Topics, which encompassed the theoretical grounding in some key topics so that clinicians can apply this knowledge to clinical scenarios throughout the course 2. Module 2 - Management of the HIV-positive person with advanced disease. This module was designed to provide clinicians with the core knowledge and skills required to assess and manage an unstable patient with opportunistic infections and other comorbidities 3. Module 3 - Management of treatment failure and HIV drug resistance. This module is designed to equip clinicians with the core knowledge and skills required to identify and manage virologic failure and to be able to present practical management plans in specific clinical situations complicating virologic failure 4. Module 4 - Special challenges with antiretroviral therapy. This module will provide clinicians with the core knowledge and skills required to manage patients on ART with co-existing morbidities The training content developed included; slide sets, trainer manuals, learner manuals and knowledge assessment questions for each sub-module. These clinical resources were used to support the health care professionals in a clinic or hospital setting. Each training will orientate participants to these resources, and reference them throughout course activities.
URL https://www.knowledgehub.org.za
 
Description South African Clinician's Society Board
Geographic Reach Local/Municipal/Regional 
Policy Influence Type Influenced training of practitioners or researchers
Impact I have played a vital role in enhancing the knowledge and skills of South African healthcare workers, particularly those in the province of KwaZulu-Natal. The South African Clinicians Society holds a strong influence over clinical practices of the Treatment and Prevention of TB. I have provided input to the SA clinicians society based on the experience gained in the SUTHI trial.
 
Description WHO Clinical Guideline Development Group
Geographic Reach Multiple continents/international 
Policy Influence Type Membership of a guideline committee
Impact The Consolidated Guidelines on the use of Antiretroviral Drugs for treating and preventing HIV infection
 
Description WHO TB-HIV Technical Working Group
Geographic Reach Africa 
Policy Influence Type Membership of a guideline committee
Impact Contributions made as a member of the WHO TB-HIV Technical Working Group will potentially lead to a higher quality of care for TB, HIV and TB/HIV patients resource limited settings. Via the CAPRISA 013 study, we are in a position to share the best practices for enhancing integrated TB and HIV practices in Primary Healthcare Clinics.
 
Description MRC-CAPRISA HIV-TB Pathogenesis and Treatment Research Unit
Amount $829,871 (USD)
Organisation South African Medical Research Centre 
Sector Public
Country South Africa
Start 04/2015 
End 03/2025
 
Title A viral load monitoring standard operating practice 
Description We developed, piloted and scaled up a manual to improve viral load testing in PHC clients. This manual is an easy to use document for nurses , complete with tools for recording high viral loads. The pilot phase of this manual demonstrated a nearly 40% increase in viral load coverage in clinics that adopted our manual. 
Type Of Material Physiological assessment or outcome measure 
Year Produced 2018 
Provided To Others? Yes  
Impact Viral load coverage increased substantially upon adoption of this tool. 
URL https://www.ncbi.nlm.nih.gov/pubmed/30775284
 
Description Quality Improvement Mentorship 
Organisation Institute for Healthcare Improvement (IHI)
Country United States 
Sector Charity/Non Profit 
PI Contribution CAPRISA has sub-contracted IHI to provide input and guidance into the implementation of the study intervention. The study intervention is Quality Improvement to improve the integration of TB and HIV services in order to reduce TB-related deaths in HIV-infected patients.
Collaborator Contribution The Institute for Healthcare Improvement has built capacity within the CAPRISA team to lead and implement the Quality Improvement intervention in this study. IHI provides mentorship to CAPRISA's QI mentors
Impact 10 CAPRISA staff have been trained by IHI on Quality Improvement Leadership Management
Start Year 2016
 
Description South African Department of Health (SA DOH) Liaison 
Organisation BroadReach Group
Department BroadReach Healthcare
Country South Africa 
Sector Private 
PI Contribution The CAPRISA team have partnered with BroadReach Healthcare (BRHC) as they are a support partner to the SA DoH. In the interests of sustainability of the intervention and inclusivity of stakeholders that can provide valuable input into the project, we have a Memorandum of Understanding (MOU) with BRHC to share best practices on enhancing TB-HIV service integration
Collaborator Contribution BRHC has assisted in negotiating access to SA DOH clinics
Impact None as yet
Start Year 2016
 
Description CAP 013 Implementation Science Study report back on effectiveness of quality improvement on delivery of integrated treatment services on mortality in TB-HIV co-infected patients 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Policymakers/politicians
Results and Impact This talk was presented to the provincial TB directorate and TB advisory group , and implications on QI scale-up activities within the TB and HIV programme was discussed extensively
Year(s) Of Engagement Activity 2021
 
Description Collaborative Learning Session Workshop 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Study participants or study members
Results and Impact On the 01 - 02 December 2016, the study intervention began with a Collaborative Learning Session for the intervention clinics in the Ugu district of KwaZulu Natal. Thirty nurses, data clerks and Operational Managers attended the session. The session served as an introduction to the principles of Quality Improvement, data analysis to improve clinic performance, developing PDSAs. A Quality Improvement Advisor from IHI provided input and oversight of the training. This session was an excellent starting point for intervention clinics to develop their Quality Improvement plas
Year(s) Of Engagement Activity 2016