AUGUST 2020TB CARE II is funded by United States Agency for International Development (USAID) under Cooperative Agreement Number AID-OAA-A-10-0021. The project team includes prime recipient, University Research Co., LLC (URC), and sub-recipient organizations Jhpiego, Partners In Health, Project HOPE along with BEA Enterprises; Brigham and Women’s Hospital; the Canadian Lung Association; Clinical and Laboratory Standards Institute; Dartmouth Medical School: The Section of Infectious Disease and International Health; Euro Health Group; McGill University; and The New Jersey Medical School Global Tuberculosis Institute.

ContextOne of the most serious threats to global tuberculosis (TB) control efforts is drug-resistant TB (DR-TB). It includes multi-drug resistant TB (MDR-TB), resistant to two of the most powerful TB drugs, isoniazid and rifampicin, and the even more severe extensively drug-resistant TB (XDR-TB). DR-TB develops when TB drugs are used inappropriately or incorrectly, if ineffective formulations are used, or if the treatment isn’t completed. It can also be spread through person-to-person transmission.

Several gaps in the DR-TB care continuum undermine success. According to the World Health Organization, there were an estimated 484,000 cases of MDR-TB in 2018. However, only 51% of people with bacteriologically confirmed TB were tested for rifampicin resistance – the first gap in the TB care continuum. As a result, only 38% of the estimated cases were notified. The second gap in the continuum is registering diagnosed cases on treatment: in 2018, 84% of notified cases, were started on treatment. Treatment involves a complex regimen lasting between 9 and 20 months, creating the third gap in care: only 56% of MDR-TB patients were successfully treated. In addition to challenges with treatment adherence, MDR-TB treatment services are often centralized and reliant on hospital-based models of care, limiting access to care.

The USAID TB CARE II Project worked to reduce these gaps in MDR-TB care, supporting the implementation of the U.S. Government’s National Action Plan for Combating Multidrug-Resistant Tuberculosis (NAP), and the USAID “Global Accelerator to End TB”. The project built global commitment and capacity for combating MDR-TB by

Improving Capacity and Collaboration to Combat Drug-Resistant Tuberculosis

gathering evidence and advocating for effective service delivery models, developing guidance, and strengthening health systems. A key focus was strengthening patient-centered care to increase treatment success. TB CARE II supported National TB Programs (NTPs) to decentralize MDR-TB services closer to the patient and to improve the quality of MDR-TB care. Through long-term field support programs in Bangladesh, Malawi, and South Africa, TB CARE II engaged NTPs, civil society, and communities to expand clinical and programmatic capacity in MDR-TB programming, supporting the development of local solutions and the growth of self-reliance. (For more information, see the country-specific briefs).

The USAID TB CARE II Project (2010-2020)▶ Provided global leadership and technical support

to National TB Programs and other stakeholders to accelerate the implementation of TB, TB-HIV co-infection, and multi-drug resistant TB services.

▶ Particular emphasis on innovative technological approaches to improve TB case detection and treatment, and interventions related to infection control and programmatic management of drug-resistant TB.

▶ Strengthened TB program capacity and fostered commitment to ending TB by empowering government partners, civil society, communities, and the private sector to develop local solutions to address bottlenecks and strengthen health systems for TB control.

2 Improving Capacity and Collaboration to Combat Drug-Resistant Tuberculosis

Key interventions and resultsClosing the gap in diagnosing MDR-TB In 2010, TB diagnostic capability was accelerated with the introduction of GeneXpert MTB/RIF, a fast molecular-based test. It provides results of TB and rifampicin resistance in 2 hours, rather than the 10 days needed for a culture methods, allowing patients to rapidly begin treatment. However, its use in low-resource settings was limited by the high cost of the GeneXpert system and cartridges.

In Bangladesh and Malawi, TB CARE II provided focused technical support to integrate diagnosis using GeneXpert into the health system. The project supported the NTPs and National TB Reference Laboratories (NTRL) to develop GeneXpert diagnostic algorithms, standard operating procedures (SOP), and training modules; train laboratory technicians on operation and maintenance of the Xpert MTB/RIF machines; and establish referral network and sputum collection and transportation systems linking peripheral sputum microscopy centers with the Xpert sites.

Between 2011 and 2015, the project procured and helped place:

• 39 GeneXpert machines in Bangladesh, which detected 9,354 cases of TB and 2,749 cases of MDR-TB.

• 11 GeneXpert machines in Malawi, which diagnosed 2,368 TB cases and 75 MDR-TB cases.

TB CARE II also built the capacity of the laboratory networks – from microscopy centers to the NTRL – by strengthening the supply chain for equipment, reagents, and consumables, training laboratory technicians, and improving biosafety. In Bangladesh, for instance, the project helped establish a new regional TB reference laboratory (RTRL) in Khulna, initiated a new one for Sylhet, and upgraded the RTRL in Chittagong.

Closing the gap in starting treatmentHospital-based MDR-TB treatment: As MDR-TB case-finding improves, hospital capacity to manage the increasing number of MDR-TB patients is often strained. In Bangladesh, TB CARE II supported the NTP to set up 124 new MDR-TB beds at the National Institute of Diseases of the Chest and Hospital and at five district chest diseases clinics. Health workers at the facilities

received additional training and mentoring to ensure they had the knowledge and skills for the clinical and programmatic management of DR-TB patients.

Community-based MDR-TB treatment: Decentralizing treatment to the community-level relieves the burden on hospitals while continuing to provide the patient with daily support, even as they live in their own home. The community-based programmatic management of DR-TB (cPMDT) model involves treatment initiation at the hospital, with discharge after sputum conversion (usually less than two months), and finishing the remaining months of treatment at home with the support of a community-based provider of directly observed therapy (DOT).

TB CARE II introduced the model to Bangladesh, Malawi, and South Africa by supporting the NTP to develop SOPs, train outpatient DR-TB teams and DOT providers, and establish intensive monitoring and supervision systems. (Also see technical brief on community engagement).

The results of cPMDT were significant. For example, in Bangladesh, the expansion of inpatient capacity and early release of patients from hospital to continue treatment at the community level helped reduce the delay for treatment initiation from more than two months in 2011 to less than a week in 2014, releasing beds for admission of newly diagnosed patients, and almost eliminating the number of patients on waiting list for treatment.

Drawing on the lessons from Bangladesh, Malawi, and other countries with cPMDT programs, TB CARE II identified global best practices, developing global

Laboratory technicians in Bangladesh receive training on using GeneXpert

Improving Capacity and Collaboration to Combat Drug-Resistant Tuberculosis 3

MDR-TB treatment, situations that complicate MDR-TB management, and indications for surgical intervention in MDR-TB.

• Training webinars hosted on the project-supported DR-TB Learning Network (since incorporated in the TB Academy and made available on YouTube) provided instruction on topics such as basics of clinical management of MDR-TB, pediatric TB, pharmacovigilance, cPMDT, and TB infection control. Over 1,300 people from 64 countries participated the webinars.

• Guidelines, such as the PIH Guide to the Medical Management of MDR-TB (2014), Management of MDR-TB in Children: A Field Guide (2016), and Community-Based Care for Drug-Resistant Tuberculosis: A Guide for Implementers (2017), increased access to global best practices standards.

Improving quality of care: In Bangladesh, Malawi, and South Africa, TB CARE II worked with the NTPs to scale-up effective approaches to improve the quality of MDR-TB care. This included holding MDR-TB service providers accountable through improved supervision systems, institutionalizing regular review meetings to monitor progress in the treatment of MDR-TB patients, and improving recording and reporting systems to support program managers in identifying and addressing performance gaps. For example, the project supported TB programs to adopt digital health solutions for data collection and reporting systems, and to use geomapping to improve the management of MDR-TB patients and contacts.

resources such as the Community-Based Care for Drug-Resistant Tuberculosis: A Guide for Implementers (2017).

To introduce and scale-up cPMDT in countries prioritized under the NAP, TB CARE II organized a workshop on Best Practices in DR-TB Community Care: Development of National Community-Based DR-TB Care Plans in Pretoria, South Africa in 2017. It brought together 72 NTP directors and other high-level advisors from all ten NAP countries to draft national action plans for roll-out or scale-up of cPMDT. Countries continued receiving focused technical assistance after the workshop.

Closing the gap in treatment successClinical and programmatic capacity: In its field support programs, TB CARE II worked with NTPs to strengthen systems for training and supervising laboratory technicians, health providers and staff from community levels to referral facilities, and TB program managers in MDR-TB programming and service delivery. Recognizing the urgent need for MDR-TB capacity building globally, the project also built capacity in other high TB-burden countries. For example:

• The PMDT Fellowship Program brought TB practitioners for yearly training on MDR-TB at one of the project-support Centers of Excellence in in Russia, Lesotho, or Peru.

• The online Clinical Case Discussion Series gave providers the opportunity to discuss real-life MDR-TB cases, learning about topics such as side effects of

TB CARE II staff visit a DOT provider’s house for supervision and mentoring in Bangladesh

Adherence support through digital solutions: Digital health solutions were also leveraged to improve adherence to the long treatment regimen for MDR-TB. TB CARE II developed the ConnecTB mobile which provides health workers with immediate access to individualized treatment regimens, enables community DOT providers to record DOT sessions, and flags reminders for follow-up actions, including side effect management and contact tracing. The application was tested and scaled-up in Bangladesh and South Africa, where it increased MDR-TB treatment retention rates to 90%-100%. In South Africa, the application was adopted by NGOs who work directly with multiple facilities to receive MDR-TB patient referrals

https://tb.academy/webinar-archives/https://www.youtube.com/user/DRTBTrainingNetwork/feedhttps://www.pih.org/practitioner-resource/pih-guide-to-the-medical-management-of-multidrug-resistant-tuberculosis-2nd/the-pih-guide-to-the-medical-management-of-multidrug-resistant-tuberculosishttps://www.pih.org/practitioner-resource/pih-guide-to-the-medical-management-of-multidrug-resistant-tuberculosis-2nd/the-pih-guide-to-the-medical-management-of-multidrug-resistant-tuberculosishttp://sentinel-project.org/wp-content/uploads/2016/12/Field_Handbook_3rd-Ed-30-Nov2016.pdfhttp://sentinel-project.org/wp-content/uploads/2016/12/Field_Handbook_3rd-Ed-30-Nov2016.pdfhttps://tbcare2.org/wp-content/uploads/2018/09/Community-Based-DR-TB-20180830-1.pdfhttps://tbcare2.org/wp-content/uploads/2018/09/Community-Based-DR-TB-20180830-1.pdfhttps://tbcare2.org/wp-content/uploads/2018/09/Community-Based-DR-TB-20180830-1.pdfhttps://tbcare2.org/wp-content/uploads/2018/09/Community-Based-DR-TB-20180830-1.pdfhttps://tbcare2.org/wp-content/uploads/2018/09/Community-Based-DR-TB-20180830-1.pdf

4 Improving Capacity and Collaboration to Combat Drug-Resistant Tuberculosis

for subsequent follow up and management. (See technical brief on digital solutions).

To support the scale-up of digital solutions for MDR-TB, TB CARE II organized a global consultation 2018. The workshop brought NTPs from thirteen countries, including eight countries prioritized under the NAP, with technology companies, industry groups, and civil society organizations to select solutions appropriate for their TB control context and digital ecosystem and develop country roadmaps. Following the workshop, TB CARE II provided targeted technical support to support roadmap implementation.

Comprehensive support to MDR-TB patients: MDR-TB patients may experience significant pain, face stigma and discrimination, isolation, and financial barriers to obtaining food or transport for facility check-ups. In 2015, TB CARE II worked with the South African National Department of Health to develop and roll out Comprehensive Guidelines for TB and DR-TB Palliative Care and Support. Building on the experience in South Africa, TB CARE II worked with other TB control partners to support USAID to develop the USAID DR-TB Care Package (2018), a set of supportive care elements meant to improve the quality and patient-centeredness of community-based care for people living with DR-TB. The project provided technical assistance to support NAP countries in adopting the package, improving the quality of life for patients with DR-TB and contributing to their treatment success.

New short-course for DR-TB therapy: New drugs and regimens are urgently needed to enable faster and safer MDR-TB treatment. As two new anti-TB drugs, bedaquiline and delamanid, were brought to market, TB CARE II assisted the UNITAID-funded EndTB Project to assess whether the new treatment was as good or better than the current regimen, and to evaluate novel, short, all-oral combinations of drugs for MDR-TB. Specifically,

TB CARE II supported NTPs in Haiti, Kazakhstan, Liberia, and Sierra Leone to introduce and monitor the new treatment regimens by developing and/or updating MDR-TB guidelines, SOPs, and training materials; strengthening laboratory and diagnostic capacity; and procuring consumables and equipment.

A key element in the introduction of new drugs and shorter treatment regimens is preventing adverse events through active TB drug-safety monitoring and manage-ment (aDSM). TB CARE II organized regional workshops Eastern Europe/Central Asia, and Africa, bringing together NTPs, national drug authorities, and pharmacovigilance centers to develop roadmaps, action plans, and reporting mechanisms for aDSM implementation at the country level. TB CARE II continued to provide technical support following the workshops, focusing on supporting pharma-covigilance electronic reporting tool implementation.

Conclusions TB CARE II provided global leadership and focused technical support to build capacity and foster collaboration to combat MDR-TB. The project encouraged efforts to improve access to high-quality, patient-centered diagnostic services and MDR-TB care and to enhance adherence to MDR-TB treatment. cPMDT and innovative digital solutions improved service delivery and provided patients with choices, helping address bottlenecks to treatment success. Aligned with the Global TB Accelerator, the project engaged governments, civil society, communities, and the private sector in exchanging information and developing or identifying solutions to effectively address gaps in MDR-TB care, accelerating progress toward ending TB. By building clinical and programmatic capacity and strengthening commitment to reaching and curing every case of MDR-TB, TB CARE II supported countries in advancing on their Journey to Self-Reliance.

USAID Bureau for Global Health | TB Team500 D Street SW | Washington, DC | 1.571.309.0217

Hala Jassim AlMossawi: Acting Director, TB CARE II • hjassim@urc-chs.com

University Research Co., LLC • 5404 Wisconsin Avenue, Suite 800 • Chevy Chase, MD 20815, USA • http://www.urc-chs.com

https://www.urc-chs.com/sites/default/files/Related%20URC%20publication_Palliative%20Care%20and%20TB.pdfhttps://www.urc-chs.com/sites/default/files/Related%20URC%20publication_Palliative%20Care%20and%20TB.pdfhttps://tbcare2.org/wp-content/uploads/2019/03/DR-TB-Practical-Toolkit_8-31.pdf