Stop TB Strategy: implementation and planning
Eight main themes emerge from this review of the transition from DOTS to the Stop TB Strategy during 2006.
The majority of HBCs have developed strategic plans that recognize most of the elements of the Stop TB Strategy but which are not yet in line with the Global Plan. The identification of extensively drug-resistant tuberculosis (XDR-TB) during 2006 has prompted many countries to review the quality of their TB control strategy, and to take the necessary steps to strengthen basic TB control. However, some country plans are modest in terms of the investments needed, especially to improve the quality of DOTS, to treat patients with MDR-TB, and to implement TB/HIV collaborative activities on a large scale (see Financing TB Control).
Human resource development
The strength and sustainability of NTPs depend on timely, adequate and ongoing training and deployment of personnel. The performance of staff depends on various factors such as motivation, training, supervision, salaries and working conditions, all of which must be included in carefully-formulated and implemented HRD policies.
With the transition from DOTS to the Stop TB Strategy, HRD is becoming more complex. Compared with previous years, NTPs are now producing more comprehensive HRD plans, and there is a growing recognition that HRD consists of more than training. Also needed are routine data to monitor staff turnover, improved working conditions, and motivation and retention strategies. The systematic development of human capacity is becoming central to TB control in many countries.
Monitoring missions have shown that many NTPs now have a system and structure for HRD. However, the quality of the system is often insufficient and the HR management capacity is often inadequate at provincial and district levels. One of the key challenges is to retain enough competent staff to cover TB control when general health service staff are overstretched. Few countries routinely report data related to HRD, or systematically review staffing and training during routine supervision. Such information would lead to improvements in training and recruitment.
HRD needs better advocacy and promotion, and NTP staff need to understand its essential role in TB control. The lessons learnt by NTPs in countries such as India and Indonesia on how HRD should be organized and managed should be widely disseminated. Furthermore, there must be greater collaboration on HRD among government departments and ministries that service the whole health system.
Quality-assured laboratory and treatment services
The prompt diagnosis and effective treatment of all types of TB underpin the Stop TB Strategy. Both functions require a strong laboratory network, but the quality of laboratory services has been given too little attention. Like DOTS, the Stop TB Strategy requires high-quality sputum smear microscopy. Implementation of the strategy also requires the phased expansion of culture and DST facilities, but this is being done slowly in all regions except the Americas and Europe. Although all HBCs require more funds to develop their laboratory networks, India in particular needs significant additional investment.
While there have been major improvements in the procurement, supply and use of quality-assured anti-TB drugs, NTPs must be prepared to confront new challenges, such as XDR-TB. Standardized, free-of-charge, short-course chemotherapy is now routinely used worldwide. Patient kits and FDCs are also being increasingly used. However, some weaknesses need to be rectified, such as the use of WHO-recommended Category I regimen in only half of the countries in Europe. Of greater concern is the observation that all WHO regions had at least one country that experienced first-line drug stock-outs at some level during 2005, and seven HBCs reported first-line drug stock-outs at the peripheral level.
Collaborative TB/HIV activities
The TB and HIV/AIDS control programmes in most countries have begun to respond to the challenge presented by the interaction between these two epidemics. But the majority of countries do not yet offer widely the essential diagnostic and treatment services: HIV testing, screening for TB among HIV-positive people, and the provision of CPT, ART and IPT. Low rates of HIV testing are, in most countries, currently the principal obstacle to providing ART to TB patients. The coverage of these services in 2005 was far less than anticipated by the Global Plan in 2006, the first year of its implementation. It is therefore clear that TB/HIV collaborative activities need to be stepped-up rapidly, to respond to the TB emergency declaration in Africa,1 and to satisfy the needs of “universal access” as described in the Global Plan.
This report shows that there were significant improvements between 2003 and 2005, at least in some aspects of diagnosis and treatment in some countries. For example, Kenya, Malawi and Rwanda are now testing a growing number of notified TB cases for HIV, providing CPT to around 80% of their HIV-positive TB patients, and ART to around 30%. The total number of reported patients beginning ART in the African Region increased about 40-fold between 2003 and 2005.
In 2005, CPT was more widely available to HIV-positive TB patients than ART. In part this is because CPT is cheaper and easier to distribute and administer than ART, which must be taken for life. But CPT is also provided at the periphery of health services, while ART is often available only in hospitals to which fewer patients have access. As the costs of diagnosis and treatment fall, and as experience in the care of HIV-positive TB patients grows, it will be easier to simplify and decentralize the provision of ART.
There has been less progress in screening HIV-positive people for TB, even though screening appears to be an efficient way of finding TB cases, and despite the demonstrated efficacy of preventive therapy (IPT) for those who have not (yet) progressed to active TB. Botswana, uniquely, has shown that IPT can be provided to HIV-positive people on a large scale.
The expansion of HIV testing among TB patients, and the recording and reporting of test results, will provide important information for monitoring and evaluation. With this information, TB epidemic trends can be monitored separately among HIV-positive and HIV-negative populations, so as to obtain a better understanding of the underlying epidemiology and impact of TB control. It will also be possible to monitor treatment outcomes according to HIV status, and in particular mortality. Smear-positive patients treated under DOTS in Africa had higher death rates than in any other WHO region in 2004. This is presumably because of the high prevalence of HIV in the region, but the contribution of HIV to TB deaths in Africa has not yet been demonstrated directly on a large scale.
In this context, several countries including Brazil, Jamaica, Belize, Estonia and the Russian Federation, have developed their own recording and reporting systems to ensure that information on TB and HIV is systematically collected, compiled and analysed. The quality of information about TB and HIV will increase greatly as more countries follow the revised (2006) WHO guidelines on recording and reporting.2
MDR-TB surveillance and control
The long-term vision for control of MDR-TB includes DRS and treatment of MDR-TB as standard components of all TB control programmes. True integration of surveillance and treatment of MDR-TB requires the scale-up of culture and DST services, which were the primary limiting factors for expansion in 2006.
Currently, few countries, with the exception of the established market economies and the subregions of Central and Eastern Europe, are providing diagnostic services including culture and DST for all TB cases. In most countries, culture and DST are provided to a group of patients selected on a clinical basis, often treatment failures or contacts of known MDR-TB patients. Therefore, routine surveillance data and survey data obtained through the Global DRS Project are poorly correlated, with the exception of the European Region which provides wide access to culture and DST services.3
A total of 182 countries filled in the WHO standard data collection form for MDR-TB data for 2005, but only 104 countries reported at least one MDR-TB case, and the majority of countries reported less than 50 cases. It is expected that expansion of culture and DST, as well as treatment for MDR-TB as outlined in the Global Plan, will improve the routine surveillance of drug resistance, particularly among re-treatment cases. In the meantime, the Global DRS Project continues to play an important role in supplementing routine surveillance, and in monitoring trends in drug resistance. The Global Plan anticipates that 20 000 and 36 000 MDR-TB cases will be treated according to international standards in 2006 and 2007, respectively. In 2005, the total number of MDR-TB patients reported, and the number reported as being diagnosed in GLC programmes (probably overestimated), were far below the Global Plan proposal for 2006. However, the number of known MDR-TB patients is growing, and the proportion treated under the GLC is expected to increase from about a third (35%) in 2006 to a half (47%) in 2007.
The 2004 cohort of MDR-TB patients was the first for which data on treatment outcomes were collected. The treatment success rate for patients in GLC projects was 61% on average; patients treated outside GLC projects did not fare so well (54% treatment success).4 In future, we expect treatment outcomes in GLC projects to improve as chronic cases are cured or die, and as cohorts include a higher proportion of new MDR-TB patients carrying bacteria that are typically resistant to fewer drugs. In addition, the GLC has in recent years approved more countries without a history of second-line drug use. In such settings, MDR-TB control is likely to yield better treatment outcome results as susceptibility to the most effective second-line drugs may be preserved, perhaps permitting shorter regimens with fewer, less toxic drugs.
The number of GLC-approved, MDR-TB control programmes is increasing rapidly, both as a result of more funding for TB control from the GFATM, and through the integration of MDR-TB management into general TB control efforts, as outlined in the Stop TB Strategy and described in the new guidelines for the management of drug-resistant TB.5 The GLC is receiving a growing number of applications from low-income countries (as defined by the World Bank). By the end of 2006, 15 low-income countries had been approved by the GLC, among which 10 were approved during the past two years. In addition, applications from two low-income countries were under GLC review.
Although the number of GLC-approved MDR-TB treatments is increasing, with an estimated global incidence of over 400 000 MDR-TB cases, most patients remain undiagnosed and untreated. And many of those patients who have been identified are still treated inadequately, with inappropriate diagnostic and treatment procedures.
WHO and its partners will focus on assisting countries in planning, piloting and scaling-up procedures for the management of MDR-TB, following the new guidelines and in line with the Global Plan. Several HBCs and high MDR-TB prevalence countries have plans and resources to improve MDR-TB management. By the end of 2006, the newly-established UNITAID6 also agreed to scale-up access to second-line anti-TB drugs by contributing significant financial resources for GLC-approved countries.
Extensively drug-resistant TB
Although resistance to second-line TB drugs is not a recent development, it gained considerable attention during 2006, following a review of findings by supranational TB reference laboratories, and a highly-publicized occurrence of resistance to second-line drugs among HIV-infected TB patients in South Africa,7 coupled with high mortality. The term extensively drug-resistant TB (XDR-TB) is defined as TB due to strains that are resistant to the two most important first-line drugs, isoniazid and rifampicin (MDR-TB), and further resistance to a fluoroquinolone and at least one second-line injectable agent (amikacin, kanamycin and/or capreomycin).8 DST is not routinely carried out in most national reference laboratories. Therefore, to assess the magnitude of the XDR-TB problem, second-line testing must be conducted on isolates from MDR-TB patients identified in routine drug-resistance surveys. This is under way in at least 10 countries, and data will be available in 2007.
Strengthening health systems, improving access to care
The Stop TB Strategy reinforces the natural linkages between TB control and general health systems. It highlights the need for NTPs to actively participate in efforts to improve health policy, human resources, financing, management, logistics, service delivery and information systems.
Most HBCs have developed plans for TB control jointly with a range of stakeholders involved in health-care planning and health systems development. Several NTPs have actively engaged in SWAPs, MTEFs and PRSPs. However, this may not be sufficient in the context of the current, wide-ranging debate on health system strengthening. Most NTPs need to participate more actively in that debate, particularly in countries with ongoing health sector reforms.
Some of the innovative but well-tested approaches, which are integral components of the Stop TB Strategy, provide opportunities for NTPs to strengthen health systems while also enhancing TB control. These include community-based TB care (linking community and health services), PAL (TB care in the context of all respiratory problems) and PPM (exposing and sensitizing non-state health-care providers to public health through collaboration with NTPs).
So far, a few countries have initiated PAL, and some have begun scaling up. Countries, including those with a high prevalence of HIV infection, should actively consider starting PAL implementation and mobilize the required resources through, for example, applications to the GFTAM. PPM has been shown in some settings not only to improve access to care for the poor but also to reduce costs to patients.9 There has been a significant increase in the number and the scale of initiatives to actively engage all health-care providers through PPM approaches to TB care and control. This is being facilitated by two important tools launched during 2006: the International Standards for Tuberculosis Care and Engaging all health care providers in TB control: guidance on implementing public–private mix approaches. All regions have now included PPM in the regional TB control plans, and more countries are mainstreaming PPM planning into the national planning and implementation process. All HBCs have some form of PPM activities on the ground. Increased attention to PPM in countries also means a significant increase in the need for technical assistance in this area. Major challenges for PPM scale-up are skilled staff in countries and adequate external and internal technical assistance for country-level implementation.
Working with people and communities
Community-based TB care has been shown to improve both access to services and adherence to treatment, and is in place in many countries.10 However, it needs to be promoted actively and implemented more widely.
The wider involvement of communities in TB care and prevention – going beyond patient care – should be based on the assessment of possible synergies with existing community initiatives, and with a view to improving physical, social and economic access to services for TB care and control. The vision underlying principles for community empowerment is one of partnership between health systems and communities, aimed at establishing a patient-centred approach, with earlier and higher case detection, better treatment adherence throughout the period of treatment, and mitigation of the economic impact of the disease on patients and their families. So far, the approach to ACSM under the Stop TB Strategy has been uneven. WHO and partners, including a wide range of civil society organizations, will address these challenges by publishing guidelines for community empowerment early in 2007. These guidelines will serve as a basis for developing country-specific strategies, and should benefit all countries, especially those which have increased funding mechanisms such as the GFATM.
Research to improve TB control
Implementation of the various components of the Stop TB Strategy requires a greater and more systematic effort on the part of countries to plan, design and undertake research. This will be required as much for the rapid deployment of new and improved technology as for the implementation of innovative, programme-based approaches to TB control. The limited research activities reported by NTPs in 2006 included surveys of the prevalence of HIV infection among TB patients, surveys of drug resistance, and studies on health-seeking behaviour and the effectiveness of FDCs, and the evaluation of PPM initiatives. The development and promotion of a set of research priorities, the harnessing and strengthening of research capacity at the regional, national and local levels, and the establishment of institutional mechanisms to support research are all needed to reinforce component 6 of the Stop TB Strategy.
2 The revised TB recording and reporting forms – version 2006. Geneva, World Health Organization, 2006. Available at www.who.int/tb/dots
3 Data not presented in this report. This is a repeat of the analysis presented in Global tuberculosis control: surveillance, planning and financing. WHO report 2006. Geneva, World Health Organization, 2006 (WHO/HTM/TB/2006.362). The reanalysis gives essentially the same results.
4 This is lower than reported in another publication from the same GLC-approved countries (Nathanson E et al. Multidrug-resistant tuberculosis management in resource-limited settings. Emerging Infectious Diseases, 2006, 12:1389–1397). The paper reported that an average of 70% of MDR-TB patients were successfully treated (higher among new, 77%, than among previously treated MDR-TB patients, 69%). In that source, the number of patients was higher because the data covered three years instead of one year in this report. The MDR-TB patients discussed in the article also included a high proportion of severe chronic cases, with 65% of patients resistant to both first- and second-line anti-TB drugs.
5 Guidelines for the programmatic management of drug-resistant tuberculosis. Geneva, World Health Organization, 2006 (WHO/HTM/TB/2006.361).
6 UNITAID is a financing mechanism established in 2006 to facilitate access to high-quality drugs and diagnostics for HIV, TB and malaria, led by Brazil, Chile, France, Norway and the United Kingdom, and based primarily on a tax contribution to the price of airline tickets.
7 Gandhi N et al. Extensively drug-resistant tuberculosis as a cause of death in patients co-infected with tuberculosis and HIV in a rural area of South Africa. Lancet, 2006, 368:1575–1580.
8 Fluoroquinolones and injectable agents are the most effective second-line anti-TB drugs, and the only ones that have bactericidal effect. They are therefore recommended in the initial phase of any MDR-TB treatment regimen. Fluoroquinolones and aminoglycosides are the most common second-line anti-TB drugs, largely available also in most low-income countries. XDR-TB is therefore a term intended to describe a resistance pattern for which patients are much less likely to be successfully treated with existing second-line regimens. See: Guidelines for the programmatic management of drug-resistant tuberculosis. Geneva, World Health Organization, 2006 (WHO/HTM/TB/2006.361).
9 Floyd K et al. Cost and cost-effectiveness of PPM-DOTS for tuberculosis control: evidence from India. Bulletin of the World Health Organization, 2006, 84:437-445.
10 Community contribution to TB care: practice and policy. Geneva, World Health Organization, 2003 (WHO/CDS/TB/2003.312).