By Theo Smart
The world is still a long way off meeting some of the TB control targets linked to the UN Millennium Development Goals (MDGs). At the Union World Conference on Lung Health in December, several experts proposed taking more aggressive action to reach targets to reduce the global burden of TB and TB-related mortality.
Recommendations ranging from adopting more proactive strategies to detect cases sooner and shorten diagnostic delays, to rolling out HIV treatment earlier in order to prevent TB, and offering TB treatment to all people with advanced HIV (even without a confirmed diagnosis). This article reviews some of the proposals for more aggressive action.
Technically, the world has already met the 2015 MDG goal of halting and reversing the increasing incidence of TB, because it peaked at a very high level in 2004. But the World Health Assembly and the Stop TB Partnership set the bar a bit higher by linking this goal to several other targets or milestones to be achieved by 2005 including:
- Detecting 70% of new smear-positive patients arising each year, and successfully treating 85% of these cases;
- Cutting TB prevalence and death rates to half the 1990 level by 2015;
- Cutting the global incidence of active TB to less than 1 case per million people per year by 2050 (thus eliminating the TB as a health threat of global significance).
But of these other milestones, only the 85% treatment success target has been reached — and that has only happened very recently, in 2008 — though not in every important region, such as sub-Saharan Africa, according to the recent update to the 2009 Global Tuberculosis Report).1
Even so, the epidemiological impact of this achievement may be limited because programmes only seem to be diagnosing or at least reporting about 62% of the estimated number of smear-positive TB cases. That means that close to 40% of smear-positive (infectious) TB cases could remain undiagnosed and capable of spreading the disease in the community and sometimes (see below) in health facilities.
“Many DOTS countries are achieving 85% cure rates, which is reassuring, but the minimum of 70% case detection is not yet achieved in many settings,” said Dr Léopold Blanc of the World Health Organisation’s Stop TB Department, during a session on TB case finding among vulnerable populations.2 “And I just want to stress that 70% case detection was a target for 2005 — we are in 2009. Four years later, we have to get out of this 70%. We have to aim for 100%.”
Likewise, even though TB prevalence and mortality rates are falling in most settings, the 2015 targets are unlikely to be met globally, according to the update to the Global Tuberculosis Report, because of the continuing high rates in Africa. Rather disturbingly, the reported death rates don’t even include the deaths of HIV-positive people with TB, so the actual mortality rates have to be much higher. Nevertheless, because of the impact of HIV on the TB epidemic during the 1990s and 2000s — and the large population of people with HIV and at increased risk of TB, it will be impossible to achieve the TB prevalence and mortality targets in Africa without tackling HIV.
Of course, recommended activities including collaborative TB/HIV activities such as the Three I’s, health systems strengthening, developing new tools for diagnosis, treatment and prevention, and empowering and educating people with TB and in the affected communities (Advocacy, Communication and Social Mobilisation or ACSM) could have a great impact on TB control. But Dr Blanc stressed that these interventions have not been widely implemented. (Encouragingly, this Union World Conference contained a large number of symposia on the Three I’s, often running concurrently).
Improving case detection
Nevertheless, a way forward is needed to more rapidly achieve the MDGs according to Dr Blanc: “we need to accelerate efforts in TB control by aiming at 100% case detection — universal access — and by shortening diagnostic delays.”
He described a framework WHO has developed to identify bottlenecks and constraints that limit identification of TB in vulnerable populations; and to indicate actions to reduce delays (whether due to the patient or health sector) and improve case detection and notification. The framework considers the steps between the time of infection and starting treatment, including the development of active disease, the recognition of symptoms, approaching the health services, getting a diagnosis from the health system, to case notification. Each step provides an opportunity for intervention.
For instance, delays in patient health seeking behaviour could be reduced by more effective ACSM programmes that educate people to recognise the symptoms of TB and seek a diagnosis, and by minimising barriers to accessing a diagnosis, perhaps by decentralising diagnostic services.
Delays on the part of the health service could be addressed by making sure effective TB screening is implemented with broader indications for who should be screened, and by taking actions to improve the quality and efficiency of diagnostic services.
Developing effective collaboration between the public health sector and private providers (including non-governmental organisations, faith-based organisations, traditional and informal health care providers) referred to as a public-private mix (or PPM) could also help alert the health system to TB cases that have been identified but not yet notified, making certain that they receive appropriate referrals and care.
“But there is a short cut for some targeted groups through this path and around the many obstacles to diagnosis— active case finding,” said Dr Blanc. Active case finding can avoid both patient and health system delays entirely through early identification and diagnosis of active disease before an individual seeks medical attention.
Dr Blanc stressed that active case finding “is not about screening the entire population, but should be focused at the populations and groups most at risk” such as prisoners, the poor, people living in congested urban settlements, refugees, migrants, women, household contacts and in particular children. Analysis of local epidemiological data should guide the selection of which groups to target first.
However, some audience members stressed that active case finding among the general population might be justified in settings where the burden of TB is particularly high. Indeed, this approach paid off in Dr Corbett’s DetecTB study in Harare — though the yield was greater in some communities than others.
Meanwhile, an active case finding study performed in a rural district of Ethiopia had a very high yield of smear-positive TB.3 The study used health extension officers to provide door-to-door active case finding which identified 2.5 times the number of cases identified by passive case finding during the same period. In other words, for every smear-positive TB case in treatment, there were at least 2.5 undetected smear positive TB cases. The survey also identified a higher proportion of female patients than were being diagnosed by passive case finding.
A similar finding was made by another study that compared the gender of people diagnosed by passive case finding verses active case finding (screening of household contacts) in Peru.4 Over a period of five years, 60% of the 1259 TB cases identified by passive case finding were men, while active case finding identified TB in an approximately equal proportion of men and women (51%). “Furthermore, active case finding in household contacts diagnosed TB after a significantly shorter cough duration than passive case finding (median 15 days (IQR 7-30) vs. 30 days (IQR 15-60) respectively, p<0.001),” the authors wrote.
A number of other presentations and posters at the conference explored some of these other community-based approaches to increasing case detection in more depth.
Public-private mix: engaging more providers in case finding and notification
Dr Noor Ahmad Baloch, the National TB Control Programme Manager in Pakistan described how diverse types of formal and informal providers can be engaged in TB case finding and management.5
TB is a major public health problem in Pakistan. In a population of 170 million there are about new 300,000 cases (75% among people of reproductive age) and 15,000 new MDR TB cases each year. DOTS was introduced in 2001 and fully implemented at all public facilities by 2005. But around 40% of the total population lives in peri-urban low-income communities, with poor housing, inadequate water, sanitation and little or no access public health services.
Most of this population is dependent upon “a huge and diverse private sector providing health care to the population,” said Dr Baloch. “There are general practitioners, hospitals, for-profit, not-for-profits and non-governmental organizations — and one NGO has 108 outlets that exclusively provide TB services. There are also informal practitioners, many of whom are not qualified, not registered, not licensed, illegally practicing.”
A systematic approach was adopted to research and prepare for implementing the PPM. This started with a study assessing the knowledge of providers, conducted at sample sites in two large cities with 600 doctors providing TB services. Out of all of these doctors, only one knew that the first and the priority diagnostic tool for TB is sputum smear microscopy — most were instead relying on chest x-rays.
Once these doctors were trained and provided with free TB medications, an evaluation found that they readily adopted the DOTS strategy.
Next, a country-wide institutional analysis was conducted among all the stakeholders, assessing the capacity, gaps and needs of hospitals, NGOs and others providing TB care.
Based on this analysis, a national strategic framework was developed with six different models for delivery of TB services working with the different types of providers available in different areas (rural and urban). Operational guidelines and a mechanism for monitoring and evaluation were also developed.
The presentation focused on two models: social franchise marketing targeted to peri-urban low-income communities in very large cities; and a district led model, serving low income populations with poor access to TB services in both urban and rural areas.
In social franchising models, the private sector providers are trained and empowered to delivery branded and quality assured health services: in this case, TB diagnosis and treatment services.
In Pakistan, the social franchise marketing model provides active case finding through media marketing, ‘chest camps’ and interpersonal communication with community advocates who identify and refer suspects for diagnosis, with smear microscopy provided by a private laboratory.
The district-led model strengthens passive case finding — with diagnostic services being provided after the patient presents for care and smear microscopy is performed by either a public lab or NGO/ CBO supported lab.
In both models, the department of health provides free treatment, which is prescribed to the patient by a trained GP — though directly observed therapy may be provided by the practitioner, an outreach worker or lay healthworker. The social franchisee is responsible for default tracing, reporting and quality assurance in the franchise social marketing model, while the district health sector provides these services for the district-led model.
Of course, before launching, materials, including the ACSM strategy and reporting and recording tools, were developed and resources mobilised (the Global Fund initially supported the Social Franchise Marketing). The target population had to be identified, surveyed and mapped. A training programme was developed and implemented and supply logistics worked out.
But in the space of just a few years, the social franchise marketing model engaged about one thousand GPs, large numbers of community workers and 54 private labs in five very large cities in Pakistan — covering a total population of 40 million. After 2005, the number of TB cases (smear-positive and all types) diagnosed and notified by GPs jumped dramatically (by around 12-20 fold). In the last couple years, the private sector has contributed 18-26% of the cases to national case notification.
While the model is feasible to provide TB services to the vulnerable population, “it needs evidence-based refinement for scale-up, keeping in mind sustainability,” said Dr Baloch, because there have recently been concerns about the sustainability of the project as Global Fund support for staff salaries has dried up.
In Myanmar, TB services are also being provided by the private sector via social franchising.6 Population Services International (PSI) presented a poster at the conference reporting that TB services — free to the patient but made available through the private sector — could be scaled up very rapidly (to over 600 clinics within five years), and reach significant numbers of cases (the programme is responsible for 10% of case notifications nationally). As time goes on, and new, more remote clinics join the franchise, the programme has became more effective at reaching the poor.
The TB service is branded as ‘Family DOT’ using the same logo as the National TB Programme, and in addition to TB diagnosis and care, participants receive free nutritional and adherence support. Community health workers are paid both to perform active case finding and provide treatment support. The National TB Programme provides treatment for free and franchisees are not paid to delivery TB services (though they can charge for other services they may provide the patients).
PSI currently pays for many of the services that are provided but argues that the model would be sustainable with public funding — though the cost effectiveness of some services might be a concern. (A paper on the earlier days of the programme by Lönnroth et al in Health Policy and Planning Advance Access is also available online.
Engaging private and informal care providers to reduce diagnostic delay
Several posters from Africa emphasised another important reason to engage healthcare providers (formal or informal) — to reduce diagnostic delay. A study in Kampala found that the mean delay between symptoms and reaching the public health services was 7.4 weeks — during which time people had consulted 4 different healthcare providers outside the public health services, including nurses, midwives, drug shops and private GPs.7
Another poster reported that in the slums near Nairobi, 72.6% of TB patients first sought care from one of these providers, and as a result the average patient delay (between recognition of symptoms and diagnosis) was seven weeks.8
A pilot programme was launched in one of the settlements (Kawangware). First, a mapping exercise was conducted to identify all the potential providers in the area. They were then invited to a sensitisation/training meeting on TB and on the tasks that the providers would be expected to carry out. Participants were given referral forms and asked to refer all patients with a cough of two weeks or more to the nearest diagnostic centre, and provided with regular supervision.
Out of 106 providers identified, 48 attended the training session and 25 participated in the initiative. In the space of six months 267 TB suspects were referred, though only 26.5% completed the referral. Almost half of these were diagnosed with TB however, and TB case finding at the diagnostic lab increased by 46% during that period. Subsequently, the programme has been expanded to other communities — and a number of new DOTS centres establish to reduce clinic congestion.
With an estimated 200,000 traditional healers (or sangomas) in South Africa, compared to 25,000 doctors, 80% of the black population go to a sangoma as their front-line healthcare provider, according to a poster from Dr Krista Dong and colleagues from iTEACH and Edendale Hospital in KwaZulu Natal.9 Despite calls for greater cooperation between the health services and sangomas, there has been no systematic integration of the traditional healers into South Africa’s TB or HIV programmes.
In 2006, iTEACH engaged a network of 300 sangomas interested in improving their knowledge about TB and HIV, but existing certification services were only available in English. iTEACH developed materials, including a patient referral form to document the signs and symptoms of TB, AIDS or drug side effects and in 2009 launched a counselling certification course in the local language (isiZulu). During 2010, traditional healers will be engaged to provide adherence support/defaulter tracking and a pilot study will evaluate the use of healer referral form.
Dong et al note that many doctors and nurse are reluctant to work with traditional healers — particularly because they have observed cases of toxicity due to ingestion of herbal remedies. However, the sangomas engaged in the iTEACH programme “uniformly acknowledge that TB and HIV cannot be cured with traditional or herbal remedies and infection and that patients must be referred to clinics and hospitals for effective treatment and management,” Dong et al reported. Meanwhile, the majority of patients are enthusiastic about being able to receive support from both the formal health services and their local sangoma.
Reducing diagnostic delay at the health facility
Dr Dong also gave an oral presentation on the use of community-based workers to increase the use of bacteriologically confirmed diagnosis, increase diagnosis and reduce diagnostic delay at Edendale Hospital.10
She first reviewed all the frightening facts related to the HIV and TB epidemics in KwaZulu-Natal, South Africa where Edendale Hospital is situated: the province is the epicentre of the HIV epidemic, and has the highest TB burden in a country with the fifth highest TB burden globally; district cure rates are extremely low, and there are rising rates of multidrug resistant- (MDR) and extensively drug resistant- (XDR) TB. Edendale Hospital serves an area covering about one million people — the antenatal HIV prevalence is 60%, and 50-80% of the beds contain patients with HIV. There is also a high inpatient TB burden with about 200 new cases each month — and an 2007 MRC study found that 40% of coughing patients had culture positive TB.
But despite all this, “there have been no deaths due to TB in three years,” said Dr Dong, pausing for effect, “because they die in OPD, they die on arrival to the ward before receiving TB results — and their deaths are never registered.” However, post-mortem results suggest that at least 40% of deaths in the public sector in KZN are TB culture-positive.
In 2005, bacteriologic coverage was only 23%. Sputum request forms were not filled in, were filled in incorrectly or simply not getting to the lab. Doctors complained that they never got results back anyway, and the average turn-around time did indeed exceed the average length of hospital stay.
HATIP 105 has previously described how Dong and colleagues were able to turn the situation around by hiring and training a couple of community health workers, called `TB warriors`, who were given the responsibility to collect sputum specimens, make sure that sputum request forms are filled out, take specimens to the lab, collect results and get them to the patient.
Bacteriologic coverage at the hospital has now increased to 95% and within a few month of launching the TB warriors, the lab turn around times have shortened dramatically to less than 0.5 days. Dr Dong says that provincial “buy-in has now occurred” and the programme will soon be scaled up by the government.
Quality assurance programmes for laboratories can also improve the confidence of clinicians and decrease the turnaround time (and diagnostic delay). According to a presentation on the FIDELIS initiative, a case finding venture funded by Canada and the International Union Against Tuberculosis and Lung Disease, projects that implemented innovative activities in microscopy laboratories were among the most successful interventions piloted.11 Fidelis supported 52 different case finding projects for patients with limited access to TB care — using strategies such as general health systems strengthening, active or semi-active case finding, IEC/ACSM projects, PPM activities, incentives, and lab improvement. Unfortunately, the initiative was not really designed to establish the relative effectiveness of the strategies.
Improving screening tools and targeting HIV
The effectiveness of active case finding may be limited by the appropriateness of screening tools being used in the target population, and HATIP has previously described efforts to refine TB screening tools in people with HIV.
There were a couple of important presentations at the conference with more recent findings on this matter, including one with the preliminary results on a meta-analysis undertaken by WHO’s STOP TB Department to identify the best constellation of signs and symptoms to confidently exclude active TB disease in people with HIV. We will discuss these findings and their implications in a future issue, since WHO will be holding a meeting in a couple of weeks to discuss the data, and the development of a new policy that will more closely integrate intensified case finding in people with HIV with the delivery of isoniazid preventive therapy (IPT) to those in whom TB is excluded.