Disconnected DOTS: Tackling Tuberculosis Is More Than Just Therapy – Sumit Raybardhan

Introduction
Tuberculosis (TB) was believed to be relatively well-controlled public health disease, till its’ re-emergence in the mid-1980s. Several factors, including the HIV/AIDS epidemic, rising poverty rates, and demographic pressures lead to this re-emergence (1). It was in this context that the World Health Organization (WHO) declared TB to be a public health emergency and developed a global public health framework to combat this disease. The directly observed therapy short-course (DOTS) strategy was launched in 1993 providing a ‘blueprint’ for TB control (1). The strategy centred around the concept of directly observing a patient taking their TB medication by a health care professional and involved government commitment to TB control, passive TB case detection, secure and regular supply of essential TB drugs, and a monitoring and evaluation system for the TB program (1). The WHO’s recommended strategy of DOTS has been a cornerstone of global public health programs in tackling tuberculosis. However, the strategy’s focus on direct observation of TB treatment is of particular concern and will be the focus of this paper.

TB is a chronic infectious disease that requires the administration of complex medication regimens. TB primarily affects the respiratory system and requires taking three to four medications daily for at least 4 to 6 months (2). Furthermore, these medications can have significant side effects, including gastrointestinal disturbances, peripheral nerve damage, and liver and kidney effects. Consequently, many patients are deterred from initiating and maintaining taking TB medications during the treatment period. Therefore, an important component of any TB control strategy is to ensure patients are taking their medication properly and consistently. This requires careful monitoring and proper patient education. Poor adherence to TB treatment regimens remains a major barrier to TB control (2, 3), as such behaviour reduces treatment efficacy, causes drug resistance, and increases morbidity and mortality (2).
Although DOTS has provided a framework to try and control TB, it does not take into account the importance of adherent behaviour to TB treatment success. This strategy fails to address the social elements of non-adherent behaviour that is driving this epidemic. The DOTS strategy focuses on the treatment aspect of TB, without effectively illuminating the social and behavioural dimensions of this disease. India, an important testing ground for many of the principles of DOTS, fully adopted this strategy into its national TB control initiative in 1992. However, despite a national TB program that is based on the DOTS strategy, India continues to have nearly 25% of new TB cases in the world and accounts for 30% of the tuberculosis disease burden (4). In this paper, I will draw on the Indian experience to illustrate the social and behavioural vacuum in which the DOTS strategy is operating in. However, given the global utility of this public health strategy, the experiences in other countries that have implemented DOTS will also illuminate the appropriateness of this strategy.

DOT fails to encourage self-efficacy
WHO recognized that treatment adherence was key for successful TB control and grounded DOTS around the concept of directly observed therapy (DOT), whereby a health care provider observes a patient take the TB medication for at least 2 months of treatment (1). In of itself DOT is not based on any social theory, even though it aims to address the issue of medication adherence, which has many social and behavioural facets (1,2). Fundamentally, DOT breaches patient autonomy and self-care, thereby directly interfering with the concept of self-efficacy posited by social cognitive theory. Empowering patients is important to establish and maintain medication adherent behaviour, by observing a patient take a TB medication, it removes any sense of confidence or autonomy the patient might have in pursuing adherent behaviour (1,2). The WHO has advocated for the use of DOTS without taking into account that it promotes a very paternalistic model of health care, and creates an imbalance of power and capacity between the public health professional and infected patient (5).

The importance of patient autonomy as a predictor for TB treatment adherence has been recognized in many settings (1), and in fact there has been a growing trend to implement DOTS as a patient-centred strategy (6). However, this is still not the norm. Many countries are still implementing DOTS using health care providers as the only source for observing patients taking their medications.

In an international survey looking at DOTS implementation, the ramifications of such an approach, was seen in India and other countries, where patients perceive that utilizing health care workers in observing them taking TB medications is constrictive and indicates mistrust, which subsequently decreased self-care (1). A separate Indian survey evaluating the impact of the revised national TB strategy, found a majority of patients did not participate in DOT programs because of the logistical issues of attending a clinic where the TB medication could be observed being taken (7). A notable finding from this survey, also found that providers (i.e. health care workers) of DOT would selectively screen only those patients who were deemed to comply with the DOT program. Furthermore, the research found that those that were most likely to be refused DOT treatment were “in absolute poverty, socially marginalized, and itinerant labourers” (7). The authors concluded that in an attempt to meet TB control targets, the DOT program was failing to provide TB care to the potentially most vulnerable patients (7).

DOT provides the wrong focus
The study findings that I have mentioned earlier point to the problem of depending on DOT for dealing with TB medication adherence. It removes patient autonomy and impinges on self-efficacy, creating a constrictive and non-empowering environment where the patient cannot pursue medication adherent behaviour. Furthermore, by moving the focus onto the patient, DOT programs, detract the responsibilities that health care providers and health care systems have in providing the necessary elements whereby patients can engage in medication adherent behaviour (5). Rather, as in the case of India, health care providers are focused on achieving TB control targets.

There are considerable consequences of ensuring TB medication adherence through a process such as DOT. By removing patient autonomy and not taking into account the social dimension of medication adherence, DOT provides a narrow context in which to understand these issues. Primarily, DOT is an individual level intervention that constrains the view of medication adherence into a bio-medical context, forcing a proximate understanding of why patients do not adhere to their TB medications. It fails to contextualize the risk factors for medication non-adherence.

Contextualizing risk factors has been argued as an important element in disease modification (8), which holds even more significance with a disease that spreads through social means, such as TB does. Indeed stigmatization of TB is an important barrier to accessing and completing TB treatment found globally (9) and in South East Asian countries (10,11). However, understanding these important social links can be restricted by DOT, as it provides a bio-medical perspective. These links are not just superficial in terms of determining risk factors for contracting and spreading TB, but also filter down to treatment issues. The implementation of DOT as a public health strategy implicitly has driven research into identifying patient-related factors for understanding when such programs fail and how to improve implementation of DOT (12). However, since the early 1990s it has been recognized that patient adherence to TB medication is multifaceted, and not only requires an understanding of patient related factors but the social and economic context in which they operate (13).

Unfortunately in India, this limited view of medication adherence as promoted by the DOT strategy, has been the primary driver for research in India. An Indian study conducted in 1992 to understand why patients were not adhering to medications identified health beliefs, education, and socioeconomic factors as strong predictors for not adhering to medications (14), however, remarkably the authors conclude that educational interventions (patient-related factors) are key to improving medication adherence (12). More recently in 2006, a study conducted in south India, where authors identified education and access as key reasons for not being able to comply with DOT programs, still primarily concluded of the importance of developing TB educational materials for improving adherence (15).

Contextualizing medication non-adherence is needed
The spread of TB is heavily influenced by social determinants (12). One of the primary determinants is poverty and the associated issue of health care access (9,12,13). Non-adherence to TB medication needs to be understood in this context. Simply using DOT as a tool for TB control does not address the issues of poverty and access, since the strategy can only be implemented when the patient accesses the health care system. There is no active provision to seek out patients who are suffering from TB and cannot access the health care system. In order to be an effective and sustainable public health intervention that ensures TB medication adherence, DOT must make these social realities explicit. Evidence both in India and it’s neighbour, Pakistan, point to the issues of poverty and health care access as barriers to TB medication adherence (7,10,15), however little has been done to incorporate these issues into the DOT strategy.

Indeed, the global experience from implementing DOT, has been varied. In most settings there is great variation between and within countries regarding observation of a patient taking the medication (16). Some programs, such as the one in Gambia, provide medications on a weekly or biweekly basis to the patients to take home for administration, which ultimately is self-administration (1). Countries such as South Africa, Malawi, Colombia, have adopted a patient-centred approach. These strategies include patients choosing who will be their supervisor and a decentralization of supervisory responsibilities by allowing community lay-workers supervise administration of TB medication (1, 17). Initial assessments of these programs have shown that these methods provide more efficient TB control (1), compared to the biomedical-centred approach of a health care provider initiated observation of TB treatment.

Patient centred modifications made to DOTS are essential to understand treatment adherence of a disease that is spread socially. Allowing patients to choose their own medication administration supervisor or decreasing the number of supervisory visits, increases patient autonomy and self-efficacy. In addition, decentralizing supervisory responsibilities to the community can increase access.

Implications
The WHO as the global public health agency that developed the DOT strategy, should make these issues explicit in the strategy, so as to provide guidance to governments on how to properly tackle medication adherence issues around TB. Medication non-adherence is a critical component in TB treatment failure, the rise of resistant TB strains, and the spread of this disease. It is even more significant with the advent of the HIV and TB co-epidemics. This was not more evident than the recent outbreak of the highly drug-resistant strain of TB in South Africa. Not only was the strain resistant to first-line TB medications, but also several second-line TB medications as well. Even though the majority of infected individuals also tested positive for HIV, it also infected health care personnel, with a case fatality rate of 98% (18).

Conclusions
The DOT component of the DOTS strategy proposed by the WHO is a misspent opportunity to tackle a complex issue that is integral to properly control TB. It aims to tackle an issue heavily steeped in social and economic factors, without any grounding in social theory. Consequently it shifts focus to patient related issues both in regard to research and implementation, ultimately failing to recognize the broad social constructs impeding TB medication adherence. Given the importance of medication adherence to TB control and the urgent need for an effective public health strategy that tackles this issue, the DOT component should be revised to reflect the intricate social, behavioural and economic realities of TB medication adherence.


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Failure to Focus Enough on Sociological and Economic Aspects Detrimental to Tuberculosis Treatment – Christine Jones

Tuberculosis is a respiratory disease caused by the bacteria Mycobacterium tuberculosis. The bacteria forms nodules in an infected person’s lungs and can be transmitted to others via aerosolized droplets when a person talks, coughs, or sneezes in close proximity to another. TB is pandemic in many parts of the world, such as Africa, the former Soviet Union, and some parts of Asia. Scientists estimate that over one-third of the world population is infected with TB and that the disease caused 1.6 million deaths in 2005 alone(12). TB can be treated, but it takes roughly 6 months to fully remove the bacteria from a person’s system and multiple drugs must be used. The World Health Organization recommends a drug delivery program called Directly Observed Treatment, short course (DOTs)(12). This treatment method requires health care workers to observe and document patients taking their medication every day. Though this treatment program has proven successful, TB prevalence rates are not falling as fast as they should.

Prevention and treatment measures for the control of Tuberculosis world-wide have been hindered because not enough attention has been paid to the community support of TB patients, receipt of health care and sociological aspects related to TB cases associated with HIV infection, and prohibitive socioeconomic factors which affect many patients.

More Focus Needed on Community Based Prevention and Education Programs

It has been said that it takes a village to raise a child. A similar statement could be made about TB patients. It takes community support for people with TB to seek correct treatment and to adhere to treatment once it has begun. Many studies have shown that there is a general lack of knowledge about the disease which can lead to stigma and a general lack of support for those suffering from it. It is vital to adequately educate communities about TB and to engage them in TB prevention and treatment efforts. Also, it is important for health care workers to understand cultural differences and views about the disease and to work alongside community members when administering care to patients.

A study conducted in a rural community in South Africa found that the most common reason for people not to seek care and treatment for TB was fear about the stigma attached to the disease(3). People are afraid that by being diagnosed with, and receiving treatment for TB, their disease status will become known to their family, friends, and the rest of the community. It is hard for patients to hide the fact that they have TB because of the nature of treatment which involves daily trips to a health care facility to receive drugs. Patients are often afraid that having their disease status known will cause social isolation from friends and acquaintances and even lead them to being shunned from their own family(1). If community members do not know much about the disease, or if the information they have is incorrect, this can lead to fear towards, and discrimination of, people with TB. Researchers in Thailand found that low knowledge of TB lead to higher levels of stigma(10). Therefore, education for patients, but also for the entire community, about the etiology and treatment of TB is vital in order for more people to seek the correct care and complete treatment.

Several studies have shown that many people know very little about how tuberculosis is transmitted and these ideas vary depending on their culture and where people are from. A study conducted in Tanzania found that community members had a variety of incorrect ideas about how one contracted TB including tobacco smoking, drinking milk contaminated with cow hair, dust, and witchcraft(7). Other studies conducted in South Africa and Nepal found that community members associated people with TB with sexual promiscuity, lack of adherence to religious rules, and heavy drinking(1,3). These responses were generated from general community members, and also traditional healers and religious leaders. This demonstrates that both the public as well as community leaders need better information about TB. In order for the general public to become more informed about TB, education must begin with the community leaders since, from a cultural standpoint, they are going to be the people the average citizen looks to for guidance. As a low amount of knowledge was associated with stigma, a high amount of TB knowledge is associated with social support given to TB patients from the community(10).

Information is often hard to find, though. Reports from rural South Africa and Tanzania state that health messages about TB were presented in a confusing light which appeared to challenge traditional beliefs and often information pamphlets found in health care facilities were too small or were incomprehensible because they were written in English(3,7). Educational materials will do no good unless they can be easily understood by all members of the community and are sensitive to cultural differences which many vary significantly depending on the area.

In order to foster community involvement and support for TB patients, it is essential that health care workers take the lead in educating the general public and community leaders. Almost 40% of TB patients in a South Africa community admitted to first seeking treatment from a traditional healer when they first began to have TB symptoms(3). Another study showed that patients seeking treatment for TB put much less value on modern health care facilities and more on traditional healers(7). If this is the case, it is necessary for health care workers to collaborate with the healers in order to identify TB patients and to provide them with the correct treatment. Also, health care workers must encourage community and religious leaders to help disseminate accurate educational information since these are the people who have the best understanding and sensitivity towards the beliefs and culture of the population.

Family and friends must be supportive prior to, and during, a patient’s TB treatment. Research shows that treatment support systems that involve enlisting family and community members to encourage and ensure a patient takes his or her medication can have positive effects on treatment adherence(3). Because treatment of TB is a long process it is not surprising that patients would need motivation and encouragement to continue. One is much more likely to complete a task if they know they are supported by the people around them. Patient support groups where individuals can talk about their fears and experiences, along with community involvement such as informational meetings and educational outreach are extremely beneficial to fostering an environment where patients can feel good about seeking health care and are encouraged to finish their treatment(5). Education about the disease can serve not only to decrease stigma, but also increase social support for patients. Health care workers must collaborate with the public to encourage community support groups and enlist help from leaders, such as priests, traditional healers, and others who have influence over the community, to promote an environment that will lead to better TB treatment outcomes.

TB and HIV/AIDS Must Be Treated Together

In many African countries half or more of TB patients are also HIV positive(2). Because of their HIV status, patients who are also co-infected with TB are much more likely to have a rapid progression of disease and have the opportunity to pass it on to more people before they receive treatment. The DOTs program alone is unlikely to be sufficient on its own in these areas to control the spread of TB. It cannot be ignored that TB and HIV are inextricably linked and that treatment strategies and support must take into account the sociological aspects, such as stigma, that surround HIV/AIDS. Also, the entire health care delivery system in areas with high HIV prevalence needs to be overhauled. Instead of separate clinics that provide care for each disease individually, HIV and TB health care centers need to merge in order to provide holistic care for both diseases which would promote case-finding and better support for patients.

In many areas of the world HIV/AIDS is unfortunately still a highly stigmatized disease. Being co-infected with both TB and HIV exacerbates the stigma surrounding TB patients. It has been shown in Thailand that TB patients who also exhibit symptoms suggestive of HIV/AIDS are more highly stigmatized than patients who present with TB symptoms alone(10). Because HIV and TB are so closely tied together, it is often difficult for the general public to differentiate between the two diseases. HIV and TB are often misconstrued as the same disease that leads to misconceptions about TB and how it is transmitted. In Zambia, both TB and HIV were associated with sexual taboo and ‘sexual pollution,’ and similar findings in Vietnam and Kenya showed that people believed TB had a sexual origin because of its ties with HIV which increased the stigma surrounding the disease(3). The general public not being able to differentiate between HIV and TB highlights the need for more education about both diseases. Though ideas about the sexual origin of HIV are relatively correct, people associating sex and promiscuity with TB simply leads to higher levels of stigma. Community members viewing HIV and TB as practically synonymous, and the moral implications of sexual promiscuity associated with HIV, lead family members and friends to discriminate against the affected person and treat them poorly. Studies dealing with stigma in Tanzania have shown that community members, believing that a person is co-infected with TB and HIV, speak very poorly about the sick person and segregate them in the community(7). Misconceptions about HIV and TB, which increase the stigma surrounding the disease, lead to patients being more reticent about seeking treatment and for their illness. Education needs to focus on disseminating correct information about the two diseases and to make sure people differentiate the two. Informative approaches such as these can lead to better treatment seeking behavior in patients and can also assist in stigma reduction(7).

Along with dispelling discrimination and stigma directed at co-infected people in the community, the health care system itself must adapt to treating people who have both TB and HIV. Health care workers cannot treat TB patients in high HIV prevalent areas in the same way that TB is treated in areas with low HIV prevalence. Family Health International found that, after some pilot studies were conducted in Africa, improved collaboration between TB and HIV programs reduced stigma and provided patients a wider range of interventions and support(4). Currently, health care facilities dealing with TB and HIV/AIDS can be thought of as two independent entities. Patients go to one facility to get TB treatment and they must go to another clinic to be treated for HIV. Most TB treatment centers have not adapted to the fact that they are now currently treating large numbers of people with HIV/AIDS and have not responded enough to the different social and medical needs that HIV infection presents(2). In areas with high prevalence of HIV, TB and HIV treatment centers need to combine forces in order to offer patients holistic treatment for both diseases. This can significantly help in case finding for both diseases, as it has been found that there can be high rates of undiagnosed TB in HIV infected persons, and TB is often the first clinical manifestation of immune deficiency, so many TB patients may also have undiagnosed cases of HIV(2). By having patients treated for both diseases at the same treatment center it would be much easier for health care workers to find new cases of both TB and HIV by offering screening for both diseases when patients come in for treatment. Also, HIV counseling can be provided to all TB patients before and after testing, thereby providing education and support for dealing with co-infection. In Tanzania, studies have shown that TB patients had misconceptions about co-infection, and it was often believed that if a person had HIV/AIDS that TB could not be cured(7). Care and support for both diseases at the same time ensures that patients receive the correct information and receive the encouragement needed to complete treatment.

By combining treatment facilities, health care workers would need to be trained in the treatment and care of both HIV and TB patients. In most cases, health care workers care for patients with one disease or the other, which means that co-infected individuals receive two sets of information from different health care providers who may or may not know much about the other disease, or may not even know that their patient is co-infected. Along these lines, in sub-Saharan Africa, research has shown that HIV treatment centers have not viewed TB as a priority, health care workers may not know much about TB, and may even fear TB(6). By combining treatment centers, health care workers can become cross-trained in both TB and HIV treatment practices. This will ensure that patients get the correct information about their diseases, they can have continuous care from a single health care provider, and will be able to receive care in an environment that will be supportive and nurturing for people with co-infections. Stigma against TB and HIV also may be able to be mitigated by having treatment for both diseases provided in the same building because patients and community members would become used to seeing HIV and TB being treated together and more educational information about co-infection could be disseminated.

Socioeconomic Status Must Be Factored Into Prevention and Treatment Initiatives


Low socio-economic status of TB patients can have a detrimental effect on their adherence to treatment. Research has shown that even though governmental organizations provide TB treatment at no cost, there is still a considerable financial burden placed on patients and their families. Families of low socio-economic status, which is the demographic with the highest numbers of TB cases, often find the cost of completing treatment, or the cost of seeking treatment in the fist place, prohibitive. Even when TB drugs can be obtained at no charge, patients are often faced with other financial burdens, such as lost wages at work and the costs to travel to clinics. Children receive less care at home, and are sometimes forced to drop out of school to care for their parents or go to work themselves in order to support the family.

One study completed in India showed that, on average, TB patients lost up to 3 months worth of wages while receiving care and between 67% and 75% of patients had to borrow money on account of their disease(9). With the loss of family income, it is not surprising that this has an adverse affect on the children of TB patients. It has been shown that a fifth of school-aged children drop-out of school because of a parent’s illness either to care for them or to help earn money for the family(9). Because of the financial burden, patients of low-socio-economic status are far more likely to drop out of treatment programs. The amount of travel required to reach treatment facilities increases the risk of non-adherence to treatment even further(8). Under the DOTs system of treatment, patients must visit the clinic every day to receive medication. Not only does this daily travel enhance the loss of wages from work, but patients must pay out of pocket the travel costs to reach the clinic. This is especially a problem in rural areas where people are often required to travel great distances to reach treatment facilities. It has been shown in Ghana that patients who live close to clinics have a much higher treatment completion rate than those who live farther away(11).

Socio-economic status plays a large role in whether people will even seek treatment for TB in the first place. In a study conducted in a rural part of China, 37% of people with suspected TB cases did not seek any professional care for their symptoms(13). Though treatment is free if received at government-run clinics, private clinics still charge for diagnosis and treatment of TB. This means that unless there is a government-run clinic nearby, many patients will opt not to be diagnosed in fear of high medical bills. It has been shown that the poorest tenth of TB patients on average spent more than their entire annual household income on care when it was not received at a full-subsidized care facility(13).

Though TB treatment is supposed to be free, there are still far too many financial burdens for families of low socio-economic status to overcome in order to receive care. Even when patients received treatment at a free clinic it has been shown that 26% of their annual income went to costs indirectly related to their disease, including transportation to health care facilities and loss of wages(13). TB treatment programs cannot stop at providing free diagnostics and drugs since this clearly does not give equal access to health care for all. Treatment programs need to look at ways to help subsidize other costs patients incur due to the receipt of treatment. Access to free treatment, especially in rural areas needs to be improved, since it is financially prohibitive for patients to seek treatment at private care facilities, even if they may be closer to where they live.

Conclusion


In their latest report, published in 2006, outlining the international strategy for TB control, the World Health Organization still treated the disease as a biomedical rather than a social disease(1). Though DOTs has been an effective treatment strategy, it must be combined with community education and outreach programs to help reduce stigma, health care strategies to support TB and HIV co-infected patients, and determine ways to make treatment economically feasible for everyone.

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