A voluntary health worker project (Operation Elsies River) was started in a high incidence TB area in the Western Cape of South Africa, in order to assist the local TB control programme with case-holding. The objective is to evaluate the effectiveness of this group of volunteers in enhancing adherence of notified TB patients to TB treatment. A cohort study was conducted with 351 TB patients (203 children and 148 adults). The data from the child and the adult groups were analysed separately. The child group was more adherent to TB treatment than adults. The supervision option with staff dedicated to the treatment of TB, such as the clinic and the SANTA creche, achieved better adherence results for pre-school children. The supervision modalities for adults did not differ in their adherence performance even following adjustment for confounders.

The supervision option provided by the volunteers did not significantly improve the adherence of adult patients to anti-TB treatment.

Since chemotherapy first proved efficacious for TB, a significant number of patients have failed to complete an adequate course of therapy. An enormous research performed over the last 40 years has contributed greatly to our understanding of the complex nature of why patients fail to take their medication as prescribed. Despite our increased knowledge of such patient behaviours, modern medical practitioners, to date, have neither the means to identify in advance all patients who will fail to take their medication, nor the means to detect all those who are not taking their medication during the course of their therapy. In the case of a communicable disease such as TB, the well-being of the patient and the interest of the public health overlap. Physicians, in general, and public health officers, in particular, are charged not only with ensuring that individuals are adequately treated so that they may be cured of their disease, but health care professionals are legally obligated to ensure that adequate treatment occurs to protect the public from the threat of TB.

The authors have deduced six steps to optimize patient adherence which is termed as “Denver Model” The principles of using these steps would maximize the efficiency of DOT by eliminating as many barriers as possible and by creating a structure that readily locate the “lost” patient. They are: (i) Know the patient: Initial encounters with the patient should be used to aggressively gather information. The goal of these sessions should be to identify as many points as possible at which the patient connects with the community. (ii) Assign a case manager: Each patient should have one health care professional who is identified as a specific contact. If at all possible, this contact should have fluency in the patient’s first language; if that is not possible, the contact should arrange for an adequate translator to be present for sessions with the patient. Ideally, the case worker and patient will establish a sound and stable therapeutic relationship. (iii) Establish inducements and enablers: Many patients with TB are afflicted with numerous social ills in addition to their disease. Homelessness, hunger, and substance abuse can make TB seem the least of their worries; thus, adherence to medication assumes a low priority. If the TB clinic can meet some of the patient’s other needs, contact with the clinic assumes a higher priority, and the likelihood of adherence to therapy is much greater. The use of “enablers” has also been advocated. Enablers are services that remove barriers to the patient’s participation. For a patient without transportation an enabler might be a bus token or a taxi voucher; for a mother it might be child care so that she can come to the clinic. All of this sounds expensive, but the ultimate total cost of inducements and enablers is far less than the cost of inpatient care in the case of the patient who fails these outpatient efforts, not to mention the cost of caring for the additional cases that will result from failure to treat. (iv) Be flexible: Every attempt should be made to accommodate the patient’s needs and schedule. Whenever possible, reliable contacts in the community should be identified so the patient can get medication 24 hours a day. (v) Involve community workers: Part-time employment of reliable members of the patient’s community can prove invaluable. Ideally, this would be an individual who knows the patient and the patient’s neighbourhood, someone who could quickly locate the patient if he/she failed to show for an appointment and who could determine the reason for the missed appointment as well as administer the missed dose. (vi) Issue an order of quarantine: Patients should clearly understand that their adherence to medical therapy is legally mandated and is offered in lieu of physical quarantine. The patient should receive an order of quarantine that clearly explains this and makes clear that failure to present for medication doses may result in incarceration for the duration of therapy.

Nearly thirty years of experience with the direct observation of antituberculous chemotherapy in Denver have proven these to be effective measures. Each case of TB in Denver County is treated with impartiality. Every patient with TB received DOT and no exceptions are made.

In Pakistan, TB is a major health problem and is perceived as a stigmatised disease. Implementation of DOTS is limited to only few districts due to poor functioning of primary health care and inability to strengthen them before DOTS implementation. Bethania Hospital (BH) in Sialkot town of Punjab province in Pakistan is the acknowledged centre for treatment of TB patients since 1970. Still the major problem faced by BH has been poor compliance. Various alternatives to improve compliance were tried e.g., hospitalization for initial 6 weeks, introduction of SCC of 8 months, which had some improvement, but was not appreciable as SCC regimen had 12% initial defaulter and 34% of these put on treatment did not complete the treatment.

Keeping in view the social attitude and the health beliefs of the local people, it was decided to offer intensive counselling to improve treatment adherence. The objective of the study was to assess the overall impact of counselling on treatment defaulting and to identify sub-groups in which counselling was the most effective. The statistical design was a randomised controlled intervention trial. A total of 1019 adult TB patients were interviewed and taken into the study and the control group during full one year of 1995. Baseline data were obtained through semi-structured interviews by trained para-medicals of both genders and belonging to the same socio-economic background. Patients were followed until the end of treatment. The counselling was given at the start of treatment and at each subsequent visit for ambulatory patients, or weekly for hospitalized patients in the study group. The counselling, combined health education with strategies was aimed to strengthen the self-efficacy. Control group patients received the usual care. According to treatment policy, patients scheduled for SCC were advised to accept hospitalisation for the 2 months of intensive phase of treatment. Ambulatory patients mainly received a 12-month regimen. Of the 63% of patients who accepted hospitalisation, only 40% remained hospitalised for the full 2 months. The outcome measure was treatment default, cure, referral or death. Results showed that the default rate was 54% in the control and 47% in the intervention group; the default risk ratio was 8.7, implying a reduction in defaulting of 13%. Intensive counselling has a significant, although limited, impact on treatment adherence. The impact was stronger in women, ambulatory patients, re-treatment patients, women who worked at home, and patients who were not the main providers, those with poor knowledge of the disease or those with a short treatment delay. Counselling does not eliminate the need for closely supervised treatment but it is a useful additional strategy for improving treatment adherence. In the long run counselling has the potential to reduce the stigmatisation of TB patients. In countries like Pakistan, where the implementation of DOT is currently hampered by the absence of functional health infrastructure at the peripheral level, the combined strategy of counselling and family based DOT could offer a valid alternative to the immense and urgent problem of TB control.

Non-adherence to treatment by patients is a major impediment, worldwide, in controlling TB. Failure of approaches attempted so far, in effectively tackling the problem of non-adherence, has led to the inclusion of directly observed or supervised chemotherapy as an essential element of the WHO's revised strategy for global TB control. Supervise chemotherapy has also been made the most important component of India's NTP being revitalized with the help of a loan from the World Bank and technical assistance from WHO. The reason for advocating supervised chemotherapy in India is the failure to ever achieve desirable cure rates, under a well designed NTP in operation for ever 3 decades. The demonstration projects of several NGO's, claiming success in achieving high cure rates, rarely provide hard data as evidence and their results are often considered anecdotal and unsuitable for wider application. This paper presents alternative approaches adopted by two NGO‘s providing services to large populations in different settings, one a most backward area of rural Gujarat and the other in the slums of Bombay. Both organizations could ensure reasonably high levels of treatment completion and cure rates under field conditions. While the urban NGO used pre-registration screening and motivation as tools to ensure treatment completion and cure, the rural NGO successfully employed the services of the female anganwadi workers of the Integrated Child Development Services(ICDS) scheme. The reproducibility and wider applicability of some important elements of these approaches are discussed.

Measures known to improve adherence such as short course chemoprophylaxis and directly observed therapy can be enhanced to a significant extent by the use of incentives. Adherence to TB therapy is influenced by several factors, including the health care system, complexity of therapeutic regimens and patient’s characteristics. Individual factors that negatively influence patient’s adherence are the most difficult to counter. Preventive TB therapy is doubly challenging because the benefit of treatment is not felt, while toxicity from the medication, when it occurs, is experienced immediately. Ingenious incentives therefore have to make it worth the patient’s while. During a study on preventive regimens, a request for an incentive, Sustacal, was observed to help completion of preventive regimens. Components of individual TB programs may help in patient adherence; it is important for health care staff to identify these aspects and, if they are successful, utilize these as an incentive to complete treatment.

The feasibility of involving ‘Dai’s’ in supervised administration of an oral 6-month SCC regimen in DTP was studied in 2 districts. A concurrent comparison was made between the Dai Method and the present DTP procedure, called the PHI Method, in terms of treatment completion and cure rates at the end of treatment period. A total of 617 patients were observed; 332 in Dai method and 285 in PHI method. About 68% of patients in the Dai method and 33% in the PHI method took more than 75% of treatment in both intensive and continuation phases. The outcome in terms of smear negativity at the end of treatment period was 86.9% and 72.2% respectively. There were 17 (5.72%) deaths in the Dai method and 16 (8.5%) in the PHI method. Treatment completion and cure rates were significantly higher in the Dai method. It is concluded that Dais can be used for supervised drug administration in DTP for increasing the cure rates.

The feasibility of improving adherence to and outcome of treatment among smear positive pulmonary tuberculosis patients by involving traditional birth attendants (Dais) in administering anti-tuberculosis drugs was earlier studied and 86.9% were reported to be cured, 5.72% had died and 7.38% had remained sputum positive, at the end of 6 months. The present study reports the status of those patients at the end of 2 years. Of the 288 patients eligible for follow up, 283 could be contacted through home visits and interviewed for the presence of symptoms and further treatment taken; if dead, the cause of death was ascertained from relatives. Two sputum specimens were also collected from the contacted patients for microscopy, culture and drug sensitivity tests. At the end of 2 years, 79.6% had remained relapse free 7.42% had relapsed and 3.53% remained sputum positive (chronic cases) while 8.5% had died. Of the 251 patients interviewed, 131 still had chest symptoms, 2 years after treatment, but only 24 of them had bacteriologically positive disease. The remaining 7 sputum positive cases were either having non suggestive symptoms or no symptoms.

In view of the above findings, it is considered that DOTS delivered through Dais is feasible