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EXECUTIVE SUMMARY

Tuberculosis (TB) is a widely spread disease globally that causes millions of people’s death worldwide. Treatment for TB is complex and usually involves taking several antibiotics at once for a long time (sometimes up to two years). Considering the severity of the treatment regimen, it becomes hard for the patients to adhere and complete proposed treatment and particularly for those who are infected with drug-resistant strain of TB. Poor adherence to treatment remains significant problem that prevents countries from obtaining high treatment success rates that is essential for health systems to control the epidemic and decrease spread of the disease. A new study from Georgia looks at adherence to treatment factors among drug resistant TB (DR-TB) patients and provides evidence that may help policy-makers develop effective strategies for improving treatment outcomes among DR-TB patients. The study findings might be helpful for other countries in the region where TB burden is also high.

PROBLEM STATEMENT

• Tuberculosis remains a global health challenge for the public health throughout the world. According to the World Health Organization (WHO) statistics, in 2015, 10.4 million people fell ill with TB of which 1.8 million died from the disease. TB has been a leading cause of death among infectious diseases1.

• In Georgia, the incidence rate of all forms of TB reached 74.7 per 100,000 population in 2015. Even though Georgia has seen a decreasing trend of TB incidence for the past several years, Drug Resistant TB (DR-TB) prevalence rate is still high. In 2015, 11.6% of the new cases ofpulmonary TB and 38.8% of previously treated cases accounted to be drug resistant2.

• The rate of treatment interruption (patients who stopped taking treatment) among DR-TB patients is high, which creates a risk of drug resistant TB spread.

1Global Tuberculosis Report 2016, WHO 2Statistical Yearbook “Health Care in Georgia” 2015, NCDC

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ACKNOWLEDGEMENT

Policy Brief was developed by Lela Sulaberidze and Ivdity Chikovani.

Curatio International Foundation would like to express its gratitude towards the National Center for Tuberculosis and Lung Diseases for supporting the field work implementation for the study. The research team would also like to thank all respondents who agreed to dedicate their time and effort to the study.

The study was implemented under the TDR/WHO small grants scheme financial support. The views expressed in the publication are those of the authors and do not necessarily represent those of the TDR/WHO.

All rights reserved. Results may be used or reproduced without obtaining prior written permission from the authors but with appropriate citation.

© Curatio International Foundation 2016

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EPIDEMIOLOGICAL REVIEWThe number of TB cases has been decreased in Georgia for the past decade.

Figure 1: TB cases per 100,000 population, 2005-2015 yy.

Source: Statistical Yearbook “Health Care in Georgia” 2015, NCDC

Georgia no longer belongs to the group of the countries with a high burden of DR-TB since 2016, however, DR-TB prevalence rate is still high among new and previously treated TB cases.

Figure 2: DR-TB prevalence in Georgia, 2005-2015 yy.

All Cases New Cases

New Cases Previously treated cases

Source: Statistical Yearbook “Health Care in Georgia” 2015, NCDC

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As for the treatment outcomes, it should be noted that treatment success rate among DR-TB patients is not satisfactory enough in the country.

Figure 4: Treatment Success rate (%) among DR-TB patients, 2015

Source: Global Tuberculosis Report, 2016, WHO

DR-TB prevalence is higher in Georgia, compared to the countries in Central and Eastern Europe.

Figure 3: DR-TB prevalence among new and previously treated cases (%), 2015

Source: Global Tuberculosis Report, 2016, WHO Statistical Yearbook “Health Care in Georgia” 2015, NCDC

New cases Previously treated cases

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The trend for the past several years shows that every third of DR-TB patients stopped treatment.

Figure 5: M/XDR-TB treatment outcome (%) 2011-2013yy cohorts

Source: National Center for Tuberculosis and Lung Diseases, 2015

ABOUT THE STUDY

In 2016 Curatio International Foundation conducted a qualitative study to investigate factors that enhance or hinder treatment adherence among DR-TB patients.

The study was conducted in Tbilisi, Adjara and Samegrelo-Zemo Svaneti regions using in-depth interviews with a randomly selected sample of TB patients and focus group discussions (FGD) with health care providers. The target audience for the study was comprised with the following types of patients and health personnel:

• DR-TB patients, lost to follow-up from treatment • DR-TB patients who were currently receiving treatment but had difficulties to adhere to the treatment regimen, so-called “recalcitrant patients” • DR-TB patients, who finished treatment successfully • Phtisiatrists, DOT1 -nurses, primary health care nurses providing DOT services in rural areas, epi demiologists.

Set of in-depth interviews were provided also with the key informants. Data generated from the interviews and FGDs were analysed using a conceptual framework that outlines a range of structural, personal, social and health system factors affecting adherence to TB treatment2.

The document summarizes main findings of the study and proposes recommendations for further improvement of the system.

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Treatment success Lost to follow-up Died Treatment failed Not evaluated

1DOT - Directly Observed Therapy 2Munro, S. A. et al (2007). Patient Adherence to Tuberculosis Treatment: A Systematic Review of Qualitative Re search. PLoS Medicine, 4(7), e238. http://doi.org/10.1371/journal.pmed.0040238

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Study conceptual framework

STUDY FINDINGS

The study revealed different types of factors affecting treatment adherence among DR-TB patients in Georgia. The findings are grouped into structural, social, personal and health system factors according to the study conceptual framework.

Structural FactorsSome social and economic factors prevent patients from completing the treatment. Despite the fact that the treatment is free, some patients cannot find time for it because of their work. If a patient has to choose between employment and treatment, preference is given to employment.

“...I stopped the treatment because I am the only man in the family. I have two sisters who are single and I cannot leave my family members hungry. I had to work but it is very difficult to combine work and treatment at the same period...”

A lost to follow-up patient

There exist some conflict between the Labor Code and TB treatment regimen. Working hours of employed patients and difficulty in obtaining sick leave for treatment do not allow them to comply with the treatment regimen. In addition to this, some patients do not disclose their disease to the employers because of stigma or fear to lose their jobs. Therefore, it is difficult for such patients to combine the work and treatment regimens and they are forced to abandon treatment.

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On the other hand, communication with colleagues helps patients to overcome treatment related adverse events. As successfully treated TB patients reported they paid less attention to theunpleasant feelings caused by the TB drugs during work, which helped them to cope with such factors.

Due to financial problems low economic status patients face difficulties in terms of performing additional tests and purchasing medications required for side effects management.

The monetary incentive system works well among the patients, especially for those who are under economic constraints.

“…Of course side effects mean additional expenses because you have to buy additional medications. Although this voucher creates additional motivation because some people have no money at all and this helps…”

A patient who has successfully completed TB treatment

Besides the monetary voucher drug resistant tuberculosis patients also receive a voucher that covers their transport costs. The amount covered by the transport voucher equals the public transportation cost to visit a DOT center. The voucher was also found to be positively influencing adherence to treatment.

Social factorsSupport from family and society is crucial during the treatment as patients report. Conversations with family members and friends help patients not to feel alone, not to loose hope, be lessirritated and do not miss visits at DOT centers.

“...Support from family members is very important. You feel that you are not alone. Sometimes I was too lazy to go to the DOT center but my wife insisted and forced me…” A patient who successfully completed the treatment

Lack of attention from family and friends negatively affects adherence to treatment. When a family member is actively involved in the treatment process and supervises the patient’s visits, the patient has more responsibility towards himself and his family and tries to fulfil visits. Patients who have family support are usually those who successfully accomplish treatment.

Decisions made by the majority of patients are greatly influenced by peer experiences. The majority of patients reported that their decision to continue receiving medicines was a result of negative consequences of abandoning treatment, which they had seen among other patients. Successful treatment stories and peers experience on different coping strategies with side effects had positive influence on treatment adherence.

“… For example, I was looking for patients who had finished treatment wonder-ing how they felt and how much time had passed since their treatment…”

A patient who successfully completed the treatment

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Peers’ influence turned out to be negative when patients shared information on how to avoid receiving some medicines and different methods of deceiving health personnel.

Although stigma has never been named as the main reason for treatment interruption among respondents, some patients reported that they concealed information about their illness and tried to avoid communication with other people.

Personal factors

Service providers inform patients about the disease, special characteristics of the treatment regimen and possible occurrence of side effects on a regular basis. Almost all patients confirmed that they received detailed information about TB from health personnel. Although, information deficit was revealed with lost to follow-up and recalcitrant patients: one fourth of these patients reported that they missed visits to the DOT center or stopped treatment because TB symptoms disappeared or they felt much better. There were also some cases when patients interrupted the treatment and then resumed it after deterioration of the heath condition.

“...I stopped the treatment a year ago and have not visited the TB hospital to receive medicine ever since. Physically I was feeling well so I decided that medicine was no longer needed...”

A lost to follow-up patient

Patients who had successfully finished TB treatment reported that one of the main motivators for them to complete treatment was their family. These patients had correct understanding of risks associated with untreated Tuberculosis, so they tried to complete the treatment in order to protect their family members and friends.

Health system factors

Free treatment and TB program management

The opportunity of receiving treatment free of charge was viewed as a huge benefit provided to the patients by the National TB Program. Many people emphasized that they received expensive treatment free of charge within this program.

Besides free health services and pharmaceuticals, all respondents reported that they received medicines continuously at DOT centers without interruptions. Specialists and service providers working in this area indicate that TB program is well managed throughout the country. They positively assess existence of properly running laboratory system, uninterrupted supply of pharmaceuticals and good program monitoring system.

Service providers expressed dissatisfaction with their limited involvement in the decision making process. As for the patients’ involvement in the decision making process, it must be noted that patients did not even expect they should participate in the process.

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Personnel’s Financial Motivation

Service providers complain about low salaries which is below the average salary level in Georgia. According to the service providers, their only stimulus is professional motivation. In the frame of National TB Program, a doctor’s minimum monthly remuneration equals to 360 GEL and 280 GEL for DOT-nurses. A doctor’s salary is considerably lower than a primary healthcare nurse’s salary. This definitely reduces doctors’ motivation.

“…Salaries are rather low. It is rather bad that primary healthcare nurses have a salary of GEL 450, while doctors receive only GEL 360. This is a demotivating factor for us…”

Phthisiatrists’ FGD

The same problem was identified in case of epidemiologists. They talked about an overloaded work volume and complained about inadequate financing of their efforts.

The research also demonstrated that service providers do not have full financial supportnecessary for the performance of their obligations within the program. Doctors and nurses have to cover communication expenses with patients out of their own pockets, which is not a small share of their monthly salary. At the same time, frequent communication positively influences the patients’ adherence to treatment behavior.

“…When a patient does not come to take a medicine, we have to find out where he is and why he has not come. We spend our salary to top up the mobile phone account because we have to communicate with patients over the phone all the time … “

Doctors and nurses FGD

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Health Personnel

The majority of patients reported the positive role of the health personnel during treatment period. Great attention from doctors and nurses and support at TB treatment facilities wereemphasized by the patients when describing interaction with health personnel. Attentive and compassionate health personnel significantly influence the patients’ behavior and stimulates them to complete treatment.

“…Physicians and nurses were positively disposed towards patients. They were equally attentive to everyone and they motivated us to take drugs. They often talked to us and supported us in everything. Nurses play a rather big role in the treatment process; they provide moral support and additional consultations…”

A patient who has successfully completed TB treatment

FGDs with specialists revealed lack of young specialists working in this field. As a result, the level of accepting and introducing innovations is low. Low salaries and health risks accompanied with TB service delivery decrease the interest of young health personnel to work in this field.

Epidemiologists are responsible to work with lost to follow-up patients in the frame of the National TB Program. The research demonstrated that this part of the program does not work effectively. In order to reach lost to follow-up patients, epidemiologists mostly use phone call communication because transportation costs are not reimbursed for them.

“... It would be good if I could make repeated calls to convince them; if there were incentives; if we were given money for transportation, for example GEL 10. In this case we would manage to return lost to follow-up patients in treatment...”

Epidemiologists FGD

Besides low remunerations, the Program currently does not have any incentive mechanisms (financial or other) for service providers to stimulate their work.

“…There is not even a small gift for us for a cured patient. World TB Day in the past, where Phtisiatrists from Georgia used to meet each other, exchange information during the dinner in the evening. This was some kind of expression of gratitude, there is nothing like that nowadays…”

Regional Phtisiatrists’ FGD

Geographic Distribution and Infrastructural Conditions of TB treatment Facilities

Integration of the services into the primary healthcare system increased geographic access to services for rural population. But in Tbilisi, both patients and specialists reported about existence of a geographic barrier to access services. Transportation of patients to DOT centers is a problem because there are only four DOT centers in Tbilisi, that are not evenly distributed in the city.

“... Even though we reimburse them for their travel expenses under the Global Fund project, spending 3-4 hours every day to reach the TB treatment facility and return back is a problem for patients; moreover, only MDR patients get compensation... “

A field specialist

The patients living in regions face geographic barrier of access to services in terms of management of side effects. They often have to go to Tbilisi to receive these services. In addition to this, existing infrastructural problems and poor sanitary conditions at inpatienthospitals in regions result in geographic access barrier for patients as they seek to get inpatient service in Tbilisi, where conditions are satisfactory.

Noteworthy that DOT centers also have infrastructural problems. E.g.: regional facilities do not have enough space for provision of high quality ambulatory services. Despite the fact that the condition of integrated facilities was improved, they often do not meet international standards for service delivery, such as constant natural or artificial ventilation and ultraviolet lights in doctor’s rooms.

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Due to the inadequate space or poor sanitary conditions of ambulatory facilities, patients do not have an opportunity to talk to each other and share experiences that would help them to overcome difficulties. As it has already been mentioned above, sharing of personal experiences has a positive impact on the treatment process.

“…Conditions should be improved to encourage a patient to enter the TB facilities. I used to go home right after taking the medicine. I did not want to stay there and talk to other patients … “

A lost to follow-up patient

The challenges of DOT

Patients point out difficulties associated with DOT regimen. Pill burden is emphasized as one of the main challenges of concomitant treatment by the patients. They find it difficult to take a high number of pills at the health care facility for a long time on a daily basis.

Although DR-TB patients under treatment receive transportation voucher to visit treatment facilities, patients involved in a new scheme of treatment also complain about visiting TB treatment facilities 2 times a day. Under the new scheme of treatment patients receive TB drug infusions, which should take place in hospital settings.

“… It is not difficult to take medicines in the morning but when I come here in the evening then I feel sick. I have to come here twice a day and I drive here. My father and my friends accompany me sometimes …”

A recalcitrant patient

The impact of Side-effects and system-level gaps in side effects management

Occurrence of side effects, frequency and their management play an important role on treatment adherence. Almost all patients involved in the study reported having treatment related physical and/or mental side effects. A big proportion of lost to follow-up patients attributed non-adherence to experiencing side effects.

“…Initially, after taking drugs I used to recover more easily. Doctors gave me everything included in the program – against vomiting, liver-protectors - but eventually I felt very bad and nothing helped me to recover …”

A lost to follow-up patient

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According to experts’ explanations, effective management of side effects caused by TB drugs requires specific knowledge of different systems by health personnel. Several drugs are financed by the National TB Program for side-effects management for DR-TB patients, but besides this there are some investigations and specialists’ consultations patients with side-effects seek to attend. Patients living in Tbilisi have better access to such services due to their proximity to the National Center for Tuberculosis and Lung Diseases (NCTLD), where such services are available. The Center has different specialists such as cardiologist, neurologist, psychiatrist, gastroenterologist, endocrinologist, etc. who are involved in the management of side effects. Moreover, patients living in Tbilisi are better informed and use the universal health coverage program services rather than patients living in rural places. In regions, patients either visit such kind of specialists directly or get services in Tbilisi, that are associated with additional expenses.

Most of patients reported having problems like anxiety, insomnia, depression etc., the management of which requires involvement of a psychologist/psychiatrist. Service providers and field exerts also emphasize the need of psychological support strengthening countrywide. Such services similarly to other specialists services are provided in Tbilisi National Center however are not readily available for majority of patients who need such care.

“...Patients need psychological support. Sometimes he is so exhausted that does not want to take a medicine any more…”

A spouse of a recalcitrant patient

“… Some of patients become rather reserved and find it harder to deal with this psychologically, such people need to be supported by a psychologist …”

A patient who has successfully completed the treatment

Risks Associated with TB Service provision

In 2011 the vertical management of TB services underwent changes. As part of the reform integrated model of TB Services was introduced meaning that private primary care providers in regions were imposed to carry out TB services. As field specialists report, regulations does not guarantee that private providers would maintain service uninterrupted provision as the obligations are valid until 2018.The situation is exacerbated by lack of motivation of service providers at the institutional and personal levels to maintain TB services. In particular, it has become evident that managers/owners of health facilities are not interested in implementing unprofitable TB services and service providers have low motivation to improve performance since there are no mechanisms that link performance to the payment.

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RECOMMENDATIONS

The study made it clear that the structural, social, individual factors as well as health

system factors are closely interlinked and mutually influence each other. Therefore, a

successful strategy to deal with the factors negatively affecting adherence to TB

treatment must be based on multi-sectoral approach to tackle with existing difficulties.

The recommendations given below are based on the study outcomes.

• Legal/regulatory changes:

• The Labor Code provision on temporary disability term must be reviewed taking into account the needs for TB treatment

• Regulations need to be developed/refined in order to ensure continuity of services rendered by private service providers

• Involvement of peer educators in the treatment process is important to enable sharing of their personal experience with other patients using different strategies (peer-to-peer groups, social media etc.)

• Improvement of the communication messages through emphasizing treatment adherence barriers

• Ensuring increased participation of patients and service providers in the decision making processes

• Ensuring increased motivation of service providers by introducing results-based financing mechanisms:

• Providing incentives for health personnel• Providing institutional incentives for health facilities

• Increasing the efficiency of tracing lost to follow-up patients through operational costs reimbursement and epidemiologists financial motivation

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• Opening additional DOT centers in Tbilisi and integration in the primary healthcare services in order to improve geographic access

• Timely introduction of global innovations in the country with the aim to simplify DOT regimen

• Improvement of access to side effect management:

• Use of Telemedicine to reduce geographical and financial barriers, save patients’ time and improve quality of services

• Integrate mental health services into the primary healthcare

• Reimburse expenses on medications for socially vulnerable patients

• Motivating young professionals to enter the TB field by reducing financial barriers on postgraduate studies.

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