factors associated adherence to tb treatment in georgia report (eng)

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Barriers and Facilitators to Adherence to Treatment

among Drug Resistant Tuberculosis Patients

in Georgia

Study Report

January, 2017

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Acknowledgments

Curatio International Foundation would like to acknowledge financial support from the

TDR/WHO small grants scheme, which made it possible to conduct this study.

Curatio International Foundation expresses gratitude towards the National Center of

Tuberculosis and Lung Diseases for supporting the field work implementation of the study.

The research team would also like to express gratitude to the respondents who devoted

their time to the study.

The study report was prepared by Lela Sulaberidze and Ivdity Chikovani under the

supervision of George Gotsadze. The views expressed in the publication are those of the

authors and do not necessarily reflect the views of TDR/WHO.

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Table of Content

ACKNOWLEDGMENTS I

INTRODUCTION 1

THE GLOBAL THREAT 1

GLOBAL STRATEGIES FOR THE FIGHT AGAINST TB EPIDEMICS 1

DESCRIPTION OF THE TB RELATED SITUATION IN GEORGIA 1

EPIDEMIOLOGICAL REVIEW 3

PROBLEM STATEMENT 5

METHODOLOGY 6

PURPOSE OF THE STUDY 6

DESCRIPTION OF THE STUDY POPULATION 6

METHODS 7

SAMPLING 8

DATA ANALYSIS 8

STUDY CONCEPTUAL FRAMEWORK 9

ETHICAL PRINCIPLES 10

RESULTS 11

STRUCTURAL FACTORS 11

MONETARY INCENTIVES FOR PATIENTS 12

SOCIAL FACTORS 13

SUPPORT FROM FAMILY AND FRIENDS 13

PEER INFLUENCE 14

STIGMA 14

PERSONAL FACTORS 15

AWARENESS 15

MOTIVATION 15

HEALTH SYSTEM FACTORS 16

FREE TREATMENT 16

PROGRAM MANAGEMENT 16

THE DECISION MAKING PROCESS 17

MEDICAL PERSONNEL 17

PERSONNEL’S FINANCIAL MOTIVATION 18

GEOGRAPHIC DISTRIBUTION OF MEDICAL INSTITUTIONS 19

MEDICAL FACILITY INFRASTRUCTURE 20

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DIFFICULTIES OF THE DOT REGIMEN 21

SIDE EFFECTS AND SYSTEMIC MANAGEMENT PROBLEMS 21

SERVICE PROVISION RISKS 22

DISCUSSION 23

SOCIAL AND STRUCTURAL FACTORS 23

PERSONAL FACTORS 24

HEALTH SYSTEM FACTORS 24

RECOMMENDATIONS 26

REFERENCES 28

1

Introduction

The Global Threat

Tuberculosis (TB) remains a global challenge to public health throughout the world. Millions

of people fall ill with TB every year. According to the World Health Organization (WHO), in

2015, 10.4 people fell ill with TB, of whom 1.8 million died. TB has been a leading cause of

death among infectious diseases.1 In 2015 TB death rates exceeded HIV/AIDS death rates.

People of all ages can be infected with TB. In the age structure of the diseased, TB cases

prevail in the economically active segment of the adult population (aged 15-44). Therefore,

the disease burden is important in terms of its impact on a country’s economy. It has been

estimated that TB currently causes a loss of around 12 trillion US dollars to the global

economy, and it is expected that this loss will reach 16.7 trillion dollars by 2050 if the

current spread of the disease is maintained.2

Global Strategies for the Fight against TB Epidemics

From 2000 to 2015, global and national efforts to reduce the disease burden were set by the

Millennium Development Goals (MDGs); in particular, target 6c of MDGs focused on the

reduction of new TB cases. The Stop TB partnership, which was established in 2001,

introduced new targets for countries to halve the TB prevalence and mortality rates

registered in 1990 by 2015. According to the Global TB Report 2015, these targets were

achieved: mortality rates in 2015 dropped by 47% compared to 1990 (the biggest decrease

was registered in the period following the year 2000), while the TB prevalence rate fell by

42% between 1990 and 2015.3 In 2015, following the end of a 15-year cycle of the

implementation, the MDGs were replaced by new Sustainable Development Goals (SDGs),

which are due to be implemented by 2030. The Stop TB strategy was also replaced by the

End TB strategy, which covers the period 2016-2035.

Description of the TB Related Situation in Georgia

The fighting against TB is one of the most important objectives of the health care system of

Georgia. As a result, reducing the spread of the infection among people is one of the goals

of the National TB Program.4

According to official statistics provided by the National Center of Disease Control and Public

Health (NCDCPH), the TB incidence in Georgia reached 74.7 per 100,000 population in 2015.

Even though Georgia has seen a decreasing trend in TB incidence over the past several

years, the Drug Resistant TB (DR-TB) prevalence rate is still high, accounting for 11.6% and

38.8% of new and of previously treated TB cases in 2015, respectively5 (Figure 3).

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The rate of loss to follow-up among patients with DR-TB is high (33%), which creates a risk

of spreading drug resistant forms of TB (Figure 5).

Patients have access to free TB diagnostic and treatment services as part of the National TB

Program. The program has been implemented by the National Center for Tuberculosis and

Lung Diseases (NCTLD). In 2012, the NCDCPH was assigned to carry out surveillance of TB as

part of the National TB Program, to trace the contacts of TB patients and to work with

patients who are lost to follow-up. Sputum microscopy and the transportation mechanism

from TB treatment facilities to TB laboratories are organized by the NCDCPH laboratory

network.6 Second-line TB drugs are purchased with the financial support of donors,

specifically the Global Fund, the governments of the US and of France. The TB control

strategy based on DOTs principles was partially implemented in 1995 in Georgia and

achieved full country coverage in 1999.

Georgia has achieved significant results through the introduction of internationally

recognized strategies and practices. For example, the country has met MDG 6c and the Stop

TB Partnership 2015 targets through reducing the prevalence and mortality rates of TB by

50% compared to 1990.6

As part of the national TB program, services are provided by public and private healthcare

providers. Currently state owned centers have been maintained, mostly in Tbilisi. In 2011, as

a result of one of the reforms of the healthcare system – the privatization of medical

facilities – the vertical system of management was changed and an integrated model of TB

service provision was introduced instead. As part of the reform, private providers in the

regions were required to carry out TB services.7 Private providers are due to perform this

obligation until 2018, in line with the requirements of the reform.

As part of the reform, TB services were integrated into primary healthcare facilities to

improve geographical access to DOT services for the population living in rural areas. Since

2012, patients have been taking drugs under the direct supervision of nurses working at

primary healthcare facilities as well.7

The national TB program provides patients with full coverage for diagnostic and treatment

service costs. A primary care physician refers people suspected of having TB to TB facilities,

where they have free access to TB services.

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Epidemiological Review

The number of TB cases has been decreased in Georgia in 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 countries with a high burden of DR –TB. As of

2016, however, the DR-TB prevalence rate is still high among new and previously treated TB

cases.

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

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

40

60

80

100

120

140

160

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

TB c

ases

per

100

,000

po

pu

lati

on

All cases New cases

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

New cases Previously treated cases

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DR-TB prevalence is higher in Georgia than in 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

Regarding treatment outcomes, it should be noted that the 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

0

10

20

30

40

50

60

70

80

Romania CzechRepublic

Bulgaria * Latvia * Georgia * Armenia * Lithuania * Estonia * Belarus

%

New cases Previously treated cases

41

0

10

20

30

40

50

60

70

80

Estonia * Latvia * Belarus Bulgaria * Armenia * Georgia * Romania Lithuania *

%

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The trend over the past several years shows that one-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

Problem statement

High rates of loss to follow-up among DR-TB patients increases both the risk of spreading

the disease widely and disease-related health care costs.8 A retrospective cohort study

conducted in Georgia in 2013 revealed a high proportion (29%) of loss to follow-up among

TB patients, with over 40% of these cases occurring during the first eight months of

treatment initiation.9 While the study documented individual related risk-factors, including

gender (male sex), illicit drug use, tobacco smoking, a history of previous anti-TB treatment

and pulmonary TB, it did not identify programmatic factors that led to poor TB treatment

outcomes. Scientific literature describes the key barriers to adherence to treatment that

have been identified for years as a result of qualitative studies conducted on the issues. The

main factors that enhance or hinder adherence to treatment are as follows: the

organizational structure of TB treatment and surveillance services; regulations; the financial

burden; the knowledge, attitudes and practices towards TB treatment; personal qualities

(behavioral traits); side-effects caused by the treatment; individual interpretation of

“illness” and “wellness”; family, and community support.10,11,12

This document summarizes the factors affecting adherence to DR-TB treatment in Georgia

that were studied as part of our research and proposes recommendations to overcome

existing weaknesses.

50

46

41

34

32

33

6

6

9

3

3

6

7

13

11

2011

2012

2013

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

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Methodology

Purpose of the Study

The research aims to study in detail the factors related to loss to follow-up from the

perspective of patients, providers and the health system, and to develop relevant

recommendations in an effort to improve patient adherence to TB treatment.

The study aims to answer two important questions: 1) What factors enhance or hinder the

process of adherence to treatment among DR-TB patients? and 2) How can the health care

system be strengthened to improve treatment outcomes?

The research evidence will help policy makers to design and implement effective strategies

to improve TB treatment outcomes throughout the country. Considering that many former

Soviet Union countries face similar challenges in terms of TB epidemic control and

management, the evidence identified for Georgia could be relevant to other countries in this

region.

Description of the Study Population

The population groups participating in the research were as follows:

TB patients. Given the purpose of this research, the largest target group consists of

TB Program beneficiaries. During the study implementation, patients were divided

into the following subgroups:

DR-TB patients who interrupted treatment (lost to follow-up patients). For the

purpose of this research, the term “Treatment Default” has the meaning defined

by the World Health Organization as treatment interruption when the patient

does not visit a medical institution to receive appropriate medical treatment for

at least two consecutive months.

DR-TB patients who are currently undergoing treatment but do not accurately

comply with the regime i.e. so called “recalcitrant” patients.

DR-TB patients who successfully completed treatment.

The target group consisted of persons aged over 18 who speak Georgian.

Key Informants. This group consists of the people who manage the TB program in

Georgia, policy makers, healthcare managers and other specialists working at the

Ministry of Labor, Health and Social Affairs of Georgia, the National Center of

Disease Control and Public Health, the National Center of Tuberculosis and Lung

Diseases, as well as representatives of NGOs who have important information about

the TB Program implementation process in Georgia.

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Service Providers. This group consists of doctors (phtisiatrists and epidemiologists)

and nurses (DOT nurses, primary healthcare nurses involved in DOT services at rural

ambulatory hospitals), who provide TB diagnostic and treatment services to patients.

Methods

The study was implemented using a qualitative research approach. Data were generated

from in-depth interviews, semi-structured interviews and focus group discussions (FGDs).

In-depth interviews were conducted with the specialists in this field in order to

collect information about the problems or systemic shortfalls that occurred during

the TB Program implementation in Georgia. In total, 6 interviews of this type took

place;

Semi-structured interviews were conducted with patients; and

FGDs were conducted with service providers. Meetings were organized with

phthisiatrists, epidemiologists and nurses who provide DOT services at special TB

departments, primary healthcare centers or any place convenient for patients (so

called “visiting nurses”).

The geographic area of the research included Tbilisi and the regions of Adjara and

Samegrelo – Zemo Svaneti. The regions were selected based on a high incidence of

tuberculosis, the diversity of urban and rural areas with high and low density

settlements as well as geographic diversity (plains and mountains), and differences in

healthcare service provision and transport infrastructure.

The distribution of the FGDs across the study locations is shown in the Table 1 below:

Table 1. FGDs distribution accross the study locations

FGD Participants Tbilisi Samegrelo Adjara

Visiting nurses

DOT nurses

DOT nurses in the primary healthcare

facilities

Phtisiatrists

Epidemiologists

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Sampling

We used different sampling approaches to recruit different types of respondents in the

study (please see Table 2 below):

In order to select specialists working in this sector, we used the target sampling method (the

respondents were selected based on the research team’s knowledge and experience) and

Snowball sampling (when a participant gives information about persons who are very

knowledgeable about TB related issues). The targeted selection method was used to select

service providers.

A two-stage sampling process was applied to select patients. At the first stage, employees of

the National Center of Tuberculosis and Lung Diseases who worked on electronic data bases

and patient registration had to retrieve data based on patients’ geographic locations. For

the purpose of this research, every n-th patient was selected proportionally from Tbilisi. In

total 60 patients were selected. At the second stage, employees of the Adherence Unit of

the National Center of Tuberculosis and Lung Diseases (two people) called the selected

patients and offered them to participate in the study. The patients received information

about the purpose, objectives and type of the research. If a patient agreed to participate,

he/she received a telephone call from a researcher to agree the time and place of the

interview.

Table 2. Sampling methods used in the study

Respondent Category Sampling Method

Specialists “Snowball Principle”, target sampling

Service Providers Target sampling

Patients Random sampling

Data Analysis

The information received during the interviews and discussions was analyzed using the

qualitative data analysis software Nvivo. At the beginning, a thematic tree for the NVivo

software was built in order to code the data and group the results.

The interviews were recorded on a Dictaphone in agreement with the respondents. Based

on the audio records, the researcher’s assistant prepared verbatim transcripts in which a

number was assigned to each respondent, without any personal identifiers.

In order to build a detailed coding tree, a group of researchers studied the interviews

organized in the transcript format. After the tree was built, the data analysis started. The

data coding and analysis process was supervised by the leading expert.

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Study Conceptual Framework

For the conceptual framework of this research we used a model in which different factors

were clustered into groups of structural, personal, and social factors, as well as a group of

health system factors. The conceptual framework was based on the results of qualitative

research into tuberculosis treatment adherence, which is described in the systemic

overview of 44 publications.10

The structural group consists of the factors that are beyond a patient’s control and can

hinder adherence, despite a patient’s strong motivation.

Social factors influence personal factors and may improve adherence by increasing a

patient’s awareness level, changing his/her attitude to the disease and increasing

motivation. On the other hand, stigma and marginalization create adherence problems.

According to the conceptual framework, the factors influencing patients’ behavior can be

divided into structural and social factors on the one hand, and health system factors on the

other hand. Personal factors also influence health system factors, i.e. the personal and

system factors have mutual influence on each other.

Picture 1. Conceptual framework

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Ethical Principles

The research was conducted in compliance with the World Medical Association's Helsinki

Declaration principles on medical research involving human subjects, which limits access to

information about the participant’s identity, identification data, place of work and other

personal information.

The research protocol and instruments were submitted to the NCDCPH National Bioethics

Committee. The protocol was also sent to the National Center of Tuberculosis and Lung

Diseases for approval by the Ethics Commission. On April 19, 2016 we received consent from

the National Bioethics Committee (Minutes N2016-022). The consent from the National

Center of Tuberculosis and Lung Diseases was received later.

The respondents were informed that when their answers were cited in the Research Report,

only the respondent’s category would be specified.

In order to comply with ethical principles, respondents were selected rather cautiously,

according to the above described procedure.

Face to face interviews were conducted in a private environment: a residential apartment or

nearby open area (a yard, garden or park).

Before interviews started, information about the study was once again provided to patients

by means of an information leaflet or telephone call. They were also informed that they

could call and ask questions about the study at any time. After this procedure and before

starting the interview, respondents signed an informed consent form to participate in the

study. If a patient refused to sign the form, a researcher signed it based on a patient’s oral

consent attained.

Audio records of interviews / focus group discussions were made in agreement with

respondents and focus group participants. If they were against audio records, the

researcher or his/her assistant wrote down respondents’ answers. In the case of focus

groups, the researcher’s assistant took notes of the focus group discussion results.

The audio records were stored in compliance with the organization’s data management

policy, which implies limited access to the data (access rights were only given to the people

participating in the study) and destruction of the data six months after the end of the study.

The informed consent forms are stored in a safe place and will be destroyed 3 years after

the end of the study.

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Results

Before presenting the qualitative research results, we will briefly present the social and

demographic characteristics of the respondents. 70% of the respondents are male. The

average age is 42 (The median age - 39). Other characteristics of the patients are presented

in the Table 3 below:

Table 3. Socio-demographic characteristics of the patients

Respondent

Category

Marital Status:

Married

Social Status:

Vulnerable

Employement

status:Employed

Conviction Record:

Former Prisoner

Successfully completed

treatment (N=20) 65% 5% 80% 10%

Lost to follow-up

patients (N=20) 45% 30% 40% 20%

Recalcitrant patients

(N=20) 60% 30% 27% 20%

As expected, the study revealed different positive and negative factors influencing

adherence to TB treatment.

The study results are presented according to the conceptual framework.

Structural Factors

Some social and economic factors prevent patients from completing the treatment. Despite

the fact that the treatment is provided to patients free of charge under the national TB

program, some patients cannot find time for it because of their employment or social

conditions (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 time...”

A lost to follow-up patient

The working hours of employed patients do not allow them to comply with the treatment

regime. Besides, some patients do not tell their employers about their disease because of

stigma or fear of losing their jobs. Therefore, it is difficult for such patients to combine the

work and treatment regimes:

“...I work at a distribution company where nobody knows about my disease. If they

find out, I will lose my job. I distribute bakery products so they will fire me

immediately. On Saturday, I do not receive the medicine because it can only be taken

at the Center before 12 o’clock in the afternoon, but I finish work at 2. My working

hours start at 5 o’clock in the morning...” A recalcitrant patient

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On the other hand, communication with colleagues and going to work helps patients to

overcome negative side effects of treatment and/or bad reactions to the treament. Those

patients who successfully completed the treatment stated that during work they paid less

attention to the sensations caused by the pharmaceuticals, which helped them to cope with

such factors.

“...I have ideal colleagues. When they saw that I felt week and went out for

some rest, they did not make a problem out of this. I continued working and

did not sit at home all the time, which turned out to be a good decision.

Because when I was sitting idly and paying attention to the sickness, it lasted

longer...”

A patient who has successfully completed treatment

Due to financial problems, patients with a low social status face difficulties in terms of taking

additional tests and purchasing medications for managing side effects (the side effect

problems are discussed in detail below, in the section dedicated to the healthcare).

“...I paid less than GEL 10 for a visit to a cardiologist but the doctor prescribed

medicines for GEL 40. These were medicines for one week i.e. it would cost me

GEL 160 per month. I was prescribed a two-month treatment course. It is

difficult to by pharmaceuticals because I am the only employed member in a

family with two children...”

A recalcitrant patient

Monetary Incentives for Patients

The incentive system works well among patients, especially in case of patients with low

economic status, for whom it provides a certain source of income. In some cases, a

monetary voucher works as an incentive.

“…Of course side effects mean additional expenses because you have to buy

additional medications. Nevertheless, this voucher creates additional

motivation because some people have no money at all and this helps…”


Besides the monetary voucher, patients also receive a voucher that covers their transport

costs. The amounts covered by the transport voucher equals the costs of coming from the

patient’s home to the DOT center by public transport. This voucher is given only to patients

with resistant tuberculosis.

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Social Factors

Support from Family and Friends

According to patients, support from family members and society is very important during

the treatment. Conversations with family members help to overcome such problems as

loneliness, irritation and laziness to visit the center. The positive influence of support from

family members and society was mentioned by those patients who successfully completed

the treatment. None of them lived alone and all of them stressed the importance of support

from family members and friends:

“...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

“...During the last period he became more nervous and irritated than before.

Although we behaved as if nothing was going on - as if the disease was not a

difficult one and could be easily cured. A correct approach to patients is very

important. An individual approach to each person is necessary. For example, if

I had not forced my husband to receive medicines, I do not know where we

would be now…”

A recalcitrant patient’s wife

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 a more responsible attitude towards himself and the family:

“...Because of my job I often had to go on business trips. I could not control

whether or not she went to receive medication…”

A lost to follow-up patient’s wife

“…When I returned home, problems started in my family. My wife caught the

TB infection from me. This became one of the reasons for our divorce. As a

result, I had to bring up three children alone. In autumn, one of the children

had to be taken to school but I did not feel well because of the side effects of

the medicines. I was unable to pay attention to the child. Following my return

from Abastumani, I had to take medicines for one year and four months – in

total for 18 months, but I could not complete the treatment...”


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Peer Influence

Decisions made by the majority of patients are greatly influenced by experiences shared by

other patients. According to respondents, the exchange of information about difficulties

overcome by other patients has a positive impact on adherence to treatment. The majority

of patients said that their decision to continue receiving medicine was a result of the

negative consequences of abandoning treatment, which they saw among other patients.

The positive influence of stories about successful treatment and coping with side effects

were mentioned with the same frequency.

“…I did not want to miss a day after I saw the condition of patients who

cheated and threw the drugs away…”


“… For example, I sought patients who had completed treatment wondering

how they felt and how much time had passed since their treatment…”


Peers’ influence turned out to be negative when patients shared information on how to

avoid receiving some medicines and different methods of deceiving medical personnel.

Stigma

Due to stigma, patients conceal information about their illness and avoid communication

with people since they are afraid that the attitude toward them will change. Stigma was

mentioned by recalcitrant and defaulting patients as well as by those who successfully

completed the TB treatment. That said, only 15% of patients mentioned this issue and it has

never been named as the main reason for abandoning treatment.

“...Since our region is small, people look differently at those who have

tuberculosis. This is why many of them, even family and friends, do not know

about our participation in the program...”

A recalcitrant patient’s spouse

“...During that period I often stayed at home and avoided contacts with many

people. Someone might suspect something, so I preferred to stay at home...”


Specialists working in the sector emphasize the existence of stigma among medical

personnel. In a very few cases, patients also mentioned this.

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Personal Factors

Awareness

According to phtisiatrists, they regularly inform patients in detail about the disease, its

process, special characteristics of the treatment regime and its possible side effects. Almost

all patients confirmed that they received detailed information about tuberculosis from

medical personnel. Despite this, an information deficit was revealed in case of defaulting

and recalcitrant patients. One fourth of these patients stated that they missed visits to the

DOT center or stopped treatment altogether because tuberculosis symptoms disappeared

or they felt much better. There were also some cases when patients abandoned the

treatment and then resumed it after the deterioration of their heath condition.

“...During the first two months I visited the center regularly, received the

medicine every day and got better. After two months I stopped the treatment

because I was fine...” A lost to follow-up patient

“...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...”


In some cases, patients expressed skeptical attitudes towards the new treatment scheme,

based on the belief that the new pharmaceuticals were experimental.

Motivation

Patients who had successfully completed TB treatment stated that one of their main sources

of motivation was the need to take care of family members, in addition to their own health.

These patients had a correct understanding of the seriousness of the disease and related

risks, so they tried to complete the treatment in order to avoid creating problems for their

family members and friends.

“...I do not want to infect someone with tuberculosis. I could not allow a

situation when any of my family members and friends would have to go

through the same suffering as I did. And of course I wanted to recover...”


“... My motivating factors were my child and husband. I did not want to do

any harm…” A patient who has successfully completed treatment

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Health System Factors

The health system factors were divided into two groups – poor health system factors and

clinical factors. Health system factors include service organization and management issues

that influence adherence to TB treatment, while clinical factors are related to practical

medical activities.

Free Treatment

Patients spoke positively about the existence of the National TB Program in Georgia. The

opportunity to receive treatment free of charge was viewed as a huge benefit provided to

the population by the state. Many people stressed the high cost of the pharmaceuticals

which they received free of charge within this program.

“…I believe this is a rather expensive treatment, probably even one hundred

out of thousand patients would not be able to receive treatment, if patients

covered the treatment costs. This is a great support and everyone should take

advantage of this opportunity by all means…”

A patient who has successfully completed the treatment

Program Management

Besides free medical services and pharmaceuticals, all respondents spoke positively about

the opportunity to receive medicines continuously at DOT centers, which shows that the

program is working properly.

As for the management of the National TB Program, specialists and service providers

working in this area gave positive assessments to the appropriate laboratory network,

uninterrupted supply of pharmaceuticals, good program monitoring system and Doctors

Council.

Providers emphasized the positive steps made in the provision and management of TB

services. The majority of phtisiatrists spoke about a properly running laboratory system,

namely the opportunity to make tests timely and safely, the introduction of a new method

of lab diagnostics, the well organized transportation system and the implementation of the

Cold Chain principles. In addition, they also stressed the existence of a system that ensured

a continuous supply of medications and an opportunity to work without interruptions.

Service providers spoke about the benefits of the monitoring system, which did not allow

them to relax. They also expressed positive views about the approach focused on teaching,

17

mutual respect and healthy collegial relations between employees of the monitoring

division and service providers, which had a positive impact on their work:

“…Supervisors come from the center. The regional coordinator, who checks all

the forms, also arrives. They talk to a patient, his/her relatives and count

drugs. The system is organized very well; you have to do things even if you do

not want to. Moreover, the system focuses on teaching. Otherwise, we would

not have been here, everyone would have run away. The key point is that there

is a special approach, which is being further improved…”

Regional phthisiatrists' FGD

The Decision Making Process

Service providers expressed dissatisfaction with their limited involvement in the decision

making process. According to them, different changes were made in the program without

taking into account their views or even without their participation in the discussions. In

order to achieve progress, changes must be made taking into account specific practical

experience. Service providers gave several examples of such practice, namely the process of

development/improvement of reporting forms and improvement/simplification of sputum

transportation service.

“...I do not understand why they invited us to the meeting if the problem had

been already resolved. Our views were not taken into account... ”


As for the participation of patients in the decision making process, it must be noted that

patients did not even express such expectations.

Medical Personnel

The majority of patients stressed many times the positive role of medical personnel during

the long and difficult treatment period. Patients talked about attentive treatment they

received from doctors and nurses. According to them, nurses not only gave them the

prescribed medication but also provided moral support. If a patient was late, nurses

communicated with him/her frequently and in a number of cases tried to be flexible and

take into account a patient’s work schedule.

Attentive and compassionate medical personnel significantly influences patients’ behavior

and encourages 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 the treatment

18

Target group discussions with specialists revealed a lack of young specialists working in this

field. As a result, the levels of acceptance and introduction of innovations are low. Low

salaries and health risks decrease the interest of young medical personnel in working in this

field.

Personnel’s Financial Motivation

Low Salaries

The research revealed a financial problem related to service providers – namely, low

remuneration, which is below the average salary level. According to service providers, their

only stimulus is professional (intrinsic) motivation. In compliance with the Government

Resolution regulating the National TB Program, a phtisiatrist’s minimum monthly

remuneration is GEL 360, while DOT-nurse’s is GEL 280 (after taxes). As a rule, an average

monthly salary offered by employers equals a minimum salary. Indeed, a phtisiatrist’s salary

is considerably lower than a primary healthcare nurse’s salary, which definitely reduces

doctors’ motivation.

“…Salaries are rather low. It is rather bad that primary healthcare nurses have

a salary of GEL 450, while phtisiatrists receive GEL 360. This is a demotivating

factor for us…” Regional Phthisiatrists’ FGD

The same problem was identified in the case of epidemiologists. They talked about an

overloaded work volume and complained about inadequate financing of their efforts.

“…Epidemiologists’ work is not appreciated. We have to trace TB patients

contacts and visit families. We are at risk of infection, but nobody notices

that. It would be good if they changed the salaries or, if not, give us vacation

compensations...”

Epidemiologists' FGD

The research also demonstrated that service providers do not have the full financial

support necessary to perform their obligations within the program. Doctors and nurses

have to cover the costs of communication with patients out of their own pockets, which is

not a small share of their monthly salary. At the same time, the examples above showed

that frequent communication positively influences the patients and stimulates them during

the treatment process.

“…When a patient does not come to take a medicine, we have to find out

where s/he is and why s/he has not come. We spend our salary to top up our

mobile phone accounts because we have to communicate with patients over

the phone all the time…” FGD with phthisiatrists and nurses

19

The Epidemiology Department is responsible for working with defaulting patients within the

framework of the National TB Program. However, our research demonstrated that the

system of finding lost to follow-up patients is not effective. In order to contact patients,

epidemiologists mostly use phone calls because transport costs are not covered.

“... 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...”

Epidemiologists’ FGD

Besides low remuneration, the Program currently does not have any incentive mechanisms

(financial or otherwise) for service providers, which usually has a negative impact on their

efficiency:

“…There is not even a small gift for us for a cured patient. We used to hold a

conference on World Tuberculosis Day in the past. Phtisiatrists from Georgia

used to meet each other, exchange information and we had dinner in the

evening. This was some kind of expression of gratitude, but there is nothing

like that nowadays…”


Lost to follow-up patients stated that, before the treatment default, medical personnel very

actively contacted them when they missed visits and asked about the reasons why. After the

patient defaulted, medical personnel asked questions about the main reason but then all

communication stopped. Once a patient is designated lost to follow-up, medical personnel

are no longer obliged to contact them. Patients view this as a lack of attention from medical

personnel.

“...Nobody is interested in us anymore. After my default, I did not get any calls

from the doctor during 7 months. Nobody has called and asked where I was

and why I stopped coming for the medicine. Only after 6-7 months, I was

called and asked to come for an interview (in order to participate in this

research)… ”


Geographic Distribution of Medical Institutions

The integration of services into the primary healthcare system increased geographic access

to services for rural population. This was mentioned by both patients and specialists.

At the same time, both patients and specialists talked about the existence of a geographic

barrier to service access for the Tbilisi population. The transportation of patients to DOT

20

centers is a problem because, at present, there are only four DOT centers in Tbilisi and their

locations are not evenly distributed.

“... Even though we reimburse them for their travel expenses under the Global

Fund project, spending 3-4 hours every day getting to and from the clinic is a

barrier and problem for patients; moreover only MDR patients get

compensation...”

A field specialist

The population living in regions has service access problems in terms of managing side

effects. They often have to go to Tbilisi to receive these services. As there is no adequate in-

patient hospital infrastructure in the regions, geographic access to such services is a

problem for regional population. Since regional in-patient hospital buildings are amortized

and the sanitary/hygiene conditions are poor, patients have to go to Tbilisi for such services.

Medical Facility Infrastructure

It is important to mention that DOT centers also have infrastructural problems. For example,

regional facilities do not have enough space to provide high quality ambulatory services.

Despite the fact that the condition of integrated facilities was improved, they often do not

meet international standards such as constant natural or artificial ventilation and ultraviolet

lights in doctors’ rooms.

Sanitary conditions at state-owned DOT centers are unsatisfactory since the buildings are

old and amortized.

“…Of course nurses maintained hygiene at the treatment facilities but the

building was rather old, walls were destroyed. It would be good to change or

repair the building. Worst of all, in X dispensary TB treatment unit is on the

first floor and people, including many children, live on the second floor…”

A lost to follow-up patient patient

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 noted above, sharing personal experiences has a positive impact

on the treatment process.

“…Conditions should be improved to encourage a patient to enter the office. I

used to go home right after taking the medicine. I could not and did not feel

like staying there and talking to others…”


Unlike in Tbilisi hospitals, where conditions are satisfactory, infrastructural problems were

also revealed in regional in-patient hospitals.

21

Concerning clinical problems, difficulties were identified with regard to the DOT regime, pill

burden and side effects caused by the treatment.

Difficulties of the DOT Regimen

According to patients the treatment regime, which takes place under immediate

supervision, is problematic. This problem was mentioned equally by patients from rural and

urban areas. It is difficult for patients to visit medical facilities every day over a very long

period in order to take medicine. This causes the so called “pill burden”, which is difficult for

patients.

Patients included into the new treatment scheme have to visit a medical facility twice a day,

which is problematic even though they have transport vouchers. According to the new

scheme, patients have to take TB medicines in the form of infusions that can only be made

at in-patient hospitals.

“… It is not difficult to take medicines in the morning but when I have to come

here in the evening as well I start feeling sick. I have to come twice a day and I

drive here. Sometimes my father and my friends accompany me…”

A recalcitrant patient

Side Effects and Systemic Management Problems

The existence, frequency and management of side effects considerably influence adherence

to TB treatment. Many patients participating in the research talked about treatment related

physical and mental side effects. All lost to follow-up patients named side effects as one of

the main reasons for interrupting the treatment.

The management of side effects requires a knowledge of different organ systems by medical

personnel. Moreover, according to experts, specific knowledge and experience are

necessary to manage of side effects caused by TB medications.

“…Initially I used to recover more easily after taking drugs. They gave me

everything included in the program – against vomiting, for liver, but

eventually I felt very bad and nothing helped me…”


The National Program finances several medications for the management of side effects

suffered by patients with DR-TB. In addition, some tests and consultations with narrow

profile specialists are available for patients. The Tbilisi population has better access to such

services due to their availability at the National Center of Tuberculosis and Lung Diseases.

The Center has hired different specialists who play an important role in the management of

side effects. Moreover, Tbilisi patients are better informed and use universal healthcare

22

services to their benefit. In regions, patients either visit narrow profile doctors directly or

come to Tbilisi, which means additional expenses.

“…The management of side effects has been a problem because this involves

managing different systemic problems, such as the gastrointestinal tract. We

have faced this problem mostly in regions. We have not had this problem in

Tbilisi because the TB center has hired different specialists who are involved in

the management of side effects... ”

A field specialist

“…The program covers certain medications, for example, hepatoprotectors,

but side effects are managed weakly compared to TB treatment. The level of

treatment provided in Georgia is actually the same as in leading countries in

the world, but this does not apply to the management of side effects and

other remaining services. All those who travelled to France noted that the

situation was better there in this respect…”

A field specialist

The majority of patients talked about problems like nervousness, irritability, sleeplessness,

depression etc., which require the assistance of a psychologist/psychiatrist. Doctors and

other specialists working in this field also stressed the need for psychological assistance.

“...Patients need psychological support. Sometimes she is so exhausted that

she does not want to take a medicine any more…”

A spouse of a recalcitrant patient

“…Some of them 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

Service Provision Risks

The study revealed the existence of service continuity risks. Some problems that put at risk

the provision of service by private service providers were identified in the regulations. The

situation is exacerbated by a lack of motivation at the institutional and personal levels.

Namely, it has become evident that the heads of medical facilities show less interest in

implementing unprofitable activities such as TB services, and that service providers have low

incentives to improve performance indicators since there are no mechanisms linked to

results.

“…They have undertaken an obligation, which they have performed more or

less. However, the term for the performance of these obligations will end soon

and I am not sure what is going to happen…”

A field specialist

23

Discussion

Social and Structural Factors

Apart from the influence of the health system factors, patients’ adherence to treatment also

greatly depends on social and structural factors. The study made it evident that support

received from family and friends by patients who successfully completed the treatment

was one of the positive factors that contributed to their success. In case of employed

patients, a supportive work environment is equally important.

The fear of losing a job often forces patients to make a choice between medical treatment

and income needed for existence. According to the results of quantitative research

conducted in Georgia in 2013, which studied 167 cases of patients with DR-TB, risk factors

for treatment default were the fear of losing a job and a lack of social support.13 Studies

conducted in other countries also identified employment as a barrier to treatment

adherence.10,14,15,16

Patients fear losing their jobs if their employers and colleagues learn about their illness.

Besides, the Labor Code is not flexible and does not protect patients from losing jobs when

intensive medical treatment becomes necessary. According to the Labor Code, the

maximum length of sick leave for temporary disability is 40 consecutive calendar days,

which is much less than the duration of the intensive phase of TB treatment (the first two

months after it starts).17

Financial Incentives and compensation for transport costs were found to have a positive

influence on treatment adherence. The transport voucher increases patients’ motivation to

complete treatment. Moreover, in the case of social poverty the voucher is an additional

source of income for patients and can also be used to finance the additional medications

and tests needed to overcome side effects. The positive influence of financial vouchers on

successful treatment results has also been identified in other countries.18

The Influence of Peers and sharing of personal experience among patients influences

treatment adherence. Personal stories of other patients about overcoming the unpleasant

side effects of medicines are especially important for those who are new to the Program,

because the number of questions the patients have is considerably larger at the initial stage.

On the other hand, patients may teach each other different tricks to avoid taking medicines,

which endangers their achievement of desired outcomes. Therefore, communication

between peers must be organized to ensure that patients who have already completed

treatment focus on appropriate issues.19

Patients mentioned stigma as one of the social factors causing them to hide their illness.

Even so, stigma has never been named as the main reason for abandoning treatment. The

same findings came out of the quantitative research conducted in Georgia in 2013: stigma

did not influence patients’ decision to abandon treatment.13 Nevertheless, as mentioned

24

above, in combination with the employment factor, stigma creates an unfavorable

environment for treatment adherence.

Personal Factors

The research showed that one fourth of recalcitrant and defaulting patients abandoned

treatment because they no longer had symptoms and believed that they were cured. This

became a reason for their irregular visits or abandoning treatment. Despite the fact that

medical personnel gave the required information to patients, this incorrect perception was

still a problem and may be caused by their education levels and poor attitude to the disease.

Scientific literature describes cases when improvements in a health condition becomes a

reason for treatment default.10,14,19 This means that patients’ understanding of the disease

must be improved through different methods, such as involving peers, educating family

members and medical personnel’s use of a better communication strategy in order to

ensure the dissemination of correct and timely messages.

Care for family members was named as the main motivator of patients who successfully

completed the treatment. This group had a correct understanding of the disease, which

increased their feeling of responsibility towards family members and their desire to protect

them from the same problems.

Health System Factors

Out of all the positive health system factors, almost all of the patients emphasized access to

free treatment within the National TB Program. Moreover, as a result of the proper

organization of the Program the patients do not have to wait to receive different services

and medications. TB field specialists and phtisiatrists also frequently emphasized providing

uninterrupted TB services to the patients. They also mentioned existence of a good program

monitoring system, which according to specialists is focused on teaching, and stimulates

health personnel to work better. Healthy collegial relations between the management team

and service providers stimulate better provision of medical services by service providers.

However, service providers are unhappy due to their limited participation in the decision

making process, because they have to implement these decisions and face any difficulties

that arise. Patients are not involved in the decision making process and do not expectat to

be. They do not realize how important their participation in the decision-making process is.

According to WHO recommendations, patients’ involvement plays a major role in the

patient-focused approach. This approach is based on the principle adopted in the Almaty

Declaration, according to which participation of people in the planning and implementation

of their health care is a human right.20

Attentive and positively disposed medical personnel are important for treatment

adherence. Medical personnel provide moral support to patients during the difficult and

lengthy treatment process. However, it must be mentioned that such an attitude is driven

25

exclusively by professional (intrinsic) motivation. The monthly remuneration of phtisiatrist

doctors is 2.5 times lower than the average nominal salary1 and even lower than the salary

of a primary healthcare nurse. Moreover, doctors and DOT nurses spend some share of their

low salaries on communication with patients. Epidemiologists have been assigned the role

of collecting information about lost to follow-up patients and returning them to the

program. However, because of insufficient financing of operating expenses this role is not

properly fulfilled. At the same time, at present the system does not have any financial or

other incentive mechanisms to ensure the effective performance of medical personnel.

Many scientific papers stress the positive influence of result oriented financing mechanisms

on the improvement of service providers’ efficiency.21 It is also worth mentioning that the

low financial rewards and risks inherent in the work makes this field unattractive you young

medical staff, which will ultimately cause a personnel deficit problem.

The reform that integrated DOT services into the rural primary healthcare centers in 2012 to

address the problem of geographical accessibility to in-patient service in the regions had a

positive influence on treatment adherence, because the centers are located near patients’

homes, which allows them to save transport time and money. A geographic access problem

currently exists in Tbilisi because there are only four DOT centers unevenly distributed in

city districts. This complicates treatment adherence among patients with DR-TB because

they have to spend several hours every day to get to the DOT centers.

Apart from the geographic access problem, there is also a problem related to the

infrastructure of medical facilities. Since the space of such facilities is small and/or the

sanitary conditions are unsatisfactory, patients are not willing or able to stay there, which

makes it impossible to share experiences with other patients, even though, as noted above,

experience sharing could positively influence TB treatment adherence. Infrastructural

problems can be addressed either by renovating old buildings (which are mainly located in

Tbilisi) or by integrating these services into the primary healthcare system (as was done in

regions). It is equally important to refine the requirements set for the institutions that

provide TB services. According to international TB management standards, service provider

facilities must have constant natural or artificial ventilation and ultraviolet lighting.22 In

Georgia this is just a recommendation in the TB Management Guideline,23 while according to

the Decree of the Government of Georgia on Adoption of Technical Regulations for High-risk

Medical Activities ultraviolet lighting is not required at all.24 Therefore, these regulations

must be brought in line with international standards.

1 The National Statistics Office of Georgia, average nominal monthly salary of hired employees, 2015

26

Regarding the clinical factors that influence TB treatment adherence, the research revealed

negative impact of difficulties related to the DOT regime. Studies carried out in other

countries also confirmed that the need to receive a large number of medicines for an

extended period is a negative factor. In order to improve TB treatment adherence, it is

necessary to develop and introduce new approaches to the DOT regime on a constant basis.

The same applies to side effects, which frequently become the reason for TB treatment

default.25 Research carried out in Georgia in 2013 also demonstrated that depression was

one of the main side effects causing default.13 Our study revealed that in order to manage

side effects, patients living in rural areas visit the National Center of Tuberculosis and Lung

Diseases in Tbilisi, which creates geographic and financial problems. The center hired

different specialists who are involved in the management of side effects. In order to

optimize costs it is possible to use TV Medicine in the regions and to manage patients’ side

effects remotely with a team of experienced specialists. The possibilities offered by TV

medicine are widely used in different countries.26 The study found out that the management

of side effects expressed in mental problems poses a specific problem due to system

fragmentation. One of the solutions would be the integration of mental healthcare services

into the primary healthcare system, which ould be also used for different medical needs.

The study also identified risks related to the continuous provision of services by service

providers in the future. This risk is caused by problems in the current regulations and by the

non-profitability of TB services.

Recommendations

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

factors in the healthcare sector are very closely interlinked and self-reinforcing. Therefore, a

multi-sector vision and approach needs to be applied to resolve the problems. The

recommendations given below are based on the study outcomes.

• Legal/normative changes:

• The Labor Code provision on temporary disability term must be reviewed to

take into account the need for TB treatment;

• Regulations need to be developed/refined in order to ensure the continuity

of services rendered by private service providers;

• The involvement of peer educators is necessary in the treatment process to share

their personal experiences with other patients using different strategies (formation

of groups, use of the social media etc.);

27

• Communication messages should be improved by emphasizing treatment adherence

barriers;

• Increased participation of patients and service providers should be ensured in the

decision making process;

• Increase the motivation of service providers by introducing result-based

remuneration mechanisms:

• Providing incentives for medical personnel;

• Providing incentives for heads and owners of medical facilities;

• Increase the efficiency of tracing lost to follow-up patients through operational costs

reimbursement and epidemiologists’ financial motivation;

• Fully integrate DOT centers into primary healthcare services in order to improve

geographic access for patients and open additional centers in Tbilisi in order to

reduce geographic barriers;

• Introduce global innovations in TB treatment on a timely basis throughtout the

country with the aim of simplifying the DOT regimen;

• Improve access to side effect management:

• Use Telemedicine to reduce geographical and financial barriers, save

patients’ time and improve the clinical quality of services;

• Integrate mental health services into primary healthcare;

• Reimburse expenses on medications for socially vulnerable patients;

• Motivate young professionals to enter the TB field by reducing the financial barrier

to postgraduate studies.

28

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