Implementation fidelity of directly observed treatment, short-course for Tuberculosis in public health centers of Kembata Tembaro Zone, Southern Nations Nationalities and People Region, Ethiopia

doi:10.21203/rs.3.rs-4417845/v1

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Research Article

Implementation fidelity of directly observed treatment, short-course for Tuberculosis in public health centers of Kembata Tembaro Zone, Southern Nations Nationalities and People Region, Ethiopia

https://doi.org/10.21203/rs.3.rs-4417845/v1

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Introduction: Ethiopia is one of 30 countries with high tuberculosis (TB) burden, with an incidence of 140 per 100,000 people. Kembata Tembaro Zone (KTZ) has lower tuberculosis case notification and treatment success rates, 60% and 82% respectively in 2019, as compared to the national and World Health Organization (WHO) targets. The aim of the present study was to evaluate the implementation fidelity of the directly observed treatment, short-course for Tuberculosis.

Methods: A Multiple case study evaluation design with a mixed method was employed from May 10 to June 4, 2021. A total of 91 patients were interviewed. Similarly, a document review of 384 patients, 16 key informant interviews, and a resource inventory were conducted. The quantitative data were entered into Epi-Data (V4.0.64) and exported to Statistical Package for the Social Sciences version 26(SPSS 26) for analysis. The qualitative data were transcribed, translated, coded, categorized, and analyzed using thematic analysis. The overall implementation fidelity was measured based on the predetermined criteria.

Results: The overall level of TB Direct Observed Treatment Short-course (DOTS) implementation fidelity was 73.9%, to which availability of resources (81%), provider’s adherence to the national guideline (73.1%), quality of TB DOTS delivery (75.9), and participant responsiveness contributed (63.9%).

Conclusion: The overall level of implementation fidelity of TB DOTS services in the public health centers was at a low level based on the predetermined set of judgment criteria. Training should be provided to the providers, Acid-fast bacillus (AFB) reagents should be supplied, standard updated guidelines should be made available, and providers should strictly comply with the standard guidelines. There should also be a full-time assigned TB DOTS provider in the TB units.

Health Policy

Implementation fidelity

Tuberculosis

Directly Observed Treatment Short Course

Kembata Tembaro Zone

Mycobacterium tuberculosis (MTB), which is the causative agent of the disease TB may have killed more persons than any other microbial pathogens. TB is an infectious disease that is a significant contributor to poor health and a leading cause of death worldwide. Prior to the COVID-19 pandemic, TB was the primary cause of death caused by a single infectious agent, surpassing even HIV/AIDS(1, 2). Globally it is believed that approximately 10.6 million individuals contracted TB in 2021, representing a rise of 4.5% from the previous year's count of 10.1 million(1). The incidence rate of TB increased by 3.6% from 2020 to 2021.There are 30 high TB burden countries which account for 87% of the global TB burden and 8 countries (India, Indonesia, China, Philippines, Pakistan, Nigeria, Bangladesh and South Africa) share 2/3rd of the total from the global burden. Africa shares 23% of the world TB incidence according to 2022 global TB report(1, 3).

Ethiopia is one of the 30 high TB burden countries with an annual case detection and treatment success rate of 69% (140 per 100,000 populations) and 95% respectively. Around 0.7% of the new and 12% of the previously treated TB patients had Multidrug-Resistant Tuberculosis (MDR TB)(4). As part of the world, Ethiopia has begun an effort to control TB in the early 1960s and DOTS were implemented in four pilot areas of the country since 1997(2, 5). The DOTS is an approach used to treat a TB patient in a way that is sensitive and supportive to the patient’s needs. The aim of the treatment is to cure the patient from TB, prevent death from TB disease and its late effects, prevent relapse, prevent the development of acquired drug resistance, and decrease transmission(5, 6). All TB-diagnosed patients are recommended to take their anti-TB medications under the direct observation of a treatment supporter. Ensuring adequate availability of anti TB drugs, laboratory reagents, medical supplies and equipment is needed for the successful implementation of DOTS(6). A study conducted in health facilities of southern Ethiopia revealed that availability and accessibility of DOTS are determinants in a quarter of TB patients for implementation of the service(7).

Previous studies about the implementation status of DOTS in different parts of Ethiopia showed that service were given by professionals who were not got adequate training, incorrect prescription of anti-TB drug regimen and dose, improper sputum follow-up examination and poor patient-provider interaction were the major problems(8–10).

The annual case detection rate and treatment success rate in the study area in 2020 was 60% and 82% respectively which is lower than the country achievement (69% case detection and 95% treatment success rate (11). Even if the DOTs have been implemented in all public health centers of the study area since 1997, to our best knowledge no evaluation was conducted on the implementation status and implementation fidelity of DOTs. Therefore, this study is conducted in order to provide a full picture in the implementation of DOTs service. The study has assessed the availability of the needed resources, treatment adherence, quality of TB treatment delivery from patient’s perspective and patient’s responsiveness towards DOTS given in the health centers found in Kembata Tembaro zone, Southern Nations Nationalities and People Region, Ethiopia.

Facility based multiple case study design with a mixed method were employed and both qualitative and quantitative data were collected concurrently to evaluate the implementation fidelity of directly observed treatment of tuberculosis short course in Kembata Tembaro zone, Southern Nations, Nationalities and People’s region. The evaluation was conducted from May 10 to June 9, 2021. The cases of this study were public health centers found in Kembata Tembaro Zone.

The zone has a total of 962,815 population in which females consists of 484,296. There are 10 administrative districts and the zone has one general hospital, 4 primary hospitals, 33 governmental and 3 non-governmental health centers and a total of 138 health posts.

Variables and Measurements

A formative evaluation approach was used to evaluate the implementation fidelity of directly observed treatment of TB. Adherence was assessed using 12 set of indicators to determine whether TB DOT providers adhere to the national TB treatment guideline. Quality of delivery was assessed using 18 set of indicators whether the TB DOT service given to patients attain some expected level of quality. Resource availability was measured using 88 set of indicators to determine whether the required essential drugs and medical supplies were supplied or not in the health facilities.

Participant responsiveness was assessed by measuring the level of patient satisfaction to the TB DOT service using 8 items each containing a five-point Likert scale (1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied and 5 = very satisfied) alternatives. The overall Participant responsiveness was measured by the mean of the score given by patients on their level of satisfaction. This score was calculated with SPSS and their averages were taken to standardize and compare the present evaluation findings with other studies. Intervention complexity and facilitation strategies were measured qualitatively by interviewing the study participants.

The indicators were given weight by the stakeholders before the evaluation and indicator scores were calculated by using this formula (Indicator score=\(\frac{\text{o}\text{b}\text{s}\text{e}\text{r}\text{v}\text{e}\text{d} \text{n}\text{u}\text{m}\text{b}\text{e}\text{r}\text{*}\text{i}\text{n}\text{d}\text{i}\text{c}\text{a}\text{t}\text{o}\text{r} \text{w}\text{e}\text{i}\text{g}\text{h}\text{t}}{\text{e}\text{x}\text{p}\text{e}\text{c}\text{t}\text{e}\text{d} \text{n}\text{u}\text{m}\text{b}\text{e}\text{r}}\)). The judgment parameter was determined based on the calculated indicator score and set as high > = 85%, medium 75%-84.9%, low 60%-74.9% and poor < = 59.9%. Weight of indicators and dimensions were set as 25% for availability, 35% for adherence, 20% for quality of TB DOTS delivery and 20% for participant responsiveness.

Sample size and sampling procedures

For the quantitative study all medical records of TB patient who were on treatment during the evaluation period and additionally one year (July 2019 to June 2020) medical record of TB patients on unit TB register were reviewed. Moreover, all TB patients who came to the health center for DOT were interviewed and eight public health centers were assessed for availability of required resources for the service. For qualitative study, seven TB DOTS providers, six heads of public health centers and four district TB focal were interviewed.

Among the total of 10 administrative districts (7 woredas and 3 town administrations) 50% of them were selected by a simple random sampling technique. Then 50% of health centers that are found in the selected administrative districts were selected randomly to be included in the study(12). Accordingly, 8 public health centers from the administrative districts were selected.

Data Collection tool and procedures

The tools used to collect data were developed by referring different literatures, global and national tuberculosis treatment guidelines and recommendations (5, 13–15). The tool consists of a structured questionnaire for patient exit interview, data extraction tool for document review (S1 Table), a checklist for resource inventory (S2 Table) and semi-structured in-depth interview guide for key informant interview. All tools were primarily developed in English, translated to Amharic, and translated back to English for consistency.

Validity and reliability: validity of the data collection tool was measured by taking 5% of the sample in a health center which were not sampled in the study. Internal consistency of the results was measured across variables within the questionnaire with Cornbrash’s alpha. Accordingly, the measurement tool alpha level is in the recommended range (0.74). Four BSc nurses and two health officers were employed for data collection and supervision respectively. Training was given prior to data collection by the principal evaluator for both data collectors and supervisors for two days.

Data management and analysis

Quantitative data were checked for completeness and was edited, coded and entered in to Epi data (version 4.6) then exported to SPSS version 26 for analysis. Univariate analysis (including means, standard deviations, frequencies and percentages) was

done and presented in tables and texts. Qualitative data were transcribed first and then translated and coded. The codes were categorized in to different categories and then thematized. Finally, the qualitative data were presented in narrative form to complement the quantitative findings. The evaluation findings were interpreted based on pre-determined judgment matrix. Additionally, the performance of each case (public health centers) was analyzed based on the collected data and displayed in table and narrate.

Ethical consideration

Ethical clearance was obtained from the institutional review board of Jimma University, faculty of public health with reference number JHRPGD/53/21, and permission letter were obtained from Kembata Tembaro Zone health department and from each facilities before data collection. Additionally, the study participants were informed about the purpose of the study and written informed consents (oral for clients who could not read and write) were obtained. The confidentiality of information was maintained by excluding personal identifiers, interviewing privately, and the signed consent forms are stored in lockable board. Appropriate COVID-19 preventive measures were practiced while collecting the data.

A total of 384 TB patient records were reviewed from a unit TB register and for the smear positive pulmonary TB patient’s laboratory AFB register were reviewed to cross check whether sputum follow up tests were done at the end of 2nd, 5th and 6th month of their treatment. Among the 384 TB patients 89.6% of them reach continuation phase of treatment. More than half (51.8%) of patients were between the age 25 to 49 and 53.4% of them were males. Majority (66.9%) of TB patients are pulmonary TB patients. From the total 374(97.4%) are newly diagnosed patients (Table 1).

Table 1

Characteristics of TB patients recorded on unit TB register of Kembata Tembaro zone health centers, SNNPR, Ethiopia, 2021
Characteristics		Frequency	Percentage
Age	15–24	128	33.3
	25–49	185	51.8
	>=50	57	14.8
Sex	Male	205	53.6
Sex	Female	179	46.4
TB type	Pulmonary	257	66.9
TB type	Extra pulmonary	127	33.3
Patient category	New	374	97.4
	Relapse	9	2.3
	Treatment after failure	1	0.3

Adherence

Content

Among 384 TB patients 99.7% of them had received the correct anti-TB drug regimen and 96.3% of them received the correct dose during the intensive phase of treatment. However, during the continuation phase from 344 patients 87.2% and 82.8% of TB patients received the correct drug regimen and dose respectively. Nutritional assessment was done for 67.7% of TB patients and HIV test was offered for 91.7% of them (Table 2).

Most of TB DOTS providers (n = 5) mentioned that there was unavailability of full time assigned DOTS providers in the TB treatment unit. One participant explained:

“All health care workers whether being trained or not, gives a service in the TB unit. Therefore, most of the time professionals forget to measure the weight of the patient and even if they measure, they failed to record on unit TB register” (A 26-year-old male DOT provider).

Other study participant added:

“Even if the weight scale is not functional, I measure my patient’s weight in the medical OPD rooms. However, when other professionals deliver the service, they use the intensive phase measured weight” (A 25-year-old male TB DOTS Provider).

Some of the key informants stated that nutritional assessment is measuring the patient’s weight. One participant expressed:

“I think that assessing nutritional status of TB patient is measuring their weight during treatment initiation and at the end of 2nd month” (A 35-year-old female DOTS provider).

Other study participants stated unavailability of height measuring tape is the reason why they didn’t assess their patient’s nutritional status. One participant clarified this issue:

“Of course, nutritional assessment means calculating the patient’s body mass index (BMI) by measuring their weight and height, but I have no height measuring tape here in TB room” (A 36-year-old male DOTS provider).

Of the individuals who were identified as having smear positive pulmonary TB, follow-up sputum examinations were conducted for 79% of them at the second month, 64.7% at the fifth month, and 66.9% at the sixth month of treatment. (Table 2).

Failing to request for regular sputum follow up examination was observed in all of the health centers. One participant explained:

“Even if I have ordered a sputum follow up request, the request paper frequently returns back without result and when I communicate with the laboratory professionals, they said there is no acid alcohol” (A 36-year-old male DOTS provider).

Among 190 smear positive pulmonary TB patents drug susceptibility test was done for only 20.5% of them (Table 2). Some TB DOTS providers mentioned that they don’t know whether they have to send smear positive TB patient’s sample for drug susceptibility test or not. A participant elaborate on this issue:

“I have been trained on comprehensive TB care 3 years back but no refreshment training after that and I have no idea about what drug sensitivity test is and where to send a sample” ( A 35-year-old female DOTS Provider).

Frequency

All 91 patients who were on treatment take their anti TB drug on daily basis without interruptions.

Duration

Among the 91 TB patients 5(5.5%), 77(84.6%) and 9(9.9%) of them take their daily DOTS in front of a health care provider for the first two weeks, for the intensive phase only and for both intensive & continuation phase respectively (Table 2).

Table 2

Level of TB DOTS providers adherence among public health centers in Kembata Tembaro Zone, SNNPR, Ethiopia, 2021
Indicator	Angecha (n, %)	Funemura (n, %)	Damboya (n, %)	Teza (n, %)	Doyogena (n, %)	Durame (n, %)	Hadero (n, %)	Mare (n, %)
Proportion of TB patient who had received standard anti TB treatment regimen during IP	38(100)	31(96.8)	49(100)	55(100)	48(100)	27(100)	89(100)	46(100)
Proportion of TB patient who had received correct TB drug dose during IP	34(89.4)	31(96.8)	46(93.8)	54(98.1)	47(97.9)	27(100)	86(93.6)	45(97.8)
Proportion of smear positive pulmonary TB patient for whom sputum follow up examination was done at the end of 2nd month of treatment	13(92.8)	6(42.8)	18(78.2)	55(100)	7(38.8)	6(75)	35(81.3)	24(96)
Proportion of smear positive pulmonary TB patient for whom sputum follow up examination was done at the end of 5th month of treatment	11(78.5)	1(9)	17(85)	23(88.4)	3(20)	6(75)	14(41.1)	22(88)
Proportion of smear positive pulmonary TB patient for whom sputum follow up examination was done at the end of 6th month of treatment	11(84.6)	1(9)	17(85)	55(100)	1(6.6)	6(75)	15(48.3)	24(96)

Proportion of TB patient whose BMI is calculated during treatment initiation	11(9.2)	6(18.7)	15(30.6)	55(100)	30(62.5)	21(77.7)	76(85.3)	46(100)
Proportion of TB patients who were screened for HIV	37(97.3)	25(78.1)	45(91.8)	52(94.5)	33(68.7)	26(77.7)	88(98.8)	46(100)
Proportion of pulmonary TB patient for whom drug susceptibility test was performed	0(0)	0(0)	0(0)	1(3.4)	0(0)	2(20)	22(45.8)	15(93.3)
Proportion of TB patients whose weight was measured at the end of IP	28(82.3)	12(50)	31(75.6)	47(97.9)	34(70.8)	20(86.9)	71(91)	44(95.6)
Proportion of TB patient who had received standard anti TB treatment regimen during the continuation phase	32(91.4)	13(54.1)	34(82.9)	55(100)	37(82.2)	21(91.3)	70(85.3)	45(97.8)
Proportion of TB patient who had received correct dose during the continuation phase	29(82.8)	12(50)	32(78)	45(93.7)	33(77.7)	21(91.3)	70(85.3)	43(95.5)
Proportion of TB patients who had received their DOT for the intensive and continuation phase	0(0)	0(0)	0(0)	6(85.7)	0(0)	0(0)	0(0)	0(0)
Overall Level of Adherence	62.17 (low)	38.8 (poor)	61.6 (low)	75 (medium)	48 (poor)	66.9 (low)	65.8 (low)	81.5 (medium)

(Judgment > = 85 High levels, 75-84.9 Medium 60-74.9, Low < = 59.9 Poor)

Most of DOT providers agree that appointing patients to come daily for drug collection was very difficult to them since the patients have to pay every day for transportation and the drugs also tired patients. One DOTS provider stated:

“It is very exhausting for the patients to come daily for collecting drugs, therefore I will give them daily for the first two weeks then I will see their progress and appoint them to come every week by giving them a 1-week drug” (A 25-year-old male DOTS Provider).

The overall level of adherence of health care providers towards the national TB treatment guideline was 73.11% which is in the low-level range as per the predetermined judgment criteria (Table 3).

Table 3

Judgment Matrix for adherence sub-dimension on evaluation of TB DOTS in public health centers of Kembata Tembaro Zone, SNNPR, Ethiopia, 2021
Indicators	E	O	W	S	A	JP
The proportion of TB patients who had received standard anti-TB treatment regimen during intensive phase	384	383	4	3.99	99.7	>=85 High level of adherence 75-84.9 Medium Level of Adherence 60-74.9 Low Level of Adherence <=59.9 Poor Level of Adherence
The proportion of TB patients who had received the correct TB drug dose during intensive phase	384	370	4	3.85	96.4
The proportion of smear-positive pulmonary TB patients for whom sputum follow-up examination was done at the end of 2nd month of treatment	172	136	2	1.58	79.1
The proportion of smear-positive pulmonary TB patients for whom sputum follow-up examination was done at the end of 5th month of treatment	150	97	2	1.29	64.7
The proportion of smear positive pulmonary TB patients for whom sputum follow-up examination was done at the end of 6th month of treatment	145	97	2	1.34	66.9
Proportion of TB patients whose BMI is calculated during treatment initiation	384	260	2	1.35	67.7
The proportion of TB patients who were screened for HIV	384	352	2	1.83	91.7
Proportion of pulmonary TB patient for whom drug susceptibility test was performed	191	40	2	0.42	20.9
Proportion of TB patients whose weight was measured at the end of intensive phase	344	287	2	1.67	83.4
Proportion of TB patient who had received standard anti TB treatment regimen during the continuation phase	344	300	4	3.49	87.2
Proportion of TB patient who had received correct dose during the continuation phase	344	285	4	3.31	82.8
Proportion of TB patients who had received their DOT on daily basis	91	91	2	2	100
The proportion of TB patients who had received their DOT for the intensive and continuation phase	60	6	3	0.3	10
Overall Level of Adherence	73.1					Low
E: Expected, O: Observed, W: Weight, S: Score ((observed X weight)/Expected), A: Achievement in percentage ((S/W) 100), JP: Judgment Parameter

Moderating factors

Socio demographic characteristics of Respondents

A total of 91 TB patients were interviewed to assess the quality of TB DOTS delivery and the responsiveness of TB patients towards the DOTS delivered in the health centers. From 91 respondents, 51.6% of them were males. The mean age of respondents was 33.75(SD = 15.9) years and most 37.4% of the respondents were in the age group of 15 to 24. Majority (81.3%) of respondents were Protestants. Most (70.3%) of respondents were from rural and 37.4% of them can’t read and write. forty four percent of respondents were farmers by profession (Table 4).

Table 4

Socio-demographic characteristics of TB patients on treatment in Kembata Tembaro zone health centers, SNNPR, Ethiopia, 2021 (N = 91)
Characteristics		Frequency	Percentage
Age	15–24	34	37.4
	25–34	15	16.5
	35–44	20	21.9
	>=45	22	24.2
Sex	Male	47	51.6
Sex	Female	44	48.4
Religion	Protestant	74	81.3
	Orthodox	11	12.1
	Muslim	5	5.5
	Catholic	1	1.1
Residence	Rural	64	70.3
Residence	Urban	27	29.7

Educational Status	No formal Education	34	37.4
	Primary	34	37.4
	Secondary & above	23	25.3
Occupation	Farmer	40	44
	Student	30	33
	Merchant	21	23

Quality of DOTS delivery

Forty-four percent of patients responded that the waiting time before being served was unacceptable and 59% of them were not served by the same health care provider. Most (76%) of patients stated that they didn’t went to other health facility for TB services. A total of 43(47%) of patients were counseled on the importance of observed treatment. Sixty-nine percent of smear positive TB patients were told about the need for follow up sputum examination and 77% of them were told when the transmission stops. Around 85% of patients responded that health care providers were respectful and 62% of them mentioned that the providers listen them carefully. Fifty three percent of patients stated that the provider didn’t observe them while taking their drugs and 64% of patients close contacts were not screened for TB (Table 5).

Table 5

Quality of TB DOTS delivery in public health centers found in Kembata Tembaro Zone, SNNPR, Ethiopia, 2021
		Health Center Name											Total
		Angecha (n, %)		Funemura (n, %)	Damboya (n, %)	Teza (n, %)	Doyogena (n, %)		Durame (n, %)		Hadero (n, %)		Total
AVAILABILITY OF TB SERVICES													(n, %)
Acceptability of waiting time before being served	Yes	6(60)		8(53.3)	7(53.8)	4(57.1)	6(50)		3(42.8)		17(62.9)		51(56)
Attended by same provider	Yes	3(30)		2(13.3)	4(30.7)	2(28.5)	7(58.3)		4(57.1)		15(55.5)		37(40.6)
Availability of anti TB drugs	Yes	10(100)		6(40)	13(100)	7(100)	12(100)		7(100)		27(100)		82(90)
Went to other facility for TB services	No	7(70)		9(60)	9(69.3)	4(57.1)	10(83.3)		6(87.7)		19(70.4)		69(76)
Availability of service during working hours	Yes	5(50)		13(86.7)	8(61.5)	7(100)	9(75)		6(85.7)		21(77.8)		69(76)
COMMUNICATION AND INFOTRMATION
Counselled on when transmission stops	Yes	4(50)	3(27.3)		7(87.5)	3(100)	4(80)		3(100)		23(100)		47(77)
Counselled that TB is curable	Yes	9(90)	9(60)		12(92.3)	7(100)	12(100)		7(100)		26(96.3)		82(90)
Counselled on importance of observed treatment	Yes	6(60)	6(40)		7(53.8)	4(57.1)	6(50)		3(42.8)		11(40.7)		43(47)
Counselled on side effect of anti-TB drugs	Yes	6(60)	8(53.3)		8(61.5)	7(100)	12(100)		7(100)		27(100)		75(82)
Counselled on the need of sputum examination	Yes	4(50)	7(63.6)		7(87.5)	3(100)	4(80)		3(100)		14(60.8)		42(69)
Counselled on duration of treatment	Yes	7(70)	6(40)		12(92.3)	7(100)	12(100)		7(100)		27(100)		78(86)
PATIENT PROVIDER INTERACTION
Provider treat with respect	Yes	9(90)	11(73.3)		9(69.2)	7(100)	8(66.7)	7(100)		26(96.3)		77(85)
Provider invite to room and offer chair	Yes	9(90)	0(0)		10(76.9)	3(42.8)	0(0)	7(100)		27(100)		56(62)
Provider listen carefully	Yes	6(60)	5(33.3)		9(69.2)	3(42.8)	10(83.3)	4(57.1)		19(70.3)		56(62)
Provider explain in a way you understand	Yes	7(70)	10(66.7)		8(61.5)	5(71.4)	8(66.7)	4(57.1)		17(62.9)		59(65)
Privacy respected	Yes	4(40)	10(66.7)		7(53.8)	5(71.4)	7(58.3)	6(85.7)		17(62.9)		56(62)
PROFESSIONAL COMPETENCE
Provider observe while taking drugs	Yes	6(60)	4(26.7)		6(46.1)	3(42.8)	0(0)	4(57.1)		20(74)		43(47)
Provider examined your close contacts	Yes	3(30)	5(33.3)		5(38.4)	3(42.8)	5(41.7)	3(42.8)		9(33.3)		33(36)

Thirty-eight percent of patients weren’t invited to TB room and offered chair by the DOTS provider. As observed in many of the health centers the TB room is either a very narrow or built by a local material which is sub-standard. One participant explained:

“As you have seen now the TB unit is very narrow and it can’t even accommodate more than a person at a time therefore, I only give them a drug through window like a shop keeper” (A 25-year-old male TB DOT provider).

Another respondent added:

“It is very difficult to construct a new room for the TB unit from the health center budget and it is obvious that a quality service couldn’t be given in this situation” (A 42-year-old Woreda TB focal).

Additionally, there is also lack of commitment among the TB DOTS providers. One study participant stated:

“There is no shortage of anti TB drugs but what we encounter in frequent times is TB DOTS providers didn’t timely request the pharmacy store person using the internal facility request and report format” (A 34- year-old health center head).

The overall quality of TB DOTS delivery in public health centers of Kembata Tembaro zone was 75.95% which is labeled as medium level as per the predetermined judgment criteria (Table 6).

Table 6

Judgment Matrix for quality of TB DOTS delivery in public health centers of Kembata Tembaro Zone, SNNPR, Ethiopia, 2021
Indicators	E	O	W	S	A	JP
The proportion of patients who respond that the waiting time before being served is acceptable	91	52	1	0.57	57.14	>=85 High level of DOTS delivery 75-84.9 Medium Level of DOTS delivery 60-74.9 Low Level of DOTS delivery <=59.9 Poor Level of DOTS delivery
Proportion of patient who respond that they are served by the same provider	91	37	1	0.41	40.66
Proportion of patient who respond that anti-TB drugs are available when they require	91	82	1	0.9	90.11
Proportion of patient who respond that they went to other health center for TB services or treatment	91	28	1	0.31	30.77
Proportion of patient who respond that services were available during the working hours of the health center	91	69	1	0.76	75.82
The proportion of patient who respond that DOTS provider told them when they stop spreading the disease	91	70	1	0.77	76.92
Proportion of patient who respond that DOTS provider told them that TB can be cured	91	82	1	0.9	90.11
Proportion of patient who respond that DOTS provider told them about the importance of observed treatment	91	43	2	0.95	47.25
Proportion of patient who respond that the DOTS provider told them about side effects of TB drugs	91	75	1	0.82	82.42
Proportion of patient who respond that the DOTS provider told them about the need for sputum follow up tests	91	63	1	0.69	69.23
Proportion of patients who respond that the DOTS provider told them about the duration of TB treatment	91	80	1	0.88	87.91
Proportion of patient who responds that the TB care provider treat them with respect	91	77	1	0.85	84.62
The proportion of patients who respond that TB care provider invite them into the room and offered chair	91	56	1	0.62	61.54
The proportion of patient responds pond that the TB care provider listens to them carefully	91	56	1	0.62	61.54
The proportion of patient who respond that the TB care provider explains things in a way they understand	91	59	1	0.65	64.84
Proportion of patient who responds that the TB care provider respect their privacy during the examination	91	56	1	0.62	61.54
Proportion of patients who respond that the DOTS provider observed them while taking anti TB drug	91	43	2	0.95	47.25
Proportion of patients who respond that their close contacts were screened for TB in this health center	91	33	1	0.36	36.26
Overall Level of DOTS delivery			20	12.6	75.95
E: Expected, O: Observed, W: Weight, S: Score ((observed X weight)/Expected), A: Achievement in percentage ((S/W) 100), JP: Judgment Parameter

Participant Responsiveness

One third (66%) of patients were satisfied with the daily visiting of health center for treatment but 58.2% of them were satisfied with the time spent in waiting for the service. Majority (85.4%) of patients were satisfied with the availability of anti TB drugs while only 70% of them were satisfied with the availability of laboratory services when needed for sputum examination. The overall level of patient’s responsiveness towards the TB DOTS were 69.34% which is labeled as poor level according to the predetermined set of judgment criteria and it is comparable across all public health centers with the higher (77%) in Damboya health center and the lower (64.4%) in Funemura health center (Tables 7and 8).

Table 7

Level of responsiveness of TB patients to TB DOTS service in public health centers of Kembata Tembaro Zone, SNNPR, Ethiopia, 2021
Level of responsiveness	Health Center Name							Total (%)
Level of responsiveness	Angecha (%)	Funemura (%)	Damboya (%)	Teza (%)	Doyogena (%)	Durame (%)	Hadero (%)	Total (%)
on the daily visiting of health center	70	71.7	77	60.7	66.7	53.5	61.1	66.2
with the working hours of TB clinic	75	71.7	78.8	71.4	72.9	60.7	73.1	72.8
with the time spent in waiting service	65	41.6	76.9	57.1	45.8	78.5	56.4	58.2
with the availability of anti TB drug	65	35	76.9	64.2	75	85.7	65.7	64.8
with the availability of laboratory service	68.7	70.4	75	83.3	75	66.6	66.3	70
with the friendliness of DOTS provider	75	75	75	67.8	66.7	82.1	82.4	76
to the providers respect	75	75	76.9	78.5	75	78.5	76.8	76.3
with the explanation of provider	67.5	75	80.7	67.8	68.7	78.5	74	73.6
Overall Responsiveness Level	70.15	64.4	77.15	68.8	68.2	73	69.4	69.1

Table 8

Judgment Matrix for participant responsiveness on TB DOTS in public health centers of Kembata Tembaro Zone, SNNPR, Ethiopia, 2021
Indicators	E*	O*	W*	S*	A*	Judgment Parameter
Proportion of patient’s responsiveness on the daily visiting of health center for TB treatment	91	60	3	1.98	65.93	≥ 85% = High Level of responsiveness 75% − 84.9% = Medium level of responsiveness 60% − 74.9% = Low level of responsiveness ≤ 59.9% = Poor level of responsiveness
Proportion of patient’s responsiveness on the working hours of TB clinic	91	66	2	1.45	72.53
Proportion of patient’s responsiveness with the time spent in waiting for service	91	53	2	1.16	58.24
Proportion of patient’s responsiveness with the availability of anti-TB drugs	91	59	3	1.95	64.84
Proportion of patient’s responsiveness with the availability of laboratory service	91	64	3	2.11	70.33
Proportion of patient’s responsiveness with the friendliness of TB DOTS provider	91	70	2	1.54	76.92
Proportion of patient’s responsiveness with the DOTS provider respect and willingness to respond to questions	91	70	2	1.54	76.92
Proportion of patient’s responsiveness with the competence of DOTS provider	91	65	3	2.14	71.43
Overall Score of Participant Responsiveness			20	13.87	69.34
E: Expected, O: Observed, W: Weight, S: Score ((observed X weight)/Expected), A: Achievement in percentage ((S/W) 100)

Facilitation Strategies

Most Woredas (districts) give a regular supportive supervision to health centers every quarter and TB program is one of the areas of focus during supervision but there is no specific supportive supervision regarding the TB program.

A 39-year-old woreda TB focal stated:

"There was a quarterly meeting and supportive supervision in the TB program last year, which was organized with the assistance of the Challenge TB project. However currently, there is no organization available to organize such events, and the Woreda has insufficient funds to host them.”

Another respondent added:

"I have been working at the TB clinic for the past year and a half, but I have not yet receive any feedback regarding the services provided here" (A 25-year-old DOTS provider).

There were no mechanisms to motivate the TB DOTS providers in the health centers. One of the DOTS providers explain the issue as follows

"I don't receive any compensation for working at this clinic. I call patients when their treatment is interrupted, and sometimes I even pay for transportation to visit them at their home out of my own pocket" (A 29-year-old male TB DOTS provider).

Intervention Complexity

It is found out that most of the health centers use the national TB treatment guideline and there was no difficulty in understanding of the currently used protocols to treat patients.

A TB DOTS provider mentioned:

“I give the combination of RHZE drug for the first 2 months based on their weight and RH for the rest 4 months for pulmonary TB patients, but for extra pulmonary patients the duration of continuation phase may extend up to 10 months” ( A 40 -year-old female TB DOTS provider).

Another participant added:

“The TB medications are prepared in a kit and one kit it is enough for a patient who took 3 tabs per day and the blisters color differ for the drugs taken in the intensive and continuation phase” (A36-year-old male TB DOTS provider).

Almost all DOTS providers stated that daily DOTS provision to patients at the health center is challenging in the treatment of patients. A participant stated:

“I want to follow the progress of my patients but appointing them to come daily for taking drug is very difficult as most of them are weak due to the disease and the cost of transportation is also a challenge for them” (A 26-year-old male TB DOTS provider).

A 35-year-old female DOTS provider added:

Instead of appointing my patients to come daily to the health center, I give the patients drugs to the health extension worker and communicate with her about the patient’s progress

Availability

Human Resource: From the 8 TB DOTS providers half of them are health officers and the rest are nurses. Among the DOTS providers five of them have been trained on comprehensive TB care. Regarding experience all of them had at least 4 years of clinical experience and 3 of them had at least 2 years of experience in providing DOTS (Table 9).

One of the key informant participants stated that:

"Last year, we had two trained TB treatment professionals at our health center. However, both of them have left to work at the woreda hospital. We are currently providing TB treatment services with untrained health professionals" (A 27-year-old health center head).

Another respondent added:

“Due to shortage of budget, we couldn’t conduct refreshment training for professionals working in the TB Clinics” (A 42-year-old male woreda TB focal).

Table 9

Distribution of human resource working in TB unit of Kembata Tembaro Zone health Centers, SNNPR, Ethiopia, 2021
HC name	TB DOTS PROVIDER
HC name	Profession	Clinical experience (years)	Experience in TB Clinic (years)	Training	Year training attended
Angecha	Nurse	10	1	Trained	2016
Funemura	Health Officer	4	2	Trained	2018
Damboya	Nurse	8	3	Trained	2019
Teza	Health Officer	12	4	Trained	2020
Doyogena	Nurse	10	6 Month	Not trained
Durame	Health Officer	4	1	Not trained
Hadero	Health Officer	6	8 Month	Not trained
Mare	Nurse	5	1	Trained	2020

Guideline and registrations: All public health centers had standard Unit TB and AFB registrations but there was no standard TB treatment guideline in two of them namely Doyogena and Mare health centers. One respondent described:

“We have requested the woreda to give us a guideline but they reported that the guideline is not available then we have decided to copy the training manual and availed it in the TB unit” (A 34-year-old male head of health center).

Drugs and Medical Supplies: Anti TB drugs were available in all of the public health centers but AFB reagent specifically acid alcohol were stock out in the past one month in two of the public health centers namely Doyogena and Mare health centers. Functional adult weight scale is available only in three of the public health center TB clinics namely Teza, Durame and Hadero health centers.

A 45-year-old male woreda TB focal stated: “Previously there were NGO’s that supply reagents and other medical supplies but now no one is supporting the TB program and there is a frequent interruption of reagents in the health centers”.

Additionally, there is a problem for availing reagents as stated by one of the health centers head: “Reagents especially acid alcohol is the frequently reported shortage and buying this reagent from market is possible but there is an issue of quality in the reagents that it is not guaranteed” ( A 34-year-old male health center head).

The overall level of availability in the public health centers of Kembata Tembaro zone is 81% which is labeled as medium level as per the predetermined set of judgment criteria (Table 10).

Table 10

Judgment Matrix for TB DOTS service resource availability in public health centers of Kembata Tembaro Zone, SNNPR, Ethiopia, 2021
Indicator	E	O	W	S	A	Judgment Parameter
Proportion of health center with trained DOT provider	8	5	3	1.9	62.5	≥ 85% = High Level 75% − 84.9% = Medium level 60% − 74.9% = Low level ≤ 59.9% = Poor
Proportion of health center with TB treatment providing unit available	8	8	3	3	100
Proportion of health center with no stock out of anti TB drugs in the past 1-month period	8	8	3	3	100
Proportion of health center with no stock out of AFB reagent in the past 1- month period	8	6	4	3	75
Proportion of health center with functional adult weight scale in the TB unit	8	3	3	1.1	37.5
Proportion of health center with AFB registration	8	8	3	3	100
Proportion of health center with standard unit TB register	8	8	3	3	100
Proportion of health center with standard treatment guideline	8	6	3	2.25	75
Overall Score of Availability			25	20.25	81
E: Expected, O: Observed, W: Weight, S: Score ((observed X weight)/Expected), A: Achievement in percentage ((S/W) 100)

The present evaluation findings shows that the overall level of fidelity of implementation in public health centers of Kembata Tembaro zone was at low level (73.9%) based on the judgment parameter. The adherence of health care providers to the national TB treatment guideline was at low level (73.1%) and the quality of TB treatment delivery was at medium level (75.95%). TB patient’s responsiveness towards the TB treatment service received was at low level (69.4%) and the availability of needed resources for TB treatment provision was at medium level (81.2%).

Adherence:

The national guideline recommends that an appropriate anti TB regimen with the correct dosage should be prescribed to all TB patients(5). In line with this the current study shows almost all (99.7%) patients receive a correct drugs regimen during their intensive phase of treatment and more than eight in ten (87.2%) of patients during the continuation phase. This might be due to the easily understandable current treatment protocol and preparation of anti TB drugs in a combined form. This finding is comparable with the study conducted in south Asia which states around 90% of patients received a correct drug regimen(16). Another study conducted in health facilities of Bahir Dar city administration also shows 94.4% of patients get the correct anti-TB drug regimen(17).

In addition to this the current study revealed that 96.3% and 82.8% of TB patients received a correct anti-TB drug dosage during their intensive and continuation phase respectively. This finding is comparable with a study conducted in Limmu genet district hospital, Oromia region which is 86.8% on both phases(18). The current finding was lower than the study in south Asia, which is 100% during both phases of treatment. This difference might be due to the study conducted in south Asia has an inpatient TB care unit unlike our study setting. However the present study finding is higher than a study conducted in public health facilities of Southwest Ethiopia which is 91% during intensive and 52.7% during continuation phase (19). This difference might be due to the difference in the study setting, sample size, and method. Our study uses both qualitative and quantitative method, whereas the study in south west uses only quantitative method.

Our study showed that sputum follow up examination for smear positive pulmonary TB patients were done at 2nd month of treatment for 79%, at 5th month 64.7%, and at 6th month for 66.9% of patients. However, the national TB treatment guideline recommends that AFB microscopy examination should be requested to all bacteriologically confirmed TB patients at the end of 2nd, 5th and 6th month of treatment(5). The difference observed in the current study might be due to the absence of full time assigned trained health care provider in the TB units and due to the interruption of acid alcohol reagent. Another study conducted in public health facilities of Southern Nations Nationalities and Peoples Region showed that sputum smear examination was done for 63.8% at 2nd month, 18.4% at 5th month, and 17.8% at 6th month of treatment which is far below the finding of the current study(20). The finding of the current study also shows a better result than the study in Limmu genet, Oromia region which states that only 55% of patients had sputum examination at the end of intensive phase(18). The existence of the discrepancy might be due to different in study setting and method. Previous study only uses facilities from rural area where as our study uses both facility which have better access interms of human and material resource.

It is recommended in the national guideline that all TB patients should be screened for HIV at the time of treatment initiation(5). In the current study more than nine in ten (92%) of patients offered an HIV test and this might be due to the assignment of untrained health care providers in the TB unit. The current study finding is comparable with the study done in Nepal which is 91.5%(21). Studies conducted in public health facilities of Debre tabor town, East Wollega and Wolaita Sodo zone shows an approximate result of 98.9%, 96% and 98% of patients screening for HIV respectively(9, 22, 23).

The national TB treatment guideline recommends that all pulmonary smear positive TB patients should get drug susceptibility tests(5). In contrary with this, our evaluation showed that DST was done only for one fifth of pulmonary smear positive patients. This discrepancy might be due to knowledge gap of the TB DOTS providers due to lack of refreshment training.

Findings from this study shows around 83% of patients weight was measured at the start of continuation phase of treatment. However, it is recommended in the national TB treatment guideline that all TB patient’s weight should be measured and kept on the proper drug dose at the end of intensive phase treatment(5). This difference might be due to the lack of functional weight measuring scale in the TB unit and lack of commitment among the health care providers. The current study finding is comparable with the study done in South west Ethiopia which is 82.7% and higher than the finding of a study conducted in Debre tabor town which is 63% (19, 22). This discrepancy might be because of the existence of differences in study period and sample size.

Our evaluation showed that 73.11% of TB DOTS services were implemented in line with the national standards and revealed that many of the services were not consistent with the national guideline recommendations.

Moderators

Quality of TB DOT delivery

The national TB treatment guideline recommends that TB care providers should be caring, respectful and compassionated while providing the service to all TB patients. In our study around 62% of patients were invited in to the room and offered chair by the TB DOT providers and this finding is congruent with the study done in Bahir Dar city administration which reported that 67% clients were invited to room offered chair (17). However, this is much lower than a study conducted in public health facilities of Ilu Aba Bor Zone which is 95.4%(24). This difference might be due to the sub-standard level of TB units in most of the health centers in the current study area and difference in the compassionate care between health care providers.

The current study shows about 47.3% of TB patients were told about the importance of observed treatment which is lower than a study conducted in Bahir Dar city administration and Ilu Aba Bor Zone which is 59.9% and 59.6% respectively (17, 24). This discrepancy might be due to difference in measurement of the variable. In our study the variable was measured both in self-report and direct observation however, the study in Bahir Dar and Ilu Aba Bor uses only one of them.

The present study revealed 64.8% of patients respond TB care provider explains things in a way they understand and this is lower than the study conducted in health facilities of North Shewa which was reported as 88.9% (25). The discrepancy might be due to the number of trained TB DOTS providers and the number of samples used in the studies. The overall quality of TB DOT services was 75.9%, which is medium and needs improvement.

Participant Responsiveness

Finding from our evaluation reveals that patient’s satisfaction towards the working hour appropriateness was 72.8% which is in line with the finding of the study conducted in North Shewa (25). Other study conducted in Ilu Aba Bor zone also shows an approximate result which reported 79%(24). According to this study patients’ rate towards the respect given by the health care providers is 77% which is higher than both the study conducted in North Shewa and Ilu Aba Bor zone which was 72.5% and 67.9% respectively (24, 25). This difference might be due to the study setting and out study included only health centers in which load of clients are less as compared to the study conducted in the Ilu Aba Bor zone which includes both health center and hospitals. Another reason might be due to the difference in delivering compassionate care among TB DOTS providers.

In this study, patients’ satisfaction on the waiting time before being served is 58.2% which is congruent with the study conducted in Bahir Dar city which was 56.2% (17) but lower than a study done in North Shewa and Ilu Aba Bor Zone which were 74% and 77.8% respectively (24, 25). The existence of the discrepancy might be due to the absence of full time assigned TB DOTS provider in the health centers. The other finding of the present study shows patients satisfaction towards the competence of TB DOTS provider is 71% which is lower than the study conducted in North Shewa Zone and Bahir Dar City administration which were 75% and 83.3% respectively (17, 25). The difference might be due to the studies conducted in North Shewa and Bahir Dar included both health centers and hospitals where a service was delivered with advanced health professionals. Another reason could be due to the difference in the sample size used in the studies.

Moreover, the findings showed extra pulmonary TB patients were more likely associated with dissatisfaction than pulmonary TB patients. This may be due to the long duration of treatment among the EPTB patients and the additional ancillary drugs prescribed for them. The satisfaction of patients with the overall TB DOT services was 69%, which is low and needs improvement.

Availability of resources

The findings of our evaluation showed that TB treatment unit, anti-TB drugs, AFB registers and unit TB registers were 100% available in the public health centers which is congruent with the guideline recommendation(26). Other finding from this evaluation showed more than half of the public health centers had no functional adult weight scale in TB room.

The national TB treatment guideline recommends an adequate and uninterrupted supply of reagents as part of programmatic activities to achieve sustainable program implementation(5). The unavailability of AFB reagent was due to the phase out of the NGO that used to supply the public health centers and the issue of guarantee on the commercially available reagents.

Moreover, TB DOTS were given by untrained professionals in more than one third of public health centers. This was due to turnover of trained professionals and the absence refreshment training due to budget shortage. This finding is lower than the service availability and readiness assessment conducted in public health facilities of Ethiopia which showed 71% of health centers has at least one trained health care provider on TB DOTS(13).

All of the health centers have a separate room for TB treatment but only two of them had a standard TB unit with a waiting room. World Health Organization (WHO) and Ethiopian Food and Drug Authority (EFDA) recommends that TB room should be at least located in 8 square meter, windows as large as a minimum of 150*200cm in an opposite direction to each other and wall as high as 2.5 meter. Accordingly, most (75%) of the health centers in the current study are below the standard and this might be because of COVID-19 pandemic demanded significant attention and resources, program managers were gave less attention to program which was true for other programs too, leading to inadequate resource allocation and infrastructure (5, 14).

The present evaluation revealed that one of the constraints in the provision of TB treatment is lack of necessary resources which had an implication that the service provision was below the required amount for targeted beneficiaries.

Limitation of the study

One of the limitations faced in this study were since the study were conducted at the health center level patients might respond in a relative positive way, social desirability bias, by fearing of being recognized. This issue was addressed by ensuring them that their response is only for research purpose. The other limitation was the difficulty in extracting the required data from a unit TB register since many of the recorded data were not recorded completely. This issue was mitigated by reviewing additional registers like laboratory AFB register and by methodological triangulation.

Resources for TB DOTS service are moderately available, but there is a shortage of trained health care providers and frequent stock outs of AFB reagents. Additionally, functional adult weight scales are not available at TB units. Adherence to DOTS provider guidelines is low, with substandard patient sputum follow up examinations, nutritional assessments, drug susceptibility tests, and weight monitoring. The study found that the quality of TB DOTS delivery is moderate. Specifically, patients were not always attended by the same provider, not consistently counseled on the importance of observed treatment or the need for sputum examination, and providers did not dedicate enough time to actively listen to their patients.

Our study found a low level of patient responsiveness to the provided DOTS service. Patients reported dissatisfaction with the daily visits to the health center for TB treatment, long wait times, and patients perceived the DOTS providers as incompetent. The results of this evaluation can guide decision makers at various levels to address the specific problem areas and take appropriate action.

AFB

Acid-fast bacillus

DOT

Direct observed treatment

DOTS

Direct Observed Treatment Short-course

HIV

Human Immunodeficiency Virus

MDR-TB

Multidrug-Resistant Tuberculosis

MTB

Multidrug-Resistant Tuberculosis

SNNPR፡ Southern Nations Nationalities and People Region

Tuberculosis

WHO

World Health Organization.

Acknowledgment

We are very grateful to Jimma University for its technical and financial support. We would also like to thank Kembata Tembaro Zone health department staffs and all of the study participants who participated in this evaluation for their information and commitment. Our appreciation also goes to the data collectors and supervisors for their unreserved contribution.

Authors’ contributions

TL, developed the proposal, carried out data collection, conducted the analysis, was involved in reviewing the manuscript and had full access to all the data in the study and had final responsibility for the decision to submit for publication. BME and YS provided general guidance in overall study progress and participated in reviewing the proposal, reviewing the analysis and participating in final study document development. SS, AT, and TG participated in data collection management. AM and TL in analyzing the data and reviewing the manuscript draft. AM writes the first draft of the manuscript. All authors read and approved the final manuscript and are accountable for all aspects of the work.

Funding

This study did not receive any specific funding from external agencies. Nonetheless, the study budget was supported by the postgraduate school at Jimma University. It is important to note that the university did not have any involvement in the study design or conceptualization.

Availability of data and materials

Data will be available upon request from the corresponding authors.

Disclosure

All authors declared that they have no competing interest.

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The authors declare no competing interests.

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Implementation fidelity of directly observed treatment, short-course for Tuberculosis in public health centers of Kembata Tembaro Zone, Southern Nations Nationalities and People Region, Ethiopia

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Abstract

Introduction

Materials and methods Evaluation Design and Setting

Variables and Measurements

Sample size and sampling procedures

Data Collection tool and procedures

Data management and analysis

Ethical consideration

Results

Adherence

Content

Frequency

Duration

Moderating factors

Socio demographic characteristics of Respondents

Quality of DOTS delivery

Participant Responsiveness

Facilitation Strategies

Intervention Complexity

Availability

Discussion

Adherence:

Moderators

Limitation of the study

Conclusion

Abbreviations

Declarations

References

Additional Declarations

Supplementary Files

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