Effect of integrating traditional care with modern healthcare to improve tuberculosis control programs in Ethiopia: a protocol for a cluster-randomized controlled trial

Abstract Background Tuberculosis (TB) remains a major cause of morbidity and mortality in the world, despite being a preventable and curable disease. The World Health Organization (WHO) End-TB Strategy, aligned with the Sustainable Development Goals (SDGs), sets a target of reducing the TB mortality...

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Main Authors: Desalegne Amare, Fentie Ambaw, Kefyalew Addis Alene
Format: Article
Language:English
Published: BMC 2023-09-01
Series:Trials
Subjects:
Online Access:https://doi.org/10.1186/s13063-023-07559-8
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author Desalegne Amare
Fentie Ambaw
Kefyalew Addis Alene
author_facet Desalegne Amare
Fentie Ambaw
Kefyalew Addis Alene
author_sort Desalegne Amare
collection DOAJ
description Abstract Background Tuberculosis (TB) remains a major cause of morbidity and mortality in the world, despite being a preventable and curable disease. The World Health Organization (WHO) End-TB Strategy, aligned with the Sustainable Development Goals (SDGs), sets a target of reducing the TB mortality rate by 95%, TB incidence rate by 90%, and catastrophic costs due to TB by 2035, compared with a 2015 level. To achieve these ambitious targets, several interventions have been implemented in the last few years, resulting in major progress toward reducing the burden of TB. However, over one-third of the global TB cases remained undetected and never received treatment. Most of those undetected cases were found in low- and middle-income countries such as Ethiopia. Though several interventions were implemented to increase TB case detection and mitigate catastrophic costs associated with TB, sustaining these interventions in resource-constrained settings remains challenging. Consequently, an alternative method is needed to increase TB case detection while decreasing diagnosis delays and catastrophic costs. Therefore, this study aimed to integrate traditional TB care into modern TB care to improve TB control programs, including early TB case detection, and reduce catastrophic costs in high TB burden settings such as Ethiopia. Methods A cluster randomized controlled trial will be conducted in northwest Ethiopia to determine the effectiveness of integrating traditional care with modern TB care. The intervention will be conducted in randomly selected districts in the South Gondar Zone. The control group will be an equal number of districts with usual care. The intervention comprised three key components, which include referral linkage from traditional to modern health care; training of health professionals and traditional care providers in three different rounds to increase their knowledge, attitude, and skills toward the referral systems; and TB screening at traditional health care sites. The primary outcomes of interest will be an increase in case detection rate, and the secondary outcomes of interest will be decreased diagnosis delays and catastrophic costs for TB patients. Data will be collected in both the intervention and control groups on the main outcome of interest and a wide range of independent variables. Generalized linear mixed models will be used to compare the outcome of interest between the trial arms, with adjustment for baseline differences. Discussion This cluster-randomized controlled trial study will assess the effectiveness of a strategy that integrates traditional healthcare into the modern healthcare system for the control and prevention of TB in northwest Ethiopia, where nearly 90% of the population seeks care from traditional care systems. This trial will provide information on the effectiveness of traditional and modern healthcare integration to improve TB case detection, early diagnosis, and treatment, as well as reduce the catastrophic costs of TB. Trial registration ClinicalTrials.gov NCT05236452. Registered on July 22, 2022.
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spelling doaj.art-b0ec2fce1bb746d4bb564f96b558ce0c2023-11-26T14:08:55ZengBMCTrials1745-62152023-09-0124111210.1186/s13063-023-07559-8Effect of integrating traditional care with modern healthcare to improve tuberculosis control programs in Ethiopia: a protocol for a cluster-randomized controlled trialDesalegne Amare0Fentie Ambaw1Kefyalew Addis Alene2School of Health Sciences, Bahir Dar UniversitySchool of Public Health, Bahir Dar UniversitySchool of Population Health, Faculty of Health Sciences, Curtin UniversityAbstract Background Tuberculosis (TB) remains a major cause of morbidity and mortality in the world, despite being a preventable and curable disease. The World Health Organization (WHO) End-TB Strategy, aligned with the Sustainable Development Goals (SDGs), sets a target of reducing the TB mortality rate by 95%, TB incidence rate by 90%, and catastrophic costs due to TB by 2035, compared with a 2015 level. To achieve these ambitious targets, several interventions have been implemented in the last few years, resulting in major progress toward reducing the burden of TB. However, over one-third of the global TB cases remained undetected and never received treatment. Most of those undetected cases were found in low- and middle-income countries such as Ethiopia. Though several interventions were implemented to increase TB case detection and mitigate catastrophic costs associated with TB, sustaining these interventions in resource-constrained settings remains challenging. Consequently, an alternative method is needed to increase TB case detection while decreasing diagnosis delays and catastrophic costs. Therefore, this study aimed to integrate traditional TB care into modern TB care to improve TB control programs, including early TB case detection, and reduce catastrophic costs in high TB burden settings such as Ethiopia. Methods A cluster randomized controlled trial will be conducted in northwest Ethiopia to determine the effectiveness of integrating traditional care with modern TB care. The intervention will be conducted in randomly selected districts in the South Gondar Zone. The control group will be an equal number of districts with usual care. The intervention comprised three key components, which include referral linkage from traditional to modern health care; training of health professionals and traditional care providers in three different rounds to increase their knowledge, attitude, and skills toward the referral systems; and TB screening at traditional health care sites. The primary outcomes of interest will be an increase in case detection rate, and the secondary outcomes of interest will be decreased diagnosis delays and catastrophic costs for TB patients. Data will be collected in both the intervention and control groups on the main outcome of interest and a wide range of independent variables. Generalized linear mixed models will be used to compare the outcome of interest between the trial arms, with adjustment for baseline differences. Discussion This cluster-randomized controlled trial study will assess the effectiveness of a strategy that integrates traditional healthcare into the modern healthcare system for the control and prevention of TB in northwest Ethiopia, where nearly 90% of the population seeks care from traditional care systems. This trial will provide information on the effectiveness of traditional and modern healthcare integration to improve TB case detection, early diagnosis, and treatment, as well as reduce the catastrophic costs of TB. Trial registration ClinicalTrials.gov NCT05236452. Registered on July 22, 2022.https://doi.org/10.1186/s13063-023-07559-8TuberculosisTraditional health careService integrationCluster-randomized controlled trialEthiopia
spellingShingle Desalegne Amare
Fentie Ambaw
Kefyalew Addis Alene
Effect of integrating traditional care with modern healthcare to improve tuberculosis control programs in Ethiopia: a protocol for a cluster-randomized controlled trial
Trials
Tuberculosis
Traditional health care
Service integration
Cluster-randomized controlled trial
Ethiopia
title Effect of integrating traditional care with modern healthcare to improve tuberculosis control programs in Ethiopia: a protocol for a cluster-randomized controlled trial
title_full Effect of integrating traditional care with modern healthcare to improve tuberculosis control programs in Ethiopia: a protocol for a cluster-randomized controlled trial
title_fullStr Effect of integrating traditional care with modern healthcare to improve tuberculosis control programs in Ethiopia: a protocol for a cluster-randomized controlled trial
title_full_unstemmed Effect of integrating traditional care with modern healthcare to improve tuberculosis control programs in Ethiopia: a protocol for a cluster-randomized controlled trial
title_short Effect of integrating traditional care with modern healthcare to improve tuberculosis control programs in Ethiopia: a protocol for a cluster-randomized controlled trial
title_sort effect of integrating traditional care with modern healthcare to improve tuberculosis control programs in ethiopia a protocol for a cluster randomized controlled trial
topic Tuberculosis
Traditional health care
Service integration
Cluster-randomized controlled trial
Ethiopia
url https://doi.org/10.1186/s13063-023-07559-8
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