Effect of Integrating Traditional Tuberculosis Care With Modern Health Care on Case Detection

NCT05236452 | Completed DMC

• 1 other identifier: 353/2021
• Study Type: interventional
• Target: 918
• Locations: 1 country
• Sites: 1

Brief Summary

Although many interventions are implemented to increase TB case detection, decrease diagnosis delay, and avoid catastrophic costs, there are no significant changes and the end TB goal will not be achieved in 2035. Innovative intervention that considers indigenous knowledge and unique culture and religious perspectives because many people go to traditional healers and holy water for healing. Therefore, integrating traditional tuberculosis care with modern care increase case detection, decrease diagnosis delay, and avoid catastrophic costs. There is no literature clearly defining integrating traditional TB care with modern care, but for the purpose of this study, integrating traditional care with modern care is defined as the collaboration of two systems through referral linkage. TB screening and diagnosis services will be done collaboratively in traditional and modern care services. A referral linkage model will be used to detect TB cases in both traditional and modern care services. Health care providers, traditional healers, priests, pastors, and imams will participate in the integration process. TB detection or diagnosis services will be integrated through referral linkage and strengthening capacity-building strategies. Traditional care centers and modern health care services will work collaboratively to improve TB case detection, reduce care costs, and avoid diagnosis delays. The standardized operational procedure of the full interventional package is described below. There are four steps of the intervention phases. These are the preliminary phase, preparation for implementation and refinement on a small scale phase, administering the intervention, and end-line assessment of outcomes. The intervention will be providing training for traditional and modern care practitioners, patient education, TB screening, and bidirectional referral linkage. This study hypothesized that integrating traditional care with modern care at the primary care level will increase the TB case detection rate by fifteen percentage points. Integrating traditional care with modern care at the primary care level will decrease TB diagnosis delay by fifteen percentage points. Integrating traditional care with modern care at the primary care level also will decrease the cost of TB care by 15 percentages of points

Conditions

Tuberculosis; Tuberculosis, Pulmonary; Tuberculosis Infection

Keywords

Tuberculosis; Case detection; Case notification; Case detection rate; Cost of TB care; Diagnosis delay; Patient satisfaction

Outcome Measures

Primary Outcomes (1)

• Tuberculosis case detection rate

  The case detection rate is calculated as the number of cases notified divided by the number of cases estimated for that year, expressed as a percentage. Tuberculosis case detection is diagnosed in a patient and is reported within the national surveillance system, and then to WHO. The case detection rate is expressed as the number of cases notified divided by the number of cases estimated for that year, expressed as a percentage.

  The outcome will be measured at 12 months

Study Arms (2)

Integrating of the traditional TB care with modern care through screening, and referral linkage

EXPERIMENTAL

Integrating traditional care with modern care is a collaboration of two systems through referral linkage. A referral linkage model will be used to detect TB cases in both traditional and modern care services. Health care providers, traditional care providers will participate in the integration process.

Other: Training for traditional and modern care providers

Patients proceed with the usual care/ control group

ACTIVE COMPARATOR

The control group will be followed the existing passive case-findings system (self-referral patients to nearby health facilities that use the same national guidelines to treat TB). The usual care will be carried out using nationally standardized guidelines. The findings obtained from the control groups will be compared with the intervention groups. Finally, changes among the two groups will be assessed and concluded.

Other: Training for traditional and modern care providers

Interventions

Training for traditional and modern care providers OTHER

The intervention arm includes training for traditional and modern care providers, patient education, screening, and referring to TB suspected cases plus the usual care. The training will be provided three times which will be delivered every three months. In the first round, traditional practitioners will be trained for 5 days. In this round, the training will be also delivered to modern health care providers on how to communicate and work with traditional care providers for 2-day. Then, a one-day interactive discussion session will be prepared for both traditional and modern care providers. In the second round and third rounds, one-day training will be carried out at three and six months. TB suspected cases at traditional foster and holy water and patients who need spiritual support from health care providers will be screened every case in every day for one year. Referring to TB suspected cases will also apply for every case every day for one year

Integrating of the traditional TB care with modern care through screening, and referral linkage; Patients proceed with the usual care/ control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All sick people who come to traditional healers' clinic or holy water with cough for two weeks or more, unintentional weight loss, anorexia, fever, chest pain, chillness, night sweating, and/or fatigues will be included in the study.
• All TB suspected patients who come to the health facilities with self-referral will be included in the study
• Health facilities in the study area should have at least a microscope diagnostic service will be included in the study
• All HEWs, TB focal persons at each level (health centers, hospitals, Woreda, Zone, and regional health bureau), traditional healers, clergy, pastors, Imams, and patients on anti-tuberculosis treatment will be the potential candidates for this study.

You may not qualify if:

• Patients coming from traditional care centers and health facilities outside of the intervention and control area will be excluded from the study.
• Debtera and Witch (Tinquaye) were excluded from this study because they have no known structure. In addition, people go to witch and Debtera secretly because they fear stigma and discrimination by society.

Sponsors & Collaborators

• Bahir Dar University: lead

Study Sites (1)

Bahir Dar University

Bahir Dar, Amhara, 6000, Ethiopia

Location

Related Publications (3)

• Amare D, Alene KA, Ambaw F. Effect of integrating traditional and modern healthcare systems on tuberculosis case detection in Ethiopia: a cluster randomized controlled study. Infect Dis Poverty. 2025 Mar 3;14(1):16. doi: 10.1186/s40249-024-01270-9.

  PMID: 40025607 DERIVED

• Amare D, Alene KA, Ambaw F. Impact of integrating traditional care with the modern healthcare system in reducing tuberculosis diagnosis delays in Ethiopia: a clustered randomized controlled study. Trop Med Health. 2024 Nov 13;52(1):83. doi: 10.1186/s41182-024-00641-0.

  PMID: 39533424 DERIVED

• Amare D, Ambaw F, Alene KA. Effect of integrating traditional care with modern healthcare to improve tuberculosis control programs in Ethiopia: a protocol for a cluster-randomized controlled trial. Trials. 2023 Sep 11;24(1):582. doi: 10.1186/s13063-023-07559-8.

  PMID: 37697429 DERIVED

MeSH Terms

Conditions

Tuberculosis; Tuberculosis, Pulmonary; Latent Tuberculosis; Patient Satisfaction

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Latent Infection; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The random allocation process, enrolling participants and participants assigned in the intervention group will be done by statisticians who will not have awareness about the characteristics of the intervention and control groups using the computer random.org website. The study subjects will be unaware of the intervention they received. Laboratory personnel who will be involved in the tuberculosis diagnosis and a person who will assess the outcomes of intervention will be unaware of the group assignment. Intervention outcomes will be assessed by research assistants who are not participating in participant recruitment and they are masked. The study participants, caretakers/attendants, and healthcare providers will be masked at any point.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Participants will be randomly allocated to the intervention and control arms. In the intervention arm training for practitioners, patient education, screening, and referring suspected TB cases from traditional care centers to modern care services and vice versa.

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 11, 2022
• Study Start: July 1, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1)