An interventional study of A novel PTLD clinical diagnostic algorithm in Post Pulmonary Tuberculosis and Post-Tuberculous Bronchiectasis, sponsored by Mbarara University of Science and Technology. Not yet recruiting at 1 site in Uganda. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-16.
Sponsored by Mbarara University of Science and Technology · Not applicable, Interventional, and Diagnostic
The goal of this clinical trial is to determine whether a structured diagnostic algorithm improves the identification and referral of people with post-tuberculosis lung disease (PTLD) in primary healthcare facilities in Uganda. The clinical trial will, in addition, assess how feasible and acceptable it is for health workers to use this algorithm as part of routine care.
The main trial questions are:
The research team will compare four health centre level III (HCIII) facilities ( two using the diagnostic algorithm and two using standard care) to see if the algorithm helps with early diagnosis and referral of PTLD. Health centre level III in Uganda are the primary health facilities and have provision for tuberculosis treatment.
Participants will be screened for PTLD at the time they complete tuberculosis treatment at their local health facility.
At intervention sites, participants will undergo assessment using a structured PTLD diagnostic algorithm developed in earlier stages of this research. The algorithm will be based on a symptom questionnaire and clinical criteria. At control sites, participants will be evaluated using standard practices (consensus clinical definition only).
Participants clinically suspected to have PTLD. will be referred to Mbarara Regional Referral Hospital.
Primary care health facilities will:
Background Tuberculosis (TB) remains a major cause of death globally, with around 1.5 million deaths in 2020. These figures account only for deaths during the active disease phase, not those occurring after microbiologic cure. People who complete pulmonary TB treatment are about four times more likely to die early compared to the general population. Studies show up to 50% of TB survivors report health issues consistent with post-TB lung disease (PTLD). In Malawi, 61% of TB patients still had symptoms at treatment completion, and 28% had irreversible lung damage after five years. Pulmonary TB is now seen as a risk factor for chronic lung disease and poor quality of life. Between 60-90% of TB survivors face limited exercise ability, respiratory symptoms, and reduced quality of life. PTLD is marked by abnormal spirometry (airflow obstruction or low forced vital capacity) and recurrent symptoms often misdiagnosed as TB relapse. This leads to unnecessary TB treatment and drug-related side effects, especially with false-positive Xpert tests in the absence of smear or culture confirmation. PTLD is frequently missed in low-income, TB-endemic settings due to limited resources. Chest imaging shows lung cavities, bronchiectasis, and fibrosis. Spirometry reveals obstructive, restrictive, or mixed patterns, but these tests are not routinely available at primary health centers. Newer tests to distinguish PTLD from TB relapse have not been widely adopted, and culture-the gold standard-is not easily accessible. PTLD receives little attention in global TB guidelines, leading to limited research and diagnostic tools in low- and middle-income countries. Patients at risk of PTLD could be identified using pre-treatment chest X-rays, history, and physical exams, but these approaches are underused. The burden of PTLD varies across sub-Saharan Africa depending on local settings and case definitions. For example, a study in Tanzania found that 90% of people treated for TB in the past five years showed signs of PTLD. Despite a proposed definition from a recent post-TB symposium, no standard PTLD diagnostic criteria exist for low-resource settings. A study in three African countries showed inconsistent PTLD diagnosis, including in Ethiopia, where providers failed to diagnose PTLD in eligible patients. This highlights a critical gap in PTLD diagnosis. More research is needed to create a practical diagnostic tool and understand the barriers to clinical diagnosis. The overall aim of this trial is to build on an existing cohort and design a diagnostic algorithm for PTLD suitable for TB-endemic, low-income settings. PTLD presents a serious but often ignored challenge in TB-endemic areas. People finishing TB treatment should be assessed for overall health, including lung function and nutrition. However, low-income settings lack access to advanced tests like spirometry, relying only on symptom checks. TB programs often overlook PTLD, and health workers at primary facilities may have limited awareness. This trial focuses on improving early PTLD diagnosis at primary health centers, which can impact care for other chronic diseases. While training programs have improved diagnosis of non-communicable diseases, few focus on PTLD. A simple screening algorithm is needed for use at the primary care level. This trial aims to address both personal and system-level barriers to diagnosis. In Uganda, TB treatment is offered at primary health facilities, so early PTLD diagnosis depends on front-line clinicians. PTLD diagnosis is especially difficult at level-three health centers (HC3s) due to limited knowledge, no access to spirometry or imaging, and lack of clear guidelines.
Innovation Innovation A pilot cluster randomized clinical trial in post-TB morbidity is a step closer to improving post-TB care. Importantly, the selected health facilities will focus on post-TB diagnosis and care which has not been part of routine care. Despite the recommendation by the first PTLD symposium, this study aim presents an opportunity to solve this health challenge using locally generated data that can be applied to other low-income settings eliminating a one-size-fits-all approach.
Approach The main idea is that adding a clinical diagnostic algorithm to TB clinicians' workflow will support timely PTLD diagnosis and referrals for advanced care.
Design: This will be a prospective two-arm cluster randomized clinical trial (RCT) using the diagnostic algorithm designed in Aim 1 as the intervention. The primary outcome will be the duration of appropriate referral from level three health centers (HC3s) to a post-TB clinic at Mbarara Regional Referral Hospital (MRRH). The aim is to test the feasibility of implementing a clinical diagnostic algorithm for PTLD aiding clinicians at primary healthcare facilities (HC3s) in making accurate diagnoses of PTLD and facilitating timely referrals for effective treatment.
Study Setting: This study will be conducted at HC3s within Mbarara district Study Participants: The study will involve HC3s selected from the health facilities used for the qualitative interviews in Aim 2. TB clinicians at each health facility will screen individuals who have completed TB treatment for potential PTLD.
Participants: TB clinicians will screen people who completed TB treatment for PTLD.
Procedures: Study Procedures: Four HC3s will be recruited from a catchment area within 10 km radius of MRRH. Facility in-charges identified in Aim 2 will be contacted and requested to participate in the clinical trial. Upon their agreement, the in-charges will sign an informed consent form, following which the facilities will be randomly allocated to either the intervention or control group in a 1:1 ratio. A comprehensive training manual focusing on PTLD aligned with consensus guidelines will be developed for all clinicians at the selected HC3s. This training in form of continuing medical education (CME) will emphasize the significance of PTLD screening in TB survivors presenting with respiratory symptoms after completing TB treatment. The intervention will be the diagnostic algorithm that the investigators developed in Aim 1 as a visual aid whereas the control group will rely their clinical judgment and knowledge gained from the CME. Nurses or clinicians attending to TB patients at each HC3 will be requested to screen for PTLD in all TB survivors declared cured. This includes individuals returning to the TB department of each health facility with symptoms after TB cure. Those with a high suspicion for PTLD based on the diagnostic algorithm (intervention) or clinical judgment (control) will be referred to Mbarara Regional Referral Hospital for further diagnostics and care. A one-page triplicate referral form will be used to track referrals and ensure successful referral completion. The study team will conduct zoom conferences every fortnight with each of the four HC3 teams and to identify registration or referral gaps. No monetary incentives will be provided, but monthly internet and airtime will be provided to the contact health workers involved in the trial. Transport reimbursement and a snack will be provided to patients referred to MRRH. The study will be conducted following the guidelines of good practice in pilot interventional studies. Data Collection: Baseline and endpoint questionnaires will be completed by TB clinicians or any other designated personnel (such as a nurse) in collaboration with our research team. In addition to the routine programmatic TB outcomes documentation, data on patients screened for PTLD will be captured using a standardized data collection tool captured in REDCap. This will include participants demographics and TB treatment history including their prior eCBSS numbers. Facility demographic characteristics will be recorded. The data collection tools will be streamlined to ensure efficient data capture minimizing the potential for questionnaire fatigue. To prevent participants from being recorded at different HC3s due to their close proximity, the investigators will prioritize the recording of eCBSS numbers.
Outcomes: The primary outcome is the time from first visit with PTLD symptoms at HC3 to arrival at MRRH. With no current PTLD screening program, a 50% screening rate will indicate implementation success.
Secondary outcomes:
Feasibility of a full RCT will be based on:
Sample Size: Since this is a feasibility study, study is not powered to test an efficacy hypothesis. However, this study has maximum acceptable confidence interval for an anticipated intra-cluster correlation coefficient of 0.05, at a set cluster size of 20 which is typical for pilot cluster trials, with a coefficient of variation 0.1 and anticipated proportion of 0.5 (50%) for our primary outcome. Therefore FOUR (4) clusters are needed to estimate this proportion (50%) with a lower 0.9 confidence (10% margin of error) limit of 0.27 and upper confidence interval limit 0.73 Key Deliverables: The feasibility of a diagnostic algorithm will be presented in a larger cluster randomized clinical trial to scale up for timely PTLD diagnosis.
Key Deliverable: Demonstrate feasibility of a full-scale cluster RCT to improve PTLD diagnosis.
Challenges and Alternatives: There is a possibility of questionnaire fatigue given the existing programmatic TB questionnaires. However, strategies will be implemented to minimize missing data: Given the average patient load at HC3s TB units (an average 15 patients in a month), our study procedures and short electronic questionnaires are not expected to pose a significant workload. Secondly, monthly airtime and internet will be provided to both groups and an additional incentive such as a mobile phone loan for completing REDCap questionnaires. If the clinical algorithm demonstrated poor diagnostic accuracy, behavioral change will be assessed based on the impact of PTLD-focused CME using the consensus definition as the primary intervention compared to current practice.
1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.
This study's planned enrollment of 80 is below the median of 150 across 820 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →Mbarara University of Science and Technology is the lead sponsor of 31 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A health facility must meet all of the following criteria to participate in the study.
Patients screened at participating facilities must meet all of the following:
Exclusion Criteria:
A facility will be excluded if:
A patient will be excluded if:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Primary health care facilities (level three health centers in Uganda) randomized to this arm will implement a diagnostic algorithm developed based on clinical and demographic characteristics earlier in this study to screen tuberculosis (TB) survivors for post-tuberculosis lung disease (PTLD). TB clinicians will use a structured questionnaire and visual aid during routine care to identify PTLD. Patients with suspected PTLD will be referred to Mbarara Regional Referral Hospital, a tertiary center with a functional post-TB care clinic for further evaluation and care
Behavioral: A novel PTLD clinical diagnostic algorithm
Primary health care facilities (level three health centres in Uganda) randomized to this arm will continue routine clinical care after receiving basic training through continuous medical education about post-tuberculosis (TB) lung disease (PTLD) but will not use the diagnostic algorithm. TB clinicians will rely on the guideline-based clinical judgment to identify and refer suspected PTLD cases to Mbarara Regional Referral Hospital.
A clinical diagnostic algorithm designed to help TB clinicians identify patients at risk of post-tuberculosis lung disease (PTLD) at the end of TB treatment. The algorithm is implemented as a visual aid and structured questionnaire integrated into routine care. Clinicians use it to screen TB survivors and refer suspected PTLD cases to a post-TB clinic for confirmatory evaluation and management.
Primary care interval
The primary care interval (PCI) is the time (in days) between the date a TB survivor presents at a Health Center III (HC3) with symptoms suggestive of post-tuberculosis lung disease (PTLD) and the date they arrive at the post-TB clinic at Mbarara Regional Referral Hospital (MRRH) for confirmatory diagnosis and care. This time will be calculated using patient records and referral logs. The outcome will be compared between the intervention arm (use of diagnostic algorithm) and control arm (standard clinical judgment).
Time frame: Six months
Proportion of TB survivors screened for post-TB lung disease (PTLD)
The proportion of TB survivors declared cured who are screened for post-TB lung disease (PTLD) at participating HC3s. This will be presented as a percentage.
Time frame: Six months
Referral completion rate
Proportion of TB survivors referred to Mbarara Regional Referral Hospital (MRRH) who successfully arrive at the post-TB clinic for evaluation. This proportion will include all referred patients from participating HC3s
Time frame: Six months
Confirmed post-TB lung disease rate
Proportion of referred patients who receive a confirmed diagnosis of PTLD at Mbarara regional referral hospital post-TB clinic using imaging and/or spirometry.
Time frame: 6 months
Screening Fidelity
Implementation fidelity of post-TB lung disease (PTLD) screening, defined as the proportion of eligible TB survivors screened using either the diagnostic algorithm (intervention arm) or clinical judgment (control arm).
Time frame: 6 months
Feasibility of data capture
Proportion of eligible TB survivors for whom complete screening and referral data were entered into the REDCap database by health centre-three facility staff.
Time frame: 6 months
Algorithm usability and acceptability
Proportion of clinicians in the intervention arm who report that the diagnostic algorithm was easy to use and helpful in clinical decision-making.
Time frame: At study termination (6 months)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified individual participant data leading to published results will be made available upon reasonable request starting 12 months after study completion, for researchers with a methodologically sound proposal.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Starts 12 months after publication of primary results and will be available for five years
Access criteria: Scientists, Researchers, patients and organizations that care for lung health will be able to access de-identified participant data. Scientific data generated will be archived in the National Institute of Allergy and Infectious Diseases (NIAID)'s TB Portals Program, a web-based, open-access repository of multi-domain tuberculosis data and tools. TB-Portals program is freely accessible through the Registry of Research Data Repositories. Data will be deposited after the publicaton of our clinical trial results. Our study data will be findable through the NIH data repository. All our publications will be open access and will contain a clause to emphasize that our data is freely and easily accessible through the NIH. The global research community will have access for as long as the data is available at the NIH databases. The NIH data repository will have full control on the decisions about how long to preserve the data.
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Mbarara University of Science and Technology