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Spirometry screening for post-tuberculosis lung disease among adolescents and adults in Mozambique

Implementation of spirometry screening for post-tuberculosis lung disease (PTLD) among adolescents and adults enrolled within the National Tuberculosis Control Program of Carmelo Hospital in Chókwè District, Mozambique: A hybrid type III effectiveness-implementation study protocol

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN92021748
Enrollment
115
Registered
2024-09-16
Start date
2024-08-01
Completion date
Unknown
Last updated
2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary lung function screening (spirometry) in persons completing 6 months of treatment for active TB Infections and Infestations

Interventions

This study involves pulmonary lung function screening (spirometry) in persons completing 6 months of treatment for active TB. To document the prevalence of PTLD in patients enrolled at Carmelo Hospit

Sponsors

Tulane University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Primary outcome: 1. Aged =15 years of age 2. Enrolled in the National TB Control Program (NTCP) at Carmelo Hospital (CHC) with a GeneXpert-positive sputum 3. Completed six months of TB treatment and considered TB-cured 4. Ability to understand and comply with study procedures Semi-structured key-informant interviews: 1. Participants at the central level of the NTCP in Maputo (Mozambique’s capital city) 2. Administrators of CHC and at each of the three selected peripheral health facilities 3. Clinicians (physician, medical technician, and nurse) responsible for implementing the spirometry screening program at CHC, as well as all clinicians responsible for treating TB at each of the three selected peripheral health facilities

Exclusion criteria

Exclusion criteria: 1. Less than 15 years of age 2. Active respiratory symptoms at the time of screening that are indicative of a new acute respiratory illness

Design outcomes

Primary

MeasureTime frame
Prevalence of post-tuberculosis lung disease amongst persons completing 6 months of treatment for active TB measured using spirometry and symptom screening at baseline (completion of 6 months of TB treatment) and at 6 months after completion of TB treatment.

Secondary

MeasureTime frame
Site-, provider-, and individual-level determinants that either promote or inhibit the successful adoption, implementation, and maintenance of the spirometry screening program will be measured using semi-structured key-informant interviews evaluating constructs from the Consolidated Framework for Implementation Research (CFIR), including perceptions about the intervention characteristics (e.g., facilitators, potential challenges, eligibility, and cost); outer setting factors influencing use (e.g., perception of patient needs and resources, demand creation, commitment); inner setting factors impacting uptake and fidelity to the intervention (e.g., resources needed, workload, standard operating procedures, infrastructure); characteristics of individuals (e.g., knowledge, competency, belief it can be done with quality); and process factors of implementation (e.g., fidelity, execution, and evaluation) within each health facility. These interviews will be performed after the completion of the spirometry portion of the study

Countries

Mozambique

Contacts

Public ContactTroy D. Moon
tmoon2@tulane.edu+1 5048623412

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 6, 2026