A Clinical Risk Score for Early Management of TB in Uganda

NCT05122624 | Completed Results

• 2 other identifiers: R21AI161301IRB00015699
• Study Type: interventional
• Target: 3,332
• Locations: 1 country
• Sites: 1

Brief Summary

Although curative treatment exists, tuberculosis (TB) remains the leading cause of infectious mortality worldwide - often because people seek care for TB symptoms in highly resource-constrained clinics that cannot provide same-day diagnostic testing. The research team has developed an easy-to-use clinical risk score that, if implemented in these settings, might help clinicians identify patients at high risk for TB and thereby start treatment for those patients on the same day. This study will investigate the effectiveness and implementation of this score in four peri-urban clinics in Uganda, providing critical pragmatic data to inform (or halt) the design of a definitive large-scale cluster randomized trial.

Conditions

Tuberculosis, Pulmonary

Outcome Measures

Primary Outcomes (2)

• Difference in 7-day Treatment Initiation From Pre-implementation to Post-implementation

  The percentage of participants with microbiologically confirmed TB who initiated treatment within 7 days during post-implementation 'minus' The percentage of participants with microbiologically confirmed TB who initiated treatment within 7 days during pre-implementation

  Up to 12 months post intervention

• Implementation: Percentage of Encountered Patients at Intervention Arm Who Initiated the Same-day Treatment Based on PredicTB Score as Indicated

  Percentage of patients who initiated same-day treatment divided by the number of patients who had a higher PredicTB score than the clinic-specific score of treatment threshold in the post-implementation period in intervention arm

  Up to 12 months

Secondary Outcomes (8)

• Incremental Cost-effectiveness of PredicTB

  Months 0 - 12

• Difference in TB Mortality From Pre-implementation to Post-implementation

  12 Months

• Difference in Loss to Care From Pre-implementation To Post-implementation

  12 Months

• Difference in Percentage of Participants With Microbiologically Confirmed TB

  Up to 12 months post-implementation

• Reach: Percentage of Patients Who Were Administered (or Evaluated) by PredicTB Score

  Up to 12 months

Study Arms (2)

Score intervention arm

EXPERIMENTAL

The PredicTB score will be implemented in this arm.

Other: PredicTB score

Control arm

NO INTERVENTION

The standard of care will be conducted in this arm.

Interventions

PredicTB score OTHER

This is an easy-to-use clinical risk score designed to improve early management of tuberculosis in highly resource-constrained settings where same-day microbiological testing is unavailable. It consists of readily accessible demographic and clinical data and is scored from 1-10. We will train clinic staff in eight clinics (four study clinics and four comparison clinics) on the Ugandan standard of care for the diagnosis and treatment of TB. In addition, in the four study clinics, we will provide training on the PredicTB score.

Score intervention arm

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult patients submitting sputum for a new diagnosis of pulmonary TB in the four study clinics and four comparison clinics between month -6 and month 18 will have their records abstracted by study staff.

You may not qualify if:

• Age \< 15 years old

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Makerere University

Kampala, Uganda

Location

Related Publications (1)

• Baik Y, Musoke M, Twinamasiko A, Lamunu M, Nabacwa V, Sanyu A, Robsky KO, Sung J, Kityamuwesi A, Katamba A, Dowdy DW. Effectiveness and Implementation of a Clinical Risk Score for Early Diagnosis of Tuberculosis in Uganda: A Pragmatic, Clustered Randomization Clinical Trial. Ann Am Thorac Soc. 2025 Oct;22(10):1476-1483. doi: 10.1513/AnnalsATS.202404-422OC.

  PMID: 40587503 DERIVED

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Yeonsoo Baik
• Organization: Johns Hopkins Bloomberg School of Public Health

ybaik3@jh.edu

410-955-2378

Study Officials

• David W Dowdy, MD/PHD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study includes an intervention arm (four clinics) and a control arm (four clinics).

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 17, 2021
• Study Start: November 10, 2021
• Primary Completion: July 15, 2023
• Study Completion: February 29, 2024
• Last Updated: July 23, 2024
• Results First Posted: July 23, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)