# PredicTB: Validating a clinical risk score for early management of tuberculosis in Ugandan primary health clinics

> **NIH NIH R21** · JOHNS HOPKINS UNIVERSITY · 2022 · $162,809

## Abstract

PROJECT SUMMARY
An estimated 1.5 million people die of tuberculosis (TB) every year. Many of these are people who seek care in
under-resourced clinics (for example, in rural areas or informal settlements) where same-day TB diagnosis is
not available. These patients are often unable to return promptly to receive their results and start treatment,
resulting in ongoing disease transmission and often death. If TB treatment could be started on the same day as
these patients initially seek care, substantial mortality and transmission could be averted. Our team has
developed and validated a clinical risk score (“PredicTB”) for adult pulmonary TB that could aid in clinical
decision-making. This risk score ranges from 1-10, can be calculated by hand in under a minute using readily
available clinical data (e.g., age, sex, self-reported HIV status), and has sufficiently high accuracy to inform
decisions about same-day empiric treatment initiation while confirmatory test results are pending. Same-day
treatment initiation improves patient outcomes for other infectious diseases (for example, sexually transmitted
diseases including HIV), and this novel clinical risk score holds similar promise for TB, the leading cause of
infectious mortality worldwide. However, before conducting a large-scale cluster randomized trial to evaluate
whether this score could improve patient-important outcomes, it is critical to first generate evidence that this
score could be effective and be implemented in the most-resource-limited settings for which it is intended.
We propose a type 2 hybrid effectiveness-implementation evaluation of the PredicTB clinical risk score in four
peri-urban clinics in Uganda, with an additional four clinics serving as a comparison group. Our Specific Aims
are to evaluate the effectiveness of PredicTB on clinical outcomes including rapid treatment initiation, TB
mortality, and loss to care (Aim 1); to evaluate the implementation of PredicTB in terms of reach, adoption,
implementation, and maintenance (Aim 2); and the project the long-term impact and cost-effectiveness of
PredicTB implementation (Aim 3). Our primary outcome is the increase in the proportion of patients with
microbiologically confirmed TB who start treatment within seven days of initial presentation. To accomplish our
aims, we will adopt a highly pragmatic study design in which we train clinicians in the use of the PredicTB
score and perform quarterly site visits but otherwise minimize contact between study staff and treating
clinicians. This will enable us to evaluate whether implementation of PredicTB is likely to impact clinical
decision-making and patient outcomes under actual field settings. If successful, this evaluation will provide
critical data to justify (or halt) the conduct of a large-scale pragmatic clinical trial – not only will it generate
preliminary evidence of effectiveness, but it will also inform appropriate implementation. Patients in highly
resource-constrained setti...

## Key facts

- **NIH application ID:** 10371151
- **Project number:** 5R21AI161301-02
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** David Wesley Dowdy
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $162,809
- **Award type:** 5
- **Project period:** 2021-03-16 → 2024-02-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10371151

## Citation

> US National Institutes of Health, RePORTER application 10371151, PredicTB: Validating a clinical risk score for early management of tuberculosis in Ugandan primary health clinics (5R21AI161301-02). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10371151. Licensed CC0.

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