NCT04122404: TBPOC

POC Strategies to Improve TB Care in Advanced HIV Disease

Completed NA Last updated 23 May 2022

What this trial tests

NA trial testing LF-LAM in Extrapulmonary Tuberculosis in 425 participants. Completed in 30 January 2022.

Timeline

14 October 2019

Primary endpoint
30 January 2022

30 January 2022

Quick facts

Lead sponsor	University of Southern Denmark
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	diagnostic
Enrollment	425
Start date	14 October 2019
Primary completion	30 January 2022
Estimated completion	30 January 2022
Sites	3 locations across Ghana

Drugs / interventions tested

• LF-LAM

Conditions studied

• Extrapulmonary Tuberculosis — all drugs for Extrapulmonary Tuberculosis →
• Tuberculosis, Pulmonary — all drugs for Tuberculosis, Pulmonary →
• Human Immunodeficiency Virus (HIV) — all drugs for Human Immunodeficiency Virus (HIV) →
• Acquired Immunodeficiency Syndrome — all drugs for Acquired Immunodeficiency Syndrome →

Sponsor

University of Southern Denmark

Who can join

18 and older, any sex, with Extrapulmonary Tuberculosis or Tuberculosis, Pulmonary. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Tuberculosis (TB) remains the major cause of morbidity and mortality among patients with HIV. Sub-optimal diagnostics contributes towards poor patient outcome and there is an urgent need to identify non-sputum-based point-of-care diagnostic tests. The urine based lateral flow lipoarabinomannan TB diagnostic test (LF-LAM) is a simple, inexpensive point-of-care test. In 2015, the World Health Organization endorsed LF-LAM for conditional use among patients with advanced HIV, but uptake of the test in clinical practices has been poor.

The investigators aim to identify point-of-care (POC) strategies that can improve TB case detection and clinical outcomes among patients with advanced HIV. The project includes a main study and two sub-studies.

The main study is a multicenter stepped wedge cluster-randomized controlled trial of LF-LAM implementation among patients with advanced HIV with 8-weeks follow-up. LF-LAM will be added to standard care and implemented stepwise at three hospitals in Ghana. Education in national TB treatment guidelines in collaboration with the Tuberculosis Control programme in Ghana, and Clinical audit of clinical staff with feedback, will be used to assess and strengthen LF-LAM implementation. The primary outcome time to TB treatment, for which a sample size of 690 participants will provide \>90% power to detect a minimum of 7 days reduction. Secondary outcomes are: TB related morbidity, TB case detection, time to TB diagnosis and overall early mortality at 8 weeks. The HIV-associated TB epidemiology including genotypic analyses of M. tuberculosis isolates obtained through the main study will be described. In sub study A, focused ultrasound of lungs, heart and abdomen will be performed in a sub cohort of 100 participants. In sub study B, the investigators will establish a biobank and data warehouse for storage of blood, urine and sputum samples collected from participants that enter the study at Korle-Bu Teaching hospital.

It is expected that LF-LAM will lead to earlier diagnosis and treatment of TB. Findings may further guide scaling-up of LF-LAM. The HIV-associated epidemic including genotypic properties and resistance properties which is important for improved management will be detailed. The investigators further expect to evaluate the potential of bedside ultrasound as a clinical tool in management of HIV/TB co-infected patients. The unique Ghanaian HIV-cohort and biobank may facilitate rapid evaluation of future prognostic biomarkers and new point-of-care TB diagnostic tests.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Xpert Ultra versus Xpert MTB/RIF for pulmonary tuberculosis and rifampicin resistance in adults with presumptive pulmonary tuberculosis.
   Zifodya JS, Kreniske JS, Schiller I, Kohli M, et al · · 2021 · cited 136× · PMID 33616229 · DOI 10.1002/14651858.cd009593.pub5
2. The in-hospital tuberculosis diagnostic cascade and early clinical outcomes among people living with HIV before and during the COVID-19 pandemic - a prospective multisite cohort study from Ghana.
   Åhsberg J, Bjerrum S, Ganu VJ, Kwashie A, et al · · 2023 · cited 4× · PMID 36632893 · DOI 10.1016/j.ijid.2022.12.044
3. Use of the urine Determine LAM test in the context of tuberculosis diagnosis among inpatients with HIV in Ghana: a mixed methods study.
   Åhsberg J, Tersbøl BP, Puplampu P, Kwashie A, et al · · 2023 · cited 2× · PMID 38249371 · DOI 10.3389/fpubh.2023.1271763