POC Strategies to Improve TB Care in Advanced HIV Disease (TBPOC)

May 16, 2022 updated by: Johanna Maria Åhsberg, University of Southern Denmark

Point-of-care Strategies to Improve Tuberculosis Care Among Severely Immunosuppressed HIV-infected Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

425

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ghana
      • Accra, Ghana
        • Korle Bu Teaching Hospital
      • Tema, Ghana
        • Tema General Hospital
      • Teshie, Ghana
        • Lekma Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HIV-positive
  • 18 years and above
  • Able to give informed consent
  • Admitted at the wards attached to the research site ART/HIV-clinic
  • Eligible for LF-LAM testing (defined by WHO in the LF-LAM policy update 2019): CD4-cell-count ≤200 cells/μL (the last measured CD4-cell-count); or a WHO clinical stage 3 or 4 event at presentation for care; or seriously ill defined by WHO (respiratory rate > 30/min, temperature > 39°C, heart rate > 120/min or unable to walk unaided); or a positive WHO TB symptom screening including one of the following symptoms: current cough, fever, weight loss, or night sweats

Exclusion Criteria:

  • Anti-tuberculous treatment including preventive treatment with Isoniazide within the last 60 days
  • Earlier participation in the same study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Intervention

Routine TB diagnostic care (sputum smear microscopy, sputum Xpert MTB/Rif / sputum Xpert MTB/Rif Ultra, sputum culture) + Intervention

Intervention: LF-LAM is made available at the study site for the clinical staff to use; Training of clinical staff in national TB guidelines and LF-LAM use together with staff from the National TB Programme in Ghana
Diagnostic test: LF-LAM
Open label multi-center stepped wedge cluster-randomized controlled trial with implementation of LF-LAM. All clusters (i.e. HIV/ART clinic attached wards) start with standard of care and are then randomized to switch to the intervention phase at predefined time points.
Other Names:
  • Lateral flow urine lipoarabinomannan assay
  • Determine TM TB LAM Ag test
No Intervention: Standard of care
Routine TB diagnostic care (sputum smear microscopy, sputum Xpert MTB/Rif / sputum Xpert MTB/Rif Ultra, sputum culture)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to TB treatment initiation
Time Frame: 8 weeks follow up
Time to TB treatment initiation defined by time from TB diagnosis suspected to start of anti-tuberculous treatment provided.
8 weeks follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TB related morbidity
Time Frame: 8 weeks follow up
The difference in the proportion of TB patients with reduced TB morbidity score at 8 weeks follow up using "The Bandim tuberculosis score" with grading 0-13, where a reduction in the score may be used as a measurement of clinical improvement.
8 weeks follow up
TB case detection
Time Frame: 8 weeks follow up
Defined as proportion of patients with (i) microbiologically confirmed TB diagnosis and (ii) clinically confirmed TB diagnosis
8 weeks follow up
Time to TB diagnosis
Time Frame: 8 weeks follow up
8 weeks follow up
Time to all-cause mortality.
Time Frame: 8 weeks follow up
Mortality rates during follow up. Underpowered
8 weeks follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Collaborators

Odense University Hospital
University of Ghana
Odense Patient Data Explorative Network
National Tuberculosis Control Programme, Ghana
Tema General Hospital, Ghana
Lekma Hospital, Ghana
Korle-Bu Teaching Hospital, Ghana

Investigators

  • Principal Investigator: Johanna Åhsberg, MD, Dept. of Infectious Diseases, Odense University Hosp., Univ. of Southern Denmark
  • Study Director: Isik Somuncu Johansen, Prof, Dept. of Infectious Diseases, Odense University Hosp., Univ. of Southern Denmark
  • Study Chair: Margaret Lartey, Prof, School of Medicine and Dentistry, University of Ghana
  • Study Chair: Stephanie Bjerrum, MD, Dept. of Infectious Diseases, Odense University Hosp., Univ. of Southern Denmark
  • Study Chair: Åse Bengaard Andersen, Prof, Dept. of Infectious Diseases, Odense University Hosp., Univ. of Southern Denmark
  • Study Chair: Ernest Kenu, MD, Dept. of Epidemiology and Disease Control, Univ. of Ghana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2019

Primary Completion (Actual)

January 30, 2022

Study Completion (Actual)

January 30, 2022

Study Registration Dates

First Submitted

October 8, 2019

First Submitted That Met QC Criteria

October 8, 2019

First Posted (Actual)

October 10, 2019

Study Record Updates

Last Update Posted (Actual)

May 23, 2022

Last Update Submitted That Met QC Criteria

May 16, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OP_861

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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