POC Strategies to Improve TB Care in Advanced HIV Disease

  • STATUS
    Recruiting
  • days left to enroll
    85
  • participants needed
    690
  • sponsor
    University of Southern Denmark
Updated on 11 May 2021
HIV Infection
tuberculosis
cough
HIV Vaccine
night sweats

Summary

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.

Details
Condition HIV, HIV infection, AIDS, Pulmonary tuberculosis, HIV/AIDS, AIDS and AIDS related infections, Acquired Immune Deficiency Syndrome (AIDS - Pediatric), HIV (Pediatric), HIV Infections, Extrapulmonary Tuberculosis, human immunodeficiency virus, hiv disease, acquired immunodeficiency syndrome (aids), sida, acquired immune deficiency syndrome (aids)
Treatment LF-LAM
Clinical Study IdentifierNCT04122404
SponsorUniversity of Southern Denmark
Last Modified on11 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

HIV-positive
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/L (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 > 39C, 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
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