POC Strategies to Improve TB Care in Advanced HIV Disease
POC Strategies to Improve TB Care in Advanced HIV Disease
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.
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