HIV-associated tuberculosis Infections and Infestations
Conditions
Interventions
A screening strategy for HIV-infected adult patients requiring acute admission to hospital medical wards, based on testing of urine with the Determine TB-LAM lateral-flow assay and Xpert MTB/RIF assay
Sponsors
London School of Hygiene & Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Requires acute admission to a hospital medical ward 2. Have confirmed HIV-infection 3. Willing and able to provide informed consent
Exclusion criteria
Exclusion criteria: 1. Aged <18 years 2. Has been admitted to a medical ward for longer than 48 hours 3. Has received treatment for TB within the preceding 12 months, or has received isoniazid preventative therapy (IPT) within the last 6 months 4. Residence does not lie within a pre-defined geographic area or plans to leave this area during the period of trial follow-up 5. Unable or unwilling to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Risk of all-cause mortality at 56 days after randomization from any cause, compared between arms. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to all-cause mortality 2. Proportions of patients with: 2.1. Microbiologically confirmed diagnosis of TB 2.2. Clinically diagnosed TB disease 3. Time from randomisation to: 3.1. TB diagnosis 3.2. Start of TB treatment in days 4. Proportion of patients receiving: 4.1. Antibacterial treatment 4.2. In ART naïve patients, proportion starting ART and time to ART initiation in days 5.1. Duration of hospital stay in days 5.2. Cumulative incidence of hospital readmission (c) cumulative incidence of loss to follow-up All measured at 56 days after randomization | — |
Countries
Malawi, South Africa
Outcome results
None listed