Diagnoses Disease, HIV Coinfection, Tuberculosis
Conditions
Brief summary
The overall aim of this study is to assess the potential of an expanded TB testing strategy to increase the number of HIV-positive patients with microbiologically diagnosed TB who are started on treatment in adult wards of sub-Saharan Africa.
Detailed description
To investigate the effect of an expanded TB screening strategy among HIV-positive patients admitted to hospital (including Ultra on sputum, stool and urine, and AlereLAM on urine, performed regardless of presence of TB symptoms) on the proportion of microbiologically-confirmed TB cases starting treatment within 72 hours of enrolment, compared to Ultra testing (on sputum/any tissue) and AlereLAM (on urine) in only those patients who are symptomatic for TB or fulfilling WHO testing recommendations. to assess the impact of this screening strategy on 2-month all-cause mortality. • to assess the feasibility of multiple specimens' collection for TB diagnosis within 72 hours of enrolment.
Interventions
DIAGNOSTIC_TESTConcentrated urine with Xpert Ultra
Molecular TB diagnostic test on urine
DIAGNOSTIC_TESTStool with Xpert Ultra
Molecular TB diagnostic test on stool
Sponsors
Ludwig-Maximilians - University of Munich
Instituto Nacional de Saúde, Mozambique
Centro de Investigação em Saúde de Manhiça
National Institute for Medical Research, Tanzania
Ifakara Health Institute
Ospedale San Raffaele
Swiss Tropical & Public Health Institute
African Society for Laboratory Medicine
Heidelberg University
Barcelona Institute for Global Health
Foundation for Innovative New Diagnostics, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults (18 years old and above) 2. Confirmed HIV infection by serology (including both antiretroviral (ART)- naïve and experienced) 3. Admitted to the hospital (adult medical wards) at the time of enrolment.
Exclusion criteria
1. Unable to provide informed consent (if no authorized relatives are in the position to provide the consent) 2. Living outside the catchment area of the participating hospital(s) 3. with plans to migrate outside the catchment area within 2 months after recruitment. 4. Currently receiving anti-TB therapy or having received anti TB therapy in the last 6 months prior to enrolment 5. Receiving preventive TB treatment in the preceding 6 months 6. Patients admitted for traumatic reasons, acute abdomen, delivery (maternal conditions), or for planned/scheduled surgery. 7. Referred from other hospital.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| proportion of participants diagnosed with microbiologically confirmed TB and started on TB treatment within 72 hours of enrolment | 72 hours after enrolment | The proportion of participants diagnosed with microbiologically confirmed TB and started on TB treatment within 72 hours of enrolment, separately for intervention and control arm. The numerator is the number of participants per study arm who are diagnosed with microbiologically confirmed TB and start on treatment within 72 hours of enrolment. The denominator is the number of participants enrolled per study arm. We will compare this indicator between both study arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eight-week all-cause mortality | 8 weeks after enrolment | Eight-week all-cause mortality (main secondary endpoint) among all participants enrolled. The numerator will be number of deaths during eight weeks after enrolment, the denominator is the number of participants enrolled. We will compare this indicator between both study arms. |
| The proportion of participants who are diagnosed with TB (irrespective of bacteriological confirmation) and started TB treatment within 72 hours of enrolment. | 72 hours after enrolment | The proportion of participants who are diagnosed with TB (irrespective of bacteriological confirmation) and started TB treatment within 72 hours of enrolment. The numerator is the number of participants diagnosed with TB (with or without bacteriological confirmation) who started treatment within 72 hours of enrolment; the denominator is the number of participants enrolled. |
Countries
Mozambique, Tanzania
Outcome results
None listed