TB-CAPT EXULTANT - HIV
Tuberculosis, HIV Coinfection, Diagnoses Disease
About this trial
This is an interventional diagnostic trial for Tuberculosis
Eligibility Criteria
Inclusion Criteria:
- Adults (18 years old and above)
- Confirmed HIV infection by serology (including both antiretroviral (ART)- naïve and experienced)
- Admitted to the hospital (adult medical wards) at the time of enrolment.
Exclusion Criteria:
- Unable to provide informed consent (if no authorized relatives are in the position to provide the consent)
- Living outside the catchment area of the participating hospital(s)
- with plans to migrate outside the catchment area within 2 months after recruitment.
- Currently receiving anti-TB therapy or having received anti TB therapy in the last 6 months prior to enrolment
- Receiving preventive TB treatment in the preceding 6 months
- Patients admitted for traumatic reasons, acute abdomen, delivery (maternal conditions), or for planned/scheduled surgery.
- Referred from other hospital.
Sites / Locations
- Centro de Investigação em Saúde de Manhiça-FundaçãoRecruiting
- Instituto Nacional de Saúde (INS)Recruiting
- Ifakara Health Institute (IHI)Recruiting
- National Institute of Medical Research (NIMR)Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
intervention arm
control arm
The intervention arm for this trial consists of HIV patients with TB testing performed regardless of presence of TB symptoms. Testing will be done on expectorated sputum, stool and concentrated urine with Ultra, and urine with AlereLAM. To fulfil exploratory objectives, we will also collect and store 2x tongue swabs for molecular TB diagnostic assay (Xpert Ultra and/or LumiraDx) testing, blood for testing with CRP, and urine samples which will be stored for retrospective FujiLAM testing and analysis.
The control arm for this trial will consist of patients managed according to the current WHO recommended TB testing practices for HIV positive inpatients (as of Q1 2020). TB testing will be done as follows: Sputum Ultra performed whenever the patient has cough, fever, weight loss over night sweats and/or Ultra performed on any tissue (including lymph nodes) from patients with clinical suspicion of extrapulmonary TB. and/or: Urine Alere TB-LAM performed if patients have signs and symptoms of TB (pulmonary and/or extrapulmonary), or with advanced HIV disease, or who are seriously ill, or else irrespective of signs and symptoms of TB, but combined with a CD4 cell count of less than 200 cells/mm .