Clinical trial NCT04568967: TB-CAPT EXULTANT - HIV
Official title: Expanding Xpert Ultra Testing for TB Diagnosis Among HIV-positive Patients Admitted to Hospital in Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
HIV Coinfection
Diagnoses Disease
Lead sponsor: Foundation for Innovative New Diagnostics, Switzerland
Sponsor class: OTHER
Collaborators: name: Ludwig-Maximilians - University of Munich
name: Instituto Nacional de Saúde, Mozambique
name: Centro de Investigação em Saúde de Manhiça
name: National Institute for Medical Research, Tanzania
name: Ifakara Health Institute
name: Ospedale San Raffaele
name: Swiss Tropical & Public Health Institute
name: African Society for Laboratory Medicine
name: Heidelberg University
name: Barcelona Institute for Global Health
First posted: 2020-09-29
Enrollment: 1172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: proportion of participants diagnosed with microbiologically confirmed TB and started on TB treatment within 72 hours of enrolment
timeFrame: 72 hours after enrolment
Secondary outcomes:
measure: Eight-week all-cause mortality
timeFrame: 8 weeks after enrolment
measure: The proportion of participants who are diagnosed with TB (irrespective of bacteriological confirmation) and started TB treatment within 72 hours of enrolment.
timeFrame: 72 hours after enrolment
Other outcomes:
Locations:
city: Manhiça
country: Mozambique
facility: Centro de Investigação em Saúde de Manhiça-Fundação
state: Vila Da Manhiça
city: Maputo
country: Mozambique
facility: Instituto Nacional de Saúde (INS)
city: Bagamoyo
country: Tanzania
facility: Ifakara Health Institute (IHI)
city: Mbeya
country: Tanzania
facility: National Institute of Medical Research (NIMR)
Study officials:
affiliation: Barcelona Institute for Global Health
name: Alberto García-Basteiro, MD
role: PRINCIPAL_INVESTIGATOR
References: