NCT04568967

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,172

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 29, 2020

Completed
1.9 years until next milestone

Study Start

First participant enrolled

September 5, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 4, 2025

Status Verified

April 1, 2025

Enrollment Period

2.3 years

First QC Date

September 23, 2020

Last Update Submit

April 3, 2025

Conditions

TuberculosisHIV CoinfectionDiagnoses Disease

Outcome Measures

Primary Outcomes (1)

  • proportion of participants diagnosed with microbiologically confirmed TB and started on TB treatment within 72 hours of 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.

    72 hours after enrolment

Secondary Outcomes (2)

  • Eight-week all-cause mortality

    8 weeks after enrolment

  • 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

Study Arms (2)

intervention arm

EXPERIMENTAL

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.

Diagnostic Test: Concentrated urine with Xpert UltraDiagnostic Test: Stool with Xpert Ultra

control arm

NO INTERVENTION

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 .

Interventions

Concentrated urine with Xpert UltraDIAGNOSTIC_TEST

Molecular TB diagnostic test on urine

intervention arm
Stool with Xpert UltraDIAGNOSTIC_TEST

Molecular TB diagnostic test on stool

intervention arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Centro de Investigação em Saúde de Manhiça-Fundação

Manhiça, Vila Da Manhiça, 1929, Mozambique

Location

Instituto Nacional de Saúde (INS)

Maputo, 1100, Mozambique

Location

Ifakara Health Institute (IHI)

Bagamoyo, 53502, Tanzania

Location

National Institute of Medical Research (NIMR)

Mbeya, 2410, Tanzania

Location

Related Publications (1)

  • Mangu C, Cossa M, Ndege R, Khosa C, Leukes V, de la Torre-Perez L, Machiana A, Kivuma B, Mnzava D, Zachariah C, Manjate P, Tagliani E, Schacht C, Buech J, Singh S, Ehrlich J, Riess F, Sanz S, Kranzer K, Cox H, Sabi I, Nguenha D, Meggi B, Weisser M, Ntinginya N, Schumacher S, Ruhwald M, Penn-Nicholson A, Garcia-Basteiro AL; TB-CAPT Consortium. Expanding Xpert MTB/RIF Ultra(R) and LF-LAM testing for diagnosis of tuberculosis among HIV-positive adults admitted to hospitals in Tanzania and Mozambique: a randomized controlled trial (the EXULTANT trial). BMC Infect Dis. 2024 Aug 15;24(1):831. doi: 10.1186/s12879-024-09651-z.

    PMID: 39148008DERIVED

MeSH Terms

Conditions

TuberculosisHIV Infections

Interventions

Defecation

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Alberto García-Basteiro, MD

    Barcelona Institute for Global Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2020

First Posted

September 29, 2020

Study Start

September 5, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

April 4, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

Individual, de-identified participant data may be shared, including data dictionaries. Available documents include the study protocol and statistical analysis plan. Templates of the informed consent forms may be shared upon request. The data will be available immediately following publication with no end date, will be shared with anyone who wishes to access them, and will be available for any purpose of analyses.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
After publication of the primary peer-reviewed manuscript

Locations

MO(2)TA(2)