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Completed

NCT Number: NCT04568967

TB-CAPT EXULTANT - HIV

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.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Communicable Diseases Diagnoses Disease Genital Diseases Gram-Positive Bacterial Infections HIV Coinfection HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mycobacterium Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Investigação em Saúde de Manhiça-Fundação, Manhiça, Vila Da Manhiça, Mozambique

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Concentrated urine with Xpert Ultra

Diagnostic Test

Molecular TB diagnostic test on urine

Stool with Xpert Ultra

Diagnostic Test

Molecular TB diagnostic test on stool

Primary outcomes

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

    Time frame: 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 outcomes

  1. Eight-week all-cause mortality

    Time frame: 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.

  2. The proportion of participants who are diagnosed with TB (irrespective of bacteriological confirmation) and started TB treatment within 72 hours of enrolment.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Foundation for Innovative New Diagnostics, Switzerland

Other

Collaborators

  • African Society for Laboratory Medicine
  • Barcelona Institute for Global Health
  • Centro de Investigação em Saúde de Manhiça
  • Heidelberg University
  • Ifakara Health Institute
  • Instituto Nacional de Saúde, Mozambique
  • Ludwig-Maximilians - University of Munich
  • National Institute for Medical Research, Tanzania
  • Ospedale San Raffaele
  • Swiss Tropical & Public Health Institute

Registry information

Official study title

Expanding Xpert Ultra Testing for TB Diagnosis Among HIV-positive Patients Admitted to Hospital in Africa

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 29, 2020
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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