Tuberculosis Clinical Trial
Official title:
Expanding Xpert Ultra Testing for TB Diagnosis Among HIV-positive Patients Admitted to Hospital in Africa
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.
Status | Recruiting |
Enrollment | 1172 |
Est. completion date | December 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Mozambique | Centro de Investigação em Saúde de Manhiça-Fundação | Manhiça | Vila Da Manhiça |
Mozambique | Instituto Nacional de Saúde (INS) | Maputo | |
Tanzania | Ifakara Health Institute (IHI) | Bagamoyo | |
Tanzania | National Institute of Medical Research (NIMR) | Mbeya |
Lead Sponsor | Collaborator |
---|---|
Foundation for Innovative New Diagnostics, Switzerland | 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 |
Mozambique, Tanzania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Eight-week all-cause mortality | 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. | 8 weeks after enrolment | |
Secondary | The proportion of participants who are diagnosed with TB (irrespective of bacteriological confirmation) and started TB treatment within 72 hours of 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. | 72 hours after enrolment |
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