Rapid urine-based Screening for Tuberculosis to reduce AIDS-related Mortality in hospitalized Patients in Africa (STAMP) trial

• Register: ISRCTN
• Last refreshed on: 20 August 2018
• Main ID: ISRCTN71603869
• Date of registration: 08/05/2015
• Prospective Registration: Yes
• Primary sponsor: London School of Hygiene & Tropical Medicine
• Public title: Rapid urine-based Screening for Tuberculosis to reduce AIDS-related Mortality in hospitalized Patients in Africa (STAMP) trial
• Scientific title: Rapid urine-based Screening for Tuberculosis to reduce AIDS-related Mortality in hospitalized Patients in Africa (STAMP): a pragmatic, multicentre, individually randomized clinical trial
• Date of first enrolment: 01/09/2015
• Target sample size: 2600
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN71603869
• Study type: Interventional
• Study design: Pragmatic multicentre individually randomized clinical trial (Diagnostic)

Countries of recruitment

Malawi, South Africa

Contacts

• Name: Katherine Fielding

Key inclusion & exclusion criteria

Inclusion criteria: 1. Requires acute admission to a hospital medical ward
2. Have confirmed HIV-infection
3. Willing and able to provide informed consent
Exclusion criteria: 1. Aged <18 years
2. Has been admitted to a medical ward for longer than 48 hours
3. Has received treatment for TB within the preceding 12 months, or has received isoniazid preventative therapy (IPT) within the last 6 months
4. Residence does not lie within a pre-defined geographic area or plans to leave this area during the period of trial follow-up
5. Unable or unwilling to provide informed consent

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

HIV-associated tuberculosis
Infections and Infestations

Intervention(s)

A screening strategy for HIV-infected adult patients requiring acute admission to hospital medical wards, based on testing of urine with the Determine TB-LAM lateral-flow assay and Xpert MTB/RIF assay and testing of sputum with Xpert MTB/RIF assay (intervention arm). This will be compared to sputum testing alone (standard of care arm).

Primary Outcome(s)

Risk of all-cause mortality at 56 days after randomization from any cause, compared between arms.

Secondary Outcome(s)

1. Time to all-cause mortality
2. Proportions of patients with:
2.1. Microbiologically confirmed diagnosis of TB
2.2. Clinically diagnosed TB disease
3. Time from randomisation to:
3.1. TB diagnosis
3.2. Start of TB treatment in days
4. Proportion of patients receiving:
4.1. Antibacterial treatment
4.2. In ART naïve patients, proportion starting ART and time to ART initiation in days
5.1. Duration of hospital stay in days
5.2. Cumulative incidence of hospital readmission (c) cumulative incidence of loss to follow-up

All measured at 56 days after randomization

Secondary ID(s)

LOI:13.016 / pFACT6451 / ITCRZE64

Source(s) of Monetary Support

Wellcome Trust, Department for International Development, Medical Research Council

Ethics review

Status:
Approval date:
Contact:

1. London School of Hygiene & Tropical Medicine Research Ethics Committee, 05/05/2015, ref: 9630 2. College of Medicine Research Ethics Committee (Malawi), 03/08/2015, ref: P.06/15/1743 3. University of KwaZulu-Natal Biomedical Research Ethics Committee (South Africa), 09/09/2015, ref: BFC215/15

Results

• Results available: Yes
• Date Completed: 31/01/2018