Skip to content

''Ubumi Bwandi” TB Infection Trial

A pragmatic parallel arm randomized controlled trial evaluating the role and performance of novel TB skin tests and interferon-? release assays (IGRAs) for initiation of preventive treatment for tuberculosis infection in Zambia.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202402859908544
Enrollment
2900
Registered
2024-02-05
Start date
2024-02-05
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis

Interventions

Arm 2 Novel skin test
Arm 3 Novel Rapid IGRA Ndola site only

Sponsors

Stop TB Partnership
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: •Household contacts of people with TB residing in residing in Chawama, Matero and Chipata sub-districts who are eligible for TPT •Participant or Parents/guardian (if participant <18) willing and able to provide written informed consent (with child assent if aged 12 and above). •Individuals eligible for TPT according to Zambian national guidelines; including household contacts of TB patients (all ages), people living with HIV who have not received TPT in the last 3 years (adults and children) and others at high risk including other immunosuppressive conditions or treatments, diabetes mellitus, health care workers or others exposed to TB in their work. •Screened negative on symptom screen and CXR for TB, or those with an abnormal CXR in whom TB disease has been excluded using Xpert testing •Willingness to provide signed informed consent (participant 18 and above, parent or legal guardian <18) or assent if participant is 12 -18 (with parental/guardian consent) . •Willingness and ability to comply to the trial process

Exclusion criteria

Exclusion criteria: •Individuals with active TB disease •Individuals in whom active TB cannot be excluded •Individuals whose are household contacts of a person with active tuberculosis that is suspected or proven to be multidrug-resistant TB. •Previously completed treatment for TB disease or LTBI within the last 12 months •Has had a skin test done within the last 12 months. •Has skin condition on both forearms at skin test injection site which would make induration reading challenging (such as, tattoos, scars, eczema). •Active TB disease •Women who are pregnant or breastfeeding •Individuals who have completed treatment for TB disease or TPT within the last 12 months

Design outcomes

Primary

MeasureTime frame
The primary outcome of this trial is the proportion of identified household contacts starting TPT -study 1 Primary outcome: The primary outcome of this trial is the proportion of individuals who correctly start, or do not start TPT -study 2

Secondary

MeasureTime frame
1. The ability and willingness of nurses within the routine health system to conduct Cy-TB testing. 2. Measure the “TPT cascade” to understand who is offered and accepts different steps in the process.

Countries

Zambia

Contacts

Public ContactChepela Ngulube

Research Governance Officer

chepela@zambart.org.zm+260211254710

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026