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TB Fast Track

TB Fast Track: a study to evaluate the effect of a point-of-care TB test-and-treat algorithm on early mortality in people with HIV accessing ART, a trial with randomisation at clinic level

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN35344604
Enrollment
2616
Registered
2012-09-12
Start date
2012-12-20
Completion date
Unknown
Last updated
2019-12-10

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

Conditions

HIV-associated tuberculosis Infections and Infestations Tuberculosis

Interventions

A management strategy based on a point of care technology-based algorithm to rapidly identify individuals at high risk of TB, based on urine LAM, haemoglobin and body mass index, and ensure that those

Sponsors

London School of Hygiene & Tropical Medicine (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. HIV positive 2. Eligible and willing to start ART 3. CD4 150 cells/ul or less

Exclusion criteria

Exclusion criteria: 1. Age <18 years 2. Currently on TB treatment, or completed TB treatment in the last 3 months 3. First trimester of pregnancy, or desiring pregnancy in the next 6 months 4. Contraindication to efavirenze, based on current South African ART guidelines 5. Too sick to be managed in ambulatory care

Design outcomes

Primary

MeasureTime frame
All-cause mortality at 6 months after enrolment

Secondary

MeasureTime frame
1. Duration of hospital admission in first 6 months after enrolment 2. Time from enrolment to ART start 3. Proportion of patients retained in care, i.e. documented to have attended clinic for HIV care at 6 months (window: 150-240 days) after enrolment 4. Study-defined serious adverse events (particularly hepatotoxicity, hypersensitivity, peripheral neuropathy, and nephrotoxicity) in the intervention arm 5. Economic outcomes

Countries

South Africa

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 5, 2026