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Enhanced screening and management for advanced HIV patients, incorporating Cryptococcal disease prevention, TB treatment and same day/rapid ART Initiation: a stepped wedge cluster randomised trial

Enhanced screening and management for advanced HIV patients, incorporating Cryptococcal disease prevention, TB treatment and same day/rapid ART Initiation: a stepped wedge cluster randomised trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR201901672543518
Enrollment
900
Registered
2019-01-14
Start date
2018-07-02
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

HIV/AIDS Tuberculosis Cryptococcal disease

Interventions

Enhanced package of care for TB and Cryptoccocal disease in individuals with advanced HIV
South African standard of care for individuals with advanced HIV disease

Sponsors

Medecins Sans Frontieres OCB
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients aged 18 years and older 2) New HIV positive patients with CD41000 copies/ml and CD4<200 cell counts/ µl 4) Patients returning after defaulting for more than 3 months with a CD4<200 5) Written, informed consent for data collection (control and intervention arms) 6) Written, informed consent for participation in intervention (intervention arm)

Exclusion criteria

Exclusion criteria: 1) Patients requiring hospitalization

Design outcomes

Primary

MeasureTime frame
Proportion of patients initiated < 200 CD4 retained in care at 6 months and 12 months.

Secondary

MeasureTime frame
Proportion of patients initiated < 200 CD4 diagnosed with extrapulmonary TB and pulmonary TB;Proportion of patients with CD4 <200 found to have cryptococcal antigenaemia;Median time to ART initiation (for naïve);Virological suppression (VL<1000) 6 and 12 months following ART initiation (for naïve) ;TB outcomes for all those diagnosed with TB;Proportion of eligible patients initiating ART on the same day;Disease free survival at 6 months on Fluconazole for the prevention of cryptococcal disease;Overall mortality

Countries

South Africa

Contacts

Public ContactJelena Pavlovic

Epidemiologist

msfocb-capetown-epi@brussels.msf.org+27214481058

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026