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

Not Applicable

Recruiting

• Conditions: HIV/AIDS; Tuberculosis; Cryptococcal disease

• Registration Number: PACTR201901672543518
• Lead Sponsor: Medecins Sans Frontieres OCB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-21
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

1) Patients aged 18 years and older
2) New HIV positive patients with CD4< 200 cell counts/µl
3) Immunosuppressed on ART treatment patients with VL>1000 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

1) Patients requiring hospitalization

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients initiated < 200 CD4 retained in care at 6 months and 12 months.

Secondary Outcome Measures

Name	Time	Method
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