Same-day Versus Rapid ART Initiation in HIV-positive Individuals Presenting With Symptoms of Tuberculosis

Not Applicable

Active, not recruiting

• Conditions: Human Immunodeficiency Virus (HIV) Infection

• Registration Number: NCT05452616
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-7-6
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 611

Inclusion Criteria

Inclusion Criteria:<br><br> - 12 years or older<br><br> - HIV-positive<br><br> - Not taking ART (naïve or reported no ART intake since 90 days or more)<br><br> - Presenting with one or more TB symptoms according to W4SS<br><br> - Unknown TB status<br><br> - Planning to continue care at the study facility for at least 30 weeks<br><br> - Willing and able to consent (age 18 years or older) or assent with guardian consent<br> (age 12 to 17 years)<br><br>Exclusion Criteria:<br><br> - Medical condition requiring admission or referral to a higher level health facility<br> at enrolment<br><br> - Symptoms or clinical signs suggestive for diseases of the CNS<br><br> - Positive cryptococcal antigen test (CrAg)<br><br> - Reporting to be pregnant<br><br> - Taking TB treatment, TB preventive therapy (TPT) or treatment against cryptococcal<br> meningitis

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HIV viral suppression <400 copies/mL

Secondary Outcome Measures

Name	Time	Method
Retention in care;Engagement in care;Disengagement from care;Lost to follow-up;Non-traumatic mortality;Serious adverse events (SAEs);TB-Immune reconstitution inflammatory syndrome (IRIS);Incidence of TB disease (microbiologically confirmed and/or clinical diagnosis);HIV viral suppression