NCT05452616Completed
Same-day Versus Rapid ART Initiation in HIV-positive Individuals Presenting With Symptoms of Tuberculosis
Same-day Versus Rapid ART Initiation in HIV-positive Individuals Presenting With Symptoms of Tuberculosis: an Open-label Randomized Non-inferiority Trial in Lesotho and Blantyre District, Malawi
Source: ClinicalTrials.gov · Last updated 4 Apr 2025
Brief summary (registry, in English)
SaDAPT is a pragmatic, randomized, therapeutic-use trial comparing two approaches ("ART first" versus "TB results first") for the timing of ART initiation in PLHIV with presumptive TB, but no signs of central nervous system (CNS) disease, in a routine primary and secondary care setting in southern Africa with regard to HIV viral suppression (VL \<400 copies/mL) 26 weeks after enrolment.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 610 (actual)
- First submitted
- 6 Jul 2022
- Start date
- 19 Oct 2022
- Primary completion date
- 26 Nov 2024
- Lead sponsor
- University Hospital, Basel, Switzerland
- Diseases
- Tuberculosis, HIV
- NCT number
- NCT05452616
What you commit to
- Study type: Interventional
- Participants enrolled: 610
- From 19 Oct 2022 to the primary completion date, 26 Nov 2024
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Taking TB treatment, TB preventive therapy (TPT) or treatment against cryptococcal meningitis
Other illness
- Medical condition requiring admission or referral to a higher level health facility at enrolment
- Symptoms or clinical signs suggestive for diseases of the CNS
Other
- Positive cryptococcal antigen test (CrAg)
- Reporting to be pregnant
Who the study is looking for
- 12 years or older
- HIV-positive
- Not taking ART (naïve or reported no ART intake since 90 days or more)
- Presenting with one or more TB symptoms according to W4SS
- Unknown TB status
- Planning to continue care at the study facility for at least 30 weeks
- Willing and able to consent (age 18 years or older) or assent with guardian consent (age 12 to 17 years)
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SolidarMed Lesotho, Premium House #224, Kingsway, Maseru West Coordinator of this site? Confirm its status | Maseru | Lesotho | Unknown status |
| Kamuzu University of Health Sciences, Helse Nord Tuberculosis Initiative Coordinator of this site? Confirm its status | Blantyre | Malawi | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.