Same-day Versus Rapid ART Initiation in HIV-positive Individuals Presenting With Symptoms of Tube… (NCT05452616) | Clinical Trial Compass
CompletedNot Applicable
Same-day Versus Rapid ART Initiation in HIV-positive Individuals Presenting With Symptoms of Tuberculosis
Lesotho, Malawi610 participantsStarted 2022-10-19
Plain-language summary
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.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
Exclusion Criteria:
* Medical condition requiring admission or referral to a higher level health facility at enrolment
* Symptoms or clinical signs suggestive for diseases of the CNS
* Positive cryptococcal antigen test (CrAg)
* Reporting to be pregnant
* Taking TB treatment, TB preventive therapy (TPT) or treatment against cryptococcal meningitis
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.