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 range12 Years

SexALL

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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

What they're measuring

HIV viral suppression <400 copies/mL

Timeframe: 26 (22 - 40) weeks after enrolment

Trial details

NCT IDNCT05452616

SponsorUniversity Hospital, Basel, Switzerland

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-26

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