An interventional study of ART first- Therapeutic use trial and TB results first- Therapeutic use trial in Human Immunodeficiency Virus (HIV) Infection, sponsored by University Hospital, Basel, Switzerland. Completed at 2 sites in 2 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2025-04-04.
Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Treatment
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.
In this randomized controlled trial (RCT) two different, guideline-approved algorithms for antiretroviral therapy (ART) initiation in people living with HIV (PLHIV) with presumptive Tuberculosis (TB), but no signs of central nervous system (CNS) disease will be compared. In one arm, same-day initiation (SDI) of ART will be applied ("ART first") for all participants independent of the status or results of initial TB investigations. In the other arm, an approach with deferral of ART initiation until TB is excluded or confirmed and TB treatment initiated will be applied ("TB results first"). The direct comparison of the two approaches in a pragmatic, two-country RCT conducted in a representative high-prevalence setting will provide evidence on the open question of optimal timing of ART initiation in the large subgroup of PLHIV with presumptive TB outside the CNS.
Exclusion Criteria:
ART initiation on the day of enrolment independent of TB investigations
Other: ART first- Therapeutic use trial
ART initiation only after active TB has been refuted or confirmed
Other: TB results first- Therapeutic use trial
ART initiation on the day of enrolment independent of TB investigations in PLHIV with presumptive TB but no signs of CNS disease. The trial uses treatments and drug-doses as per international and national guidelines. All treatment components will be applied at standard dosage and no new substances or alternative indications will be tested.
Deferral of ART initiation until active TB has been refuted or confirmed. PLHIV presenting with symptoms (cough, fever, night sweat, weight loss) are defined as presumptive TB, and should have microbiological TB investigations. Routine TB investigations in Malawi and Lesotho usually consist of two sputum bottles for analysis using nucleic acid amplification tests (Xpert MTB/RIF (Ultra)).The trial uses treatments and drug-doses as per international and national guidelines. All treatment components will be applied at standard dosage and no new substances or alternative indications will be tested.
HIV viral suppression <400 copies/mL
HIV viral suppression \<400 copies/mL (obtained from routine laboratory reports at study facility, from laboratory reports of referral facility in case of transfer out, or from dried blood spot (DBS) sample for participants without documented clinic visit but found during home visit tracing)
Time frame: 26 (22 - 40) weeks after enrolment
Retention in care
Retention in care, defined as a documented ART clinic visit between 22 and 30 weeks after enrolment
Time frame: 26 (22 - 30) weeks after enrolment
Engagement in care
Engagement in care, defined as reporting regular ART intake, irrespective if a documented visit took place between 22 and 30 weeks after enrolment
Time frame: 26 (22 - 30) weeks after enrolment
Disengagement from care
Disengagement from care, defined as non-engaged in care but reached through patient tracing
Time frame: 26 (22 - 30) weeks after enrolment
Lost to follow-up
Lost to follow-up, defined as non-retained in care and not reached through tracing
Time frame: 26 (22 - 30) weeks after enrolment
Non-traumatic mortality
Non-traumatic mortality
Time frame: during the first 30 weeks after enrolment
Serious adverse events (SAEs)
SAEs
Time frame: during the first 30 weeks after enrolment
TB-Immune reconstitution inflammatory syndrome (IRIS)
TB-Immune reconstitution inflammatory syndrome (IRIS) is defined as Adverse event of special interest (AESIs): AESIs
Time frame: during the first 30 weeks after enrolment
Incidence of TB disease (microbiologically confirmed and/or clinical diagnosis)
Incidence of TB disease (microbiologically confirmed and/or clinical diagnosis), defined as any TB diagnosis after enrolment not classified as prevalent TB at enrolment
Time frame: during the first 30 weeks after enrolment
HIV viral suppression
HIV viral suppression using different thresholds (\<20 copies/mL; \<100 copies/mL; \<1000 copies/mL)
Time frame: at 26 (22 - 40) weeks
Prevalence of active TB diagnosed at enrolment (exploratory endpoint)
Prevalence of active TB, defined as TB diagnosed clinically or microbiologically through the TB investigations at enrolment
Time frame: up to a maximum of 28 days after enrolment
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — * An anonymized key dataset necessary for reproducing the primary and key secondary endpoints will be made freely available in an appropriate repository, such as zenodo.org, alongside the publication of the study results. Besides removal of variables not required for key analysis, we will remove participant identifier, study site and exact date information. Requests for access to more detailed data may be made to the corresponding author by submitting a proposal, which will be reviewed by the trial consortium. * The statistical report for the primary and key secondary endpoints and the code to produce it will be published together with the data set.
Supporting information: Study protocol, Sap, Icf, Analytic code
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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University Hospital, Basel, Switzerland