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Human Immunodeficiency Virus (HIV) InfectionSaDAPTNCT05452616

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

A study testing ART first- Therapeutic use trial and TB results first- Therapeutic use trial in people with Human Immunodeficiency Virus (HIV) Infection, run by University Hospital, Basel, Switzerland at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 years and older
What is being tested?
ART first- Therapeutic use trial and TB results first- Therapeutic use trial
Could I receive a placebo?
No, everyone receives an active treatment
How many people
610 participants
Where
2 sitesin 2 countries
Study dates
19 Oct 2022to 14 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Lesotho1 site

  • SolidarMed Lesotho, Premium House #224, Kingsway, Maseru West

    Maseru

Other trials in Lesotho

Malawi1 site

  • Kamuzu University of Health Sciences, Helse Nord Tuberculosis Initiative

    Blantyre

Other trials in Malawi

About this study

Official title: 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

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.

Read the detailed description

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.

Being tested
ART first- Therapeutic use trial, TB results first- Therapeutic use trial
Keywords
Tuberculosis (TB) infection, Acquired immunodeficiency syndrome, Antiretroviral therapy (ART), Immune reconstitution inflammatory syndrome, People living with HIV (PLHIV), Same-day initiation (SDI) of ART, TB preventive treatment, Sub-Saharan African countries, HIV/TB-coinfection, immune reconstitution inflammatory syndrome (IRIS)
Medical subject headings
Acquired Immunodeficiency Syndrome, Tuberculosis, Infections, Immune Reconstitution Inflammatory Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ART first- Therapeutic use trialOther

    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.

  • TB results first- Therapeutic use trialOther

    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.

Study groups in NCT05452616
Study groupRoleWhat they receive
"ART first" armActive comparatorART initiation on the day of enrolment independent of TB investigations
Receives: Other: ART first- Therapeutic use trial
"TB results first" armActive comparatorART initiation only after active TB has been refuted or confirmed
Receives: Other: TB results first- Therapeutic use trial

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 26 (22 - 40) weeks after enrolment

Secondary outcomes (9)

  1. Retention in care

    Retention in care, defined as a documented ART clinic visit between 22 and 30 weeks after enrolment

    Measured: 26 (22 - 30) weeks after enrolment

  2. 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

    Measured: 26 (22 - 30) weeks after enrolment

  3. Disengagement from care

    Disengagement from care, defined as non-engaged in care but reached through patient tracing

    Measured: 26 (22 - 30) weeks after enrolment

  4. Lost to follow-up

    Lost to follow-up, defined as non-retained in care and not reached through tracing

    Measured: 26 (22 - 30) weeks after enrolment

  5. Non-traumatic mortality

    Non-traumatic mortality

    Measured: during the first 30 weeks after enrolment

  6. Serious adverse events (SAEs)

    SAEs

    Measured: during the first 30 weeks after enrolment

  7. TB-Immune reconstitution inflammatory syndrome (IRIS)

    TB-Immune reconstitution inflammatory syndrome (IRIS) is defined as Adverse event of special interest (AESIs): AESIs

    Measured: during the first 30 weeks after enrolment

  8. 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

    Measured: during the first 30 weeks after enrolment

  9. HIV viral suppression

    HIV viral suppression using different thresholds (<20 copies/mL; <100 copies/mL; <1000 copies/mL)

    Measured: at 26 (22 - 40) weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2022
  2. Study start19 Oct 2022
  3. Primary completion26 Nov 2024
  4. Study completion14 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, parallel, open-label, 1:1 individually randomized, non-inferiority trial
Masking
None (open label)
Enrolment
610 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05452616
Sponsor's protocol ID
AO_2022-00031; am22Labhardt
Acronym
SaDAPT
Status last verified
Apr 2025
First submitted
6 Jul 2022
Last updated
4 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Gerber F, Semphere R, Lukau B, Mahlatsi P, Mbale H, Sanchez-Samaniego G, Sass N, Amstutz A, Molatelle M, Marake NB, Tarumbiswa T, Nliwasa M, Ayakaka I, Glass TR, MacPherson P, Burke RM, Labhardt ND. Same-day versus rapid ART initiation in people with HIV and symptoms of tuberculosis (SaDAPT): a randomised, non-inferiority trial in Lesotho and Malawi. Lancet HIV. 2026 Apr;13(4):e225-e234. doi: 10.1016/S2352-3018(25)00276-0. Epub 2026 Feb 12.

    PubMed 41692011

  • Gerber F, Semphere R, Lukau B, Mahlatsi P, Mtenga T, Lee T, Kohler M, Glass TR, Amstutz A, Molatelle M, MacPherson P, Marake NB, Nliwasa M, Ayakaka I, Burke R, Labhardt N. Same-day versus rapid ART initiation in HIV-positive individuals presenting with symptoms of tuberculosis: Protocol for an open-label randomized non-inferiority trial in Lesotho and Malawi. PLoS One. 2024 Feb 8;19(2):e0288944. doi: 10.1371/journal.pone.0288944. eCollection 2024.

    PubMed 38330045

Questions about this trial

What is this clinical trial studying?

A study testing ART first- Therapeutic use trial and TB results first- Therapeutic use trial in people with Human Immunodeficiency Virus (HIV) Infection, run by University Hospital, Basel, Switzerland at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Lesotho, Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HIV viral suppression <400 copies/mL (time frame: 26 (22 - 40) weeks after enrolment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05452616, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.

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