Same-day Versus Rapid ART Initiation in HIV-positive Individuals Presenting With Symptoms of Tuberculosis
SaDAPT
1 other identifier
interventional
610
2 countries
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2022
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2022
CompletedFirst Posted
Study publicly available on registry
July 11, 2022
CompletedStudy Start
First participant enrolled
October 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 26, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 14, 2025
CompletedApril 4, 2025
April 1, 2025
2.1 years
July 6, 2022
April 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (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)
26 (22 - 40) weeks after enrolment
Secondary Outcomes (9)
Retention in care
26 (22 - 30) weeks after enrolment
Engagement in care
26 (22 - 30) weeks after enrolment
Disengagement from care
26 (22 - 30) weeks after enrolment
Lost to follow-up
26 (22 - 30) weeks after enrolment
Non-traumatic mortality
during the first 30 weeks after enrolment
- +4 more secondary outcomes
Other Outcomes (1)
Prevalence of active TB diagnosed at enrolment (exploratory endpoint)
up to a maximum of 28 days after enrolment
Study Arms (2)
"ART first" arm
ACTIVE COMPARATORART initiation on the day of enrolment independent of TB investigations
"TB results first" arm
ACTIVE COMPARATORART initiation only after active TB has been refuted or confirmed
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Basel, Switzerlandlead
- Swiss National Science Foundationcollaborator
- SolidarMedcollaborator
- Kamuzu University of Health Sciences, Malawicollaborator
- Swiss Tropical & Public Health Institutecollaborator
- Malawi-Liverpool-Wellcome Trust Clinical Research Programmecollaborator
- London School of Hygiene and Tropical Medicinecollaborator
Study Sites (2)
SolidarMed Lesotho, Premium House #224, Kingsway, Maseru West
Maseru, Lesotho
Kamuzu University of Health Sciences, Helse Nord Tuberculosis Initiative
Blantyre, Malawi
Related Publications (1)
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.
PMID: 38330045DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Niklaus Labhardt, Prof. Dr. DTM&H, MIH
Division of Clinical Epidemiology, University Hospital Basel
- PRINCIPAL INVESTIGATOR
Rachael Mary Burke, BMBCh, MSc, DTM&H
London School of Hygiene and Tropical Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2022
First Posted
July 11, 2022
Study Start
October 19, 2022
Primary Completion
November 26, 2024
Study Completion
January 14, 2025
Last Updated
April 4, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- • Within 3 months after publication of primary results
- Access Criteria
- • Open access
* 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.