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

University Hospital Basel

Status: Completed

Conditions: Human Immunodeficiency Virus (HIV) Infection

Treatments: Other: ART first- Therapeutic use trial; Other: TB results first- Therapeutic use trial

Study type: Interventional

Funder types: Other

Identifiers

NCT05452616

AO_2022-00031 am22Labhardt;

Details and patient eligibility

About

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.

Full 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.

Enrollment: 610 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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610 participants in 2 patient groups

"ART first" arm

Active Comparator group

Description:

ART initiation on the day of enrolment independent of TB investigations

Treatment:

Other: ART first- Therapeutic use trial

"TB results first" arm

Active Comparator group

Description:

ART initiation only after active TB has been refuted or confirmed

Treatment:

Other: TB results first- Therapeutic use trial