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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

610 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-19

Study Completion Date

2025-01-14

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Human Immunodeficiency Virus (HIV) Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, parallel, open-label, 1:1 individually randomized, non-inferiority trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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"ART first" arm

ART initiation on the day of enrolment independent of TB investigations

Group Type ACTIVE_COMPARATOR

ART first- Therapeutic use trial

Intervention Type OTHER

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" arm

ART initiation only after active TB has been refuted or confirmed

Group Type ACTIVE_COMPARATOR

TB results first- Therapeutic use trial

Intervention Type OTHER

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.

Interventions

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ART 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.

Intervention Type OTHER

TB results first- Therapeutic use trial

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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No