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TB SCReening Improves Preventive Therapy Uptake in Pregnant Women With HIV

ConditionsPregnant HIV Positive WomenHIVTuberculosis (TB)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age16+
SponsorUniversity of California, San Francisco

About this trial

Because pregnant women have been excluded from clinical research, including tuberculosis (TB) research, little is known about diagnosing, treating and preventing TB in pregnant women. We plan to perform a two-stage randomized trial that will identify best practices for screening pregnant and postpartum women for active TB (screening by symptoms vs. C-reactive protein levels) and the optimal timing of TPT initiation, relative to pregnancy (immediately during pregnancy or deferred to postpartum). Because undiagnosed TB among pregnant women with HIV is associated with many devastating complications to both the mother and fetus, this research has the potential to improve maternal and birth outcomes worldwide.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • CRP screening (TB screening intervention arm)

    Diagnostic test

    In the TB screening trial, participants will be randomized to one of two WHO-recommended TB screening strategies: symptom-based TB screening (current practice) or CRP-based TB screening. Participants randomized to CRP-based screening will have CRP concentrations measured by study staff at the point-of-care, using blood obtained by finger prick. Participants randomized to the CRP arm with CRP ≥5 mg/L will be regarded as TB screen-positive. Participants randomized to the CRP arm with CRP \<5 mg/L will be regarded as TB screen-negative.

  • Deferred TPT (TPT delivery trial intervention arm)

    Other intervention

    In the TB preventive therapy (TPT) delivery trial, participants will be randomized to either immediate (antepartum) TPT (current recommendation) or deferred (postpartum) TPT, where TPT is deferred to 4 weeks postpartum. Participants randomized to deferred TPT will initiate TPT 4 weeks after delivery.

Treatment groups

1,500 Participants
are divided into 2 treatment groups
Group A: WHO 4-part symptom screening (TB screening control arm)Other 1 intervention
Group B: Immediate TPT (TPT control arm)Other 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of TB cases detected

The primary outcome for the TB screening trial is the proportion of TB cases detected by baseline and repeated rounds of TB screening, up to 6-months postpartum

Time frame
Up to 6 months postpartum
2

Composite safety outcome

The primary safety outcome of the TPT delivery trial is the composite endpoint that includes spontaneous abortion, stillbirth, low birthweight, preterm birth and neonatal death

Time frame
Up to 28 days postpartum
3

Composite effectiveness outcome

The primary effectiveness outcome of the TPT delivery trial is a composite endpoint of maternal 2-year TB incidence and all-cause mortality.

Time frame
Up to 2-years after TPT initiation

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

Makerere University

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov

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