TB SCReening Improves Preventive Therapy Uptake in Pregnant Women With HIV (TB SCRIPT-Moms)

University of California San Francisco (UCSF)

Status: Begins enrollment in 3 months

Conditions: Tuberculosis (TB); HIV; Pregnant HIV Positive Women

Treatments: Other: Deferred TPT (TPT delivery trial intervention arm); Diagnostic Test: CRP screening (TB screening intervention arm)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07278453

R61HL178398 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 1,500 estimated patients

Sex: Female

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

For the TB screening trial, eligible patients include pregnant women with a viable singleton pregnancy by ultrasound, confirmed HIV infection, no current or planned TB treatment, no treatment with a drug with anti-mycobacterial activity within the past 2 weeks, no history of TB treatment or TPT within the past 2 years, lives within 20 km of the enrollment site, plans to deliver at the enrollment site, no plans to transfer antenatal care to a non-participating clinic, and no signs or symptoms of early or active labor.

For the TPT delivery trial, eligible participants are participants in the TB screening trial who screened negative for TB by their randomization assignment, are eligible for TPT, are not taking any drug contraindicated for use with rifamycins, are not a contact with a TB case with known drug resistance to isoniazid or rifampin, are not heavy or binge alcohol consumers, do not have a history of liver disease, do not have liver enzymes ≥3-times the upper limit of normal.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,500 participants in 2 patient groups

WHO 4-part symptom screening (TB screening control arm)

Other group

Description:

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 symptom-based screening will be screened by study staff using the WHO 4-part symptom screen (W4SS). Participants randomized to the W4SS arm who report ≥1 TB symptom (current cough, fever, night sweats, weight loss/inappropriate weight gain) in the past 30 days will be regarded as TB screen-positive. Participants randomized to the W4SS arm who none of the 4 TB symptoms in the past 30 days will be regarded as TB screen-negative.

Treatment:

Diagnostic Test: CRP screening (TB screening intervention arm)

Immediate TPT (TPT control arm)

Other group

Description:

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 immediate TPT will immediately initiate TPT (while pregnant), in accordance with current WHO TPT recommendations for pregnant women with HIV.

Treatment:

Other: Deferred TPT (TPT delivery trial intervention arm)