TB SCReening Improves Preventive Therapy Uptake in Pregnant Women With HIV

NCT ID: NCT07278453

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-06-30
• Study Completion Date: 2031-06-30

Brief Summary

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.

Conditions

Pregnant HIV Positive Women; HIV; Tuberculosis (TB)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

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

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.

Group Type: OTHER

CRP screening (TB screening intervention arm)

Intervention Type: 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.

Immediate TPT (TPT control arm)

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.

Group Type: OTHER

Deferred TPT (TPT delivery trial intervention arm)

Intervention Type: OTHER

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.

Interventions

CRP screening (TB screening intervention arm)

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.

Intervention Type: DIAGNOSTIC_TEST

Deferred TPT (TPT delivery trial intervention arm)

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Makerere University

OTHER

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christina Yoon, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Kampala Capital City Authority (KCCA) clinics

Kampala, , Uganda

Countries

Uganda

Central Contacts

Rachel Abbott, MPH

Role: CONTACT

rachel.abbott@ucsf.edu

(628)-206-3514

Facility Contacts

Shafic Makumbi

Role: primary

smakumbi@idrc-uganda.org

+256 754 186 376

Other Identifiers

R61HL178398

Identifier Type: NIH

Identifier Source: secondary_id

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R61HL178398

Identifier Type: NIH

Identifier Source: org_study_id

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