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NCT Number: NCT07278453

TB SCReening Improves Preventive Therapy Uptake in Pregnant Women With HIV

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.

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Key information

Conditions

Pregnant HIV Positive Women Acquired Immunodeficiency Syndrome Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Communicable Diseases Genital Diseases Gram-Positive Bacterial Infections HIV HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mycobacterium Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Tuberculosis Tuberculosis (TB) Urogenital Diseases Virus Diseases

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kampala Capital City Authority (KCCA) clinics

Kampala, Uganda

Location contact

Annettee Nakimuli, MMed

PRINCIPAL_INVESTIGATOR

Shafic Makumbi

CONTACT

[email protected]

+256 754 186 376

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. Proportion of TB cases detected

    Time frame: Up to 6 months postpartum

    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

  2. Composite safety outcome

    Time frame: Up to 28 days postpartum

    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

  3. Composite effectiveness outcome

    Time frame: Up to 2-years after TPT initiation

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

Study contacts

Contact information is provided by the study sponsor or research team.

Rachel Abbott, MPH

CONTACT

[email protected]

(628)-206-3514

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Makerere University
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Optimal Tuberculosis Screening and Tuberculosis Preventive Therapy Delivery Strategies to Improve Maternal and Birth Outcomes Among Pregnant Women With HIV in Uganda: a Randomized Trial

Acronym: TB SCRIPT-Moms

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Dec 12, 2025
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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