TB SCReening Improves Preventive Therapy Uptake in Pregnant Women With HIV

Официальное название

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

Обзор

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.

Вмешательства

• Диагностический тест 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
• Другое 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.

Первичные конечные точки

• Proportion of TB cases detected [Срок оценки: Up to 6 months postpartum]
• Composite safety outcome [Срок оценки: Up to 28 days postpartum]
• Composite effectiveness outcome [Срок оценки: Up to 2-years after TPT initiation]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Скрининг

Центры проведения

Uganda · 1 центр

• Kampala Capital City Authority (KCCA) clinics — Kampala

Идентификаторы

NCT: NCT07278453 · R61HL178398 · R61HL178398

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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