NCT07278453Not yet recruiting
TB SCReening Improves Preventive Therapy Uptake in Pregnant Women With HIV
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
Source: ClinicalTrials.gov · Last updated 12 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 1500 (estimated)
- First submitted
- 2 Dec 2025
- Start date
- Jun 2026
- Primary completion date
- Jun 2031
- Lead sponsor
- University of California, San Francisco
- Diseases
- Tuberculosis, HIV
- NCT number
- NCT07278453
What you commit to
- Study type: Interventional
- Planned participants: 1500
- From Jun 2026 to the primary completion date, Jun 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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.
Age in the registry: 16 years to - · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kampala Capital City Authority (KCCA) clinics Coordinator of this site? Confirm its status | Kampala | Uganda | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.