Pregnant HIV Positive WomenTB SCRIPT-MomsNCT07278453
TB SCReening Improves Preventive Therapy Uptake in Pregnant Women With HIV
A study testing CRP screening (TB screening intervention arm) and Deferred TPT (TPT delivery trial intervention arm) in people with Pregnant HIV Positive Women and HIV, run by University of California, San Francisco at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant HIV Positive Women, HIV, Tuberculosis (TB)
- What is being tested?
- CRP screening (TB screening intervention arm) and Deferred TPT (TPT delivery trial intervention arm)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteUganda
- Study dates
- Jun 2026to Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Uganda1 site
Kampala Capital City Authority (KCCA) clinics
Kampala
Shafic Makumbi, +256 754 186 376, smakumbi@idrc-uganda.org
Annettee Nakimuli, MMed
About this study
Official 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
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)
- Being tested
- CRP screening (TB screening intervention arm), Deferred TPT (TPT delivery trial intervention arm)
- Keywords
- pregnant women with HIV, pregnant women, hiv, tuberculosis, screening, tuberculosis preventive therapy
- Medical subject headings
- Tuberculosis, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| WHO 4-part symptom screening (TB screening control arm) | Other | 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. Receives: Diagnostic Test: CRP screening (TB screening intervention arm) |
| Immediate TPT (TPT control 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 immediate TPT will immediately initiate TPT (while pregnant), in accordance with current WHO TPT recommendations for pregnant women with HIV. Receives: Other: Deferred TPT (TPT delivery trial intervention arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of TB cases detected
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
Measured: Up to 6 months postpartum
Composite safety outcome
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
Measured: Up to 28 days postpartum
Composite effectiveness outcome
The primary effectiveness outcome of the TPT delivery trial is a composite endpoint of maternal 2-year TB incidence and all-cause mortality.
Measured: Up to 2-years after TPT initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study startJun 2026 (estimated)
- Primary completionJun 2031 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant HIV Positive WomenStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Makerere University, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Christina Yoon, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278453
- Sponsor's protocol ID
- R61HL178398
- Other IDs
- R61HL178398
- Acronym
- TB SCRIPT-Moms
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07278453
- Acronym / sponsor ID
- TB SCRIPT-Moms / R61HL178398
- Conditions
- Pregnant HIV Positive Women, HIV, Tuberculosis (TB)
- Keywords
- pregnant women with HIV, pregnant women, hiv, tuberculosis, screening, tuberculosis preventive therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Makerere University, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2031 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WHO 4-part symptom screening (TB screening control arm) | Other | Diagnostic Test: 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 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. |
| Immediate TPT (TPT control arm) | Other | Other: 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 immediate TPT will immediately initiate TPT (while pregnant), in accordance with current WHO TPT recommendations for pregnant women with HIV. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | WHO 4-part symptom screening (TB screening control arm) |
| 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. | Other | Immediate TPT (TPT control arm) |
Primary outcome
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
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christina Yoon, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRP screening (TB screening intervention arm) and Deferred TPT (TPT delivery trial intervention arm) in people with Pregnant HIV Positive Women and HIV, run by University of California, San Francisco at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Abbott, MPH ((628)-206-3514, rachel.abbott@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of TB cases detected (time frame: Up to 6 months postpartum). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.