Tuberculosis (TB)TIPPNCT07419568
Burden of Tuberculosis Among Pregnant and Postpartum Women in Guinea-Bissau
A study testing Enhanced protocol in people with Tuberculosis (TB) and Tuberculosis Infection, Latent, run by Aarhus University Hospital at 1 site in Guinea-Bissau.
Trial summary
This study aims to address critical diagnostic and data gaps in tuberculosis (TB) care among pregnant and postpartum women in Guinea-Bissau, a high-burden, resource-limited setting. Read more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis (TB), Tuberculosis Infection, Latent, Pregnancy
- What is being tested?
- Enhanced protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 1 siteGuinea-Bissau
- Study dates
- Feb 2026to Nov 2027
- Phase
- Interventional
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 15 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant women ≥ 15 years of age
- Residing in the study
- Attending ANC consultations at health centre in Bandim, Belem or Cuntum
- Must provide informed consent
Who cannot join
- Pregnant women ≤ 15 years of age
- Inability to provide informed consent
- Residing outside of the study area
- Receives TB treatment at the time of, or a year prior to, enrolment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Guinea-Bissau1 site
Projecto Saude de Bandim
Bissau
Anita Magdalena Zalisz, 957007723 ext. +245, anita.magdalena.zalisz@clin.au.dk
About this study
Official title: Assessing the Burden of Tuberculosis Among Pregnant and Postpartum Women: Implications for Integrating Tuberculosis Screening Into Routine Antenatal Care in Guinea-Bissau
This study aims to address critical diagnostic and data gaps in tuberculosis (TB) care among pregnant and postpartum women in Guinea-Bissau, a high-burden, resource-limited setting. Recognising that current TB screening during antenatal care (ANC) relies largely on unstructured symptom questions, the study will integrate more systematic and innovative approaches into routine maternal health services.
The project will implement the Bandim TBscore II as a structured triage tool to classify symptom severity and guide referrals. To strengthen diagnostic capacity, two novel tools will be evaluated: stool-based GeneXpert testing (a method recommended in children and explored here as a feasible alternative for pregnant women) and artificial intelligence-powered chest X-ray interpretation software designed to enhance TB detection where radiological expertise is lacking.
The study will also generate comprehensive, population-based data on TB and TB infection (TBI) among pregnant, postpartum women and women of reproductive age in Guinea-Bissau. The results are intended to inform health policy, both locally and in high-income countries, by providing evidence to improve TB screening protocols and care for this vulnerable group. Ultimately, the study seeks to develop scalable strategies that can be replicated across low- and middle-income countries to advance maternal and child health and support global TB eradication efforts.
- Conditions
- Tuberculosis (TB), Tuberculosis Infection, Latent, Pregnancy, Tuberculosis Diagnosis, Maternal Health
- Being tested
- Enhanced protocol
- Medical subject headings
- Tuberculosis, Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced protocolDiagnostic test
In the intervention, and inclusion and subsequent ANC visits, pregnant women will be interviewed by midwives regarding TB exposure and previous TB, and systematically screened with the Bandim TBscore II, which categorises patients based on the severity of their symptoms. Women exhibiting moderate symptoms (TBscoreII=2-3) suggestive of TB will be referred for GeneXpert testing sputum and/or faecal samples, while individuals with more severe symptoms (TBscoreII=4-8) will additionally receive chest radiography, which will be analysed with AI software. Due to high co-infection rates, all HIV-positive women, regardless of their Bandim TBscore II, will be tested with both GeneXpert and chest radiography. Women with positive GeneXpert results will be referred for treatment, while women with chest radiography will attend a consultation with a TB specialist. Participants will be reassessed for TB symptoms at each subsequent ANC visit and at 6 months postpartum.
| Study group | Role | What they receive |
|---|---|---|
| Baseline | No intervention | At enrolment and during subsequent ANC visits, midwives at the participating health centres will perform a systematic, symptom-based evaluation, inquiring about the presence of multiple TB-related symptoms, as delineated by the Bandim TBscore II. Notably, in this phase of the study, the outcome of the Bandim TBscore II will not serve as basis for diagnostic decision-making. Throughout the baseline phase, midwives will exercise clinical discretion, adhering to national guidelines and established routine practices, to determine whether referral for TB diagnostic testing is warranted. The only TB diagnostics available and used in standard ANC routine is sputum GeneXpert. In line with national guidelines and practices, all pregnant women undergo HIV testing at their first ANC visit. |
| Intervention (Enhanced protocol) | Active comparator | In the intervention, and inclusion and subsequent ANC visits, pregnant women will be interviewed by midwives regarding TB exposure and previous TB, and systematically screened with the Bandim TBscore II, which categorises patients based on the severity of their symptoms. Women exhibiting moderate symptoms (TBscoreII=2-3) suggestive of TB will be referred for GeneXpert testing sputum and/or faecal samples, while individuals with more severe symptoms (TBscoreII=4-8) will additionally receive chest radiography, which will be analysed with AI software. Due to high co-infection rates, all HIV-positive women, regardless of their Bandim TBscore II, will be tested with both GeneXpert and chest radiography. Women with positive GeneXpert results will be referred for treatment, while women with chest radiography will attend a consultation with a TB specialist. Participants will be reassessed for TB symptoms at each subsequent ANC visit and at 6 months postpartum. Receives: Diagnostic Test: Enhanced protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of active TB cases
Number of number of bacteriologically or radiologically confirmed active TB cases comparing baseline and intervention (enhanced protocol)
Measured: From enrolment to 6 months postpartum
Secondary outcomes (2)
TBI prevalence
Number of pregnant women with confirmed TBI
Measured: At enrolment
Progression from TBI to active TB disease
Number of women which develop active TB disease during pregnancy or postpartum period
Measured: From enrolment to 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis (TB)Studies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Designed as stepped-wedge cluster randomised trial
- Masking
- None (open label)
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bandim Health Project
- Responsible party
- Principal investigator, Frauke Rudolf, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419568
- Sponsor's protocol ID
- 044/CNES/INASA/2025
- Acronym
- TIPP
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided