Tuberculosis (TB), Tuberculosis Infection, Latent, Pregnancy, Tuberculosis Diagnosis, Maternal Health
Conditions
Brief 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. 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.
Interventions
DIAGNOSTIC_TESTEnhanced protocol
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.
Sponsors
Aarhus University Hospital
Bandim Health Project
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Designed as stepped-wedge cluster randomised trial
Eligibility
Sex/Gender
FEMALE
Age
15 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of active TB cases | From enrolment to 6 months postpartum | Number of number of bacteriologically or radiologically confirmed active TB cases comparing baseline and intervention (enhanced protocol) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TBI prevalence | At enrolment | Number of pregnant women with confirmed TBI |
| Progression from TBI to active TB disease | From enrolment to 6 months postpartum | Number of women which develop active TB disease during pregnancy or postpartum period |
Countries
Guinea-Bissau
Contacts
CONTACTAnita Magdalena Zalisz, MSc
Outcome results
None listed