Burden of Tuberculosis Among Pregnant and Postpartum Women in Guinea-Bissau

NCT07419568 | Not Yet Recruiting

• 1 other identifier: 044/CNES/INASA/2025
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis (TB); Tuberculosis Infection, Latent; Pregnancy; Tuberculosis Diagnosis; Maternal Health

Outcome Measures

Primary Outcomes (1)

• Number of active TB cases

  Number of number of bacteriologically or radiologically confirmed active TB cases comparing baseline and intervention (enhanced protocol)

  From enrolment to 6 months postpartum

Secondary Outcomes (2)

• TBI prevalence

  At enrolment

• Progression from TBI to active TB disease

  From enrolment to 6 months postpartum

Study Arms (2)

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.

Diagnostic Test: Enhanced protocol

Interventions

Enhanced protocol DIAGNOSTIC_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.

Intervention (Enhanced protocol)

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aarhus University Hospital: lead
• Bandim Health Project: collaborator

Study Sites (1)

Projecto Saude de Bandim

Bissau, Guinea-Bissau

Location

MeSH Terms

Conditions

Tuberculosis; Latent Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Central Study Contacts

Anita Magdalena Zalisz, MSc

CONTACT

957007723; anita.magdalena.zalisz@clin.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Designed as stepped-wedge cluster randomised trial

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 19, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

GU (1)