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

February 14, 2026 updated by: Frauke Rudolf, Aarhus University Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

720

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Baseline
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.
Active Comparator: Intervention (Enhanced 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.
Diagnostic test: Enhanced 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of active TB cases
Time Frame: From enrolment to 6 months postpartum
Number of number of bacteriologically or radiologically confirmed active TB cases comparing baseline and intervention (enhanced protocol)
From enrolment to 6 months postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TBI prevalence
Time Frame: At enrolment
Number of pregnant women with confirmed TBI
At enrolment
Progression from TBI to active TB disease
Time Frame: From enrolment to 6 months postpartum
Number of women which develop active TB disease during pregnancy or postpartum period
From enrolment to 6 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital

Collaborators

Bandim Health Project

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

February 9, 2026

First Submitted That Met QC Criteria

February 14, 2026

First Posted (Actual)

February 19, 2026

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 14, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 044/CNES/INASA/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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