Tests an improved diagnostic routine for tuberculosis in primary health centers

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people aged 15 or older who may have tuberculosis (TB), with cough, sputum production, or weight loss.

Age

15 years or older (up to 120 years)

Sex

All sexes can join

Disease stage

People who may have TB, with cough, sputum production and/or weight loss of any duration. TB is not yet confirmed.

Earlier treatment

People who had TB treatment within the past year cannot join.

Main reasons for not taking part

• TB treatment within the past year
• Brain problems that make it hard to give informed consent or follow the treatment plan

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 15 and 120 years old?YesNo

What the trial wants to find out

As estimated by the WHO 10.6 million new Tuberculosis (TB) cases were identified in 2022- while more than three million went undetected and untreated. The low detection rate illustrates the failure to recognise and diagnose TB in the current cascade of healthcare and is a major obstacle to effective TB control programs. This multi-centre cluster-randomised clinical trial will evaluate the effect (i.e., diagnostic yield) of improving the point-of-care diagnostics already in place in most primary health-care centres in low-resource settings. The present study will be conducted in two different geographical settings in the Western and Eastern African countries of Guinea Bissau and Ethiopia. This improved clinical diagnostic pathway may improve case detection rates at primary healthcare level, ensuring prompt commencement of treatment, thereby diminishing transmission risk in the community and improving treatment outcomes. The Optimized Diagnostic Procedure (ODP) will utilize instructed sputum sampling and pooling as well as computer-aided detection (CAD) chest X-ray (CXR) and additional pooled sputum sample as well as non-sputum sampling (faecal and a buccal/tongue swab and saliva) for GeneXpert Ultra PCR (Xpert) as state-of-the-art add-ons to the routine diagnostic pathway for TB. This adds to the key components of the WHO "End TB" strategy - early diagnosis - and if successful, may be rapidly approved by the WHO and implemented by governments globally with potentially major public health benefits.

The 2 groups in the trial

• Enhanced Usual Diagnostic Procedure (EUDP)No study treatment, for comparison

  The standard TB diagnostics in both settings consist of performing the sputum smear analysis by the clinical routine. Smear-negative cases will be followed as per standard routine (Figure 1A).

• The Optimized Diagnostic Procedure (ODP) interventionExisting treatment, for comparison

  1. Oral and mobile phone-guided instructions by study staff 2. Pooling of two spot sputum samples (9) 3. Smear-negative cases at the first visit will be assessed for persisting symptoms and referred to a CXR unit.

  Treatment: ODP