To support access to life-saving tuberculosis testing and treatment, we evaluated whether placing portable, low complexity, WHO-recommended rapid molecular diagnostics at primary care clinics increased diagnoses and accelerated anti-tuberculosis treatment initiation compared to routine off-site testing.
We conducted an open cluster-randomised trial of primary care clinics in Mozambique and Tanzania that provided tuberculosis diagnosis and treatment. Clinics were randomly assigned (1:1) to either on-site testing with Molbio Truenat MTB-Plus and RIF-Dx assays (intervention), or standard of care with referral-based testing using Xpert MTB/RIF Ultra (control). Adults (age ≥18 years) presenting to clinics with symptoms of presumptive pulmonary tuberculosis were eligible for inclusion if they could produce sputum and consented to participate.
The primary outcome was the absolute number and proportion of participants with microbiologically confirmed tuberculosis who started treatment within 7 days of enrolment (their first visit), assessed among those with outcome data from follow-up calls (analysis population), among all enrolled participants who met eligibility criteria.