Clinic Versus Hotspot Active Case Finding and Linkage to Preventive Therapy (ACF/TPT) Strategy Evaluation for TB: A Cluster-Randomized Crossover Trial

What this Trial Is About

Researchers are evaluating two strategies for active tuberculosis (TB) case finding and linkage to TB treatment or preventive therapy in peri-urban Uganda. This five-year study compares a facility-based approach, which recruits individuals attending a large public health facility regardless of TB symptoms, to a hotspot-based approach, which targets geographic areas identified as having a high burden of undiagnosed TB. The study aims to determine which strategy results in more TB patients being diagnosed and started on treatment or preventive therapy. The study uses a cluster-randomized, multiple-period crossover design to compare these two interventions. Both strategies use the same infrastructure, including personnel, equipment, and supplies, for TB screening by mobile chest X-ray with artificial intelligence-based reading followed by confirmatory sputum testing for those with abnormal X-rays. Those who test negative for TB but are eligible may be linked to TB preventive therapy, currently limited to people with close TB contact or known HIV infection. The hotspot-based intervention places this infrastructure in high TB burden zones for four months at a time, while the facility-based intervention operates on the grounds of a health facility. Participants aged 5 years and older, including children 5-14 years old who are close contacts of TB patients, may take part after providing consent or assent with parental consent when appropriate. Participants will undergo TB screening, confirmatory testing, and linkage to treatment or preventive therapy as needed. The study will measure the number of TB cases diagnosed and linked to care, preventive therapy initiations, and compare these outcomes between the two strategies and against regions with no intervention. Follow-up and data collection occur during and shortly after each four-month intervention period. The total duration of participation varies depending on cluster assignment and crossover timing.

Clinic-based Versus Hotspot-focused Active TB Case Finding