Effectiveness of a Home-based Approach to Child Contact Investigation and Tuberculosis Preventive Treatment Management by Community Health Workers in Ethiopia: A Pragmatic Cluster-randomized Trial

BACKGROUND: Tuberculosis preventive treatment (TPT) is highly effective at preventing tuberculosis (TB) disease but is poorly implemented. We aimed to determine whether home-based contact management improves TPT uptake among close child contacts compared to the facility-based standard of care. METHODS: We conducted a pragmatic cluster-randomized trial among close contacts of TB clients aged <15 years in 18 primary health facilities in Oromia, Ethiopia. Facilities were randomized 1:1 to home-based or facility-based contact management. The intervention was conducted by community health workers (CHWs) and task-shared with TB focal persons. The primary endpoint was the cluster-level ratio of the number of contacts aged <15 years initiated on TPT per TB client. RESULTS: The cluster-level mean number of child contacts initiated on TPT per TB client was 40% higher in the home-based (1.7 contacts per TB client) versus facility-based arm (1.3 contacts per TB client; rate ratio 1.4, 95% confidence interval [CI]: .7-2.7). In the care continuum, assuming 2.1 children <15 years per household, 73% and 63% of children completed TPT in the 2 arms, respectively. One child failed TPT and 2 children discontinued TPT due to drug-related adverse reactions in the home-based and facility-based arms, respectively. CONCLUSIONS: Home-based contact management by CHWs increased the number of children initiated on TPT by 40% without negative effects on treatment outcomes. Though not statistically significant, on a larger scale, the increased number of children identified and initiated on TPT has the potential to substantially reduce the burden of pediatric TB in Ethiopia and elsewhere. CLINICAL TRIALS REGISTRATION: NCT04369326.