Safety of 3-month rifampicin-isoniazid TPT in child household contacts in a community-based intervention.

BACKGROUND: The WHO recommends shorter TB preventive treatment (TPT) regimens and decentralised delivery models to improve effectiveness. This study evaluated the safety of a 3-month rifampicin-isoniazid (3RH) regimen administered by community health workers (CHWs) in households in Cameroon and Uganda.METHODS: A cluster-randomised trial was conducted among child contacts of TB patients. We compared the safety of 3RH delivered by CHWs at home (intervention) vs standard-of-care, facility-based administration of 3RH. Safety outcomes included adverse events (AEs), serious adverse events (SAEs), and adverse reactions (ARs). We described the steps from symptom identification by CHWs to classification by a clinician.RESULTS: Of 1,316 children initiated on 3RH, AEs were reported in 8.7% (81/936) in the intervention arm versus 11.3% (43/380) in the standard-of-care arm, P = 0.15. Overall, 37 SAEs occurred in 36 children, all non-medication related. There were 16 ARs reported, occurring in 1.0% (9/936) of children in the intervention arm and 1.6% (6/380) in the standard-of-care arm, P = 0.22. During 4,608 follow-up visits, 21 children reporting AR symptoms were identified by CHWs, 16 were assessed by clinicians, and 4 ARs were confirmed.CONCLUSIONS: The 3RH regimen was safe, including when administered by trained CHWs in community settings, supporting its use in decentralised healthcare models.