B Tchakounte Youngui , B K Tchounga, D Atwine, A Vasiliu, B Cuer, L Simo, R Okello, P Tchendjou, A Kuate Kuate, S Turyahabwe, J Cohn, S M Graham, M Casenghi, M Bonnet
BACKGROUND: The WHO recommends shorter TB preventive treatment (TPT) regimens and decentralized delivery models to improve effectiveness.
OBJECTIVE: 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.
Trial registration: ClinicalTrials.gov NCT03832023
Funding: Unitaid
SRF contact: Dr Atwine Daniel (Country PI):
Article link: https://pubmed.ncbi.nlm.nih.