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 decentralised 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.
Boris Tchakounte Youngui, MD, MPH, Daniel Atwine, MD, PhD, David Otai, MPH, Anca Vasiliu, MD, PhD, Bob Ssekyanzi, MD, MPH, Colette Sih, MD, MPH, Rogacien Kana, MSc, Rinah Arinaitwe, MSc, Benjamin Cuer, PhD, Leonie Simo, MD, Richard Okello, MD, MPH, Patrice Tchendjou, MD, PhD, Martina Casenghi, PhD, Albert Kuate Kuate, MD, Stavia Turyahabwe, MPH, Jennifer Cohn, MD, MPH, Maryline Bonnet, MD, PhD, and Boris Kevin Tchounga, MD, PhD, on behalf of the CONTACT Study Group
Anca Vasiliu, Sabrina Eymard-Duvernay, Boris Tchounga, Daniel Atwine, Elisabete de Carvalho, Sayouba Ouedraogo, Michael Kakinda, Patrice Tchendjou, Stavia Turyahabwe, Albert Kuate Kuate, Georges Tiendrebeogo, Peter J. Dodd, Stephen M. Graham, Jennifer Cohn, Martina Casenghi & Maryline Bonnet.
Nyashadzaishe Mafirakureva, Boris K Tchounga, Sushant Mukherjee, Boris Tchakounte Youngui, Bob Ssekyanzi, Leonie Simo, Richard F Okello, Stavia Turyahabwe, Albert Kuate Kuate, Jennifer Cohn, Anca Vasiliu, Martina Casenghi, Daniel Atwine, Maryline Bonnet, Peter J Dodd
Anca Vasiliu1* , Georges Tiendrebeogo1, Muhamed Mbunka Awolu2, Cecilia Akatukwasa3, Boris Youngui Tchakounte2, Bob Ssekyanzi3, Boris Kevin Tchounga2, Daniel Atwine3, Martina Casenghi4, Maryline Bonnet1 and on behalf of the CONTACT study group
Maryline Bonnet, Anca Vasiliu, Boris K Tchounga, Benjamin Cuer, Katherine Fielding, Bob Ssekyanzi, Boris Tchakounte Youngui, Jennifer Cohn, Peter J Dodd, Georges Tiendrebeogo, Patrice Tchendjou, Leonie Simo, Richard F Okello, Albert Kuate Kuate, Stavia Turyahabwe, Daniel Atwine, Stephen M Graham, Martina Casenghi, CONTACT study group