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Article History

Received: 7 November 2023

Accepted: 21 February 2025

First Online: 11 March 2025

Declarations

:

: The study was approved by the LSHTM Research Ethics Committee (reference 0735-2), the Addis Ababa University College of Health Sciences Institutional Review Board (reference 083/13/Psy), and the Ethiopian National Research Ethics Review Committee (reference 310/048/2015).In the trial informed consent was taken from both the person with schizophrenia and the caregiver by a psychiatric nurse. In this process an information sheet was given to the person with schizophrenia and the caregiver and elaborately discussed and explained. Time for questions was given and non-technical language was used. Sufficient time was allowed for participants to think about the information, with extra time if the person with schizophrenia was unwell or seemed to have cognitive difficulties. Although many caregivers and participants were illiterate, written information was still given to review with assistance at a later time. The nurse used clinical judgement to determine if the person with schizophrenia has capacity to provide informed consent. When the person with schizophrenia was deemed not to have capacity, consent was sought from the caregiver. Assent was then sought from the person with schizophrenia. If the person with schizophrenia regained capacity during the trial, they were asked for consent at that time.

: Not applicable.

: The authors declare no competing interests.