Gureje, Oye http://orcid.org/0000-0001-7449-0506
Makanjuola, Victor
Kola, Lola
Yusuf, Bidemi
Price, Leshawndra
Esan, Oluyomi
Oladeji, Bibilola D.
Appiah-Poku, John
Haris, Benjamin
Othieno, Caleb
Seedat, Soraya
Funding for this research was provided by:
ational Institute of Mental Health (5U19MH098718 – 05)
Article History
Received: 7 May 2017
Accepted: 6 September 2017
First Online: 10 October 2017
Ethics approval and consent to participate
: Ethics approval was obtained from the NIMH Data Safety and Monitoring Board, the University of Ibadan/University College Hospital Ethics Committee (UI/EC/12/0219) and the Ethics Committee of the Kwame Nkrumah University of Science and Technology (CHRPE/AP/512/16).Patients presenting to the CAPs facility during the recruitment period, and who provide consent to be screened, are assessed for eligibility by the RAs. Patients who meet all of the eligibility criteria, including have a PANSS score of ≥ 60, proceed to the next stage of the enrollment procedure. Following screening and confirmation of eligibility by the RAs, a potential participant is assessed for capacity to consent by an independent social worker who has been trained to conduct such assessment. Potential participants who are deemed to have capacity are approached for consent following the provision of full trial information by the RAs. For eligible patients who are found to lack capacity to consent, a caregiver is approached to provide proxy consent. If the caregiver provides consent on behalf of the patient, the latter is still required to give assent before they are enrolled into the trial. The consenting procedure of any non-literate patient or caregiver has to be the signed confirmation of an independent adult and literate witness before enrollment is deemed to have been completed. Baseline assessments of consented participants are conducted within 3 days of enrollment while outcome assessments are conducted at 3 and 6 months following trial entry.All Consent Forms are being administered in the local language translations. The translations are in the form of everyday use of the languages to make them understandable to all respondents, including those who have had no formal education. The translations were conducted through a process of translations and back translation by a three-member panel of bilingual members of the study team who are proficient in the source English and target study languages.
: Not applicable.
: The authors declare that they have no competing interests.
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