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Authors
Sikkema, K. J. https://orcid.org/0000-0003-0371-5119
Rabie, S.
King, A.
Watt, M. H.
Mulawa, M. I.
Andersen, L. S.
Wilson, P. A.
Marais, A.
Ndwandwa, E.
Majokweni, S.
Orrell, C.
Joska, J. A.
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Funding
Funding for this research was provided by:
National Institute of Mental Health (R01MH118004)
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Article History
Received: 15 June 2022
Accepted: 9 August 2022
First Online: 18 August 2022
Declarations
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: The trial was approved by the Human Research Ethics Committee (HREC) of the University of Cape Town (HREC 137/2019), the Institutional Review Board (IRB) of the Columbia University (IRB Study Number: AAAS3667), and the City of Cape Town research office (8274/24822). The trial is additionally registered with ClinicalTrials.gov (REF NCT04793217). Our proposed DSMB was approved by NIMH. All participants will give written informed consent prior to enrollment, which includes information on foreseeable risks, voluntary participation, and confidentiality. Across both conditions, the allocated intervention will be discontinued for participants who withdraw consent. Trial data will be stored in a safe, HIPAA-compliant fashion. All identifiable data will remain at UCT. Adverse events and protocol deviations will be reported according to Columbia University, UCT, and NIMH guidelines.
: No individual participant data is shared in this manuscript. Informed consent materials are available from the corresponding author on request.<b>Competing interests {28}</b>The authors declare that they have no competing interests.
