| Title {1} | SMSs as an Alternative to Provider-Delivered Care for Unhealthy Alcohol Use: Study Protocol for Leseli, an Open-Label Randomised Controlled Trial of mhGAP-Remote vs mhGAP-Standard in Lesotho |
| Trial registration {2a and 2b}. | The trial was registered at Clinicaltrials.gov: NCT05925270, on June 29th, 2023. Please refer to the clinicaltrials.gov registry for this trial at this link: https://clinicaltrials.gov/study/NCT05925270. All items from the WHO trial registration data set can be found within the protocol. See supplementary materials for the SPIRIT checklist. |
| Protocol version {3} | Protocol version number 1.0 (Date: 15th May, 2023) |
| Funding {4} | This study is funded by the Swiss National Science Foundation (PZ00P1_201690, PI: Belus). |
| Author details {5a} | |
| Name and contact information for the trial sponsor {5b} |
Division of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, Totengässlein 3, 4051 Basel, Switzerland Contact: + 41612652525 |
| Role of sponsor {5c} | The study design, collection, management, analysis, and interpretation of data, writing of the report, and the decision to submit the report for publication are the sole decision of the authors. |