Protocol for an individual-level, two arm, superiority RCT within an adaptive platform trial: Enhanced patient counselling and SMS reminder messages to improve access to community-based eye care services in Meru, Kenya

Background The Vision Impact Project (VIP) is a major community-based eye screening programme running in Kenya with the aim of promoting eye health for all. Previous studies embedded within the programme in Meru County have found that a third of people who are screened require care for an eye problem, however only half of these people manage to access outreach treatment clinics. Access varies between sociodemographic groups, and only 30% of young adults (18-44 years old) were able to access care. In previous mixed-methods work our team conducted interviews and surveys with non-attenders from this ‘left-behind’ group to explore what could be done to improve access. Methods Younger adults told us that better counselling at the point of referral would be likely to improve attendance rates. Based on their feedback, we have developed a script that will be read to participants in the intervention arm at the point of referral, and then sent as a reminder SMS the following day. We will assess whether attendance rates are higher among those randomised to receive this enhanced counselling compared to those who receive standard care. The primary outcome will be the proportion of people from the left-behind group who attend triage clinic. Our secondary analysis will examine overall mean attendance across all groups. We will calculate Bayesian posterior probabilities of attendance in each arm every seven days and continually recruit participants until one of two stopping rules have been met: there is a >95% probability that one arm is best or there is a >95% probability that the difference between the arms is <1%. Discussion This Bayesian RCT will be embedded into the clinical workflow software that is used to manage referrals and clinic attendance. It will test whether a simple, low-cost, service user-derived intervention is able to improve access to services among a population group that is currently being left behind. Trial Registration ISRCTN 11329596, Registered on 02 February 2024 View this table: ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial ISRCTN11329596 ### Funding Statement This work was supported by the National Institute for Health Research (NIHR) (using the UKs Official Development Assistance (ODA) Funding) and Wellcome [215633/Z/19/Z] under the NIHR-Wellcome Partnership for Global Health Research. The views expressed are those of the authors and not necessarily those of Wellcome, the NIHR or the Department of Health and Social Care. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Ethical approval for this work was given by the London School of Hygiene and Tropical Medicine, and the Kenya Medical Research Institute (KEMRI) scientific and ethics review unit. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Patient-level data will be pseudo-anonymised removing names and any other key identifiers before it is shared. Only the least amount of data will be shared, and where possible it will be fully anonymised and aggregated. All published findings will be at anonymous aggregate subpopulation level. In line with the UK concordat on open research data (2016), anonymised data from this trial will be made available to bona fide research groups (evidenced via CVs and the involvement of a qualified statistician), and in line with the trials publicly available Data Management Plan (Additional file 1: Appendix 1), following review and approval from the trials data monitoring committee. * AE : Adverse Events CI : Chief Investigator DSMB : Data Safety Monitoring Board LSHTM : London School of Hygiene and Tropical Medicine PI : Principal Investigator RGIO : Research Governance and Integrity Office SAE : Serious Adverse Event SMS : Short Message Service VIP : Vision Impact Project