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:

BackgroundThe 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. MethodsYounger 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%. DiscussionThis 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 RegistrationISRCTN 11329596, Registered on 02 February 2024 Administrative Information O_TBL View this table: org.highwire.dtl.DTLVardef@1d5f90forg.highwire.dtl.DTLVardef@d26da7org.highwire.dtl.DTLVardef@11d2ffdorg.highwire.dtl.DTLVardef@139a021org.highwire.dtl.DTLVardef@3ff4e7_HPS_FORMAT_FIGEXP M_TBL C_TBL