safetxt: A randomised controlled trial of an intervention delivered by mobile phone messaging to reduce sexually transmitted infections (STI) by increasing sexual health precaution behaviours in young people. Methods Used to Improve Recruitment

Problem

Trial recruitment is a crucial task as full recruitment provides trials with sufficient power to detect intervention effects. Yet, only 56% of publicly funded trials in the UK achieve their target recruitment sample size. The NIHR-funded safetxt trial is a single blind randomised controlled trial to evaluate the effect of a safer sex intervention delivered by text message on Chlamydia and Gonorrhoea infection at 12 months. 5000 people aged 16-24 are being recruited from 45 UK GU and Sexual and Reproductive Health services. We describe our evidence based recruitment methods.

Approach

We utilised mixed methods informed by evidence from behavioural science including: monitoring recruitment, feedback from sites, and rewards. We facilitated shared learning between recruiting staff across clinics. Promotional materials were developed and evaluated to address barriers to recruitment.

Findings

45 GU and Sexual and Reproductive Health Services across the UK are involved in the recruitment endeavour and further sites have shown an interest. Over 4000 participants have been recruited, with a current rate of around 320 participants each month. Differences in clinical pathways and staffing levels may have influenced recruitment rates at different sites. Staff report screening log data on a monthly basis. Barriers to recruitment are discussed at trial management meetings and solutions are fed back to sites. Telephone and face-to-face meetings with recruiting staff have generated ideas to increase recruitment, enabled new services to learn from experienced recruiters, facilitated mutual learning and resulted in the development of materials to support staff in recruitment. New recruiting staff have been buddied up with experienced staff to discuss tips and share ideas. Monthly newsletters have been distributed to all staff highlighting major achievements and competitions have been held to develop engagement and motivation. We have provided certificates to thank staff for achieving recruitment milestones and to include in their nursing appraisals. Promotional materials have been produced to support recruiting sites. Ideas for posters and leaflets were appraised at focus groups. Recruiting staff were involved in developing materials before they were finalised. Materials produced by recruiting clinics to promote the trial internally to colleagues have been developed and shared with other sites.

Consequences

safetxt recruited ahead of schedule for most of the recruitment period and remains closely behind the projected recruitment rate. It will be a major achievement if the safetxt collaboration between GU and Sexual and Reproductive Health services and the trial management team recruit 5000 participants on time.