Pilot trial of targeted sexual risk reduction intervention package

  • Research type

    Research Study

  • Full title

    Sexual risk reduction interventions for patients attending sexual health clinics; feasibility to conduct an effectiveness trial (Sante project)

  • IRAS ID

    195021

  • Contact name

    Smaragda Agathou

  • Contact email

    randd@uclh.nhs.net

  • Sponsor organisation

    UCL

  • ISRCTN Number

    ISRCTN16738765

  • Clinicaltrials.gov Identifier

    Z6364106/2016/02/43, UCL data protection registration

  • Duration of Study in the UK

    0 years, 6 months, 1 days

  • Research summary

    Sexually transmitted infections (STIs) continue to represent a major public health challenge in the UK. Research is required to identify brief, pragmatic, labour non-intensive interventions that can be tailored to the level of risk of the individual attending a range of different sexual health services in England. We have completed a mixed-methods study to identify a package of interventions that are feasible and acceptable, and developed a triage tool for targeting these interventions. Prior to conducting a full randomized controlled trial of targeted risk reduction interventions at sexual health services, a pilot feasibility trial is needed.

    This trial will be run in six intervention and three control clinics. In the trial we will monitor the number of service users who are triaged, offered an intervention and the intervention uptake rate. All service users attending the clinics during the recruitment period and who are young (aged 16 – 25) or men who have sex with men (MSM) will be monitored. The recruitment period in each clinic will be 2-3 months.

    In a sub-set of 700 patients, we will seek consent to follow them up 6 weeks (either by phone or email) and ask if they would be willing to return to the clinic for a follow-up appointment or return a self-swab or urine postal sample.

    We will conduct semi-structured interviews with 30 service users and healthcare providers (HCP), from each participating clinic. For service users these interviews will cover their experience of the interventions and reasons for accepting (or not) to complete the intervention. The HCP interviews will check intervention fidelity and their experience of implementation.

    The study is being coordinated by University College London in collaboration with Brighton and Sussex Medical School, with funding from the NIHR HTA scheme.

  • REC name

    London - Chelsea Research Ethics Committee

  • REC reference

    16/LO/0673

  • Date of REC Opinion

    16 May 2016

  • REC opinion

    Further Information Favourable Opinion