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
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