Condition category
Infections and Infestations
Date applied
17/07/2015
Date assigned
05/08/2015
Last edited
05/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
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 any of a range of different sexual health (SH) services. In order to test the feasibility of conducting a study of targeted risk reduction interventions at sexual health services, we need to understand what is currently done within these settings, and whether potential interventions would be appropriate and desirable to both providers and patients. This study will be mapping current practice in UK SH clinics with respect to delivery of sexual risk reduction interventions and identifying best practice, exploring opportunities and challenges to the delivery of candidate risk reduction interventions in SH clinics.

Who can participate?
Service managers, doctors, nurses, health advisors and psychologists working at sexual health services including genito-urinary medicine (GUM), contraceptive and sexual health (CASH) or Brook clinic, and patients aged 16 or older attending a GUM, CASH or Brook clinic.

What does the study involve?
We plan to carry out five interlinked activities, collecting information from both service providers and service users. We will conduct interviews with service providers and patients to gain an understanding of current approaches and attitudes to risk assessment in SH services and behavioural interventions, and the resources available and used for this. This information will be used to design a web-based survey which will be sent to all SH service providers. A patient survey will be conducted where patients are asked to indicate their preferences for the design of various candidate risk reduction interventions. Finally, we will use focus groups to find out how previously identified interventions can be appropriately adapted to use in the NHS. These activities will provide candidate interventions, and indicate opportunities for implementing them and the challenges to consider.

What are the possible benefits and risks of participating?
Service provider participants will receive information on their current practices for risk assessment and reduction, and determining the resources currently spent and available for this activity. Patient participants will not directly benefit, but this public health and health services research study may benefit the respondents indirectly by informing appropriate interventions for sexual risk reduction. In addition, patient participants for interviews and focus group discussions will receive compensation for their time. We feel the potential risks and burdens to patient participants to be limited, but they could include some distress during interviews if they are uncomfortable with the topic being discussed. During the consent process, we will make it very clear that participants do not need to answer any questions they are uncomfortable with and can terminate their involvement at any point. In the focus group discussions, we will be grouping participants together based on sexual orientation, gender and age to make participants more comfortable discussing their thoughts on sexual health services. For all participants, there will be some burden on their time. In every case participants will be made aware of this during the consent process. Surveys and interviews will be kept as short as possible. The focus group discussion will also be kept as short as possible but will last a maximum of one hour and participants will be compensated for time spent.

Where is the study run from?
Central and North West London NHS Trust and Brighton and Sussex University Hospitals NHS Trust (UK).

When is the study starting and how long is it expected to run for?
June 2015 to December 2015.

Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK).

Who is the main contact?
Dr Carina King
c.king@ucl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Carina King

ORCID ID

http://orcid.org/0000-0002-6885-6716

Contact details

Centre for Sexual Health & HIV Research
Mortimer Market Centre
Mortimer Market
London
WC1E 6JB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

18925; HTA 12/191/05

Study information

Scientific title

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

Acronym

Study hypothesis

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 any of a range of different sexual health (SH) services. In order to test the feasibility of conducting a trial of targeted risk reduction interventions at sexual health services, we need to understand what is currently done within these settings, and whether potential interventions would be appropriate and desirable to both providers and patients. This study will be mapping current practice in UK SH clinics with respect to delivery of sexual risk reduction interventions and identifying best practice, exploring opportunities and challenges to the delivery of candidate risk reduction interventions in SH clinics.

Ethics approval

First MREC approval date 19/05/2015, ref: 15/LO/0690

Study design

Non-randomised; Observational; Design type: Qualitative

Primary study design

Observational

Secondary study design

Qualitative

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Infectious diseases and microbiology, Public health; Subtopic: Infection (all Subtopics), Public health; Disease: Infectious diseases and microbiology , All Public health

Intervention

We plan to carry out 5 interlinked activities, collecting information from both service providers and service users. We will conduct semi-structured interviews with service providers and patients to gain an understanding of current approaches and attitudes to risk assessment in SH services and behavioural interventions, and the resources available and used for this (ACTIVITIES 1 & 3). This information will be used to inform the design of a web-based survey which will be sent to all SH service providers (ACTIVITY 2). A patient survey (a discrete choice experiment) will be conducted, where patients are asked to indicate their preferences for the design of various candidate risk reduction interventions (potential candidate interventions are being identified from a systematic literature review) (ACTIVITY 4). Finally, we will use focus groups to elicit stakeholder opinion on how previously identified interventions can be appropriately adapted to the NHS setting (ACTIVITY 5). These activities will provide candidate interventions, and indicate opportunities for implementing them and the challenges to consider.

Study Entry: Registration only

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Feasibility of delivering targeted interventions in sexual health settings; Timepoint(s): December 2016

Secondary outcome measures

Not provided at time of registration

Overall trial start date

17/06/2015

Overall trial end date

10/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Service providers:
1. Any of service manager and professional members of the multidisciplinary team (doctors, nurses, health advisors, psychologists)
2. Working at sexual health services including: Genito-urinary medicine (GUM), contraceptive and sexual health (CASH) or Brook clinic

Patients:
1. Attendance at a GUM, CASH or Brook clinic
2. 16 years or older

Target Gender: Male & Female ; Lower Age Limit 16 years

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 1059; UK Sample Size: 1059

Participant exclusion criteria

Service providers:
1. In post for less than 3 months

Patients:
1. Younger than 16 years
2. Lacking capacity to give informed consent
3. Unable to speak English

Recruitment start date

09/07/2015

Recruitment end date

31/12/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Central and North West London NHS Trust
NW1 2PL
United Kingdom

Trial participating centre

Brighton and Sussex University Hospitals NHS Trust
BN1 6AG
United Kingdom

Sponsor information

Organisation

University College London (UK)

Sponsor details

UCL Biomedicine Research & Development Unit
Maple House
149 Tottenham Court Road
London
W1T 7NF
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK); HTA/12/191/05

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We plan to publish the results in academic journals, including a manuscript of patient preferences and current provider practices. We will also disseminate our findings to our PPI group and through various user-groups.

Our ethical approval and patient consent does not include publication of participant-level data. As the majority of our data will be individual qualitative interview and focus group discussion data we do not feel it is appropriate to store this in a public repository. For the quantitative data from the patient questionnaires and participant web-survey, we will make this available upon request following approval by the Principle Investigator and the signing of a data sharing agreement, which has been approved by the appropriate ethical committees.

Intention to publish date

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes