Plain English Summary
Background and study aims
The London boroughs of Southwark and Lambeth have some of the highest rates of sexually transmitted infections (STIs) in England. Current face-to-face clinical services are unable to meet demand for sexual healthcare. Sexual Health 24 (SH:24) is an innovative internet-based sexual health service that aims to improve access to sexual healthcare in Lambeth and Southwark. We want to see whether this service can reduce the number of people diagnosed with at least one STI and increase the number of people asking to be tested for such an infection.
Who can participate?
Participants can be of either sex, aged between 16-30 and resident in the boroughs of Lambeth and Southwark. They must be sexually active (at least one partner in the last 12 months), have access to the internet and willing to take an STI test.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 (intervention group) are given access to the Sexual Health 24 website offering postal STI kits, test results via text message or by phone (HIV only) and details of local treatment clinics. Those in group 2 (control group) are given access to a website with details of local sexual health clinics where participants can get an STI test in person. Six weeks into the study, the number of participants diagnosed with at least one STI and complete at least one STI test in each group are compared.
What are the possible benefits and risks of participating?
Some participants may find this study helpful, particularly if they have been considering taking an STI test. Undetected cases will be diagnosed by those who follow through with the test, and infected participants will be signposted to treatment. It is possible that participants that do not have much privacy at home may risk possible consequences if they participate in internet-based STI testing. However, this risk will be minimised as we will ensure at recruitment that participants have sufficient privacy to participate in the study.
Where is the study run from?
1. King's College Hospital NHS Foundation Trust (UK)
2. Guy's and St Thomas' Hospital NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
November 2014 to July 2015
Who is funding the study?
Guys and St Thomas' Charity (UK)
Who is the main contact?
Emma Wilson
emma.wilson@lshtm.ac.uk
Study website
Contact information
Type
Scientific
Contact name
Dr Paula Baraitser
ORCID ID
http://orcid.org/0000-0002-3354-6494
Contact details
Weston Education Centre
10 Cutcombe Road
London
SE5 9RJ
United Kingdom
-
paula_baraitser@mac.com
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
v6
Study information
Scientific title
Can internet-based sexual health services increase diagnoses of sexually transmitted infections (STIs)? Evaluation of an internet-based sexual health service
Acronym
N/A
Study hypothesis
Internet-based sexual health services offering postal self-administered STI kits can increase diagnoses of sexually transmitted infections when compared to standard care.
Ethics approval(s)
NRES Committee London - Camberwell and St Giles, 09/09/2014, ref: 14/LO/1477
Study design
Interventional study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Internet/virtual
Study type
Treatment
Patient information sheet
Available on our study website www.gettestednow.org.uk
Condition
Sexual health
Intervention
An internet-based sexual health service (intervention) versus standard face-to-face sexual health services (control)
Intervention type
Other
Primary outcome measure
At 6 weeks we will assess:
1. % of participants diagnosed with at least one STI in each arm
2. % of participants who complete at least one STI test in each arm
Secondary outcome measures
At 6 weeks we will assess:
1. % of participants prescribed treatment in each arm
2. Time to test (from randomisation)
3. Time to treatment (from randomisation)
4. % of intervention group who agree that internet-based testing is acceptable
5. % of intervention group adhere to prescribed internet-testing pathway
Overall study start date
22/11/2014
Overall study end date
31/01/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 16-30
2. Resident in the London boroughs of Southwark and Lambeth
3. Sexually active (at least 1 sexual partner in last 12 months)
4. Access to the internet (smart phone, PC or laptop)
5. Willing to take an STI test
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
3000
Participant exclusion criteria
1. Non-English language speakers as the websites will be in English
2. Those unable to give informed consent such as people with severe learning disabilities
Recruitment start date
22/11/2014
Recruitment end date
31/08/2015
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Weston Education Centre
10 Cutcombe Road
London
SE5 9RJ
United Kingdom
Sponsor information
Organisation
Kings College Hospital NHS Foundation Trust (UK)
Sponsor details
161 Denmark Hill
London
SE5 8EF
England
United Kingdom
+44 (0)2032991980
kch-tr.research@nhs.net
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Charity
Funder name
Guy's and St Thomas' Charity
Alternative name(s)
Guy's and St Thomas' Charity, Guy's and St Thomas' Foundation, GSTTFoundation
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Protocol article | protocol | 15/01/2016 | Yes | No | |
Protocol article | addendum to protocol | 10/08/2016 | Yes | No | |
Results article | results | 27/12/2017 | Yes | No | |
HRA research summary | 28/06/2023 | No | No |