Can internet-based sexual health services increase diagnoses of sexually transmitted infections (STIs)? Evaluation of an internet-based sexual health service

ISRCTN ISRCTN13354298
DOI https://doi.org/10.1186/ISRCTN13354298
Secondary identifying numbers v6
Submission date
11/11/2014
Registration date
21/11/2014
Last edited
15/01/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Dr Paula Baraitser
Scientific

Weston Education Centre
10 Cutcombe Road
London
SE5 9RJ
United Kingdom

ORCiD logoORCID ID 0000-0002-3354-6494
Email paula_baraitser@mac.com

Study information

Study designInterventional study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Internet/virtual
Study typeTreatment
Participant information sheet Available on our study website www.gettestednow.org.uk
Scientific titleCan internet-based sexual health services increase diagnoses of sexually transmitted infections (STIs)? Evaluation of an internet-based sexual health service
Study acronymN/A
Study hypothesisInternet-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
ConditionSexual health
InterventionAn internet-based sexual health service (intervention) versus standard face-to-face sexual health services (control)
Intervention typeOther
Primary outcome measureAt 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 measuresAt 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 date22/11/2014
Overall study end date31/01/2017

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants3000
Participant inclusion criteria1. 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 exclusion criteria1. 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 date22/11/2014
Recruitment end date31/08/2015

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Weston Education Centre
10 Cutcombe Road
London
SE5 9RJ
United Kingdom

Sponsor information

Kings College Hospital NHS Foundation Trust (UK)
Hospital/treatment centre

161 Denmark Hill
London
SE5 8EF
England
United Kingdom

Phone +44 (0)2032991980
Email kch-tr.research@nhs.net
ROR logo "ROR" https://ror.org/01n0k5m85

Funders

Funder type

Charity

Guy's and St Thomas' Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Guy's and St Thomas' Charity, Guy's and St Thomas' Foundation, GSTTFoundation
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

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

Editorial Notes

15/01/2018: Publication reference added.
30/09/2016: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/07/2015 to 31/08/2015.
2. The overall trial end date was changed from 31/07/2015 to 31/01/2017.
3. Publication reference added.

18/01/2016: Publication reference added.