Condition category
Infections and Infestations
Date applied
11/11/2014
Date assigned
21/11/2014
Last edited
30/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Trial website

http://www.gettestednow.org.uk

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

Internet

Trial 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

Phase

Drug names

Primary outcome measures

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 trial start date

22/11/2014

Overall trial end date

31/01/2017

Reason abandoned

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

Patient

Age group

Adult

Gender

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

United Kingdom

Trial 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
United Kingdom
+44 (0)2032991980
kch-tr.research@nhs.net

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Guy's and St Thomas' Charity

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26772143
2016 addendum to protocol in: https://www.researchprotocols.org/2016/3/e141/

Publication citations

Additional files

Editorial Notes

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.