title: Can Internet-Based Sexual Health Services Increase Diagnoses of Sexually Transmitted Infections (STI)? Protocol for a Randomized Evaluation of an Internet-Based STI Testing and Results Service.
abstract: BACKGROUND
  Ensuring rapid access to high quality sexual health services is a key public health objective, both in the United Kingdom and internationally. Internet-based testing services for sexually transmitted infections (STIs) are considered to be a promising way to achieve this goal. This study will evaluate a nascent online STI testing and results service in South East London, delivered alongside standard face-to-face STI testing services.
  
  
  OBJECTIVE
  The aim of this study is to establish whether an online testing and results services can (1) increase diagnoses of STIs and (2) increase uptake of STI testing, when delivered alongside standard face-to-face STI testing services.
  
  
  METHODS
  This is a single-blind randomized controlled trial. We will recruit 3000 participants who meet the following eligibility criteria: 16-30 years of age, resident in the London boroughs of Lambeth and Southwark, having at least one sexual partner in the last 12 months, having access to the Internet and willing to take an STI test. People unable to provide informed consent and unable to read and understand English (the websites will be in English) will be excluded. Baseline data will be collected at enrolment. This includes participant contact details, demographic data (date of birth, gender, ethnicity, and sexual orientation), and sexual health behaviors (last STI test, service used at last STI test and number of sexual partners in the last 12 months). Once enrolled, participants will be randomly allocated either (1) to an online STI testing and results service (Sexual Health 24) offering postal self-administered STI kits for chlamydia, gonorrhoea, syphilis, and HIV; results via text message (short message service, SMS), except positive results for HIV, which will be delivered by phone; and direct referrals to local clinics for treatment or (2) to a conventional sexual health information website with signposting to local clinic-based sexual health services. Participants will be free to use any other interventions or services during the trial period. At 6 weeks from randomization we will collect self-reported follow-up data on service use, STI tests and results, treatment prescribed, and acceptability of STI testing services. We will also collect objective data from participating STI testing services on uptake of STI testing, STI diagnoses and treatment. We hypothesise that uptake of STI testing and STI diagnoses will be higher in the intervention arm. Our hypothesis is based on the assumption that the intervention is less time-consuming, more convenient, more private, and incur less stigma and embarrassment than face-to-face STI testing pathways. The primary outcome measure is diagnosis of any STI at 6 weeks from randomization and our co-primary outcome is completion of any STI test at 6 weeks from randomization. We define completion of a test, as samples returned, processed, and results delivered to the intervention and/or clinic settings. We will use risk ratios to calculate the effect of the intervention on our primary outcomes with 95% confidence intervals. All analyses will be based on the intention-to-treat (ITT) principle.
  
  
  RESULTS
  This study is funded by Guy's and St Thomas' Charity and it has received ethical approval from NRES Committee London-Camberwell St Giles (Ref 14/LO/1477). Research and Development approval has been obtained from Kings College Hospital NHS Foundation Trust and Guy's and St Thomas' NHS Foundation Trust. Results are expected in June 2016.
  
  
  CONCLUSIONS
  This study will provide evidence on the effectiveness of an online STI testing and results service in South East London. Our findings may also be generalizable to similar populations in the United Kingdom.
  
  
  BACKGROUND
  International Standard Randomized Controlled Trial Number (ISRCTN): 13354298; http://www.isrctn.com/ISRCTN13354298 (Archived by WebCite at http://www.webcitation.org/6d9xT2bPj).
authors.affiliation: Department of Population Health, Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, United Kingdom. emma.wilson@lshtm.ac.uk.
authors.forename: Emma
authors.identifier: http://orcid.org/0000-0001-7091-2417
authors.initials: E
authors.lastname: Wilson
authors.forename: Caroline
authors.identifier: http://orcid.org/0000-0003-1711-0006
authors.initials: C
authors.lastname: Free
authors.forename: Tim P
authors.identifier: http://orcid.org/0000-0001-5850-3610
authors.initials: TP
authors.lastname: Morris
authors.forename: Michael G
authors.identifier: http://orcid.org/0000-0003-0808-4192
authors.initials: MG
authors.lastname: Kenward
authors.forename: Jonathan
authors.identifier: http://orcid.org/0000-0002-4479-1604
authors.initials: J
authors.lastname: Syred
authors.forename: Paula
authors.identifier: http://orcid.org/0000-0002-3354-6494
authors.initials: P
authors.lastname: Baraitser
keywords: Internet; eHealth; services; sexually transmitted infections