Mixed-methods evaluation of a novel online sexually transmitted infection results service.

Authors:Jo Gibbs*,Catherine RH Aicken,Lorna J Sutcliffe, Voula Gkatizdou, Laura J Tickle, Kate Hone, S Tariq Sadiq, Pam Sonnenberg, Claudia S Estcourt

*Corresponding author Jo Gibbs

Centre for Population Research in Sexual Health and HIV Sexual Health and HIV Research, UCL Research Department of Infection and Population HealthInstitute of Global Health, Mortimer Market Centre, off Capper Street, London WC1E 6JB

02031082071

Affiliations:

(JG, CRHA, PS): Research Department of Infection and Population Health Population Research in Sexual Health and HIV, Institute of Global Health, University College London, London, UK

(JG, CSE, LJS, LJT) Blizard Institute, Barts and the London School of Medicine & Dentistry, Queen Mary University of London, London, UK

(CSE) School of Health & Life Science, Glasgow Caledonian University, Glasgow, UK

(KH, VG) College of Engineering, Design and Physical Sciences, Brunel University London, Uxbridge, UK;

(STS) Applied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George’s University of London, London, UK

Word count (excluding title page, abstract, references, figures, tables): 1532

Keywords: Sexually transmitted infections, chlamydia, test results service, short messaging service (SMS), eHealth, eSexual health

ABSTRACT

Objectives: Evidence on optimal methods for providing STI test results is lacking. We evaluated an online results service, developed as part of an eSexual Health Clinic (eSHC).

Methods: We evaluated the online results service using a mixed-methods approach within large exploratory studies of the eSHC. Participants werechlamydia-positive and negative users of online postal self-sampling services in six National Chlamydia Screening Programme (NCSP) areas, and chlamydia-positive patientsfrom two genitourinary medicine (GUM) clinics, between 21.07.14-13.03.15. Participantsreceived a discreetly-worded‘NHS no-reply’text message(SMS) informing them that their test results were ready and providing a web-link to a secure website. Participants logged in with their date of birth and mobile telephone or clinicnumber. Chlamydia-positive patients were offered online management. All interactions with the eSHC system were automatically logged and their timing recorded.Post-treatment, a service evaluation survey (n=152) and qualitative interviews (n=36) were conducted, by telephone. Chlamydia-negative patients wereoffereda short online survey (n=274).Data were integrated.

Results: 92%(134/146) of NCSP chlamydia-positive, 82% (161/197) of GUM chlamydia-positive patients, and89%(1776/1997) of NCSP chlamydia-negative participantsaccessed test results within 7 days. 91% of chlamydia-positive patients were happy with the results service; 64% of those who had tested previously found the results service better or much better than previous experiences. 90%of chlamydia-negative survey participantsagreedthey would be happy to receive results this way in the future.Interviewees described accessing results with ease, and appreciated the privacy and control the two-step process gave them.

Conclusion: A discreet SMS to alert users/patients that results are available, followed by provisionof results via a secure website,was highly acceptable,irrespective of test result and prior testing history. The eSHC results service affordedusers privacy and control over when they viewed results without compromising access.

INTRODUCTION184 words

Timely provision of sexually transmitted infection (STI) test results (optimally within 10 working days of testing1) enables prompt treatment to reduces the risk of complications developing clinical sequelaeand,prevent onward transmission, and provides early opportunities for risk reduction and prevention of onward transmission. Notification of negative results gives reassurance and is an important opportunity for health promotion. 2

The literature informing methods of results provision is variable and Sservices in the UK have introduceduse a range of methods for communicating results, largely without good quality evidence or robust evaluation, [1] . Methods for communicating results includinge : (1)Face-to-face (patient returns to clinic);3,4(2) Telephone call;3,5(3) Letter; (4) Automated telephone service;6,7(5)Short message service (SMS);3–5,8–10(6) Email;3–5and (7) Online.3,5,11–19While these usually convey both positive and negative results, previously it has been common to have a ‘No news is good news’ approach, where patients are told that they will only be informed of positive results, has been adopted.3,20,21

A driveEffortsto improve efficiency and service deliveryfor automation whilst recognising that young people, a group at high risk of STIs, tend to be avid adopters of digital technology,has have led many sexual health services to embrace eHealth for delivery of a number of for some elements of routine sexual health care, including results communicationprovision of test results. We developed and piloted an eSexual Health Clinic (eSHC), which included an online chlamydia pathway (OCP) composed of an automated online clinical consultation for people with genital chlamydia, with electronic prescription via community pharmacy, partner notification, and surveillance, supported by a telephone clinical helpline.[2]

The eSHC required included a results service designed for confidential, private access to results, and for chlamydia-positive users to continue onto the OCP.; which enableda method for users to access their results that takes into account the need for confidentiality and, privatelycy, with and the ability for those testing positive for chlamydia to continue seamlessly onto the OCP. We evaluated an onlinethis results serviceitwithin large, mixed-methods exploratory studies of the using a mixed-methods approach within large exploratory studies of the eSHC.

METHODS (400398)

Design of the online results service

We followed the Medical Research Council (MRC) Framework for the development of complex interventions23 to design and evaluate the eSHC.DThe multi-disciplinary development (modelling) phase of the eSHC[3] included specific research to develop anto identify theoptimal method for results provision. This included Ttwo qualitative studies among young (16-24-year-old) potential users),which explored the acceptability[4] and the usability[5]of online STI care, . Both studiesincluded including participants’ views and preferences about results provision. Findings suggested that making noavoiding referring reference to sexual health or STI testing in electronic messages was important in maintaining privacy, and that the NHS ‘brand’conferred was associated with perceived legitimacy of the serviceand trustworthiness.[4][5]

Informed by these findings and the literature[1]we opted for a two-step model. Firstly, the eSHC system sends users a discreetly-worded SMS from the secure NHS SMS and webmail system (NHS.net). stating that results are ready and providing a link to the eSHC web- application. The sender is displayed as ‘NHS no-reply’ on users’ phones. The message states that results are ready and provides a link to the eSHC web application.Secondly, users log on with their date of birth and mobile phone or clinic number to view results and are provided with information on the same web-page. For chlamydia-positive users who tested positive for chlamydia,this consists of succinct information about the infection was provided, links to relevant,NHS and reputable non-governmental organisation patient information websites, and an offer of online management is provided (see Web appendix) (see Figure 1).For users who testedtesting negative, information about the window- period (the interval of time between being infected and the infection being detectable with a test) and health promotion advice weaare provided. The SMS and online text (wording) were cognitively tested to ensure ease of comprehension.[6]

eSHC evaluation

This results service was evaluated as part ofwithin We then conductedproof-of-concept exploratory studies using chlamydia as an exemplar. Details of the study design and key results have been published previously.[7]

Briefly, pParticipants had undergone STI testing via: 1) an online postal self-sampling service (Checkurself) in six South London National Chlamydia Screening Programme (NCSP) areas in South London,and2) two Greater London genitourinary (GUM) clinics in Greater London,between 21.07.14-13.03.15.[7] To meet the exploratory studies’ need to evaluate the eSHC with sufficient numbers of chlamydia-positive patients, we included GUM patients were included only if they testing ed positive for chlamydia, and while NCSP participants testing positive or negative for chlamydia, were eligiblehad chlamydia positive and negative results.

The results for eligible NCSP online postal self-sampling users were automatically downloaded onto the eSHC system daily. GUM clinic results administrators reviewed records of attenders with positive chlamydia test results daily, and entered eligible patients’ details onto the eSHC system. The eSHC system automatically sent SMSs at 09.00 on weekdays, coinciding with the eSHC clinical helpline opening hours (09.00-17.00 weekdays).If pResponsibility for notifying pPatients who had not accessed their results within seven days,responsibility for contacting them was wereas passed back to the relevant testing service,NCSP testing site or GUM clinic, so that forthose testing positive could to be contacted by other means.The Web Appendix illustratesAn illustration ofhow the results service was operationalised in different settings can be found in the web appendix.

We used mMixed-methodsto evaluation ofe the online results service.

The automated eSHC system automatically logged all interactions with the web-application and their timing.captured data on all participants. Aincluding automatically logging, with timings recorded, all interactions with the eSHC system. were automatically logged and their timing recorded., including when each SMS was sent, when and how many times patients accessed their results, when those testing positive accessed the OCP and when those testing negative accessed health promotion.

The acceptability of the results service was evaluated in: (1) a telephone survey of During telephone follow-up of the chlamydia-positive patients, administered in their clinical follow-up telephone call (which took place by telephone two weeks after test results were available). (2) Qualitative interviews among ), a questionnaire about acceptability of the results service was administered by Research Health Advisers. This included fixed-response and open-ended questions about the acceptability of the results service. AIn addition, a purposive sample of 36 chlamydia-positive patients participated in qualitative interviews (20/36 female, aged 18-35)[25]about their experience of using the eSHC,[8] including results notification. (3) An online survey of People testing cchlamydia-negative users were invited to complete a short online survey about the acceptability of the results notification method.

The datasetsData were analysed descriptively, and findings were integrated.Free- text responses from survey questionsand interviewsqualitative findings were used to explain and enrich the quantitative findings.

Ethical approvalwas granted by Brighton & Sussex (NHS) Research Ethics Committee, REC reference 13/LO/1111; IRAS project ID: 112513.

RESULTS(609608)

Ninety-two percent (134/146) of chlamydia-positive NCSP patients,82% (161/197) of chlamydia-positive GUM patients and 89% (1776/1997) of chlamydia-negative NCSP usersaccessed their results via the results service within five days. Of these, 97% of those testing positive (284/295) and 97% of those testing negative (1716/1776) accessed their results on the day they received their text.

The automated system captured data on all participants. 152/221 (69%) of chlamydia-positive patients completed the telephone survey, and 36 qualitative interviews were conducted. 331/1776 (response rate 19%) chlamydia-negative users completed the online survey.

Use of the results service

Ninety-two percent (134/146) of chlamydia-positive NCSP patients,82% (161/197) of chlamydia-positive GUM patients and 89% (1776/1997) of chlamydia-negative NCSP usersaccessed their results via the results service within fivedays. Of these, 97% of those testing positive (284/295) and 97% of those testing negative (1716/1776) accessed their results on the day they received their text.

Qualitative interviewees typically described accessingtheir results as soon as they noticed the SMS, irrespective of where they were. Those who were in public places often described being able to access their result online with sufficient privacy from those around them, using their phones to do so. For instance, one man, working in a shared office, described how ‘on my mobile I was, I was sure that nobody was looking’ (24-year-old man tested via Checkurself). In the case of privacy concerns and constraints (e.g. being particularly busy, lacking internet connectivity), some interviewees described accessing their results a short while later,in the case of privacy concerns (‘it’s not something I’d have wanted to open up on my desktop computer [at work],’ (26-year-old man tested in GUM) and constraints, such as being particularly busy or lacking mobile internet. The only interviewee describing the latter (a 20-year-old woman tested in GUM), accessed her results the following day, describing that the additional wait made her feel ‘a bit, like, nervous’ but sheTheywelcomed the online results service, for the ability it gave her them to log on when theyshe felt ready. Survey free-text responses reflected this concern for privacy, with some respondents commenting (in free-text responses) that they appreciated not having ‘chlamydia’ in the SMS.

Acceptability

Chlamydia-positive patients

Of the 152 chlamydia-positive patients who completed completing the telephone survey, 138 (91%) reported being happy with the online results service, although 7% (10/152) reported that they would have preferred their result to be displayed within the SMS (Table 1).

Table 1: Acceptability of the STI results service: survey results

Chlamydia positive / Chlamydia negative
Total (n) / Tested previously (n) / Tested previously (n) / Never tested before (n)
Thought the way they got results this time compared to previous experience/s was:
Much better / 14/41 (34%) / 100/274 (36%)
Better / 13/41 (32%) / 26/274 (17%)
About the same / 11/41 (27%) / 97/274 (35%)
Worse / 3/41 (7%) / 29/274 (11%)
Much worse / 0 / 0
Would be happy to get results this way in the future / 241/269 (90%)
Happy with the way they got their results / 138/152 (91%) / 63/64 (98%)
If tested positive in the future would be happy to access results this way / 61/64 (95%)
Would rather have got result via email with link to access result / 0/152 / 3/62 (5%)
Would rather have result in text message / 10/152 (7%) / 27/62 (44%)
Text message wasn’t clear / 1/152 (1%)
Amount of information given with results was
Not enough / 1/108 (1%)
About right / 107/108 (99%)
Too much / 0/108

Interviewees discussed tThe two- step process for accessing results to obtain test results was discussed positively, compared to simply receiving results in a text message, ‘cos you don’t know who’s gonna be like holding your phone at the time’ (26-year-old man tested in GUM). Logging on was generally described as easy and straightforward.

66% (27/41) of those who had tested for chlamydia previously, reported preferring the online results service to their previous experience. However, some interviewees, who were familiar with receiving their negative results directly in a text message, assumed that the results notification SMS message requiring that they a second log on step, meant that they had a tested positive result. This affected their feelings about logging on and and was associated with a sense ofthe urgency about of doing so. This young woman described how she felt ‘very apprehensive’ and checked her result immediately: ‘I wasn’t gonna wait. [...] And I think it was a lot to do with the fact that it said “Your results are now ready to view online”. I’ve, I’ve never had anything before […] , so I was kind of – I just knew there was something, because usually it’d just be like, oh “All of your results are negative”’ (22-year-old woman tested in GUM).

99% (107/108) of chlamydia-positive survey participantspatients answering the survey reported that the amount of information given with their online results was “about right”, and this was alsowhich was typical of the qualitative intervieweesresponses from qualitative interviewees.

Chlamydia-negative users

Ninety percent (241/269) of the chlamydia-negative users who had tested for chlamydia previouslywith previous testing experience,reported they would be happy to use the results service again. Free- text responses indicated that some usersappreciated the increased privacy and confidentiality, professionalism and security of the results service, despite the increased time it took to log onin to access the result (rather than having a result in a text message). However, others considered felt that the log-oin methodwas notinsufficiently secure enough. Some chlamydia-negative users reportedhaving made similar assumptions that concerns to those testing positive when the novel results service led them to assume that theirbeing asked to log in meant theirresult was positive. Some users would rather havepreferreceived their results by SMS, as thisit was faster and associated withprovoked less anxiety. 98% (63/64) of those who had tested testing for the first time were happy with the online service but 44% (27/62) of first-time testersthese would have preferred their result displayed within the SMS. However, 53% (146/274) ofAmong chlamydia-negative participants who had tested previously, 53% (146/274) reported that the online results service was better than their previous experience.

Twenty-eight percent (389/1776) of chlamydia-negative users accessed the health promotion web-page.

DISCUSSION(344342)_

We developed and evaluated a novel two-stage process for users toonlineaccess to STI results, underpinned by formative research. online. It used an SMS to alert patients that results were ready, followed by a log in step to see results and provide health promotion information (for those testing negative) and online care (for those testing positive) within a secure web site We have shown it to be . We showed that this is an effective and acceptable way to provide both positive and negative chlamydia test results for first-time testers and those who had previous experience of STI testing from online postal self-sampling service, and GUM clinics. A high proportion of users accessed their results promptly, which is important from both an individual and public health perspective to prevent onward transmission and complications of infection. The higher proportion of NCSP patients compared to GUM patients (92% vs 82%) who accessed their results online is possibly because GUM patients may have expected to receive their results by usual clinic practice.