Developing an Online Program for Self-Management of Fatigue, Pain, and Urgency in Inflammatory Bowel Disease: Patients' Needs and Wants.

BACKGROUND: Inflammatory bowel disease (IBD) is a lifelong relapsing-remitting condition, characterized by troublesome symptoms including fatigue, pain, and bowel urgency. These symptoms can persist even in clinical remission and have a debilitating impact on social, work-related and intimate domains of life. Symptom self-management can be challenging for some patients, who could potentially benefit from an online self-management tool. AIMS: We aimed to understand patients' symptom self-management strategies and preferred design for a future online symptom self-management intervention. METHODS: Using exploratory qualitative methods, we conducted focus group and individual interviews with 40 people with IBD recruited from UK clinics and from community-dwelling members of the Crohn's and Colitis UK charity; data were collected using a digital audio recorder, and transcribed and anonymized by a third party (professional) transcriber. We used framework analysis for focus group data and thematic analysis for interview data. RESULTS: The data provided three core themes: ways of coping; intervention functionality; and intervention content. Participants attempt to manage all three symptoms simultaneously, recognizing the combined influence of factors such as food, drink, stress, and exercise on all symptoms. They wanted an accessible online intervention functioning across several platforms, with symptom and medication management, and activity-tracking features. CONCLUSIONS: Patients reported numerous ways of self-managing symptoms of fatigue, pain, and urgency/incontinence related to IBD and expressed their needs for content, design, and functionality of the proposed intervention. Based on this and existing intervention development literature, the IBD-BOOST online self-management intervention has now been developed and is undergoing testing.

Patient Strategies for Managing the Vicious Cycle of Fatigue, Pain and Urgency in Inflammatory Bowel Disease: Impact, Planning and Support.

BACKGROUND: Inflammatory bowel disease (IBD) causes inter-related symptoms of fatigue, pain and urgency which can persist in remission. AIM: To understand how people with IBD experience and self-manage these symptoms and to inform the future development of an online self-management programme. METHODS: Using exploratory qualitative methods, we recruited participants from clinic and community settings. Focus groups, conducted across the UK, were audio-recorded and professionally transcribed. Transcripts were analysed over four rounds using framework analysis. Eight patients were consulted to agree the final structure of data and themes. RESULTS: Seven focus groups were held; five gave useable data. Twenty-six participants (15 female; ages 21-60 years; disease duration 2-40 years) with Crohn's disease (n = 10), ulcerative colitis (n = 14) and IBD-unclassified (n = 2) attended one of these five focus groups. Three core themes emerged: The Negative Impact of Symptoms, Positively Taking Control and Seeking and Receiving Support. The persistent, often stark impact of multiple co-existing symptoms on physical and emotional wellbeing can force unwanted adjustments and limitations in working, social and intimate arenas of life. Unpredictable symptoms are challenging and impact each other in negative vicious cycles. Managing diet, pacing, accepting background levels of fatigue, pain and urgency, seeking support, exercising and attending to mental wellbeing, are all perceived as helpful in self-managing symptoms. CONCLUSION: Fatigue, pain and urgency are troublesome for patients, especially in combination, suggesting that these should be addressed simultaneously by clinicians. Participants reported several strategies for self-management, providing patient-focused evidence to inform future development of a self-management intervention programme.

Communication Strategies Used to Obtain Clinical Histories Before Remotely Prescribing Antibiotics for Postal Treatment of Uncomplicated Genital Chlamydia: Service Evaluation.

BACKGROUND: Web-based services for testing of sexually transmitted infections are widely available across the United Kingdom. Remote prescriptions with medications posted home may support prompt treatment; however, the absence of face-to-face contact with clinicians raises clinical safety issues as medical history may not be accurately provided. OBJECTIVE: This service evaluation aimed to capture the use and explore the safety of 3 remote communication strategies employed within a web-based service offering remote prescriptions of antibiotics, delivered via post, for uncomplicated genital Chlamydia trachomatis. User acceptability and time-from-diagnosis-to-treatment were also obtained. METHODS: Three iterations of the service were compared, where medical history was collected via SMS text message, telephone, or a secure web form before a prescription was issued. We contacted users after they were issued a prescription and completed the medical history a second time via telephone, asking when they took their medication and how they felt about the service. The primary safety measure was agreement in information supplied at 2 assessments (ie, clinical and evaluation assessment) on key elements of safe prescribing: allergies, current medications, or contraindicating clinical conditions or symptoms. Agreement in information between clinical and evaluation assessment was summarized as a binary variable. Factors associated with the assessment agreement variable were explored using univariate and multivariate analysis. The secondary evaluation measures were recall of and adherence to instructions for taking medication, time-from-diagnosis-to-treatment, and acceptability of the web-based service. RESULTS: All web-based service users, resident in the London Boroughs of Lambeth and Southwark with a positive chlamydia diagnosis, who were eligible for and chose postal treatment between February 15, 2017, and October 24, 2017, were invited to participate in this service evaluation. Of 321 eligible users, 62.0% (199) participated. A total of 27.6% (55/199) users completed the clinical assessment via SMS text message, 40.7% (81/199) users via telephone, and 31.7% (63/199) users via a secure web form. Those who were assessed for prescription via SMS text message were less likely to have an agreement in safe prescribing information than those assessed via telephone (adjusted odds ratio [aOR] 0.22, 95% CI 0.08-0.61; P=.004). We found no statistically significant difference in odds of agreement between the web form and telephone assessment (aOR 0.50, 95% CI 0.17-1.43; P=.20). Median time-to-treatment was 4 days (IQR 3-5.5). In addition, 99.0% (196/199) of users reported understanding remote communication, and 89.9% (178/198) would use the service again. CONCLUSIONS: Postal treatment is an acceptable and rapid treatment option for uncomplicated genital chlamydia. Clinical assessment via SMS text message before remote prescription may not be accurate or sufficient. As health care is delivered via the web, strategies that support safe remote prescribing are increasingly important, as is their evaluation, which should be robust and carefully considered.

Choose to test: self-selected testing for sexually transmitted infections within an online service.

OBJECTIVE: To describe the outcomes of user-led, choice of test within an online sexual health service. METHODS: We analysed routinely collected data from a free, online sexual health service in Essex, UK that enabled users to select their tests. The service website provided information on all sexually transmitted infections, recommended a testing package based on sexuality and ethnicity, and invited users to modify this if they chose. Data on orders were analysed for the 6 months before (May-October 2016) and after (October-April 2017) implementation. RESULTS: We compared 7550 orders from 6253 users before and 9785 orders from 7772 users after implementation. There was no difference in the proportion of chlamydia (p=0.57) or gonorrhoea (p=0.79) tests that were positive between the two periods. HIV and syphilis positives were too few in our sample during both periods for analysis. During implementation, men who have sex with men (530 users) were offered genital, rectal and oral chlamydia and gonorrhoea testing plus HIV and syphilis testing. In 17.2% of orders, users removed tests. Black or ethnic minority users excluding those who reported as men who have sex with men (805 users) were offered chlamydia, gonorrhoea and HIV testing. In 77.9% of orders, users added a test. All other users were offered chlamydia and gonorrhoea tests only. In 65.2% of orders, users added tests. We observed a reduction in orders of 3083 blood tests (31%). CONCLUSION: Users engaged with the 'choose to test' intervention. Although a majority added tests, the intervention was cost saving by reducing the HIV and syphilis tests ordered.

Web-Based Activity Within a Sexual Health Economy: Observational Study.

BACKGROUND: Regular testing for sexually transmitted infections (STIs) is important to maintain sexual health. Self-sampling kits ordered online and delivered in the post may increase access, convenience, and cost-effectiveness. Sexual health economies may target limited resources more effectively by signposting users toward Web-based or face-to-face services according to clinical need. OBJECTIVE: The aim of this paper was to investigate the impact of two interventions on testing activity across a whole sexual health economy: (1) the introduction of open access Web-based STI testing services and (2) a clinic policy of triage and signpost online where users without symptoms who attended clinics for STI testing were supported to access the Web-based service instead. METHODS: Data on attendances at all specialist public sexual health providers in an inner-London area were collated into a single database. Each record included information on user demographics, service type accessed, and clinical activity provided, including test results. Clinical activity was categorized as a simple STI test (could be done in a clinic or online), a complex visit (requiring face-to-face consultation), or other. RESULTS: Introduction of Web-based services increased total testing activity across the whole sexual health economy by 18.47% (from 36,373 to 43,091 in the same 6-month period-2014-2015 and 2015-2016), suggesting unmet need for testing in the area. Triage and signposting shifted activity out of the clinic onto the Web-based service, with simple STI testing in the clinic decreasing from 16.90% (920/5443) to 12.25% (511/4172) of total activity, P<.001, and complex activity in the clinic increasing from 69.15% (3764/5443) to 74.86% (3123/4172) of total activity, P<.001. This intervention created a new population of online users with different demographic and clinical profiles from those who use Web-based services spontaneously. Some triage and signposted users (29.62%, 375/1266) did not complete the Web-based testing process, suggesting the potential for missed diagnoses. CONCLUSIONS: This evaluation shows that users can effectively be transitioned from face-to-face to Web-based services and that this introduces a new population to Web-based service use and changes the focus of clinic-based activity. Further development is underway to optimize the triage and signposting process to support test completion.

Internet-accessed sexually transmitted infection (e-STI) testing and results service: A randomised, single-blind, controlled trial.

BACKGROUND: Internet-accessed sexually transmitted infection testing (e-STI testing) is increasingly available as an alternative to testing in clinics. Typically this testing modality enables users to order a test kit from a virtual service (via a website or app), collect their own samples, return test samples to a laboratory, and be notified of their results by short message service (SMS) or telephone. e-STI testing is assumed to increase access to testing in comparison with face-to-face services, but the evidence is unclear. We conducted a randomised controlled trial to assess the effectiveness of an e-STI testing and results service (chlamydia, gonorrhoea, HIV, and syphilis) on STI testing uptake and STI cases diagnosed. METHODS AND FINDINGS: The study took place in the London boroughs of Lambeth and Southwark. Between 24 November 2014 and 31 August 2015, we recruited 2,072 participants, aged 16-30 years, who were resident in these boroughs, had at least 1 sexual partner in the last 12 months, stated willingness to take an STI test, and had access to the internet. Those unable to provide consent and unable to read English were excluded. Participants were randomly allocated to receive 1 text message with the web link of an e-STI testing and results service (intervention group) or to receive 1 text message with the web link of a bespoke website listing the locations, contact details, and websites of 7 local sexual health clinics (control group). Participants were free to use any other services or interventions during the study period. The primary outcomes were self-reported STI testing at 6 weeks, verified by patient record checks, and self-reported STI diagnosis at 6 weeks, verified by patient record checks. Secondary outcomes were the proportion of participants prescribed treatment for an STI, time from randomisation to completion of an STI test, and time from randomisation to treatment of an STI. Participants were sent a £10 cash incentive on submission of self-reported data. We completed all follow-up, including patient record checks, by 17 June 2016. Uptake of STI testing was increased in the intervention group at 6 weeks (50.0% versus 26.6%, relative risk [RR] 1.87, 95% CI 1.63 to 2.15, P < 0.001). The proportion of participants diagnosed was 2.8% in the intervention group versus 1.4% in the control group (RR 2.10, 95% CI 0.94 to 4.70, P = 0.079). No evidence of heterogeneity was observed for any of the pre-specified subgroup analyses. The proportion of participants treated was 1.1% in the intervention group versus 0.7% in the control group (RR 1.72, 95% CI 0.71 to 4.16, P = 0.231). Time to test, was shorter in the intervention group compared to the control group (28.8 days versus 36.5 days, P < 0.001, test for difference in restricted mean survival time [RMST]), but no differences were observed for time to treatment (83.2 days versus 83.5 days, P = 0.51, test for difference in RMST). We were unable to recruit the planned 3,000 participants and therefore lacked power for the analyses of STI diagnoses and STI cases treated. CONCLUSIONS: The e-STI testing service increased uptake of STI testing for all groups including high-risk groups. The intervention required people to attend clinic for treatment and did not reduce time to treatment. Service innovations to improve treatment rates for those diagnosed online are required and could include e-treatment and postal treatment services. e-STI testing services require long-term monitoring and evaluation. TRIAL REGISTRATION: ISRCTN Registry ISRCTN13354298.

Screening for Child Sexual Exploitation in Online Sexual Health Services: An Exploratory Study of Expert Views.

BACKGROUND: Sexual health services routinely screen for child sexual exploitation (CSE). Although sexual health services are increasingly provided online, there has been no research on the translation of the safeguarding function to online services. We studied expert practitioner views on safeguarding in this context. OBJECTIVE: The aim was to document expert practitioner views on safeguarding in the context of an online sexual health service. METHODS: We conducted semistructured interviews with lead professionals purposively sampled from local, regional, or national organizations with a direct influence over CSE protocols, child protection policies, and sexual health services. Interviews were analyzed by three researchers using a matrix-based analytic method. RESULTS: Our respondents described two different approaches to safeguarding. The "information-providing" approach considers that young people experiencing CSE will ask for help when they are ready from someone they trust. The primary function of the service is to provide information, provoke reflection, generate trust, and respond reliably to disclosure. The approach values online services as an anonymous space to test out disclosure without commitment. The "information-gathering" approach considers that young people may withhold information about exploitation. Therefore, services should seek out information to assess risk and initiate disclosure. This approach values face-to-face opportunities for individualized questioning and immediate referral. CONCLUSIONS: The information-providing approach is associated with confidential telephone support lines and the information-gathering approach with clinical services. The approach adopted online will depend on ethos and the range of services provided. Effective transition from online to clinic services after disclosure is an essential element of this process and further research is needed to understand and support this transition.

How online sexual health services could work; generating theory to support development.

BACKGROUND: Online sexual health services are an emerging area of service delivery. Theory of change critically analyses programmes by specifying planned inputs and articulating the causal pathways that link these to anticipated outcomes. It acknowledges the changing and contested nature of these relationships. METHODS: We developed two versions of a theory of change for an online sexual health service. The first articulated the theory presented in the original programme proposal and the second documented its development in the early stages of implementation through interviews with key programme stakeholders. RESULTS: The programme proposal described an autonomous and empowered user completing a sexual health check using a more convenient, accessible and discreet online service and a shift from clinic based to online care. The stakeholder interviews confirmed this and described new and more complex patterns of service use as the online service creates opportunities for providers to contact users outside of the traditional clinic visit and users move between online and clinic based care. They described new types of user/provider relationships which we categorised as: those influenced by an online retail culture; those influenced by health promotion outreach and surveillance and those acknowledging the need for supported access. CONCLUSIONS: This analysis of stakeholder views on the likely the impacts of online sexual health services suggests three areas for further thinking and research. 1. Co-development of clinic and online services to support complex patterns of service use. 2. Developing access to online services for those who could use them with support. 3. Understanding user experience of sexual health services as increasing user autonomy and choice in some situations; creating exclusion and a need for support in others and intrusiveness and a lack of control in still others. This work has influenced the evaluation of this programme which will focus on; mapping patterns of use to understand how users move between the online and clinic based services; barriers to use of online services among some populations and how to overcome these; understanding user perceptions of autonomy in relation to online services.

Would you tell everyone this? Facebook conversations as health promotion interventions.

BACKGROUND: Health promotion interventions on social networking sites can communicate individually tailored content to a large audience. User-generated content helps to maximize engagement, but health promotion websites have had variable success in supporting user engagement. OBJECTIVE: The aim of our study was to examine which elements of moderator and participant behavior stimulated and maintained interaction with a sexual health promotion site on Facebook. METHODS: We examined the pattern and content of posts on a Facebook page. Google analytics was used to describe the number of people using the page and viewing patterns. A qualitative, thematic approach was used to analyze content. RESULTS: During the study period (January 18, 2010, to June 27, 2010), 576 users interacted 888 times with the site through 508 posts and 380 comments with 93% of content generated by users. The user-generated conversation continued while new participants were driven to the site by advertising, but interaction with the site ceased rapidly after the advertising stopped. Conversations covered key issues on chlamydia and chlamydia testing. Users endorsed testing, celebrated their negative results, and modified and questioned key messages. There was variation in user approach to the site from sharing of personal experience and requesting help to joking about sexually transmitted infection. The moderator voice was reactive, unengaged, tolerant, simplistic, and was professional in tone. There was no change in the moderator approach throughout the period studied. CONCLUSIONS: Our findings suggest this health promotion site provided a space for single user posts but not a self-sustaining conversation. Possible explanations for this include little new content from the moderator, a definition of content too narrow to hold the interest of participants, and limited responsiveness to user needs. Implications for health promotion practice include the need to consider a life cycle approach to online community development for health promotion and the need for a developing moderator strategy to reflect this. This strategy should reflect two facets of moderation for online health promotion interventions: (1) unengaged and professional oversight to provide a safe space for discussion and to maintain information quality, and (2) a more engaged and interactive presence designed to maintain interest that generates new material for discussion and is responsive to user requests.

Development and test-retest reliability of a new, self-report questionnaire assessing healthcare use and personal costs in people with inflammatory bowel disease: the Inflammatory Bowel Disease Resource Use Questionnaire (IBD-RUQ).

Background and aims: The increasing prevalence of inflammatory bowel disease (IBD) poses a substantial economic burden globally on health systems and societies. Validated instruments to collect data on healthcare and other service utilisation by patients with IBD are lacking. We developed a self-report patient questionnaire to capture key resource utilisation from health services, patient and societal perspectives. Methods: The IBD Resource Use Questionnaire (IBD-RUQ), developed by a multidisciplinary team, including patients, comprises 102 items across the six categories of outpatient visits, diagnostics, medication, hospitalisations, employment and out-of-pocket expenses over the past three months. The test-retest reliability of the IBD-RUQ was studied by administering it twice among patients with IBD with a 2-week time gap. The intraclass correlation coefficients and the average cost from the healthcare, societal and patient perspectives, between test and retest assessments, overall and by service category, were summarised. Results: The IBD-RUQ captures health service use, employment and out-of-pocket expenses. Of 55 patients who completed the first questionnaire, 48 completed the retest questionnaires and were included in the analyses. Test-retest reliability for categories of medications, diagnostics, specialist outpatient and inpatient services, and days off work due to IBD ranged from moderate to excellent; primary care visits showed more limited reliability. The annualised average self-reported health service, out-of-pocket and loss of productivity costs were £4844, £320 and £545 per patient, respectively. Conclusions: The IBD-RUQ is a reliable and valid self-report measure of resource utilisation in adults with IBD and can be used to measure costs associated with IBD.

Agreement between self-reported and researcher-measured height, weight and blood pressure measurements for online prescription of the combined oral contraceptive pill: an observational study.

OBJECTIVES: To compare agreement between self-reported height, weight and blood pressure measurements submitted to an online contraceptive service with researcher-measured values and document strategies used for self-reporting. DESIGN: An observational study. SETTING: An online sexual health service which provided the combined oral contraceptive pill, free of charge, to users in Southeast London, England. PARTICIPANTS: Between August 2017 and August 2019, 365 participants were recruited. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome, for which the study was powered, was the agreement between self-reported and researcher-measured body mass index (BMI) and blood pressure measurements, compared using kappa coefficients. Secondary measures of agreement included sensitivity, specificity and Bland Altman plots. The study also describes strategies used for self-reporting and classifies their clinical appropriateness. RESULTS: 327 participants fully described their process of blood pressure measurement with 296 (90.5%) classified as clinically appropriate. Agreement between self-reported and researcher-measured BMI was substantial (0.72 (95% CI 0.42 to 1.0)), but poor for blood pressure (0.06 (95% CI -0.11 to 0.23)). Self-reported height and weight readings identified 80.0% (95% CI 28.4 to 99.5) of individuals with a researcher-measured high BMI (≥than 35 kg/m2) and 9.1% (95% CI 0.23 to 41.3) of participants with a researcher-measured high blood pressure (≥140/90 mm Hg). CONCLUSION: In this study, while self-reported BMI was found to have substantial agreement with researcher-measured BMI, self-reported blood pressure was shown to have poor agreement with researcher-measured blood pressure. This may be due to the inherent variability of blood pressure, overdiagnosis of hypertension by researchers due to 'white coat syndrome' or inaccurate self-reporting. Strategies to improve self-reporting of blood pressure for remote prescription of the combined pill are needed.

Supported online self-management versus care as usual for symptoms of fatigue, pain and urgency/incontinence in adults with inflammatory bowel disease (IBD-BOOST): study protocol for a randomised controlled trial.

BACKGROUND: Despite being in clinical remission, many people with inflammatory bowel disease (IBD) live with fatigue, chronic abdominal pain and bowel urgency or incontinence that limit their quality of life. We aim to test the effectiveness of an online self-management programme (BOOST), developed using cognitive behavioural principles and a theoretically informed logic model, and delivered with facilitator support. PRIMARY RESEARCH QUESTION: In people with IBD who report symptoms of fatigue, pain or urgency and express a desire for intervention, does a facilitator-supported tailored (to patient needs) online self-management programme for fatigue, pain and faecal urgency/incontinence improve IBD-related quality of life (measured using the UK-IBDQ) and global rating of symptom relief (0-10 scale) compared with care as usual? METHODS: A pragmatic two-arm, parallel group randomised controlled trial (RCT), of a 12-session facilitator-supported online cognitive behavioural self-management programme versus care as usual to manage symptoms of fatigue, pain and faecal urgency/incontinence in IBD. Patients will be recruited through a previous large-scale survey of unselected people with inflammatory bowel disease. The UK Inflammatory Bowel Disease Questionnaire and global rating of symptom relief at 6 months are the co-primary outcomes, with multiple secondary outcomes measured also at 6 and 12 months post randomisation to assess maintenance. The RCT has an embedded pilot study, health economics evaluation and process evaluation. We will randomise 680 patients, 340 in each group. Demographic characteristics and outcome measures will be presented for both study groups at baseline. The UK-IBDQ and global rating of symptom relief at 6 and 12 months post randomisation will be compared between the study groups. DISCUSSION: The BOOST online self-management programme for people with IBD-related symptoms of fatigue, pain and urgency has been designed to be easily scalable and implemented. If it is shown to improve patients' quality of life, this trial will enable clinicians and patients to make informed management decisions. This is the first trial, to our knowledge, focused on multiple symptoms prioritised by both people with IBD and health professionals. TRIAL REGISTRATION: ISRCTN71618461 . Registered on 9 September 2019.

Expanding choice through online contraception: a theory of change to inform service development and evaluation.

BACKGROUND: This study presents the theory of change underpinning an intervention to provide online contraceptive care in an inner London area with high rates of unplanned pregnancy. It aims to suggest attributes of an effective service and to identify key questions for its evaluation. METHODS: Thematic analysis of an online sexual and reproductive health programme funding application and 21 semi-structured interviews with a purposive sample of stakeholders selected to provide expertise in contraception and online health. RESULTS: A theory of change model summarised the positive processes of change which could be initiated through increased access to contraceptive supplies, online information and remote interaction and support. Stakeholders predicted that perceptions of convenience and anonymity of online access would vary across the target population. They stressed the importance of trusting service-users' capabilities for autonomous contraceptive decision-making, but expressed concerns that online access could be detrimental for those requiring more complex care. Concerns were alleviated by the prospect of responsive support through text messaging and phone calls, and when the online service was positioned as part of a broader system of provision including physical services. CONCLUSIONS: This study has revealed priority areas for the ongoing development of an online contraception service and pertinent evaluation questions. Evaluative research should test assumptions within the theory of change model, exploring the characteristics and circumstances of those preferring online access over existing services and the value of convenience, anonymity, autonomous access and responsive support in executing effective contraceptive choices within a new landscape of contraceptive delivery.

Online testing for sexually transmitted infections: A whole systems approach to predicting value.

BACKGROUND: Online testing for sexually transmitted infections has a lower unit cost than testing in clinical services and economic analysis has focused on the cost per test and cost per diagnosis in clinics and online. However, online services generate new demand for testing and shift activity between services, requiring system-level analysis to effectively predict cost-effectiveness. METHODS AND FINDINGS: Routinely collected, anonymised, retrospective data on sexual health service activity from all specialist services (clinic and online) within an inner London sexual health economy were collated and harmonised to generate a complete dataset of individual level clinic attendances. Clinic activity and diagnoses were coded using nationally standardised codes assigned by clinicians. Costs were taken from locally or regionally agreed sexual health tariffs. The introduction of online services changed patterns of testing. In an inner London sexual health economy, online STI testing increased total number of tests, the total cost of testing and total diagnoses while slightly reducing the average cost per diagnosis. Two years after the introduction of online services 37% of tests in the were provided online and total diagnoses increased. The positivity of online services is generally lower than that in clinics but varies between contexts. Where the positivity ratio between clinic and online is less than the cost ratio, online services will reduce cost per diagnosis. In this analysis, areas with different classifications as urban and rural had different clinic/online positivity ratios changing the cost effectiveness between areas. Even after the introduction of online services, simple STI testing activity continues in clinics and providers should consider online-first options where clinically appropriate. CONCLUSIONS: Online services for STI testing are not 'stand alone'. They change STI testing behaviour with impacts on all elements of the sexual health economy. Planning, development and monitoring of such services should reference the dynamic nature of these systems and the role of online services within them.

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.

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. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN): 13354298; http://www.isrctn.com/ISRCTN13354298 (Archived by WebCite at http://www.webcitation.org/6d9xT2bPj).

Can text messages increase safer sex behaviours in young people? Intervention development and pilot randomised controlled trial.

BACKGROUND: Younger people bear the heaviest burden of sexually transmitted infections (STIs). Partner notification, condom use and STI testing can reduce infection but many young people lack the knowledge, skills and confidence needed to carry out these behaviours. Text messages can provide effective behavioural support. The acceptability and feasibility of a randomised controlled trial of safer sex support delivered by text message are not known. OBJECTIVES: To assess the acceptability and feasibility of a randomised controlled trial of a safer sex intervention delivered by text message for young people aged 16-24 years. DESIGN: (1) Intervention development; (2) follow-up procedure development; (3) a pilot, parallel-arm randomised controlled trial with allocation via remote automated randomisation (ratio of 1 : 1) (participants were unmasked, whereas researchers analysing samples and data were masked); and (4) qualitative interviews. SETTING: Participants were recruited from sexual health services in the UK. PARTICIPANTS: Young people aged 16-24 years diagnosed with chlamydia or reporting unprotected sex with more than one partner in the last year. INTERVENTIONS: A theory- and evidence-based safer sex intervention designed, with young people's input, to reduce the incidence of STIs by increasing the correct treatment of STIs, partner notification, condom use and STI testing before unprotected sex with a new partner. The intervention was delivered via automated mobile phone messaging over 12 months. The comparator was a monthly text message checking contact details. MAIN OUTCOME MEASURES: (1) Development of the intervention based on theory, evidence and expert and user views; (2) follow-up procedures; (3) pilot trial primary outcomes: full recruitment within 3 months and follow-up rate for the proposed primary outcomes for the main trial; and (4) participants' views and experiences regarding the acceptability of the intervention. RESULTS: In total, 200 participants were randomised in the pilot trial, of whom 99 were allocated to the intervention and 101 were allocated to the control. We fully recruited early and achieved an 81% follow-up rate for our proposed primary outcome of the cumulative incidence of chlamydia at 12 months. There was no differential follow-up between groups. In total, 97% of messages sent were successfully delivered to participants' mobile phones. Recipients reported that the tone, language, content and frequency of messages were appropriate. Messages reportedly increased knowledge of and confidence in how to use condoms and negotiate condom use and reduced stigma about STIs, enabling participants to tell a partner about a STI. CONCLUSIONS: Our research shows that the intervention is acceptable and feasible to deliver. Our pilot trial demonstrated that a main trial is feasible. It remains unclear which behaviour change techniques and elements of the intervention or follow-up procedures are associated with effectiveness. A further limitation is that in the trial one person entering data and the participants were unmasked. A randomised controlled trial to establish the effects of the intervention on STIs at 12 months is needed. TRIAL REGISTRATION: Current Controlled Trials ISRCTN02304709. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 57. See the NIHR Journals Library website for further project information.

Exploration of gender differences of Chlamydia trachomatis infection amongst young people reveals limitations of using sexual histories to assess risk in high-prevalence areas.

In England, chlamydia positivity in young men occurs at a slightly older age group (20-24 years) than positivity among young women (16-20 years) but total rates of infection among the population aged under 25 years are similar. Where there is variation, explanations often focus on individual sexual risk behaviours. We aimed to explore the extent to which variations in chlamydia positivity could be explained by reasons for attendance and sexual behaviour at a sexual health clinic in a high-prevalence area of England. Data routinely collected during clinic appointments were extracted retrospectively from the medical records of 952 clinic users (634 women) aged 16 to 24. We tested for associations with chlamydia positivity using the Chi square statistic and multiple logistic regression for men and women separately; 19.5% of men tested positive (95% CI: 15.1-23.8) compared to 11.5% of women (95% CI: 9.0-14.0). Reporting a partner with symptoms or a sexually transmitted infection diagnosis was significantly associated with a positive diagnosis (Men OR: 3.14, 95% CI: 1.5-6.25; Women OR: 3.78, 95% CI: 1.83-7.83). All other reasons for attendance and all sexual behaviour variables were not significantly associated with a positive diagnosis. Differences in chlamydia positivity between men and women attending this service cannot be explained by individual sexual behaviours found to be associated with higher risk of infection in national studies. Our findings question the utility of individual behavioural data routinely collected during clinic appointments for predicting risk of sexually transmitted infections in high-prevalence areas.