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

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          Abstract

          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.

          Abstract

          In a single-blind randomised trial, Emma Wilson and colleagues assess the impact of an e-STI service on testing uptake and cases diagnosed.

          Author summary

          Why was this study done?
          • Internet-accessed sexually transmitted infection testing (e-STI testing) is increasingly available. Yet the effectiveness of e-STI testing compared to face-to-face services is unclear.

          What did the researchers do and find?
          • We conducted a large randomised controlled trial in London, United Kingdom, to assess the effects of an e-STI testing and results service (SH:24) on uptake of STI testing and STI cases diagnosed and treated, when delivered alongside usual care.

          • The intervention offered postal self-sampling test kits for chlamydia, gonorrhoea, HIV, and syphilis, results delivered via text message or telephone, and web-based safer sex health information.

          • We found that e-STI testing almost doubled uptake of testing among all groups, including groups at high risk for STIs.

          • A larger study is required to understand the effects of e-STI testing on STI diagnosis and STI cases treated.

          • Further research is required to evaluate the proportion of those diagnosed who are treated. Our findings suggest that additional inputs may be required to strengthen linkages to treatment (e.g., postal treatment).

          What do these findings mean?
          • e-STI testing should be considered as a complement to existing services and as an effective measure to increase uptake of STI testing.

          • The effect of e-STI testing on cases diagnosed and treated requires further evaluation.

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          Most cited references28

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          Increasing response rates to postal questionnaires: systematic review.

          To identify methods to increase response to postal questionnaires. Systematic review of randomised controlled trials of any method to influence response to postal questionnaires. 292 randomised controlled trials including 258 315 participants INTERVENTION REVIEWED: 75 strategies for influencing response to postal questionnaires. The proportion of completed or partially completed questionnaires returned. The odds of response were more than doubled when a monetary incentive was used (odds ratio 2.02; 95% confidence interval 1.79 to 2.27) and almost doubled when incentives were not conditional on response (1.71; 1.29 to 2.26). Response was more likely when short questionnaires were used (1.86; 1.55 to 2.24). Personalised questionnaires and letters increased response (1.16; 1.06 to 1.28), as did the use of coloured ink (1.39; 1.16 to 1.67). The odds of response were more than doubled when the questionnaires were sent by recorded delivery (2.21; 1.51 to 3.25) and increased when stamped return envelopes were used (1.26; 1.13 to 1.41) and questionnaires were sent by first class post (1.12; 1.02 to 1.23). Contacting participants before sending questionnaires increased response (1.54; 1.24 to 1.92), as did follow up contact (1.44; 1.22 to 1.70) and providing non-respondents with a second copy of the questionnaire (1.41; 1.02 to 1.94). Questionnaires designed to be of more interest to participants were more likely to be returned (2.44; 1.99 to 3.01), but questionnaires containing questions of a sensitive nature were less likely to be returned (0.92; 0.87 to 0.98). Questionnaires originating from universities were more likely to be returned than were questionnaires from other sources, such as commercial organisations (1.31; 1.11 to 1.54). Health researchers using postal questionnaires can improve the quality of their research by using the strategies shown to be effective in this systematic review.
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            Prevalence, risk factors, and uptake of interventions for sexually transmitted infections in Britain: findings from the National Surveys of Sexual Attitudes and Lifestyles (Natsal)

            Summary Background Population-based estimates of prevalence, risk distribution, and intervention uptake inform delivery of control programmes for sexually transmitted infections (STIs). We undertook the third National Survey of Sexual Attitudes and Lifestyles (Natsal-3) after implementation of national sexual health strategies, and describe the epidemiology of four STIs in Britain (England, Scotland, and Wales) and the uptake of interventions. Methods Between Sept 6, 2010 and Aug 31, 2012, we did a probability sample survey of 15 162 women and men aged 16–74 years in Britain. Participants were interviewed with computer-assisted face-to-face and self-completion questionnaires. Urine from a sample of participants aged 16–44 years who reported at least one sexual partner over the lifetime was tested for the presence of Chlamydia trachomatis, type-specific human papillomavirus (HPV), Neisseria gonorrhoeae, and HIV antibody. We describe age-specific and sex-specific prevalences of infection and intervention uptake, in relation to demographic and behavioural factors, and explore changes since Natsal-1 (1990–91) and Natsal-2 (1999–2001). Findings Of 8047 eligible participants invited to provide a urine sample, 4828 (60%) agreed. We excluded 278 samples, leaving 4550 (94%) participants with STI test results. Chlamydia prevalence was 1·5% (95% CI 1·1–2·0) in women and 1·1% (0·7–1·6) in men. Prevalences in individuals aged 16–24 years were 3·1% (2·2–4·3) in women and 2·3% (1·5–3·4) in men. Area-level deprivation and higher numbers of partners, especially without use of condoms, were risk factors. However, 60·4% (45·5–73·7) of chlamydia in women and 43·3% (25·9–62·5) in men was in individuals who had had one partner in the past year. Among sexually active 16–24-year-olds, 54·2% (51·4–56·9) of women and 34·6% (31·8–37·4) of men reported testing for chlamydia in the past year, with testing higher in those with more partners. High-risk HPV was detected in 15·9% (14·4–17·5) of women, similar to in Natsal-2. Coverage of HPV catch-up vaccination was 61·5% (58·2–64·7). Prevalence of HPV types 16 and 18 in women aged 18–20 years was lower in Natsal-3 than Natsal-2 (5·8% [3·9–8·6] vs 11·3% [6·8–18·2]; age-adjusted odds ratio 0·44 [0·21–0·94]). Gonorrhoea (<0·1% prevalence in women and men) and HIV (0·1% prevalence in women and 0·2% in men) were uncommon and restricted to participants with recognised high-risk factors. Since Natsal-2, substantial increases were noted in attendance at sexual health clinics (from 6·7% to 21·4% in women and from 7·7% to 19·6% in men) and HIV testing (from 8·7% to 27·6% in women and from 9·2% to 16·9% in men) in the past 5 years. Interpretation STIs were distributed heterogeneously, requiring general and infection-specific interventions. Increases in testing and attendance at sexual health clinics, especially in people at highest risk, are encouraging. However, STIs persist both in individuals accessing and those not accessing services. Our findings provide empirical evidence to inform future sexual health interventions and services. Funding Grants from the UK Medical Research Council and the Wellcome Trust, with support from the Economic and Social Research Council and the Department of Health.
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              Smoking cessation support delivered via mobile phone text messaging (txt2stop): a single-blind, randomised trial

              Summary Background Smoking cessation programmes delivered via mobile phone text messaging show increases in self-reported quitting in the short term. We assessed the effect of an automated smoking cessation programme delivered via mobile phone text messaging on continuous abstinence, which was biochemically verified at 6 months. Methods In this single-blind, randomised trial, undertaken in the UK, smokers willing to make a quit attempt were randomly allocated, using an independent telephone randomisation system, to a mobile phone text messaging smoking cessation programme (txt2stop), comprising motivational messages and behavioural-change support, or to a control group that received text messages unrelated to quitting. The system automatically generated intervention or control group texts according to the allocation. Outcome assessors were masked to treatment allocation. The primary outcome was self-reported continuous smoking abstinence, biochemically verified at 6 months. All analyses were by intention to treat. This study is registered, number ISRCTN 80978588. Findings We assessed 11 914 participants for eligibility. 5800 participants were randomised, of whom 2915 smokers were allocated to the txt2stop intervention and 2885 were allocated to the control group; eight were excluded because they were randomised more than once. Primary outcome data were available for 5524 (95%) participants. Biochemically verified continuous abstinence at 6 months was significantly increased in the txt2stop group (10·7% txt2stop vs 4·9% control, relative risk [RR] 2·20, 95% CI 1·80–2·68; p<0·0001). Similar results were obtained when participants that were lost to follow-up were treated as smokers (268 [9%] of 2911 txt2stop vs 124 [4%] of 2881 control [RR 2·14, 95% CI 1·74–2·63; p<0·0001]), and when they were excluded (268 [10%] of 2735 txt2stop vs 124 [4%] of 2789 control [2·20, 1·79–2·71; p<0·0001]). No significant heterogeneity was shown in any of the prespecified subgroups. Interpretation The txt2stop smoking cessation programme significantly improved smoking cessation rates at 6 months and should be considered for inclusion in smoking cessation services. Funding UK Medical Research Council, Primary Care Research Networks.
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                Author and article information

                Contributors
                Role: ConceptualizationRole: Data curationRole: InvestigationRole: MethodologyRole: Project administrationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: InvestigationRole: MethodologyRole: SupervisionRole: Writing – original draftRole: Writing – review & editing
                Role: Formal analysisRole: MethodologyRole: Writing – review & editing
                Role: InvestigationRole: Project administrationRole: Writing – review & editing
                Role: SoftwareRole: Writing – review & editing
                Role: SupervisionRole: Writing – review & editing
                Role: Data curationRole: Writing – review & editing
                Role: Data curationRole: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: ConceptualizationRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: SupervisionRole: Writing – original draftRole: Writing – review & editing
                Role: Academic Editor
                Journal
                PLoS Med
                PLoS Med
                plos
                plosmed
                PLoS Medicine
                Public Library of Science (San Francisco, CA USA )
                1549-1277
                1549-1676
                27 December 2017
                December 2017
                : 14
                : 12
                : e1002479
                Affiliations
                [1 ] Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, United Kingdom
                [2 ] Medical Research Council Clinical Trials Unit at UCL, London, United Kingdom
                [3 ] King’s Centre for Global Health and Health Partnerships, School of Population Health & Environmental Sciences, King’s College London, London, United Kingdom
                [4 ] Burrell Street Sexual Health Clinic, Guy’s and St Thomas’ NHS Foundation Trust, London, United Kingdom
                [5 ] Department of Sexual Health and HIV, King’s College Hospital NHS Foundation Trust, London, United Kingdom
                World Health Organization, SWITZERLAND
                Author notes

                I have read the journal's policy and the authors of this manuscript have the following competing interests: EW, SB and ER report receiving PhD studentships from Guy's and St. Thomas' charity via SH:24 (a not-for-profit community interest company); PB, ASM-J and JS report grants from Guy’s and St Thomas’ charity via SH:24 (a not-for-profit community interest company) during the conduct of the study; CF reports receiving funding for her time from Guy’s and St Thomas’ Charity paid via SH:24 (a not-for-profit community interest company). PB and ASM-J are both directors of SH:24 (a not-for-profit community interest company).

                ‡ These authors are joint senior authors on this work.

                Author information
                http://orcid.org/0000-0001-7091-2417
                http://orcid.org/0000-0001-5850-3610
                http://orcid.org/0000-0002-4479-1604
                http://orcid.org/0000-0002-0227-2152
                Article
                PMEDICINE-D-17-02796
                10.1371/journal.pmed.1002479
                5744909
                29281628
                2887c335-b65d-4b94-a1ba-9d31705cbe1e
                © 2017 Wilson et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 10 August 2017
                : 23 November 2017
                Page count
                Figures: 3, Tables: 4, Pages: 20
                Funding
                Funded by: funder-id http://dx.doi.org/10.13039/501100000380, Guy's and St Thomas' Charity;
                Award ID: MAJ120505
                Award Recipient :
                Funded by: Medical Research Council (GB)
                Award ID: MC_UU_12023/21
                Award Recipient :
                Funded by: funder-id http://dx.doi.org/10.13039/501100000265, Medical Research Council;
                Award ID: MC_UU_12023/29
                Award Recipient :
                Guy's and St Thomas' Charity funded the study (grant number MAJ120505). PB was the principal grant holder. EW, JS, IA, SB, ER, CF were also supported by this grant. https://www.gsttcharity.org.uk/. TPM was supported by the Medical Research Council (grant numbers MC_UU_12023/21 and MC_UU_12023/29). https://www.mrc.ac.uk/. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
                Categories
                Research Article
                Medicine and Health Sciences
                Infectious Diseases
                Sexually Transmitted Diseases
                Biology and Life Sciences
                Organisms
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                Chlamydia
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                Diagnostic medicine
                HIV diagnosis and management
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                Urology
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