{"paper_id":"efc2e7f1-a9bd-4d7d-a6e4-88e131d7fa4a","body_text":"Control of fertility, and feeling satisfied with a chosen method of contraception are\ncrucial to the health and wellbeing of women, but unintended pregnancy remains\ncommon and costly for individuals and for health services. Globally, about 40% of\npregnancies are estimated to be unplanned. 1  In Britain, around 45% of pregnancies are unplanned or ambivalent 2  despite a range of freely available effective contraceptive methods, and\nabortion rates in England and Wales have changed little since 2011. 3\nPreventing unintended pregnancy involves many steps, including timely education,\nawareness and socially influenced behaviours to seek, choose and use contraception\nconsistently and correctly. 4  Health services have a key role to play by supporting people to choose and\nuse an appropriate method that best meets their needs, but many people are not aware\nof the range of different methods available to them. 5 , 6  The contraceptive pill and\ncondoms are well known and widely used, but are not the most effective contraceptive\nmethods. Long-acting reversible contraception (LARC), which includes intrauterine\ndevices, intrauterine systems, implants and injections, are at least 20 times more\neffective than oral contraceptive pills and condoms 7 , 8  but these methods are less well\nknown, and not all services have the capacity to fit them. 9\nIncreasingly women turn to online sources of information on sexual health, 10  but information is of variable quality and accuracy 11  and misperceptions about contraception are common. 12  Hormonal contraception methods have many potential benefits apart from\ncontrol of fertility, including treatment of acne, reduced period pain, lighter\nperiods or no withdrawal bleeds, and reduction in premenstrual symptoms, 13  but women may be more aware of risks and side effects than benefits of contraception. 12\nInteractive (tailored) digital interventions are effective for increasing\ncontraception knowledge 14  uptake of more effective contraceptive methods and contraception\nadherence, 15 – 17  and decreasing\nunplanned pregnancy. 18 , 19  Digital interventions offer the advantages of intervention\ncontent accuracy and fidelity, and the potential to reach large audiences with\nrelatively low dissemination costs. 20  We therefore developed an interactive website to aid informed choice of\ncontraceptive method and then conducted a randomised controlled trial to evaluate\nits impact in clinic populations.\n\nTo assess the efficacy of the  Contraception Choices  website in\ncomparison with control (waiting list) on uptake of long-acting contraceptive\nmethods, and satisfaction with method choice in young women.\n\nWe conducted an individually randomised, parallel group-controlled trial that started\nas a feasibility trial and ended as an efficacy (clinical) trial. Approval was given\nby London Camden & Kings Cross Research Ethics Committee (Reference\n17/LO/0112).\nWe conducted two systematic reviews of the literature to generate the evidence\nbase for the website: a review of reviews of factors influencing contraception\nchoice and use and a review of interactive digital interventions for\ncontraception. To gain the views of contraceptive users, we recruited women from\nsites in London that represent the settings in which the great majority of\ncontraceptive care occurs in the UK: 21  a general practice, two sexual health centres, an abortion clinic, a\ncommunity pharmacy and an antenatal clinic. Eligibility criteria were women aged\n15–30 years, ability to give informed consent, and interest in taking part in\ncontraceptive research. We conducted focus groups and individual interviews to\nexplore the views of 74 young women relating to contraception (access,\nacceptability, barriers, concerns, benefits and personal decisions around\nchoices) and their views on website design and content. Working iteratively with\nthe young women and a commercial software company (Moore Wilson), we synthesised\nthe findings from the systematic reviews and qualitative research with women’s\nviews to develop a trial-ready, self-guided website offering tailored\nadvice.\nThe  Contraception Choices  website offers tailored information to\nhelp users to decide which method of contraception might suit them best, to\nfacilitate informed choices, satisfaction with choice, and uptake of more\neffective methods (Logic Model, supplementary material).  Contraception\nChoices  provides information about contraception: videos of women\nand health professionals discussing contraceptive experiences, concerns and\nmisperceptions; an infographic representing contraception effectiveness;\n Did you Know?  and  Contraception FAQ \nsections which address common concerns, and an interactive decision tool\n What’s right for me?  (See Supplementary file: Screenshots).\nThe  What’s right for me?  tool ( Figure 2 ) elicits seven individual\npriorities concerning contraception attributes. For example, selecting ‘Regular\nperiods’ highlights methods compatible with regular periods (simultaneously\nfading out those that can alter the menstrual cycle) and the algorithm scores\nthe highlighted methods more highly. Three methods most consistent with the\nindividual’s preferences are displayed and compared side-by-side, and the user\ncan export their results by email or text message.  www.contraceptionchoices.org  ( Figure 1a  and  Figure 1b ).\nContraception Choices  website: home page.\nThe website content and design is underpinned by a number of different\ntheoretical principles including the following:  Human-centred design  and  collaboration with target\nusers – we involved target users in content and design\ndecisions, to ensure that content met young women’s needs,\npriorities and preferences. 20 Tailoring  – the  What’s right for me? \ndecision tool offers tailored information on contraception method\nchoices to increase relevance for more effective learning,\nengagement, and behaviour change. 22 Health belief model  – the  Effectiveness \ninfographic addresses perceptions of risk of pregnancy, showing the\nrelative effectiveness of different contraception methods. Social cognitive theory  –  Contraception\nChoices  videos draw on the influence of peers by\nfeaturing young women discussing their experiences of contraception\nincluding the potential benefits of different methods. The  COM B model: capability, opportunity, motivation-behaviour\nmodel 23  – this takes into account factors which are on pathways to\nbehaviour change. A  social determinants of health framework 24  underpins the design of two infographics which convey\nbarriers to contraception use across different domains: individual\nwomen, partners, family, peers, community, health services and wider\nsociety.\nHuman-centred design  and  collaboration with target\nusers – we involved target users in content and design\ndecisions, to ensure that content met young women’s needs,\npriorities and preferences. 20\nTailoring  – the  What’s right for me? \ndecision tool offers tailored information on contraception method\nchoices to increase relevance for more effective learning,\nengagement, and behaviour change. 22\nHealth belief model  – the  Effectiveness \ninfographic addresses perceptions of risk of pregnancy, showing the\nrelative effectiveness of different contraception methods.\nSocial cognitive theory  –  Contraception\nChoices  videos draw on the influence of peers by\nfeaturing young women discussing their experiences of contraception\nincluding the potential benefits of different methods.\nThe  COM B model: capability, opportunity, motivation-behaviour\nmodel 23  – this takes into account factors which are on pathways to\nbehaviour change.\nA  social determinants of health framework 24  underpins the design of two infographics which convey\nbarriers to contraception use across different domains: individual\nwomen, partners, family, peers, community, health services and wider\nsociety.\n\nInclusion criteria: women aged 15–30 years with a current or future need for\ncontraception, attending one of the study sites, able to read English, with an\nactive email account and access to the internet and willing to be followed up for 6\nmonths. Exclusion criteria: unable to provide informed consent (e.g. severe learning\ndifficulties) or need for a language advocate (because the intervention was intended\nto be accessed in private). At the sites described above, women waiting for their\nappointment (or in the pharmacy) were approached by a researcher with a ‘tablet’\ncomputer and invited to take part in the trial. Women recruited via the online\nbooking system were sent a text message inviting them to view the\n Contraception Choices  website before their booked appointment.\nThose who expressed interest were recruited online via the tablet computer using\nsoftware designed specifically for this trial, to confirm eligibility and register\ninformed consent.\nParticipants were asked to complete a short questionnaire at baseline which\nincluded demographic data (age, ethnicity, highest completed level of education)\nand whether English was their first language; current use of contraception, or\nreasons for non-use (including being pregnant); contraception method; from where\nthe method was obtained, and whether it was free or paid for; satisfaction with\ncurrent contraception (very satisfied, satisfied, neither satisfied or\ndissatisfied, dissatisfied and very dissatisfied); ever used contraceptive\nmethods (same list as current use); and self-reported sexually transmitted\ninfections in the last 3 months. Automated, computerised randomisation occurred\nimmediately after baseline data collection.\nA randomisation list was generated by a random number based algorithm in the\ncomputer software Stata 25  and incorporated into the trial software programme to allocate all\nparticipants to either the intervention or control group. The randomisation list\nwas stratified by setting and used varying block sizes. Allocation was immediate\n(online) and concealed. Those randomised online to the intervention group gained\naccess to the  Contraception Choices  website immediately; women\nrandomised to the control group could access the website at the end of data\ncollection, at which point we emailed them with a link to the website.\nAt 3 and 6 month follow-up, participants were emailed a short online survey\nasking what method of contraception they were using (including none) and how\nsatisfied they were with the method; whether they had had a pregnancy and, if\nso, the outcome of the pregnancy (ongoing, gave birth, miscarried, terminated,\nor prefer not to say); and self-reported sexually transmitted infection in the\nprevious 3 months.\nAll participants were asked whether they had visited the  Contraception\nChoices  website (control participants were asked in order to assess\n‘contamination’) and asked a free-text question: “Has being in the study had any\ngood or bad effects on your life?” Intervention group participants only were\nasked further questions about the website: how helpful it was in terms of\n‘getting useful information about contraception’ and ‘finding a method of\ncontraception that is right for you’ (five response options from very helpful to\nvery unhelpful); whether they had discussed the website with anyone (including a\ndoctor or nurse, pharmacist, partner, family or friends) and “What did you like\nor dislike about the website?” (as a free-text question).\nParticipants were sent electronic vouchers for completing follow-up surveys (£5\nfor the 3 month survey, £15 for the 6 month survey). All follow-up emails\nincluded a link to enable participants to withdraw from the study, including one\nsent immediately after enrolment.\nThe analysis of the primary outcomes was conducted blinded to allocation.\nThe primary outcome for the initial feasibility trial was follow-up rate at 6\nmonths. Secondary outcomes at 6 months were: effectiveness of contraceptive\nmethod used, grouped from least to most effective as follows: no method,\nwithdrawal or natural method, condoms or diaphragm, pill, patch or ring, LARC or\nsterilisation; change in effectiveness of method between baseline and 6 months;\npregnancy and sexually transmitted infection.\nAs we were developing  Contraception Choices , its popularity with\nyoung women became very evident. Moreover, our presentations of the website to\ncolleagues were met with demand to use it immediately in clinical practice.\nFuture funding for a definitive trial was highly uncertain and withholding the\nwebsite for a number of years, in order that a definitive trial with a control\ngroup of women who had not seen the website might be funded and completed, felt\nunpalatable. Fortunately, the opportunity arose to increase recruitment at\nminimal cost (see below) and so we were able to expand the feasibility trial\ninto an efficacy trial by substituting the primary outcome (follow-up rate at 6\nmonths) for two primary clinical outcomes that were originally secondary\noutcomes – use of LARC at 6 months and satisfaction with contraceptive method at\n6 months. (We pre-specified that we would consider the trial to have\ndemonstrated superiority of the intervention if a statistically significant\nbenefit were observed for one or both outcomes without clear evidence of harm\nfor either). Secondary outcomes were effectiveness of contraceptive method at 6\nmonths; change in method from baseline to 6 months; pregnancy by 6 months and\ndiagnosed sexually transmitted infection reported at 3 or 6 months.\nTo increase recruitment for the efficacy trial, we took advantage of an online\nbooking system for appointments at one site (sexual and reproductive health\nclinic) by adding a hyperlink about the trial into the text message that women\nreceived to confirm their contraception clinic appointment. Clicking on the\nhyperlink took them directly to the trial website for recruitment and\nrandomisation.\nThe original target sample size for the feasibility trial was 80 participants per\nsetting, based on estimating a follow-up rate at 6 months of 70% to within 10%\nprecision (95% CI 60% to 80%) for each setting. Changing the design to a\nclinical efficacy trial resulted in a total sample size of 930 participants,\nbased on the power to assess the effect of the intervention on the revised\nprimary outcome, use of LARC at 6 month follow-up. Specifically, assuming a\nfollow-up rate of 70%, this sample size provides at 82% power to detect as\nsignificant (at the 5% level) an increase from 35% (control group prevalence) to\n47% in LARC use in the intervention group. No formal sample size calculation was\nmade for the other primary outcome. The standard 5% significance level was taken\nbecause although there are two primary outcomes we use results from both to\nassess whether the intervention is beneficial.\nThe primary analysis was by modified intention-to-treat, basing analysis on those\nwho completed at least one follow-up outcome questionnaire. For each primary and\nsecondary outcome listed earlier we present the percentage of participants if\nthe outcome is binary (e.g. use of LARC) or ordinal (e.g. effectiveness of\nmethod, satisfaction with method) together with a 95% confidence interval. These\npercentages and means are reported separately by intervention and standard care\narm. To formally assess differences between arms we used logistic regression\n(for binary outcomes), or ordinal logistic regression (for ordinal outcomes),\nreporting adjusted odds ratios with 95% confidence intervals.\nThe primary outcome of LARC use at 6 months was analysed among women in need of\ncontraception (i.e. not pregnant or currently trying to become pregnant) and the\nprimary outcome of satisfaction with method was analysed among women who were\nusing a method at 6 months. The primary outcome of LARC use at 6 months was\nanalysed stratified by LARC use at baseline, leading to three intervention\neffects: the effect in baseline LARC users, the effect in baseline non-users,\nand the overall effect adjusted for baseline LARC use. We pre-specified that if\nfewer than 90% of baseline LARC users in the control arm are using a LARC method\nat 6 months, then the primary effect measure would be the overall adjusted\nintervention effect, and otherwise (due to limited scope for increase in\nbaseline LARC users) the primary effect measure would be the effect in baseline\nnon-users only. Besides adjustment for baseline LARC use, analysis of both\nprimary outcomes was also adjusted for satisfaction with method at baseline and\nby setting. A further subgroup analysis, based on testing an interaction term,\nwas conducted for both primary outcomes to assess whether the effect of the\nintervention varies by setting (specifically between online and in-person\nrecruitment). Comparisons for the primary outcomes between arms were based on\nmultiple imputation where the primary outcomes at 6 months were imputed based on\nthe outcomes at 3 months for participants who completed the 3 month outcome\nquestionnaire but failed to complete the questionnaire at 6 months. Imputation\nwas conducted using the chained equations approach and implemented using the mi\nimpute function, 10  twenty imputed datasets were generated. Considering our secondary\noutcomes, analysis of contraceptive effectiveness was restricted to women in\nneed of contraception at 6 months, reporting of a change in method was\nrestricted to women in need of contraception at both baseline and 6 months, and\nanalysis of pregnancy at 6 months was restricted to women who were not pregnant\nor trying for a baby at baseline. All analysis was conducted in Stata 15\nsoftware.\nA post hoc decision was made to conduct a ‘per-protocol’ analysis for the primary\noutcomes based on a comparison of intervention arm participants who reported\nseeing the  Contraception Choices  website with all control arm\nparticipants.\nAll free-text comments from the 3 month and 6 month trial follow up surveys were\nimported into NVIVO software, and coded. We used thematic analysis to identify\npatterns and links across the data set. Two researchers (AG and JAS)\nindependently coded the data, categorised data by theme, and identified\nrelationships between concepts to develop a coding frame. Coding decisions were\nreviewed by a third researcher (JB).\nThe funding source had no role in the writing of the manuscript or the decision\nto submit it for publication.\n\nThe first participant was randomised on 4 July 2017 and the last on 22 December\n2017. The first recruitment through the online booking service was on 31 October\nand the last on 22 December 2017. Recruitment online was much faster than in the\nclinics. It took approximately 6 months to recruit 419 women from the clinic\nsites, and just over seven weeks to recruit 508 women via the online booking\nsystem ( Table\n1 ).\nBaseline characteristics by study arm.\nLARC: long-acting reversible contraception\nThe last follow-up survey was completed on 16 August 2018. The CONSORT diagram\n( Figure 2 ) details\nthe flow of participants through the trial. In total, 927 women were randomised\nto the website (n = 464) or to control group (n = 463) of whom 739 (80%)\nprovided follow-up data at 6 months, and 786 women (86%) provided data at 3\nand/or 6 months for analysis of primary outcomes with imputation.\nCONSORT diagram.\nFollow-up rates were similar across all sites (data not shown) except for the\nabortion service, where the follow-up rate was only 50%. The quality of the\nfollow up survey data collected was very high, with all respondents providing\nthe primary outcome data. Eighteen (2%) women (11 in the intervention group and\n7 in the control group) withdrew from the trial without offering reasons but\nthey did not request that their data be withdrawn from analysis.\nThe proportion of women who reported that they had seen the  Contraception\nChoices  website at any time during the trial was 86% in the\nintervention group and 7% in the control group, indicating good exposure in the\nintervention group and little ‘contamination’ in the control group.\nJust over two-thirds of participants were from White ethnic groups, half were\neducated to degree level and four-fifths reported English as their first\nlanguage ( Table 1 ).\nTen percent were pregnant at enrolment, while 90% indicated a current need for\ncontraception to avoid unintended pregnancy. The most common method reported at\nbaseline was the oral contraceptive pill at 39.5% (n = 167) in the intervention\ngroup and 34.6% (n = 146) in the control group, followed by LARC methods ( Table 1 ). Around\ntwo-thirds of women were satisfied with their current method at baseline. (Only\none woman reported being sterilised at baseline; she is not included in\nsubsequent analysis because she did not complete a follow-up.)\nThere were no significant difference between intervention and control groups in\nthe proportion of women using LARC at 6 months [30.4% intervention\n versus  31.0% control; adjusted odds ratio after imputation\n0.87 (95% confidence interval 0.60–1.28)], or in level of satisfaction with\ncontraceptive method [proportion being ‘satisfied’ or ‘very satisfied’ 82.6%\nintervention  versus  82.1% control; adjusted ordinal odds ratio\nafter imputation 0.93 (95% CI 0.69–1.25) based on the five ordered\nresponses].\nAround half of the participants in each group changed their method of\ncontraception between baseline and 6 months; the most common change was to a\nmore effective method (24% intervention group; 21% control) but 19% in the\nintervention group and 16% in the control group changed to a less effective\nmethod ( Table 2 ).\nAmong women who were using LARC at baseline, the proportion using LARC at 6\nmonths was significantly higher in the control group than the intervention group\n( Table 2 ). Among\nparticipants not using LARC at baseline, there was a non-significantly higher\nproportion using LARC at 6 months in the intervention group. Across both study\narms, satisfaction with method of contraception improved from around two-thirds\nat baseline to four-fifths at follow-up. There was no difference between groups\nin the proportion of women who were pregnant at 6 months (among women who were\nneither pregnant nor trying for a baby at baseline) or the proportion who\nreported a diagnosed sexually transmitted infection (STI) at 3 or 6 months\n( Table 2 ).\nComparison of outcomes between arms.\nLARC: long-acting reversible contraception\nAnalysis restricted to the following subgroups as indicated\n1. Not pregnant or trying for baby at 6 months\n2. Using a method at 6 months\n3. Not pregnant or trying for baby at baseline or 6 months, clear\nreporting of method at both time points\n4. Not pregnant or trying for baby at baseline\n5. Completed 3 and 6 month questionnaire items\nAdjusted for the following baseline factors as indicated\n6. LARC use, satisfaction with method, and setting\n7. satisfaction with method and setting\n8. effectiveness of method, satisfaction with method, and setting\n9. effectiveness of method\nThe effects of the intervention on the primary outcomes did not vary\nsignificantly between online and in-person recruitment (data not shown). Post\nhoc, per-protocol analysis of the primary outcomes was not appreciably different\nto the modified intention-to-treat analysis ( Table 3 ).\nPost hoc per-protocol analysis of primary outcomes.\nLARC: long-acting reversible contraception.\nAnalysis restricted to the following subgroups as indicated.\n1. Not pregnant or trying for baby at 6 months.\n2. Using a method at 6 months.\n* Adjusted for LARC use at baseline, satisfaction with method at\nbaseline, and setting.\nOf the 364 intervention participants with 6-month follow-up data, 309 (85%)\nreported seeing the  Contraception Choices  website. Of those,\n97% found it helpful or very helpful for “getting useful information about\ncontraception” and 87% responded that it was helpful or very helpful for\n“finding a method of contraception that is right for you.”\nOver 91% (423/464) of intervention participants provided free-text comments about\nthe website in follow-up surveys. Comments were strikingly positive, with praise\nfor attractive website design, and the clarity of information presented.\nAnalysis of the free-text comments indicated that the  Contraception\nChoices  website helped to increase participant’s knowledge about\ncontraceptive methods and address their concerns, helped with thinking about\nchanging to a different method, and feeling better prepared before clinic\nappointments.\n\nWomen liked information which helped them to weigh up the advantages and\ndisadvantages of different methods: “Gives you the ups and downs about each choice and also helps advise which\none to choose.” “I feel more clued up about potential contraception choices which is great! I\nthink far too many think that the pill is the only way forward which is\nwrong!”\n“Gives you the ups and downs about each choice and also helps advise which\none to choose.”\n“I feel more clued up about potential contraception choices which is great! I\nthink far too many think that the pill is the only way forward which is\nwrong!”\n\nWomen valued tailored feedback such as the  What’s right for me? \ndecision aid, to help them to choose contraceptive methods to suit their priorities. “It’s what I’ve always looked for, a clear way to compare methods of\ncontraception and find the best for you… It may seem crazy, but it’s really\nhard to find reliable and objective facts on contraception online.” “I liked how easy it was to tailor a contraception to you and that it\nconsidered things like not wanting a period.”\n“It’s what I’ve always looked for, a clear way to compare methods of\ncontraception and find the best for you… It may seem crazy, but it’s really\nhard to find reliable and objective facts on contraception online.”\n“I liked how easy it was to tailor a contraception to you and that it\nconsidered things like not wanting a period.”\n\nMany women appreciated information which addressed concerns and misperceptions, which\nwas not necessarily easy to find elsewhere: “I was particularly interested in reading that you don’t need a break from\nhormonal contraception.” “It’s cleared up some of my doubts and things I worried about (probably\nunconsciously!) about hormonal contraception.” “Really useful, accessible information covering concerns that you wouldn’t\nnormally see on a medical website, like… specifically stopping periods.”\n“I was particularly interested in reading that you don’t need a break from\nhormonal contraception.”\n“It’s cleared up some of my doubts and things I worried about (probably\nunconsciously!) about hormonal contraception.”\n“Really useful, accessible information covering concerns that you wouldn’t\nnormally see on a medical website, like… specifically stopping periods.”\n\nSeveral participants discussed their intention to change or consider swapping to a\nnew method as a result of what they had learned or seen on the website. Of those who\ncommented, all were thinking of switching to a more effective long-acting reversible\ncontraceptive method. “I think it’s (the website) got me thinking more about which contraception I\nshould use. I’m quite happy with my pill and currently not sexually active,\nbut I do think I would like to switch to a LARC if I am in a relationship\nagain.”\n“I think it’s (the website) got me thinking more about which contraception I\nshould use. I’m quite happy with my pill and currently not sexually active,\nbut I do think I would like to switch to a LARC if I am in a relationship\nagain.”\n\nMany participants reported feeling more empowered to speak to healthcare\nprofessionals about contraception and feeling better prepared for appointments to\ndiscuss contraception: “It has made me feel more confident. Prior I didn’t really have anyone to\nspeak to about contraception and I didn’t feel comfortable discussing it\nwith my doctors so this bridged the gap.” “It has led to an increased conversation with my GP practice regarding\nsuitable alternative methods to the combined pill.” “I think it’s really good to go in [to an appointment] prepared with what\nyou’ve looked at and have an idea in your head before you make a decision\nabout it.”\n“It has made me feel more confident. Prior I didn’t really have anyone to\nspeak to about contraception and I didn’t feel comfortable discussing it\nwith my doctors so this bridged the gap.”\n“It has led to an increased conversation with my GP practice regarding\nsuitable alternative methods to the combined pill.”\n“I think it’s really good to go in [to an appointment] prepared with what\nyou’ve looked at and have an idea in your head before you make a decision\nabout it.”\n\nAlthough some participants wanted to change to a more effective method of\ncontraception, there were a number of reported barriers to accessing contraception. “I wanted the coil but I found it difficult to find someone to fit it in\nLondon.” “Long waiting times. GP did not offer the services to get implant fitted.\nLack of sexual health clinics in my area means very long waiting times.”\n“I wanted the coil but I found it difficult to find someone to fit it in\nLondon.”\n“Long waiting times. GP did not offer the services to get implant fitted.\nLack of sexual health clinics in my area means very long waiting times.”\n\nThere were only 12 neutral or negative comments, often from women who gave positive\ncomments too, such as: “Positive: easy to navigate, clear concise bullet points for\nadvantages/disadvantages of each contraceptive method. Negative: no\ninformation relating to contraception as a treatment for endometriosis.”\n“Positive: easy to navigate, clear concise bullet points for\nadvantages/disadvantages of each contraceptive method. Negative: no\ninformation relating to contraception as a treatment for endometriosis.”\nFive negative comments were from women who wanted more specific information about\nparticular contraceptive methods, and one person sought information about handling\ndifficult conversations with general practitioners.\n\nIn this randomised trial of the  Contraception Choices  website, we\ndid not find significant differences between intervention and control groups in use\nof LARC or satisfaction with contraceptive method by 6 months. There were no\nsignificant differences in reported adverse effects, including pregnancy and STI\ndiagnoses. The  Contraception Choices  website was very positively\nevaluated by young women, who indicated that it helped them to learn about\ncontraception, to think about changing to a different method, and to feel better\nprepared before clinic appointments. However, difficulty accessing health services\nis an important barrier to accessing chosen methods of contraception.\nGlobally, there are an estimated 1.7 billion women of reproductive age (15–49 years). 26  Ensuring access to accurate information about contraception to facilitate\ninformed decisions about choice and use of contraception is an essential but\nchallenging step towards prevention of unintended pregnancy. 27 , 28  This paper\ndescribes the evaluation of  Contraception Choices , an interactive\nwebsite to aid informed choice of contraception. The evidence base for the website\ncame from extensive systematic review of published literature and empirical\nqualitative research with young women, and the intervention is underpinned by\nbehaviour change theory. The evaluation method was unusually rigorous for a website\n– according to recent NICE guidance, a randomised trial is the standard reserved for\ndigital health technologies that aim to prevent and manage disease. 29\nThe women who took part in the trial broadly reflect the ethnic diversity of London, 30  the proportion of graduates 31  and the proportion of people whose main language is English in the UK. 32  At the outset, we did not expect to complete an efficacy (Phase III) trial of\nthe website, but the demand for  Contraception Choices  from service\nproviders, combined with the opportunity to rapidly expand recruitment and enlarge\nthe trial, led to the transition from a feasibility to an efficacy trial. Aside from\ndelays due to the lengthy process of obtaining all research permissions, the study\nprocedures overall worked well, the online trial processes were highly efficient and\nthe follow-up rate was good, with 86% of participants providing primary outcome data\nat 3 or 6 months. Recruitment in person was completed within the anticipated 6\nmonths, but recruiting online (via the online booking system) was much more\nefficient, being faster and at no additional cost. Just over half of all\nparticipants were recruited this way in less than eight weeks.\nOur study underscores other evidence that online trials are an efficient and\nacceptable way to conduct clinical trials of low-risk interventions. 33  However, choice of methodology and appropriate time-scale for evaluating the\nimpact of digital health interventions remains a key question; guidance on\nevaluation of complex interventions from the UK Medical Research Council, 34  for example, with its meticulous but slow progression through development,\nfeasibility, evaluation and implementation, seems out of step with the rapid pace of\nchange in digital health.\nDigital interventions such as  Contraception Choices  can meet a need\nfor convenient, trustworthy online information and support for contraception\ndecision-making. 35 , 36  Our findings clearly show that the website was popular and well\nreceived by users and healthcare providers. Given the strikingly positive feedback\nabout the website from women, the high level of intervention engagement (over\nfour-fifths viewed the website) and low ‘contamination’ in the control group (only\n7% of the control group reported seeing the website), the lack of difference in\nprimary outcomes between groups was surprising.\nPossible reasons for the observed lack of impact relate to the many influences on\ncontraceptive use which are beyond an individual woman’s control, 4  for example, the opinions of partners, peers, religious leaders and the wider\ncommunity, 4 , 37  and barriers to accessing services for a desired method,\nincluding difficulties in getting appointments, long waiting times and a lack of\nservices that can fit LARC methods. Other possible explanations include needing\nlonger follow-up for intentions to translate into action; measurement reactivity\n(i.e. the possible impact of asking the control group about their contraception\nuse); the limitations of a broad outcome measure like ‘satisfaction with method’;\nthe possibility that both intervention and control group were receiving high quality\nclinical care; and nearly a third were already using LARC methods at baseline so\nthat the website could not show an additional impact. With hindsight, we might have\nseen significant differences between groups had we included intermediate outcomes,\nsuch as ‘feeling better informed about choice of methods’ or ‘feeling confident\nabout discussing different contraceptive methods with a health professional’, but\nultimately, clinically important outcomes are the number of women using an effective\ncontraceptive method that they are happy with and the prevention of unwanted\npregnancy.\nIn terms of implementing digital health interventions in NHS services, we found that\ndirecting patients to the  Contraception Choices  website via an\nautomated text message to confirm a clinic appointment was simple and effective,\nwithout additional cost. Offering the link at the time of booking an appointment\nfacilitates access to the website well before a contraceptive consultation and some\nwomen commented that they felt better prepared for their consultation as a result.\nThe  Contraception Choices  website was offered for self-directed use\nbefore appointments (in clinic settings or at home), but the website could also be\njointly accessed during consultations. For example, the three tailored contraception\noptions generated by the  What’s right for me?  feature can be\ndiscussed with clinicians, and the website can also be displayed on the health\nprofessional’s computer screen during consultations. In this study, we did not aim\nto assess such a development in clinical practice, but an area for future research\nis to examine whether it could lead to more efficient or satisfying consultations,\nfor both patients and clinicians, with potentially better clinical or health service outcomes. 38  Electronic interventions for contraception which offer tailored material,\nincreased frequency of intervention administration, and/or structured follow-up with\na healthcare provider appear important for longer-term impact: 35  high quality evidence is needed on the effectiveness of different\nintervention designs, and cost-effectiveness of different models of intervention\ndelivery.\nContraception Choices  is currently attracting over 15,000 visits a\nmonth and is promoted via a link on the NHS website 39  which receives around 11 million visits per year. The availability of the\nwebsite on the internet offers many possibilities for further use and evaluation. In\nour systematic review, we found remarkable consistency across the globe in factors\ninfluencing contraception choice, uptake and use. With appropriate adaptations,\nContraception Choices may be of benefit to populations in different settings (e.g.\nschools) or different countries; we are currently exploring its utility in Botswana,\na country with advanced e-health capacity and high HIV prevalence. We see a real\nopportunity to use  Contraception Choices  with vulnerable\npopulations, including those where information and education to support effective\nuse of contraception are scarce.\nIn conclusion, the  Contraception Choices  website was very popular\nwith young women for its attractive design, engaging presentation of trustworthy\ninformation, and guidance in choosing a method tailored to individual preferences.\nHowever, we did not find any significant difference in use of LARC or satisfaction\nwith contraceptive method at 6 months. Our systematic reviews confirmed multiple\nfactors affecting women’s choice and use of contraception which go beyond informed\nchoice, such as the influence of others including partners, friends, family, school,\nreligion, wider culture and health services. The lack of effect on clinical outcomes\nin this trial, despite highly positive feedback from participants, highlights a gap\nbetween improving delivery of personalised information and impact on contraceptive\nuse. An interactive website can address individual barriers to contraception choice\nand use such as lack of knowledge, concerns and misunderstandings, but interventions\nat other levels are needed to complement this approach.","source_license":"CC-BY-4.0","license_restricted":false}