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To review the highest level of available evidence, a systematic map identified systematic reviews that evaluated the effectiveness of interventions to improve contraception choice and increase contraception use. Systematic reviews published since 2000 were identified from searches of nine databases. Data were extracted using a coding tool developed for this systematic map. Methodological quality of included reviews was assessed using AMSTAR 2 criteria. Fifty systematic reviews reported evaluations of interventions for contraception choice and use addressing three domains (individual, couples, community); Meta-analyses in 11 of the reviews mostly addressed interventions for individuals. We identified 26 reviews covering High Income Countries, 12 reviews covering Low Middle-Income Countries and the rest a mix of both. Most reviews (15) focussed on psychosocial interventions, followed by incentives (6) and m-health interventions (6). The strongest evidence from meta-analyses is for the effectiveness of motivational interviewing, contraceptive counselling, psychosocial interventions, school-based education, and interventions promoting contraceptive access, demand-generation interventions (community and facility based, financial mechanisms and mass media), and mobile phone message interventions. Even in resource constrained settings, community-based interventions can increase contraceptive use. There are gaps in the evidence on interventions for contraception choice and use, and limitations in study designs and lack of representativeness. Most approaches focus on individual women rather than couples or wider socio-cultural influences on contraception and fertility. This review identifies interventions which work to increase contraception choice and use, and these could be implemented in school, healthcare or community settings.

Background The quality of school-based sex and relationships education (SRE) is variable in the UK. Digitally-based interventions can usefully supplement teacher-delivered lessons and positively impact sexual health knowledge. Designed to address gaps in core SRE knowledge, STASH (Sexually Transmitted infections And Sexual Health) is a peer-led social network intervention adapted from the successful ASSIST (A Stop Smoking in Schools Trial) model, and based on Diffusion of Innovation theory. This paper describes how the STASH intervention was developed and refined. Methods Drawing on the Six Steps in Quality Intervention Development (6SQuID) framework, we tested a provisional programme theory through three iterative stages -: 1) evidence synthesis; 2) intervention co-production; and 3) adaptation - which incorporated evidence review, stakeholder consultation, and website co-development and piloting with young people, sexual health specialists, and educators. Multi-method results were analysed in a matrix of commonalities and differences. Results Over 21 months, intervention development comprised 20 activities within the three stages. 1) We identified gaps in SRE provision and online resources (e.g. around sexual consent, pleasure, digital literacy), and confirmed critical components including the core ASSIST peer nomination process, the support of schools, and alignment to the national curriculum. We reviewed candidate social media platforms, ruling out all except Facebook on basis of functionality restrictions which precluded their use for our purposes. 2) Drawing on these findings, as well as relevant behaviour change theories and core elements of the ASSIST model, we co-developed new content with young people and other stakeholders, tailored to sexual health and to delivery via closed Facebook groups, as well as face-to-face conversations. 3) A pilot in one school highlighted practical considerations, including around peer nomination, recruitment, awareness raising, and boundaries to message sharing. From this, a revised STASH intervention and programme theory were co-developed with stakeholders. Conclusions STASH intervention development required extensive adaptation from the ASSIST model. Although labour intensive, our robust co-development approach ensured that an optimised intervention was taken forward for feasibility testing. Evidencing a rigorous approach to operationalising existing intervention development guidance, this paper also highlights the significance of balancing competing stakeholder concerns, resource availability, and an ever-changing landscape for implementation. Trial registration ISRCTN97369178.

BACKGROUND Reducing the rates of sexually transmitted infections (STIs) among young people is a public health priority. The best way to avoid STIs from penetrative sex is to use a condom, but young people report inconsistent use. A missed opportunity to intervene to increase condom use is when young people access self-sampling kits for STIs through the internet. The potential of this opportunity is enhanced by the increasing numbers of young people being tested through this route every year in England. Hence, in a cocreation by young people, stakeholders, and researchers, Wrapped was developed––a fully automated, multicomponent, and interactive digital behavior change intervention developed for users of STI self-sampling websites, who are aged 16-24 years. OBJECTIVE This paper is a protocol for a feasibility randomized controlled trial (fRCT). The fRCT seeks to establish whether it is feasible to run a randomized controlled trial to test the effectiveness and cost-effectiveness of Wrapped. Wrapped aims to reduce the incidence of STIs through increasing correct and consistent use of condoms among users of STI self-sampling websites, who are aged 16-24 years. METHODS A 2-arm parallel-group randomized fRCT of Wrapped plus usual care, compared to usual care only (basic information on STIs and condom use), with a nested qualitative study. A minimum of 230 participants (aged 16-24 years) are recruited from an existing chlamydia self-sampling website. Participants are randomized into 1 of 2 parallel groups (1:1 allocation). Primary outcomes are the percentage of users recruited to the fRCT and the percentage of randomized participants who return a chlamydia self-sampling kit at month 12. Additionally, besides chlamydia positivity based on biological samples, surveys at baseline, month 3, month 6, and month 12, are used to assess condom use attitude, behavioral capability, self-efficacy, and intention, along with details of any partnered sexual activity and condom use, and health economic data. Nested qualitative interviews with trial participants are used to gain insight into the factors affecting recruitment and attrition. RESULTS Recruitment to the fRCT began in March 2021 and was completed in October 2021. Data collection was completed in December 2022. CONCLUSIONS This feasibility study will provide data to inform the design of a future-definitive trial. This work is timely given a rapid rise in the use of internet testing for STIs and the sustained high levels of STIs among young people. CLINICALTRIAL ISRCTN Registry ISRCTN17478654; http://www.isrctn.com/ISRCTN17478654 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/43645

HIV is still the leading cause of death in Sub-Saharan Africa (SSA), despite medical advances. eHealth interventions are effective for HIV prevention and management, but it is unclear whether this can be generalised to resource-poor settings. This systematic review aimed to establish the effectiveness of eHealth interventions in SSA. Six electronic databases were screened to identify randomised controlled trials (RCTs) published between 2000 and 2020. Meta-analyses were performed, following Cochrane methodology, to assess the impact of eHealth interventions on HIV-related behaviours and biological outcomes. 25 RCTs were included in the review. Meta-analyses show that eHealth interventions significantly improved HIV management behaviours (OR 1.21; 95% CI 1.05–1.40; Z = 2.67; p = 0.008), but not HIV prevention behaviours (OR 1.02; 95% CI 0.78–1.34; Z = 0.17; p = 0.86) or biological outcomes (OR 1.17; 95% CI 0.89–1.54; Z = 1.10; p = 0.27) compared with minimal intervention control groups. It is a hugely important finding that eHealth interventions can improve HIV management behaviours as this is a low-cost way of improving HIV outcomes and reducing the spread of HIV in SSA. PROSPERO registration number: CRD42020186025.

Introduction In Saudi Arabia, sexual and reproductive health education is not offered in any formal setting, and there is a significant lack of knowledge amongst Saudi women. This study aimed to explore barriers to Saudi women’s sexual and reproductive wellbeing. Methods The study employed qualitative methods using semi-structured interviews with women in Riyadh, Saudi Arabia in 2019. The data were analysed using thematic analysis. Results Twenty-eight women were interviewed. Sexual and reproductive wellbeing is a complex matter affected by personal, familial, environmental, socio-cultural, religious, and institutional factors. Being unmarried is a significant barrier to accessing sexual and reproductive information and services, with ignorance signifying modesty and purity. Parental control acted as a barrier to acquiring knowledge and accessing essential healthcare services. Schools contribute to lack of awareness, with teachers omitting sexual and reproductive health-related subjects and evading answering questions. Conclusions There are multiple factors that restrict Saudi women’s access to sexual and reproductive health information and services, impacting their overall wellbeing. Research and policy efforts should be directed towards overcoming the complex barriers to Saudi women’s sexual and reproductive wellbeing. Public health initiatives are needed to improve youth, parents, and teacher’s knowledge, and improve public perceptions towards sexual and reproductive health education.

To explore the views, attitudes, and experiences of South Asian women in the UK regarding sexual health services.We performed virtual semi-structured interviews with South Asian women 18 and over living in the UK. We explored participants' experiences of accessing sexual health services, including contraception, smear tests and sexually transmitted infection (STI) tests. We coded interview transcripts and analysed them thematically.From February to April 2021, we conducted 14 interviews with South Asian women between the ages of 18 and 40 living in England and Wales, from February to April 2021. We identified four overarching themes: Access to sexual health services, entry to sexual health services, quality of sexual health services and stigma associated with sexual health services. Important barriers to sexual health services include limited knowledge of local provision, stigma and shame, and concerns about confidentiality. Participants found it difficult to discuss their sexual health (with anyone) and were often being met with judgement and a lack of partnership from clinicians.Our results suggest that South Asian women are uncomfortable accessing sexual health services and communicating their sexual health concerns with health care professionals. Service providers should collaborate with community-based organisations to ensure that services are discrete, confidential, and culturally appropriate.

OBJECTIVES: To examine the psychosexual impact and disclosure experiences of women testing HPV-positive following cervical screening.DESIGN: In-depth semi-structured interviews.METHODS: Interviews were conducted with 21 women of screening age (i.e. those aged 24-65 years) in England who self-reported testing HPV-positive in the context of cervical screening in the last 12 months. Data were analysed using Framework Analysis.RESULTS: The sexually transmitted nature of HPV, and aspects relating to the transmission of HPV and where their HPV infection had come from, had an impact on women's current, past and future interpersonal and sexual relationships. Most women had disclosed their HPV infection to others, however the factors influencing their decision, and others' reactions to disclosure differed. The magnitude and extent of psychosexual impact was influenced by how women conceptualized HPV, their understanding of key aspects of the virus, concerns about transmitting HPV and having a persistent HPV infection.CONCLUSIONS: Increasing knowledge of key aspects of HPV, such as its high prevalence and spontaneous clearance, and the differences between HPV and other STIs, may increase women's understanding of their screening result and reduce any negative psychosexual consequences of testing HPV-positive. Referring to HPV as an infection that is passed on by skin-to-skin contact during sexual activity, rather than an STI, may help to lessen any psychosexual impact triggered by the STI label.

Background: There is no formal sexual and reproductive health (SRH) education currently offered in Saudi Arabia. Lack of knowledge and misconceptions are evident among Saudi women, which can lead to negative sexual and reproductive experiences. The aim of this study is to explore Saudi women's SRH knowledge, perceptions and experiences. Methods: Qualitative semi-structured interviews with Saudi women were conducted. Interviews took place in a public hospital in Riyadh, Saudi Arabia. Interviews were conducted in Arabic, recorded and transcribed verbatim, to allow for thematic analysis of the data. The following themes were identified: experience with menarche, deep-rooted negative views towards sex, difficulty discussing SRH topics, knowledge of sex and reproduction, generational gap, sources of SRH information and the role of the mother. Results: A total of 28 women, both married and unmarried, aged 20–50 years were interviewed. A profound lack of SRH knowledge was observed among Saudi women which contributed greatly to negative experiences both in childhood and adulthood. Lack of knowledge about menstruation often caused emotional distress for young girls, and menarche was associated with bad memories and negative emotions. Lack of knowledge about sexual intercourse and the deep-rooted negative views towards sex were linked with physical and psychological issues for women. Women rarely received information from their parents or teachers and preferred the internet for their SRH information. Conclusion: There is a substantial unmet need for SRH education for women in Saudi Arabia. It is our recommendation that SRH education should be tailored to meet Saudi women's unique needs, while understanding specific socio-cultural barriers to SRH education and discussions. Research and policy efforts should be directed towards regulating and producing evidence-based health information on the internet, particularly Arabic language websites.

BACKGROUND Digital technology offers good opportunities for HIV prevention. This systematic review assesses the effectiveness of interactive digital interventions (IDIs) for prevention of sexually transmitted HIV. METHODS We conducted a systematic search for randomized controlled trials (RCTs) of IDIs for HIV prevention, defining 'interactive' as producing personally tailored material. We searched databases including the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINAHL, PsycINFO, grey literature, reference lists, and contacted authors if needed.Two authors screened abstracts, applied eligibility and quality criteria and extracted data. Meta-analyses used random-effects models with standardized mean differences (SMD) for continuous outcomes and odds ratios (OR) for binary outcomes, assessing heterogeneity using the I2 statistic. RESULTS We included 31 RCTs of IDIs for HIV prevention. Meta-analyses of 29 RCTs comparing IDIs with minimal interventions (e.g. leaflet, waiting list) showed a moderate increase in knowledge (SMD 0.56, 95% CI 0.33 to 0.80), no effect on self-efficacy (SMD 0.13, 95% CI 0.00 to 0.27), a small improvement in intention (SMD 0.16, 95% CI 0.06 to 0.26), improvement in HIV prevention behaviours (OR 1.28, 95% CI 1.04 to 1.57) and a possible increase in viral load, but this finding is unreliable.We found no evidence of difference between IDIs and face-to-face interventions for knowledge, self-efficacy, intention, or HIV-related behaviours in meta-analyses of five small RCTs. We found no health economic studies. CONCLUSION There is good evidence that IDIs have positive effects on knowledge, intention and HIV prevention behaviours. IDIs are appropriate for HIV prevention in a variety of settings.Supplementary Video Abstract, http://links.lww.com/QAD/B934.

BackgroundYoung people report higher levels of unsafe sex and have higher rates of sexually transmitted infections than any other age group. Schools are well placed to facilitate early intervention, but more effective approaches are required. Peer-led approaches can augment school-based education, but often fail to capitalise on mechanisms of social influence. The potential of using social media in sexual health has not been tested in school settings.ObjectivesFinalise the design of the Sexually Transmitted infections And Sexual Health (STASH) intervention; assess the recruitment and retention of peer supporters, and acceptability to participants and stakeholders; assess the fidelity and reach, in addition to the barriers to and facilitators of, implementation; refine programme theory; understand the potential of social media; determine design parameters for a future randomised controlled trial, including economic evaluation; and establish whether or not progression criteria were met.DesignThis was a feasibility study comprising intervention development and refinement of the STASH pilot and non-randomised feasibility trial in six schools. Control data were provided by students in the year above the intervention group.SettingSecondary schools in Scotland.ParticipantsStudents aged 14–16 years, teachers and intervention delivery partners.InterventionsThe STASH intervention was adapted from A Stop Smoking In Schools Trial (ASSIST) (an effective peer-led smoking intervention). Based on diffusion of innovation theory, the STASH study involves peer nomination to identify the most influential students, with the aim of recruiting and training 15% of the year group as peer supporters. The peer supporters deliver sexual health messages to friends in their year group via conversations and use of Facebook (www.facebook.com; Facebook, Inc., Menlo Park, CA, USA) to share varied content from a curated set of web-based resources. Peer supporters are given support themselves via follow-up sessions and via trainer membership of Facebook groups.Main outcome measuresThe primary outcome was whether or not progression criteria were met in relation to intervention acceptability and feasibility. The study also piloted indicative primary outcomes for a full-scale evaluation.Data sourcesPeer supporter questionnaire; observations of activities; interviews with trainers, teachers, peer supporters and students; monitoring log of peer supporter activities (including on Facebook and meeting attendance); questionnaire to control year group (baseline characteristics, social networks, mediators and sexual health outcomes); baseline and follow-up questionnaire (approximately 6 months later) for intervention year group.ResultsA total of 104 students were trained as peer supporters (just over half of those nominated for the role by their peers). Role retention was very high (97%). Of 611 students completing the follow-up questionnaire, 58% reported exposure to STASH study activities. Intervention acceptability was high among students and stakeholders. Activities were delivered with good fidelity. The peer supporters were active, representative of their year group and well connected within their social network. Carefully managed social media use by peer supporters augmented conversations. A primary outcome of ‘always safer sex’ was identified, measured as no sex or always condom use for vaginal or anal sex in the last 6 months. The intervention cost £42 per student. Six progression criteria were met. A seventh criterion (regarding uptake of role by peer supporters) was not.LimitationsSmall feasibility study that cannot comment on effectiveness.ConclusionsThe STASH intervention is feasible and acceptable within the context of Scottish secondary schools. The results support continuation to a full-scale evaluation.Future workSmall-scale improvements to the intervention, refinement to programme theory and funding sought for full-scale evaluation.Trial registrationCurrent Controlled Trials ISRCTN97369178.FundingThis project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full inPublic Health Research; Vol. 8, No. 15. See the NIHR Journals Library website for further project information.

Sexual difficulties are common, but there is limited access to specialist services. People concerned about their sexual functioning may not seek help, and patients and health professionals can find...

BackgroundHuman papillomavirus (HPV)-based cervical screening is now replacing cytology-based screening in several countries and many women in screening programmes will consequently receive HPV-positive results. Because of the sexually transmitted nature of HPV, receiving an HPV-positive result may raise questions about disclosing the infection to a sexual partner.ObjectiveTo review the quantitative and qualitative literature exploring women’s concerns about disclosing a high-risk cervical HPV infection to a sexual partner.MethodsWe searched MEDLINE, PsycINFO, CINAHL Plus, Web of Science and EMBASE for studies reporting at least one disclosure-related outcome among women with high-risk HPV. We also searched the grey literature and carried out forward/backward citation searches. A narrative synthesis for quantitative studies and a thematic synthesis for qualitative studies were conducted.ResultsThirteen articles met the inclusion criteria (12 qualitative, 1 quantitative). In the quantitative study, 60% of HPV-positive women felt disclosing an HPV result was ‘risky’. Concerns about disclosing HPV to a sexual partner were influenced by the stigma that is associated with having an STI and uncertainty about how their partner would respond. Women questioned how, when and to whom they should disclose their HPV-positive status.ConclusionsThe studies included in this review provide rich information about the range of concerns women have, the reasons for these concerns, and the questions women have about disclosing HPV to sexual partners. As studies were predominantly qualitative, the prevalence of concerns is unclear.

Unintended pregnancy has a huge adverse impact on maternal, child and family health and wealth. There is an unmet need for contraception globally, with an estimated 40% of pregnancies unintended worldwide. We systematically searched PubMed and specialist databases for systematic reviews addressing contraceptive choice, uptake or use, published in English between 2000 and 2019. Two reviewers independently selected and appraised reports and synthesised quantitative and qualitative review findings. We mapped emergent themes to a social determinants of health framework to develop our understanding of the complexities of contraceptive choice and use. We found 24 systematic reviews of mostly moderate or high quality. Factors affecting contraception use are remarkably similar among women in very different cultures and settings globally. Use of contraception is influenced by the perceived likelihood and appeal of pregnancy, and relationship status. It is influenced by women’s knowledge, beliefs, and perceptions of side effects and health risks. Male partners have a strong influence, as do peers’ views and experiences, and families’ expectations. Lack of education and poverty is linked with low contraception use, and social and cultural norms influence contraception and expectations of family size and timing. Contraception use also depends upon their availability, the accessibility, confidentiality and costs of health services, and attitudes, behaviour and skills of health practitioners. Contraception has remarkably far-reaching benefits and is highly cost-effective. However, women worldwide lack sufficient knowledge, capability and opportunity to make reproductive choices, and health care systems often fail to provide access and informed choice.

Objective To quantify the effects of a series of text messages (safetxt) delivered in the community on incidence of chlamydia and gonorrhoea reinfection at one year in people aged 16-24 years. Design Parallel group randomised controlled trial. Setting 92 sexual health clinics in the United Kingdom. Participants People aged 16-24 years with a diagnosis of, or treatment for, chlamydia, gonorrhoea, or non-specific urethritis in the past two weeks who owned a mobile phone. Interventions 3123 participants assigned to the safetxt intervention received a series of text messages to improve sex behaviours: four texts daily for days 1-3, one or two daily for days 4-28, two or three weekly for month 2, and 2-5 monthly for months 3-12. 3125 control participants received a monthly text message for one year asking for any change to postal or email address. It was hypothesised that safetxt would reduce the risk of chlamydia and gonorrhoea reinfection at one year by improving three key safer sex behaviours: partner notification at one month, condom use, and sexually transmitted infection testing before unprotected sex with a new partner. Care providers and outcome assessors were blind to allocation. Main outcome measures The primary outcome was the cumulative incidence of chlamydia or gonorrhoea reinfection at one year, assessed by nucleic acid amplification tests. Safety outcomes were self-reported road traffic incidents and partner violence. All analyses were by intention to treat. Results 6248 of 20 476 people assessed for eligibility between 1 April 2016 and 23 November 2018 were randomised. Primary outcome data were available for 4675/6248 (74.8%). At one year, the cumulative incidence of chlamydia or gonorrhoea reinfection was 22.2% (693/3123) in the safetxt arm versus 20.3% (633/3125) in the control arm (odds ratio 1.13, 95% confidence interval 0.98 to 1.31). The number needed to harm was 64 (95% confidence interval number needed to benefit 334 to ∞ to number needed to harm 24) The risk of road traffic incidents and partner violence was similar between the groups. Conclusions The safetxt intervention did not reduce chlamydia and gonorrhoea reinfections at one year in people aged 16-24 years. More reinfections occurred in the safetxt group. The results highlight the need for rigorous evaluation of health communication interventions. Trial registration ISRCTN registry ISRCTN64390461 .

Background Effective sex education is the key to good sexual health. Peer-led approaches can augment teacher-delivered sex education, but many fail to capitalise on mechanisms of social influence. We assessed the feasibility of a novel intervention (STASH) in which students (aged 14–16) nominated as influential by their peers were recruited and trained as Peer Supporters (PS). Over a 5–10-week period, they spread positive sexual health messages to friends in their year group, both in-person and via social media, and were supported to do so via weekly trainer-facilitated meetings. The aims of the study were to assess the feasibility of STASH (acceptability, fidelity and reach), to test and refine the programme theory and to establish whether the study met pre-set progression criteria for continuation to larger-scale evaluation. Methods The overall design was a non-randomised feasibility study of the STASH intervention in 6 schools in Scotland. Baseline (n=680) and follow-up questionnaires (approx. 6 months later; n=603) were administered to the intervention year group. The control group (students in year above) completed the follow-up questionnaire only (n=696), 1 year before the intervention group. The PS (n=88) completed a brief web survey about their experience of the role; researchers interviewed participants in key roles (PS (n=20); PS friends (n=22); teachers (n=8); trainers (n=3)) and observed 20 intervention activities. Activity evaluation forms and project monitoring data also contributed information. We performed descriptive quantitative analysis and thematic qualitative analysis. Results The PS role was acceptable; on average across schools >50% of students nominated as influential by their friends, signed up and were trained (n=104). This equated to 13% of the year group. Trained PS rarely dropped out (97% completion rate) and 85% said they liked the role. Fidelity was good (all bar one trainer-led activity carried out; PS were active). The intervention had good reach; PS were reasonably well connected and perceived as ‘a good mix’ and 58% of students reported exposure to STASH. Hypothesised pre-conditions, contextual influences and mechanisms of change for the intervention were largely confirmed. All bar one of the progression criteria was met. Conclusion The weight of evidence supports continuation to full-scale evaluation. Trial registration Current controlled trials ISRCTN97369178

ObjectivesMany countries are implementing human papillomavirus (HPV)‐based cervical screening due to the higher sensitivity of the test compared with cytology. As HPV is sexually transmitted, there may be psychosexual consequences of testing positive for the virus. We aimed to review the literature exploring the psychosexual impact of testing positive for high‐risk cervical HPV.MethodsMEDLINE, PsycINFO, CINAHL Plus, Web of Science, and EMBASE were searched with no date limits. We also searched the grey literature, reference lists of included articles and carried out forward citation searching. Eligible studies reported at least one psychosexual outcome among HPV‐positive women. Qualitative and quantitative papers were included. We extracted data using a standardised form and carried out a quality assessment for each article. We conducted a narrative synthesis for quantitative studies and a thematic synthesis for qualitative studies.ResultsTwenty‐five articles were included. Quantitative study designs were diverse making it difficult to determine the impact that an HPV positive result would have in the context of routine screening. The qualitative literature suggested that psychosexual concerns cover a broad range of aspects relating to women's current and past relationships, both interpersonal and sexual.ConclusionsThe psychosexual impact of testing positive for high‐risk cervical HPV is unclear. This review highlights the need for further research in the context of HPV‐based cervical screening. As primary HPV testing is introduced more widely, it is important to understand women's responses to testing HPV positive in the cancer screening context to minimise any adverse psychosexual impact.

Background Effective use of contraception can reduce numbers of unintended pregnancies, but misunderstandings and concerns about contraception abound. Increasingly, women seek health-care information online. Objectives To develop an interactive website to aid informed choice of contraceptive method, including long-acting reversible contraception (Phase I), and test its effectiveness in a parallel, single-blind randomised trial (Phase II). Approval came from London – Camden & King’s Cross Research Ethics Committee (reference 17/LO/0112). Setting and participants For both phases, women aged 15–30 years were recruited from general practice, sexual health services, maternity services, community pharmacies and an abortion service. Design In Phase I, we conducted three systematic literature reviews, a review of YouTube (YouTube, LLC, San Bruno, CA, USA) videos about contraception, and focus groups and interviews with young women to explore barriers to and concerns and misperceptions about contraception. We then iteratively co-designed an interactive website, Contraception Choices [URL: www.contraceptionchoices.org (accessed June 2020)], with young women and a software company. In Phase II, we evaluated the website through a randomised trial that began as a feasibility trial. Early demand for Contraception Choices stimulated a design change from a feasibility to an efficacy trial, with follow-up for clinical outcomes at 3 and 6 months. A randomisation list was incorporated into the trial software program to allocate participants to the intervention (website) or control group (standard care). Intervention Contraception Choices is a co-designed, evidence-based, interactive website to aid informed choice of contraception. It provides information about different methods, addresses common concerns and offers tailored contraceptive options in response to individual preferences. Main outcome measures Qualitative – participant views and experience of the intervention, assessed through qualitative interviews. Quantitative primary outcomes – follow-up rate at 6 months in the initial feasibility trial, using a long-acting reversible contraception method, and satisfaction with contraceptive method at 6 months in the efficacy trial. Results A total of 927 women were randomised online to the website (n = 464) or control group (n = 463), of whom 739 (80%) provided follow-up data at 6 months [786 women (85%) provided data at 3 and/or 6 months that were included in the analysis of primary outcomes]. There was little difference between groups in the proportion using long-acting reversible contraception at 6 months [30.4% intervention vs. 31.0% control, adjusted odds ratio after imputation 0.87 (95% confidence interval 0.60 to 1.27)] or in satisfaction with contraceptive method [proportion being ‘satisfied’ or ‘very satisfied’, 82.6% intervention vs. 82.1% control, adjusted odds ratio 0.93 (95% confidence interval 0.69 to 1.25)]. Qualitative evaluation indicated highly positive views about the website and increased knowledge of contraceptive methods that could dispel misperceptions. Women appreciated having information tailored to their specific needs and felt better prepared before consultations. Limitations We did not include intermediate measures, such as knowledge of contraceptive methods, intention to change method or confidence in discussing contraception with a health-care professional, which may have indicated other benefits of using the website. In future, the website should be studied in different settings (e.g. schools and in routine practice) to see whether or not it improves the quality or efficiency of contraceptive consultations. Conclusions Our systematic review indicated wide-ranging influences on women’s use of contraception globally. The website, Contraception Choices, was very popular with young women and contraception service providers. It was not associated with statistically significant differences in use of long-acting reversible contraception or satisfaction with contraceptive method at 6 months. Trial registration Current Controlled Trials ISRCTN13247829. 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. 24, No. 56. See the NIHR Journals Library website for further project information.

BACKGROUND There is strong interest in the use of social media to spread positive sexual health messages through young people’s social networks. However, research suggests this potential may be limited by a reluctance to be visibly associated with sexual health content online, and by lack of trust in the veracity of peer sources. OBJECTIVE To investigate opportunities and challenges of using social media to facilitate peer-to-peer sharing of sexual health messages within the context of a secondary school-based and peer-led sexual health intervention (STASH; Sexually Transmitted infections And Sexual Health). METHODS Following training, and as part of their role, student-nominated peer supporters (aged 14-16) invited school friends to trainer-monitored, private Facebook groups. Peer supporters posted curated educational sex and relationships content within these groups. Data come from a feasibility study of the STASH intervention in 6 UK schools. To understand student experiences of the social media component we used data from: 11 semi-structured paired and group interviews with peer supporters and their friends (collectively, ‘students’; n=42; aged 14-16); a web-based post-intervention questionnaire to peer supporters (n=88); and baseline and follow-up questionnaires to students in the intervention year group (n=680 and 603 respectively). We carried out thematic analysis of qualitative data and descriptive analysis of quantitative data. RESULTS Message-sharing by peer supporters was hindered by variable engagement with Facebook. The trainer-monitored and private Facebook groups were acceptable to student members (peer supporters and their friends), and reassuring to peer supporters, but led to engagement that ran parallel to – rather than embedded in –their routine social media use. The offline context of a school-based intervention helped legitimate and augment the Facebook posts; but even where friends were receptive to STASH messages, they did not necessarily engage visibly. Preferences for content design varied, but humor, color and text brevity were important. Preferences for online versus offline message-sharing varied. CONCLUSIONS Invitation-only social media groups formed around peer supporters’ existing friendship networks hold potential for diffusing messages in peer-based sexual health interventions. Ideally, interactive opportunities should not be limited to single social media platforms and should run alongside offline conversations. There are tensions between offering young people autonomy to engage flexibly and authentically, and the need for adult-oversight of activities for information accuracy and safeguarding. CLINICALTRIAL Isrctn97369178

IntroductionYoung people aged 16 to 24 have the highest prevalence of genital chlamydia and gonorrhoea compared with other age groups and re-infection rates following treatment are high. Long-term adverse health effects include subfertility and ectopic pregnancy, particularly among those with repeated infections. We developed the safetxt intervention delivered by text message to reduce sexually transmitted infection (STI) by increasing partner notification, condom use and (STI) testing among young people in the UK.Methods and analysisA single-blind randomised trial to reliably establish the effect of the safetxt intervention on chlamydia and gonorrhoea infection at 1 year. We will recruit 6250 people aged 16 to 24 years who have recently been diagnosed with chlamydia, gonorrhoea or non-specific urethritis from health services in the UK. Participants will be allocated to receive the safetxt intervention (text messages designed to promote safer sexual health behaviours) or to receive the control text messages (monthly messages asking participants about changes in contact details) by an automated remote online randomisation system. The primary outcome will be the cumulative incidence of chlamydia and gonorrhoea infection at 1 year assessed by nucleic acid amplification tests. Secondary outcomes include partner notification, correct treatment of infection, condom use and STI testing prior to sex with new partners.Ethics and disseminationEthics approval was obtained from NHS Health Research Authority - London – Riverside Research Ethics Committee (REC reference: 15/LO/1665) and the London School of Hygiene & Tropical Medicine. We will submit the results of the trial for publication in peer-reviewed journals.Trial registration numberInternational Standard Randomised Controlled Trials Number:ISRCTN64390461. Registered on 17thMarch 2016.WHO trial registration data setavailable at:http://apps.who.int/trialsearch/Trial2.aspx?TrialID=ISRCTN64390461.Trial protocol version12, 19thJuly 2018.

Background In Islamic societies, issues related to sexual and reproductive health (SRH) are rarely discussed and considered sensitive subjects. This review aimed to identify any personal, religious, cultural, or structural barriers to SRH service and education among Muslim women worldwide. Methods A search for qualitative and quantitative studies was conducted on seven electronic databases. A narrative synthesis using thematic analysis was conducted. Results Fifty-nine studies were included from 22 countries: 19 qualitative, 38 quantitative and two mixed methods. Many Muslim women have poor SRH knowledge, and negative attitudes which influence their access to, and use of SRH services. Barriers to contraception use among Muslim women included a lack of basic reproductive knowledge, insufficient knowledge about contraception, misconceptions, and negative attitudes. Women had negative attitudes towards family planning for limiting the number of children but not for child spacing, which reflected religious views towards family planning. Religious and cultural beliefs were barriers to contraception use and access to SRH services and information. Family and the community have a significant impact on women’s contraceptive use and access to SRH services. Husband and family opposition played a significant role in contraception access and use. Fear of stigmatization and being labelled as having pre-marital sexual relations among unmarried women acted as the main barrier to accessing contraception and seeking SRH information and services. Conclusion The findings reveal that there are multiple levels of factors that influence Muslim women’s SRH. Poor SRH knowledge and practices among Muslim women is complex matter that is affected by personal, community, cultural, religious factors and existing policies and regulations. All these factors overlap and are affected by each other. There is an urgent need for interventions addressing modifiable barriers to SRH education and services to improve knowledge, informed choice and access to services to facilitate better sexual and reproductive wellbeing for Muslim women. It is important to note that while this review aimed to report findings on Muslim women, we acknowledge that significant variations exist within every culture and religion.

Partner abuse (PA) is common among young people, but is often missed by professionals working in health, social care, education and the criminal justice system. This paper explores the types of PA experienced by young people and links with sexual health to see whether there are factors which indicate greater vulnerability to abuse. Young people aged 16 to 20 from across the UK (n=1,754) completed an online survey in 2010–11. We report experience of emotional, physical and sexual partner abuse and model the associations with demographic and sexual health variables in bivariate analysis using logistic regression. A third of participants reported one or more types of PA within the previous three months, regardless of gender of partner. PA was significantly associated with sexually transmitted infection (Odds Ratios 1.6 and 2.9 for young women and young men respectively), regretted sex (OR 2.7 and 1.9), distress or worry about sex life (OR 2.7 and 4.6), sexual problems, numbers of sexual partners (OR 1.2 for each additional partner), and sexual health service use (for young men) (OR=1.9). These ‘indicators’ may be noticed by professionals who work with young people, and can act as prompts to ask about partner abuse.

Objective Improving use of effective contraception to prevent unintended pregnancy is a global priority, but misperceptions and concerns about contraception are common. Our objective was to evaluate an interactive website to aid informed choice of contraception. Methods The Contraception Choices website is an interactive digital intervention which offers tailored advice to aid contraception decision-making ( www.contraceptionchoices.org ). In a parallel single-blind trial, we randomised 927 women aged 15–30 years from six clinic settings to access the intervention website (n = 464) or to a waiting-list control group (n = 463). The study was initially a feasibility trial, evolving into an evaluation of efficacy, with two primary outcomes at six months: long-acting reversible contraception (LARC) use, and satisfaction with contraceptive method. Secondary outcomes included self-reported pregnancy and sexually transmitted infection diagnoses. Free-text comments on the 3 and 6 month outcome surveys were analysed thematically. Findings There was no significant difference between intervention and control groups in the proportion of women using LARC [30.4% intervention versus 31.0% control; adjusted odds ratio 0.87 (95% confidence interval 0.60 to 1.28)]; satisfaction with contraceptive method [82.6% versus 82.1%; adjusted ordinal odds ratio 0.93 (95% CI 0.69 to 1.25)]; self-reported pregnancy [3.3% versus 4.1%; adjusted odds ratio 0.90 (95% CI 0.45 to 1.79)] nor sexually transmitted infection [5.3% versus 4.7%; adjusted odds ratio 0.72 (95% CI 0.55 to 2.36)]. Highly positive free-text comments from intervention participants indicated that the website facilitates contraception choice and can help women feel better prepared before consultation with healthcare providers. Interpretation The Contraception Choices website was popular for its design, trustworthy information and decision aids but it was not associated with significant differences in use of LARC or satisfaction with contraceptive method. An interactive website can aid contraception choice, but interventions that address factors beyond women’s control, such as access to services, and partner, family or community influences are needed to complement this approach. Research in context Preventing unintended pregnancy through effective use of contraception is essential for women’s health, but choosing between different contraceptive methods can be challenging, and the opportunity for adequate discussion during routine consultations is often constrained. Evidence before this study We conducted two systematic literature reviews: 1) Factors influencing contraception choice, uptake and use: a meta-synthesis of systematic reviews; and 2) Effectiveness of interactive digital interventions (IDI) for contraception choice, uptake and use. For the first review we searched PubMed, CDSR, Epistemonikos, DoPHER, DARE, NHS Economic Evaluation Database, Campbell Library, NIHR Health Technology Assessment, and Health Evidence Canada databases for systematic reviews which addressed contraceptive choice, uptake or use, from 2000 to 2017. PROSPERO registration number: CRD42017081521 https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=81521 . We synthesised the findings of 18 systematic reviews of mostly moderate or high quality. They highlighted the importance of women’s knowledge, beliefs, perceptions of side effects and health risks, as well as relationship status, social network, economic and healthcare factors on contraception choice and use. For the second review, we searched 23 electronic databases, trials registers and reference lists for randomised controlled trials of IDI for contraception, including CENTRAL, MEDLINE, EMBASE, CINAHL, ERIC, ASSIA and PsycINFO, from start date to June 2017. PROSPERO registration number: CRD42017081636. We found only five randomised trials of IDI, all from the USA. Risk of bias prevented synthesis of results. www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=81636 . Added value of this study Women’s common concerns about contraception – fear of hormones, weight gain, cancer, infertility, mood changes, breaks from contraception and changes in bleeding patterns – underpinned development of a new interactive website ( www.contraceptionchoices.org ). Contraception Choices addresses women’s concerns through succinct text; Q and A format ( Frequently Asked Questions, Did you Know?; videos of women and health professionals); an effectiveness infographic, and an interactive decision aid ( What’s right for me?). In an online randomised trial with 927 women attending clinics, we found no association of the Contraception Choices intervention with the primary outcomes – satisfaction with contraceptive method and uptake of long-acting reversible methods at 6 months. Nor did we find an association with secondary adverse outcomes – sexually transmitted infections or pregnancy. Comments from women indicated that the website can meet young women’s need for information on the benefits and drawbacks of contraception, help them to make informed decisions, and feel better prepared before healthcare consultations. Contraception Choices is now available on the NHS website: www.nhs.uk/conditions/contraception/which-method-suits-me Implications of all the available evidence Interactive digital interventions (websites) can aid contraception choice, but other intervention research is needed to address wider influences on unintended pregnancy, including partner views, friends, family, the media, wider society and experiences with healthcare professionals. Future research could examine the impact of the website in different settings, e.g. schools or different countries. We hypothesise that use of the website during contraceptive consultations might improve the efficiency or quality of consultation, for both patients and healthcare providers. Appropriate methodology and time-scale for evaluating digital health interventions remains a key question.

BACKGROUND: Young people aged 16-24 years are disproportionately affected by sexually transmitted infections (STIs). STIs can have serious health consequences for affected individuals and the estimated annual cost of treatment to the National Health Service is £620 million. Accordingly, the UK government has made reducing the rates of STIs among this group a priority. A missed opportunity to intervene to increase condom use is when young people obtain self-sampling kits for STIs via the internet.OBJECTIVE: Our aim was to develop a theory-based tailored intervention to increase condom use for 16-24-years-olds accessing chlamydia self-sampling websites.METHODS: The intervention, Wrapped, was developed using Intervention Mapping and was co-designed with young people. The following steps were performed: (1) identification of important determinants of condom use and evidence of their changeability using computer and digital interventions; (2) setting the intervention goal, performance objectives, and change objectives; (3) identification of Behavior Change Principles (BCPs) and practical strategies to target these determinants; and (4) development of intervention materials able to deliver the BCPs and practical strategies.RESULTS: Users of existing chlamydia self-sampling websites are signposted to Wrapped after placing an order for a sampling kit. Salient barriers to condom use are identified by each user and relevant intervention components are allocated to target these. The components include the following: (1) a sample box of condoms, (2) an online condom distribution service, (3) a product for carrying condoms, (4) a condom demonstration video, (5) a series of videos on communication about condom use, and (6) erotic films of real couples discussing and demonstrating condom use.CONCLUSIONS: This intervention will be directed at young people who may be particularly receptive to messages and support for behavior change due to their testing status.

Sexually transmitted infections (STIs) continue to represent a major public health challenge. There is evidence that behavioural interventions to reduce risky sexual behaviours can reduce STI rates in patients attending sexual health (SH) services. However, it is not known if these interventions are effective when implemented at scale in SH settings in England.The study (Santé) had two main objectives - (1) to develop and pilot a package of evidence-based sexual risk reduction interventions that can be delivered through SH services and (2) to assess the feasibility of conducting a randomised controlled trial (RCT) to determine effectiveness against usual care.The project was a multistage, mixed-methods study, with developmental and pilot RCT phases. Preparatory work included a systematic review, an analysis of national surveillance data, the development of a triage algorithm, and interviews and surveys with SH staff and patients to identify, select and adapt interventions. A pilot cluster RCT was planned for eight SH clinics; the intervention would be offered in four clinics, with qualitative and process evaluation to assess feasibility and acceptability. Four clinics acted as controls; in all clinics, participants would be consented to a 6-week follow-up STI screen.SH clinics in England.Young people (aged 16-25 years), and men who have sex with men.A three-part intervention package - (1) a triage tool to score patients as being at high or low risk of STI using routine data, (2) a study-designed web page with tailored SH information for all patients, regardless of risk and (3) a brief one-to-one session based on motivational interviewing for high-risk patients.The three outcomes were (1) the acceptability of the intervention to patients and SH providers, (2) the feasibility of delivering the interventions within existing resources and (3) the feasibility of obtaining follow-up data on STI diagnoses (primary outcome in a full trial).We identified 33 relevant trials from the systematic review, including videos, peer support, digital and brief one-to-one sessions. Patients and SH providers showed preferences for one-to-one and digital interventions, and providers indicated that these intervention types could feasibly be implemented in their settings. There were no appropriate digital interventions that could be adapted in time for the pilot; therefore, we created a placeholder for the purposes of the pilot. The intervention package was piloted in two SH settings, rather than the planned four. Several barriers were found to intervention implementation, including a lack of trained staff time and clinic space. The intervention package was theoretically acceptable, but we observed poor engagement. We recruited patients from six clinics for the follow-up, rather than eight. The completion rate for follow-up was lower than anticipated (16% vs. 46%).Fewer clinics were included in the pilot than planned, limiting the ability to make strong conclusions on the feasibility of the RCT.We were unable to conclude whether or not a definitive RCT would be feasible because of challenges in implementation of a pilot, but have laid the groundwork for future research in the area.Current Controlled Trials ISRCTN16738765.This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inReducing sexually transmitted infections (STIs) is a public health priority. Those most likely to be diagnosed with a STI are young people (aged 16–25 years) and men who have sex with men. Studies in other countries have shown that interventions aimed at changing sexual behaviour (e.g. increasing condom use) can reduce the chance of getting new STIs in patients attending sexual health (SH) clinics. However, it is not clear if these interventions will work in English sexual health clinics, or if they could be implemented within existing resources. This study aimed to find out if effective interventions could be adapted to an English setting and tested this in a randomised trial. The scientific literature was searched for potential interventions and 33 trials were found. Effective methods included videos, digital web-based interventions, self-testing kits and talking sessions (e.g. counselling). Patients and providers were asked which interventions were acceptable and preferences for digital and one-to-one talking interventions were found. Providers suggested that these were feasible to deliver. Data routinely collected from patients (e.g. number of partners) were used to select patients at a higher risk of having a STI, a computerised risk score calculation was developed, and the highest risk group was directed to a one-to-one counselling intervention. There were no appropriate digital interventions available; therefore, a stand-in web page was created to signpost users to appropriate SH resources. This was offered to all patients. The intervention package was piloted in two SH settings rather than the planned four because of a lack of clinic staff time and space. It was planned to follow up a subset of patients from all eight clinics 6 weeks after their visit to collect information on STI diagnoses. Patients were recruited from six clinics, but only 16% of patients completed the survey and returned a sample. It was not possible to conclude definitively whether or not a randomised trial is feasible because of challenges in implementation and recruitment.

Background There is a strong interest in the use of social media to spread positive sexual health messages through social networks of young people. However, research suggests that this potential may be limited by a reluctance to be visibly associated with sexual health content on the web or social media and by the lack of trust in the veracity of peer sources. Objective The aim of this study was to investigate opportunities and challenges of using social media to facilitate peer-to-peer sharing of sexual health messages within the context of STASH (Sexually Transmitted Infections and Sexual Health), a secondary school-based and peer-led sexual health intervention. Methods Following training, and as a part of their role, student-nominated peer supporters (aged 14-16 years) invited school friends to trainer-monitored, private Facebook groups. Peer supporters posted curated educational sex and relationship content within these groups. Data came from a feasibility study of the STASH intervention in 6 UK schools. To understand student experiences of the social media component, we used data from 11 semistructured paired and group interviews with peer supporters and their friends (collectively termed students; n=42, aged 14-16 years), a web-based postintervention questionnaire administered to peer supporters (n=88), and baseline and follow-up questionnaires administered to students in the intervention year group (n=680 and n=603, respectively). We carried out a thematic analysis of qualitative data and a descriptive analysis of quantitative data. Results Message sharing by peer supporters was hindered by variable engagement with Facebook. The trainer-monitored and private Facebook groups were acceptable to student members (peer supporters and their friends) and reassuring to peer supporters but led to engagement that ran parallel to—rather than embedded in—their routine social media use. The offline context of a school-based intervention helped legitimate and augment Facebook posts; however, even where friends were receptive to STASH messages, they did not necessarily engage visibly on social media. Preferences for content design varied; however, humor, color, and text brevity were important. Preferences for social media versus offline message sharing varied. Conclusions Invitation-only social media groups formed around peer supporters’ existing friendship networks hold potential for diffusing messages in peer-based sexual health interventions. Ideally, interactive opportunities should not be limited to single social media platforms and should run alongside offline conversations. There are tensions between offering young people autonomy to engage flexibly and authentically and the need for adult oversight of activities for information accuracy and safeguarding.

Background Online sexual health research can be convenient, efficient and low cost, but there are debates about the adequacy of online informed consent, privacy, and the acceptability of different methods of follow-up. Objectives To explore women's views and experiences of the Contraception Choices feasibility trial procedures and the place of digital interventions for contraception decision making. Methods We analysed data from two sources: (1) Qualitative interviews. Eighteen interviews were conducted with women who had taken part in the Contraception Choices pre-trial feasibility study, to evaluate recruitment and online trial procedures. (2) Free-text comments. Women in the main Contraception Choices randomised controlled trial were followed up at 3 and 6 months, and asked ‘Please tell us what you liked or disliked about the website’ and ‘Has being in the study had any good or bad effects on your life?’ A total of 387 and 414 comments were made at 3 and 6 months respectively. Data were analysed thematically. Results Participants liked being involved in a study about contraception, although recruitment from an abortion clinic was less acceptable than in other sexual health settings. Women found the trial procedures straightforward, and expressed no major concerns about online self-registration, informed consent or online data collection. Online survey questions about contraception and fertility were acceptable, and participants liked the convenience of being followed up by email or text. Conclusions Participants appreciated the advantages of the online research design and did not express concerns about consent or privacy. Women would welcome digital interventions for contraception in a variety of settings.

Introduction Teenage pregnancy remains a worldwide health concern which is an outcome of, and contributor to, health inequalities. The need for gender-aware interventions with a focus on males in addressing teenage pregnancy has been highlighted as a global health need by WHO and identified in systematic reviews of (relationship and sexuality education (RSE)). This study aims to test the effectiveness of an interactive film-based RSE intervention, which draws explicit attention to the role of males in preventing an unintended pregnancy by reducing unprotected heterosexual teenage sex among males and females under age 16 years. Methods and analysis A phase III cluster randomised trial with embedded process and economic evaluations. If I Were Jack encompasses a culturally sensitive interactive film, classroom materials, a teacher-trainer session and parent animations and will be delivered to replace some of the usual RSE for the target age group in schools in the intervention group. Schools in the control group will not receive the intervention and will continue with usual RSE. Participants will not be blinded to allocation. Schools are the unit of randomisation stratified per country and socioeconomic status. We aim to recruit 66 UK schools (24 in Northern Ireland; 14 in each of England, Scotland and Wales), including approximately 7900 pupils. A questionnaire will be administered at baseline and at 12–14 months postintervention. The primary outcome is reported unprotected sex, a surrogate measure associated with unintended teenage pregnancy. Secondary outcomes include knowledge, attitudes, skills and intentions relating to avoiding teenage pregnancy in addition to frequency of engagement in sexual intercourse, contraception use and diagnosis of sexually transmitted infections. Ethics and dissemination Ethical approval was obtained from Queen’s University Belfast. Results will be published in peer-reviewed journals and disseminated to stakeholders. Funding is from the National Institute for Health Research. Trial registration number ISRCTN99459996

Background: \ud Young people in the UK are at highest risk of sexually transmitted infections and report higher levels of unsafe sex than any other age group. Involving peer supporters in intervention delivery is acceptable to students and effective in reducing risk behaviours via ‘diffusion of innovation’, particularly where peer supporters are influential in their networks. Informal peer-led interventions offer a useful alternative to peer-led didactic teaching, which has shown limited effects. Building on the successful ASSIST anti-smoking intervention, the ‘STis And Sexual Health’ (STASH) intervention involves identification and recruitment of the most influential students as peer supporters, training and support to these students by specialist trainers, positive sex and relationships messages, spread by peer supporters to their friendship groups in person and via social media.\ud \ud Methods/design: \ud This protocol describes a feasibility trial of the STASH intervention in six schools. It builds on an earlier study phase of intervention co-development using patient and public involvement (PPI) activities, followed by a pilot of intervention components and evaluation tools in one school. Participants are fourth year (S4) students (aged 14–16) in state-funded Scottish secondary schools who have received some level of teacher-led sex education. The previous cohort of S4 students (those completing S4 in the year prior to the intervention) will serve as controls. Data will be collected from controls (month 16), baseline (month 20–21) and follow-up (month 27–30) via a web-based questionnaire, which will measure (and test the reliability of) primary outcome measures for a phase III trial (delayed initiation of/abstinence from sex and consistent condom use), secondary outcomes and mediators of sexual behaviour (including school climate and social networks). The main feasibility outcome is whether the study meets pre-set progression criteria regarding feasibility and acceptability, measured largely via a process evaluation (basic measures in all 6 schools and in-depth in 2-4 schools). An economic evaluation reporting costs alongside consequences will be conducted.\ud \ud Discussion: \ud This study will inform decisions on the feasibility, design and sample size for a phase III effectiveness trial to assess whether the STASH intervention is effective in reducing the risk of sexually transmitted infections in young people.\ud \ud Trial registration: \ud ISRCTN97369178.

This study assessed a newly developed Sexual Communication Self-Efficacy Scale designed to measure the sexual communication self-efficacy of adolescent men and women. Three-hundred and seventy-four U.K. adolescents completed this new scale, along with several other validity measures. Factor analysis revealed that the Sexual Communication Self-Efficacy Scale consisted of five underlying factors: contraception communication, positive sexual messages, negative sexual messages, sexual history, and condom negotiation. These factors demonstrated high internal consistency and presents evidence to support construct validity. This scale may have utility in assessing the effectiveness of interventions designed to enhance sexual communication and sexual health behaviors among young people.

BackgroundThis report details the development of the Men’s Safer Sex website and the results of a feasibility randomised controlled trial (RCT), health economic assessment and qualitative evaluation.Objectives(1) Develop the Men’s Safer Sex website to address barriers to condom use; (2) determine the best design for an online RCT; (3) inform the methods for collecting and analysing health economic data; (4) assess the Sexual Quality of Life (SQoL) questionnaire and European Quality of Life-5 Dimensions, three-level version (EQ-5D-3L) to calculate quality-adjusted life-years (QALYs); and (5) explore clinic staff and men’s views of online research methodology.Methods(1) Website development: we combined evidence from research literature and the views of experts (n = 18) and male clinic users (n = 43); (2) feasibility RCT: 159 heterosexually active men were recruited from three sexual health clinics and were randomised by computer to the Men’s Safer Sex website plus usual care (n = 84) or usual clinic care only (n = 75). Men were invited to complete online questionnaires at 3, 6, 9 and 12 months, and sexually transmitted infection (STI) diagnoses were recorded from clinic notes at 12 months; (3) health economic evaluation: we investigated the impact of using different questionnaires to calculate utilities and QALYs (the EQ-5D-3L and SQoL questionnaire), and compared different methods to collect resource use; and (4) qualitative evaluation: thematic analysis of interviews with 11 male trial participants and nine clinic staff, as well as free-text comments from online outcome questionnaires.Results(1) Software errors and clinic Wi-Fi access presented significant challenges. Response rates for online questionnaires were poor but improved with larger vouchers (from 36% with £10 to 50% with £30). Clinical records were located for 94% of participants for STI diagnoses. There were no group differences in condomless sex with female partners [incidence rate ratio (IRR) 1.01, 95% confidence interval (CI) 0.52 to 1.96]. New STI diagnoses were recorded for 8.8% (7/80) of the intervention group and 13.0% (9/69) of the control group (IRR 0.75, 95% CI 0.29 to 1.89). (2) Health-care resource data were more complete using patient files than questionnaires. The probability that the intervention is cost-effective is sensitive to the source of data used and whether or not data on intended pregnancies are included. (3) The pilot RCT fitted well around clinical activities but 37% of the intervention group did not see the Men’s Safer Sex website and technical problems were frustrating. Men’s views of the Men’s Safer Sex website and research procedures were largely positive.ConclusionsIt would be feasible to conduct a large-scale RCT using clinic STI diagnoses as a primary outcome; however, technical errors and a poor response rate limited the collection of online self-reported outcomes. The next steps are (1) to optimise software for online trials, (2) to find the best ways to integrate digital health promotion with clinical services, (3) to develop more precise methods for collecting resource use data and (4) to work out how to overcome barriers to digital intervention testing and implementation in the NHS.Trial registrationCurrent Controlled Trials ISRCTN18649610.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 91. See the NIHR Journals Library website for further project information.

Objective To test the procedures proposed for a main trial of a safer sex intervention for young people delivered by mobile phone text message (‘safetxt’). Design and setting Pilot randomised controlled trial. Participants were recruited through sexual health services in the UK. An independent online randomisation system allocated participants to receive the safetxt intervention or to receive the control text messages (monthly messages about participation in the study). Texting software delivered the messages in accordance with a predetermined schedule. Participants Residents of England aged 16–24 who had received either a positive chlamydia test result or reported unsafe sex in the last year (defined as more than 1 partner and at least 1 occasion of sex without a condom). Intervention The safetxt intervention is designed to reduce sexually transmitted infection in young people by supporting them in using condoms, telling a partner about an infection and testing before unprotected sex with a new partner. Safetxt was developed drawing on: behavioural science; face-to-face interventions; the factors known to influence safer sex behaviours and the views of young people. Outcomes The coprimary outcomes of the pilot trial were the recruitment rate and completeness of follow-up. Results We recruited 200 participants within our target of 3 months and we achieved 81% (162/200) follow-up response for the proposed primary outcome of the main trial, cumulative incidence of chlamydia at 12 months. Conclusions Recruitment, randomisation, intervention delivery and follow-up were successful and a randomised controlled trial of the safetxt intervention is feasible. Trial registration number ISRCTN02304709; Results.

ObjectiveBehavioural interventions have been shown to reduce sexual behaviours associated with increased risk of sexually transmitted infections in young people (MethodsWe conducted a sequential mixed methods study with sexual health service providers and users in 2015/2016. Qualitative interviews with providers and service users (heterosexual young people and MSM) in London and Brighton allowed us to explore a range of experiences and expectations. A subsequent national web-survey of service providers measured the feasibility of delivery within existing resources and preferences for intervention attributes.ResultsWe conducted 35 service user (15 heterosexual young people; 20 MSM) and 26 provider interviews and had 100 web-survey responses. We found considerable heterogeneity in prevention services offered. Service users and providers were broadly supportive of tailoring interventions offered, but service users raised concerns about automated, data-driven triage, particularly around equity and fairness of service delivery. Digital technologies, including social media or apps, were appealing to providers, being less resource intensive. However, one-to-one talking interventions remained popular with both service users and providers, being familiar, trustworthy and personal. Key tensions between desirability of interventions and availability of resources to deliver them were acknowledged/recognised by providers and users.ConclusionOverall, behavioural interventions to reduce sexual behaviour risks were viewed favourably by service providers and users, with key considerations including: privacy, personalisation and convenience. However, introducing desirable targeted interventions within heterogeneous sexual health settings will require resources to adapt interventions and research to fully understand the barriers and facilitators to use within routine services.

Objectives We aimed to determine the feasibility of an online randomised controlled trial (RCT) of the Men’s Safer Sex website, measuring condom use and sexually transmitted infection (STI). Methods For this study 159 men aged ≥16 with female sexual partners and recent condomless sex or suspected STI were recruited from three UK sexual health clinics. Participants were randomised to the intervention website plus usual clinic care ( n = 84), or usual clinic care only ( n = 75). Online outcome data were solicited at 3, 6, and 12 months. Results Men were enrolled via tablet computers in clinic waiting rooms. Software errors and clinic Wi-Fi access presented significant challenges, and online questionnaire response rates were poor (36% at 3 months with a £10 voucher; 50% at 12 months with £30). Clinical records (for STI diagnoses) were located for 94% of participants. Some 37% of the intervention group did not see the intervention website ( n = 31/84), and (as expected) there was no detectable difference in condomless sex with female partners (IRR = 1.01, 95% CI 0.52 to 1.96). New acute STI diagnoses were recorded for 8.8% (7/80) of the intervention group, and 13.0% (9/69) of the control group over 12 months (IRR = 0.75, 95% CI 0.29 to 1.90). Conclusion It is likely to be feasible to conduct a future large-scale RCT to assess the impact of an online intervention using clinic STI diagnoses as a primary outcome. However, practical and technical challenges need to be addressed before the potential of digital media interventions can be realised in sexual health settings. Trial registration number: ISRCTN18649610

BackgroundYounger 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.ObjectivesTo 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.SettingParticipants were recruited from sexual health services in the UK.ParticipantsYoung people aged 16–24 years diagnosed with chlamydia or reporting unprotected sex with more than one partner in the last year.InterventionsA 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.ResultsIn 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.ConclusionsOur 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 registrationCurrent Controlled Trials ISRCTN02304709.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 57. See the NIHR Journals Library website for further project information.

Background Sexually transmitted infections (STI) are a major public health problem, with high social and economic costs. Condoms are effective for prevention of STI, but there are many barriers to successful use. Men are less likely than women to visit health professionals, and can be reluctant to discuss their sexual health with practitioners, partners or friends. An online intervention offers an alternative way to reach men at risk of STI. Digital interventions are very suitable for sexual health promotion because access can be private, anonymous and self-paced. Interventions can be targeted for specific groups (e.g. by age, gender or sexuality), and content can be tailored for individuals. Digital interventions can be expensive to develop, but offer the advantages of intervention content fidelity and the potential to reach large audiences at relatively low dissemination costs. Interventions can improve sexual behaviour as well as increasing knowledge, self-efficacy and safer sex intention, but more evidence is needed to establish effects on biological outcomes such as STI. The Men’s Safer Sex website (MenSS) is an interactive digital intervention (IDI) which provides information and tailored advice on sexual wellbeing and barriers to condom use. The website was offered to men in the waiting rooms of NHS sexual health clinics, with the aim of increasing condom use and reducing STI. Aims: To determine the feasibility and best design for a randomised controlled trial to test the effect of the Men’s Safer Sex website on condom use and STI amongst men attending sexual health clinics. Methods: Men aged 16 and over with female sexual partners and recent unprotected sex or suspected acute STI were recruited from three UK sexual health clinics (N = 159). Participants were randomised (using an automated computer algorithm) to the MenSS website in addition to usual clinic care, or to usual care only. Participants were invited via email to complete online follow-up questionnaires at 3, 6, and 12 months. The primary outcome was condom use at 3 months, with secondary outcomes of STI rates (self-reported and from clinical records). A total of £50 in online shopping vouchers was offered for completing online questionnaires. Results: Eighty-four men were allocated to receive the intervention, and 75 were randomised to the control arm. Clinical records were located for 94% of participants (for STI diagnoses over 12 months), but response rates for the online questionnaire were poor: 36% at 3 and 6 months, and 50% at 12 months. There was no detectable difference in condom use between groups, but the numbers were very small due to the low online questionnaire response rate. There were fewer clinical diagnoses of STI over one year in the intervention group who were offered the MenSS website, but the differences were non-significant (Incidence rate ratio 0.75, 95% CI 0.29 to 1.89). No harms or adverse events were identified. Conclusions The best way to assess the impact of the MenSS website was by recording STI diagnoses from clinical records. Response rates for the online questionnaire were poor despite offers of incentives. There were many challenges to conducting an online trial of a sexual health website including ethical committee concerns about email content, poor reliability of trial-related software, balancing data protection and security protocols against ease of access for participants, barriers to patient access to IT in NHS clinics, and trying to ensure that participants engage with a digital intervention for long enough. Whilst digital interventions have great potential for health promotion, we encountered significant obstacles to online research, and to implementation of an IDI in an NHS clinical setting.