School-based relationship and sexuality education intervention engaging adolescent boys for the reductions of teenage pregnancy: the JACK cluster RCT.

Background: The need to engage boys in gender-transformative relationships and sexuality education (RSE) to reduce adolescent pregnancy is endorsed by the World Health Organization and the United Nations Educational, Scientific and Cultural Organization. Objectives: To evaluate the effects of If I Were Jack on the avoidance of unprotected sex and other sexual health outcomes. Design: A cluster randomised trial, incorporating health economics and process evaluations. Setting: Sixty-six schools across the four nations of the UK. Participants: Students aged 13-14 years. Intervention: A school-based, teacher-delivered, gender-transformative RSE intervention (If I Were Jack) versus standard RSE. Main outcome measures: Self-reported avoidance of unprotected sex (sexual abstinence or reliable contraceptive use at last sex) after 12-14 months. Secondary outcomes included knowledge, attitudes, skills, intentions and sexual behaviours. Results: The analysis population comprised 6556 students: 86.6% of students in the intervention group avoided unprotected sex, compared with 86.4% in the control group {adjusted odds ratio 0.85 [95% confidence interval (CI) 0.58 to 1.26], p = 0.42}. An exploratory post hoc analysis showed no difference for sexual abstinence [78.30% intervention group vs. 78.25% control group; adjusted odds ratio 0.85 (95% CI 0.58 to 1.24), p = 0.39], but more intervention group students than control group students used reliable contraception at last sex [39.62% vs. 26.36%; adjusted odds ratio 0.52 (95% CI 0.29 to 0.920), p = 0.025]. Students in schools allocated to receive the intervention had significantly higher scores on knowledge [adjusted mean difference 0.18 (95% CI 0.024 to 0.34), p = 0.02], gender-equitable attitudes and intentions to avoid unintended pregnancy [adjusted mean difference 0.61 (95% CI 0.16 to 1.07), p = 0.01] than students in schools allocated to receive the control. There were positive but non-significant differences in sexual self-efficacy and communication skills. The total mean incremental cost of the intervention compared with standard RSE was £2.83 (95% CI -£2.64 to £8.29) per student. Over a 20-year time horizon, the intervention is likely to be cost-effective owing to its impact on unprotected sex because it would result in 379 (95% CI 231 to 477) fewer unintended pregnancies, 680 (95% CI 189 to 1467) fewer sexually transmitted infections and a gain of 10 (95% CI 5 to 16) quality-adjusted life-years per 100,000 students for a cost saving of £9.89 (95% CI -£15.60 to -£3.83). Limitations: The trial is underpowered to detect some effects because four schools withdrew and the intraclass correlation coefficient (0.12) was larger than that in sample size calculation (0.01). Conclusions: We present, to our knowledge, the first evidence from a randomised trial that a school-based, male engagement gender-transformative RSE intervention, although not effective in increasing avoidance of unprotected sex (defined as sexual abstinence or use of reliable contraception at last sex) among all students, did increase the use of reliable contraception at last sex among students who were, or became, sexually active by 12-14 months after the intervention. The trial demonstrated that engaging all adolescents early through RSE is important so that, as they become sexually active, rates of unprotected sex are reduced, and that doing so is likely to be cost-effective. Future work: Future studies should consider the longer-term effects of gender-transformative RSE as students become sexually active. Gender-transformative RSE could be adapted to address broader sexual health and other settings. Trial registration: This trial is registered as ISRCTN10751359. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (PHR 15/181/01) and will be published in full in Public Health Research; Vol. 11, No. 8. See the NIHR Journals Library website for further project information.

Adolescent pregnancy is often thought to be an issue for young women alone, but it is important to engage young men to tackle the problem and find solutions. The If I Were Jack intervention was especially designed to engage with boys as well as girls aged 14 years and to promote positive masculinity and gender equality to prevent adolescent pregnancy and promote positive sexual health. It uses tailored interactive films and resources, made with the help of students and teachers, to make it relevant to each of the four UK nations. This relationship and sexuality education intervention encourages adolescents to avoid unprotected sex by delaying sexual activity until they feel ready and to use reliable contraception once sexually active. It also promotes knowledge, attitudes (such as beliefs about gender and masculinities), skills and intentions for safe and pleasurable relationships. In this trial, we compared students in 33 schools randomly allocated to deliver the intervention with students in 33 schools that continued with their usual relationship and sexuality education practices. Four schools withdrew, two because of COVID-19 school closures. This left a total of 6556 students who completed questionnaires at the start of the study and 12­14 months later. Responses from all these students showed that If I Were Jack had a positive impact on knowledge, attitudes and intentions required for safe and pleasurable relationships, but did not have a significant effect on overall avoidance of unprotected sex. This was because the intervention had no effect on delaying sexual activity. However, we found that the intervention was effective in increasing the use of reliable contraception as students became sexually active, as well as for those who already were sexually active prior to receiving the intervention. We also found that If I Were Jack was likely to provide value for money by reducing unintended pregnancies and improving sexual health.

Evaluation of a pregnancy loss education intervention for undergraduate nursing students in Northern Ireland: A pre- and post-test study.

BACKGROUND: Research highlights the importance of compassionate communication, adequate delivery of information, and professional support to help alleviate parental distress following pregnancy loss. However, many healthcare professionals do not feel sufficiently trained to deal with pregnancy loss in practice. We aimed to address this deficiency with an evidence-informed educational intervention to increase knowledge, skills, self-awareness, and confidence regarding pregnancy loss among UK nursing students. METHODS: Educational resources, which included an 82-minute podcast and 40-minute online lecture were developed. The podcast focused on the lived experiences of three women who had experienced miscarriage, stillbirth, and termination of pregnancy for medical reasons. The pre-recorded lecture included definitions of types of pregnancy loss, discussion of the importance of communication, and information on the clinical management of pregnancy loss. Students were presented with both the lecture and podcast as a self-directed element of existing curricula. A pre-test/post-test cross-sectional survey design was used to investigate the impact of the educational intervention. The Perinatal Bereavement Care Confidence Scale (PBCCS) was completed by 244 first year BSc Nursing students before and up to a week after receiving the intervention. Quantitative data were analysed using a Paired Samples Wilcoxon test. Responses to open-ended questions, which allowed students to give feedback on the intervention content and delivery were analysed using Qualitative Content Analysis. RESULTS: 96% (n = 235) of the sample reported having no prior experience or training in the management and support of those experiencing pregnancy loss. At pre-test, 88% (n = 215) of students rated themselves as not confident in dealing with pregnancy loss in a professional capacity. Post-test, we found statistically significant effects for perceived competency on all learning outcomes (p < .001). Qualitative analysis of n = 745 individual text responses to open-ended questions indicated four categories related to the perceived value of using real-life stories for learning, demystifying a taboo subject, and providing tools for practice. Respondents suggested the inclusion of more information on memory-making, support networks, and mental health following pregnancy loss. CONCLUSIONS: The educational intervention increased student nurses' perceived knowledge, confidence, and skills in caring for families experiencing pregnancy loss. This offers potential for increased quality of care for those experiencing pregnancy loss in healthcare settings, increased patient satisfaction, and improved mental health-related outcomes.

Pregnancy loss following miscarriage and termination of pregnancy for medical reasons during the COVID-19 pandemic: a thematic analysis of women's experiences of healthcare on the island of Ireland.

BACKGROUND: Losing a baby during pregnancy can be a devastating experience for expectant parents. Many report dedicated, compassionate healthcare provision as a facilitator of positive mental health outcomes, however, healthcare services have been severely impacted during the COVID-19 pandemic. AIM: To explore women's experiences of healthcare service provision for miscarriage and termination of pregnancy for medical reasons (TFMR) on the island of Ireland during the COVID-19 pandemic. METHODS: Findings combine data from elements of two separate studies. Study 1 used a mixed methods approach with women who experienced miscarriage and attended a hospital in Northern Ireland. Study 2 was qualitative and examined experiences of TFMR in Northern Ireland and Ireland. Data analysed for this paper includes open-ended responses from 145 women to one survey question from Study 1, and semi-structured interview data with 12 women from Study 2. Data were analysed separately using Thematic Analysis and combined for presentation in this paper. RESULTS: Combined analysis of results indicated three themes, (1) Lonely and anxiety-provoking experiences; (2) Waiting for inadequate healthcare; and (3) The comfort of compassionate healthcare professionals. CONCLUSIONS: Women's experiences of healthcare provision were negatively impacted by COVID-19, with the exclusion of their partner in hospital, and delayed services highlighted as particularly distressing. Limited in-person interactions with health professionals appeared to compound difficulties. The lived experience of service users will be helpful in developing policies, guidelines, and training that balance both the need to minimise the risk of infection spread, with the emotional, psychological, and physical needs and wishes of parents. Further research is needed to explore the long-term impact of pregnancy loss during a pandemic on both parents and health professionals delivering care.

Involving men and boys in family planning: A systematic review of the effective components and characteristics of complex interventions in low- and middle-income countries.

Background: Involving men and boys as both users and supporters of Family Planning (FP) is now considered essential for optimising maternal and child health outcomes. Evidence on how to engage men and boys to meet FP needs is therefore important. Objectives: The main objective of this review was to assess the strength of evidence in the area and uncover the effective components and critical process- and system-level characteristics of successful interventions. Search Methods: We searched nine electronic databases, seven grey literature databases, organisational websites, and the reference lists of systematic reviews relating to FP. To identify process evaluations and qualitative papers associated with the included experimental studies, we used Connected Papers and hand searches of reference lists. Selection Criteria: Experimental and quasi-experimental studies of behavioural and service-level interventions involving males aged 10 years or over in low- and middle-income countries to increase uptake of FP methods were included in this review. Data Collection and Analysis: Methodology was a causal chain analysis involving the development and testing of a logic model of intervention components based on stakeholder consultation and prior research. Qualitative and quantitative data relating to the evaluation studies and interventions were extracted based on the principles of 'effectiveness-plus' reviews. Quantitative analysis was undertaken using r with robust variance estimation (RVE), meta-analysis and meta-regression. Qualitative analysis involved 'best fit' framework synthesis. Results: We identified 8885 potentially relevant records and included 127 in the review. Fifty-nine (46%) of these were randomised trials, the remainder were quasi-experimental studies with a comparison group. Fifty-four percent of the included studies were assessed as having a high risk of bias. A meta-analysis of 72 studies (k = 265) showed that the included group of interventions had statistically significantly higher odds of improving contraceptive use when compared to comparison groups (odds ratio = 1.38, confidence interval = 1.21 to 1.57, prediction interval = 0.36 to 5.31, p < 0.0001), but there were substantial variations in the effect sizes of the studies (Q = 40,647, df = 264, p < 0.0001; I 2 = 98%) and 73% was within cluster/study. Multi-variate meta-regression revealed several significant intervention delivery characteristics that moderate contraceptive use. These included community-based educational FP interventions, interventions delivered to women as well as men and interventions delivered by trained facilitators, professionals, or peers in community, home and community, or school settings. None of the eight identified intervention components or 33 combinations of components were significant moderators of effects on contraceptive use. Qualitative analysis highlighted some of the barriers and facilitators of effective models of FP that should be considered in future practice and research. Authors' Conclusions: FP interventions that involve men and boys alongside women and girls are effective in improving uptake and use of contraceptives. The evidence suggests that policy should continue to promote the involvement of men and boys in FP in ways that also promote gender equality. Recommendations for research include the need for evaluations during conflict and disease outbreaks, and evaluation of gender transformative interventions which engage men and boys as contraceptive users and supporters in helping to achieve desired family size, fertility promotion, safe conception, as well as promoting equitable family planning decision-making for women and girls.

Effects of gender-transformative relationships and sexuality education to reduce adolescent pregnancy (the JACK trial): a cluster-randomised trial.

BACKGROUND: The need to engage boys in gender-transformative relationships and sexuality education (RSE) to reduce adolescent pregnancy is endorsed by WHO. We aimed to test an intervention which used a gender-transformative approach to engage adolescents in RSE to prevent unprotected sex. METHODS: This cluster-randomised trial with process and economic evaluations tested a school-based intervention entitled If I Were Jack versus standard RSE (control) for students (aged 14-15 years) in UK schools. Schools were randomly allocated (1:1) and masked to allocation at baseline. The primary outcome was self-reported avoidance of unprotected sex (sexual abstinence or use of reliable contraception at last sex) after 12-14-months. We analysed the data using intention-to-treat mixed effects regression models. FINDINGS: Of 803 schools assessed for eligibility, 263 schools were invited by letter, of which 66 schools agreed to be randomly assigned, of which 62 schools completed follow-up. The trial was done between Feb 1, 2018, and March 6, 2020. 8216 students participated at baseline in 2018; 6561 (79·85%) provided 12-14 months follow-up. There was no significant difference in the primary outcome of avoidance of unprotected sex: 2648 (86·62) of 3057 in the intervention group avoided unprotected sex versus 2768 (86·41%) of 3203 in the control group (adjusted odds ratio [aOR] 0·85 [95% CI 0·58-1·26], p=0·42). Exploratory post-hoc analysis of the two components of the primary outcome showed that significantly more intervention students used reliable contraception at last sex compared with control students and there was no significant difference between the groups for sexual abstinence. No adverse events were reported. INTERPRETATION: The intervention had a null effect on the primary outcome of preventing unprotected sex (increasing sexual abstinence or use of reliable contraception) in the whole student population. However, the results showed significant increases in use of reliable contraceptives for sexually active students. Engaging all young people early through RSE is important so that as they become sexually active, rates of unprotected sex are reduced. FUNDING: National Institute for Health Research.

Termination of pregnancy for fetal anomaly: a systematic review of the healthcare experiences and needs of parents.

BACKGROUND: Improved technology and advances in clinical testing have resulted in increased detection rates of congenital anomalies during pregnancy, resulting in more parents being confronted with the possibility of terminating a pregnancy for this reason. There is a large body of research on the psychological experience and impact of terminating a pregnancy for fetal anomaly. However, there remains a lack of evidence on the holistic healthcare experience of parents in this situation. To develop a comprehensive understanding of the healthcare experiences and needs of parents, this systematic review sought to summarise and appraise the literature on parents' experiences following a termination of pregnancy for fetal anomaly. REVIEW QUESTION: What are the healthcare experiences and needs of parents who undergo a termination of pregnancy following an antenatal diagnosis of a fetal anomaly? METHODS: A systematic review was undertaken with searches completed across six multi-disciplinary electronic databases (Medline, Embase, PsycINFO, CINAHL, Web of Science, and Cochrane). Eligible articles were qualitative, quantitative or mixed methods studies, published between January 2010 and August 2021, reporting the results of primary data on the healthcare experiences or healthcare needs in relation to termination of pregnancy for fetal anomaly for either, or both parents. Findings were synthesised using Thematic Analysis. RESULTS: A total of 30 articles were selected for inclusion in this review of which 24 were qualitative, five quantitative and one mixed-methods. Five overarching themes emerged from the synthesis of findings: (1) Contextual impact on access to and perception of care, (2) Organisation of care, (3) Information to inform decision making, (4) Compassionate care, and (5) Partner experience. CONCLUSION: Compassionate healthcare professionals who provide non-judgemental and sensitive care can impact positively on parents' satisfaction with the care they receive. A well organised and co-ordinated healthcare system is needed to provide an effective and high-quality service. TRIAL REGISTRATION: PROSPERO registration number: CRD42020175970 .

Factors affecting the emotional wellbeing of women and men who experience miscarriage in hospital settings: a scoping review.

BACKGROUND: Miscarriage can be a devastating event for women and men that can lead to short- and long-term emotional distress. Studies have reported associations between miscarriage and depression, anxiety, and post-traumatic stress disorder in women. Men can also experience intense grief and sadness following their partner's miscarriage. While numerous studies have reported hospital-related factors impacting the emotional wellbeing of parents experiencing miscarriage, there is a lack of review evidence which synthesises the findings of current research. AIMS: The aim of this review was to synthesise the findings of studies of emotional distress and wellbeing among women and men experiencing miscarriage in hospital settings. METHODS: A systematic search of the literature was conducted in October 2020 across three different databases (CINAHL, MEDLINE and PsycInfo) and relevant charity organisation websites, Google, and OpenGrey. A Mixed Methods appraisal tool (MMAT) and AACODS checklist were used to assess the quality of primary studies. RESULTS: Thirty studies were included in this review representing qualitative (N = 21), quantitative (N = 7), and mixed-methods (N = 2) research from eleven countries. Findings indicated that women and men's emotional wellbeing is influenced by interactions with health professionals, provision of information, and the hospital environment. Parents' experiences in hospitals were characterised by a perceived lack of understanding among healthcare professionals of the significance of their loss and emotional support required. Parents reported that their distress was exacerbated by a lack of information, support, and feelings of isolation in the aftermath of miscarriage. Further, concerns were expressed about the hospital environment, in particular the lack of privacy. CONCLUSION: Women and men are dissatisfied with the emotional support received in hospital settings and describe a number of hospital-related factors as exacerbators of emotional distress. IMPLICATIONS FOR PRACTICE: This review highlights the need for hospitals to take evidence-informed action to improve emotional support services for people experiencing miscarriage within their services.

Adaptation of a gender-transformative sexual and reproductive health intervention for adolescent boys in South Africa and Lesotho using intervention mapping.

Background: Rates of adolescent HIV and unintended pregnancy in southern Africa are amongst the highest in the world. Gender-transformative interventions that address underlying gender inequalities and engage both males and females have been emphasised by the World Health Organisation, amongst others, to target prevention. However, few such gender-transformative interventions have been rigorously developed or evaluated.Objective: To expedite potential impact and reduce development costs, we conducted a needs assessment to inform the co-design, in consultation with local stakeholders, of adapted versions of an existing gender-transformative Relationships and Sexuality Education intervention for use in South Africa and Lesotho.Methods: Adaptation of the intervention was guided by a modified version of Intervention Mapping (IM). This process involved consultation with separate adolescent, community and expert advisory groups and a collaboratively conducted needs assessment, which drew on focus groups with adolescents (8 groups, n = 55) and adults (4 groups, n = 22) in South Africa and Lesotho, and was informed by our systematic review of the literature on the determinants of condom use among adolescents in the region.Results: The findings clarified how the intervention should be adapted, which individual- and environmental-level determinants of condom use to target, and actions for facilitating successful adoption, evaluation and implementation in the new settings.Conclusions: The IM approach allows for a systematic appraisal of whether components and processes of an existing intervention are appropriate for a new target population before costly evaluation studies are conducted. The findings will be of interest to those wishing to rigourously develop and evaluate gender-transformative interventions engaging men to improve health for all.

Adolescent condom use in Southern Africa: narrative systematic review and conceptual model of multilevel barriers and facilitators.

BACKGROUND: Adolescent HIV and pregnancy rates in Southern Africa are amongst the highest in the world. Despite decades of sexual and reproductive health (SRH) programming targeting adolescents, recent trends suggest there is a continued need for interventions targeting condom use for this age group. METHODS: This review synthesises evidence from qualitative studies that describe the determinants of condom use among adolescents in Southern Africa. We conducted systematic searches in four databases. Data were extracted, appraised for quality and analysed using a 'best-fit' framework synthesis approach. RESULTS: We coded deductively findings from 23 original studies using an a priori framework and subsequently conducted thematic analysis. Synthesised findings produced six key themes relating to: 1) pervasive unequal gender norms and restrictive masculinities favouring male sexual decision-making and stigmatising condom use in committed relationships; 2) other social norms reflecting negative constructions of adolescent sexuality and non-traditional family planning; 3) economic and political barriers including poverty and a lack of policy support for condom use; 4) service-level barriers including a lack of youth-friendly SRH services and comprehensive sex education in schools; 5) interpersonal barriers and facilitators including unequal power dynamics in sexual partnerships, peer influences and encouraging condoning condom use, and inadequate communication about SRH from parents/caregivers; and 6) negative attitudes and beliefs about condoms and condom use among adolescents. A conceptual model was generated to describe determinants of condom use, illustrating individual-, interpersonal- and structural-level barriers and facilitating factors. CONCLUSION: SRH programming targeting barriers and facilitators of condom use at multiple levels is recommended in Southern Africa. We present a multilevel integrated model of barriers and facilitators to guide adolescent SRH decision-making, programme planning and evaluation. Given the existence of multilevel barriers and facilitators, interventions should, likewise, take a multilevel approach that incorporates locally relevant understanding of the individual-, interpersonal- and structural-level barriers and facilitators to condom use among adolescents in the region.

Nothing so practical as theory: a rapid review of the use of behaviour change theory in family planning interventions involving men and boys.

BACKGROUND: There is growing recognition of the need for interventions that effectively involve men and boys to promote family planning behaviours. Evidence suggests that the most effective behavioural interventions in this field are founded on theoretical principles of behaviour change and gender equality. However, there are few evidence syntheses on how theoretical approaches are applied in this context that might guide best practice in intervention development. This review addresses this gap by examining the application and reporting of theories of behaviour change used by family planning interventions involving men and boys. METHODS: We adopted a systematic rapid review approach, scoping findings of a previously reported evidence and gap map of intervention reviews (covering 2007-2018) and supplementing this with searches of academic databases and grey literature for reviews and additional studies published between 2007 and 2020. Studies were eligible for inclusion if their title, abstract or keywords referred to a psychosocial or behavioural intervention targeting family planning behaviours, involved males in delivery, and detailed their use of an intervention theory of change. RESULTS: From 941 non-duplicate records identified, 63 were eligible for inclusion. Most records referenced interventions taking place in low- and middle-income countries (65%). There was a range of intervention theories of change reported, typically targeting individual-level behaviours and sometimes comprising several behaviour change theories and strategies. The most commonly identified theories were Social Cognitive Theory, Social Learning Theory, the Theory of Planned Behaviour, and the Information-Motivation-Behaviour Skills (IMB) Model. A minority of records explicitly detailed gender-informed elements within their theory of change. CONCLUSION: Our findings highlight the range of prevailing theories of change used for family planning interventions involving men and boys, and the considerable variability in their reporting. Programmers and policy makers would be best served by unified reporting and testing of intervention theories of change. There remains a need for consistent reporting of these to better understand how complex interventions that seek to involve men and boys in family planning may lead to behaviour change.

Family planning (FP) programmes aim to enable people to achieve their desired family size. Successful programmes are essential for encouraging better health outcomes for individuals and families. Historically, FP programmes have focused on the sexual and reproductive health and rights of women and girls, and while this is necessary, it has also contributed to the exclusion of men and boys from FP programmes. There is growing evidence to suggest, however, that involving men and boys in FP may increase its uptake and improve health outcomes for all. However, we still know relatively little about the best ways to involve men and boys in FP programmes in order to ensure success. Research is ongoing to rectify this.When we look at public health behaviour change programmes in general, we find that many successful programmes incorporate theories of behaviour change into their design. These theories guide the kinds of activities and materials that the programme employs in order to promote behaviour change. In the field of FP, there is little information about the kinds of behaviour change theories that might be used to design programmes. This review aimed to address this by reviewing the global literature on FP programmes that involved men and boys to identify relevant behaviour-change theories. We found a range of theories that will be of use to programme planners. We also found, however, that there was lots of variability in the way theories were reported. We make recommendations for how this problem might be resolved.

Gender-transformative programming with men and boys to improve sexual and reproductive health and rights: a systematic review of intervention studies.

BACKGROUND: Global health organisations advocate gender-transformative programming (which challenges gender inequalities) with men and boys to improve sexual and reproductive health and rights (SRHR) for all. We systematically review evidence for this approach. METHODS: We previously reported an evidence-and-gap map (http://srhr.org/masculinities/wbincome/) and systematic review of reviews of experimental intervention studies engaging men/boys in SRHR, identified through a Campbell Collaboration published protocol (https://doi.org/10.1002/CL2.203) without language restrictions between January 2007 and July 2018. Records for the current review of intervention studies were retrieved from those systematic reviews containing one or more gender-transformative intervention studies engaging men/boys. Data were extracted for intervention studies relating to each of the World Health Organization (WHO) SRHR outcomes. Promising programming characteristics, as well as underused strategies, were analysed with reference to the WHO definition of gender-transformative programming and an established behaviour change model, the COM-B model. Risk of bias was assessed using Cochrane Risk of Bias tools, RoB V.2.0 and Risk of Bias In Non-randomised Studies of Interventions. FINDINGS: From 509 eligible records, we synthesised 68 studies comprising 36 randomised controlled trials, n=56 417 participants, and 32 quasi-experimental studies, n=25 554 participants. Promising programming characteristics include: multicomponent activities of education, persuasion, modelling and enablement; multilevel programming that mobilises wider communities; targeting both men and women; and programmes of longer duration than three months. Six of the seven interventions evaluated more than once show efficacy. However, we identified a significant risk of bias in the overall available evidence. Important gaps in evidence relate to safe abortion and SRHR during disease outbreaks. CONCLUSION: It is widely acknowledged by global organisations that the question is no longer whether to include boys and men in SRHR but how to do so in ways that promote gender equality and health for all and are scientifically rigorous. This paper provides an evidence base to take this agenda for programming and research forward.

Engaging parents in digital sexual and reproductive health education: evidence from the JACK trial.

BACKGROUND: Research evidence and international policy highlight the central role that parents play in promoting positive sexual behaviour and outcomes in their children, however they can be difficult to engage in sexual and reproductive health (SRH) education programmes. Digital health promotion that uses online and mobile technologies (OMTs) to promote parent-child communication may offer an innovative solution to reach parents, however, few programmes have used OMTs to involve parents in SRH, and none have reported lessons learned in relation to optimising engagement. This study addresses this gap in the literature by reporting acceptability and feasibility of using OMTs to engage parents in SRH education. Findings will be relevant for those wishing to develop and implement digital SRH programmes with parents internationally. METHODS: The Jack Trial is a UK-wide cluster randomised controlled trial recruiting over 8000 adolescents from 66 socially and religiously diverse post-primary schools. An embedded mixed-methods process evaluation explored user engagement with parent components of the If I Were Jack SRH education programme, which include online animated films and a parent-teen homework exercise. RESULTS: A total of 109 adolescents, teachers, parents and SRH policy experts took part in semi-structured interviews and focus groups, 134 parents responded to an online survey, and 3179 adolescents completed a programme engagement and satisfaction questionnaire. Parents who accessed the materials were positive about them; 87% rated them as 'good or excellent' and 67% said they helped them have conversations with their child about SRH. Web analytics revealed that 27% of contacted parents accessed the digital materials, with 9% viewing the animated films. Only 38% of teachers implemented the homework exercise, mainly because they assumed that students would not complete it or it might result in backlash from parents. CONCLUSIONS: While digital parental materials show promise for engaging parents in SRH education, this study suggests that in order to optimise engagement, parental components that give parents the necessary skills to have conversations with their children about sex should be coupled with efforts to increase school and teacher confidence to communicate with parents on sensitive topics. TRIAL REGISTRATION: ISRCTN99459996 .

Can Teenage Men Be Targeted to Prevent Teenage Pregnancy? A Feasibility Cluster Randomised Controlled Intervention Trial in Schools.

The World Health Organisation advocates a direct focus on adolescent men in reducing adolescent pregnancy; however, no trials have been conducted. This trial (ISRCTN11632300; NCT02092480) determines whether a novel Relationship and Sexuality Educational intervention, If I Were Jack, is acceptable and feasible to implement in mixed sex UK classrooms. The intervention is a teacher-delivered intervention that emphasises male alongside female  responsibility in preventing unintended pregnancies and is designed to prevent unprotected sex. The trial was a parallel-group cluster randomised controlled feasibility trial with embedded process and cost evaluation in eight secondary schools (unit of randomisation) among 831 pupils (mean age 14) in Northern Ireland, alongside a qualitative evaluation of transferability in ten schools in Scotland, Wales and England. The sampling strategy was a maximum variation quota sample designed to capture a range of school management types. Four schools were randomised to each arm and the control arm continued with usual practice. Study duration was 12 months (from November 2014), with follow-up 9 months post-baseline. Results demonstrated that the intervention was acceptable to schools, pupils and teachers, and could be feasibly implemented, cost-effectively, with minor enhancements. The between-group difference in incidence of unprotected sex (primary outcome at pupil level) of 1.3% (95% CI 0.5-2.2) by 9 months demonstrated a potential effect size consistent with those reported to have had meaningful impact on teenage pregnancy. The study responds to global health policy for a paradigm shift towards inclusion of men in the achievement of sexual and reproductive health goals in a practical way by demonstrating that a gender-sensitive as well as a gender transformative intervention targeting males to prevent teenage pregnancy is acceptable to adolescent men and women and implementable in formal education structures. If I Were Jack now merits further effectiveness testing.

JACK trial protocol: a phase III multicentre cluster randomised controlled trial of a school-based relationship and sexuality education intervention focusing on young male perspectives.

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.

Recruiting faith- and non-faith-based schools, adolescents and parents to a cluster randomised sexual-health trial: experiences, challenges and lessons from the mixed-methods Jack Feasibility Trial.

BACKGROUND: The move toward evidence-based education has led to increasing numbers of randomised trials in schools. However, the literature on recruitment to non-clinical trials is relatively underdeveloped, when compared to that of clinical trials. Recruitment to school-based randomised trials is, however, challenging, even more so when the focus of the study is a sensitive issue such as sexual health. This article reflects on the challenges of recruiting post-primary schools, adolescent pupils and parents to a cluster randomised feasibility trial of a sexual-health intervention, and the strategies employed to address them. METHODS: The Jack Trial was funded by the UK National Institute for Health Research. It comprised a feasibility study of an interactive film-based sexual-health intervention entitled If I Were Jack, recruiting over 800 adolescents from eight socio-demographically diverse post-primary schools in Northern Ireland. It aimed to determine the facilitators and barriers to recruitment and retention to a school-based sexual-health trial and identify optimal multi-level strategies for an effectiveness study. As part of an embedded process evaluation, we conducted semi-structured interviews and focus groups with principals, vice-principals, teachers, pupils and parents recruited to the study as well as classroom observations and a parents' survey. RESULTS: With reference to social learning theory, we identified a number of individual-, behavioural- and environmental-level factors that influenced recruitment. Commonly identified facilitators included perceptions of the relevance and potential benefit of the intervention to adolescents, the credibility of the organisation and individuals running the study, support offered by trial staff, and financial incentives. Key barriers were prior commitment to other research, lack of time and resources, and perceptions that the intervention was incompatible with pupil or parent needs or the school ethos. CONCLUSIONS: Reflecting on the methodological challenges of recruiting to a school-based sexual-health feasibility trial, this study highlights pertinent general and trial-specific facilitators and barriers to recruitment, which will prove useful for future trials with schools, adolescent pupils and parents. TRIAL REGISTRATION: ISRCTN 11632300 . Registered on 19 December 2014.

Knowledge translation in men's health research: development and delivery of content for use online.

BACKGROUND: Men can be hard to reach with face-to-face health-related information, while increasingly, research shows that they are seeking health information from online sources. Recognizing this trend, there is merit in developing innovative online knowledge translation (KT) strategies capable of translating research on men's health into engaging health promotion materials. While the concept of KT has become a new mantra for researchers wishing to bridge the gap between research evidence and improved health outcomes, little is written about the process, necessary skills, and best practices by which researchers can develop online knowledge translation. OBJECTIVE: Our aim was to illustrate some of the processes and challenges involved in, and potential value of, developing research knowledge online to promote men's health. METHODS: We present experiences of KT across two case studies of men's health. First, we describe a study that uses interactive Web apps to translate knowledge relating to Canadian men's depression. Through a range of mechanisms, study findings were repackaged with the explicit aim of raising awareness and reducing the stigma associated with men's depression and/or help-seeking. Second, we describe an educational resource for teenage men about unintended pregnancy, developed for delivery in the formal Relationship and Sexuality Education school curricula of Ireland, Northern Ireland (United Kingdom), and South Australia. The intervention is based around a Web-based interactive film drama entitled "If I Were Jack". RESULTS: For each case study, we describe the KT process and strategies that aided development of credible and well-received online content focused on men's health promotion. In both case studies, the original research generated the inspiration for the interactive online content and the core development strategy was working with a multidisciplinary team to develop this material through arts-based approaches. In both cases also, there is an acknowledgment of the need for gender and culturally sensitive information. Both aimed to engage men by disrupting stereotypes about men, while simultaneously addressing men through authentic voices and faces. Finally, in both case studies we draw attention to the need to think beyond placement of content online to delivery to target audiences from the outset. CONCLUSIONS: The case studies highlight some of the new skills required by academics in the emerging paradigm of translational research and contribute to the nascent literature on KT. Our approach to online KT was to go beyond dissemination and diffusion to actively repackage research knowledge through arts-based approaches (videos and film scripts) as health promotion tools, with optimal appeal, to target male audiences. Our findings highlight the importance of developing a multidisciplinary team to inform the design of content, the importance of adaptation to context, both in terms of the national implementation context and consideration of gender-specific needs, and an integrated implementation and evaluation framework in all KT work.

Design and development of a film-based intervention about teenage men and unintended pregnancy: applying the Medical Research Council framework in practice.

Following the UK Medical Research Council's (MRC) guidelines for the development and evaluation of complex interventions, this study aimed to design, develop and optimise an educational intervention about young men and unintended teenage pregnancy based around an interactive film. The process involved identification of the relevant evidence base, development of a theoretical understanding of the phenomenon of unintended teenage pregnancy in relation to young men, and exploratory mixed methods research. The result was an evidence-based, theory-informed, user-endorsed intervention designed to meet the much neglected pregnancy education needs of teenage men and intended to increase both boys' and girls' intentions to avoid an unplanned pregnancy during adolescence. In prioritising the development phase, this paper addresses a gap in the literature on the processes of research-informed intervention design. It illustrates the application of the MRC guidelines in practice while offering a critique and additional guidance to programme developers on the MRC prescribed processes of developing interventions. Key lessons learned were: (1) know and engage the target population and engage gatekeepers in addressing contextual complexities; (2) know the targeted behaviours and model a process of change; and (3) look beyond development to evaluation and implementation.

Feasibility trial of a film-based educational intervention for increasing boys' and girls' intentions to avoid teenage pregnancy: Study protocol.

The World Health Organisation, amongst others, recognises that adolescent men have a vital yet neglected role in reducing teenage pregnancies and that there is a pressing need for educational interventions designed especially for them. This study seeks to fill this gap by determining the feasibility of conducting an effectiveness trial of the If I Were Jack intervention in post-primary schools. This 4-week intervention aims to increase teenagers' intentions to avoid unintended pregnancy and addresses gender inequalities in sex education by explicitly focusing on young men. A cluster randomised feasibility trial with embedded process evaluation will determine: recruitment, participation and retention rates; quality of implementation; acceptability and feasibility of the intervention and trial procedures; and costs.

"You're wha...?!".

The importance of including fathers in reproductive planning, pregnancy and childbirth cannot be overstated and it is increasingly recognised that addressing their sense of exclusion from maternity services requires further action. One very overlooked area, however, is in helping young men, alongside their partners, in preventing an unintended teenage pregnancy. The UK has the highest rate of teenage pregnancy in Western Europe and, while teenage men are seen as half of the problem, they are rarely regarded as half of the solution. We argue that education is an essential part of the process of increasing men's sense of inclusion and describe If I were Jack, an educational resource about unintended teenage pregnancy which has been developed specifically for young men.