Factors affecting shared decision-making concerning menopausal hormone therapy.

Menopausal hormone therapy (MHT) is an effective treatment for menopause-related symptoms. Menopause management guidelines recommend a personalized approach to menopause care, including MHT use. Decision-making around menopause care is a complex, iterative process influenced by multiple factors framed by perspectives from both women and healthcare providers (HCPs). This narrative review aims to summarize evidence around factors affecting decision-making regarding menopause-related care. For HCPs, the provision of individualized risk estimates is challenging in practice given the number of potential benefits and risks to consider, and the complexity of the data available, especially within time-limited consultations. Women seeking menopause care have the difficult task of making sense of the benefit versus risk profiles to make choices in line with their decisional needs influenced by sociocultural/economic, educational, demographic, and personal characteristics. The press, social media, and influential celebrities also impact the perception of menopause and decision-making around it. Understanding these factors can lead to improved participation in shared decision-making, satisfaction with the decision and decision-making process, adherence to treatment, reduced decisional regret, efficient use of resources, and ultimately long-term satisfaction with care.

The effectiveness of interventions to disseminate the results of non-commercial randomised clinical trials to healthcare professionals: a systematic review.

BACKGROUND: It is unclear how to disseminate the results of randomised controlled trials effectively to health professionals and policymakers to improve treatment, care or prevention through changing policy and practice. This systematic review examined the effectiveness of different methods of dissemination of clinical research results to professional audiences. METHODS: We systematically reviewed the published and grey literature from 2000 to 2022 for studies assessing different approaches for disseminating clinical study results to professional audiences (health professionals, policymakers and guideline developers). Two reviewers assessed potentially relevant full texts for inclusion. We grouped studies by intervention type, synthesising findings using effect direction plots. Outcomes were grouped into out-takes (e.g. awareness, knowledge, understanding), outcomes (e.g. attitude changes) and impact (changes in policy/practice). The quality of evidence was assessed using GRADE. RESULTS: Our search identified 13,264 unique records, of which 416 full texts were assessed for eligibility. Of 60 studies that were identified as eligible for inclusion, 20 evaluated the effectiveness of interventions to disseminate clinical research results (13 RCTs, 2 observational studies, 3 pre- and post-intervention surveys and 2 cross-sectional surveys). Studies were grouped by intervention: 7 studies that involved face-to-face meetings between the target audience and trained educators were classified as 'outreach interventions'; 5 studies that provided a summary format for systematic review findings (e.g. summary of findings tables) were grouped together. There was high certainty evidence of a small beneficial impact of outreach interventions on health and moderate certainty evidence of impact on practice (mostly prescribing). There was no evidence of impact on policy and very low certainty around benefits on outcomes and out-takes. We found no consistent benefits of summary formats for systematic review results on outcomes or out-takes (moderate quality evidence). Other interventions with less evidence are reported in the Additional Materials. CONCLUSIONS: Outreach interventions to disseminate clinical research results can lead to changes in practice and improvements in health. However, these interventions can be resource-intensive. Investment is vital to identify and implement effective and cost-effective ways to disseminate results, so that the potential benefits of trials to patients can be realised. TRIAL REGISTRATION: International Prospective Register of Systematic Reviews (PROSPERO), CRD42019137364.

Vortioxetine for the treatment of post-COVID-19 condition: a randomized controlled trial.

Hitherto no therapeutic has received regulatory approval for the treatment of post-COVID-19 condition (PCC). Cognitive deficits, mood symptoms and significant reduction in health-related quality of life (HRQoL) are highly replicated and debilitating aspects of PCC. We sought to determine the impact of vortioxetine on the foregoing symptoms and HRQoL in persons living with PCC. An 8-week randomized, double-blind, placebo-controlled study of adults ≥ 18 years of age residing in Canada and who are experiencing symptoms of World Health Organization (WHO)-defined PCC, with a history of confirmed SARS-CoV-2 infection, was conducted. Recruitment began November 2021 and ended January 2023. Of the 200 participants enrolled (487 invited: 121 ineligible and 59 eligible but declined participation; 307 cleared pre-screening stage), a total of 149 participants were randomized (1:1) to receive either vortioxetine (5-20 mg, n = 75) or placebo (n = 74) daily for 8 weeks of double-blind treatment (i.e. end point). The primary outcome was the change from baseline-to-end point in the Digit Symbol Substitution Test. Secondary outcomes included the effect on depressive symptoms and HRQoL, as measured by changes from baseline-to-end point on the Quick Inventory of Depressive Symptomatology 16-item and WHO Wellbeing Scale 5-item, respectively. A total of 68 (90.7%) participants randomized to vortioxetine and 73 (98.6%) participants randomized to placebo completed all 8 weeks. Between-group analysis did not show a significant difference in the overall change in cognitive function [P = 0.361, 95% confidence interval (CI) (-0.179, 0.492)]. However, in the fully adjusted model, a significant treatment × time interaction was observed in favour of vortioxetine treatment with baseline c-reactive protein (CRP) as a moderator (P = 0.012). In addition, a significant improvement in Digit Symbol Substitution Test scores were observed in vortioxetine versus placebo treated participants in those whose baseline CRP was above the mean (P = 0.045). Moreover, significant improvement was obtained in measures of depressive symptoms [P < 0.001, 95% CI (-4.378, -2.323)] and HRQoL [P < 0.001, 95% CI (2.297, 4.647)] in vortioxetine-treated participants and between the treatment groups [depressive symptoms: P = 0.026, 95% CI (-2.847, -0.185); HRQoL: P = 0.004, 95% CI (0.774, 3.938)]. Although vortioxetine did not improve cognitive function in the unadjusted model, when adjusting for CRP, a significant pro-cognitive effect was observed; antidepressant effects and improvement in HRQoL in this debilitating disorder were also noted.

Factors associated with bacterial sexually transmitted infections among people of South Asian ethnicity in England.

OBJECTIVES: Despite being the largest ethnic minority group in England, South Asians have historically had low levels of utilisation of sexual health services (SHS) and sexually transmitted infection (STI) diagnoses, although recent data suggests this may be changing. This study aimed to investigate factors associated with a bacterial STI diagnosis among South Asians attending SHS in England. METHODS: Using data from the GUMCAD STI Surveillance system, a descriptive analysis of South Asians attending SHS in England in 2019 was carried out. Factors associated with a bacterial STI diagnosis were examined using univariate and multivariable logistic regression models adjusted for age, Asian ethnic subgroup, HIV status, patient's region of residence and Index of Multiple Deprivation quintile. Analyses were stratified by gender and sexual orientation (heterosexual male versus gay, bisexual and other men who have sex with men (GBMSM) versus women of any sexual orientation). Crude and adjusted associations were derived using binary logistic regression. RESULTS: There were 121 842 attendances by South Asians to SHS in England in 2019. Compared with heterosexual South Asian men, GBMSM had a higher odds of being diagnosed with a bacterial STI (adjusted odds ratio (aOR) 2.32, 95% CI 2.19 to 2.44) and South Asian women had a lower odds (aOR 0.83, 95% CI 0.78 to 0.87). For women and heterosexual South Asian men, a diagnosis was associated with younger age, being of any other Asian background other than Bangladeshi, Indian or Pakistani and not being HIV positive. For heterosexual South Asian men, there was an association with increasing socioeconomic deprivation. For GBMSM, a bacterial STI diagnosis was associated with known HIV-positive status and living in London. CONCLUSION: People of South Asian ethnicity in England are heterogeneous with regard to their sexual health needs, which should be explored further through focused research and policy.

Transgender identity in young people and adults recorded in UK primary care electronic patient records: retrospective, dynamic, cohort study.

Objectives: To quantify the change in proportion of young people and adults identified as transgender in UK primary care records and to explore whether rates differ by age and socioeconomic deprivation. Design: Retrospective, dynamic, cohort study. Setting: IQVIA Medical Research Data, a database of electronic primary care records capturing data from 649 primary care practices in the UK between 1 January 2000 and 31 December 2018. Participants: 7 064 829 individuals aged 10-99 years, in all four UK countries. Main outcome measures: Diagnostic codes indicative of transgender identity were used. Sex assigned at birth was estimated by use of masculinising or feminising medication and procedural/diagnostic codes. Results: 2462 (0.03%) individuals had a record code indicating a transgender identity. Direction of transition could be estimated for 1340 (54%) people, of which 923 were assigned male at birth, and 417 were assigned female at birth. Rates of recording in age groups diverged substantially after 2010. Rates of the first recording of codes were highest in ages 16-17 years (between 2010 and 2018: 24.51/100 000 person years (95% confidence interval 20.95 to 28.50)). Transgender codes were associated with deprivation: the rate of the first recording was 1.59 (95% confidence interval 1.31 to 1.92) in the most deprived group in comparison with the least deprived group. Additionally, the rate ratio of the proportion of people who identified as transgender was 2.45 (95% confidence interval 2.28 to 2.65) in the most deprived group compared with the least deprived group. Substantial increases were noted in newly recorded transgender codes over time in all age groups (1.45/100 000 person years in 2000 (95% confidence interval 0.96 to 2.10) to 7.81/100 000 person years in 2018 (6.57 to 9.22)). In 2018, the proportion of people with transgender identity codes was highest in the age groups 16-17 years (16.23 per 10 000 (95% confidence interval 12.60 to 20.57)) and 18-29 years (12.42 per 10 000 (11.06 to 13.90)). Conclusion: The rate of transgender identity recorded in primary care records has increased fivefold from 2000 to 2018 and is highest in the 16-17 and 18-29 age groups. Transgender diagnostic coding is associated with socioeconomic deprivation and further work should investigate this association. Primary and specialist care should be commissioned accordingly to provide for the gender specific and general health needs of transgender people.

Muslim women's views and experiences of family planning in Saudi Arabia: a qualitative study.

BACKGROUND: Islamic beliefs are associated with decreased contraceptive use compared to other religions, and Muslim women's contraceptive needs are often unmet. Research is needed to provide an in-depth understanding of the complex set of barriers to Muslim women's contraceptive use. Therefore, we aimed to explore Muslim women's awareness and experiences with family planning in Saudi Arabia and investigate barriers to contraceptive use and access to family planning. METHODS: A qualitative study using semi-structured interviews with women in a public hospital, in Riyadh, Saudi Arabia, between January and June 2019. Data was analysed using reflexive thematic analysis. RESULTS: Twenty-eight women participated in the study. Women's contraceptive awareness was limited to two methods. Women expressed positive attitudes towards family planning and did not believe it is forbidden in Islam. Barriers to contraception use included lack of knowledge, misconceptions, fear of side effects, family and community and social norms. Many women expressed that they have the right to use contraception, even if their husbands disapprove. Our findings show that healthcare providers rarely offered contraceptive advice, even when requested. Healthcare providers often prescribe oral contraceptives without offering information on other methods available. CONCLUSION: Our findings suggest that education plays a fundamental role in reproductive autonomy. Men's role in family planning should be encouraged through sharing reproductive responsibility and supporting women's contraceptive choices. Efforts should be directed towards improving women's awareness of different methods of contraception.

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.

Muslim women's perspectives on the barriers to sexually transmitted infections testing and diagnosis in Saudi Arabia.

Background: Muslim women are especially vulnerable to sexually transmitted infections (STI) and are at higher risk of under-detection. Evidence on the unique barriers to STI testing and diagnosis among Muslim communities is severely lacking. Understanding the complexity of accessing STI testing and diagnosis in Muslim communities is an area that requires further exploration. We aimed to explore the multilevel barriers to STI testing and diagnosis among Muslim women. Methods: We conducted qualitative semi-structured interviews informed by the ecological model of health. This study took place in Riyadh Saudi Arabia in 2019 with women aged over 18. Data were analysed using reflexive thematic analysis. Results: Twenty-eight women were interviewed from different ages, marital status, employment, and educational levels. Muslim women's perceived barriers to STI testing and diagnosis included personal, socio-cultural, and service-level barriers. Lack of knowledge about STIs, denial, and underestimating the seriousness of infection and symptoms were among the many individual barriers to STIs testing and diagnosis. Religious views towards extramarital sex and negative views of people with STIs is a significant barrier to STI testing and diagnosis. Lack of patient confidentiality and providers' judgement and mistreatment were also cited as barriers to seeking healthcare. Conclusion: Barriers to STI testing and diagnosis exist on many levels including personal, socio-cultural, religious, and healthcare services, and at policy level. Multilevel interventions are needed to reduce the stigma of STIs and facilitate access to sexual health services among Muslims. It is our recommendation that policy and research efforts are directed to enhance trust in the doctor-patient relationship through better clinical training as well as implementing stricter regulations to protect patients' confidentiality in healthcare settings.

The impact of COVID-19 on patient engagement with primary healthcare: lessons from the saudi primary care setting.

BACKGROUND: There have been significant achievements in controlling COVID-19 in Saudi Arabia (SA), but as in most healthcare settings worldwide, health services have been seriously disrupted. Also, with pandemic control measures such as lockdowns and curfews, and innovations such as digital health services, the delivery of primary healthcare (PHC) services has dramatically changed. However, little is known about patients' experiences of PHCs during the pandemic, their views on the pandemic-related interventions in SA, and patient views on impact on their medical care. METHODS: Qualitative semi-structured online interviews were conducted for twenty-four Saudi patients across SA aged 18 and above who were diverse in terms of age, gender, education and health status. Data were analysed using thematic analysis yielding four major themes as an impact of COVID-19 on patient engagement with PHCs. RESULTS: The COVID-19 pandemic has had profound mixed impacts on patient engagement with PHC in SA. Fear of infection or of breaking lockdown rules has negatively impacted the utilisation of PHCs but positively changed patients' attitudes towards seeking medical help for self-limiting conditions. The pandemic has also negatively impacted routine preventive care at PHCs, especially for patients with long-term health conditions. The mandatory use of some digital health services in SA that existed pre-pandemic has provided patients with a perception of better care during the pandemic. Yet, a lack of awareness of optional digital health services, such as virtual clinics, hindered optimal use. Despite pandemic-related disruption of patient engagement with PHCs, the reduced waiting time in PHC centres and healthcare providers' communication and empathy during the pandemic contributed to patients' perceptions of better care compared to pre-pandemic. However, patients living outside the main cities in SA perceived care quality as less good during the pandemic compared to PHCs in the main cities in SA. CONCLUSION: The lessons learned from patients' experiences and views of PHCs during the pandemic were beneficial in promoting patient engagement with PHCs. The digital health services mandated in response to the pandemic have accelerated digital health innovation in SA and allowed patients to recognise the benefits of digital health. This has huge potential for increasing continuous patient engagement with PHCs. Yet, patients' experiences of digital health services during the pandemic are essential for informing appropriate implementation and utilisation of e-health services. Patients' positive experiences of PHCs during the pandemic, such as the reduction in waiting times and the perception of improved healthcare providers' professionalism, communication and empathy, can be built on to sustain engagement with PHC services. These findings might have significance for clinicians and policymakers to support patient engagement with PHCs, particularly in healthcare systems like SA that struggle with the overuse of emergency departments (EDs) for PHC-treatable conditions.

Clinical efficacy and safety of Zuranolone (SAGE-217) in individuals with major depressive disorder.

Major depressive disorder (MDD) is a common mental disorder with a high rate of morbidity and mortality. Dysfunctional signaling of gamma-aminobutyric acid (GABA) has been implicated in some studies in the etiology of MDD. Zuranolone (SAGE-217) is a novel, oral neuroactive steroid and an investigational positive allosteric modulator of synaptic and extrasynaptic GABAA receptors. Herein, we aimed to evaluate the efficacy and safety of Zuranolone in individuals with MDD. We reviewed seven studies including 1662 participants with MDD. Zuranolone was investigated as an oral, once-daily, 14-day treatment course. The results of our synthesis indicate that the antidepressant effects of Zuranolone are rapid, clinically meaningful, and replicated across multiple randomized clinical trials. In addition to replicated efficacy, Zuranolone is associated with an acceptable level of treatment-emergent adverse events and discontinuation without serious adverse events. It is believed that Zuranolone's antidepressant effects arise from its ability to enhance inhibitory GABAergic signaling by increasing synaptic and extrasynaptic GABAA activity and regulation of GABAA receptor expression. Taken together, preliminary evidence suggests the potential for antidepressant effects of Zuranolone. Zuranolone has been approved by FDA for postpartum depression, and is showing efficacy in major depressive disorder. Future research vistas should seek to determine the durability of this treatment approach as well as its effects on domain-specific outcomes (e.g., anhedonia, circadian rhythm, arousal systems) along with application in other diagnostic entities (e.g., bipolar depression).

Site staff perspectives on communicating trial results to participants: Cost and feasibility results from the Show RESPECT cluster randomised, factorial, mixed-methods trial.

BACKGROUND/AIMS: Sharing trial results with participants is an ethical imperative but often does not happen. Show RESPECT (ISRCTN96189403) tested ways of sharing results with participants in an ovarian cancer trial (ISRCTN10356387). Sharing results via a printed summary improved patient satisfaction. Little is known about staff experience and the costs of communicating results with participants. We report the costs of communication approaches used in Show RESPECT and the views of site staff on these approaches. METHODS: We allocated 43 hospitals (sites) to share results with trial participants through one of eight intervention combinations (2 × 2 × 2 factorial; enhanced versus basic webpage, printed summary versus no printed summary, email list invitation versus no invitation). Questionnaires elicited data from staff involved in sharing results. Open- and closed-ended questions covered resources used to share results and site staff perspectives on the approaches used. Semi-structured interviews were conducted. Interview and free-text data were analysed thematically. The mean additional site costs per participant from each intervention were estimated jointly as main effects by linear regression. RESULTS: We received questionnaires from 68 staff from 41 sites and interviewed 11 site staff. Sites allocated to the printed summary had mean total site costs of sharing results £13.71/patient higher (95% confidence interval (CI): -3.19, 30.60; p = 0.108) than sites allocated no printed summary. Sites allocated to the enhanced webpage had mean total site costs £1.91/patient higher (95% CI: -14, 18.74; p = 0.819) than sites allocated to the basic webpage. Sites allocated to the email list had costs £2.87/patient lower (95% CI: -19.70, 13.95; p = 0.731) than sites allocated to no email list. Most of these costs were staff time for mailing information and handling patients' queries. Most site staff reported no concerns about how they had shared results (88%) and no challenges (76%). Most (83%) found it easy to answer queries from patients about the results and thought the way they were allocated to share results with participants would be an acceptable standard approach (76%), with 79% saying they would follow the same approach for future trials. There were no significant effects of the randomised interventions on these outcomes. Site staff emphasised the importance of preparing patients to receive the results, including giving opt-in/opt-out options, and the need to offer further support, particularly if the results could confuse or distress some patients. CONCLUSIONS: Adding a printed summary to a webpage (which significantly improved participant satisfaction) may increase costs to sites by ~£14/patient, which is modest in relation to the cost of trials. The Show RESPECT communication interventions were feasible to implement. This information could help future trials ensure they have sufficient resources to share results with participants.

Muslim women's knowledge, views, and attitudes towards sexually transmitted infections in Saudi Arabia: A qualitative study.

BACKGROUND: The cultural sensitivity surrounding sexuality in Islamic communities has an impact on awareness and prevention of sexually transmitted infections (STIs). This study explores Muslim women's knowledge, views, and attitudes towards STIs and people living with HIV/AIDs in Saudi Arabia. METHODS: We conducted qualitative semi-structured interviews with Muslim women from Saudi Arabia. Interviews took place in a public hospital in Riyadh, Saudi Arabia in 2019. Data were transcribed, coded, and analysed using a reflexive thematic analysis. RESULTS: Twenty-eight women were interviewed, the majority were college educated and employed. Participants lacked knowledge about STIs, and there were significant misconceptions. The majority of women expressed extremely negative attitudes towards STIs, particularly towards people living with HIV/AIDS. Participants believed that judgemental attitudes and stigmatisation of people with HIV/AIDS were justified if an infection was transmitted through extramarital sex. Men were believed to be the source of STIs, and STIs were viewed as punishment from God for extramarital sexual relations that are forbidden in Islam. Protection against STIs was believed to be achieved by strengthening religious beliefs. CONCLUSION: Attitudes towards people with STIs, HIV/AIDS in particular, were highly influenced by religious views towards extramarital sex, as well as lack of knowledge and misconceptions. There is an urgent need for accurate information and improved awareness of sexual health including STIs among Muslims in Saudi Arabia. Public health efforts should be directed towards reducing stigma and discrimination against people living with HIV/AIDS in Saudi Arabia and other Islamic communities.

An Intervention to Increase Condom Use Among Users of Sexually Transmitted Infection Self-sampling Websites (Wrapped): Protocol for a Randomized Controlled Feasibility Trial.

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. TRIAL REGISTRATION: ISRCTN Registry ISRCTN17478654; http://www.isrctn.com/ISRCTN17478654. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/43645.

A peer-led, school-based social network intervention for young people in the UK, promoting sexual health via social media and conversations with friends: intervention development and optimisation of STASH.

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.

Interventions to support contraceptive choice and use: a global systematic map of systematic reviews.

BACKGROUND: 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. METHODS: 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. FINDINGS AND CONCLUSION: 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.

Exploring the psychosexual impact and disclosure experiences of women testing positive for high-risk cervical human papillomavirus.

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.

Factors affecting contraceptive choice in women over 40: a qualitative study.

OBJECTIVE: To explore the views of women over 40 years in choosing and using contraception, and to inform how contraceptive counselling for this age group could be improved. DESIGN, SETTING AND PARTICIPANTS: Fourteen women aged 40-52 years were recruited through social media platforms to take part in online, semistructured, in-depth interviews. Transcripts were analysed using a qualitative thematic approach. RESULTS: (1) Participants were anxious about unplanned pregnancy, and still highly motivated to avoid this. (2) Changes of contraceptive method over the lifecourse were occasionally precipitated by emergent health conditions, but healthcare providers often recommended a change in method on the basis of age alone. (3) Participants were experiencing perimenopausal symptoms but were largely unaware of how hormonal contraception could be used to treat these symptoms. (4) Prior negative experiences with contraceptive methods, coercive experiences with healthcare providers, and traumatic life events all contributed to a narrowing of contraceptive preference in later life. CONCLUSION: Women over 40 years may be highly motivated to avoid pregnancy. This age group may have complex contraceptive histories with emerging perimenopausal symptoms. Women over 40 years may have accumulated adverse experiences which impact their contraceptive choices. These factors need to be explored by clinicians, to facilitate shared decision-making.

Effectiveness of a behavioural intervention delivered by text messages (safetxt) on sexually transmitted reinfections in people aged 16-24 years: randomised controlled trial.

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.

Factors influencing contraception choice and use globally: a synthesis of systematic reviews.

BACKGROUND: 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. METHODS: 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. FINDINGS: 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. INTERPRETATION: 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.

Views, attitudes and experiences of South Asian women concerning sexual health services in the UK: a qualitative study.

OBJECTIVE: To explore the views, attitudes, and experiences of South Asian women in the UK regarding sexual health services. METHODS: 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. RESULTS: 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. CONCLUSION: 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.