Sima Berendes

Objective: The global target to halve the prevalence of anemia by 2025 has not been met. New strategies are needed. This systematic review examined the effect of tranexamic acid on anemia, menstrual health and wellbeing in women of reproductive age. Methods: We searched six databases from inception to 30 August 2025 and reference lists of seven related reviews. We included randomized trials comparing the effects of tranexamic acid with placebo or standard care on uterine bleeding. Eligible participants had normal menstrual bleeding or any type of non-pregnant abnormal uterine bleeding. Outcomes included hemoglobin concentration and anemia prevalence as the primary outcome, estimated blood loss, quality of life, thromboembolic events, and other adverse events. We conducted meta-analyses and assessed risk of bias (Cochrane risk-of-bias tool for randomized trials) and the certainty of evidence. Results: We included 17 trials in the review and 15 in the meta-analyses. None of the trials reported adequate data on hemoglobin concentration. For the anemia outcome, only one small trial contributed data (risk ratio 0.15, 95% confidence interval 0.01 to 2.74, very low certainty). Meta-analyses of secondary outcomes showed that tranexamic acid reduced objectively measured menstrual blood loss among women with heavy menstrual bleeding (6 trials, mean difference −47.0 milliliters, 95% confidence interval −56.6 to −37.4, I ² = 13%, moderate certainty) and in women with intrauterine devices (3 trials, mean difference −41.6 milliliters, 95% confidence interval −52.2 to −30.9, I ² = 64%, low certainty) and improved quality of life in women with heavy menstrual bleeding (2 trials, mean difference 0.5, 95% confidence interval 0.4 to 0.7, I ² = 0%, moderate certainty). The risk of nausea or vomiting was similar between groups (4 trials, risk ratio 1.0, 95% confidence interval 0.6 to 1.8, I ² = 0%, moderate certainty). Certainty of evidence for other outcomes ranged from very low to low, including for thromboembolic events, with only one event reported in the control arm of one trial. Conclusions: Tranexamic acid appears to reduce menstrual blood loss, but its impact on anemia is unclear. High-quality randomized trials of TXA for menstruating women with anemia are needed.

Background Increasing rates of sexually transmitted infections (STIs) and antimicrobial resistance among young people underscore the urgent need for preventative interventions. Interventions should be evidence-based and tailored to the unique risks and needs associated with varying age, sex and sexual orientation. We used data from the Safetxt trial to explore whether young people’s age, sex and sexual orientation influence (1) their risk of STI reinfection and condom use and (2) the effect of the Safetxt intervention on STI reinfection and condom use. Methods We conducted exploratory secondary analyses of data from the Safetxt trial that evaluated a theory-based digital sexual health intervention tailored according to sex and sexual orientation. We recruited 6248 young people with STIs from 92 UK sexual health clinics and assessed outcomes after 1 year, including the cumulative incidence of STI reinfection and condom use at last sex. We used adjusted logistic regression and margins plots to visualise effect modification. Results There were differences in STI reinfection and condom use by age, sex and sexuality. Age was associated with STI reinfection (OR 0.90, 95% CI 0.87 to 0.94) with evidence for interaction between age and sexuality (pConclusions Future digital health interventions tailored for diverse sexuality groups need to target young people early enough to have an impact on sexual behaviour. Specific novel interventions are needed for older MSM. Trial registration number ISRCTN64390461.

Pregnant women and their babies face significant risks from three vaccine-preventable diseases: COVID-19, influenza and pertussis. However, despite these vaccines’ proven safety and effectiveness, uptake during pregnancy remains low. We conducted a systematic review (PROSPERO CRD42023399488; January 2012–December 2022 following PRISMA guidelines) of interventions to increase COVID-19/influenza/pertussis vaccination in pregnancy. We searched nine databases, including grey literature. Two independent investigators extracted data; discrepancies were resolved by consensus. Meta-analyses were conducted using random-effects models to estimate pooled effect sizes. Heterogeneity was assessed using the I² statistics. From 2681 articles, we identified 39 relevant studies (n = 168 262 participants) across nine countries. Fifteen studies (39%) were randomized controlled trials (RCTs); the remainder were observational cohort, quality-improvement or cross-sectional studies. The quality of 18% (7/39) was strong. Pooled results of interventions to increase influenza vaccine uptake (18 effect estimates from 12 RCTs) showed the interventions were effective but had a small effect (risk ratio = 1.07, 95% CI 1.03, 1.13). However, pooled results of interventions to increase pertussis vaccine uptake (10 effect estimates from six RCTs) showed no clear benefit (risk ratio = 0.98, 95% CI 0.94, 1.03). There were no relevant RCTs for COVID-19. Interventions addressed the ‘three Ps’: patient-, provider- and policy-level strategies. At the patient level, clear recommendations from healthcare professionals backed by text reminders/written information were strongly associated with increased vaccine uptake, especially tailored face-to-face interventions, which addressed women’s concerns, dispelled myths and highlighted benefits. Provider-level interventions included educating healthcare professionals about vaccines’ safety and effectiveness and reminders to offer vaccinations routinely. Policy-level interventions included financial incentives, mandatory vaccination data fields in electronic health records and ensuring easy availability of vaccinations. Interventions had a small effect on increasing influenza vaccination. Training healthcare providers to promote vaccinations during pregnancy is crucial and could be enhanced by utilizing mobile health technologies.

Objectives People aged 16–24 are more likely than other age groups to acquire sexually transmitted infections (STI). Safetxt was a randomised controlled trial of a theory-based digital health intervention to reduce STIs among 16–24 year-old people in the UK. We report results of qualitative research regarding participants’ perceptions and experiences of the intervention and trial participation. Design Qualitative thematic analysis following a critical realist paradigm of written open feedback comments provided in the 12-month follow-up questionnaire and semistructured interviews. Setting Safetxt trial participants were recruited from UK sexual health clinics. Participants Trial inclusion criteria: people aged 16–24 diagnosed with or treated for chlamydia, gonorrhoea or non-specific urethritis. Optional open feedback provided by 3526 of 6248 safetxt participants at 12 months and interviews with a purposive sample of 18 participants after the trial. Results We summarise and report results in seven broad themes. According to recipients, the safetxt intervention increased awareness of the importance of avoiding STIs and ways to prevent them. Participants reported improved confidence, agency, sexual well-being and communication about sexual health with partners, friends and family. Recipients attributed increased condom use, increased STI testing after (rather than before) sex with new partners, and more confident partner notification to the intervention. Recipients described a reduced sense of isolation and stigma in having an STI. Control group participants reported that having had an STI and receiving control texts asking them to report any changes in contact details acted as reminders to use condoms and get tested. We also summarise participant recommendations for future interventions and studies. Conclusions While control group participants reported precautionary behaviours were ‘triggered’ by trial participation, intervention recipients reported additional benefits of the intervention in increasing precautionary behaviours and in broader aspects of sexual health such as confidence, communication, emotional well-being and agency. Trial registration ISRCTN registry ISRCTN64390461.

Background: Maternal vaccinations against Influenza, Pertussis, and Covid-19 are recommended in the UK, and vaccines against further infections may become available soon. However, many pregnant women, especially in socially and ethnically diverse areas, have low vaccine uptake. Qualitative studies on the reasons and possible solutions are needed that are inclusive of disadvantaged and minority ethnic groups. We therefore aimed to understand the complex interplay between structural and behavioural factors contributing to the low maternal vaccine uptake in socially and ethnically diverse areas in London in the Covid-19 context. Methods: In 2022, we conducted semi-structured interviews and a focus group discussion among a purposive sample of 38 pregnant/recently pregnant women and 20 health service providers, including 12 midwives. Participants were recruited in ethnically diverse London boroughs. We followed a critical realist paradigm and used a thematic analysis approach. Results: The sample included participants who took all, some or none of the maternal vaccines, with some participants unsure whether they had taken or been offered the vaccines. Decision-making was passive or active, with the expectation for pregnant women to do their 'own research'. Participants described various individual, social and contextual influences on their decision-making as they navigated the antenatal care system. Missing or conflicting information from providers meant knowledge gaps were sometimes filled with misinformation from unreliable sources that increased uncertainties and mistrust. Both pregnant women and providers described structural and organisational factors that hindered access to information and vaccinations, including lack of training, time and resources, and shortcomings of health information systems and apps. Some participants described factors that facilitated vaccination uptake and many made recommendations for improvements. Conclusions: Our study showed how structural and organisational factors can compound uncertainties around maternal vaccination among socially and ethnically diverse populations. Results highlight the need for more reliable resources, streamlined workflows, improved electronic information systems and training in their use. Roles and responsibilities should be clarified with potential greater involvement of nurses and pharmacists in vaccine provision. Education and communication should consider individual (language/digital) skills and needs for information and reassurance. Further research is needed to co-produce solutions with service users and providers.

Background Maternal vaccinations against Influenza, Pertussis, and Covid-19 are recommended in the UK, and vaccines against further infections may become available soon. However, many pregnant women, especially in socially and ethnically diverse areas, have low vaccine uptake. Qualitative studies on the reasons and possible solutions are needed that are inclusive of disadvantaged and minority ethnic groups. We therefore aimed to understand the complex interplay between structural and behavioural factors contributing to the low maternal vaccine uptake in socially and ethnically diverse areas in England in the Covid-19 context.Methods In 2022, we conducted semi-structured interviews and a focus group discussion among a purposive sample of 38 pregnant/recently pregnant women and 20 health service providers, including 12 midwives. Participants were recruited in ethnically diverse London boroughs. We followed a critical realist paradigm and used a thematic analysis approach.Results The sample included participants who took all, some or none of the maternal vaccines, with some participants unsure whether they had taken or been offered the vaccines. Decision-making was passive or active, with the expectation for pregnant women to do their 'own research'. Participants described various individual, social and contextual influences on their decision-making as they navigated the antenatal care system. Missing or conflicting information from providers meant knowledge gaps were sometimes filled with misinformation from unreliable sources that increased uncertainties and mistrust. Both pregnant women and providers described structural and organisational factors that hindered access to information and vaccinations, including lack of training, time and resources, and shortcomings of health information systems and apps. Some participants described factors that facilitated vaccination uptake and many made recommendations for improvements.Conclusions Our study showed how structural and organisational factors can compound uncertainties around maternal vaccination among socially and ethnically diverse populations. Results highlight the need for more reliable resources, streamlined workflows, improved electronic information systems and training in their use. Roles and responsibilities should be clarified with potential greater involvement of nurses and pharmacists in vaccine provision. Education and communication should consider individual (language/digital) skills and needs for information and reassurance. Further research is needed to co-produce solutions with service users and providers.

Background: The prevalence of genital chlamydia and gonorrhoea is higher in the 16–24 years age group than those in other age group. With users, we developed the theory-based safetxt intervention to reduce sexually transmitted infections. Objectives: To establish the effect of the safetxt intervention on the incidence of chlamydia/gonorrhoea infection at 1 year. Design: A parallel-group, individual-level, randomised superiority trial in which care providers and outcome assessors were blinded to allocation. Setting: Recruitment was from 92 UK sexual health clinics. Participants: Inclusion criteria were a positive chlamydia or gonorrhoea test result, diagnosis of non-specific urethritis or treatment started for chlamydia/gonorrhoea/non-specific urethritis in the last 2 weeks; owning a personal mobile phone; and being aged 16–24 years. Allocation: Remote computer-based randomisation with an automated link to the messaging system delivering intervention or control group messages. Intervention: The safetxt intervention was designed to reduce sexually transmitted infection by increasing partner notification, condom use and sexually transmitted infection testing before sex with new partners. It employed educational, enabling and incentivising content delivered by 42–79 text messages over 1 year, tailored according to type of infection, gender and sexuality. Comparator: A monthly message regarding trial participation. Main outcomes: The primary outcome was the incidence of chlamydia and gonorrhoea infection at 12 months, assessed using nucleic acid amplification tests. Secondary outcomes at 1 and 12 months included self-reported partner notification, condom use and sexually transmitted infection testing prior to sex with new partner(s). Results: Between 1 April 2016 and 23 November 2018, we assessed 20,476 people for eligibility and consented and randomised 6248 participants, allocating 3123 to the safetxt intervention and 3125 to the control. Primary outcome data were available for 4675 (74.8%) participants. The incidence of chlamydia/gonorrhoea infection was 22.2% (693/3123) in the intervention group and 20.3% (633/3125) in the control group (odds ratio 1.13, 95% confidence interval 0.98 to 1.31). There was no evidence of heterogeneity in any of the prespecified subgroups. Partner notification was 85.6% in the intervention group and 84.0% in the control group (odds ratio 1.14, 95% confidence interval 0.99 to 1.33). At 12 months, condom use at last sex was 33.8% in the intervention group and 31.2% in the control group (odds ratio 1.14, 95% confidence interval 1.01 to 1.28) and condom use at first sex with most recent new partner was 54.4% in the intervention group and 48.7% in the control group (odds ratio 1.27, 95% confidence interval 1.11 to 1.45). Testing before sex with a new partner was 39.5% in the intervention group and 40.9% in the control group (odds ratio 0.95, 95% confidence interval 0.82 to 1.10). Having two or more partners since joining the trial was 56.9% in the intervention group and 54.8% in the control group (odds ratio 1.11, 95% confidence interval 1.00 to 1.24) and having sex with someone new since joining the trial was 69.7% in the intervention group and 67.4% in the control group (odds ratio 1.13, 95% confidence interval 1.00 to 1.28). There were no differences in safety outcomes. Additional sensitivity and per-protocol analyses showed similar results. Limitations: Our understanding of the mechanism of action for the unanticipated effects is limited. Conclusions: The safetxt intervention did not reduce chlamydia and gonorrhoea infections, with slightly more infections in the intervention group. The intervention increased condom use but also increased the number of partners and new partners. Randomised controlled trials are essential for evaluating health communication interventions, which can have unanticipated effects. Future work: Randomised controlled trials evaluating novel interventions in this complex area are needed. Trial registration: This trial is registered as ISRCTN64390461. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 11, No. 1. See the NIHR Journals Library website for further project information.

Background Digital health interventions (DHI) have been used to enhance the uptake of postpartum contraception and reduce unmet contraception needs. We conducted a systematic review of the effectiveness of DHI on postpartum contraceptive use and repeated pregnancy. Method We searched MEDLINE, Embase, Global Health, CINAHL and Cochrane CENTRAL (January 1990–July 2020). Randomised controlled trials (RCTs) of DHI promoting contraception among pregnant or postpartum women were included. Two researchers screened articles and extracted data. We assessed the risk of bias, certainty of evidence (CoE) and conducted meta-analyses following Cochrane guidance. Results Twelve trials with 5527 women were included. Interventions were delivered by video (four trials), mobile phone counselling (three trials), short message services (SMS) (four trials) and computer (one trial). During pregnancy or the postpartum period, mobile phone counselling had an uncertain effect on the use of postpartum contraception (risk ratio (RR) 1.37, 95% CI 0.82 to 2.29, very low CoE); video-based education may moderately improve contraception use (RR 1.48, 95% CI 1.01 to 2.17, low CoE); while SMS education probably modestly increased contraception use (RR 1.12, 95% CI 1.01 to 1.23, moderate CoE). Mobile phone counselling probably increased long-acting reversible contraception (LARC) use (RR 4.23, 95% CI 3.01 to 5.93, moderate CoE). Both mobile phone counselling (RR 0.27, 95% CI 0.01 to 5.77, very low CoE) and videos (RR 1.25, 95% CI 0.24 to 6.53, very low CoE) had uncertain effects on repeated pregnancy. Conclusions During pregnancy or in the postpartum period, videos may moderately increase postpartum contraception use and SMS probably modestly increase postpartum contraception use. The effects of DHI on repeated pregnancy are uncertain. Further well-conducted RCTs of DHI would strengthen the evidence of effects on contraception use and pregnancy.

Background The use of mobile technologies to prevent STIs is recognised as a promising approach worldwide; however, evidence has been inconclusive, and the field has developed rapidly. With about 1 million new STIs a day globally, up-to-date evidence is urgently needed. Objective To assess the effectiveness of mobile health interventions delivered to participants for preventing STIs and promoting preventive behaviour. Methods We searched seven databases and reference lists of 49 related reviews (January 1990–February 2020) and contacted experts in the field. We included randomised controlled trials of mobile interventions delivered to adolescents and adults to prevent sexual transmission of STIs. We conducted meta-analyses and assessed risk of bias and certainty of evidence following Cochrane guidance. Results After double screening 6683 records, we included 22 trials into the systematic review and 20 into meta-analyses; 18 trials used text messages, 3 used smartphone applications and 1 used Facebook messages as delivery modes. The certainty of evidence regarding intervention effects on STI/HIV occurrence and adverse events was low or very low. There was moderate certainty of evidence that in the short/medium-term text messaging interventions had little or no effect on condom use (standardised mean differences (SMD) 0.02, 95% CI −0.09 to 0.14, nine trials), but increased STI/HIV testing (OR 1.83, 95% CI 1.41 to 2.36, seven trials), although not if the standard-of-care control already contained an active text messaging component (OR 1.00, 95% CI 0.68 to 1.47, two trials). Smartphone application messages also increased STI/HIV testing (risk ratio 1.40, 95% CI 1.22 to 1.60, subgroup analysis, two trials). The effects on other outcomes or of social media or blended interventions is uncertain due to low or very low certainty evidence. Conclusions Text messaging interventions probably increase STI/HIV testing but not condom use in the short/medium term. Ongoing trials will report the effects on biological and other outcomes.