Cycling can be beneficial for health, well-being and the environment; however, cycling participation in the UK remains low. Effective and cost-effective strategies are needed to support people in the community to increase cycling. The Cycle Nation Communities randomised controlled trial (RCT) will evaluate whether a 9 week multi-component cycling programme (Cycle Nation) is more effective and cost-effective than an existing national cycle training session on cycling participation, transport use and health and well-being.

This pragmatic, single-blinded, two-arm RCT will recruit ≥268 adults who cycle infrequently. Participants will be randomised to the 9 week multi-component individual/social-level group-based Cycle Nation programme or an existing national standard single group-based cycle training session. Both arms will be delivered by community-based cycling organisations in Glasgow. Participants will complete self-reported measurements at baseline, 12 weeks and 12 months. The primary outcome is the proportion of participants cycling at least weekly at 12 months. Secondary outcomes include proportion of participants cycling at least weekly at 12 weeks; change in weekly number of rides and minutes of cycling and use of private car, taxi, public transport and walking at 12 weeks and 12 months; change in motivation, perceptions of cycling safety, confidence to cycle, self-esteem, vitality, health-related quality of life and perceived general physical health at 12 weeks and 12 months. A within-trial economic evaluation from a National Health Service/personal social service and a broader societal perspective will be undertaken. Pending within-trial results, a long-term model may be developed. An embedded process evaluation will use participant and facilitator interviews, participant acceptability questionnaires, facilitator delivery proforma and session observations.

Ethical approval has been obtained from the University of Glasgow Medical, Veterinary and Life Sciences Ethics Committee (11 April 25). Findings will be published in peer-reviewed journals and communicated to stakeholders and the public.

NCT07005674.

The Infant Gut Bacterial Study in Nigeria (INBUGS-NG) investigates how delivery mode, antibiotic exposure, feeding practices and environmental factors shape gut microbiome development and acquisition of antibiotic resistance genes (ARGs) during the first year of life in northern Nigeria.

Between February and July 2024, 90 mother–infant dyads were enrolled at a tertiary hospital in Kano city, Nigeria. This was a prospective longitudinal cohort with follow-ups at 10 scheduled time points: days 0, 1, 3, 5, 7, 14, 28, 90, 180 and 365. We also intensified stool sampling after infant antibiotic administration, enabling dense early-life sampling. To date, the cohort has contributed 480 infant stool samples, 232 maternal rectal swabs, 254 breast milk samples and 806 environmental samples (total 1772). In parallel, socio-demographic, clinical and cultural data were collected using Research Electronic Data Capture (REDCap) and household visit diaries.

Baseline data show that 84/90 mothers (93.3%) received postpartum antibiotics, and 26/90 infants (28.9%) received antibiotics within the first 3 months of life. Only 8% of infants were exclusively breastfed, with early water supplementation common. Caesarean deliveries accounted for 25% of births, and the mean gestational age was 38.5 weeks. Across the cohort, high retention was achieved, and the study has generated a unique long-read metagenomic resource from an African infant population, with analyses ongoing.

Shotgun long-read metagenomic sequencing (Oxford Nanopore) will enable strain-level and plasmid-level profiling of microbial communities and ARGs. Planned analyses include associations between early-life exposures and resistome dynamics, as well as cross-cohort comparisons with a parallel study in Pakistan. Follow-up will continue through 12 months.

The objective of this scoping review is to map out what has been published in the scientific literature on the relationship between climate change-related events and how these overlap with associated changes in resource availability, transactional sex and HIV incidence and prevalence, within fishing communities in the Lake Victoria basin. This objective is informed by the fact that climate change and the associated natural resource strains in the Lake Victoria region have exacerbated existing inequities within fishing communities. Vulnerable populations, especially women, engage in strategies such as transactional sex to cope with the uncertainty of natural resource-dependent livelihoods. This practice greatly increases women’s risk of contracting HIV in this region, with prevalence rates four to five times the national averages. This scoping review will thus show how the existing empirical literature reports on climate change, transformation in natural resources and livelihoods, and transactional sex and HIV in the Lake Victoria region.

Studies that meet the following inclusion criteria will be included: align with at least two of the major concepts of interest, including climate change, transactional sex, HIV/AIDS, Lake Victoria Basin and/or empirical studies; are published in English and after 2012; and focus on the Lake Victoria basin. The scoping review will be guided by the JBI Manual for Evidence Synthesis: Scoping Reviews, supported by the standard principles of Arksey and O’Malley. The specific search strategies to be implemented were developed with guidance from an experienced research librarian to align with the inclusion criteria. The search will be conducted in relevant global databases, with two reviewers screening the results and extracting relevant data points. Finally, results will be reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews flow diagram, and summarised in figures, tables and text.

The scoping review is designed to comprehensively scope the existing literature and document the coverage of linkages between transactional sex, HIV/AIDS and sustainable livelihoods in the context of climate change with a view to informing health systems responses to human health specific to the HIV epidemic.

The proposed scoping review is registered with the Open Science Foundation (OSF), registration number:https://doi.org/10.17605/OSF.IO/9DTW4.

This study describes the prototype testing and clinical validation of the Fit-Frailty App, a fully guided, interactive mobile health (mHealth) app to assess frailty and sarcopenia. This multi-dimensional tool is freely available on the App Store and considers medical history, physical performance, cognition, nutrition, daily function and psychosocial domains. To guide management, a total frailty score and clinical summary of underlying "risk flags" are provided. Our objectives were to examine usability, feasibility, criterion and construct validity.

Cross-sectional

Outpatient geriatric medicine clinic

Community-dwelling older adults, age 65 years or older

The primary outcome of the clinical validation study was criterion validity. A research nurse administered the Fit-Frailty App during a routine clinic appointment. Clinicians simultaneously completed a paper-based frailty index (FI) tool with similar items from a comprehensive geriatric assessment (FI-CGA). Total scores for both assessments were computed using the cumulative deficits frailty index scoring method. Intraclass and Pearson correlation coefficients and 95% CIs were calculated to examine criterion validity. Secondary outcomes were construct validity, feasibility (eg, completion rates, safety occurrences, resources) and usability (eg, ratings on ease of use, time to complete the app).

In the clinical validation study (n=75, mean age 79.2, SD=7.0, 53% female), the mean total Fit-Frailty App score was 0.33 (SD=0.13) with 73% of our sample considered frail or severely frail. The app presented comparable results to FI-CGA (moderate to good validity; ICC=0.65, 95%CI=0.50–0.76) with a strong association between the measures (r=0.74, 95%CI=0.62–0.83). In our prototype and clinical cohorts, the app had a 100% completion rate with no safety occurrences and had high usability ratings.

The Fit-Frailty App is a feasible and valid tool that can be used in research and clinical settings to comprehensively assess frailty and sarcopenia by non-geriatricians and could assist with developing targeted interventions.

We conducted a pilot randomised controlled trial (the PHaCT study), including a process evaluation to assess the acceptability of a housing-led Critical Time Intervention (CTI) for prison leavers and the use of a trial design. This paper presents the process evaluation findings.

To explore the acceptability of both the intervention and the trial design to participants and those delivering the intervention, and to assess whether the intervention was delivered with fidelity.

A process evaluation following Medical Research Council guidelines. Data collection included semi-structured interviews with participants and CTI caseworkers and observations of intervention delivery. A thematic analysis of interviews and observations was conducted to understand the intervention’s implementation and contextual factors as well as the trial process acceptability.

Participants for the pilot trial were recruited from three prisons in England and Wales where the intervention was being delivered.

While 28 out of 34 trial participants consented to interviews, only one was completed. Seven caseworkers were interviewed.

A housing-led CTI to support people leaving prison at risk of homelessness, involving phased, time-limited support from caseworkers, starting prerelease and continuing postrelease, to help secure stable housing and build independence, without directly providing housing.

The intervention’s acceptability was primarily reflected through the positive feedback and success stories shared by CTI caseworkers, as well as observational data indicating high acceptance among service users. The trial design’s acceptability was challenged by concerns about randomisation and equipoise, with staff viewing randomisation as unethical due to limited support for vulnerable populations. The fidelity to the CTI intervention housing-led approach was adhered to as best as possible; stable housing was prioritised for service users before addressing other needs. Despite these efforts, both sites encountered significant challenges due to limited housing availability and complex systems for securing social housing, particularly for single men leaving prison.

This wider study faced significant challenges which impacted the process evaluation. Despite these issues, the evaluation provides important insights into the challenges of conducting trials on interventions for people leaving prison. The challenges experienced should inform future study designs with similar populations and in similar settings.

ISRCTN46969988.

To determine whether a full-scale randomised control trial (RCT) assessing the efficacy and cost-effectiveness of a housing led Critical Time Intervention (CTI) is feasible and acceptable.

Pilot parallel two-arm individual level RCT, including process evaluation and embedded exploratory health economic evaluation.

Four prisons for men across England and Wales, UK.

Men leaving prison at risk of homelessness and intervention delivery staff.

CTI has four components: (1) pre-engagement phase: assessing the needs of the client and implementing a plan pre-discharge; (2) transition to community: forming relationships and goal setting; (3) try out: encouraging problem-solving and managing practical issues and (4) transfer of care: developing long-term goals and transferring responsibilities to community providers.

Progression criteria: recruitment, retention, acceptability of the processes (CTI and trial method) and fidelity of intervention delivery. We also assessed the completeness of primary, secondary and exploratory outcome measures and estimated intervention costs.

The recruitment progression criterion was met, with 92% (34/37) of approached individuals consenting to participate (target: 50%). However, the overall recruitment target of 80 was not achieved, and retention was low, only 18% (6/34) provided follow-up data, well below the 60% threshold. Retention was hindered by systemic challenges, including changes to prison release policies and reduced probation support. While the CTI model was acceptable to staff and service users, the trial design, particularly randomisation, was not. Intervention fidelity met the progression criteria. Baseline data collection for health economics and resource use was feasible, and intervention costs were estimated.

This pilot trial identified significant challenges to conducting a full-scale RCT of CTI in this context, particularly around retention, trial acceptability and systemic instability. While CTI remains a promising model, a traditional RCT design may not be viable in this setting without substantial structural and ethical adaptations.

ISRCTN46969988.

To analyse demographic trends and decision-making patterns regarding prenatal diagnosis (PND) in couples at risk for hereditary haemoglobinopathies at the Thalassemia and Rare Haematological Disease Centre in Turin over a 40-year period.

Retrospective observational study analysing demographic and clinical data from 1983 to 2023.

Tertiary care genetic service Centre in Orbassano (TO), Northern Italy.

Couples seeking genetic counselling and PND for hereditary haemoglobinopathies. Selection criteria included couples at risk of having children affected by β-thalassaemia major or Sickle Cell Disease (SCD).

Primary outcomes included acceptance rates of PND and pregnancy termination (TOP). Variables analysed included couples’ age at first consultation, age at first PND, birthplace, employment status, specific haemoglobinopathy risk and number of pregnancies.

The analysis identified three main factors influencing PND and TOP decisions: nationality, type of haemoglobinopathy risk and number of previous pregnancies. Age showed no significant correlation with decision-making patterns. The impact of education level and employment status could not be definitively determined due to unavailable or unfit data.

The 40-year analysis of prenatal diagnosis for haemoglobinopathies in Turin shows evolving trends influenced by immigration patterns, improved medical treatments and cultural factors, leading to increased acceptance of affected pregnancies in recent years, particularly after 2015, due to better disease management and comprehensive healthcare support. This comprehensive analysis of our centre’s experience provides valuable insights that can serve as a model for similar institutions worldwide in supporting couples through carrier screening and PND processes.

Cervical cancer (CaCx) is a leading cause of cancer-related deaths among women in South Africa, often presenting at advanced stages and requiring chemoradiotherapy. In South Africa, the burden is disproportionately high among women living with HIV, with limited access to radiotherapy further compounding treatment challenges. Despite this documented disparity, limited data exist on patients in a South African context. This protocol describes the research methodology to assess patterns of care, treatment delays, interruptions and survival outcomes in patients with advanced CaCx, addressing an urgent need for local data in low-income and middle-income countries to provide evidence-based improvements in care.

The Cervical Cancer Cohort at Charlotte Maxeke Johannesburg Academic Hospital (CMJAH-CCC), initiated in 2023, is a mixed retrospective and prospective single-centre study investigating the characteristics, challenges and outcomes of patients with advanced CaCx. It includes women aged ≥18 years with a histopathological diagnosis of stage IB3–IVA CaCx treated at CMJAH Radiation Oncology. The retrospective component covers data from September 2018 to August 2023. Data collection is complete and the team is currently conducting quality control. The prospective component began in October 2023 and aims to enrol participants over 2 years, with follow-up for up to 3 years. The study is ongoing, and an extension for continued enrolment beyond September 2025 is being sought. Participants provide baseline data on demographics, socioeconomic status, cultural influences and healthcare access, with updates every 3 months. When necessary, the next of kin provides follow-up information. The study aims to inform strategies to improve outcomes and reduce the CaCx burden in South Africa.

Ethics approval for this study was obtained from the Human Research Ethics Committee (Medical) at the University of the Witwatersrand in Johannesburg, South Africa, with an ethical clearance certificate (MM221001 MED22-09-085). The results will be widely distributed through presentations at national and international conferences and published in peer-reviewed open-access journals, ensuring wide access to the results.

Drug and vaccine safety information relevant to pregnant individuals is typically insufficient, especially so for persons living in low- and middle-income countries (LMICs). Pregnancy exposure registries (PERs) and similar systems are used to monitor medical products safety. A better understanding of the landscape of PERs in LMICs can support medicines regulatory system strengthening and preparation for new vaccine and drug introductions.

To identify PERs and related health data collection platforms in LMICs that systematically record pregnancy exposures to medical products and pregnancy outcomes to inform how future efforts, such as new vaccine introductions and treatment programmes, can better support maternal populations in these countries.

Scoping review based on methodology outlined in the Joanna Briggs Institute manual for scoping reviews.

Electronic search of Medline/PubMed, Embase, CINAHL and Global Index Medicus in June 2022, and key informants via online survey in July 2022 and interviews.

Eligible resources included registries, surveillance systems and databases that collect information on exposures to medical products during pregnancy and on subsequent maternal, perinatal and neonatal outcomes in populations located entirely or partially in LMICs. Eligible records were published from January 2000 through June 2022.

Search results were screened and data extracted using a standardised form by two independent reviewers. Instances of discordance were resolved by a third reviewer. Identified systems were categorised by resource type.

A total of 7515 records from electronic searches were screened, with 396 selected for full-text review and 47 additional records obtained from other sources. From these, 45 data collection systems located in African, Asian and Latin American LMICs were identified, with 36 currently in operation. These resources were grouped into six categories based on structure and approach and summarised according to key features, strengths and weaknesses.

This scoping review identified several resources in LMICs dedicated to drug and vaccine safety in pregnancy, but findings indicate that more investment will be needed to ensure such efforts are widespread and sustainable. Understanding the current landscape of such resources in these settings is an important step towards improving safe, world-wide access to life-saving interventions for pregnant populations.

The protocol for this review has been registered with Open Science Framework (https://doi.org/10.17605/OSF.IO/FU5AT).