The United Nations (UN) Sustainable Development Goal 6 seeks to ensure universal access to safe drinking water by 2030, but vast inequities in access exist, especially among vulnerable communities including limited resource, rural, disaster-affected areas. Flood disasters, exacerbated by the climate crisis, hinder the ability of individuals and families to meet essential drinking water needs and increase their susceptibility to waterborne illnesses. Point-of-use (POU) water treatment is an effective solution for water-insecure populations during and immediately following flood emergencies. However, an initial literature search identified knowledge gaps surrounding implementation of POU water systems. This scoping review aims to synthesise published evidence between January 2015 and July 2025 on barriers and facilitators to utilisation of POU water treatment systems during and immediately following flood-related disasters. The findings will inform efforts to promote resilience and agency among water insecure communities, specifically by equipping them with actionable knowledge on sustainable access to safe drinking water.

This scoping review will be guided by the work of Arksey and O’Malley and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. Search terms will be identified through an iterative process using the PICOT method and Boolean logic. Four databases—Scopus, PubMed, Web of Science and Google Scholar—with the addition of grey literature from UN agencies and non-governmental organisations focused on water-related issues will be searched. Two independent reviewers will apply a priori eligibility criteria to select studies. Conflicts will be resolved through discussion and a third independent reviewer absent agreement between the first two reviewers. Cohen’s kappa statistic will be calculated to assess inter-rater reliability. Data extraction will be guided by predefined data points, and the Consolidated Framework for Implementation Research will guide evidence synthesis through a solution-based approach.

Institutional research ethics review is not required because no human subjects are involved. Findings will be disseminated through a peer-reviewed publication, a policy brief, conference presentations and infographics for use by organisations serving flood disaster impacted communities.

Obesity and related cardiometabolic comorbidities, including hypertension, dyslipidaemia, diabetes, metabolic dysfunction-associated steatotic liver disease and atherosclerotic cardiovascular disease, are increasingly prevalent among individuals with inflammatory bowel disease (IBD). These conditions influence disease activity, therapeutic response, surgical outcomes and overall quality of life, yet evidence remains fragmented. The Modulate Obesity and relateD metabolic complIcations For Yielding improvements in IBD outcomes (MODIFY-IBD) initiative aims to synthesise evidence and generate consensus recommendations to guide practice and future research in this area. This study describes a protocol for a structured evidence synthesis and Research ANd Development/University of California, Los Angeles (RAND/UCLA) Appropriateness Method (RUAM) consensus process.

We will conduct three systematic reviews and a structured evidence synthesis organised into three domains: (1) the impact of obesity on IBD outcomes, (2) the burden of cardiometabolic complications in IBD and (3) the management of overweight, obesity and cardiometabolic comorbidities in IBD. A multidisciplinary international panel of gastroenterologists, surgeons, endocrinologists, hepatologists, cardiologists and dietitians will assess each statement using the RAND/UCLA appropriateness method. Panellists will rate the appropriateness of each statement (only those that fall within their area of expertise) on a 1–9 scale (1–3=inappropriate, 4–6=uncertain and 7–9=appropriate), with medians rounded up (eg, 6.5=appropriate). Agreement will be assessed using the RAND Disagreement Index (DI

This study will not involve direct patient participation, as it is based on evidence synthesis and expert consensus; therefore, formal research ethics committee approval will not be required. Patient representatives will contribute to the consensus process to provide contextual perspectives but no identifiable data will be collected.

Findings will be disseminated through publication in peer-reviewed journals, presentation at major gastroenterology and IBD conferences and communication with professional societies. A lay summary and patient-friendly infographic will also be developed to facilitate translation of recommendations into clinical practice.

CRD420251178843: a systematic review of the impact of obesity on inflammatory bowel disease outcomes.

CRD420251178799: a systematic review of cardiometabolic complications in inflammatory bowel disease.

CRD420251174653: management of overweight, obesity and cardiometabolic comorbidities in inflammatory bowel disease: a systematic review.

Masculinising chest surgery, also known as top surgery, is the most requested gender-affirming procedure among transgender and gender-diverse (TGD) adolescents, yet research on patient experiences remains limited. This study explored the experiences of TGD adolescents who were seeking or had undergone masculinising chest surgery.

Qualitative secondary analysis using existing themes framework and data from the GENDER-Q (GQ) and GENDER-Q Youth (GQY) research programmes, which aim to develop comprehensive patient-reported outcome measures for gender-affirming care.

Participants were sampled from five high-volume gender-affirming care clinics, three in Canada and two in the United States. Interviews were conducted online.

35 GQ and GQY participants aged 13–18 years who were assigned female at birth, identified as trans men or non-binary, and were pursuing (n=19) or had undergone (n=16) masculinising chest surgery.

Three major themes emerged: chest appearance, health-related quality of life (HRQL) and gender practices. Most participants expected a flatter chest that aesthetically aligned with their gender identity. Presurgery participants anticipated that surgery would allow them to engage in previously avoided physical activities and would enhance their relationships. Postoperative participants reported increased physical activity, mental resilience, bodily connection and social comfort. Most reported binder use and related reliance or discomfort as motivators for pursuing surgery.

This study highlights the multidimensional experiences surrounding masculinising chest surgery on TGD adolescents with impacts on chest appearance, HRQL and gender practices. Centering adolescents’ perspectives, these findings underscore the importance of accessible, affirming surgical care and provide valuable insights for clinicians, policymakers and future research.

Perinatal depression is a common, yet understudied, mental health disorder among women and contributes to poor engagement in prevention of mother-to-child transmission (PMTCT) of HIV in sub-Saharan Africa. Male partners are positioned to provide critical forms of social and economic support during pregnancy and postpartum, and also may contribute to women’s stress, depression and anxiety through intimate partner violence and withholding of social support. Despite the critical role of men in pregnancy outcomes and HIV prevention, few interventions have engaged men around women’s depressive symptoms, nutrition and health, and engagement in PMTCT. We will conduct a pilot trial of Mphatso, a couple-based intervention based on problem-solving therapy with couple relationship skills to reduce depressive symptoms in perinatal women, improve food insecurity and prevent HIV transmission to the infant.

We will employ a two-arm pilot randomised controlled trial in the Zomba district of Malawi to assess the feasibility and acceptability of Mphatso (meaning ‘gift’ or the child) and explore health impacts on depressive symptoms, PMTCT engagement and food insecurity. We will enrol 60 pregnant women in the second or third trimester who are living with HIV and meet criteria for probable depression based on the Edinburgh Postnatal Depression Scale and their male partners. Couples will be randomised to receive either five sessions of Mphatso (problem-management skills plus health education and relationship skills) or enhanced usual care. Feasibility and acceptability outcomes will include session attendance rates, satisfaction levels and retention at 3 months and 6 months postpartum. Exploratory analyses using regression models including time and treatment arm will be conducted to explore effects on the mothers’ and fathers’ depressive symptoms, adherence to PMTCT (antiretroviral therapy, nevirapine use, HIV testing and exclusive breastfeeding) and food insecurity.

The pilot trial has been approved by the University of California, San Francisco (Human Research Protection Program (HRPP); Protocol Number 23-40685), and the study has also been approved by the National Health Sciences Research Committee in Malawi (NHSRC; Protocol Number 24/05/4431). Results will be disseminated to study participants, health officials, policymakers, community leaders and care providers, as well as through presentations at conferences and publications in peer-reviewed journals.

NCT06659315.

A resurgent methamphetamine epidemic is a major driver of HIV incidence in the USA. Although daily oral pre-exposure prophylaxis (PrEP) is highly effective for preventing HIV acquisition, its effectiveness depends on achieving and maintaining prevention-effective adherence (ie, four or more doses per week). Digital health interventions offer a scalable method to extend the reach of behavioural approaches to HIV prevention, but evidence of their efficacy in improving objectively measured adherence remains limited. Addressing this gap is critical to maximising the clinical and public health benefits of PrEP.

From 26 January 2022 through 17 January 2025, this single-blind, parallel-group randomised controlled trial (RCT) enrolled 239 men taking PrEP who reported problematic stimulant use and who resided in California or Florida. Participants were randomised to receive five individually delivered telehealth sessions of a positive psychological intervention (n=119) or an attention-control condition (n=120), both delivered alongside remote contingency management for directly observed PrEP doses using the Spotlight mobile health application. Participants received US$20 per session and up to US$360 for uploading videos of at least four PrEP doses per week over 3 months. Follow-up assessments at 3, 6 and 12 months included surveys and dried blood spot specimens to quantify tenofovir diphosphate (TFV-DP). The primary outcome is biobehavioural HIV acquisition risk, defined as any recent condomless anal sex in the absence of TFV-DP concentrations consistent with prevention-effective adherence.

This RCT was approved by the University of Miami Institutional Review Board and registered prior to initiation of enrolment. Analyses of primary and secondary outcomes using intent-to-treat principles will be conducted after the completion of TFV-DP assays in June 2026, with results disseminated shortly thereafter through peer-reviewed publications.

This RCT was registered on www.clinicaltrials.gov (NCT04899024) prior to launching enrolment.

While improvements have been made across the HIV care continuum in South Africa, gaps remain. Relationship-focused couples-based approaches may be one avenue to improve HIV-related outcomes for men and women. Prior couples-based studies have been found to improve several HIV care and treatment outcomes in this context, but few have considered viral suppression as the primary outcome. We aimed to compare a couples-based motivational-interviewing intervention delivered to couples to similar content delivered to men and women in couples separately. We will test the efficacy of this approach in a randomised controlled trial.

Our goal is to enrol 270 heterosexual couples for this trial, with at least one partner living with HIV. Couples will be randomised into one of two arms, stratified by couples’ HIV status. The intervention arm, Simunye (‘We are one’ in isiZulu), will provide two sessions of motivational information and skills regarding HIV-related behaviours to couples together, along with relationship-focused content and skills. The content is based on Partner Steps (P-steps), a couples-focused adaptation of Life Steps, an evidence-based programme shown to improve adherence and viral suppression. The control group will receive two sessions as individuals, with similar HIV-related information but without relationship-focused content. Participants will be followed up at 6, 12 and 18 months postrandomisation. The baseline questionnaire will include measures of relationship domains such as satisfaction and communication, and measures pertaining to HIV and reproductive health (eg, fertility intentions, HIV knowledge and risk perception, and sexual behaviour), and mental health (eg, depression symptoms). The primary outcome is viral suppression, based on dried blood spots. Secondary outcomes will include other aspects of treatment engagement. We will also examine hypothesised mediators of intervention participation, for example, relationship dynamics. Primary analyses will use a multilevel modelling approach, which will feature planned time-averaged comparisons of postbaseline measurements across the intervention and control groups to test the primary hypothesis. The analysis will account for the dyadic nature of the data, for example, participants nested within couples.

This trial was approved by the Institutional Review Board (IRB) at the Human Sciences Research Council in South Africa, protocol number 2/27/01/21, and the IRB at the University of Michigan (HUM 00203672). Human subjects’ concerns or adverse events will be reported to both IRBs and the Data Safety and Monitoring Board. We will disseminate findings to community members and stakeholders via community meetings, as well as by conference presentations and publications in peer-reviewed journals.

Clinicaltrials.gov Protocol Registration NCT05231707 registered on 8 February 2022. Protocol version 2.0, 31 October 2025.

Healthcare services are mainly organised around single health conditions and need reconfiguration to meet the needs of people with multiple long-term conditions (multimorbidity). Typically, people are offered annual reviews for each of their long-term conditions separately. In a randomised controlled trial, a comprehensive computerised template based on a personalised care model increased the person-centredness of multimorbidity reviews in primary care, but there were implementation challenges. We sought to understand and address the challenges of implementing a template to support personalised primary care for people with multimorbidity (PP4M).

To explore the extent of implementation and factors influencing uptake of the PP4M intervention. To understand factors influencing implementation and normalisation of the template.

Convergent parallel mixed methods within a non-randomised hybrid implementation-effectiveness study. Normalisation Process Theory (NPT) informed design, data collection and analysis.

Primary care (general practices) in three English regions.

Quantitative: Patients aged 18 years or over and had at least three types of long-term conditions (routine data collection); staff involved in using the template in implementation practices (Normalisation MeAsure Development (NoMAD) questionnaire).

Qualitative: Staff at implementation practices.

A multimorbidity computerised template to support personalised annual reviews. NPT-informed implementation package delivered to implementation practices included: process mapping, software support and training.

Routine medical record data; NoMAD questionnaires and qualitative interviews in implementation practices.

Measures of reach, fidelity, acceptability and sustainability.

Quantitative data: descriptive statistics, logistic regression and difference-in-difference models. Qualitative data analysis conducted using NPT coding manual.

In practices that received an NPT-informed implementation package, use of the template increased more, across patients with a range of demographics and health conditions, than in those that did not receive the implementation package (OR 2.86 (95% CI 2.34 to 3.49)). The implementation package successfully triggered NPT processes of coherence and cognitive participation, and, to a lesser extent, collective action and reflexive monitoring. Contextual factors, including a lack of staff generalist skills and disease-specific incentives, impeded engagement and sustained implementation.

Focusing on the processes of normalisation as mechanisms of implementation facilitated development of an implementation strategy with potential to trigger those mechanisms, but did not sufficiently address contextual factors. Implementation strategies to support personalised care must consider wider system and practice level contextual factors, such as incentives and staff training.

https://doi.org/10.1186/ISRCTN40295449 (2022–08-03, retrospectively registered.)

The Needs Assessment Tool-Cancer (NAT-C) is a consultation guide to identify, triage and reduce unmet patient needs.

We aimed to assess NAT-C fidelity, mechanisms of action and implementation issues in UK primary care as part of a clinical and cost-effectiveness cluster randomised controlled trial of the NAT-C for people with cancer compared with usual care (registration: ISRCTN15497400).

Design: a mixed-methods process evaluation informed by normalisation process theory (NPT). Setting: 21 participating general practices in England were randomised to be trained to conduct an NAT-C guided consultation with people with cancer (excluding those in remission). General practitioner fidelity of intervention and clinical action resulting from the NAT-C consultation was noted. Two Normalisation MeAsure Development Questionnaire surveys were distributed to trained clinicians before (Survey 1) and after delivery of ≥2 NAT-C consultations (Survey 2). Semi-structured interviews were conducted with clinicians (post delivery ≥2 NAT-C consultations) and key stakeholders in primary and cancer care. Fidelity, action and paired before/after survey data were analysed using descriptive statistics. Interview data were analysed using a deductive thematic framework approach (NPT-informed). Data were narratively synthesised with cross-tabulated key findings.

Of the 360/376 (96%) NAT-C consultations delivered, 258/360 (72%) resulted in clinical action, including 50 (13%) external referrals. 14 paired before (Survey 1, n=53) and after (Survey 2, n=29) responses. Survey 1 showed positive responses across all NPT domains, but while continuing to see relevance, usefulness and legitimacy, Survey 2 highlighted concerns about insufficient resources and management support. 16 clinician participants (eight GPs, eight key stakeholders; 50% male) completed interviews. Following synthesis, we identified five themes: (1) the perceived value of the NAT-C; (2) ‘champions’ are important at all levels (practice, regionally and nationally); (3) research evidence is seen as important, but influences implementation indirectly through policy, clinical guidelines and resourced initiatives; (4) adequate resources are fundamental for implementation beyond practice level and (5) NAT-C practicalities; training is adequate, but robust functional information technology systems are needed.

Implementation requires champions and clinicians ‘buy-in’ to the patient value to legitimise use. In the context of current primary care pressures, resources were seen as essential to embed the NAT-C, but financial incentives were viewed with mixed feelings.

ISRCTN15497400.

A neglected area of patient safety research is how the characteristics of mental health staff and teams may influence incidents, specifically, through unintended and harmful consequences of clinical care. While the research literature into patient safety has increased, there is still a need to further consider safety on mental health wards, for example, the role of the staff team in containment and conflict. This review aims to explore the question, ‘How do staff and team characteristics relate to safety incidents in adult inpatient mental health settings?’.

The review will follow Whittemore and Knafl’s integrative review framework. CINAHL, Cochrane, Embase, MEDLINE, PsycINFO, Web of Science will be searched. Literature published after 1999, that includes extractable quantitative, qualitative and mixed methods data exploring the relationship between staff and team characteristics on incidents in adult inpatient mental health settings, will be suitable for inclusion. The Mixed Methods Appraisal Tool will be used for quality appraisal and data analysis and will comprise data reduction, display and comparison.

No new data or access to participants will be involved in this review. As such, ethical review will not be required. Dissemination will include publication in peer-reviewed journals and presentations at national and international conferences.

This review has been registered on PROSPERO (ref. CRD420251119981; https://www.crd.york.ac.uk/PROSPERO/view/CRD420251119981).

The roles of pharmacy staff have expanded to include public health functions, such as delivering harm reduction services for people who use drugs (PWUD), particularly unregulated substances and non-medical drug use, in response to an ongoing drug overdose crisis. Nonetheless, their involvement across the full spectrum of harm reduction services remains underexplored. This study mapped existing research describing or evaluating the implementation of harm reduction services for PWUD provided by pharmacy staff.

Scoping review.

MEDLINE, EMBASE, CINAHL, Web of Science, Scopus and Cochrane Library (inception to July 2025).

Studies reporting on the description or evaluation of harm reduction services for PWUD provided by pharmacy staff.

Two team members screened studies for eligibility and extracted the data. The data were analysed primarily to describe harm reduction services and the role of pharmacy staff.

43 articles were included. The most frequently reported harm reduction services were sexually transmitted and blood-borne infection care (33%), needle and syringe programmes (21%), naloxone distribution (19%) and medication treatment for opioid use disorder (19%). Pharmacy staff were integrated into multidisciplinary teams (79%), with their roles varying from education to medication prescribing. Included studies reported harm reduction services for PWUD delivered by pharmacy staff as effective, feasible and safe. However, implementations were not tailored to equity-deserving populations. Services primarily addressed opioid-related harms, while strategies focusing on the use of non-opioid substances were limited.

This scoping review highlights the diverse roles pharmacy staff play in delivering harm reduction services for PWUD. Positioned at the intersection of accessibility and healthcare delivery, pharmacy staff are ideally situated to expand access to equitable care. To fully harness this potential, future research and practice should embed harm reduction as a core philosophy, extending beyond individual interventions to support the creation of person-centred, non-judgmental and low-barrier services.

To determine the prevalence and factors associated with pain-related disabilities among First Nations people living off-reserve in Canada in 2017.

Secondary analysis of the 2017 Aboriginal Peoples Survey, a cross-sectional survey of individuals living in private dwellings throughout Canada.

First Nations people living off-reserve aged 15 years and older (n=9115; weighted n=482 066).

Pain-related disabilities, defined as pain-related activity limitations lasting ≥6 months.

Overall, 22.1% (95% CI 20.9% to 23.4%) of First Nations people living off-reserve reported pain-related disabilities. Prevalence was higher among females (26.1%; 95% CI (24.3% to 28.0%)), increased with age (34.3%; 95% CI (30.3% to 38.5%) among those 45 to 54 years) and was similar across geographic areas (ranging from 21.0%; 95% CI (18.3% to 23.9%) to 22.5%; 95% CI (20.8% to 24.2%)). Pain-related disabilities increased with the number of coexisting disabilities (96.2%; 95% CI (94.3% to 97.5%) among those with >3 disabilities) and was highest among those reporting physical disabilities (ranging from 88.2%; 95% CI (85.6% to 90.4%) for those with mobility disabilities to 91.0%; 95% CI (88.6% to 92.9%) for those with disability related to flexibility). Regression models suggested that individuals with unmet basic needs, housing dissatisfaction, unmet healthcare needs, a history of mental health consultations, part-time or no employment, chronic conditions, residential school attendance or a low sense of belonging were more likely to report pain-related disabilities.

Pain-related disabilities are common among First Nations people living off-reserve, and their aetiology may be multifactorial. Continued collaboration with Indigenous partners is required to contextualise findings and to inform culturally responsive clinical and rehabilitation strategies.

Poverty can have profound negative impacts on parent, child and family health. Primary care providers are in a unique position to address child poverty. Some team-based models have integrated community support workers (CSWs) for social service system navigation assistance. The overall aim of this study is to rigorously test a poverty reduction intervention (navigation of financial supports) embedded in primary care. The primary objective is to compare parenting stress between CSW-supported, structured review of financial supports and social system navigation (intervention) and receipt of written summary of local resources (usual care).

This is a multisite pragmatic superiority randomised controlled trial with a 1:1 allocation to the CSW-supported social system navigation versus no navigation. Parent–child dyads (80 parents of children aged Do you ever have difficulty making ends meet at the end of the month?’) will be recruited during a scheduled health supervision visit from primary care practices in Kingston, Ontario. Intervention group participants will have a structured review of financial supports with a trained CSW and will meet up to 6 times over 6 months. Outcomes are measured at baseline, 6 months and 12 months after randomisation. The primary outcome is the Parenting Stress Index Fourth Edition Short Form (PSI-4-SF) total score at 6 months. Secondary outcomes include household income, food insecurity, parent mental health (depression and anxiety) and child health. An internal pilot study was used to obtain more reliable estimates of the SD of PSI-4-SF at 6 months to recalculate the sample size (if needed) and assess randomisation and completion rates. Qualitative interviews conducted 9 months after enrolment explore parent experiences with the CSW intervention.

Research ethics approval by Queen’s University Health Sciences REB. Results will be shared with the College of Family Physicians of Canada, the Ontario SPOR SUPPORT Unit and academic forums.

Connecting Families (Registered 12 October 2021 at www.clinicaltrials.gov; NCT05091957).