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Support for Transgender and Nonbinary Individuals Seeking Vaginoplasty (STRIVE) study: protocol for a national randomised pragmatic trial

Por: Sage · L. · Hart · E. · Meyer · N. · Hnilicka · O. · Penkin · A. · Poteat · T. C. · Aguayo-Romero · R. · Comstock · B. A. · STRIVE Publications Committee · Dy · G. W. · Blasdel · Corman · Deutsch · Gallo · Gore · Marsiglio · Sevelius · Solo
Introduction

Transgender and gender-diverse individuals often face significant barriers to accessing gender-affirming care, such as hormones and/or surgery, leading to poorer mental health, lower quality of life, and higher rates of substance use and suicidal ideation. Vaginoplasty, the most commonly sought genital gender-affirming surgery (GGAS), is desired by over half of all trans women but has been performed in only a minority. This is due largely to limited surgeon availability and long wait times. Peer support has been shown to improve health outcomes and reduce stigma in marginalised populations, including trans communities, but has never been studied for efficacy during the perioperative period of GGAS. Building on priorities identified by multi-stakeholder engagement from the Transgender & Non-Binary Surgery Allied Research Collective, the Support for Transgender and Nonbinary Individuals Seeking Vaginoplasty (STRIVE) study aims to evaluate the efficacy of a centralised peer support and education intervention for patients seeking vaginoplasty, addressing a critical gap in perioperative care.

Methods and analysis

The STRIVE Study is a pragmatic, multi-site randomised controlled trial enrolling trans adults seeking full depth vaginoplasty. Participants are randomised to one of two arms; enhanced usual care, or a facilitated group intervention. The primary outcome is coping self-efficacy at 6 months, with a secondary outcome of surgical readiness. Primary analysis uses an intention-to-treat approach with linear mixed effects modelling, adjusting for selected baseline values and site. The feasibility evaluation data collected via qualitative interviews will be analysed thematically.

Ethics and dissemination

Approvals were granted by the primary site’s Institutional Review Board on 10 May 2024 (STUDY00026957). The trial was registered on 24 May 2024. Results will be published in open access journals and made available to community members in plain language formats.

Trial registration number

NCT06436560.

HIV testing and prevalence in fishing communities in rural Uganda: a cross-sectional study of 3197 individuals within SchistoTrack

Por: Bui · H. L. · Wilburn · L. · Nsimbe · S. W. · Nabatte · B. · Oromcan · G. W. · Mujuni · R. · Nabonge · J. · Kabatereine · N. B. · Smith · A. · Chami · G.
Objectives

To compare HIV testing coverage, prevalence and care cascade engagement between fisherfolk and the general population, and to assess the relevance of individual and community-level definitions of fisherfolk in understanding variation in HIV status and testing.

Design

Primary data collection and cross-sectional analysis in 1 year of the SchistoTrack community-based cohort.

Setting

52 shoreline villages in Pakwach, Buliisa and Mayuge districts in rural Uganda.

Participants

A total of 3197 individuals aged 5–92 years were tested for HIV in 2024. A subset of 124 HIV-positive participants had viral load measured in 2025. Statistical analyses focused on 1931 adults aged 15 years and older.

Primary and secondary outcome measures

The primary outcomes were lifetime HIV testing, testing in the past 12 months and current HIV status. Secondary measures included self-reported care cascade outcomes and viral load suppression.

Results

Overall, 6.94% (134/1931) of adult participants aged 15 years and older were with HIV (people with HIV (PWH)), of whom 22.39% (30/134) were newly diagnosed. 6% (25/415) of adults reporting fishing activities were HIV-positive. Of those, 80% (20/25) were status-aware, 76% (19/25) were on antiretroviral therapy, and 100% (8/8) of those who knew their viral load reported viral suppression. No significant differences in care cascade engagement were found between PWH reporting fishing activities and the general population. Measured viral suppression was 70.59% (72/102) among PWH with no significant differences by fishing activities. Fishing activities were significantly associated with higher odds of ever testing for HIV (OR 1.76 (95% CI 1.22 to 2.54)), but not with testing in the past 12 months or HIV status. No consistent district-level differences were observed.

Conclusions

Individuals reporting fishing activities had higher lifetime testing and comparable HIV prevalence and care cascade engagement to the general population. Gaps remain in recent testing, status awareness and viral suppression for fisherfolk.

Exploring what works, for whom, under what circumstances to transform systems: realist synthesis protocol of four ongoing studies and literature addressing health inequalities

Por: Horck · S. S. · Crone · M. · Kamphuis · C. B. M. · Stevens · G. W. J. M. · Dedding · C. · Bussemaker · J. · van der Pas · S. · van Berkel · J.
Introduction

Health inequalities remain resistant to interventions that primarily target individual behaviour. Although systems approaches are increasingly promoted, their application in practice is often not well grounded in real-world settings. In this protocol paper, we present the approach we will take in an overarching project that synthesises the combined insights of four ongoing systems-based research projects on system-based approaches for reducing health inequalities in the Netherlands. By bringing together and comparing findings across diverse contexts, populations and interventions, we aim to generate an empirically grounded understanding of what works, for whom, in what contexts and why, and to derive actionable strategies for systemic change to reduce health inequalities.

Methods and analysis

We use a realist approach to synthesise insights from the four ongoing projects. The design involves four iterative steps: (1) Identifying cross-cutting themes from project proposals and literature, (2) Developing and refining context–mechanism–outcome (CMO) configurations through literature review and Slow Science meetings, (3) Engaging Critical Friends to co-develop actionable strategies and (4) Assessing and validating these strategies across diverse contexts. Iterative feedback loops ensure continuous refinement, integration of stakeholder perspectives and exploration of emergent challenges. This design enables theory-informed, practice-based strategies to support sustainable system change in reducing health inequalities.

Ethics and dissemination

Ethical approval for the four underlying projects has been obtained from the relevant institutional review boards, and the way their data is used for this overarching project falls within their approved scope. Dissemination will be ongoing and co-created with stakeholders, including policy briefs, factsheets, educational tools and academic publications, to support uptake of strategies for systems change.

Effectiveness of etrasimod on disease activity and patient-reported outcomes in ulcerative colitis--EFFECT-UC: a non-interventional, multinational, prospective cohort study protocol

Por: Moran · G. W. · Radford · S. J. · Walsh · A. · Battat · R. · McLean · M. · Kudela · M. · Binder · E. · Kulchytska · N. · Sahin · B. · Helwig · U. · Irving · P. M.
Introduction

Etrasimod is an oral, once-daily, selective sphingosine 1-phosphate1,4,5 receptor modulator for the treatment of moderately to severely active ulcerative colitis (UC). While etrasimod demonstrated efficacy in randomised controlled trials, understanding its effectiveness in an observational setting is crucial.

Methods and analysis

EFFECT-UC is a prospective, multinational, non-interventional study to evaluate the real-world effectiveness of etrasimod in adults with moderately to severely active UC. The study consists of a 52-week treatment period and a 28-day safety follow-up period and aims to enrol ~300 patients per cohort. Eligible patients (18–64 years) are advanced therapy naïve or experienced and are initiating etrasimod in a real-world clinical setting. Treatment will be guided independently by the clinician’s judgement. Patient-reported outcomes will be collected electronically throughout the study and daily for the first 2 weeks. Exploratory data, including faecal calprotectin, endoscopy and intestinal ultrasound, will be collected at predefined visits or during standard care. Primary endpoints are symptomatic remission at week 12 and week 52. Secondary endpoints include patient-reported outcome 2 (combined rectal bleeding and stool frequency subscores) response at week 12 and week 52 and corticosteroid-free symptomatic remission at week 52.

Ethics and dissemination

Ethics approval was obtained for all sites. Recruitment is underway for cohort 1, comprising patients from the UK, Germany and Canada. Interim results for this cohort are expected in 2026 and final results in 2028; these will be submitted for publication in peer-reviewed journals and presented at appropriate congresses.

Trial registration number

NCT06294925.

Time to first optimal glycaemic control and associated factors among adult patients with diabetes at the University of Gondar Comprehensive Specialized Hospital, northwest Ethiopia: a retrospective cohort study

Por: Getahun · A. D. · Ayele · E. M. · Tsega · T. D. · Anberbr · S. S. · Geremew · G. W. · Biyazin · A. A. · Taye · B. M. · Mekonnen · G. A.
Objective

To assess the time to first optimal glycaemic control and its predictors among adult patients with type 1 and type 2 diabetes at the University of Gondar Comprehensive Specialized Hospital in Ethiopia.

Design

A retrospective cohort study.

Setting

University of Gondar Comprehensive Specialized Hospital, northwest, Ethiopia.

Participants

We recruited 423 adult diabetic patients who were diagnosed between 1 January 2018 and 30 December 2022 at the University of Gondar Comprehensive Specialized Hospital.

Outcome measures

The primary outcome was the time from diagnosis to the achievement of the first optimal glycaemic control, measured in months. A Cox proportional hazards regression model was fitted to identify predictors of time to first optimal glycaemic control. Data were collected with KoboToolbox from patient medical charts and exported to Stata V.17. The log-rank test was used to determine the survival difference between subgroups of participants.

Results

Median time to first optimal glycaemic control was 10.6 months. Among 423 adult diabetic patients, 301 (71.16%) achieved the first optimal glycaemic control during the study period. Age category (middle age (adjusted HR (AHR)=0.56, 95% CI 0.41 to 0.76), older age (AHR=0.52, 95% CI 0.33 to 0.82)), comorbidity (AHR=0.52, 95% CI 0.35 to 0.76), therapeutic inertia (AHR=0.20, 95% CI 0.13 to 0.30) and medication non-compliance (AHR=0.49, 95% CI 0.27 to 0.89) were significant predictors of time to optimal glycaemic control.

Conclusion

The median time to first optimal glycaemic control was prolonged. Diabetic care should focus on controlling the identified predictors to achieve optimal glycaemic control early after diagnosis.

Designing a strategic purchasing framework for urban primary healthcare services in Bangladesh: a protocol for a mixed-method study with a discrete choice experiment

Por: Naznin · B. · Kashfi · F. · Sehrin · F. · Dawkins · B. · Brown · G. W. · Ensor · T. · Huque · R. · Quayyum · Z. · Elsey · H.
Introduction

Rapid urbanisation in Bangladesh has posed significant challenges to the urban health system, particularly in the delivery of primary healthcare (PHC). The country’s PHC system is fragmented, involving public, non-government organization (NGO), private and informal providers, leading to inequitable access, high out-of-pocket expenditure and inefficiencies. Strategic purchasing, which links resource allocation to health priorities and outcomes, offers a potential pathway to strengthening urban PHC systems. This study aims to assess the current urban PHC system, examine stakeholders’ perspectives on the feasibility of strategic purchasing, understand community health needs and preferences and develop a policy framework for strategically purchasing PHC services in urban settings.

Method and analysis

This study will follow a sequential mixed-methods approach, integrating qualitative and quantitative data. A scoping review will be conducted to assess the characteristics and funding modalities of the existing urban PHC purchasing mechanisms. Key informant interviews with stakeholders, including policy makers and health experts, will explore the strengths and challenges of the current urban PHC system and the feasibility of implementing strategic purchasing. Community healthcare needs and preferences will be examined through in-depth interviews (IDIs), focus group discussions (FGDs) and a discrete choice experiment (DCE) survey in urban informal settlements. Insights from IDIs and FGDs will inform the DCE survey, which will present hypothetical scenarios to participants to identify the most important attributes for improving PHC services. Qualitative data will be coded deductively and inductively, and DCE data will be analysed using latent class models, with sensitivity analyses conducted using the multinomial logit model. Findings will contribute to the development of a strategic purchasing framework, validated through consultation workshops with health system stakeholders.

Ethics and dissemination

Ethical approval has been obtained from the ethics committees in both Bangladesh and the UK. Findings will be disseminated through workshops, peer-reviewed publications, policy briefs and conference presentations.

Development and pilot testing of a personalised decision aid for decision-making regarding fertility preservation in young female patients with cancer: a study protocol

Por: Jang · J. · Lee · E. M. · Chung · Y. K. · Lee · D. O. · Park · H. J. · Yim · G. W. · Lee · K. S. · Kim · J. H. · Ko · A. R. · Hong · J. H. · Kang · S.
Introduction

Infertility resulting from cancer treatment is known to be a major factor that reduces the quality of life of young cancer survivors. However, discussions and decision-making about fertility preservation before cancer treatment have been insufficient owing to barriers in the clinical field. In addition, selecting a fertility preservation option requires a complex decision-making process that considers not only medical information but also the patient’s values and preferences. Hence, an environment that more easily supports patient decision-making about fertility preservation needs to be created. Therefore, this protocol will develop and test a web-based decision aid (DA) for fertility preservation among young patients with cancer, considering patient preferences and values, evaluate acceptability and usability of the developed DA and assess its effectiveness.

Methods and analysis

This protocol outlines the development of a web-based DA for fertility preservation targeting females of reproductive age diagnosed with cancer. It includes alpha testing to evaluate the usability and acceptability of the DA, as well as beta testing to assess its effectiveness outside of clinical settings, both based on an online survey. The web-based DA for fertility preservation consists of three modules: 1) an information collection module, 2) an option suggestion module and 3) a value communication module. The information collection module collects information essential to select appropriate fertility preservation options. The option suggestion module returns all applicable fertility preservation options based on the patient’s characteristics, which are essential for determining the appropriate option, such as menarche status and desire for pregnancy. The value communication module provides information on the extent to which each fertility preservation option satisfies the patient’s values and preferences. After the development of the DA, a small group of young patients with cancer (n=10) and health providers (n=5) will be asked to use this web-based DA for fertility preservation and assess the acceptability and usability of this DA based on a survey (alpha-testing). By reflecting the feedback of acceptability and usability testing, the DA will be updated for improvement, and clinical field testing (beta-testing pilot trial) will be performed using the updated DA. Beta-testing will be conducted on young patients with cancer (aged 18–40 years) before they receive any curative cancer treatment (n=32). These patients with cancer will be randomly allocated to the DA group (intervention group) or the usual care group (control group). The DA group will use the web-based DA before treatment, and the control group will not have access to the web-based DA and will be asked to decide whether to consult a fertility preservation specialist. The primary outcome of the beta testing will be the level of decisional conflict, and the secondary outcomes will include knowledge, decision self-efficacy, decision readiness, depression severity, quality of life, counselling on fertility preservation and decision-making about fertility preservation. Outcomes, including decisional conflict, knowledge, decision self-efficacy, quality of life and depression severity, will be measured before the intervention (T0), 1 week after the intervention (T1) and 1 month after the intervention (T2). The readiness for decision-making will be assessed at T1 for the intervention group only. Counselling on fertility preservation and decision-making about fertility preservation will be assessed once after testing (T2) for both the intervention and control groups.

Ethics and dissemination

The study will be conducted in accordance with ethical standards and was approved by the Institutional Review Board at the National Cancer Centre, Korea (IRB No. NCC2024-0050). All study participants will provide written informed consent before participation. The results generated from this study will be presented at conferences or scientific meetings and disseminated through publication in a peer-reviewed journal.

Trial registration

NCT07038174 (beta-testing phase).

Associations between optimism and mental health in postradiotherapy cancer survivors: a cross-sectional survey study

Por: Man · K. H. · Ho · G. W. K.
Objectives

Cancer patients often experience psychological distress, while optimism has been identified as a protective factor. However, the mental health of postradiotherapy cancer survivors and its association with optimism remain largely unexplored. This study assesses the mental health status and optimism levels of postradiotherapy cancer survivors and evaluates their associations.

Design

Cross-sectional survey study.

Participants

114 Hong Kong cancer survivors who (1) were aged 18 years or above and (2) had received radiotherapy for their cancer treatment and finished the radiotherapy within the previous 3 years (2021–2024).

Outcome measures

Mental health was assessed using the Chinese Depression, Anxiety and Stress Scale, and optimism was measured using the Revised Life Orientation Test. Correlation and regression analyses were used to examine the associations between these measures.

Results

Participants reported overall low optimism with mild to moderate depression, anxiety and stress. Strong negative correlations were identified between optimism and depression (r=–0.833, p

Conclusions

This study highlights the importance of incorporating optimism-promoting interventions in postradiotherapy care. Routine optimism screening and gender-specific support are proposed to improve mental health outcomes for radiotherapy patients. While this study provides novel insights into postradiotherapy survivorship, further research should employ longitudinal designs and evaluate intervention effectiveness in clinical settings.

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