Conectar
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.
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.
To evaluate the feasibility of conducting a full-scale randomised controlled trial to assess the clinical and cost-effectiveness of the MAINTAIN intervention, designed to support recovery and independence following a fall among people living with dementia.
Pilot cluster randomised controlled trial (c-RCT).
Community-based healthcare services across six UK sites representing primary and secondary care settings.
31 participant-carer dyads were recruited. Eligibility criteria included a diagnosis of dementia and a recent fall. Exclusion criteria included severe comorbidity precluding participation. The consent rate was 84%, and retention at follow-up was 81%.
The MAINTAIN intervention comprised tailored, home-based therapy sessions delivered by trained professionals, focusing on functional recovery, confidence and re-engagement in daily activities, compared with usual care. The intervention was delivered over 12 weeks with booster sessions up to week 24, with the full trial period lasting 28 weeks.
Feasibility outcomes included recruitment and retention rates, intervention adherence and data completeness for outcome and economic measures. Exploratory outcomes assessed functional performance and quality of life. Feasibility outcomes were assessed at baseline, 12 weeks and 28 weeks.
Recruitment occurred over an 8-month period (September 2023–April 2024) across six UK sites. Most intervention participants (89%) attended at least 60% of planned sessions. Completion rates for outcome and economic data were high, indicating strong acceptability and feasibility of both the intervention and trial procedures.
The pilot c-RCT demonstrated that recruitment, retention and intervention delivery were feasible and well accepted. Findings support progression to a definitive trial to evaluate the effectiveness and cost-effectiveness of the MAINTAIN intervention.
ISRCTN16413728 (International Standard Randomised Controlled Trial Number registry).
Exploring the concept of patient agitation in the intensive care unit.
Patient agitation in the intensive care unit is of widespread concern and linked to negative outcomes for patients, staff, and family members. There is currently no consensus on what constitutes agitation in the intensive care context, hindering effective and tailored prevention and management.
Concept Analysis.
Walker and Avant's eight-step concept analysis approach.
A comprehensive search was carried out in the databases MEDLINE, PsychINFO and CINAHL. A total of 32 papers published between 1992 and 2023 were included, reviewed, and analysed to explore definitions, attributes, antecedents and consequences of patient agitation.
Patient agitation in the intensive care unit is characterised by excessive motor activity, emotional tension, cognitive impairment, and disruption of care, often accompanied by aggression and changes in vital signs. Antecedents encompass critical illness, pharmacological agents and other drugs, physical and emotional discomfort, patient-specific characteristics and uncaring staff behaviours. Consequences of agitation range from treatment interruptions and poor patient outcomes to the psychological impact on patients, families, and staff.
Agitation in the intensive care unit is a complex issue which significantly impacts patient treatment and clinical outcomes. For healthcare professionals, patient agitation can contribute to high workloads and job dissatisfaction. Due to the complex nature of agitation, clinicians must consider multifaceted strategies and not rely on medication alone. Further research is needed to fully understand patient agitation in the ICU. Such understanding will support the development of improved strategies for preventing and managing the behaviours.
A clearer understanding of patient agitation supports the development of tailored interventions that improve patient care, guide ICU training, and inform future research.
This concept analysis was developed with input from a patient representative.
To describe the development and refinement of the Flinders Fundamentals of Care Assessment Tool for Clinical Practice through stakeholder feedback. The tool, based on the Fundamentals of Care Framework, supports healthcare leaders and clinicians in assessing fundamental care in a practical and user-friendly manner that embraces rather than minimises the inherent complexity of this care delivery as it occurs in practice.
Multi-method study informed by participatory action principles.
Data collection involved an anonymous online survey and cognitive interviews with key stakeholders internationally to gauge perspectives on the clarity, usability, and acceptability of the tool. Data were collected between October–December 2023. Quantitative, categorical data were analysed using descriptive statistics. Qualitative data were analysed via content analysis.
Participants described the Tool as Comprehensive, Practical, and Useful. Participants liked the visual representation of results in the form of bar and radar diagrams, which aided in interpreting the outcomes. The main suggestions for improvement were: (1) Simplifying items relating to the ‘Context of Care’ dimension of the Fundamentals of Care Framework; (2) Reducing similarity between some items; (3) Separating or simplifying items with multiple components; and (4) Clarifying terminology.
Based on stakeholder feedback, the Flinders Fundamentals of Care Assessment Tool for Clinical Practice is now digitised and includes a comprehensive instruction manual and definitions for each element of the Fundamentals of Care Framework assessed within the tool. The tool supports healthcare leaders and clinicians to assess fundamental care delivery at multiple levels—individual, team, unit/ward, organisational—identifying areas of strength and improvement to inform decision-making, planning, and quality improvement. The tool offers a way of assessing fundamental care holistically as a multi-dimensional construct rather than as a series of disaggregated tasks, better reflecting and capturing the complex reality of fundamental care delivery.
The Flinders Fundamentals of Care Assessment Tool for Clinical Practice supports real-time feedback (i.e., immediate visualisation of results), facilitating its integration in clinical practice to support enhanced fundamental care delivery.
Seeking stakeholder feedback has enhanced the relevance, acceptability, and feasibility of the Flinders Fundamentals of Care Assessment Tool for Clinical Practice, facilitating its use as a decision-making and planning tool to support improved fundamental care delivery across clinical settings.
This study is reported using the CROSS and SRQR guidelines.
No Patient or Public Contribution.
The Fundamentals of Care (FoC) Framework emphasises that care quality depends not only on clinical tasks but also on interpersonal relationships and the organisational context in which care is delivered. Although patient-reported outcome and experience measures (PROMs and PREMs) have gained relevance in capturing these aspects, tools based on the FoC Framework remain limited in non-English-speaking settings.
To psychometrically validate the Spanish version of the FoC Intelligence Modelling Tool (FoC-IMT) and explore predictive relationships among the FoC dimensions: Context, Relationship and Integration of Care.
A cross-sectional study was conducted with 1053 hospitalised patients in southern Spain. Exploratory and confirmatory factor analyses (EFA and CFA) were performed, alongside a mediation analysis using partial least squares structural equation modelling (PLS-SEM) to examine directional relationships among constructs.
EFA and CFA supported a two-factor model—Context and Integration of Care—with excellent internal consistency (Cronbach's α and McDonald's ω = 0.97). CFA showed a moderate correlation between these factors. However, PLS-SEM mediation analysis revealed a directional model in which Context influences Relationship (β = 0.39), which in turn predicts Integration of Care (β = 0.89). Although embedded within Integration under CFA, the Relationship showed independent predictive power in PLS-SEM, validating its conceptual importance. This aligns with the foundational assumption of the FoC Framework: that caregiving quality is shaped not only by tasks or procedures but by the broader environment and interpersonal relationships in which care occurs.
The Spanish FoC-IMT Tool is a valid, reliable instrument for assessing person-centred care. The predictive model highlights the pivotal role of therapeutic relationships in delivering integrated, high-quality care.
Hospitalised patients contributed directly by responding to the FoC-IMT survey, thereby shaping the psychometric validation and predictive model. Patients were not involved in the study design, conduct or manuscript preparation.
As the HIV epidemic stabilises in Sub-Saharan Africa with effective antiretroviral therapy, cardiometabolic disorders (CMDs) remain the next major challenge for people living with HIV. Relationship dynamics and spousal support are important for the medical management of single diseases such as HIV, yet little is known about how couples manage the complexity of multiple competing health conditions and their synergistic effects on health. The Healthy Hearts study aimed to develop a conceptual model of dyadic management of HIV and CMDs, inform interventions for couples in Sub-Saharan Africa, and ultimately improve clinical practice and disease management for HIV and CMD comorbidities.
This study will enrol 250 couples who have at least one partner living with HIV and CMD (either hypertension or diabetes) for a prospective observational cohort study. Patients will be recruited from HIV and CMD clinics in Zomba and Blantyre, Malawi. Couples will attend four study visits at quarterly intervals over 12 months. Both partners are given interviewer-administered surveys and complete a clinical assessment. Regression techniques will be used to test associations between key constructs in our conceptual model, including communal coping, multimorbidity illness perceptions, relationship quality, psychosocial health, disease management (eg, adherence to lifestyle advice and medications) and disease outcomes (eg, viral suppression and CMD control). Findings will be used to identify elements to target in a couple-based intervention for CMD and HIV.
This study was approved by the University of California, San Francisco (HRPP (Human Research Protection Program); Protocol number 20–32126), and the National Health Sciences Research Committee of Malawi (Protocol number 21/04/2677). The results will be disseminated at local community meetings and conferences focused on relationships, CMDs and HIV and published in scientific journals.
FreshRSS 