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Oral pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention method; however, uptake and persistence have been low among southern African women. A dual prevention pill (DPP) that combines PrEP with oral contraception (OC) may increase PrEP use and better meet women’s sexual and reproductive health needs. We will gauge the DPP’s acceptability in two cross-over clinical trials.
PC952 (Zimbabwe) and PC953 (South Africa) will compare acceptability, adherence and preference for an over-encapsulated DPP versus PrEP and OCs taken separately. HIV-negative, non-pregnant cisgender females in Johannesburg, South Africa (n=96, 16–40 years) and Harare, Zimbabwe (n=30, 16–24 years) will be randomised 1:1 to the order of regimens—DPP or two separate tablets—each used for three 28-day cycles, followed by a 6-month choice period in South Africa. Monthly clinic visits include HIV and pregnancy testing; safety assessments and risk reduction and adherence counselling. We will assess adherence (monthly) based on tenofovir diphosphate drug levels in dried blood spots and by self-report. We will evaluate acceptability (monthly) and preference (end of cross-over) via computer-assisted self-interviewing and in-depth interviews with a subset of participants. Data collection started in September 2022 and ended in January 2024.
PC952 was approved by the Ministry of Health and Child Care, Medical Research Council, Research Council and Medicines Control Authority of Zimbabwe; the Chitungwiza City Health Ethics Committee; and the Joint Research Ethics Committee for the University of Zimbabwe Faculty of Medicine and Health Sciences and Parirenyatwa Group of Hospitals. PC953 was approved by the South African Health Products Regulatory Authority and the University of the Witwatersrand’s Human Research Ethics Committee. The Population Council IRB approved both studies. We will disseminate results in open-access journals, clinical trials registries, and at local and international meetings and conferences.
To reduce obesity-related disparities, reaching economically disadvantaged and/or minority status adolescents to assist them in meeting physical activity (PA) and nutrition recommendations is important. To address the problem, a 16-week intervention called Guys/Girls Opt for Activities for Life (GOAL) was designed. The purpose of this randomised controlled trial is to evaluate any effect of the intervention, compared with a control condition, on improving: (1) adolescents’ % body fat (primary outcome), moderate-to-vigorous PA (MVPA), diet quality and cardiorespiratory fitness from 0 to 4 months; (2) body mass index (BMI), overweight/obesity percentage and quality of life from 0 to 4 months and to 13 months; and (3) perceived social support, self-efficacy and motivation from 0 to 4 months with evaluation of any mediating effect on adolescent PA and diet quality. An exploratory aim is to evaluate any effect of the intervention, compared with the control, on improving parents’/guardians’ home environment, MVPA and diet quality from 0 to 4 months; and BMI from 0 to 4 months and to 13 months.
Adolescents (fifth to eighth grade) in 14 schools located in underserved urban communities are randomly assigned to the intervention or usual school offerings. One parent per adolescent is enrolled (882 dyads total). Cohort 1 includes four schools (2022–2023). Cohorts 2 and 3 include 5 schools in 2023–2024 and 2024–2025, respectively. The 16-week intervention has three components: (1) after-school GOAL club for adolescents to engage in PA and healthy eating/cooking activities; (2) three parent–adolescent meetings to empower parents to assist adolescents; and (3) GOAL social networking website for parents to share how they helped their adolescent.
The Michigan State University Biomedical Institutional Review Board provided ethical approval for the study. Findings will be shared via the trial registration database, peer-reviewed publications, conferences and community-oriented strategies.
To investigate if socioeconomic status impacts patient-reported outcomes after a surgically treated trigger finger (TF).
Data on patients with TF treated with surgery were collected from the Swedish National Quality Registry of Hand Surgery (HAKIR) 2010–2019 with an evaluation of symptoms and disability before surgery and at 3 and 12 months after surgery, using the short version of the Disabilities of Arm, Shoulder and Hand (QuickDASH) questionnaire.
Data from HAKIR and the Swedish National Diabetes Registry (ndr.nu) were combined with socioeconomic data from Statistics Sweden (
In total, 5477 patients were operated on for primary TF during the study period, of whom 21% had diabetes, with a response rate of 35% preoperatively, 26% at 3 months and 25% at 12 months.
At all time points, being born in Sweden (preoperatively B-coefficient: –9.74 (95% CI –13.38 to –6.11), 3 months postoperatively –9.80 (95% CI –13.82 to –5.78) and 12 months postoperatively –8.28 (95% CI –12.51 to –4.05); all p
Individuals with low earnings, high sick leave the same year as the surgery and those born outside of Sweden reported more symptoms both before and after surgery, but the relative improvement was not affected by socioeconomic factors.
Child maltreatment (CM) is a complex global public health issue with potentially devastating effects on individuals’ physical and mental health and well-being throughout the life course. A lack of uniform definitions hinders attempts to identify, measure, respond to, and prevent CM. The aim of this electronic Delphi (e-Delphi) study is to build consensus on definitions and types of CM for use in surveillance and multi-sectoral research in the 34 countries in the Euro-CAN (Multi-Sectoral Responses to Child Abuse and Neglect in Europe) project (COST Action CA19106).
The e-Delphi study will consist of a maximum of three rounds conducted using an online data collection platform. A multi-disciplinary expert panel consisting of researchers, child protection professionals (health and social care), police, legal professionals and adult survivors of CM will be purposefully recruited. We will approach approximately 100 experts, with between 50 and 60 of these anticipated to take part. Participants will rate their agreement with a range of statements relating to operational definitions and types of CM, and free-text comments on each of the statements to give further detail about their responses and areas of uncertainty. Consensus has been defined a priori as ≥70% of the panel agreeing or disagreeing with the statement after the final round. The responses to the open-ended questions will be analysed using a ‘codebook’ approach to thematic analysis, and used to refine the statements between rounds where no consensus is reached.
Ethical approval has been granted from the Cardiff University School of Medicine ethics committee (reference number SMREC22/96). Results will be submitted for publication in a peer-reviewed journal and presented at workshops (including for the participants) and international academic conferences. The Euro-CAN network will also be used to disseminate the results, with results briefings and presentations to key public health and other relevant organisations in the field.
The study aim was to evaluate vaccine effectiveness (VE) of COVID-19 vaccines in preventing symptomatic COVID-19 among healthcare workers (HCWs) in Zambia. We sought to answer the question, ‘What is the vaccine effectiveness of a complete schedule of the SARS-CoV-2 vaccine in preventing symptomatic COVID-19 among HCWs in Zambia?’
We conducted a test-negative case–control study among HCWs across different levels of health facilities in Zambia offering point of care testing for COVID-19 from May 2021 to March 2022.
1767 participants entered the study and completed it. Cases were HCWs with laboratory-confirmed SARS-CoV-2 and controls were HCWs who tested SARS-CoV-2 negative. Consented HCWs with documented history of vaccination for COVID-19 (vaccinated HCWs only) were included in the study. HCWs with unknown test results and unknown vaccination status, were excluded.
The primary outcome was VE among symptomatic HCWs. Secondary outcomes were VE by: SARS-CoV-2 variant strains based on the predominant variant circulating in Zambia (Delta during May 2021 to November 2021 and Omicron during December 2021 to March 2022), duration since vaccination and vaccine product.
We recruited 1145 symptomatic HCWs. The median age was 30 years (IQR: 26–38) and 789 (68.9%) were women. Two hundred and eighty-two (24.6%) were fully vaccinated. The median time to full vaccination was 102 days (IQR: 56–144). VE against symptomatic SARS-CoV-2 infection was 72.7% (95% CI: 61.9% to 80.7%) for fully vaccinated participants. VE was 79.4% (95% CI: 58.2% to 90.7%) during the Delta period and 37.5% (95% CI: –7.0% to 63.3%) during the Omicron period.
COVID-19 vaccines were effective in reducing symptomatic SARS-CoV-2 among Zambian HCWs when the Delta variant was circulating but not when Omicron was circulating. This could be related to immune evasive characteristics and/or waning immunity. These findings support accelerating COVID-19 booster dosing with bivalent vaccines as part of the vaccination programme to reduce COVID-19 in Zambia.
Certain criteria for ventilator-associated events (VAE) definition might influence the type of an event, its detection rate and consequently the resource expenditure in intensive care unit. The Impact of Infections by Antimicrobial-Resistant Microorganisms - Ventilator-Associated Pneumonia (IMPACTO MR-PAV) aims to evaluate the incidence and diagnostic accuracy of ventilator-associated pneumonia (VAP) using the current criteria for VAP surveillance in Brazil versus the VAE criteria defined by the US National Healthcare Safety Network-Center for Diseases Control and Prevention (CDC) criteria.
The study will be conducted in around 15 centres across Brazil from October 2022 to December 2023. Trained healthcare professionals will collect data and compare the incidence of VAP using both the current criteria for VAP surveillance in Brazil and the VAE criteria defined by the CDC. The accuracy of the two criteria for identifying VAP will also be analysed. It will also characterise other events associated with mechanical ventilation (ventilator-associated condition, infection-related ventilator-associated complication) and adjudicate VAP reported to the Brazilian Health Regulatory Agency (ANVISA) using current epidemiological diagnostic criteria.
This study was approved by the Institutional Review Board under the number 52354721.0.1001.0070. The study’s primary outcome measure will be the incidence of VAP using the two different surveillance criteria, and the secondary outcome measures will be the accuracy of the two criteria for identifying VAP and the adjudication of VAP reported to ANVISA. The results will contribute to the improvement of VAP surveillance in Brazil and may have implications for other countries that use similar criteria.
NCT05589727; Clinicaltrials.gov.
Countries in the WHO’s African region have found community-based surveillance useful in ensuring the effectiveness of the Integrated Disease Surveillance and Response strategy. This approach encourages community participation in the surveillance system, in addition to early detection of outbreaks and other health threats. Thus, advancements in mobile health have the potential to improve community-based surveillance in Africa. The purpose of this review is to map evidence on available mhealth tools for community-based infectious disease surveillance in Africa.
The scoping review will follow a mixed-methods approach in line with the framework of Arksey and O’Malley amended by Levac and colleagues and the Joanna Briggs Institute. To retrieve published literature, PubMed, Scopus, Web of Science, Google Scholar and Google databases will be explored. Websites of organisations involved in surveillance activities across the African region will also be explored. Authors will be interested in published literature between 2000 and 2022 in any language. The primary investigator and a second author will independently review the retrieved titles according to the inclusion criteria, while a third reviewer will resolve conflicts that may arise. The review will map evidence according to the key concepts (mhealth, community-based surveillance and Africa) to inform stakeholders and mhealth designers on best practices to adopt involving mhealth approaches at the community level and mhealth tool designs, respectively. Results following the review will be presented according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses: Extension for Scoping Review Guidelines.
Ethical approval is not required for scoping reviews as it does not involve the use of human subjects. This review is the first phase in an overall project on digital health. The findings of the review will be published in a peer-reviewed journal and disseminated at suitable forums and conferences.
Telenursing is a component of telehealth that occurs when nurses use information and communication technologies to provide care and nursing services remotely. To understand how telenursing services in surgical oncology patients can be better implemented, it is important that the success models are collected and studied. Therefore, the general objective is to develop the scoping review protocol for the survey of existing evidence on the practice of oncological perioperative telenursing.
The scoping review will be conducted following the scoping review directions of the Joanna Briggs Institute with the use of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews checklist for the review report. The databases that will be used for these searches will be: MEDLINE (PubMed), EMBASE, CINAHL, SCOPUS, Web of Science and Virtual Health Library. To search for grey literature, Google Scholar, WorldWideScience and Global ETD Search will be used. Primary studies, observational or experimental, published in any year or language will be considered. For the selection and extraction of data, two independent reviewers will read the title, summary and full text using the Rayyan software and a form prepared by the authors. The data to be extracted are related to the characterisation of the study (study design, country and year of publication) and details of the telenursing programme (surgery or surgical specialty, perioperative period, tools used, organisation and operation, outcome indicators and treatment methods and content in telenursing). Among others, the difficulties and potentialities for the development or implementation of telenursing will also be extracted, as the main result of the study.
The study does not require ethical approval as it will use previously published research data. The results will be shared in journals and scientific events and may be used for the development and implementation of oncological perioperative telenursing programmes.
Schizotypal disorder is associated with a high level of disability at an individual level and high societal costs. However, clinical recommendations for the treatment of schizotypal disorder are scarce and based on limited evidence. This review aims to synthesise the current evidence on treatment for schizotypal disorder making recommendations for clinical practice.
This systematic review protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A systematic literature search will be performed in PsychArticles, Embase, Medline and Cochrane Central Register of Controlled Trials. Additionally, we will search for relevant articles manually. Inclusion criteria are published studies including individuals diagnosed with schizotypal personality disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria, or schizotypal disorder according to International Classification of Diseases (ICD) criteria. We will include interventional studies comprising any pharmacological and non-pharmacological treatment trials for patients with schizotypal disorder, and all relevant outcome measures will be reported. Risk of bias will be assessed by Cochrane risk-of-bias tools. Data will be synthesised using narrative or thematic analysis and, if suitable, through meta-analysis.
No original data will be collected as part of this study and ethics approval is, therefore, not applicable. The results will be disseminated through peer-reviewed publication and presented at international scientific meetings. We will aim at submitting the final paper for publication within 4 months of completion of analyses. Furthermore, this systematic review will inform clinicians and researchers on the current state of evidence on treatment for schizotypal disorder. Findings may guide proposals for further research and potentially guide recommendations for clinical practice using the Grading of Recommendations Assessment, Development and Evaluation.
CRD42022375001.
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