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Microbial interactions among Gardnerella, Prevotella and Fannyhessea prior to incident bacterial vaginosis: protocol for a prospective, observational study

Por: Muzny · C. A. · Elnaggar · J. H. · Sousa · L. G. V. · Lima · A. · Aaron · K. J. · Eastlund · I. C. · Graves · K. J. · Dong · C. · Van Gerwen · O. T. · Luo · M. · Tamhane · A. · Long · D. · Cerca · N. · Taylor · C. M.
Introduction

The aetiology of bacterial vaginosis (BV), a biofilm-associated vaginal infection, remains unknown. Epidemiologic data suggest that it is sexually transmitted. BV is characterised by loss of lactic acid-producing lactobacilli and an increase in facultative and strict anaerobic bacteria. Gardnerella spp are present in 95%–100% of cases; Gardnerella vaginalis has been found to be more virulent than other BV-associated bacteria (BVAB) in vitro. However, G. vaginalis is found in women with normal vaginal microbiota and colonisation is not sufficient for BV development. We hypothesise that Gardnerella spp initiate BV biofilm formation, but incident BV (iBV) requires incorporation of other key BVAB (ie, Prevotella bivia, Fannyhessea vaginae) into the biofilm that alter the transcriptome of the polymicrobial consortium. This study will investigate the sequence of microbiologic events preceding iBV.

Methods and analysis

This study will enrol 150 women aged 18–45 years with normal vaginal microbiota and no sexually transmitted infections at a sexual health research clinic in Birmingham, Alabama. Women will self-collect twice daily vaginal specimens up to 60 days. A combination of 16S rRNA gene sequencing, qPCR for Gardnerella spp, P. bivia and F. vaginae, and broad range 16S rRNA gene qPCR will be performed on twice daily vaginal specimens from women with iBV (Nugent score 7–10 on at least 2 consecutive days) and controls (with comparable age, race, contraceptive method and menstrual cycle days) maintaining normal vaginal microbiota to investigate changes in the vaginal microbiota over time for women with iBV. Participants will complete daily diaries on multiple factors including sexual activity.

Ethics and dissemination

This protocol is approved by the University of Alabama at Birmingham Institutional Review Board (IRB-300004547) and written informed consent will be obtained from all participants. Findings will be presented at scientific conferences and published in peer-reviewed journals as well as disseminated to providers and patients in communities of interest.

Implementing a contextually appropriate foot-ankle exercise programme in primary care for the prevention of modifiable risk factors for ulcers in people with diabetes: protocol for a hybrid type 2 study

Por: Rodrigues · C. B. · Soares · P. N. C. · Schmitt · A. C. B. · Sacco · I. C. N.
Introduction

Diabetes is a highly prevalent disease that negatively impacts people’s health and quality of life. It can result in diabetic peripheral neuropathy (DPN) and foot complications, which in turn lead to ulcers and amputations. The international guidelines on diabetic foot included specific foot-ankle exercises as preventive strategy capable of modifying the risk factors for ulcers. Our aim is to test the effectiveness and to implement a contextually appropriate preventive intervention—a foot-ankle exercises programme alongside educational strategies—in a primary care setting to improve range of motion (ROM), strength, functionality of foot-ankle, and quality of life in people with diabetes.

Methods and analysis

This is a hybrid type 2 implementation-effectiveness study organised in four phases, being undertaken in Limeira, São Paulo. Phase 1, preimplementation, aims to gather information about the contextual characteristics, barriers, and facilitators and to form the implementation team. In phase 2, the implementation team will structure the foot-ankle programme, adapting it to the context of primary healthcare, and develop the training for health professionals. In phase 3, effectiveness of the 12 week group-based intervention will be tested by a cluster randomised controlled trial. Primary care units (18 clusters) will be randomly allocated to a control or intervention group, with a total sample of 356 people. Primary outcomes will be DPN symptoms and ankle and first metatarsal phalangeal joint ROM. Reach, adoption, and implementation will be evaluated by Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. In phase 4, maintenance and expansion of the programme in the municipality will be assessed.

Ethics and dissemination

This protocol and the informed consent to be signed by the participants were approved by the Ethics Committee of the School of Medicine of the University of São Paulo (CAAE:63457822.0.0000.0068, 29 November 2022). The project will generate and share data in a public repository. Results will be disseminated through peer-reviewed journals, conference proceedings, and electronic communications for health professionals.

Trial registration number

NCT05639478.

Randomised controlled trial on the effect of social support on disease control, mental health and health-related quality of life in people with diabetes from Cote dIvoire: the SoDDiCo study protocol

Por: Ekou · F. K. · Eze · I. C. · Aka · J. · Kwiatkowski · M. · Merten · S. · Acka · F. K. · Fink · G. · Utzinger · J. · Probst-Hensch · N.
Introduction

Diabetes mellitus (DM) and its severe complications contribute significantly to disability and, hence, burden of disease. Poor mental health, a frequent DM consequence, may hinder successful diabetes control in low-income and middle-income countries (LMICs). Evidence suggests social support as a cost-effective tool to improve diabetes self-management, behaviour and mental health. However, its real-world application in LMICs has rarely been tested. We aim to investigate the effect of a social support intervention on disease control, mental health and health-related quality of life in people with diabetes from Côte d’Ivoire (SoDDiCo) through a randomised controlled trial.

Methods and analysis

The trial will take place in the Centre Antidiabétique d’Abidjan, Institut National de Santé Publique, Abidjan, Côte d’Ivoire. We will prospectively randomise up to 1500 people with newly diagnosed diabetes into two parallel arms: intervention (routine care+family supporter accompanying clinical management) and control (routine care), using gender-stratified blocked randomisation with random block sizes of 10, 16, 20 and 24. Participants will undergo baseline, 3-month and 12-month postrandomisation assessments. The primary study outcome will be glycated haemoglobin (HbA1c). Secondary outcomes will include glycaemic control (HbA1c

Ethics and dissemination

The SoDDiCo trial was approved by the Ethikkommission Nordwest- und Zentralschweiz (ref: AO_2021-00041; approved: 12 July 2021) and by Comité National d'Éthique des Sciences de la Vie et de la Santé (ref: 049-22/MSHPCMU/CNESVS-kp; approved: 20 April 2022). The randomised intervention trial will follow good clinical practice guidelines. All results will be made available to the public through abstracts at conferences as well as through peer-reviewed articles. International guidelines for authorship will be respected.

Trial registration number

ISRCTN10901121, ISRCTN registry.

Impact of a capacity-building intervention on views and perceptions of healthcare providers towards the provision of adolescent sexual and reproductive health services in southeast Nigeria: a cross-sectional qualitative study

Por: Agu · I. C. · Agu · C. · Mbachu · C. · Onwujekwe · O.
Objectives

Negative views of healthcare providers towards adolescent sexual and reproductive health (SRH) services deter adolescents from seeking vital SRH services. This paper assessed the impact of an intervention on the views and perceptions of healthcare providers towards the provision of adolescent SRH services.

Design and setting

A descriptive, cross-sectional, qualitative study was conducted between 14 October and 19 November 2021 in six local government areas (LGAs) in Ebonyi state, southeast Nigeria, after the implementation of an intervention comprising of training and supportive supervision.

Participants and data collection

Data were collected through: (1) two in-depth interviews (IDIs) with LGA healthcare managers; (2) six IDIs with LGA adolescent health programme managers; (3) two focus group discussions (FGDs) with 15 primary healthcare facility managers; (4) two FGDs with 20 patent medicine vendors and (5) two FGDs with 17 community health volunteers. A total of six FGDs were held with 52 healthcare providers. The interviews were conducted using pretested interview guides. Transcripts were coded in NVivo (V.12) and themes were identified through inductive analysis.

Results

As a result of the intervention, most healthcare providers started recognising the rights of adolescents to obtain contraceptive services and no longer deny them access to contraceptive services. The providers also became friendlier and were no longer harsh in their interactions with adolescents. There were some unique findings relative to whether the providers were formal or informal healthcare providers. It was found that the informal healthcare providers were bolder and more comfortable delivering SRH services to adolescents and reported improved patronage by the adolescents. The formal healthcare providers made their facilities more conducive for adolescents by creating safe spaces and introducing extracurricular activities.

Conclusion

These findings highlight the importance of the constant capacity building of both formal and informal healthcare providers, which can address healthcare providers’ biases, views and perceptions of delivering SRH services to adolescents.

Effects of working in vulnerable contexts on the mental health of primary healthcare professionals during the COVID-19 pandemic: a mixed-methods study

Objective

The objective of this study is to analyse the relationship and psychosocial issues between working during the COVID-19 pandemic in primary healthcare (PHC) facilities located in the most vulnerable health region (HR) of the Federal District of Brazil (FDB) compared with a lesser region.

Design

Mixed-method study data. The questionnaire was based on the World Health Survey and the Convid Behavioural Survey. Quantitative data were described in absolute and relative frequency. Pearson’s 2 test verified differences according to the region (significance level

Setting

A representative sample of PHC professionals working at the Western HR and Central HR of the FDB.

Participants

111 women and 27 male PHC professionals, aged ≥ 18 years.

Outcome measures

Psychosocial variables—personal emotions towards the clients, social relationships and use of psychoactive substances (PAS).

Intervention

An online questionnaire (27 questions) and 1 open-ended question.

Results

The sample comprised 138 PHC professionals; 80.40% were female aged between 40 and 49 years old (27.3%); declared themselves as black/pardo (58.7%); were married (53.60%), and worked in family healthcare teams (47.80%). No association between working in the most vulnerable HR compared with the least one and presenting psychosocial issues, except for anger towards clients (p=0.043). 55.10% worked much more than usual, 60.80% reported being depressed, 78.20% anxious, 76.80% stressed, 77.50% had no empathy and 78.30% felt isolated from family/friends. Towards the clients, 59.40% reported empathy and 72.5% no affection/care. The consume of psychotropic medications was reported by 34.80%, and 14.50% increased alcohol/PAS use. Qualitative data leverage quantitative findings: work overload, the indifference of the Federal Government and distance from family/friends.

Conclusion

Working in the most vulnerable region and in the least one affects the psychosocial aspects of the PHC professionals equally.

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