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Comprehensive observational study evaluating the enduring effectiveness of 4CMenB, the meningococcal B vaccine against gonococcal infections in the Northern Territory and South Australia, Australia: study protocol

Por: Marshall · H. · Ward · J. · Wang · B. · Andraweera · P. · McMillan · M. · Flood · L. · Bell · C. · Sisnowski · J. · Krause · V. · Webby · R. · Childs · E. · Gunathilake · M. · Egoroff · N. · Leong · L. · Lawrence · A. · Baird · R. · Freeman · K. · Menouhos · D. · Whiley · D. M. · Karnon · J.
Introduction

The effectiveness of antibiotics for treating gonococcal infections is compromised due to escalating antibiotic resistance; and the development of an effective gonococcal vaccine has been challenging. Emerging evidence suggests that the licensed meningococcal B (MenB) vaccine, 4CMenB is effective against gonococcal infections due to cross-reacting antibodies and 95% genetic homology between the two bacteria, Neisseria meningitidis and Neisseria gonorrhoeae, that cause the diseases. This project aims to undertake epidemiological and genomic surveillance to evaluate the long-term protection of the 4CMenB vaccine against gonococcal infections in the Northern Territory (NT) and South Australia (SA), and to determine the potential benefit of a booster vaccine doses to provide longer-term protection against gonococcal infections.

Methods and analyses

This observational study will provide long-term evaluation results of the effectiveness of the 4CMenB vaccine against gonococcal infections at 4–7 years post 4CMenB programme implementation. Routine notifiable disease notifications will be the basis for assessing the impact of the vaccine on gonococcal infections. Pathology laboratories will provide data on the number and percentage of N. gonorrhoeae positive tests relative to all tests administered and will coordinate molecular sequencing for isolates. Genome sequencing results will be provided by SA Pathology and Territory Pathology/New South Wales Health Pathology, and linked with notification data by SA Health and NT Health. There are limitations in observational studies including the potential for confounding. Confounders will be analysed separately for each outcome/comparison.

Ethics and dissemination

The protocol and all study documents have been reviewed and approved by the SA Department for Health and Well-being Human Research Ethics Committee (HREC/2022/HRE00308), and the evaluation will commence in the NT on receipt of approval from the NT Health and Menzies School of Health Research Human Research Ethics Committee. Results will be published in peer-reviewed journals and presented at scientific meetings and public forums.

Impact of COVID-19 on diabetes care: mixed methods study in an Indigenous area of Guatemala

Por: Guarchaj · M. · Tschida · S. · Milian Chew · J. P. · Aguilar · A. · Flood · D. · Fort · M. P. · Morales · L. C. · Mendoza Montano · C. · Rodriguez Serrano · S. N. · Rohloff · P.
Introduction

SARS-CoV-2 has impacted globally the care of chronic diseases. However, direct evidence from certain vulnerable communities, such as Indigenous communities in Latin America, is missing. We use observational data from a health district that primarily serves people of Maya K’iche’ ethnicity to examine the care of type 2 diabetes in Guatemala during the pandemic.

Methods

We used a parallel convergent mixed methods design. Quantitative data (n=142 individuals with diabetes) included glycated haemoglobin (HbA1c), blood pressure, body mass index and questionnaires on diabetes knowledge, self-care and diabetes distress. Quantitative data was collected at two points, at baseline and after COVID restrictions were lifted. For quantitative outcomes, we constructed multilevel mixed effects models with multiple imputation for missing data. Qualitative data included interviews with providers, supervisors and individuals living with diabetes (n=20). We conducted thematic framework analysis using an inductive approach.

Results

Quantitative data was collected between June 2019 and February 2021, with a median of 487 days between data collection points. HbA1c worsened +0.54% (95% CI, 0.14 to 0.94) and knowledge about diabetes decreased –3.54 points (95% CI, –4.56 to –2.51). Qualitatively, the most important impact of the pandemic was interruption of the regular timing of home visits and peer group meetings which were the standard of care.

Conclusions

The deterioration of diabetes care was primarily attributed to the loss of regular contact with healthcare workers. The results emphasize the vulnerability of rural and Indigenous populations in Latin America to the suspension of chronic disease care.

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