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Feasibility of implementing a non-invasive self-sampling method for saliva specimens that can be used for the diagnosis of respiratory infections among paediatric patients in the Tshwane District, South Africa: a study protocol

Por: Nxele · S. · Dlangalala · T. · Gxekwa · N. V. · Ramatsokotla · S. · Musekiwa · A. · Kgatle · M. M. · Hatchett · D. B. · Shin · A. · Tu · W.-c. · Robertson · I. H. · Su · X. · Berthier · E. · Thongpang · S. · Theberge · A. B. · Mashamba-Thompson · T. P.
Introduction

Effective community-based disease management is essential for public health. In low- and middle-income countries, sustainable strategies for timely diagnosis and treatment are a research priority. This study aims to assess the feasibility of a non-invasive saliva self-sampling method, paired with digitally linked molecular point-of-care diagnostics, for detecting respiratory infections among paediatric patients in the Tshwane District, South Africa.

Methods and analysis

A field study will be conducted at Steve Biko Academic Hospital to compare saliva collection using the CandyCollect lollipop device and standard mouth swabs. The spiral groove of the lollipop device captures pathogens, which are stored in DNA/RNA preservation media and later analysed using quantitative PCR and commercially available rapid antigen tests. The multiplex respiratory pathogen panel, based on TaqMan real-time PCR technology, targets key paediatric pathogens including Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, respiratory syncytial virus (RSV) and influenza A/B. Nucleic acids will be extracted using standard viral extraction kits and analysed following manufacturer protocols. Internal controls will be included in each qPCR run, and samples with CT values below defined thresholds will be considered positive. Rapid antigen tests will detect common pathogens such as influenza A/B, RSV and SARS-CoV-2 for comparative analysis. User experience and acceptability will be assessed via child-friendly and caregiver surveys following sample collection. The study will be implemented in two phases: diagnostic performance evaluation and user feedback assessment. The protocol is aligned with the Standard Protocol Items: Recommendations for Interventional Trials 2013 checklist.

Ethics and dissemination

Ethical approval has been granted by the University of Pretoria (509/2023) and the Gauteng Department of Health (GP_202406_032). The study is registered in the Pan African Clinical Trial Registry (PACTR202411743094783). Findings will be disseminated through peer-reviewed journals, conferences and stakeholder briefings. The study complies with South Africa’s Protection of Personal Information Act. Data collection is scheduled from November 2024 to February 2025, with project completion expected within 1 year.

Trial registration number

Pan African Clinical Trial Registry (PACTR202411743094783).

Bridging the gap in full immunisation coverage with parental awareness and attitudes: a community-based cross-sectional analysis on routine childhood vaccinations in Perambalur district of Tamil Nadu, South India

Por: Mohandas · N. V. · Mohandas · V. · Dinesh · A. · Vijayakumar · K. · Anand · V. · Karve · S. S.
Objectives

To determine the independent predictors of full immunisation coverage (FIC) among children aged 12–23 months along with the parental awareness and attitudes (of children aged ≤23 months) regarding routine childhood vaccinations in Perambalur district of Tamil Nadu, South India.

Design

A community-based cross-sectional analysis.

Setting

Perambalur district situated in the central region of Tamil Nadu state, South India.

Participants

Parents of children aged ≤23 months.

Outcome measures

The primary outcome measured was the FIC and FIC plus in the district along with the parental awareness and attitudes regarding routine childhood vaccinations. The independent predictors of FIC and FIC plus were determined using multivariable logistic regression models.

Results

The study included 652 children, with a mean (±SD) age of 16.47 (±6.37) months and a male-to-female ratio of 60:40. The FIC and FIC plus of children aged 12–23 months were 91.3% (95% CI 88.64 to 93.33) and 79.7% (95% CI 76.15 to 82.80), respectively. The immunisation card retention was 97.9% among the parents of children aged 12–23 months. The independent predictors of FIC included below poverty line families (adjusted OR (AOR) 0.11; 95% CI 0.02 to 0.64), illiteracy among mothers (AOR 0.67; 95% CI 0.32 to 0.87), lack of immunisation card (AOR 0.14; 95% CI 0.03 to 0.55), lack of frequent home visits by healthcare worker (AOR 0.38; 95% CI 0.18 to 0.79) and hesitancy of parents towards vaccination (AOR 0.26; 95% CI 0.12 to 0.87).

Conclusion

This study revealed a high FIC in this specific district. However, achieving full coverage is influenced by factors like socioeconomic status, maternal education and parental attitudes. Understanding these factors is essential for improving immunisation rates and ensuring all children are protected.

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