RecruitingACTRN12626000085370

Evaluating Point-of-Care Testing in Rural Communities: Impact of Reduced Turnaround Time on Outcomes for Respiratory Infections, Group A Streptococci and Sexually Transmitted Infections.


Sponsor

Victoria University of Wellington

Enrollment

1,200 participants

Start Date

Aug 4, 2025

Study Type

Interventional

Conditions

Summary

There is urgency to address rural access to timely and safe diagnostic services for Maori with input from communities. Point of Care Testing (PoCT) combined with appropriate care pathways may potentially improve timely access to test results and treatment and ultimately reduce morbidity and mortality associated with these infections. We will explore the impact of PoCT on the clinical care pathways: Group A Streptococcus (GAS), respiratory infections including Influenza and Respiratory Syncytial Virus and sexually transmitted infections (STIs) (Chlamydia trachomatis, Neisseria gonorrhoeae). Point of Care diagnostic testing means that a swab taken from a patient (e.g. throat swab) can be tested on site in the clinic, processed on a small machine by a trained nurse or health worker and a result obtained in 30 -90 minutes depending on the infection being tested for. We hypothesise that utilising PoCT to improve timely access to care in rural Aotearoa New Zealand will reduce morbidity and mortality.


Eligibility

Sex: Both males and females

Plain Language Summary

Simplified for easier understanding

In rural New Zealand, Maori communities often face long delays between having a test done and receiving a result, which can mean infections go untreated for days. Point-of-care testing (PoCT) is a solution that brings the diagnostic test to the patient — a swab taken in the clinic can be processed on site in 30 to 90 minutes, enabling faster treatment decisions. This study is evaluating whether using PoCT for common infections — including strep throat, flu, RSV, chlamydia, and gonorrhoea — improves health outcomes in rural communities. The study will examine how PoCT fits into existing care pathways and whether it reduces complications and hospitalisations associated with these infections. It is being run through community health centres in rural areas, with a strong focus on cultural safety and community engagement, particularly for Maori whānau. You may be eligible if you attend one of the participating rural clinics and require testing for one of the infections covered by the study. Children under 16 can participate for respiratory and strep throat testing with a guardian's consent. This research recognises that timely, locally delivered diagnostic services are a matter of health equity, and its findings could reshape how rural healthcare is delivered across Aotearoa New Zealand.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Point of care testing (PoCT) for Group A Streptococcus (GAS), respiratory infections, and sexually transmitted infections (STIs) for rural communities at eight primary care sites in Aotearoa New Zeala

Point of care testing (PoCT) for Group A Streptococcus (GAS), respiratory infections, and sexually transmitted infections (STIs) for rural communities at eight primary care sites in Aotearoa New Zealand -Provision of PoCT diagnostic machines to two sites, one site has their own PoCT machines -Training of nursing and health work staff in the set-up, running, preparing samples, interpreting results, quality assurance procedures, clinical update training -This involves face-to-face hands on training at the research sites 2-3 nurses and or health workers are trained at each site -Training is provided by molecular scientist on the research team and online training from the PoCT manufacturer and a certificate is provided once training is complete. -Training is a 2-4 hour session the week prior to recruitment starting, follow up one hour sessions in person or zoom 3 monthly at each site - includes regular site visits for quality and update purposes - PoCT testing will be undertake ONLY by clinic staff who have undergone training from the molecular scientist on research team and from the PoCT manufacturers official online training - Patients will be consented face to face by the clinic staff as part of their usual clinic appointment - Clinical staff will decide if the patient requires a test depending on presentation and history - Clinical management is not changed from usual standard care, only the diagnostic test is different from usual lab pathway - Patients can have multiple tests within the study recruitment period if clinically indicated - Rural primary care clinics - Patient adherence and fidelity is not indicated in this study as it is clinical staff who make the decision to test -PoCT machines used are Cepheid Gene Xperts at two sites, Roche Liats at one site - PoCT machines are set up in a suitable and appropriate space within the clinic with appropriate biohazard disposal, clean bench space, storage facilities for supplies and access to a fridge, -testing cartridges are provided by the study - technological support provided by research team scientist and PoCT manufacturers as needed. - test running time is from 30-90 minutes depending on infection being tested for - e.g. GAS - 30mins, Chlamydia/NG 90 minutes


Locations(1)

East Cape, New Zealand

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