(P110) Clinical effectiveness, sustainability and quality of a large, decentralised molecular point-of-care testing network for STIs in regional and remote primary care clinics in Australia

Background: Following a world-first cluster-randomised controlled trial, molecular point-of-care testing (POCT) for detection of chlamydia (CT)/gonorrhoea (NG) (and later trichomoniasis, TV) was scaled-up to regional and remote primary health clinics across Australia from 2016-2022 (31 clinics by 2019; 58 by 2022). Clinics could offer molecular POCT or laboratory testing or both over this period. We evaluated the clinical effectiveness, sustainability, and quality of POCT.

Methods: Using routinely collected clinic and programmatic testing data, we (i) measured trends in monthly POCT; ii) compared the proportions of patients with positive test results treated in < 2, < 7 and < 120 days by test type (POCT vs laboratory), using risk ratios (adjusted for clinic and patient characteristics, aRR); and (iii) calculated the concordance of POCT with laboratory testing.

Results: From January 2016 to December 2022, 39463 POCT were performed (31024 CT/NG; 8439 TV). Among clinics contributing data in the first 4 years, the median number of POCTs per month was 408 (IQR:294-538) with an increasing trend over time (10.52 tests per month, p< 0.001). Of 3217 positive CT/NG tests, a greater proportion of patients received timely treatment following a POCT compared with a laboratory test ( < 2 days: 61% vs 31% [aRR 1.97]; < 7 days: 64% vs 43% [aRR 2.06]; < 120 days: 80% vs 73% [aRR 1.10]), representing 91330 infective days averted (2839 days per 100 positive tests). Differences were greater for the 1155 positive TV tests ( < 2 days: 32% vs 10% [aRR 3.2]; < 7 days: 45% vs 20% [aRR 2.25]; < 120 days: 65% vs 73% [aRR 1.2]), representing 34245 infective days averted (2965 per 100 positive tests). Of 4111 CT/NG and 2371 TV POCT with parallel laboratory tests, result concordance was 99.0% for CT, 99.3% for NG and 98.9% for TV.

Findings: Molecular POCT for STIs was scaled-up and sustained in primary care as part of a routinely implemented program with clinical effectiveness similar to that observed under trial conditions. In addition to the individual health benefits associated with earlier treatment, the reductions in number of infective days could contribute to a lower reproductive number and reduced transmissions in the community.