Trial reportSexually transmitted diseases2026
Randomized Study of Usual Care Versus Xpert ® Xpress Multiplex Vaginal Panel at the Point-of-Care for Accurate Diagnosis and Appropriate Treatment of Vaginal Infections.
Trial report in Sexually transmitted diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06438575 (Point of Care Diagnosis of Vaginal Infections to Ensure Accurate Treatment), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Point of Care Diagnosis of Vaginal Infections to Ensure Accurate Treatment: (PAT Study)
Who cites it
0 citing papers in PubMed.
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Corrections and comments
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Authors and funding
9 authors.
Funding
Abstract
backgroundThe accuracy of vaginitis diagnoses in usual care varies. This study ( clinicaltrials.gov NCT06438575) evaluated the clinical utility of Xpert ® Xpress Multiplex Vaginal Panel, a Clinical Laboratory Improvement Amendments-waived nucleic acid amplification test (NAAT), for the diagnosis of vaginal infections at the point-of-care (POC).
methodsWomen (n = 276) seeking care for vaginal symptoms (discharge, odor, itch, irritation, and discomfort) provided self-collected vaginal samples and were randomized to usual care or POC NAAT. True positives were defined as samples positive for bacterial vaginosis (BV), Candida , or Trichomonas vaginalis (TV) by two concordant Food and Drug Administration-cleared NAATs. The primary endpoint was the proportion of women prescribed appropriate Centers for Disease Control recommended or Food and Drug Administration-approved treatment for the identified conditions within 24 hours of the visit. Groups were compared using Fisher exact test.
resultsMedian participant age was 33 years (range 17-76), with self-reported race of 50% Black, 41% White, and 9% other. Twenty (7%) participants were pregnant. The prevalence of BV, Candida , and TV was 44.7%, 32.0%, and 5.1%, respectively, and 36.9% of women had no pathogens detected. For women having BV, TV, or Candida , 40/77 (51.9%) of the usual care arm received appropriate treatment versus 69/77 (89.6%) of women in the POC NAAT arm ( P < 0.001). Among women without pathogens, 21/42 (50.0%) were inappropriately treated with antifungals or antibiotics in the usual care arm versus 13/48 (27.1%) in the POC NAAT arm ( P = 0.031).
conclusionPOC NAATs have clinical utility for the diagnosis of women with vaginal symptoms, increasing the likelihood of appropriate treatment and reducing over-treatment of women without pathogens compared with usual care.
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