IMPORTANCERates of chlamydial and gonococcal infection continue to increase in the United States, as do the associated costs of untreated infections. Improved diagnostic technologies that support testing and treating in 1 clinical visit are critical to advancing efforts to control the rates of chlamydial and gonococcal infection. OBJECTIVE To evaluate the clinical performance of a point-of-care (POC) molecular diagnostic assay for the detection of chlamydia and gonorrhea.
Background: Pre-exposure prophylaxis (PrEP) is only effective in preventing new HIV infections when taken consistently. In clinical practice, asking a patient about their adherence (self-report) is the predominant method of assessing adherence to PrEP. Although inexpensive and noninvasive, self-report is subject to social desirability and recall biases. Several clinical trials demonstrate a discrepancy between self-reported adherence and biomarker-based recent adherence. Less is known about the accuracy of self-report in real-world clinical settings. This brief report addresses this knowledge gap and describes the concordance between self-reported adherence and biomarker-based adherence in real-world clinical settings. Methods: A liquid chromatography–mass spectrometry urine test for tenofovir was developed and used clinically to detect recent nonadherence (no dose in at least 48 hours) for each individual. Two clinics' standard operating procedures recommend utilization of the urine-based adherence test for patients who self-report that they are not struggling with adherence. Those who self-report struggling with adherence receive enhanced adherence support without the need for additional testing. The number of results indicating recent nonadherence from these 2 clinics were analyzed to assess the concordance between self-reported adherence and biomarker-based adherence. Results: Across 2 clinics, 3987 tests were conducted from patients self-reporting as “adherent,” and 564 [14.1%; 95% confidence interval (CI): 13.1% to 15.2%] demonstrated recent nonadherence with the liquid chromatography–mass spectrometry test. At clinic #1 in Florida, 3200 tests were conducted, and 465 (14.5%; 95% CI: 13.3% to 15.8%) demonstrated recent nonadherence. At clinic #2 in Texas, 787 tests were conducted, and 99 (12.6%; 95% CI: 10.4% to 14.9%) demonstrated recent nonadherence. Conclusions: Utilization of biomarker-based adherence monitoring at these 2 clinics resulted in 564 additional patients receiving enhanced adherence support who otherwise would not have been identified as nonadherent to their prescribed PrEP regimen. These findings suggest that objective adherence monitoring can be used clinically to enable providers to identify nonadherent patients and allocate support services accordingly.
Improved diagnostic tests and accessibility are essential for controlling the outbreak of monkeypox. We describe a saliva‐based polymerase chain reaction (PCR) assay for monkeypox virus, in vitro test performance, and clinical implementation of that assay in Los Angeles, San Francisco, and Palm Springs, CA. Finally, using prespecified search terms, we conducted a systematic rapid review of PubMed and Web of Science online databases of studies reporting the performance of oral pharyngeal or saliva‐based tests for the monkeypox virus. The assay showed in silico inclusivity of 100% for 97 strains of monkeypox virus, with an analytic sensitivity of 250 copies/ml, and 100% agreement compared to known positive and negative specimens. Clinical testing identified 22 cases of monkeypox among 132 individuals (16.7%), of which 16 (72.7%) reported symptoms, 4 (18.2%) without a rash at the time of testing. Of an additional 18 patients with positive lesion tests, 16 (88.9%) had positive saliva tests. Our systematic review identified six studies; 100% of tests on oropharyngeal specimens from 23 patients agreed with the PCR test result of a lesion. Saliva‐based PCR tests are potential tools for case identification, and further evaluation of the performance of such tests is warranted.
At the turn of the century, the Centers for Disease Control and Prevention (CDC) reported that many sexually transmitted diseases (STDs) in the United States (US) were on the decline. 1 National objectives presented in the CDC's Healthy People program to reduce Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and syphilis morbidity by 2000 were reportedly reached or were moving towards their target. 2 Public health officials reveled in the success of prevention, testing, and treatment efforts to control STD incidence, even redirecting the conversation towards plans to eliminate syphilis. 3 Unfortunately, federal funds allotted to STD prevention began to decline beginning in 2002 -decreasing by one-third by 2018, after adjusting for inflation (see Figure 1). 4,5 In nearperfect synchrony, the US experienced a severe resurgence of STDs. 6 According to the newly released CDC STD Report, the number has increased to a combined total of nearly 2.3 million reported cases of CT, NG, and primary and secondary (P&S) syphilis in 2017 alone-more than twice the number of cases reported in 2000. 7 In response, the National Coalition of STD Directors has called on the US President and the Department of Health and Human Services to declare STDs a public health crisis. 6 How did we get to this public health crisis? There is no one answer, but many factors related to federal STD prevention budget cuts help explain this resurgence: health departments are shrinking, community clinics are closing, contact tracing is dwindling, and sexual health education is minimal. 8,9 Safeguarding the public's health is a government responsibility; advocates must engage US legislators in the difficult conversation to increase funding for STD prevention, testing, and treatment services. While this plays out, we present three reasonable, evidence-based steps to address the STD crisis-learned from the efforts of
Overcrowding can increase the risk of disease transmission, such as that of SARS-CoV-2 (COVID-19), within United States prisons. The number of COVID-19 cases among prisoners is higher than that among the general public, and this disparity is further increased for prisoners of color. This report uses the example case of the COVID-19 pandemic to observe prison conditions and preventive efforts, address racial disparities for people of color, and guide structural improvements for sustaining inmate health during a pandemic in four select states: California, New York, Illinois, and Florida. To curb the further spread of COVID-19 among prisoners and their communities, safe public health practices must be implemented including providing personal protective equipment (PPE) and testing of staff and inmates, disseminating culturally and language appropriate information regarding the pandemic and preventive precautions, introducing social distancing measures, and ensuring adequate resources to safely reintegrate released prisoners into their communities.
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