Timely administration of tocilizumab improves outcome of hospitalized COVID-19 patients.

INTRODUCTION: The aim of this study was to determine the efficacy of early tocilizumab treatment for hospitalized patients with COVID-19 disease. METHODS: Open-label randomized phase II clinical trial investigating tocilizumab in patients with proven COVID-19 admitted to the general ward and in need of supplemental oxygen. The primary endpoint of the study was 30-day mortality with a prespecified 2-sided significance level of α = 0.10. A post-hoc analysis was performed for a combined endpoint of mechanical ventilation or death at 30 days. Secondary objectives included comparing the duration of hospital stay, ICU admittance and duration of ICU stay and the duration of mechanical ventilation. RESULTS: A total of 354 patients (67% men; median age 66 years) were enrolled of whom 88% received dexamethasone. Thirty-day mortality was 19% (95% CI 14%-26%) in the standard arm versus 12% (95% CI: 8%-18%) in the tocilizumab arm, hazard ratio (HR) = 0.62 (90% CI 0.39-0.98; p = 0.086). 17% of patients were admitted to the ICU in each arm (p = 0.89). The median stay in the ICU was 14 days (IQR 9-28) in the standard arm versus 9 days (IQR 5-14) in the tocilizumab arm (p = 0.014). Mechanical ventilation or death at thirty days was 31% (95% CI 24%-38%) in the standard arm versus 21% (95% CI 16%-28%) in the tocilizumab arm, HR = 0.65 (95% CI 0.42-0.98; p = 0.042). CONCLUSIONS: This randomized phase II study supports efficacy for tocilizumab when given early in the disease course in hospitalized patients who need oxygen support, especially when concomitantly treated with dexamethasone. TRIAL REGISTRATION: https://www.trialregister.nl/trial/8504.

Association of genetic variations in ACE2, TIRAP and factor X with outcomes in COVID-19.

BACKGROUND: Coronavirus disease 2019 (COVID-19), caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), can manifest with varying disease severity and mortality. Genetic predisposition influences the clinical course of infectious diseases. We investigated whether genetic polymorphisms in candidate genes ACE2, TIRAP, and factor X are associated with clinical outcomes in COVID-19. METHODS: We conducted a single-centre retrospective cohort study. All patients who visited the emergency department with SARS-CoV-2 infection proven by polymerase chain reaction were included. Single nucleotide polymorphisms in ACE2 (rs2285666), TIRAP (rs8177374) and factor X (rs3211783) were assessed. The outcomes were mortality, respiratory failure and venous thromboembolism. Respiratory failure was defined as the necessity of >5 litres/minute oxygen, high flow nasal oxygen suppletion or mechanical ventilation. RESULTS: Between March and April 2020, 116 patients (35% female, median age 65 [inter quartile range 55-75] years) were included and treated according to the then applicable guidelines. Sixteen patients (14%) died, 44 patients (38%) had respiratory failure of whom 23 required endotracheal intubation for mechanical ventilation, and 20 patients (17%) developed venous thromboembolism. The percentage of TIRAP polymorphism carriers in the survivor group was 28% as compared to 0% in the non-survivor group (p = 0.01, Bonferroni corrected p = 0.02). Genotype distribution of ACE2 and factor X did not differ between survivors and non-survivors. CONCLUSION: This study shows that carriage of TIRAP polymorphism rs8177374 could be associated with a significantly lower mortality in COVID-19. This TIRAP polymorphism may be an important predictor in the outcome of COVID-19.

Adherence to Surgical Antibiotic Prophylaxis in the Field of Vascular Surgery.

Background: Insufficient surgical antibiotic prophylaxis (SAP) can lead to prolonged hospitalization, hospital re-admissions, increased morbidity and mortality, and higher healthcare costs. Overdoing prophylaxis can result in antimicrobial resistance, Clostridium difficile infections, and acute kidney failure. Patients and Methods: To investigate the adherence to local SAP guidelines for vascular surgery, a retrospective observational single center intervention study was performed in a Dutch hospital. Results: Antibiotic choice, dose, interval, timing, and duration were adherent to the guidelines in 96%, 97%, 96%, 85%, and 41% of the surgeries, respectively. Adherence to all five aspects was achieved in only 37% of all procedures. Conclusions: Further interventions are necessary to improve specific parameters such as duration and timing.

Model-based Prediction of Critical Illness in Hospitalized Patients with COVID-19.

Background The prognosis of hospitalized patients with severe coronavirus disease 2019 (COVID-19) is difficult to predict, and the capacity of intensive care units was a limiting factor during the peak of the pandemic and is generally dependent on a country's clinical resources. Purpose To determine the value of chest radiographic findings together with patient history and laboratory markers at admission to predict critical illness in hospitalized patients with COVID-19. Materials and Methods In this retrospective study, which included patients from March 7, 2020, to April 24, 2020, a consecutive cohort of hospitalized patients with real-time reverse transcription polymerase chain reaction-confirmed COVID-19 from two large Dutch community hospitals was identified. After univariable analysis, a risk model to predict critical illness (ie, death and/or intensive care unit admission with invasive ventilation) was developed, using multivariable logistic regression including clinical, chest radiographic, and laboratory findings. Distribution and severity of lung involvement were visually assessed by using an eight-point scale (chest radiography score). Internal validation was performed by using bootstrapping. Performance is presented as an area under the receiver operating characteristic curve. Decision curve analysis was performed, and a risk calculator was derived. Results The cohort included 356 hospitalized patients (mean age, 69 years ± 12 [standard deviation]; 237 men) of whom 168 (47%) developed critical illness. The final risk model's variables included sex, chronic obstructive lung disease, symptom duration, neutrophil count, C-reactive protein level, lactate dehydrogenase level, distribution of lung disease, and chest radiography score at hospital presentation. The area under the receiver operating characteristic curve of the model was 0.77 (95% CI: 0.72, 0.81; P < .001). A risk calculator was derived for individual risk assessment: Dutch COVID-19 risk model. At an example threshold of 0.70, 71 of 356 patients would be predicted to develop critical illness, of which 59 (83%) would be true-positive results. Conclusion A risk model based on chest radiographic and laboratory findings obtained at admission was predictive of critical illness in hospitalized patients with coronavirus disease 2019. This risk calculator might be useful for triage of patients to the limited number of intensive care unit beds or facilities. © RSNA, 2020 Online supplemental material is available for this article.

[ASalmonellainfection in a pregnant traveller]. / EenSalmonella-infectie bij een zwangere reiziger.

BACKGROUND: Infectious diseases are a common problem in people who travel to countries with poor hygiene standards. Pregnant travellers are subjected to increased risk because of the higher probability of complications in case of certain infectious diseases and the variability of prenatal care quality in these countries. CASE DESCRIPTION: A pregnant patient presented herself at the emergency department with recurring fever and chills, a month after she had been to Indonesia. This was associated with a Salmonella infection; the placenta was the infection reservoir. CONCLUSION: Travelling while pregnant is not without risk. Quick diagnosis and treatment of infections, which may sometimes have an atypical presentation during pregnancy, can be of crucial importance. It is extra important for pregnant people to get travel advice before the trip, so that risks, alarming symptoms and additional hygiene measures can be discussed.

Prevalence of Anal Human Papillomavirus (HPV) and Performance of Cepheid Xpert and Hybrid Capture 2 (hc2) HPV Assays in South African HIV-Infected Women.

OBJECTIVES: This study investigated anal high-risk HPV (HR-HPV) prevalence in HIV-infected women using the Cepheid Xpert HPV assay and compares its performance with that of Hybrid Capture-2 (hc2). METHODS: A total of 199 HIV-infected women were recruited from Helen Joseph Hospital, Johannesburg. Stored ThinPrep anal swabs that had previously been tested using hc2 were tested for HPV using Xpert. RESULTS: The HR-HPV prevalence by Xpert was 40.8% and similar to hc2 (41.8%) with overall agreement of 86.7%; Cohen's kappa 0.73 (95% CI 0.63-0.82). High grade squamous intraepithelial lesions (HSIL) was associated with increasing number of multiple HPV infection (P < .001). Xpert and hc2 were similarly sensitive (77.4% and 77.4%, respectively) and specific (66.1% and 64.8% respectively) for HSIL detection. HPV16 (OR: 14.0, 95% CI: 3.9-48.0, P < .0001), HPV39/68/56/66 (OR: 4.1, 95% CI: 1.4-12, P = .01) and HPV51/59 (OR: 2.8, 95% CI: 1.1-7.6, P = .04) were independently associated with anal HSIL. CONCLUSIONS: Xpert HPV typing is a promising anal screening test in HIV-infected women that performs similarly to hc2.

Prevalence of Anal HPV and Anal Dysplasia in HIV-Infected Women From Johannesburg, South Africa.

BACKGROUND: Anal cancer is a relatively common cancer among HIV-infected populations. There are limited data on the prevalence of anal high-risk human papillomavirus (HR-HPV) infection and anal dysplasia in HIV-infected women from resource-constrained settings. METHODS: A cross-sectional study of HIV-infected women aged 25-65 years recruited from an HIV clinic in Johannesburg, South Africa. Cervical and anal swabs were taken for conventional cytology and HR-HPV testing. Women with abnormal anal cytology and 20% of women with negative cytology were seen for high-resolution anoscopy with biopsy of visible lesions. RESULTS: Two hundred women were enrolled. Anal HR-HPV was found in 43%. The anal cytology results were negative in 51 (26%); 97 (49%) had low-grade squamous intraepithelial lesions (SIL), 32 (16%) had atypical squamous cells of unknown significance, and 19 (9.5%) had high-grade SIL or atypical squamous cells suggestive of high-grade SIL. On high-resolution anoscopy, 71 (36%) had atypia or low-grade SIL on anal histology and 17 (8.5%) had high-grade SIL. Overall, 31 (17.5%) had high-grade SIL present on anal cytology or histology. Abnormal cervical cytology was found in 70% and cervical HR-HPV in 41%. CONCLUSIONS: We found a significant burden of anal HR-HPV infection, abnormal anal cytology, and high-grade SIL in our cohort. This is the first study of the prevalence of anal dysplasia in HIV-infected women from sub-Saharan Africa. Additional studies are needed to define the epidemiology of these conditions, as well as the incidence of anal cancer, in this population.

Outcomes of TB/HIV co-infected patients presenting with antituberculosis drug-induced liver injury.

BACKGROUND: South Africa has a significant burden of tuberculosis (TB). Anti-TB drug-induced liver injury (TB DILI) is one of the most serious adverse events that can arise from TB treatment (TBT). There are limited data on TB DILI among HIV-infected patients and those on antiretroviral therapy (ART). OBJECTIVE: To describe characteristics of HIV-infected patients presenting with TB DILI and the proportion reintroduced on standard or modified TBT after DILI. METHODS: This was a retrospective study of TB/HIV co-infected patients with DILI between 1 July 2009 and 30 September 2012. The primary focus of interest was HIV-infected patients with TB DILI on ART (ART/TB DILI) v. not on ART (TB DILI). RESULTS: A total of 94 patients were included, 41 with TB DILI and 53 with ART/TB DILI. Compared with patients with TB DILI, patients with ART/TB DILI were more likely to present with symptomatic DILI (71.2% v. 51.2%; p=0.03) and had a lower median alanine aminotransferase level at diagnosis (89 IU/L v. 118 IU/L; p=0.008), a lower rate of ALT decline (-23 IU/L v. -76 IU/L; p=0.047) and longer duration of TBT at DILI diagnosis (53 days v. 11 days; p<0.001). In 71.8% of patients, standard TBT was reintroduced. More patients with ART/TB DILI than TB DILI required modified TBT (37.2% v.17.1%; p=0.05; crude odds ratio 2.17; 95% confidence interval 0.95 - 4.96). The rate of death/loss to follow-up was higher in the ART/TB DILI group (18.9% v. 14.5%). CONCLUSION: A significant number of TB/HIV co-infected patients were not able to tolerate standard TBT. Furthermore, ART appears to complicate TBT, with relatively few patients reintroduced on standard TBT.

Predominant association of Raoultella bacteremia with diseases of the biliary tract.

A case series of 14 patients with Raoultella bacteremia was compared with 28 Klebsiella oxytoca and 28 Klebsiella pneumoniae bacteremia cases. Forty-three percent of Raoultella bacteremia cases were associated with biliary tract disease, compared to 32% and 22% of patients with K. oxytoca and K. pneumoniae bacteremia, respectively.

Tuberculosis in antiretroviral treatment programs in lower income countries: availability and use of diagnostics and screening.

OBJECTIVES: In resource-constrained settings, tuberculosis (TB) is a common opportunistic infection and cause of death in HIV-infected persons. TB may be present at the start of antiretroviral therapy (ART), but it is often under-diagnosed. We describe approaches to TB diagnosis and screening of TB in ART programs in low- and middle-income countries. METHODS AND FINDINGS: We surveyed ART programs treating HIV-infected adults in sub-Saharan Africa, Asia and Latin America in 2012 using online questionnaires to collect program-level and patient-level data. Forty-seven sites from 26 countries participated. Patient-level data were collected on 987 adult TB patients from 40 sites (median age 34.7 years; 54% female). Sputum smear microscopy and chest radiograph were available in 47 (100%) sites, TB culture in 44 (94%), and Xpert MTB/RIF in 23 (49%). Xpert MTB/RIF was rarely available in Central Africa and South America. In sites with access to these diagnostics, microscopy was used in 745 (76%) patients diagnosed with TB, culture in 220 (24%), and chest X-ray in 688 (70%) patients. When free of charge culture was done in 27% of patients, compared to 21% when there was a fee (p = 0.033). Corresponding percentages for Xpert MTB/RIF were 26% and 15% of patients (p = 0.001). Screening practices for active disease before starting ART included symptom screening (46 sites, 98%), chest X-ray (38, 81%), sputum microscopy (37, 79%), culture (16, 34%), and Xpert MTB/RIF (5, 11%). CONCLUSIONS: Mycobacterial culture was infrequently used despite its availability at most sites, while Xpert MTB/RIF was not generally available. Use of available diagnostics was higher when offered free of charge.

The geographic diversity of nontuberculous mycobacteria isolated from pulmonary samples: an NTM-NET collaborative study.

A significant knowledge gap exists concerning the geographical distribution of nontuberculous mycobacteria (NTM) isolation worldwide. To provide a snapshot of NTM species distribution, global partners in the NTM-Network European Trials Group (NET) framework (www.ntm-net.org), a branch of the Tuberculosis Network European Trials Group (TB-NET), provided identification results of the total number of patients in 2008 in whom NTM were isolated from pulmonary samples. From these data, we visualised the relative distribution of the different NTM found per continent and per country. We received species identification data for 20 182 patients, from 62 laboratories in 30 countries across six continents. 91 different NTM species were isolated. Mycobacterium avium complex (MAC) bacteria predominated in most countries, followed by M. gordonae and M. xenopi. Important differences in geographical distribution of MAC species as well as M. xenopi, M. kansasii and rapid-growing mycobacteria were observed. This snapshot demonstrates that the species distribution among NTM isolates from pulmonary specimens in the year 2008 differed by continent and differed by country within these continents. These differences in species distribution may partly determine the frequency and manifestations of pulmonary NTM disease in each geographical location.

Differentiation of Raoultella ornithinolytica/planticola and Klebsiella oxytoca clinical isolates by matrix-assisted laser desorption/ionization-time of flight mass spectrometry.

Ninety-nine clinical isolates previously identified as Klebsiella oxytoca were evaluated using matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS). Eight isolates were identified as Raoultella spp., being 5 Raoultella spp. and 3 K. oxytoca, by 16S rRNA sequencing. These isolates were correctly identified by applying the 10% differential rule for the MALDI-TOF MS score values. This approach might be useful to discriminate Raoultella species from K. oxytoca.

The contribution of adult attachment and perceived social support to depressive symptoms in patients with HIV.

The present study investigated the relationship between adult attachment style and depressive symptomatology in patients with HIV. Moreover, perceived social support was investigated as a potential mediator between adult attachment and depressive symptoms. A sample of 233 HIV-infected patients (90% male) completed questionnaires assessing adult attachment style (Relationship Questionnaire), depressive symptoms (Beck Depression Inventory), and perceived social support (Medical Outcomes Study Social Support Survey). After controlling for demographic and medical variables, an insecure adult attachment style was found to be strongly related with depressive symptoms. Half of the insecurely attached patients reported clinically elevated levels of distress, while one in nine securely attached patients reported elevated levels of distress (χ(2)=32.25, p=0.001). Moreover, the association between attachment style and depressive symptomatology was found to be partly mediated through perceived social support. This study strongly supports the notion that an insecure attachment style is a vulnerability factor for developing depressive symptoms that would warrant clinical attention when confronted with a chronic illness such as HIV. The clinical implications of these findings are discussed.

The effect of initiating combined antiretroviral therapy on endothelial cell activation and coagulation markers in South African HIV-infected individuals.

An increased incidence of venous thromboembolism (VTE) is observed in human immunodeficiency virus (HIV)-infected patients. Only a limited number of studies described the effect of combined antiretroviral therapy (cART) on coagulation markers. In a prospective cohort study in cART-naive South African HIV-infected individuals the effect of initiating cART on markers of endothelial cell activation, coagulation and natural anticoagulation was studied. These markers were compared to the reference ranges for an HIV-uninfected control population recruited from hospital staff. A venous ultrasound of both legs was performed to detect asymptomatic deep venous thrombosis (DVT). A total number of 123 HIV-infected participants were included. The patients were predominantly black and severely immuno-compromised. The CD4 cell count increased and the HIV viral load decreased significantly after the initiation of cART (p<0.001). The median follow-up period was 7.2 (± 1.6) months. Laboratory testing before and after initiation of cART was completed by 86 patients. Before initiating cART significantly elevated von Willebrand factor and D-dimer levels, increased activated protein C sensitivity ratio (APCsr) and decreased total and free protein S and protein C levels were observed compared to HIV-negative controls. At follow-up all markers, except APCsr, improved towards the normal range for controls without showing complete normalisation. In a subgroup of 57 patients no asymptomatic DVT was found. Compared to the controls, abnormal levels of coagulation markers were observed in HIV-infected individuals before and after the initiation of cART. Most markers improved after starting cART, but remained significantly different from the controls, indicating a persistent disturbed haemostatic balance.

Predictors and treatment strategies of HIV-related fatigue in the combined antiretroviral therapy era.

OBJECTIVE: To assess predictors and reported treatment strategies of HIV-related fatigue in the combined antiretroviral (cART) era. METHOD: Five databases were searched and reference lists of pertinent articles were checked. Studies published since 1996 on predictors or therapy of HIV-related fatigue measured by a validated instrument were selected. RESULTS: A total of 42 studies met the inclusion criteria. The reported HIV-related fatigue prevalence in the selected studies varied from 33 to 88%. The strongest predictors for sociodemographic variables were unemployment and inadequate income. Concerning HIV-associated factors, the use of cART was the strongest predictor. Comorbidity and sleeping difficulties were important factors when assessing physiological influences. Laboratory parameters were not predictive of fatigue. The strongest and most uniform associations were observed between fatigue and psychological factors such as depression and anxiety. Reported therapeutic interventions for HIV-related fatigue include testosterone, psycho-stimulants (dextroamphetamine, methylphenidate hydrochloride, pemoline, modafinil), dehydroepiandrosterone, fluoxetine and cognitive behavioural or relaxation therapy. CONCLUSION: HIV-related fatigue has a high prevalence and is strongly associated with psychological factors such as depression and anxiety. A validated instrument should be used to measure intensity and consequences of fatigue in HIV-infected individuals. In the case of fatigue, clinicians should not only search for physical mechanisms, but should question depression and anxiety in detail. There is a need for intervention studies comparing the effect of medication (antidepressants, anxiolytics) and behavioural interventions (cognitive-behavioural therapy, relaxation therapy, graded exercise therapy) to direct the best treatment strategy. Treatment of HIV-related fatigue is important in the care for HIV-infected patients and requires a multidisciplinary approach.

Markers of inflammation and coagulation indicate a prothrombotic state in HIV-infected patients with long-term use of antiretroviral therapy with or without abacavir.

BACKGROUND: Abacavir (ABC) treatment has been associated with an increased incidence of myocardial infarction. The pathophysiological mechanism is unknown. In this study markers of inflammation and coagulation in HIV-infected patients using antiretroviral therapy with or without ABC were examined to pinpoint a pathogenic mechanism. Given the important role of high sensitivity C-reactive protein (hsCRP) levels in predicting cardiovascular risk, patient groups were also analyzed according to hsCRP levels. METHODS: Patients treated with ABC and a matched control group treated without ABC were selected retrospectively. Vascular endothelial growth factor (VEGF) and markers of endothelial cell activation (von Willebrand factor (vWF), factor VIII), fibrin formation (fibrinogen, D-dimer, prothrombin fragment 1+2 (F1+2), endogenous thrombin potential (ETP)), anticoagulation markers (protein C and S, activated protein C sensitivity ratio (APCsr)) and inflammation markers (IL-6, hsCRP) were measured in citrated plasma. RESULTS: A total of 81 patients were included of whom 27 patients used an ABC-containing regimen and 54 used a non-ABC-containing regimen. Patient characteristics were not significantly different between the groups except for longer duration of use of the current antiretroviral regimen in the ABC group (p = 0.01). The median time on ABC was 68 months (interquartile range 59-80 months). No differences in coagulation and inflammation markers according to ABC use were observed. For the whole patient group elevated vWF and F1+2 levels were observed in 23% and 37%, respectively. Compared to the reference ranges for the general population increased APCsr was found in 79% and lower protein C and VEGF levels in 40% and 43%, respectively. Patients in the high-risk category for cardiovascular disease with hsCRP levels > 3 mg/L had significantly higher fibrinogen, D-dimer, F1+2 and ETP levels compared to patients from the low-risk category with hsCRP levels < 1 mg/L. CONCLUSION: HIV-infected patients using ABC showed no specific abnormalities in coagulation or inflammation markers that might explain the increased risk of myocardial infarction. For the whole group, regardless of ABC use, evidence of a prothrombotic state was observed. Thirty-three percent of patients with long-term use of antiretroviral treatment had hsCRP levels above 3 mg/L, which is strongly associated with cardiovascular disease in HIV-uninfected individuals.

The hemostatic balance in HIV-infected patients with and without antiretroviral therapy: partial restoration with antiretroviral therapy.

The incidence of arterial and venous thrombosis in HIV-infected patients is increased compared to healthy controls. In this cross-sectional analysis we measured markers of endothelial cell activation, thrombin generation, fibrinolysis and anticoagulation combined with endogenous thrombin potential (ETP) and activated protein C sensitivity ratio (APCsr) as more global markers. We included 160 consecutive HIV-infected patients with a median age of 46 years (range, 27-77), of whom 92% were male, 74% Caucasian, 11% African American, 9% Hispanic, and 6% Asian. Homosexual contact was the main transmission mode. Seventy percent of patients were using combined antiretroviral therapy (cART). In 83% of patients laboratory markers outside the normal range for a non-HIV-infected population were observed. Significant lower levels of von Willebrand factor (vWF; p = 0.03), factor VIII (p < 0.0001), D-dimer (p = 0.01), and ETP (p = 0.01) were observed in HIV-infected patients on cART compared to patients not on cART. Significant lower levels of protein C (p = 0.05) and free protein S (p < 0.0001), and increased APCsr (p < 0.0001) were found in the HIV-infected patients not on cART. A single association was observed between raised levels of fibrinogen and use of a protease inhibitor (p = 0.002). No significant difference was observed in the percentage of patients with laboratory markers outside the normal range between patients using cART-regimens containing abacavir, stavudine, or didanosine and those with other nucleoside reverse transcriptase inhibitors. Although the prevalence of coagulation abnormalities was lower in HIV-infected patients using cART, a considerable proportion of HIV-infected patients on cART show endothelial cell activation and increased APCsr, suggestive of a persistent procoagulant state.

Two cases of Mycobacterium microti-induced culture-negative tuberculosis.

We present descriptions of two human Mycobacterium microti infections: one of a patient with pulmonary disease and one of a patient with osteomyelitis of the hip. Both patients had acid-fast bacilli and a positive Mycobacterium tuberculosis complex PCR from clinical specimens, but mycobacterial cultures remained negative. The microbiological diagnosis was established by molecular methods.

The prevalence of human papillomavirus (HPV) infection in paired urine and cervical smear samples of HIV-infected women.

BACKGROUND: HIV-infected women are at increased risk for cervical dysplasia. Cervical dysplasia is caused by persistent infections with certain types of human papillomavirus (HPV). Conventional testing for genital HPV infections requires cervical cytology. A non-invasive screening method by detection of HPV DNA in urine samples is preferable but is not a routine practice. OBJECTIVES: To investigate the prevalence and concordance of HPV in paired urine and cervical smear samples and cytological results of Pap smears in HIV-infected women. STUDY DESIGN: Paired urine and cervical smear samples were collected from 27 HIV-infected women. RESULTS: The HPV prevalence in urine and cervical smear samples was 81.5% and 51.9%, respectively (p = 0.01). The concordance for HPV positivity and negativity between urine and cervical smear samples is 71%. Seven women (25.9%) had an abnormal cervical smear of Pap II or higher. In all urine samples from these cases HPV DNA was detected. CONCLUSION: In the present study we show that the HPV prevalence in urine and cervical smear samples of HIV-infected women is high and HPV test results are highly concordant. Therefore, urine samples can be used as medium for HPV testing. HPV testing in urine samples is a simple, reliable, non-invasive screening method.