Azithromycin or Doxycycline for Asymptomatic Rectal Chlamydia trachomatis.

BACKGROUND: Rectal chlamydia is a common bacterial sexually transmissible infection among men who have sex with men. Data from randomized, controlled trials are needed to guide treatment. METHODS: In this double-blind trial conducted at five sexual health clinics in Australia, we randomly assigned men who have sex with men and who had asymptomatic rectal chlamydia to receive doxycycline (100 mg twice daily for 7 days) or azithromycin (1-g single dose). Asymptomatic chlamydia was selected as the trial focus because more than 85% of men with rectal chlamydia infection are asymptomatic, and clinical guidelines recommend a longer treatment course for symptomatic infection. The primary outcome was a negative nucleic acid amplification test for rectal chlamydia (microbiologic cure) at 4 weeks. RESULTS: From August 2016 through August 2019, we enrolled 625 men (314 in the doxycycline group and 311 in the azithromycin group). Primary outcome data were available for 290 men (92.4%) in the doxycycline group and 297 (95.5%) in the azithromycin group. In the modified intention-to-treat population, a microbiologic cure occurred in 281 of 290 men (96.9%; 95% confidence interval [CI], 94.9 to 98.9) in the doxycycline group and in 227 of 297 (76.4%; 95% CI, 73.8 to 79.1) in the azithromycin group, for an adjusted risk difference of 19.9 percentage points (95% CI, 14.6 to 25.3; P<0.001). Adverse events that included nausea, diarrhea, and vomiting were reported in 98 men (33.8%) in the doxycycline group and in 134 (45.1%) in the azithromycin group (risk difference, -11.3 percentage points; 95% CI, -19.5 to -3.2). CONCLUSIONS: A 7-day course of doxycycline was superior to single-dose azithromycin in the treatment of rectal chlamydia infection among men who have sex with men. (Funded by the National Health and Medical Research Council; RTS Australian New Zealand Clinical Trials Registry number, ACTRN12614001125617.).

In-person versus electronic screening for social risks among carers of pediatric inpatients: A mixed methods randomized trial.

We aimed to compare disclosure of social risks according to self-report on an iPad versus face-to-face questions from a health professional and to explore carers' experiences of screening. This two-arm, parallel group, randomized trial was conducted from January 19, 2021, to December 17, 2021, in a public hospital pediatric ward serving a disadvantaged area of an Australian capital city. Carers of children aged ≤ 5 years admitted to the Children's Ward were eligible. The primary outcome was disclosure of social risks. The screener included nine items on food security, household utilities, transport, employment, personal and neighborhood safety, social support, housing and homelessness. Disclosure of social risks was similar between the self-completion (n = 193) and assisted-completion (n = 193) groups for all 9 items, ranging 4.1% higher for worrying about money for food (95% CI - 11.4, 3.1%) among the assisted-completion group, to 5.7% (-1.6, 13.0%) higher for unemployment among the self-completion group. In qualitative interviews, participants were positive about screening for social risks in the hospital ward setting and the majority indicated a preference for self-completion.  Conclusion: Differences in the disclosure of social risks according to self- versus assisted-completion were small, suggesting that either method could be used. Most carers expressed a preference for self- completion, which is therefore recommended as the ideal mode for such data collection for Australian pediatric inpatient settings.  Trial registration: Australia New Zealand Clinical Trial Registry ( www.anzctry.org.au ; #ACTRN12620001326987; date of registration 8 December 2020). What is Known: • Most evidence on screening of social risks in pediatric inpatient settings is from the USA. • Little is known about disclosure of social risks in countries with universal health care and social welfare. What is New: • Disclosure of social risks was similar for electronic compared with face-to-face screening. • Carers preferred electronic completion over face-to-face completion.

Tobacco Harm Reduction with Vaporised Nicotine (THRiVe): A Feasibility Trial of Nicotine Vaping Products for Smoking Cessation Among People Living with HIV.

People living with HIV (PLHIV) have high rates of tobacco smoking. Nicotine vaping products (NVPs) may promote tobacco smoking cessation and/or harm reduction. This study aimed to trial the feasibility of NVPs for promoting tobacco smoking cessation among PLHIV. The Tobacco Harm Reduction with Vaporised Nicotine (THRiVe) study was a mixed-methods trial among 29 PLHIV who used tobacco daily. Participants trialled a 12-week intervention of NVPs. This study reports descriptive analyses of quantitative data on tobacco abstinence and associated adverse events. Short-term abstinence (7-day point prevalence; i.e., no tobacco use for 7 days) was achieved by 35% of participants at Week 12 and 31% reported short-term abstinence at Week 24. Sustained medium-term abstinence (8 weeks' abstinence) was achieved by 15% of participants at Week 12 and 31% at Week 24. Most adverse events were mild. NVPs may represent a feasible and potentially effective short-to-medium term tobacco smoking cessation aid and/or harm reduction strategy among PLHIV.

Weight loss with subcutaneous semaglutide versus other glucagon-like peptide 1 receptor agonists in type 2 diabetes: a systematic review.

Glucagon-like peptide 1 receptor agonists (GLP-1 RAs) reduce elevated blood glucose levels and induce weight loss. Multiple GLP-1 RAs and one combined GLP-1/glucose-dependent insulinotropic polypeptide agonist are currently available. This review was conducted with the aim of summarising direct comparisons between subcutaneous semaglutide and other GLP-1 RAs in individuals with type 2 diabetes (T2D), particularly with respect to efficacy for inducing weight loss and improving other markers of metabolic health. This systematic review of PubMed and Embase from inception to early 2022 was registered on PROSPERO and was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses and Meta-Analysis of Observational Studies in Epidemiology guidelines. Of the 740 records identified in the search, five studies fulfilled the inclusion criteria. Comparators included liraglutide, exenatide, dulaglutide and tirzepatide. In the identified studies, multiple dosing regimens were utilised for semaglutide. Randomised trials support the superior efficacy of semaglutide over other GLP-1 RAs with respect to weight loss in T2D, but tirzepatide is more effective than semaglutide.

GC-MS Techniques Investigating Potential Biomarkers of Dying in the Last Weeks with Lung Cancer.

Predicting when a patient with advanced cancer is dying is a challenge and currently no prognostic test is available. We hypothesised that a dying process from cancer is associated with metabolic changes and specifically with changes in volatile organic compounds (VOCs). We analysed urine from patients with lung cancer in the last weeks of life by headspace gas chromatography mass spectrometry. Urine was acidified or alkalinised before analysis. VOC changes in the last weeks of life were identified using univariate, multivariate and linear regression analysis; 12 VOCs increased (11 from the acid dataset, 2 from the alkali dataset) and 25 VOCs decreased (23 from the acid dataset and 3 from the alkali dataset). A Cox Lasso prediction model using 8 VOCs predicted dying with an AUC of 0.77, 0.78 and 0.85 at 30, 20 and 10 days and stratified patients into a low (median 10 days), medium (median 50 days) or high risk of survival. Our data supports the hypothesis there are specific metabolic changes associated with the dying. The VOCs identified are potential biomarkers of dying in lung cancer and could be used as a tool to provide additional prognostic information to inform expert clinician judgement and subsequent decision making.

Exploring the readiness of senior doctors and nurses to assess and address patients' social needs in the hospital setting.

BACKGROUND: Adverse social circumstances are a key factor in health outcomes. Hospitals are an opportune setting for assessing and addressing the unmet social needs of patients, however, the readiness of healthcare workers in hospitals to undertake such tasks requires further exploration in the Australian context. This study aimed to generate a theory of doctors' and nurses' readiness to assess and address patients' social needs in a hospital setting. METHODS: A constructivist grounded theory methodology was applied, with purposive and theoretical sampling used to gather diverse perspectives of readiness during semi-structured interviews with twenty senior doctors and nurses from a variety of clinical specialties working in hospitals serving communities experiencing inequitable social and health outcomes. Line-by-line coding, memo writing, and diagramming were used in analysis to construct an interpretive theory of readiness. Application of constant comparison analytic processes were used to test the robustness of the theory. RESULTS: The readiness of doctors and nurses varies across individuals and departments, and is founded upon a state of being comfortable and confident to assess social need as determined by a range of personal attributes (e.g. knowledge of social need; skills to assess social need); a state of being willing and prepared to assess and address social need facilitated by supportive environments (e.g. departmental culture); and enabling characteristics of the clinical encounter (e.g. time, rapport). CONCLUSIONS: We found that the readiness of doctors and nurses is dynamic and impacted by a complex interplay of personal attributes along with contextual and situational factors. These findings indicate that any efforts to strengthen the readiness of doctors and nurses to assess and address social needs must target personal capabilities in addition to characteristics of the working environment.

Barriers to digital health services among people living in areas of socioeconomic disadvantage: Research from hospital diabetes and antenatal clinics.

ISSUE ADDRESSED: We sought to examine barriers to access to, use of, and benefits from digital health services in an area of socioeconomic disadvantage of Adelaide, Australia. METHODS: We conducted waiting room surveys in two hospital diabetes clinics and one hospital antenatal clinic in South Australia, and follow-up telephone interviews with 20 patients. We examined the extent of access to, use of and benefits from digital health services, and what barriers people encountered. We undertook mixed methods, with quantitative descriptive analysis and qualitative analysis. RESULTS: Thirty-seven diabetes clinic patients (54% response rate) and 99 antenatal clinic patients (33% response rate) participated. Sixty-two percent of the patients with diabetes and 27% of antenatal clinic patients had never used digital health services. Seventeen percent of patients with diabetes and 30% of antenatal clinic patients were hesitant users, and 22% of patients with diabetes and 44% of antenatal clinic patients were confident users. Barriers included struggling to afford the technology or to stay connected and a lack of trust in online health information. Potential benefits included feeling more empowered and complementing face-to-face care. CONCLUSIONS: There are socioeconomic barriers to access, use of, and ability to benefit from digital health strategies that mean not everyone will be able to benefit from digital health services. SO WHAT?: As COVID-19 accelerates the shift towards digital health services, people experiencing socioeconomic disadvantage may be excluded. If barriers to access and use are not addressed, they will exacerbate already increasing health inequities.

The impact of gender and the social determinants of health on the clinical course of people living with HIV in Myanmar: an observational study.

BACKGROUND: There is a growing recognition of the impact of gender and the social determinants of health on the clinical course of people living with HIV (PLHIV). However, the relative contribution of these factors to clinical outcomes of PLHIV is incompletely defined in many countries. This study was performed to gain a greater understanding of the non-clinical determinants of prognosis of PLHIV in Myanmar. METHODS: Selected demographic, behavioural and socioeconomic characteristics of outpatients at two specialist HIV hospitals and one general hospital in Yangon, Myanmar were correlated with their subsequent clinical course; a poor outcome was defined as death, hospitalisation, loss to follow-up or a detectable viral load at 6 months of follow-up. RESULTS: 221 consecutive individuals with advanced HIV commencing anti-retroviral therapy (ART) were enrolled in the study; their median CD4 T-cell count was 92 (44-158) cells/mm3, 138 (62.4%) were male. Socioeconomic disadvantage was common: the median (interquartile range (IQR) monthly per-capita income in the cohort was US$48 (31-77); 153 (69.9%) had not completed high school. However, in a multivariate analysis that considered demographic, behavioural, clinical factors and social determinants of health, male gender was the only predictor of a poor outcome: odds ratio (95% confidence interval): 2.33 (1.26-4.32, p = 0.007). All eight of the deaths and hospitalisations in the cohort occurred in males (p = 0.03). CONCLUSIONS: Men starting ART in Myanmar have a poorer prognosis than women. Expanded implementation of gender-specific management strategies is likely to be necessary to improve outcomes.

Role of Indices Incorporating Power, Force and Time in AF Ablation: A Systematic Review of Literature.

INTRODUCTION: Successful pulmonary vein isolation (PVI) for atrial fibrillation (AF) depends on the formation of durable transmural lesions. Recently, novel indices have emerged to guide lesion delivery. The aim of the systematic review of literature was to determine AF recurrence following ablation guided by indices incorporating force, power and time, and compare acute procedural outcomes and 12-month AF recurrence with ablation guided by contact force (CF) guided only. METHODS: PubMed, EMBASE, and Web of Science Core Collection databases were searched on 27 January 2020 using the keywords; catheter ablation, ablation index (AI), lesion size index (LSI), contact force, atrial fibrillation. RESULTS: After exclusions, seven studies were included in the analysis. AI-guided catheter ablation was associated with a 91% (n=5, 0.91 95% CI; 0.88-0.93) and 80% (n=5, 0.80, 95% CI; 0.77-0.84) freedom from AF at 12 months with and without the use of anti-arhythmic drugs respectively. As compared to CF guided ablation, AI-guided catheter ablation was associated with a 49% increase in successful first pass isolation (n=3; RR: 1.49, 95% CI; 1.38, 1.61), a 50% decrease in number of acute reconnections (n=4; RR: 0.50, 95% CI; 0.39-0.65) and a 22% (n=4, RR: 1.22, 95% CI; 1.10-1.35) increase in AF freedom without anti-arrhythmic drugs at 12 months. CONCLUSIONS: Radiofrequency ablation guided by AI was associated with higher successful first pass isolation and lower rates of acute reconnection which translates to greater freedom from AF at 12 months [CRD42019131469].

Factors Associated With Early Resumption of Condomless Anal Sex Among Men Who Have Sex With Men After Rectal Chlamydia Treatment.

BACKGROUND: The resumption of sexual activity shortly after commencing treatment for sexually transmitted infections (STIs) is poorly described despite contributing to onward transmission. With azithromycin remaining an option for rectal Chlamydia trachomatis, resuming sex too early after treatment may contribute to antimicrobial resistance because of exposure of newly acquired STIs to subinhibitory concentrations. METHODS: Clinical and sexual behavioral data were collected from men participating in a trial assessing treatment efficacy for rectal chlamydia. Data were collected at recruitment and weekly for 3 weeks after commencing treatment. Outcome measures were resumption of any sexual activity or condomless receptive anal sex within 1, 2, or 3 weeks after commencing treatment. Generalized linear regression was used to calculate adjusted risk ratios (aRR) to identify associated factors. RESULTS: Almost 1 in 10 men (9.5%; 95% confidence interval [CI], 7.2-12.1) resumed condomless receptive anal sex within 1 week of commencing treatment. This was associated with current preexposure prophylaxis use (aRR, 3.4; 95% CI, 2.5-4.8]) and having 9 or more sexual partners in the last 3 months (aRR, 3.2; 95% CI, 1.6-5.0). Most men (75.0%; 95% CI, 71.3-78.5) resumed any sexual activity within 3 weeks; this was associated with a greater number of sexual partners (4-8 partners; aRR, 1.2; 95% CI, 1.1-1.5; ≥9 partners; aRR, 1.5; 95% CI, 1.3-1.7). CONCLUSIONS: Resuming condomless receptive anal sex early after treatment may facilitate onward transmission and promote antimicrobial resistance for STIs. Although azithromycin remains a treatment option, this analysis highlights the need for new health promotion messages regarding early resumption of sex and continued surveillance for antimicrobial resistance.

Supporting the vulnerable: developing a strategic community mental health response to the COVID-19 pandemic.

OBJECTIVES: The COVID-19 pandemic poses significant risks to the vulnerable patient population supported by community mental health (CMH) teams in South Australia. This paper describes a plan developed to understand and mitigate these risks. METHODS: Public health and psychiatric literature was reviewed and clinicians in CMH teams and infectious disease were consulted. Key risks posed by COVID-19 to CMH patients were identified and mitigation plans were prepared. RESULTS: A public health response plan for CMH teams was developed to support vulnerable individuals and respond to the COVID-19 pandemic. This plan will be reviewed regularly to respond to changes in public health recommendations, research findings and feedback from patients and clinicians. CONCLUSIONS: The strategic response plan developed to address risks to vulnerable patients from COVID-19 can assist other CMH services in managing the COVID-19 pandemic.

Addressing smoking among people living with HIV: a cross-sectional survey of Australian HIV health practitioners' practices and attitudes.

People living with HIV (PLHIV) have high rates of tobacco smoking, and smoking is a leading cause of premature mortality and morbidity. It is important to understand HIV healthcare providers' practices and attitudes towards addressing smoking with their patients. An online survey that measured: (i) use of the 5A framework for addressing smoking (Ask, Assess, Advise, Assist, Arrange) and (ii) attitudes and barriers to addressing smoking cessation was distributed by relevant professional bodies. Eligible participants were Australian health practitioners providing healthcare to PLHIV. Of the 179 respondents, most reported practising at least one of the 5As: Ask (94%); Assess (78%); Advise (82%); Assist (89%); and Arrange (73%). Practising the full 5A framework (completing at least one activity from each A) was less common (62%) and associated with having undertaken smoking cessation training (OR 2.1, CI 1.1-3.9), being a medical practitioner (OR 6.0, CI 3.1-11.6), having greater perceived knowledge and resources (OR 1.7, CI 1.3-2.4) and more positive attitudes (OR 1.5, CI 1.1-2.0). Common barriers to delivering cessation assistance related to knowledge and availability of resources. Development and greater dissemination of effective smoking cessation training and resources may be required to ensure healthcare practitioners have the capacity to complete all aspects of the 5A framework for smoking cessation and support their patients with HIV who smoke.

Early initiation of antiretroviral therapy for people newly diagnosed with HIV infection in Australia: trends and predictors, 2004-2015.

OBJECTIVES: To determine trends in and predictors of early treatment for people newly diagnosed with human immunodeficiency virus (HIV) infection in Australia. DESIGN, SETTING: Retrospective cohort analysis of routinely collected longitudinal data from 44 sexual health clinics participating in the Australian Collaboration for Coordinated Enhanced Sentinel Surveillance (ACCESS) program. PARTICIPANTS: Patients diagnosed with HIV infections, January 2004 - June 2015. MAIN OUTCOME MEASURES: Commencement of antiretroviral therapy within 6 months of HIV diagnosis (early treatment); demographic, clinical, and risk group characteristics of patients associated with early treatment; trends in early treatment, by CD4+ cell count at diagnosis. RESULTS: 917 people were diagnosed with HIV infections, their median age was 34 years (interquartile range [IQR]: 27-43 years), and 841 (92%) were men; the median CD4+ cell count at diagnosis was 510 cells/µL (IQR, 350-674 cells/µL). The proportion of patients who received early treatment increased from 17% (15 patients) in 2004-06 to 20% (34 patients) in 2007-09, 34% (95 patients) in 2010-12, and 53% (197 patients) in 2013-15 (trend, P < 0.001). The probability of early treatment, which increased with time, was higher for patients with lower CD4+ cell counts and higher viral loads at diagnosis. CONCLUSIONS: The proportion of people newly diagnosed with HIV in sexual health clinics in Australia who received treatment within 6 months of diagnosis increased from 17% to 53% during 2004-2015, reflecting changes in the CD4+ cell count threshold in treatment guidelines. Nevertheless, further strategies are needed to maximise the benefits of treatment to prevent viral transmission and morbidity.

Effectiveness of Protease Inhibitor/Nucleos(t)ide Reverse Transcriptase Inhibitor-Based Second-line Antiretroviral Therapy for the Treatment of Human Immunodeficiency Virus Type 1 Infection in Sub-Saharan Africa: A Systematic Review and Meta-analysis.

Background: In sub-Saharan Africa, 25.5 million people are living with human immunodeficiency virus (HIV), representing 70% of the global total. The need for second-line antiretroviral therapy (ART) is projected to increase in the next decade in keeping with the expansion of treatment provision. Outcome data are required to inform policy. Methods: We performed a systematic review and meta-analysis of studies reporting the virological outcomes of protease inhibitor (PI)-based second-line ART in sub-Saharan Africa. The primary outcome was virological suppression (HIV-1 RNA <400 copies/mL) after 48 and 96 weeks of treatment. The secondary outcome was the proportion of patients with PI resistance. Pooled aggregate data were analyzed using a DerSimonian-Laird random effects model. Results: By intention-to-treat analysis, virological suppression occurred in 69.3% (95% confidence interval [CI], 58.2%-79.3%) of patients at week 48 (4558 participants, 14 studies), and in 61.5% (95% CI, 47.2%-74.9%) at week 96 (2145 participants, 8 studies). Preexisting resistance to nucleos(t)ide reverse transcriptase inhibitors (NRTIs) increased the likelihood of virological suppression. Major protease resistance mutations occurred in a median of 17% (interquartile range, 0-25%) of the virological failure population and increased with duration of second-line ART. Conclusions: One-third of patients receiving PI-based second-line ART with continued NRTI use in sub-Saharan Africa did not achieve virological suppression, although among viremic patients, protease resistance was infrequent. Significant challenges remain in implementation of viral load monitoring. Optimizing definitions and strategies for management of second-line ART failure is a research priority. Prospero Registration: CRD42016048985.

Smoking and HIV: what are the risks and what harm reduction strategies do we have at our disposal?

The World Health Organization estimates that smoking poses one of the greatest global health risks in the general population. Rates of current smoking among people living with HIV (PLHIV) are 2-3 times that of the general population, which contributes to the higher incidence of non-AIDS-related morbidity and mortality in PLHIV. Given the benefit of smoking cessation, strategies to assist individuals who smoke to quit should be a primary focus in modern HIV care. Tobacco harm reduction focuses on reducing health risk without necessarily requiring abstinence. However, there remains uncertainty about the safety, policy and familiarity of specific approaches, particularly the use of vaporised nicotine products. Evidence suggests that vaporised nicotine products may help smokers stop smoking and are not associated with any serious side-effects. However, there is the need for further safety and efficacy data surrounding interventions to assist quitting in the general population, as well as in PLHIV specifically. In addition, official support for vaping as a harm reduction strategy varies by jurisdiction and this determines whether medical practitioners can prescribe vaporised products and whether patients can access vaporised nicotine products. When caring for PLHIV who smoke, healthcare workers should follow general guidelines to assist with smoking cessation. These include: asking the patient about their smoking status; assessing the patient's readiness to quit and their nicotine dependence; advising the patient to stop smoking; assisting the patient in their attempt to stop smoking through referral, counselling, pharmacotherapy, self-help resources and/or health education; and arranging follow-up with the patient to evaluate their progress.

Resident Perceptions of Competency and Comfort Before and After Telemedicine-ICU Implementation.

OBJECTIVES: The purpose of this study was to examine the impact telemedicine in the intensive care unit (ICU) has on the competency, satisfaction, and education of resident physicians. METHODS: Telemedicine in the ICU was implemented in 2014 at a community hospital with 24 family medicine residents. Comfort with the performance of various common procedures; management of major medical diseases in the ICU; and level of comfort, attitudes, and satisfaction in work relationships with various staff members in the ICU were assessed before and 1 year after the telemedicine implementation. This was done by the residents' respective training year and by all year groups combined. The Likert scores for each category were averaged by year group and by the three year groups combined, and these averages were compared pre- and posttelemedicine implementation using the t test method. RESULTS: All of the residents in the program participated voluntarily in the study, a 100% response rate. The results showed significant positive effects on resident education and satisfaction among ICU nurses and residents after the implementation of telemedicine-ICU. There were negative effects on residents' learning opportunities with the family medicine attending physicians, feelings of being a valued team member, and comfort with ventilator management. CONCLUSIONS: Telemedicine-ICU implementation had mixed effects on residents' perceptions of their ICU experience and training. Further studies should be conducted to assess how to maximize resident training in this setting.

Cardiovascular disease (CVD) and chronic kidney disease (CKD) event rates in HIV-positive persons at high predicted CVD and CKD risk: A prospective analysis of the D:A:D observational study.

BACKGROUND: The Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) study has developed predictive risk scores for cardiovascular disease (CVD) and chronic kidney disease (CKD, defined as confirmed estimated glomerular filtration rate [eGFR] ≤ 60 ml/min/1.73 m2) events in HIV-positive people. We hypothesized that participants in D:A:D at high (>5%) predicted risk for both CVD and CKD would be at even greater risk for CVD and CKD events. METHODS AND FINDINGS: We included all participants with complete risk factor (covariate) data, baseline eGFR > 60 ml/min/1.73 m2, and a confirmed (>3 months apart) eGFR < 60 ml/min/1.73 m2 thereafter to calculate CVD and CKD risk scores. We calculated CVD and CKD event rates by predicted 5-year CVD and CKD risk groups (≤1%, >1%-5%, >5%) and fitted Poisson models to assess whether CVD and CKD risk group effects were multiplicative. A total of 27,215 participants contributed 202,034 person-years of follow-up: 74% male, median (IQR) age 42 (36, 49) years, median (IQR) baseline year of follow-up 2005 (2004, 2008). D:A:D risk equations predicted 3,560 (13.1%) participants at high CVD risk, 4,996 (18.4%) participants at high CKD risk, and 1,585 (5.8%) participants at both high CKD and high CVD risk. CVD and CKD event rates by predicted risk group were multiplicative. Participants at high CVD risk had a 5.63-fold (95% CI 4.47, 7.09, p < 0.001) increase in CKD events compared to those at low risk; participants at high CKD risk had a 1.31-fold (95% CI 1.09, 1.56, p = 0.005) increase in CVD events compared to those at low risk. Participants' CVD and CKD risk groups had multiplicative predictive effects, with no evidence of an interaction (p = 0.329 and p = 0.291 for CKD and CVD, respectively). The main study limitation is the difference in the ascertainment of the clinically defined CVD endpoints and the laboratory-defined CKD endpoints. CONCLUSIONS: We found that people at high predicted risk for both CVD and CKD have substantially greater risks for both CVD and CKD events compared with those at low predicted risk for both outcomes, and compared to those at high predicted risk for only CVD or CKD events. This suggests that CVD and CKD risk in HIV-positive persons should be assessed together. The results further encourage clinicians to prioritise addressing modifiable risks for CVD and CKD in HIV-positive people.

The clinical utility of the urine-based lateral flow lipoarabinomannan assay in HIV-infected adults in Myanmar: an observational study.

BACKGROUND: The use of the point-of-care lateral flow lipoarabinomannan (LF-LAM) test may expedite tuberculosis (TB) diagnosis in HIV-positive patients. However, the test's clinical utility is poorly defined outside sub-Saharan Africa. METHODS: The study enrolled consecutive HIV-positive adults at a tertiary referral hospital in Yangon, Myanmar. On enrolment, patients had a LF-LAM test performed according to the manufacturer's instructions. Clinicians managing the patients were unaware of the LF-LAM result, which was correlated with the patient's clinical course over the ensuing 6 months. RESULTS: The study enrolled 54 inpatients and 463 outpatients between July 1 and December 31, 2015. On enrolment, the patients' median (interquartile range) CD4 T-cell count was 270 (128-443) cells/mm3. The baseline LF-LAM test was positive in 201/517 (39%). TB was confirmed microbiologically during follow-up in 54/517 (10%), with rifampicin resistance present in 8/54 (15%). In the study's resource-limited setting, extrapulmonary testing for TB was not possible, but after 6 months, 97/201 (48%) with a positive LF-LAM test on enrolment had neither died, required hospitalisation, received a TB diagnosis or received empirical anti-TB therapy, suggesting a high rate of false-positive results. Of the 97 false-positive tests, 89 (92%) were grade 1 positive, suggesting poor test specificity using this cut-off. Only 21/517 (4%) patients were inpatients with TB symptoms and a CD4 T-cell count of < 100 cells/mm3. Five (24%) of these 21 died, three of whom had a positive LF-LAM test on enrolment. However, all three received anti-TB therapy before death - two after diagnosis with Xpert MTB/RIF testing, while the other received empirical treatment. It is unlikely that knowledge of the baseline LF-LAM result would have averted any of the study's other 11 deaths; eight had a negative test, and of the three patients with a positive test, two received anti-TB therapy before death, while one died from laboratory-confirmed cryptococcal meningitis. The test was no better than a simple, clinical history excluding TB during follow-up (negative predictive value (95% confidence interval): 94% (91-97) vs. 94% (91-96)). CONCLUSIONS: The LF-LAM test had limited clinical utility in the management of HIV-positive patients in this Asian referral hospital setting.