scholarly journals Design and protocol for a cluster randomised trial of enhanced diagnostics for tuberculosis screening among people living with HIV in hospital in Malawi (CASTLE study)

PLoS ONE ◽  
2022 ◽  
Vol 17 (1) ◽  
pp. e0261877
Author(s):  
Rachael M. Burke ◽  
Saulos Nyirenda ◽  
Hussein H. Twabi ◽  
Marriott Nliwasa ◽  
Elizabeth Joekes ◽  
...  
Keyword(s):  
Usual Care ◽  
Randomised Trial ◽  
Tuberculosis Treatment ◽  
Diagnostic Tools ◽  
People Living With Hiv ◽  
Random Allocation ◽  
Risk Of Death ◽  
Cluster Randomised ◽  
Living With Hiv ◽  
Urine Testing

Background People living with HIV (PLHIV) have a high risk of death if hospitalised in low-income countries. Tuberculosis has long been the leading cause of admission and death, in part due to suboptimal diagnostics. Two promising new diagnostic tools are digital chest Xray with computer-aided diagnosis (DCXR-CAD) and urine testing with Fujifilm SILVAMP LAM (FujiLAM). Neither test has been rigorously evaluated among inpatients. Test characteristics may be complementary, with FujiLAM especially sensitive for disseminated tuberculosis and DCXR-CAD especially sensitive for pulmonary tuberculosis, making combined interventions of interest. Design and methods An exploratory unblinded, single site, two-arm cluster randomised controlled trial, with day of admission as the unit of randomisation. A third, smaller, integrated cohort arm (4:4:1 random allocation) contributes to understanding case-mix, but not trial outcomes. Participants are adults living with HIV not currently on TB treatment. The intervention (DCXR-CAD plus urine FujiLAM plus usual care) is compared to usual care alone. The primary outcome is proportion of participants started on tuberculosis treatment by day 56, with secondary outcomes of mortality (time to event) measured to to 56 days from enrolment, proportions with undiagnosed tuberculosis at death or hospital discharge and comparing proportions with enrolment-day tuberculosis treatment initiation. Discussion Both DCXR-CAD and FujiLAM have potential clinical utility and may have complementary diagnostic performance. To our knowledge, this is the first randomised trial to evaluate these tests among hospitalised PLHIV.

scholarly journals Clinical characteristics and outcomes of people living with HIV hospitalized with COVID-19: a nationwide experience

2021 ◽  
Vol 32 (5) ◽  
pp. 435-443
Author(s):  
Maria Elena Ceballos ◽  
Patricio Ross ◽  
Martin Lasso ◽  
Isabel Dominguez ◽  
Marcela Puente ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Intensive Care ◽  
General Population ◽  
Clinical Characteristics ◽  
Cd4 Count ◽  
People Living With Hiv ◽  
Hiv Diagnosis ◽  
Hiv Viral Load ◽  
Risk Of Death ◽  
Living With Hiv

In this prospective, multicentric, observational study, we describe the clinical characteristics and outcomes of people living with HIV (PLHIV) requiring hospitalization due to COVID-19 in Chile and compare them with Chilean general population admitted with SARS-CoV-2. Consecutive PLHIV admitted with COVID-19 in 23 hospitals, between 16 April and 23 June 2020, were included. Data of a temporally matched-hospitalized general population were used to compare demography, comorbidities, COVID-19 symptoms, and major outcomes. In total, 36 PLHIV subjects were enrolled; 92% were male and mean age was 44 years. Most patients (83%) were on antiretroviral therapy; mean CD4 count was 557 cells/mm3. Suppressed HIV viremia was found in 68% and 56% had, at least, one comorbidity. Severe COVID-19 occurred in 44.4%, intensive care was required in 22.2%, and five patients died (13.9%). No differences were seen between recovered and deceased patients in CD4 count, HIV viral load, or time since HIV diagnosis. Hypertension and cardiovascular disease were associated with a higher risk of death ( p = 0.02 and 0.006, respectively). Compared with general population, the HIV cohort had significantly more men (OR 0.15; IC 95% 0.07–0.31) and younger age (OR 8.68; IC 95% 2.66–28.31). In PLHIV, we found more intensive care unit admission (OR 2.31; IC 95% 1.05–5.07) but no differences in the need for mechanical ventilation or death. In this cohort of PLHIV hospitalized with COVID-19, hypertension and cardiovascular comorbidities, but not current HIV viro-immunologic status, were the most important risk factors for mortality. No differences were found between PLHIV and general population in the need for mechanical ventilation and death.

scholarly journals Understanding usual care for patients with multimorbidity: baseline data from a cluster-randomised trial of the 3D intervention in primary care

BMJ Open ◽  
2018 ◽  
Vol 8 (8) ◽  
pp. e019845 ◽  
Author(s):  
Katherine Chaplin ◽  
Peter Bower ◽  
Mei-See Man ◽  
Sara T Brookes ◽  
Daisy Gaunt ◽  
...  
Keyword(s):  
Primary Care ◽  
Usual Care ◽  
External Validity ◽  
Randomised Trial ◽  
Baseline Data ◽  
Secondary Outcome ◽  
Treatment Burden ◽  
Practice Staff ◽  
Illness Burden ◽  
Cluster Randomised

ObjectivesRecent evidence has highlighted the high prevalence and impact of multimorbidity, but the evidence base for improving management is limited. We have tested a new complex intervention for multimorbidity (the 3D model). The paper describes the baseline characteristics of practices and patients in order to establish the external validity of trial participants. It also explores current ‘usual primary care’ for multimorbidity, against which the 3D intervention was tested.DesignAnalysis of baseline data from patients in a cluster-randomised controlled trial and additional data from practice staff.SettingPrimary care in the UK.ParticipantsPatients with multimorbidity (n=5253) and 154 practice staff.Primary and secondary outcome measuresUsing surveys and routinely available data, we compared the characteristics of participating and non-participating practices and participating and non-participating eligible patients.Baseline questionnaire data from patient participants was used to examine participant illness burden, treatment burden and perceptions of receiving patient-centred care. We obtained data about usual care preintervention from practice staff using questionnaires and a structured pro forma.ResultsParticipating practices were slightly larger, in less deprived areas, and with slightly higher scores for patient satisfaction compared with non-participating practices. Patients with dementia or learning difficulties were likely to be excluded by their general practitioners, but comparison of participants with non-participants identified only minor differences in characteristics, suggesting that the sample was otherwise representative. Patients reported substantial illness burden, and an important minority reported high treatment burden. Although patients reported relatively high levels of satisfaction with care, many reported not having received potentially important components of care.ConclusionThis trial achieved good levels of external validity. Although patients were generally satisfied with primary care services, there was significant room for improvement in important aspects of care for multimorbidity that are targeted by the 3D intervention.Trial registration numberISRCTN06180958; Post-results.

scholarly journals Reducing shoulder complaints in employees with high occupational shoulder exposures: study protocol for a cluster-randomised controlled study (The Shoulder-Café Study)

2019 ◽  
Author(s):  
Jeanette Trøstrup ◽  
Lone Ramer Mikkelsen ◽  
Poul Frost ◽  
Annett Dalbøge ◽  
Mette Terp Høybye ◽  
...  
Keyword(s):  
Usual Care ◽  
Mixed Model ◽  
Exercise Intervention ◽  
Randomised Trial ◽  
Self Report ◽  
Controlled Study ◽  
Cluster Randomised Trial ◽  
Cluster Randomised ◽  
First Choice ◽  
Randomised Controlled

Abstract Background: In Denmark, exercise therapy in combination with work modifications is the first choice treatment for persons with shoulder complaints and high occupational shoulder exposures. To obtain this treatment they must visit several healthcare providers, which makes usual care fragmented and uncoordinated. Therefore, we developed a new intervention which unifies the expertise that is needed. The main hypotheses are that a group-based Shoulder-Café intervention will reduce (I) shoulder complaints and (II) occupational shoulder exposures more effectively than an individual-based Shoulder-Guidance intervention (active control – enhanced usual care). Methods: A cluster-randomised trial is conducted including 120 employees with high occupational shoulder exposures. Companies (clusters) are randomised to either Shoulder-Café or Shoulder-Guidance with a 1:1 allocation ratio. Participants are 18–65 years old and have an Oxford Shoulder Score (OSS) ≤ 40. Both interventions include a home-based shoulder exercise programme, assessment of shoulder exposures by technical measurements and self-report, and general information on how to reduce shoulder exposures. The Shoulder-Café course also includes three café meetings with physiotherapist-supervised exercises, clinical shoulder evaluation, education on shoulder anatomy, workplace-oriented counselling, and an opportunity for a workplace visit by a health and safety consultant. The primary outcomes are the OSS at 6 month follow-up (hypothesis I), and the mean number of minutes/day with the arm elevated > 60° shortly after end of intervention (hypothesis II). We will use mixed model analysis that allows for company clustering, and data will be analysed according to the intention-to-treat principle. Discussion: Persons with shoulder complaints and high occupational shoulder exposures are an obvious target group for secondary prevention efforts. We developed the Shoulder-Café to reduce shoulder complaints and shoulder exposures while unifying the expertise that is needed to evaluate and treat shoulder complaints. If the intervention is effective, it would warrant widespread implementation. Trial registration: The trial was registered at Clinicaltrials.gov on 18 May 2017 (ID: NCT03159910). Keywords: Exercise, Intervention, Mechanical exposure, Occupation, Randomised controlled trial, Shoulder, Training programme.

scholarly journals Kidney Disease in HIV Infection

2019 ◽  
Vol 8 (8) ◽  
pp. 1254 ◽  
Author(s):  
Gaetano Alfano ◽  
Gianni Cappelli ◽  
Francesco Fontana ◽  
Luca Di Lullo ◽  
Biagio Di Iorio ◽  
...  
Keyword(s):  
Kidney Disease ◽  
Life Expectancy ◽  
Early Recognition ◽  
Renal Involvement ◽  
People Living With Hiv ◽  
Risk Of Death ◽  
Age Related ◽  
Stage Renal Disease ◽  
End Stage ◽  
Living With Hiv

Antiretroviral therapy (ART) has significantly improved life expectancy of infected subjects, generating a new epidemiological setting of people aging withHuman Immunodeficiency Virus (HIV). People living with HIV (PLWH), having longer life expectancy, now face several age-related conditions as well as side effects of long-term exposure of ART. Chronic kidney disease (CKD) is a common comorbidity in this population. CKD is a relentlessly progressive disease that may evolve toward end-stage renal disease (ESRD) and significantly affect quality of life and risk of death. Herein, we review current understanding of renal involvement in PLWH, mechanisms and risk factors for CKD as well as strategies for early recognition of renal dysfunction and best care of CKD.

scholarly journals Prevalence and socioeconomic factors associated with smoking in people living with HIV by sex, in Recife, Brazil

2013 ◽  
Vol 16 (2) ◽  
pp. 432-443 ◽  
Author(s):  
Joanna d’Arc Lyra Batista ◽  
Maria de Fátima Pessoa Militão de Albuquerque ◽  
Ricardo Arraes de Alencar Ximenes ◽  
Demócrito de Barros Miranda-Filho ◽  
Heloisa Ramos Lacerda de Melo ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Socioeconomic Factors ◽  
Low Income ◽  
People Living With Hiv ◽  
Cross Sectional ◽  
Heavy Alcohol ◽  
Factors Associated ◽  
Risk Of Death ◽  
Living With Hiv ◽  
Hiv Aids

Introduction: Smoking is the leading cause of preventable death in the world. The prevalence of smoking is higher in people infected with HIV than in the general population. Although it is biologically plausible that smoking increases the morbidity and mortality of people living with HIV/AIDS, few studies in developing countries have analyzed the determinants and consequences of smoking in HIV infected people. Objective: To estimate the prevalence of smoking and identify the socioeconomic factors associated with smoking and smoking cessation in patients with HIV by sex. Methods: A cross-sectional study was conducted with baseline data, obtained from an ongoing prospective cohort study of patients with HIV attending two referral centers in Recife, Northeast Region of Brazil, between July 2007 and October 2009. Results: The prevalence of current smoking was 28.9%. For both sexes, smoking was independently associated with heavy alcohol drinking and marijuana use. Among women, smoking was associated with living alone, not being married and illiteracy; and among men, being 40 years or older, low income and using crack. Compared with ex-smokers, current smokers were younger and more likely to be unmarried, heavy drinkers and marijuana users. Conclusions: It is important to incorporate smoking cessation interventions for the treatment of heavy alcohol drinkers and marijuana users with HIV/AIDS, which may increase life expectancy and quality of life, as smoking is related to risk of death, relapse of tuberculosis, and non communicable diseases.

scholarly journals Survival of people living with HIV who defaulted from tuberculosis treatment in a cohort, Recife, Brazil

2017 ◽  
Vol 17 (1) ◽  
Author(s):  
R Cunha ◽  
M Maruza ◽  
UR Montarroyos ◽  
I Coimbra ◽  
D de B Miranda-Filho ◽  
...  
Keyword(s):  
Tuberculosis Treatment ◽  
People Living With Hiv ◽  
Living With Hiv

scholarly journals The risk of severe COVID-19 and mortality from COVID-19 in people living with HIV compared to individuals without HIV - a systematic review and meta-analysis of 1 268 676 individuals

2021 ◽  
Author(s):  
Rida Arif ◽  
Asmaa Abdelmaksoud ◽  
Lovemore Mapahla ◽  
Albert Chinhenzva ◽  
Nazmul Islam ◽  
...  
Keyword(s):  
Sample Size ◽  
Strong Evidence ◽  
Vaccine Coverage ◽  
Meta Analysis ◽  
Study Data ◽  
People Living With Hiv ◽  
Risk Of Death ◽  
Care Services ◽  
The Difference ◽  
Living With Hiv

Research Purpose: Findings from existing studies have shown conflicting evidence concerning the risk of severe COVID-19 and death from COVID-19 in people living with HIV (PLHIV) compared to people without HIV. The aim of our review is to compare mortality, hospitalization, and the need for intensive care services due to COVID-19 between PLHIV and individuals without HIV based on data from the existing literature. Methods: A search in major databases of preprints was carried out and eligible studies were screened and selected. From each study, data on numbers of PLHIV and individuals without HIV were extracted. Study quality was assessed using the MethodologicAl STandard for Epidemiological Research (MASTER) scale. Data synthesis used a bias adjusted model where age and geographical subgroups were analysed. Results: From the 2757 records identified, 11 studies were included. The total participants were 1 268 676, of which 13 886 were PLHIV. Overall, the estimated effect of HIV on mortality suggested some worsening (OR 1.3, 95% CI: 0.9 – 2.0, I2 = 78.6%) with very weak evidence against the model hypothesis at this sample size. However, in individuals aged <60 years, the estimated effect on mortality suggested more worsening in PLHIV (OR 2.7, 95% CI: 1.1 -6.5, I2 = 95.7%) with strong evidence against the model hypothesis at this sample size. HIV was also associated with an estimated effect on hospitalization for COVID-19 that suggested worsening (OR 1.6, 95% CI: 1.3-2.1, I2 = 96.0%) with strong evidence against the model hypothesis at this sample size. Conclusion: People living with HIV have higher risk of death and hospitalisation from COVID-19, compared to individuals without HIV with the difference exaggerated in those younger than 60 years old. Our findings suggest that PLHIV are at higher risk than the general population and should be prioritized for vaccine coverage and monitoring if diagnosed with COVID-19.

scholarly journals Predictors of Mortality among Patients Lost to Follow up Antiretroviral Therapy

Jurnal NERS ◽  
2018 ◽  
Vol 13 (1) ◽  
pp. 114 ◽  
Author(s):  
Putu Dian Prima Kusuma Dewi ◽  
Gede Budi Widiarta
Keyword(s):  
Incidence Rate ◽  
Median Time ◽  
Secondary Data ◽  
Primary Data ◽  
People Living With Hiv ◽  
Risk Of Death ◽  
Living With Hiv ◽  
Lost To Follow Up

Introduction: The death of HIV/AIDS patients after receiving therapy in Bali is the seventh highest percentage of deaths in Indonesia. LTFU increases the risk of death in PLHA, given the saturation of people with HIV taking medication. The level of consistency in the treatment is very important to maintain the resilience and quality of life of people living with HIV. This study aims to determine the incidence rate, median time and predictors of death occurring in LTFU patients as seen from their sociodemographic and clinical characteristics.Methods: This study used an analytical longitudinal approach with retrospective secondary data analysis in a cohort of HIV-positive patients receiving ARV therapy at the Buleleng District Hospital in the period 2006-2015. The study used the survival analysis available within the STATA SE 12 softwareResults: The result showed that the incidence rate of death in LTFU patients was 65.9 per 100 persons, with the median time occurrence of 0.2 years (2.53 months). The NNRTI-class antiretroviral evapirens agents were shown to increase the risk of incidence of death in LTFU patients 3.92 times greater than the nevirapine group (HR 3.92; p = 0.007 (CI 1.46-10.51). Each 1 kg increase in body weight decreased the risk of death in LTFU patients by 6% (HR 0.94; p = 0.035 (CI 0.89-0.99).Conclusion: An evaluation and the monitoring of patient tracking with LTFU should be undertaken to improve sustainability. Furthermore, an observation of the LTFU patient's final condition with primary data and qualitative research needs to be done so then it can explore more deeply the reasons behind LTFU.

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