scholarly journals Design, analysis, and reporting of pilot studies in HIV: a systematic review and methodological study

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Hussein Ali El-Khechen ◽  
Mohammed Inam Ullah Khan ◽  
Selvin Leenus ◽  
Oluwatobi Olaiya ◽  
Zoha Durrani ◽  
...  
Keyword(s):  
Qualitative Methods ◽  
Sample Size ◽  
Contextual Information ◽  
Primary Objective ◽  
People Living With Hiv ◽  
Size Estimation ◽  
Methodological Study ◽  
Pilot Studies ◽  
Hiv Research ◽  
Living With Hiv

Abstract Background Pilot studies are essential in determining if a larger study is feasible. This is especially true when targeting populations that experience stigma and may be difficult to include in research, such as people with HIV. We sought to describe how pilot studies have been used to inform HIV clinical trials. Methods We conducted a methodological study of pilot studies of interventions in people living with HIV published until November 25, 2020, using Medline, Embase, and Cochrane Controlled Register of Trials (CENTRAL). We extracted data on their nomenclature, primary objective, use of progression criteria, sample size, use of qualitative methods, and other contextual information (region, income, level, type of intervention, study design). Results Our search retrieved 10,597 studies, of which 248 were eligible. The number of pilot studies increased steadily over time. We found that 179 studies (72.2%) used the terms “pilot” or “feasibility” in their title, 65.3% tested feasibility as a primary objective, only 2% used progression criteria, 23.9% provided a sample size estimation and only 30.2% used qualitative methods. Conclusions Pilot studies are increasingly being used to inform HIV research. However, the titles and objectives are not always consistent with piloting. The design and reporting of pilot studies in HIV could be improved.

Assessing sample size and variable number in multivariate data, with specific reference to cone morphology variation in a population of Picea sitchensis

1985 ◽  
Vol 63 (2) ◽  
pp. 232-241 ◽  
Author(s):  
Rob Scagel ◽  
Y. A. El-Kassaby ◽  
J. Emanuel
Keyword(s):  
Sample Size ◽  
Multivariate Data ◽  
Variable Number ◽  
Picea Sitchensis ◽  
Interindividual Variation ◽  
Specific Reference ◽  
Size Estimation ◽  
Pilot Studies ◽  
Nested Models ◽  
Cone Morphology

A multivariate extension of univariate sample size estimation is outlined that enables one to determine sample size for a multivariate study. The procedure is presented and illustrated by application to intraindividual and interindividual variation of cone morphology in a population of Picea sitchensis (Bong.) Carr. The method involves the stabilization of a scalar estimate of the structure of the correlation matrix (the determinant) among variables for a given sample size. The sample-specific dependency of previously described methods is avoided by random selection of several replicates in nonstructured and structured (nested) models. The procedure is best applied in pilot studies where it can aid in the characterization of multivariate data prior to analysis. Additionally, repeatability estimates for cone scale morphology are presented.

scholarly journals Creation of Data Repositories to Advance Nursing Science

2017 ◽  
Vol 41 (1) ◽  
pp. 78-95 ◽  
Author(s):  
Joseph Perazzo ◽  
Margaret Rodriguez ◽  
Jackson Currie ◽  
Robert Salata ◽  
Allison R. Webel
Keyword(s):  
Collaborative Research ◽  
Data Repository ◽  
People Living With Hiv ◽  
Cross Sectional ◽  
Data Repositories ◽  
Nursing Science ◽  
Hiv Research ◽  
Systematic Planning ◽  
Living With Hiv ◽  
And Training

Data repositories are a strategy in line with precision medicine and big data initiatives, and are an efficient way to maximize data utility and form collaborative research relationships. Nurse researchers are uniquely positioned to make a valuable contribution using this strategy. The purpose of this article is to present a review of the benefits and challenges associated with developing data repositories, and to describe the process we used to develop and maintain a data repository in HIV research. Systematic planning, data collection, synthesis, and data sharing have enabled us to conduct robust cross-sectional and longitudinal analyses with more than 200 people living with HIV. Our repository building has also led to collaboration and training, both in and out of our organization. We present a pragmatic and affordable way that nurse scientists can build and maintain a data repository, helping us continue to make to our understanding of health phenomena.

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 A Systematic Review and Meta-analysis of Alcohol Use Disorders and Its determinants in People Living with HIV in Africa: A Continent based Review and Meta-analysis study.

2020 ◽  
Author(s):  
Mogesie Necho ◽  
Asmare Belete ◽  
Yibeltal Getachew
Keyword(s):  
Alcohol Use ◽  
Cigarette Smoking ◽  
Sample Size ◽  
Associated Factors ◽  
Alcohol Use Disorder ◽  
Meta Analysis ◽  
Routine Practice ◽  
People Living With Hiv ◽  
Living With Hiv ◽  
Hiv Aids

Abstract Background Alcohol use disorder among people living with HIV/AIDS contributes to decreased adherence and effectiveness of antiretroviral medication, decreased help-seeking to HIV/AIDS care and treatment, increased load of the virus in the blood, and development of drug-resistant HIV strains. This study therefore aimed and assessed the pooled evidence on prevalence and associated factors of alcohol use disorder in retroviral infected patients in Africa. Methods We implemented our electronic data base search on PubMed, Scopus, EMBASE, and Psych-INFO libraries. In addition, WHO websites and Google scholar were also investigated for grey literatures. Moreover, we further investigated the reference lists of published articles. Stata-11meta-prop package with 95% confidence interval was used. Subgroup and sensitivity analysis were also performed. Cochran's Q- and the I2 test were used to check heterogeneity. Publication bias was evaluated with Egger's test and funnel plots. Results In this meta-analysis, we included 22 studies with a total of 16774 patients and the pooled prevalence of alcohol use disorder was 22.03%( 95% CI: 17.18, 28.67). The average prevalence of AUD in South Africa (28.77%) was higher than in Uganda (16.61%) and Nigeria (22.8%). Besides, the average prevalence of AUD in studies published before 2011, 2011–2015, and after 2015 was found to be 13.47%, 24.93% and 22.88% respectively. Moreover, the pooled magnitude of AUD among studies which utilized a sample size > 450 was 16.71% whereas it was 26.46% among studies that utilized sample size < 450. Furthermore, the pooled estimated prevalence of hazardous, harmful and dependent drinking was 10.87%, 8.1%, and 3.12% respectively. Being male was an associated factor for alcohol use disorder (AOR = 5.5%; 95% CI: 1.10, 9.98). Moreover, the average odds ratio of cigarette smoking and chat chewing were found to be 3.95% (95% CI: 3.00, 4.89) and 3.34% (95% CI: 1.71, 4.96) respectively. Conclusion The average estimated prevalence of AUD in HIV/AIDs patients was high and factors such as being Male, cigarette smoking and chat chewing were associated with it. Early detection and appropriate management of AUD and the mentioned associated factors have to be a routine practice.

Bartlett's Medical Management of HIV Infection

2019 ◽  
Author(s):  
John G. Bartlett ◽  
Robert R. Redfield ◽  
Paul A. Pham
Keyword(s):  
Hiv Infection ◽  
Nurse Practitioners ◽  
Medical Management ◽  
Clinical Care ◽  
Hiv Infections ◽  
Physician Assistants ◽  
People Living With Hiv ◽  
Hiv Research ◽  
Reference Format ◽  
Living With Hiv

With more than 30 million people living with HIV, nearly 2 million new HIV infections, and 1 million deaths in 2017 globally, the HIV epidemic continues to exert a considerable deleterious impact on the health of individuals, communities, and the economic growth of nations. However, remarkable advances have also been achieved: improvements in our scientific understanding of the biology of HIV, how it causes disease, and its prevention and treatment, coupled with unprecedented multi-sectoral global efforts, have resulted in rendering HIV infection essentially a manageable chronic disease. The 17th edition of Bartlett’s Medical Management of HIV Infection offers the best-available clinical guidance for treatment of patients with HIV, all in a portable, quick-reference format. Edited by preeminent and pioneering authorities in HIV research and clinical care, it has earned its status as the definitive work for physicians, physician assistants, nurse practitioners, pharmacists, and anyone working in the care of persons with HIV.

scholarly journals Effects of an exercise programme with people living with HIV: research in a disadvantaged setting

2014 ◽  
Vol 13 (4) ◽  
pp. 313-319 ◽  
Author(s):  
Clemens Ley ◽  
Lloyd Leach ◽  
María Rato Barrio ◽  
Susan Bassett
Keyword(s):  
Exercise Programme ◽  
People Living With Hiv ◽  
Hiv Research ◽  
Living With Hiv

Evaluating the Impact of Incentives on Clinical Trial Participation: Protocol for a Mixed-Methods, Community-Engaged Study (Preprint)

2021 ◽  
Author(s):  
Jerome Timothy Galea ◽  
Karah Yeona Greene ◽  
Brandon Nguyen ◽  
Andrea N. Polonijo ◽  
Karine Dubé ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Nationwide Survey ◽  
Trial Participation ◽  
People Living With Hiv ◽  
Monetary Incentives ◽  
Relative Importance ◽  
Clinical Trial Participation ◽  
Hiv Research ◽  
Living With Hiv ◽  
Research Studies

BACKGROUND Monetary incentives in research are frequently used to support participant recruitment and retention. However, scant empirical data exist regarding how researchers decide upon the type and amount of incentives offered. Likewise, there is little guidance to assist study investigators and institutional review boards (IRBs) in their decision-making on incentives. Monetary incentives, in addition to other factors such as the risk of harm or other intangible benefits, guide individuals’ decisions to enroll in research studies. These factors emphasize the need for evidence-informed guidance for study investigators and IRBs when determining the type and amount of incentives to provide to research participants. OBJECTIVE The specific aims are to: Aim 1) characterize key stakeholders’ views on and assessment of incentives in biomedical HIV research; Aim 2) reach consensus among stakeholders on the factors considered when choosing research incentives, including their relative importance, and, Aim 3) pilot test the use of the guidance from Aims 1 and 2 by presenting stakeholders vignettes of hypothetical research studies for which they will choose corresponding incentive types. METHODS Our two-year study involves monthly, active engagement with a stakeholder advisory board (SAB) of people living with HIV, researchers, and IRB members. For Aim 1, we will conduct a nationwide survey (N=300) among people living with HIV to understand their views regarding incentives used in HIV research. In Aim 2, we will collect qualitative data using focus groups with people living with HIV (n=60) and key informant interviews with stakeholders involved in HIV research (people living with HIV, IRB members, biomedical HIV researchers; n=36), to extend and deepen our understanding of how incentives in HIV research are perceived. These participants will also complete a conjoint analysis experiment to understand the relative importance that key attributes of HIV research studies have on study participation. Data from the nationwide survey (Aim 1) will be triangulated with the qualitative and conjoint analysis data (Aim 2) to create 25 “vignettes” that describe hypothetical HIV research studies. Finally, (Aim 3) individuals from each stakeholder group will select the most appropriate incentive they feel should be used in each of the 25 vignettes. RESULTS The SAB began monthly meetings in March 2021. All study aims are expected to be completed by December 2022. CONCLUSIONS By studying the role of incentives in HIV clinical trial participation, we will establish a decision-making paradigm to guide the choice of incentives for HIV –and eventually other types of similar research –to facilitate ethical recruitment of clinical research participants. CLINICALTRIAL ClinicalTrials.gov NCT04809636; https://clinicaltrials.gov/ct2/show/NCT04809636

scholarly journals 1022. Impact of Hospitalization on Antiretroviral Therapy for People Living with HIV

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S541-S541
Author(s):  
Amber Ladak ◽  
Henry N Young ◽  
Emily Tang ◽  
Jessica Curtis ◽  
Daniel B Chastain
Keyword(s):  
Antiretroviral Therapy ◽  
Primary Objective ◽  
Transitions Of Care ◽  
Specific Factor ◽  
People Living With Hiv ◽  
Hiv Rna ◽  
Patient Status ◽  
Persons Living With Hiv ◽  
Regimen Modification ◽  
Living With Hiv

Abstract Background Persons living with HIV (PLWH) are frequently hospitalized for reasons often unrelated to HIV. Transitioning of antiretroviral therapy (ART) while inpatient may not always be an immediate priority due to lack of knowledge, formulary restrictions, and patient status. This could lead to medication errors and gaps in therapy, which can persist at discharge, and could lead to viral rebound and disease progression. The purpose of this study was to identify effects of hospitalization on ART for PLWH. Methods This was an IRB approved, multi-center, retrospective cohort study of patients with HIV and/or AIDS based on ICD codes. Patients were included if they were at least 18 years old, receiving outpatient ART prior to admission, and hospitalized between March 2016 and March 2018. Patients were excluded if they were pregnant and only received intravenous zidovudine during their hospitalization. The primary objective was to determine the rate of ART restarted during hospitalization. Secondary objectives included rate at which inpatient ART was modified compared to outpatient regimen, and risk factors associated with regimen modification. Results Of 400 patients screened, 295 (74%) patients were on an outpatient ART regimen and were included in the study. Approximately half, 51%, were on a single tablet regimen (STR) outpatient. This population was majority male (59%) and of black race (87%). Median age was 49 years. Median CD4 count was 160 cells/mm3, while median HIV RNA for those with detectable viral load was 57,095 copies/mL. 236 of 295 patients (80%) received ART during their inpatient stay. However, 70 (30%) of these patients received a regimen that differed from their outpatient ART regimen. 69% of regimens were modified for reasons other than to optimize therapy. Patient sex, place of admission, and receipt of a STR or multi-tablet regimen (MTR) as an outpatient did not significantly impact rate of regimen modification. Conclusion Ensuring appropriate transition of ART during hospitalization remains an area in need of improvement. No one specific factor was associated with whether outpatient ART was appropriately and accurately restarted during hospitalization. Thus, there are many opportunities to improve transitions of care and antiretroviral stewardship. Disclosures All Authors: No reported disclosures

scholarly journals Current Interventions for People Living with HIV Who Use Alcohol: Why Gender Matters

2021 ◽  
Author(s):  
Wendee M. Wechsberg ◽  
Felicia A. Browne ◽  
Courtney Peasant Bonner ◽  
Yukiko Washio ◽  
Brittni N. Howard ◽  
...  
Keyword(s):  
Viral Suppression ◽  
Intervention Studies ◽  
Alcohol Misuse ◽  
Small Samples ◽  
People Living With Hiv ◽  
Alcohol Intervention ◽  
The World ◽  
Significant Efficacy ◽  
Hiv Research ◽  
Living With Hiv

Abstract Purpose of Review Alcohol is the most misused substance in the world. For people living with HIV (PLWH), alcohol misuse may impact ART adherence and viral suppression. This review of the most recently published alcohol intervention studies with PLWH examines how these studies considered gender in the samples, design, and analyses. Recent Findings Three searches were conducted initially, and 13 intervention studies fit our criteria with alcohol outcomes. In general, most studies did not consider gender and had used small samples, and few demonstrated significant efficacy/effectiveness outcomes. Five studies considered gender in their samples or analyses and/or were woman-focused with larger samples and demonstrated significant outcomes. Summary It is essential for women who misuse alcohol to not only be well represented in alcohol and HIV research but also for studies to consider the barriers to reaching them and their contextual demands and/or co-occurring issues that may affect participation and outcomes in intervention research.

scholarly journals 1306. Evaluation and Predictors of Antiretroviral (ART)-Related Medication Errors in Hospitalized People Living with HIV (PWLH)

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S471-S471
Author(s):  
Daniel B Chastain ◽  
Amber Ladak ◽  
Jessica Curtis ◽  
Emily Tang ◽  
Henry N Young
Keyword(s):  
Medication Errors ◽  
Undetectable Viral Load ◽  
International Classification Of Diseases ◽  
Primary Objective ◽  
Transitions Of Care ◽  
People Living With Hiv ◽  
Development Of Resistance ◽  
Classification Of Diseases ◽  
Clinically Significant ◽  
Living With Hiv

Abstract Background As HIV has become a chronic condition, management of the disease and preventing resistance is paramount to improving patient outcomes. Medication errors can lead to suboptimal therapy and potential development of resistance. The purpose of this study was to identify the rate of antiretroviral (ART)-related medication errors in hospitalized people living with HIV (PWLH). Methods This was a multi-center, retrospective cohort study of patients diagnosed with HIV and/or AIDS based on International Classification of Diseases codes. Patients were included if they were at least 18 years old and hospitalized between March 2016 and March 2018. Patients were excluded if they were pregnant and only received intravenous zidovudine during their hospitalization. Of the patients eligible for inclusion, 400 were randomly selected and included in this study. The primary objective was to determine the rate of inpatient ART-related medication errors. Secondary objectives included the type of errors and rate of error resolution prior to discharge. Results A total of 203 ART-related medication errors occurred during the study period (mean 0.9 ± 1.2 errors per patient). Incorrect schedule was the most common type of error followed by incorrect or incomplete regimen. More errors occurred in male patients (P = 0.01), those known to be infected with HIV on admission (P < 0.05), and in patients with an undetectable viral load (P = 0.01). Approximately 30% of ART-related medication errors were resolved prior to discharge, of which pharmacists were responsible for 25%. Incorrect schedule, incorrect or incomplete regimen, and clinically significant drug-drug interaction (DDI) were the most common medication errors that persisted at discharge. Among resolved errors, resolution of clinically significantly DDI or incorrect/incomplete ART were the most common interventions. Conclusion ART-related medication errors continue to occur in hospitalized PLWH and frequently persist at discharge. Interventions should be developed to reduce rates of ART-related medication errors on admission. Antimicrobial stewardship programs serve as an ideal platform to incorporate ART stewardship into routine activities to help minimize errors while inpatient and during transitions of care. Disclosures All authors: No reported disclosures.

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