20 results on '"Emma M Kileel"'
Search Results
2. Change in body weight and risk of hypertension after switching from efavirenz to dolutegravir in adults living with HIV: evidence from routine care in Johannesburg, South AfricaResearch in context
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Alana T. Brennan, Cornelius Nattey, Emma M. Kileel, Sydney Rosen, Mhairi Maskew, Andrew C. Stokes, Matthew P. Fox, and Willem D.F. Venter
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Integrase strand transfer inhibitors ,Dolutegravir ,Efavirenz ,Weight ,Hypertension ,South Africa ,Medicine (General) ,R5-920 - Abstract
Summary: Background: The integrase strand transfer inhibitor (INSTI) dolutegravir is recommended in World Health Organization guidelines, but is associated with weight gain. We evaluated weight change in patients switching from efavirenz to dolutegravir in first-line antiretroviral therapy (ART) in Johannesburg, South Africa. Methods: We conducted a prospective cohort study of adults (≥16 years) of black African ancestry with HIV who initiated ART between January 2010–December 2020. Patients were propensity score-matched 1:1 (unexposed i.e. remaining on efavirenz: exposed i.e. switched from efavirenz to dolutegravir) on sex, age, months on ART, first ART regimen, haemoglobin, body mass index (BMI), blood pressure, viral load and CD4 count. We used linear regression to assess the effect of switching from efavirenz to dolutegravir on weight change and hypertension 12 months after exposure. Findings: We matched 794 patients switching to dolutegravir to 794 remaining on efavirenz. Exposed patients had a higher mean change in weight (1.78 kg; 95% confidence interval (CI):1.04,2.52 kg) from start of follow-up to 12 months vs. unexposed. We also found a 14.2 percentage point increase (95% CI: 10.6,17.7) in the risk of hypertension in those exposed to dolutegravir vs those that remained on efavirenz. Interpretation: In a real-world population, patients gained more weight and were at higher risk of hypertension after switching from efavirenz to dolutegravir than those remaining on efavirenz. Longer follow-up is needed, however, to determine if INSTI-associated weight gain is associated with changes in non-communicable disease risk over the long-term, or whether weight gain is sustained, as seen in clinical trials. Funding: This study has been made possible by the generous support of the American People and the President's Emergency Plan for AIDS Relief (PEPFAR) through the United States Agency for International Development (USAID), under the terms of cooperative agreement cooperative Agreement 72067419CA00004. In addition to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 1K01MH105320-01A1.
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- 2023
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3. Successful recruitment of a multi-site international randomized placebo-controlled trial in people with HIV with attention to diversity of race and ethnicity: critical role of central coordination
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Kathleen V. Fitch, Emma M. Kileel, Sara E. Looby, Markella V. Zanni, Laura R. Sanchez, Carl J. Fichtenbaum, Edgar T. Overton, Carlos Malvestutto, Judith A. Aberg, Karin L. Klingman, Beverly Alston-Smith, Judith Lavelle, Anne Rancourt, Sharlaa Badal-Faesen, Sandra Wagner Cardoso, Anchalee Avihingsanon, Sandesh Patil, Craig A. Sponseller, Kathleen Melbourne, Heather J. Ribaudo, Katharine Cooper-Arnold, Patrice Desvigne-Nickens, Udo Hoffmann, Pamela S. Douglas, Steven K. Grinspoon, and on behalf of the REPRIEVE Investigators
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hiv ,reprieve ,recruitment ,clinical coordinating center ,cardiovascular disease ,primary prevention ,Infectious and parasitic diseases ,RC109-216 - Abstract
Background: The Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) is a multicenter, randomized, placebo-controlled trial, designed to test whether a statin medication can prevent cardiovascular disease in people with HIV. REPRIEVE recently completed enrollment of 7557 participants at over 100 clinical sites globally. Participant groups of focus were women, and racial and ethnic minorities. Objective: To describe recruitment methods and strategies developed by the REPRIEVE Clinical Coordinating Center (CCC) and share best practices learned from the recruitment process. Methods: Enrollment targets were agreed upon with the primary funder, the National Heart, Lung, and Blood Institute (NHLBI) and were milestone driven. Milestones included number of sites activated, number of participants enrolled within specific time frames, and proportion of women and minorities enrolled. Strategies to achieve these milestones included structured interviews with site-designated REPRIEVE Recruitment Champions to develop best practices, development of a multimedia campaign, and site level recruitment support. Results: Recruitment initiated March, 2015 and completed March, 2019. The final accrual target was 7500 participants over 48 months. The trial met this target within the time specified. Overall, 10,613 screens were completed, 48% of participants enrolled from sites outside of North America, 32% were female, 44% were Black or African American, and 25% were Hispanic or Latino. Conclusions: REPRIEVE met its overall projected recruitment goal by using multiple, simultaneous strategies to specifically target a diverse population including minority subgroups. REPRIEVE benefited from the development of recruitment strategies with clear targets and communication of accrual targets to study teams.
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- 2020
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4. Eliciting perspectives of the key study population: An effective strategy to inform advertisement, content and usability of an online survey for a national investigation
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Emma M. Kileel, Corinne Rivard, Kathleen V. Fitch, and Sara E. Looby
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Dietary sweeteners ,Patient-centered approaches ,Study advertisement ,Medicine (General) ,R5-920 - Abstract
This short communication demonstrates how conducting a focus group with members of a proposed study population of interest can help inform the suitability of study interventions and appeal of recruitment strategies prior to study commencement. People living with HIV (PLWH) were recruited to participate in a focus group to elicit feedback on the content and design of an online survey on sweetener knowledge and consumption; and usability of the survey which was ultimately launched nationally. Ten participants (age 55 years, 60% male, 70% non-Caucasian, 60% income
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- 2020
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5. Regional Differences in Added Sweetener Knowledge, Consumption and Body Mass Index in People with HIV in the United States
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Emma M. Kileel, Kirsten A. Dickins, Jeff Blossom, Sara E. Looby, and Kathleen V. Fitch
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Infectious Diseases ,Social Psychology ,Public Health, Environmental and Occupational Health - Published
- 2022
6. Diet in a global cohort of adults with HIV at low-to-moderate traditional cardiovascular disease risk
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Kathleen V. Fitch, Sara A. McCallum, Kristine M. Erlandson, Edgar Turner Overton, Markella V. Zanni, Carl Fichtenbaum, Judith A. Aberg, Evelynne S. Fulda, Emma M. Kileel, Laura E. Moran, Gerald S. Bloomfield, Richard M. Novak, Sigrid Pérez-Frontera, Alexandra Abrams-Downey, Gerald Pierone, Nagalingeswaran Kumarasamy, Kiat Ruxrungtham, Rosie Mngqibisa, Pamela S. Douglas, Heather J. Ribaudo, and Steven K. Grinspoon
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Adult ,Male ,Cross-Sectional Studies ,Infectious Diseases ,Cardiovascular Diseases ,Immunology ,Humans ,Immunology and Allergy ,Female ,HIV Infections ,Middle Aged ,Global Burden of Disease ,Diet - Abstract
To characterize diet quality across a global cohort of people with HIV (PWH).Cross-sectional analysis.Leveraging REPRIEVE data from baseline across five Global Burden of Disease (GBD) regions, we analyzed participant responses to the Rapid Eating Assessment for Participants questionnaire. An overall diet quality score and scores for specific diet components were generated. Higher scores indicate better diet quality.Among 7736 participants (median age 50 years, 30% women, median BMI 25.8 kg/m 2 ) overall diet quality score (max score 30) was optimal in 13% of participants and good, suboptimal or poor in 45%, 38%, and 4% of participants, respectively; saturated fat score (max score 18) was good, suboptimal, or poor in 38%, 40%, or 7% of participants, respectively. Diet quality scores differed across GBD region with the highest scores reported in the South Asia region [median 23 (21-25)] and lowest in the sub-Saharan Africa region [median 15 (12-18)]; 61% of participants in the South Asia region reported optimal diet quality compared with only 6% in the sub-Saharan Africa region. Higher atherosclerotic cardiovascular risk scores were seen with worsening diet quality.Among PWH eligible for primary CVD prevention, diet quality was suboptimal or poor for almost half of participants, and there were substantial variations in diet quality reported by GBD region.NCT02344290.
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- 2022
7. Does engagement in HIV care affect screening, diagnosis, and control of noncommunicable diseases in sub-Saharan Africa? A systematic review and meta-analysis
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Emma M Kileel, Amy Zheng, Jacob Bor, Matthew P Fox, Nigel J Crowther, Jaya A George, Siyabonga Khoza, Sydney Rosen, Willem DF Venter, Frederick Raal, Patricia Hibberd, and Alana T Brennan
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ObjectiveLow- and middle-income countries are facing a growing burden of noncommunicable diseases (NCDs). Providing HIV treatment may also provide opportunities to increase access to NCD services in under-resourced environments. We sought to investigate whether reported use of antiretroviral therapy (ART) was associated with increased screening, diagnosis, treatment, and/or control of diabetes, hypertension, chronic kidney disease, or cardiovascular disease among people living with HIV (PLWH) in sub-Saharan Africa (SSA).DesignSystematic review and meta-analysis.MethodsWe searched 10 electronic literature databases for studies published between 01 January 2011 and 31 December 2021 using a comprehensive search strategy. We sought studies reporting on screening, diagnosis, treatment, and/or control of NCDs of interest by ART use among non-pregnant adults with HIV ≥16 years of age in SSA. Random effects models were used to calculate summary odds ratios (ORs) of the risk of diagnosis by ART status and corresponding 95% confidence intervals (95% CIs), where appropriate.ResultsTwenty-five studies, describing 13,170 PLWH in SSA, 68% of whom were receiving ART, were included. ART use was associated with a small but imprecise increase in the odds of diabetes diagnosis (OR: 1.07; 95% CI: 0.71, 1.60) and an increase in the odds of hypertension diagnosis (OR: 2.10, 95% CI: 1.42, 3.09). We found minimal data on the association between ART use and screening, treatment, or control of NCDs.ConclusionDespite a potentially higher NCD risk among PLWH and regional efforts to integrate NCD and HIV care, evidence to support effective care integration models is lacking.
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- 2023
8. The importance of methods for site performance evaluation in REPRIEVE, a longitudinal, global, multicenter trial
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Evelynne S. Fulda, Carl J. Fichtenbaum, Emma M. Kileel, Markella V. Zanni, Judith A. Aberg, Carlos Malvestutto, Sandra Wagner Cardoso, Baiba Berzins, Rita Lira, Regina Harden, Gregory Robbins, Maria Martinez, Sylvia Davila Nieves, Sara McCallum, Jorge Leon Cruz, Triin Umbleja, Heather Sprenger, Francoise Giguel, Frederic Bone, Ken Wood, Mark Byroads, Kayla Paradis, Michael T. Lu, Pamela S. Douglas, Heather J. Ribaudo, Steven K. Grinspoon, and Kathleen V. Fitch
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Pharmacology (medical) ,General Medicine - Abstract
REPRIEVE, the Randomized Trial to Prevent Vascular Events in HIV, is a multicenter, primary prevention trial evaluating whether a statin can prevent major cardiovascular events in people with HIV. REPRIEVE is conducted at100 clinical research sites (CRSs) globally. Detailed, comprehensive, and novel methods for evaluating and communicating CRS performance are required to ensure trial integrity and data quality. In this analysis we describe a comprehensive multidimensional methodology for evaluating CRS performance.The REPRIEVE Data Coordinating and Clinical Coordinating Centers developed a robust system for evaluation of and communication with CRSs, designed to identify potential issues and obstacles to performance, provide real-time technical support, and make recommendations for process improvements to facilitate efficient trial execution. We describe these systems and evaluate their impact on participant retention, data management, and specimen management from 2019 to 2022, corresponding to the period from end of recruitment to present. This evaluation was based on pre-defined metrics, regular reviews, and bidirectional communication.Participant retention, data management, and specimen management all remained steady over the three-year period, although metrics varied by country of enrollment. Targeted messaging relating to certain performance metrics was effective.Site performance is vital to ensure trial integrity and achievement of key trial goals. This analysis demonstrates that utilization of a comprehensive approach allows for a thorough evaluation of CRS performance, facilitates data and specimen management, and enhances participant retention. Our approach may serve as a guidepost for maximizing future large-scale clinical trials' operational success and scientific rigor.gov Identifier: NCT02344290.
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- 2022
9. Factors Associated With Systemic Immune Activation Indices in a Global Primary Cardiovascular Disease Prevention Cohort of People With Human Immunodeficiency Virus on Antiretroviral Therapy( )
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Sara E Looby, Amy Kantor, Tricia H Burdo, Judith S Currier, Carl J Fichtenbaum, Edgar T Overton, Judith A Aberg, Carlos D Malvestutto, Gerald S Bloomfield, Kristine M Erlandson, Michelle Cespedes, Esper G Kallas, Mar Masiá, Alice C Thornton, Mandy D Smith, Jacqueline M Flynn, Emma M Kileel, Evelynne Fulda, Kathleen V Fitch, Michael T Lu, Pamela S Douglas, Steven K Grinspoon, Heather J Ribaudo, and Markella V Zanni
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Microbiology (medical) ,Male ,Lipoproteins ,Clinical Trials and Supportive Activities ,Lipopolysaccharide Receptors ,HIV Infections ,Cardiovascular ,Medical and Health Sciences ,Microbiology ,LDL ,Clinical Research ,Major Article ,Humans ,Integrases ,Prevention ,Evaluation of treatments and therapeutic interventions ,HIV ,Nucleosides ,Biological Sciences ,Middle Aged ,Atherosclerosis ,cardiovascular disease risk ,Lipoproteins, LDL ,Heart Disease ,Good Health and Well Being ,Infectious Diseases ,reproductive aging ,Cardiovascular Diseases ,6.1 Pharmaceuticals ,HIV/AIDS ,Reverse Transcriptase Inhibitors ,Female ,women ,Hydroxymethylglutaryl-CoA Reductase Inhibitors ,immune activation markers ,Biomarkers - Abstract
Background Among antiretroviral therapy (ART)–treated people with human immunodeficiency virus (PWH), persistent systemic immune activation contributes to atherogenesis atherosclerotic, cardiovascular disease (CVD) events, and mortality. Factors associated with key immune activation indices have not previously been characterized among a global primary CVD prevention cohort of PWH. Methods Leveraging baseline Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) data, we evaluated factors associated with soluble CD14 (sCD14) and oxidized low-density lipoprotein (oxLDL). Results The primary analysis cohort included 4907 participants from 5 global-burden-of-disease regions (38% female, 48% Black, median age 50 years). In fully adjusted models for sCD14, female sex and White race (among those in high-income regions) were associated with higher sCD14 levels, while higher body mass index (BMI) and current use of nucleoside reverse transcriptase inhibitor + integrase strand transfer inhibitor ART were associated with lower sCD14 levels. In fully adjusted models for oxLDL, male sex, residence in high-income regions, White race (among those in high-income regions), and higher BMI were associated with higher oxLDL levels. In a subanalysis cohort of 1396 women with HIV, increased reproductive age was associated with higher sCD14 levels but not with higher oxLDL levels. Conclusions Factors associated with sCD14 and oxLDL, 2 key indices of immune-mediated CVD risk, differ. Future studies will elucidate ways in which medications (eg, statins) and behavioral modifications influence sCD14 and oxLDL and the extent to which dampening of these markers mediates CVD-protective effects. Clinical Trials Registration NCT0234429.
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- 2022
10. Characteristics of REPRIEVE Trial Participants Identifying Across the Transgender Spectrum
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Pamela S. Douglas, Kathleen V. Fitch, Heather J. Ribaudo, Karin L. Klingman, Myron A. Waclawiw, Laura M. Smeaton, Beverly Alston-Smith, Melissa L Murry, Emma M Kileel, Katharine Cooper-Arnold, Markella V. Zanni, Shashi Sangle, Edward M. Gardner, Steven K. Grinspoon, Patrice Desvigne-Nickens, José Valdez Madruga, Beatriz Grinsztejn, and Kate Starr
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Male ,0301 basic medicine ,Waist ,Research Subjects ,Health Status ,Cardiovascular research ,Population ,Human immunodeficiency virus (HIV) ,Supplement Articles ,HIV Infections ,medicine.disease_cause ,Medical care ,Sexual and Gender Minorities ,03 medical and health sciences ,0302 clinical medicine ,Transgender ,Humans ,Immunology and Allergy ,Medicine ,030212 general & internal medicine ,education ,Aged ,education.field_of_study ,Gender identity ,business.industry ,Cardiometabolic Risk Factors ,Gender Identity ,Middle Aged ,030112 virology ,Clinical trial ,Infectious Diseases ,Female ,business ,Transsexualism ,Demography - Abstract
Because persons who identify across the transgender spectrum (PATS) are a key population in human immunodeficiency virus (HIV) yet are underreported in HIV and cardiovascular research, we aimed to characterize this population within the REPRIEVE global clinical trial (n = 7770). Acceptance of gathering gender identity was high (96%). Participation by PATS was 1.7% overall, 2.4% among natal males, 0.3% among natal females, and varied across geographic regions (from 0% in sub-Saharan Africa to 2.3% in High Income Region). Thirty percent of natal male PATS identified other than transgender. Some characteristics differed by gender. Most notably, 38% of natal male PATS receiving gender-affirming treatment had waist circumference >102 cm (compared with ≤25% in other groups). Given that PATS is a key population, HIV research should routinely report trial participation and outcomes by gender in addition to natal sex, to provide the results needed to optimize medical care to PATS.
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- 2020
11. Successful recruitment of a multi-site international randomized placebo-controlled trial in people with HIV with attention to diversity of race and ethnicity: critical role of central coordination
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Judith Lavelle, Katharine Cooper-Arnold, Craig A. Sponseller, Pamela S. Douglas, Sara E. Looby, Anne Rancourt, Heather J. Ribaudo, Udo Hoffmann, Laura Sanchez, Anchalee Avihingsanon, Carlos Malvestutto, Kathleen Melbourne, Karin L. Klingman, Kathleen V. Fitch, Sandesh Patil, Sharlaa Badal-Faesen, Beverly Alston-Smith, Reprieve Investigators, Emma M Kileel, Steven K. Grinspoon, Judith A. Aberg, Sandra W. Cardoso, Carl J. Fichtenbaum, Edgar T. Overton, Patrice Desvigne-Nickens, and Markella V. Zanni
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Adult ,Male ,medicine.medical_specialty ,International Cooperation ,media_common.quotation_subject ,Best practice ,Ethnic group ,Placebo-controlled study ,HIV Infections ,Article ,law.invention ,Young Adult ,Randomized controlled trial ,law ,Ethnicity ,Milestone (project management) ,medicine ,Humans ,Multicenter Studies as Topic ,Pharmacology (medical) ,Amino Acids ,Minority Groups ,Randomized Controlled Trials as Topic ,media_common ,business.industry ,Patient Selection ,Racial Groups ,Hispanic or Latino ,Middle Aged ,Test (assessment) ,Black or African American ,Infectious Diseases ,Cardiovascular Diseases ,Family medicine ,Structured interview ,Female ,business ,Diversity (politics) - Abstract
BACKGROUND: The Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) is a multicenter, randomized, placebo-controlled trial, designed to test whether a statin medication can prevent cardiovascular disease in people with HIV. REPRIEVE recently completed enrollment of 7557 participants at over 100 clinical sites globally. Participant groups of focus were women, and racial and ethnic minorities. OBJECTIVE: To describe recruitment methods and strategies developed by the REPRIEVE Clinical Coordinating Center (CCC) and share best practices learned from the recruitment process. METHODS: Enrollment targets were agreed upon with the primary funder, the National Heart, Lung, and Blood Institute (NHLBI) and were milestone driven. Milestones included number of sites activated, number of participants enrolled within specific time frames, and proportion of women and minorities enrolled. Strategies to achieve these milestones and included structured interviews with site-designated REPRIEVE Recruitment Champions to develop best practices, development of a multimedia campaign, and site level recruitment support. RESULTS: Recruitment initiated March, 2015 and completed March, 2019. The final accrual target was 7500 participants over 48 months. The trial met this target within the time specified. Overall, 10,613 screens were completed, 48% of participants enrolled from sites outside of North America, 32% were female, 44% were black or African American, and 25% were Hispanic or Latino. CONCLUSIONS: REPRIEVE met its overall projected recruitment goal by using multiple, simultaneous strategies to specifically target a diverse population including minority subgroups. REPRIEVE benefited from the development of recruitment strategies with clear targets and communication of accrual targets to study teams.
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- 2020
12. Change in Body Weight and Risk of Hypertension after Switching from Efavirenz to Dolutegravir in Adults Living with HIV: Evidence from Routine Care in Johannesburg, South Africa
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Alana T. Brennan, Cornelius Nattey, Emma M. Kileel, Sydney Rosen, Mhairi Maskew, Andrew C. Stokes, Matthew P. Fox, and Willem D.F. Venter
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History ,Polymers and Plastics ,General Medicine ,Business and International Management ,Industrial and Manufacturing Engineering - Published
- 2022
13. Cardiovascular Risk and Health Among People With Human Immunodeficiency Virus (HIV) Eligible for Primary Prevention: Insights From the REPRIEVE Trial
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Udo Hoffmann, Maria Saumoy, Heather J. Ribaudo, Kiat Ruxrungtham, Triin Umbleja, Pamela S. Douglas, Craig A. Sponseller, Gerald S. Bloomfield, Vicente Estrada, Carl J. Fichtenbaum, Markella V. Zanni, Edgar T. Overton, Judith S. Currier, Kathleen V. Fitch, Judith A. Aberg, Ann Marie Navar, Steven K. Grinspoon, Flavio Bustorff, Anchalee Avihingsanon, Emma M Kileel, Reprieve Investigators, and Kathleen Melbourne
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Microbiology (medical) ,Blood Glucose ,Male ,cardiovascular risk ,lifestyle modifications ,Clinical Trials and Supportive Activities ,Human immunodeficiency virus (HIV) ,HIV Infections ,Disease ,medicine.disease_cause ,Cardiovascular ,Medical and Health Sciences ,Microbiology ,law.invention ,Body Mass Index ,Randomized controlled trial ,law ,Risk Factors ,Clinical Research ,Primary prevention ,Medicine ,Humans ,Framingham Risk Score ,business.industry ,Prevention ,HIV ,atherosclerotic cardiovascular disease ,cardiovascular health ,Biological Sciences ,Major Articles and Commentaries ,AcademicSubjects/MED00290 ,Infectious Diseases ,Blood pressure ,Cardiovascular Diseases ,Heart Disease Risk Factors ,Cohort ,HIV/AIDS ,Female ,business ,Body mass index ,Demography ,cardiac prevention - Abstract
Background In addition to traditional cardiovascular (CV) risk factors, antiretroviral therapy, lifestyle, and human immunodeficiency virus (HIV)-related factors may contribute to future CV events in persons with HIV (PWH). Methods Among participants in the global REPRIEVE randomized trial, we characterized demographics and HIV characteristics relative to ACC/AHA pooled cohort equations (PCE) for atherosclerotic CV disease predicted risk and CV health evaluated by Life’s Simple 7 (LS7; includes smoking, diet, physical activity, body mass index, blood pressure, total cholesterol, and glucose). Results Among 7382 REPRIEVE participants (31% women, 45% Black), the median PCE risk score was 4.5% (lower and upper quartiles Q1, Q3: 2.2, 7.2); 29% had a PCE score, Measures of cardiovascular (CV) risk and health are not closely related in persons with human immunodeficiency virus (HIV) in the REPRIEVE trial. Poor health scores among low-CV-risk persons with HIV suggest a critical role for lifestyle interventions regardless of CV risk prediction.
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- 2021
14. Assessment of Obesity and Cardiometabolic Status by Integrase Inhibitor Use in REPRIEVE: A Propensity-Weighted Analysis of a Multinational Primary Cardiovascular Prevention Cohort of People With Human Immunodeficiency Virus
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Emma M Kileel, Janet Lo, Carlos Malvestutto, Kathleen V Fitch, Markella V Zanni, Carl J Fichtenbaum, Edgar T Overton, Nwora Lance Okeke, Princy Kumar, Esau Joao, Judith A Aberg, Esteban Martinez, Judith S Currier, Pamela S Douglas, Heather J Ribaudo, and Steven K Grinspoon
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cardiovascular risk ,obesity ,Prevention ,HIV ,Cardiovascular ,metabolic syndrome ,Major Articles ,Editor's Choice ,Infectious Diseases ,AcademicSubjects/MED00290 ,integrase inhibitors ,Oncology ,Metabolic and endocrine ,Nutrition - Abstract
Background Emerging data demonstrate that the use of integrase inhibitor (INSTI)-based antiretroviral treatment (ART) is associated with increased weight, but the cardiometabolic health consequences of increased weight remains poorly understood. Methods This analysis examined INSTI use (>6 months) at entry among REPRIEVE participants enrolled in High Income and Latin America/Caribbean Global Burden of Disease regions. Primary analyses used linear and logistic regression; secondary analyses used quantile regression to examine differences across the full data distribution. Characteristics of those with and without INSTI use were balanced using inverse probability of treatment weighting. Results Among 4500 REPRIEVE participants, 1848 were on an INSTI-based regimen at entry for an average of 2.1 ± 1.8 years. Integrase inhibitor use (vs no INSTI use) was associated with higher odds of obesity (odds ratio [OR], 1.63; 95% confidence interval [CI], 1.4–1.9) and higher mean body mass index ([BMI] +1.5kg/m2; 95% CI, 1.0–1.9) and waist circumference (+3.6cm; 95% CI, 2.6–4.6). Differences in weight related to INSTI use were greater in the upper tails of the distribution (+3.1kg/m2 [95% CI, 1.9–4.4] at the 90th centile vs +0.7kg/m2 [95% CI, 0.2–1.2] at the 50th centile) and among women and nonwhite participants, with sex and race having an additive effect on BMI. Conversely, INSTI use was not associated with differences in glucose, low-density lipoprotein cholesterol, or higher odds of metabolic syndrome or hypertension. Conclusions Differences in weight and waist circumference associated with INSTI use are (1) not uniform across people with human immunodeficiency virus, (2) greatest among women and nonwhites, and (3) concentrated at the upper tails of weight distribution. These data identify at-risk subgroups for whom long-term cardiovascular disease outcomes should be carefully assessed., INSTI-based regimens are associated with higher weight but not with increased cardiovascular risk for most INSTI users. Differences in weight are not uniform across PWH, and specific subgroups of INSTI users should be monitored for long-term CVD outcomes.
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- 2021
15. The Association of Distinct Social Determinants of Health with Added Sweetener Knowledge and Consumption in a U.S. Sample of People Living with HIV
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Emma M Kileel, Sara E. Looby, Kirsten A. Dickins, Kathleen V. Fitch, and Hui Zheng
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medicine.medical_specialty ,Social Psychology ,Social Determinants of Health ,Human immunodeficiency virus (HIV) ,Sample (statistics) ,HIV Infections ,medicine.disease_cause ,Environmental health ,medicine ,Humans ,Social determinants of health ,Association (psychology) ,Consumption (economics) ,Public health ,digestive, oral, and skin physiology ,Public Health, Environmental and Occupational Health ,food and beverages ,United States ,Health psychology ,Infectious Diseases ,Cross-Sectional Studies ,Sweetening Agents ,Income ,Psychology ,human activities ,Body mass index - Abstract
Prior studies in people living with HIV (PLWH) suggest added sweetener intake exceeds recommendations and associates with cardiometabolic abnormalities. Little is known of factors that associate with increased sweetener consumption in PLWH. This cross-sectional study explored knowledge and consumption of added sweeteners and associations of social determinants of health (SDoH) among 900 PLWH residing in the United States. Demographics, SDoH, and added sweetener knowledge and consumption were assessed via an online survey, multivariable analyses were completed. Results demonstrate that sex, race, and low educational level associated with lower sweetener knowledge. Race, age, body mass index, income, limited access to fresh fruits/vegetables, and low sweetener knowledge associated with higher sweetener consumption. Findings highlight the need for consideration of specific demographics and inequitable social circumstances when developing nutrition lifestyle strategies, inclusive of added sweetener education, that are feasible and sustainable across diverse community settings of PLWH.Estudios previos en personas que viven con el VIH (PLWH) sugieren que la ingesta adicional de edulcorantes excede las recomendaciones y se asocia con anomalías cardiometabólicas. Poco se sabe de los factores que se asocian con un mayor consumo de edulcorantes en PLWH. Este estudio transversal exploró el conocimiento y el consumo de edulcorantes agregados y las asociaciones de los determinantes sociales de la salud (SDoH) entre 900 PLWH que residen en los Estado Unidos. Lo datos demográficos, SDoH, y en conocimiento y el consumo de edulcorantes añadidos se evaluaron mediante una encuesta en línea y se completaron análisis multivariables. Los resultados demuestran que el sexo, la raza y el bajo nivel educativo se asocian con un menor conocimiento sobre edulcorantes. Raza, edad, índice de masa corporal, ingresos, acceso limitado a frutas/verduras frescas y conocimiento bajo sobre edulcorantes asociado con un mayor consumo edulcorantes. Los hallazgos resaltan la necesidad de considerar la demografía específica y las circunstancias sociales desiguales al desarrollar estrategias de estilo de vida nutricional, incluida la educación adicional sobre edulcorantes, que sean factibles y sostenibles en diversos entornos comunitarios de PLWH.
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- 2021
16. Patterns of Antiretroviral Therapy Use and Immunologic Profiles at Enrollment in the REPRIEVE Trial
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Marije van Schalkwyk, Edgar T. Overton, Steven K. Grinspoon, Nagalingeswaran Kumarasamy, Carl J. Fichtenbaum, Janet Lo, Judith A. Aberg, Esteban Martínez, Judith S. Currier, Patrice Desvigne-Nickens, Craig A. Sponseller, Breno Santos, Markella V. Zanni, Sue Siminski, Gerald S. Bloomfield, Pamela S. Douglas, Heather J. Ribaudo, Kathleen Melbourne, Kathleen V. Fitch, Yvetot Joseph, Jorge Leon-Cruz, Carlos Malvestutto, Reprieve Investigators, Emma M Kileel, and Udo Hoffmann
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Male ,REPRIEVE ,CD4-CD8 Ratio ,CD4 cell count ,Integrase inhibitor ,Supplement Articles ,HIV Infections ,Logistic regression ,Medical and Health Sciences ,law.invention ,Randomized controlled trial ,law ,Interquartile range ,cardiovascular disease ,Immunology and Allergy ,Randomized Controlled Trials as Topic ,Biological Sciences ,Middle Aged ,Corrigenda ,Infectious Diseases ,Anti-Retroviral Agents ,6.1 Pharmaceuticals ,HIV/AIDS ,Female ,Infection ,Adult ,medicine.medical_specialty ,antiretroviral therapy ,Clinical Trials and Supportive Activities ,Microbiology ,pitavastatin calcium ,statins ,CD4/CD8 ratio ,Clinical Research ,Internal medicine ,REPRIEVE Investigators ,medicine ,Humans ,business.industry ,Prevention ,HIV ,Evaluation of treatments and therapeutic interventions ,CD4 Lymphocyte Count ,Clinical trial ,Regimen ,Good Health and Well Being ,Cross-Sectional Studies ,business ,Body mass index - Abstract
Background Patterns of antiretroviral therapy (ART) use and immunologic correlates vary globally, and contemporary trends are not well described. Methods The REPRIEVE trial (Randomized Trial to Prevent Vascular Events in HIV) enrolled persons with human immunodeficiency virus (HIV) who were aged 40–75 years, receiving ART, and had low-to-moderate cardiovascular disease risk. ART use was summarized within Global Burden of Disease (GBD) super-regions, with adjusted linear and logistic regression analyses examining associations with immune parameters and key demographics. Results A total of 7770 participants were enrolled, with a median age of 50 years (interquartile range, 45–55 years); 31% were female, 43% were black or African American, 15% were Asian, 56% had a body mass index >25 (calculated as weight in kilograms divided by height in meters squared), and 49% were current or former smokers. The median CD4 T-cell count was 620/µL (interquartile range, 447–826/ µ L), and the median duration of prior ART use, 9.5 years (5.3–14.8) years. The most common ART regimens were nucleoside/nucleotide reverse-transcriptase inhibitor (NRTI) plus nonnucleoside reverse-transcriptase inhibitor (43%), NRTI plus integrase strand transfer inhibitor (25%), and NRTI plus protease inhibitor (19%). Entry ART varied by GBD region, with shifts during the trial enrollment period. In adjusted analyses, entry CD4 cell count and CD4/CD8 ratio were associated with GBD region, sex, entry regimen, duration of ART, and nadir CD4 cell count; CD4 and CD8 cell counts were also associated with body mass index and smoking status. Conclusions There were substantial variations in ART use by geographic region and over time, likely reflecting the local availability of specific medications, changes in treatment guidelines and provider/patient preferences. The analyses of CD4 cell counts and CD4/CD8 ratios may provide valuable insights regarding immune correlates and outcomes in people living with HIV. Clinical Trials Registration NCT02344290.
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- 2020
17. Eliciting perspectives of the key study population: An effective strategy to inform advertisement, content and usability of an online survey for a national investigation
- Author
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Kathleen V. Fitch, Emma M Kileel, Sara E. Looby, and Corinne Rivard
- Subjects
Study advertisement ,Appeal ,Psychological intervention ,Article ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,law ,Patient-centered approaches ,030212 general & internal medicine ,Pharmacology ,lcsh:R5-920 ,business.industry ,Advertising ,Usability ,General Medicine ,Focus group ,CLARITY ,Key (cryptography) ,Population study ,lcsh:Medicine (General) ,Early phase ,Psychology ,business ,030217 neurology & neurosurgery ,Dietary sweeteners - Abstract
This short communication demonstrates how conducting a focus group with members of a proposed study population of interest can help inform the suitability of study interventions and appeal of recruitment strategies prior to study commencement. People living with HIV (PLWH) were recruited to participate in a focus group to elicit feedback on the content and design of an online survey on sweetener knowledge and consumption; and usability of the survey which was ultimately launched nationally. Ten participants (age 55 years, 60% male, 70% non-Caucasian, 60% income
- Published
- 2020
18. Assessment of Coronary Artery Disease With Computed Tomography Angiography and Inflammatory and Immune Activation Biomarkers Among Adults With HIV Eligible for Primary Cardiovascular Prevention
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Markella V. Zanni, Michael T. Lu, Kenneth C. Williams, Júlia Karády, Edgar T. Overton, Carl J. Fichtenbaum, Susan L. Koletar, Cornelius N Van Dam, Udo Hoffmann, Jana Taron, Judith A. Aberg, Emma M Kileel, Pamela S. Douglas, Thomas Mayrhofer, Michelle Floris-Moore, Borek Foldyna, Steven K. Grinspoon, Reprieve trial, Heather J. Ribaudo, Craig A. Sponseller, Tricia H. Burdo, Kathleen V. Fitch, Judith S. Currier, Michael C. Keefer, Bingxue K Zhai, Carlos Malvestutto, and Kathleen Melbourne
- Subjects
Adult ,Male ,medicine.medical_specialty ,Computed Tomography Angiography ,Cardiology ,HIV Infections ,Coronary Artery Disease ,Disease ,medicine.disease_cause ,law.invention ,Cohort Studies ,Coronary artery disease ,Randomized controlled trial ,law ,Interquartile range ,Internal medicine ,medicine ,Humans ,Aged ,Original Investigation ,business.industry ,Research ,General Medicine ,Odds ratio ,Middle Aged ,medicine.disease ,Vulnerable plaque ,Online Only ,Cohort ,Female ,business ,Biomarkers ,Cohort study - Abstract
Key Points Question What is the extent of coronary artery disease among people with well-controlled HIV and low to moderate risk of atherosclerotic cardiovascular disease (ASCVD), and how is coronary artery disease associated with traditional risk, inflammatory, and immune activation indices? Findings In this cohort study of 755 people with HIV, coronary plaque was highly prevalent. Critical stenosis was rare, but higher-risk plaque features, including vulnerable plaque and high Leaman scores, were seen in approximately one-fifth of participants; plaque indices were associated with ASCVD risk scores and, independently, indices of inflammation and immune activation. Meaning These findings suggest that people with HIV at low to moderate risk of cardiovascular disease have a significant prevalence of coronary plaque associated with inflammation and immune activation markers., This cohort study examines the prevalence of coronary artery disease (CAD) among adults with well-controlled HIV and low to moderate risk of atherosclerotic cardiovascular disease using computed tomography angiography and assessment of inflammation and immune activation biomarkers., Importance Cardiovascular disease (CVD) is increased among people with HIV (PWH), but little is known regarding the prevalence and extent of coronary artery disease (CAD) and associated biological factors in PWH with low to moderate traditional CVD risk. Objectives To determine unique factors associated with CVD in PWH and to assess CAD by coronary computed tomography angiography (CTA) and critical pathways of arterial inflammation and immune activation. Design, Setting, and Participants This cohort study among male and female PWH, aged 40 to 75 years, without known CVD, receiving stable antiretroviral therapy, and with low to moderate atherosclerotic cardiovascular disease (ASCVD) risk according to the 2013 American College of Cardiology/American Heart Association pooled cohort equation, was part of the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE), a large, ongoing primary prevention trial of statin therapy among PWH conducted at 31 US sites. Participants were enrolled from May 2015 to February 2018. Data analysis was conducted from May to December 2020. Exposure HIV disease. Main Outcomes and Measures The primary outcome was the prevalence and composition of CAD assessed by coronary CTA and, secondarily, the association of CAD with traditional risk indices and circulating biomarkers, including insulin, monocyte chemoattractant protein 1 (MCP-1), interleukin (IL) 6, soluble CD14 (sCD14), sCD163, lipoprotein-associated phospholipase A2 (LpPLA2), oxidized low-density lipoprotein (oxLDL), and high-sensitivity C-reactive protein (hsCRP). Results The sample included 755 participants, with a mean (SD) age of 51 (6) years, 124 (16%) female participants, 267 (35%) Black or African American participants, 182 (24%) Latinx participants, a low median (interquartile range) ASCVD risk (4.5% [2.6%-6.8%]), and well-controlled viremia. Overall, plaque was seen in 368 participants (49%), including among 52 of 175 participants (30%) with atherosclerotic CVD (ASCVD) risk of less than 2.5%. Luminal obstruction of at least 50% was rare (25 [3%]), but vulnerable plaque and high Leaman score (ie, >5) were more frequently observed (172 of 755 [23%] and 118 of 743 [16%], respectively). Overall, 251 of 718 participants (35%) demonstrated coronary artery calcium score scores greater than 0. IL-6, LpPLA2, oxLDL, and MCP-1 levels were higher in those with plaque compared with those without (eg, median [IQR] IL-6 level, 1.71 [1.05-3.04] pg/mL vs 1.45 [0.96-2.60] pg/mL; P = .008). LpPLA2 and IL-6 levels were associated with plaque in adjusted modeling, independent of traditional risk indices and HIV parameters (eg, IL-6: adjusted odds ratio, 1.07; 95% CI, 1.02-1.12; P = .01). Conclusions and Relevance In this study of a large primary prevention cohort of individuals with well-controlled HIV and low to moderate ASCVD risk, CAD, including noncalcified, nonobstructive, and vulnerable plaque, was highly prevalent. Participants with plaque demonstrated higher levels of immune activation and arterial inflammation, independent of traditional ASCVD risk and HIV parameters.
- Published
- 2021
19. Comparison of visceral fat measurement by dual-energy X-ray absorptiometry to computed tomography in HIV and non-HIV
- Author
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Meghan N. Feldpausch, Jane Hubbard, Lindsay T Fourman, Janet Lo, Tara M. Holmes, Martin Torriani, Sara E. Looby, Takara L. Stanley, Ellen J. Anderson, Emma M Kileel, Steven K. Grinspoon, and Kathleen V. Fitch
- Subjects
Adult ,Male ,0301 basic medicine ,medicine.medical_specialty ,Endocrinology, Diabetes and Metabolism ,Population ,Human immunodeficiency virus (HIV) ,HIV Infections ,030209 endocrinology & metabolism ,Computed tomography ,Intra-Abdominal Fat ,medicine.disease_cause ,Article ,Body Mass Index ,03 medical and health sciences ,Absorptiometry, Photon ,Sex Factors ,0302 clinical medicine ,Internal medicine ,parasitic diseases ,Internal Medicine ,medicine ,Humans ,education ,lcsh:RC620-627 ,Visceral fat ,Dual-energy X-ray absorptiometry ,Adiposity ,education.field_of_study ,030109 nutrition & dietetics ,medicine.diagnostic_test ,business.industry ,nutritional and metabolic diseases ,Middle Aged ,medicine.disease ,Obesity ,3. Good health ,lcsh:Nutritional diseases. Deficiency diseases ,Body Composition ,Female ,Waist Circumference ,Metabolic syndrome ,Tomography, X-Ray Computed ,business ,tissues ,human activities ,Body mass index - Abstract
Background/Objectives Individuals with HIV are susceptible to visceral fat accumulation, which confers an increased risk of cardiometabolic disease. Advanced software to ascertain visceral fat content from dual-energy X-ray absorptiometry (DXA) has not been validated among this population. We sought to compare DXA with computed tomography (CT) in the measurement of visceral fat cross-sectional area (VAT) in HIV and non-HIV using Bland–Altman analyses. Subjects/Methods Data were combined from five previously conducted studies of individuals with HIV (n = 313) and controls without HIV (n = 144) in which paired DXA and CT scans were available. In cross-sectional analyses, DXA-VAT was compared with CT-VAT among participants with and without HIV. In longitudinal analyses, changes in VAT over time were compared between DXA and CT among participants with and without HIV receiving no intervention over 12 months and among individuals with HIV receiving tesamorelin—a medication known to reduce VAT—over 6 months. Results In HIV, DXA underestimated VAT compared with CT among individuals with increased visceral adiposity. The measurement bias was −9 ± 47 cm2 overall, but became progressively larger with greater VAT (P 2 among those with VAT ≥ 200 cm2. Sex-stratified analyses revealed that the relationship between VAT and measurement bias was especially pronounced in men (P P Conclusions DXA underestimated VAT relative to CT in men with and without HIV, who had increased visceral adiposity. DXA also underestimated changes in VAT over time in men and women, irrespective of HIV status. DXA-VAT should be used with caution among both HIV and non-HIV-infected populations.
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- 2019
20. Corrigendum to: Patterns of Antiretroviral Therapy Use and Immunologic Profiles at Enrollment in the REPRIEVE Trial
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Pamela S. Douglas, Marije van Schalkwyk, Udo Hoffmann, Judith A. Aberg, Craig A. Sponseller, Gerald S. Bloomfield, Esteban Martínez, Steven K. Grinspoon, Carl J. Fichtenbaum, Emma M Kileel, Carlos Malvestutto, Breno Santos, Patrice Desvigne-Nickens, Kathleen Melbourne, Jorge Leon-Cruz, Heather J. Ribaudo, Yvetot Joseph, Janet Lo, Markella V. Zanni, Judith S. Currier, Sue Siminski, Kathleen V. Fitch, Edgar T. Overton, and Nagalingeswaran Kumarasamy
- Subjects
medicine.medical_specialty ,Infectious Diseases ,Text mining ,business.industry ,medicine ,MEDLINE ,Immunology and Allergy ,Intensive care medicine ,business ,Antiretroviral therapy - Published
- 2020
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