Browsing by Author "Okeke, Nwora Lance"

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    ItemOpen Access
    Author Correction: Mortality outcomes with hydroxychloroquine and chloroquine in COVID-19 from an international collaborative meta-analysis of randomized trials.
    (Nature communications, 2021-05-14) Axfors, Cathrine; Schmitt, Andreas M; Janiaud, Perrine; Van't Hooft, Janneke; Abd-Elsalam, Sherief; Abdo, Ehab F; Abella, Benjamin S; Akram, Javed; Amaravadi, Ravi K; Angus, Derek C; Arabi, Yaseen M; Azhar, Shehnoor; Baden, Lindsey R; Baker, Arthur W; Belkhir, Leila; Benfield, Thomas; Berrevoets, Marvin AH; Chen, Cheng-Pin; Chen, Tsung-Chia; Cheng, Shu-Hsing; Cheng, Chien-Yu; Chung, Wei-Sheng; Cohen, Yehuda Z; Cowan, Lisa N; Dalgard, Olav; de Almeida E Val, Fernando F; de Lacerda, Marcus VG; de Melo, Gisely C; Derde, Lennie; Dubee, Vincent; Elfakir, Anissa; Gordon, Anthony C; Hernandez-Cardenas, Carmen M; Hills, Thomas; Hoepelman, Andy IM; Huang, Yi-Wen; Igau, Bruno; Jin, Ronghua; Jurado-Camacho, Felipe; Khan, Khalid S; Kremsner, Peter G; Kreuels, Benno; Kuo, Cheng-Yu; Le, Thuy; Lin, Yi-Chun; Lin, Wu-Pu; Lin, Tse-Hung; Lyngbakken, Magnus Nakrem; McArthur, Colin; McVerry, Bryan J; Meza-Meneses, Patricia; Monteiro, Wuelton M; Morpeth, Susan C; Mourad, Ahmad; Mulligan, Mark J; Murthy, Srinivas; Naggie, Susanna; Narayanasamy, Shanti; Nichol, Alistair; Novack, Lewis A; O'Brien, Sean M; Okeke, Nwora Lance; Perez, Léna; Perez-Padilla, Rogelio; Perrin, Laurent; Remigio-Luna, Arantxa; Rivera-Martinez, Norma E; Rockhold, Frank W; Rodriguez-Llamazares, Sebastian; Rolfe, Robert; Rosa, Rossana; Røsjø, Helge; Sampaio, Vanderson S; Seto, Todd B; Shahzad, Muhammad; Soliman, Shaimaa; Stout, Jason E; Thirion-Romero, Ireri; Troxel, Andrea B; Tseng, Ting-Yu; Turner, Nicholas A; Ulrich, Robert J; Walsh, Stephen R; Webb, Steve A; Weehuizen, Jesper M; Velinova, Maria; Wong, Hon-Lai; Wrenn, Rebekah; Zampieri, Fernando G; Zhong, Wu; Moher, David; Goodman, Steven N; Ioannidis, John PA; Hemkens, Lars G
    The original version of this Article contained an error in the spelling of the author Muhammad Shahzad, which was incorrectly given as Muhammad Shehzad. This has now been corrected in both the PDF and HTML versions of the Article.
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    ItemOpen Access
    Author Correction: Mortality outcomes with hydroxychloroquine and chloroquine in COVID-19 from an international collaborative meta-analysis of randomized trials.
    (Nature communications, 2024-02) Axfors, Cathrine; Schmitt, Andreas M; Janiaud, Perrine; Van't Hooft, Janneke; Abd-Elsalam, Sherief; Abdo, Ehab F; Abella, Benjamin S; Akram, Javed; Amaravadi, Ravi K; Angus, Derek C; Arabi, Yaseen M; Azhar, Shehnoor; Baden, Lindsey R; Baker, Arthur W; Belkhir, Leila; Benfield, Thomas; Berrevoets, Marvin AH; Chen, Cheng-Pin; Chen, Tsung-Chia; Cheng, Shu-Hsing; Cheng, Chien-Yu; Chung, Wei-Sheng; Cohen, Yehuda Z; Cowan, Lisa N; Dalgard, Olav; de Almeida E Val, Fernando F; de Lacerda, Marcus VG; de Melo, Gisely C; Derde, Lennie; Dubee, Vincent; Elfakir, Anissa; Gordon, Anthony C; Hernandez-Cardenas, Carmen M; Hills, Thomas; Hoepelman, Andy IM; Huang, Yi-Wen; Igau, Bruno; Jin, Ronghua; Jurado-Camacho, Felipe; Khan, Khalid S; Kremsner, Peter G; Kreuels, Benno; Kuo, Cheng-Yu; Le, Thuy; Lin, Yi-Chun; Lin, Wu-Pu; Lin, Tse-Hung; Lyngbakken, Magnus Nakrem; McArthur, Colin; McVerry, Bryan J; Meza-Meneses, Patricia; Monteiro, Wuelton M; Morpeth, Susan C; Mourad, Ahmad; Mulligan, Mark J; Murthy, Srinivas; Naggie, Susanna; Narayanasamy, Shanti; Nichol, Alistair; Novack, Lewis A; O'Brien, Sean M; Okeke, Nwora Lance; Perez, Léna; Perez-Padilla, Rogelio; Perrin, Laurent; Remigio-Luna, Arantxa; Rivera-Martinez, Norma E; Rockhold, Frank W; Rodriguez-Llamazares, Sebastian; Rolfe, Robert; Rosa, Rossana; Røsjø, Helge; Sampaio, Vanderson S; Seto, Todd B; Shahzad, Muhammad; Soliman, Shaimaa; Stout, Jason E; Thirion-Romero, Ireri; Troxel, Andrea B; Tseng, Ting-Yu; Turner, Nicholas A; Ulrich, Robert J; Walsh, Stephen R; Webb, Steve A; Weehuizen, Jesper M; Velinova, Maria; Wong, Hon-Lai; Wrenn, Rebekah; Zampieri, Fernando G; Zhong, Wu; Moher, David; Goodman, Steven N; Ioannidis, John PA; Hemkens, Lars G
    Correction to: Nature Communicationshttps://doi.org/10.1038/s41467-021-22446-z, published online 15 April 2021 The original version of this article contained an error in Table 1, which misidentified the trial included in the meta-analysis registered as NCT04323527 as CloroCOVID19II instead of CloroCOVID19III. The NCT04323527 registration includes the trials CloroCOVID19I and CloroCOVID19III. CloroCOVID19I was not included in the meta-analysis. In addition, the original version of the Methods section inadvertently omitted details of which formulations of hydroxychloroquine or chloroquine the reported dosages refer to. The following information has been included in the legend for Table 1 and in the corrected methods section: “In all trials that used hydroxychloroquine, dosages refer to hydroxychloroquine sulfate. In trials that used chloroquine, the dosages for ARCHAIC, ChiCTR2000030054 and ChiCTR2000031204 refer to chloroquine phosphate, while those for CloroCOVID19II and CloroCOVID19III refer to chloroquine base. The American Journal of Tropical Medicine and Hygiene has issued a retraction note (1) for one of the trials (2) that had been included in the calculations of our meta-analysis. Exclusion of the data from this trial changes neither the results nor inferences of the meta-analysis. For hydroxychloroquine, the original odds ratio for mortality was 1.11 (95% CI: 1.02–1.20; I2 = 0%; 26 trials; 10,012 patients) and excluding the retracted trial the odds ratio for mortality would remain 1.11 (95% CI: 1.02–1.20, I2 = 0%; 25 trials; 9818 patients). Retraction Notice. The American Journal of Tropical Medicine and Hygiene 107, 728-728, https://doi.org/10.4269/ajtmh.1073ret (2022). Abd-Elsalam, S. et al. RETRACTED: Hydroxychloroquine in the Treatment of COVID-19: A Multicenter Randomized Controlled Study. Am J Trop Med Hyg 103, 1635-1639, https://doi.org/10.4269/ajtmh.20-0873 (2020). The errors in Table 1 and in the Methods section have been corrected in both the PDF and HTML versions of the Article.
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    ItemOpen Access
    Awareness and acceptability of HIV pre-exposure prophylaxis (PrEP) among students at two historically Black universities (HBCU): a cross-sectional survey.
    (BMC public health, 2021-05-19) Okeke, Nwora Lance; McLaurin, Tony; Gilliam-Phillips, Ruth; Wagner, David H; Barnwell, Valerie J; Johnson, Yolanda M; James, Osaffo; Webb, Padonda B; Parker, Sharon D; Hill, Bendu; McKellar, Mehri S; Mitchell, John T

    Background

    Despite young African American adults (ages 18-24) being among the highest risk groups for HIV infection, little is known about their awareness of HIV pre-exposure prophylaxis (PrEP) - a once daily pill shown to be > 90% effective in preventing HIV. To explore awareness and acceptability of PrEP among college students in this demographic, we conducted a survey of attendees at two large historically Black universities (HBCU) in North Carolina.

    Methods

    We administered a 14-item questionnaire to students at two HBCUs in North Carolina between February and April 2018. Questions were formatted in a yes/no or multiple choice format. Questionnaire items specifically addressed PrEP awareness and acceptability. Surveys were administered to students at a campus health fair and while transiting the campus student union via iPad. Response to all questions was optional. We fit a logistic regression model to determine association of key demographic determinants with PrEP acceptability and awareness. Statistical analyses were conducted using SAS 9.4 (SAS, Cary, NC).

    Results

    Overall, 210 students participated in the survey, of which 60 completed all survey items as presented. The survey cohort was 75% female, 89% heterosexual and 39% freshmen. The mean age of respondents was 19.8 years (SD: 1.8). Fifty-two percent of survey respondents reported that they were aware of PrEP prior to the time of survey administration. Only 3% of respondents reported that they were on PrEP. The most common sources of information on PrEP were campus health services (24%) and non-social media advertising (15%). Of respondents who were aware of PrEP, 61% reported that they had heard about in the 6 months prior to survey administration, while only 19% say they were aware of it for more than a year. Regarding acceptability of PrEP, 58% of respondents reported that they would take a once a day pill for HIV if they were at risk. Our logistic regression analysis found no statistically significant associations between key demographic factors and PrEP awareness. However, persons who perceived themselves to be at risk for HIV acquisition were more likely to find once daily oral PrEP (relative risk 2.66 (95% CI 1.31-5.42)) as an acceptable prevention strategy than the rest of the survey cohort.

    Conclusions

    African American HBCU students are becoming aware of PrEP, and generally perceive the intervention as acceptable and worth consideration.
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    ItemOpen Access
    Canary in the Coal Mine? Transmitted Mutations Conferring Resistance to All Integrase Strand Transfer Inhibitors in a Treatment-Naive Patient.
    (Open forum infectious diseases, 2018-11-08) McGee, Kara S; Okeke, Nwora Lance; Hurt, Christopher B; McKellar, Mehri S
    Transmitted drug resistance to the integrase strand transfer inhibitor (INSTI) class of antiretrovirals is very rare. We present a case of a treatment-naive female patient with human immunodeficiency virus harboring resistance to all INSTIs, including bictegravir and dolutegravir.
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    ItemOpen Access
    Cardiovascular Disease Risk Management in Persons With HIV: Does Clinician Specialty Matter?
    (Open forum infectious diseases, 2020-09) Okeke, Nwora Lance; Schafer, Katherine R; Meissner, Eric G; Ostermann, Jan; Shah, Ansal D; Ostasiewski, Brian; Phelps, Evan; Kieler, Curtis A; Oladele, Eniola; Garg, Keva; Naggie, Susanna; Bloomfield, Gerald S; Bosworth, Hayden B

    Background

    The impact of clinician specialty on cardiovascular disease risk factor outcomes among persons with HIV (PWH) is unclear.

    Methods

    PWH receiving care at 3 Southeastern US academic HIV clinics between January 2014 and December 2016 were retrospectively stratified into 5 groups based on the specialty of the clinician managing their hypertension or hyperlipidemia. Patients were followed until first atherosclerotic cardiovascular disease event, death, or end of study. Outcomes of interest were meeting 8th Joint National Commission (JNC-8) blood pressure (BP) goals and National Lipid Association (NLA) non-high-density lipoprotein (HDL) goals for hypertension and hyperlipidemia, respectively. Point estimates for associated risk factors were generated using modified Poisson regression with robust error variance.

    Results

    Of 1667 PWH in the analysis, 965 had hypertension, 205 had hyperlipidemia, and 497 had both diagnoses. At study start, the median patient age was 52 years, 66% were Black, and 65% identified as male. Among persons with hypertension, 24% were managed by an infectious diseases (ID) clinician alone, and 5% were co-managed by an ID clinician and a primary care clinician (PCC). Persons managed by an ID clinician were less likely to meet JNC-8 hypertension targets at the end of observation than the rest of the cohort (relative risk [RR], 0.84; 95% CI, 0.75-0.95), but when mean study blood pressure was considered, there was no difference between persons managed by ID and the rest of the cohort (RR, 0.96; 95% CI, 0.88-1.05). There was no significant association between the ID clinician managing hyperlipidemia and meeting NLA non-HDL goals (RR, 0.89; 95% CI, 0.68-1.15).

    Conclusions

    Clinician specialty may play a role in suboptimal hypertension outcomes in persons with HIV.
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    ItemOpen Access
    COVID-19 Trials: Who Participates and Who Benefits?
    (Southern medical journal, 2022-04) Narayanasamy, Shanti; Mourad, Ahmad; Turner, Nicholas A; Le, Thuy; Rolfe, Robert J; Okeke, Nwora Lance; O'Brien, Sean M; Baker, Arthur W; Wrenn, Rebekah; Rosa, Rossana; Rockhold, Frank W; Naggie, Susanna; Stout, Jason E

    Objectives

    The coronavirus disease 2019 (COVID-19) pandemic has disproportionately afflicted vulnerable populations. Older adults, particularly residents of nursing facilities, represent a small percentage of the population but account for 40% of mortality from COVID-19 in the United States. Racial and ethnic minority individuals, particularly Black, Hispanic, and Indigenous Americans have experienced higher rates of infection and death than the White population. Although there has been an unprecedented explosion of clinical trials to examine potential therapies, participation by members of these vulnerable communities is crucial to obtaining data generalizable to those communities.

    Methods

    We undertook an open-label, factorial randomized clinical trial examining hydroxychloroquine and/or azithromycin for hospitalized patients.

    Results

    Of 53 screened patients, 11 (21%) were enrolled. Ten percent (3/31) of Black patients were enrolled, 33% (7/21) of White patients, and 50% (6/12) of Hispanic patients. Forty-seven percent (25/53) of patients declined participation despite eligibility; 58%(18/31) of Black patients declined participation. Forty percent (21/53) of screened patients were from a nursing facility and 10% (2/21) were enrolled. Enrolled patients had fewer comorbidities than nonenrolled patients: median modified Charlson comorbidity score 2.0 (interquartile range 0-2.5), versus 4.0 (interquartile range 2-6) for nonenrolled patients (P = 0.006). The limitations of the study were the low participation rate and the multiple treatment trials concurrently recruiting at our institution.

    Conclusions

    The high rate of nonparticipation in our trial of nursing facility residents and Black people emphasizes the concern that clinical trials for therapeutics may not target key populations with high mortality rates.
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    COVID-19 vaccination intention and activation among health care system employees: A mixed methods study.
    (Vaccine, 2022-08) Vasudevan, Lavanya; Bruening, Rebecca; Hung, Anna; Woolson, Sandra; Brown, Adrian; Hastings, Susan N; Linton, Tammy; Embree, Genevieve; Hostler, Christopher J; Mahanna, Elizabeth; Okeke, Nwora Lance; Bosworth, Hayden; Sperber, Nina R

    Background

    Achieving high COVID-19 vaccination rates among employees is necessary to prevent outbreaks in health care settings. The goal of the study was to produce actionable and timely evidence about factors underlying the intention and decisions to obtain the COVID-19 vaccine by employees.

    Methods

    The study was conducted from December 2020 - May 2021 with employees from a VA health care system in Southeastern US. The study used a convergent mixed methods design comprising two main activities: a cross-sectional survey conducted prior to COVID-19 vaccine distribution, and semi-structured interviews conducted 4-6 months after vaccine distribution. Data were collected about participant characteristics, vaccination intention prior to distribution, vaccination decision post-distribution, determinants of vaccination intention and decision, activating factors, sources of information and intervention needs. Data from the survey and interviews were analyzed separately and integrated narratively in the discussion.

    Results

    Prior to vaccine distribution, 77% of employees wanted to be vaccinated. Post vaccine distribution, we identified 5 distinct decision-making groups: 1) vaccine believers who actively sought vaccination and included those sometimes described as "immunization advocates", 2) go along to get along (GATGA) individuals who got vaccinated but did not actively seek it, 3) cautious acceptors who got the COVID-19 vaccine after some delay, 4) fence sitters who remained uncertain about getting vaccinated, and 5) vaccine refusers who actively rejected the COVID-19 vaccine. Participants identifying with Black or multiple races were more likely to express hesitancy in their vaccination intention.

    Conclusion

    The findings of our study highlight distinct decision-making profiles associated with COVID-19 vaccination among employees of a VA health care system, and provide tailored recommendations to reduce vaccine hesitancy in this population.
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    ItemOpen Access
    Evidence2Practice (E2P): Leveraging Implementation Science to Promote Careers in HIV Research Among Students From Historically Black Colleges and Universities.
    (Journal of acquired immune deficiency syndromes (1999), 2023-10) Okeke, Nwora Lance; Ware, Kenric B; Campbell, Russell; Taylor, Jamilah; Hung, Frances; Questell, Caroline; Brickler, Mildred P; Smith, Ukamaka D; Nawas, George T; Hanlen-Rosado, Emily; Chan, Cliburn; Bosworth, Hayden B; Aifah, Angela; Corneli, Amy

    Background

    The HIV research workforce is not representative of populations most affected by the epidemic. Innovative educational programs are needed to motivate diverse student populations to pursue careers in HIV research.

    Methods

    The Duke University Center for AIDS Research Evidence2Practice (E2P) program is a 3-day interactive workshop that introduces students from Historically Black Colleges and Universities (HBCU) to HIV pre-exposure prophylaxis, implementation science, and human-centered design. Participants develop 1-page action plans to increase awareness and uptake of pre-exposure prophylaxis on their campus. The program was evaluated using a partially mixed-method concurrent equal status study design with pre-program and post-program surveys and in-depth interviews.

    Results

    Among the 52 participating students, 44 completed the preworkshop survey, 45 completed the postworkshop survey, and 10 participated in an in-depth interview. Most participants identified as Black or African American and cisgender female. Participating in the E2P program was associated with: (1) an increase in median interest in pursuing a career in HIV research (P < 0.01) and (2) a decrease in median perceived difficulty in starting a career in HIV research (P < 0.01). Several students described that a lack of knowledge about initiating an HIV research career, a perceived lack of qualifications and knowledge about HIV science, and limited experience were major barriers to considering careers in HIV research.

    Conclusions

    The E2P program enhanced HBCU students' interest in careers related to HIV research and improved their self-efficacy to pursue such careers. On-campus educational enrichment initiatives, led by active HIV researchers and clinicians, should be a critical part of diversifying the HIV workforce.
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    ItemOpen Access
    Health Care Utilization Behaviors Predict Disengagement From HIV Care: A Latent Class Analysis.
    (Open forum infectious diseases, 2018-05) Okeke, Nwora Lance; Clement, Meredith E; McKellar, Mehri S; Stout, Jason E

    Background

    The traditional definition of engagement in HIV care in terms of only clinic attendance and viral suppression provides a limited understanding of how persons living with HIV (PLWH) interact with the health care system.

    Methods

    We conducted a retrospective analysis of patients with ≥1 HIV clinic visits at the Duke Adult Infectious Diseases Clinic between 2008 and 2013. Health care utilization was characterized by 4 indicators: clinic attendance in each half of the year (yes/no), number of emergency department (ED) visits/year (0, 1, or 2+), inpatient admissions/year (0, 1, 2+), and viral suppression (never, intermittent, always). Health care engagement patterns were modeled using latent class/latent transition analysis.

    Results

    A total of 2288 patients (median age, 46.4 years; 59% black, 71% male) were included in the analysis. Three care engagement classes were derived from the latent class model: "adherent" "nonadherent," and "sick." Patients age ≤40 years were more likely to be in the nonadherent class (odds ratio, 2.64; 95% confidence interval, 1.38-5.04) than other cohort members. Whites and males were more likely to transition from nonadherent to adherent the following year. Nonadherent patients were significantly more likely to disengage from care the subsequent year than adherent patients (23.6 vs 0.2%, P < .001).

    Conclusions

    A broader definition of health care engagement revealed distinct and dynamic patterns among PLWH that would have been hidden had only previous HIV clinic attendance had been considered. These patterns may be useful for designing engagement-targeted interventions.
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    ItemOpen Access
    Lower likelihood of cardiac procedures after acute coronary syndrome in patients with human immunodeficiency virus/acquired immunodeficiency syndrome.
    (Medicine, 2018-02) Clement, Meredith E; Lin, Li; Navar, Ann Marie; Okeke, Nwora Lance; Naggie, Susanna; Douglas, Pamela S
    Cardiovascular disease (CVD) is an increasing cause of morbidity and mortality in human immunodeficiency virus (HIV)-infected adults; however, this population may be less likely to receive interventions during hospitalization for acute coronary syndrome (ACS). The degree to which this disparity can be attributed to poorly controlled HIV infection is unknown.In this large cohort study, we used the National Inpatient Sample (NIS) to compare rates of cardiac procedures among patients with asymptomatic HIV-infection, symptomatic acquired immunodeficiency syndrome (AIDS), and uninfected adults hospitalized with ACS from 2009 to 2012. Multivariable analysis was used to compare procedure rates by HIV status, with appropriate weighting to account for NIS sampling design including stratification and hospital clustering.The dataset included 1,091,759 ACS hospitalizations, 0.35% of which (n = 3783) were in HIV-infected patients. Patients with symptomatic AIDS, asymptomatic HIV, and uninfected patients differed by sex, race, and income status. Overall rates of cardiac catheterization and revascularization were 53.3% and 37.4%, respectively. In multivariable regression, we found that relative to uninfected patients, those with symptomatic AIDS were less likely to undergo catheterization (odds ratio [OR] 0.48, confidence interval [CI] 0.43-0.55), percutaneous coronary intervention (OR 0.69, CI 0.59-0.79), and coronary artery bypass grafting (0.75, CI 0.61-0.93). No difference was seen for those with asymptomatic HIV relative to uninfected patients (OR 0.93, CI 0.81-1.07; OR 1.06, CI 0.93-1.21; OR 0.88, CI 0.72-1.06, respectively).We found that lower rates of cardiovascular procedures in HIV-infected patients were primarily driven by less frequent procedures in those with AIDS.
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    ItemOpen Access
    Mortality outcomes with hydroxychloroquine and chloroquine in COVID-19 from an international collaborative meta-analysis of randomized trials.
    (Nature communications, 2021-04-15) Axfors, Cathrine; Schmitt, Andreas M; Janiaud, Perrine; Van't Hooft, Janneke; Abd-Elsalam, Sherief; Abdo, Ehab F; Abella, Benjamin S; Akram, Javed; Amaravadi, Ravi K; Angus, Derek C; Arabi, Yaseen M; Azhar, Shehnoor; Baden, Lindsey R; Baker, Arthur W; Belkhir, Leila; Benfield, Thomas; Berrevoets, Marvin AH; Chen, Cheng-Pin; Chen, Tsung-Chia; Cheng, Shu-Hsing; Cheng, Chien-Yu; Chung, Wei-Sheng; Cohen, Yehuda Z; Cowan, Lisa N; Dalgard, Olav; de Almeida E Val, Fernando F; de Lacerda, Marcus VG; de Melo, Gisely C; Derde, Lennie; Dubee, Vincent; Elfakir, Anissa; Gordon, Anthony C; Hernandez-Cardenas, Carmen M; Hills, Thomas; Hoepelman, Andy IM; Huang, Yi-Wen; Igau, Bruno; Jin, Ronghua; Jurado-Camacho, Felipe; Khan, Khalid S; Kremsner, Peter G; Kreuels, Benno; Kuo, Cheng-Yu; Le, Thuy; Lin, Yi-Chun; Lin, Wu-Pu; Lin, Tse-Hung; Lyngbakken, Magnus Nakrem; McArthur, Colin; McVerry, Bryan J; Meza-Meneses, Patricia; Monteiro, Wuelton M; Morpeth, Susan C; Mourad, Ahmad; Mulligan, Mark J; Murthy, Srinivas; Naggie, Susanna; Narayanasamy, Shanti; Nichol, Alistair; Novack, Lewis A; O'Brien, Sean M; Okeke, Nwora Lance; Perez, Léna; Perez-Padilla, Rogelio; Perrin, Laurent; Remigio-Luna, Arantxa; Rivera-Martinez, Norma E; Rockhold, Frank W; Rodriguez-Llamazares, Sebastian; Rolfe, Robert; Rosa, Rossana; Røsjø, Helge; Sampaio, Vanderson S; Seto, Todd B; Shahzad, Muhammad; Soliman, Shaimaa; Stout, Jason E; Thirion-Romero, Ireri; Troxel, Andrea B; Tseng, Ting-Yu; Turner, Nicholas A; Ulrich, Robert J; Walsh, Stephen R; Webb, Steve A; Weehuizen, Jesper M; Velinova, Maria; Wong, Hon-Lai; Wrenn, Rebekah; Zampieri, Fernando G; Zhong, Wu; Moher, David; Goodman, Steven N; Ioannidis, John PA; Hemkens, Lars G
    Substantial COVID-19 research investment has been allocated to randomized clinical trials (RCTs) on hydroxychloroquine/chloroquine, which currently face recruitment challenges or early discontinuation. We aim to estimate the effects of hydroxychloroquine and chloroquine on survival in COVID-19 from all currently available RCT evidence, published and unpublished. We present a rapid meta-analysis of ongoing, completed, or discontinued RCTs on hydroxychloroquine or chloroquine treatment for any COVID-19 patients (protocol: https://osf.io/QESV4/ ). We systematically identified unpublished RCTs (ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, Cochrane COVID-registry up to June 11, 2020), and published RCTs (PubMed, medRxiv and bioRxiv up to October 16, 2020). All-cause mortality has been extracted (publications/preprints) or requested from investigators and combined in random-effects meta-analyses, calculating odds ratios (ORs) with 95% confidence intervals (CIs), separately for hydroxychloroquine and chloroquine. Prespecified subgroup analyses include patient setting, diagnostic confirmation, control type, and publication status. Sixty-three trials were potentially eligible. We included 14 unpublished trials (1308 patients) and 14 publications/preprints (9011 patients). Results for hydroxychloroquine are dominated by RECOVERY and WHO SOLIDARITY, two highly pragmatic trials, which employed relatively high doses and included 4716 and 1853 patients, respectively (67% of the total sample size). The combined OR on all-cause mortality for hydroxychloroquine is 1.11 (95% CI: 1.02, 1.20; I² = 0%; 26 trials; 10,012 patients) and for chloroquine 1.77 (95%CI: 0.15, 21.13, I² = 0%; 4 trials; 307 patients). We identified no subgroup effects. We found that treatment with hydroxychloroquine is associated with increased mortality in COVID-19 patients, and there is no benefit of chloroquine. Findings have unclear generalizability to outpatients, children, pregnant women, and people with comorbidities.
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    Nurse-Led Strategy to Improve Blood Pressure and Cholesterol Level Among People With HIV: A Randomized Clinical Trial.
    (JAMA network open, 2024-03) Longenecker, Christopher T; Jones, Kelley A; Hileman, Corrilynn O; Okeke, Nwora Lance; Gripshover, Barbara M; Aifah, Angela; Bloomfield, Gerald S; Muiruri, Charles; Smith, Valerie A; Vedanthan, Rajesh; Webel, Allison R; Bosworth, Hayden B

    Importance

    Despite higher atherosclerotic cardiovascular disease (ASCVD) risk, people with HIV (PWH) experience unique barriers to ASCVD prevention, such as changing models of HIV primary care.

    Objective

    To test whether a multicomponent nurse-led strategy would improve systolic blood pressure (SBP) and non-high-density lipoprotein (HDL) cholesterol level in a diverse population of PWH receiving antiretroviral therapy (ART).

    Design, setting, and participants

    This randomized clinical trial enrolled PWH at 3 academic HIV clinics in the US from September 2019 to January 2022 and conducted follow-up for 12 months until January 2023. Included patients were 18 years or older and had a confirmed HIV diagnosis, an HIV-1 viral load less than 200 copies/mL, and both hypertension and hypercholesterolemia. Participants were stratified by trial site and randomized 1:1 to either the multicomponent EXTRA-CVD (A Nurse-Led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention) intervention group or the control group. Primary analyses were conducted according to the intention-to-treat principle.

    Intervention

    The EXTRA-CVD group received home BP monitoring guidance and BP and cholesterol management from a dedicated prevention nurse at 4 in-person visits (baseline and 4, 8, and 12 months) and frequent telephone check-ins up to every 2 weeks as needed. The control group received general prevention education sessions from the prevention nurse at each of the 4 in-person visits.

    Main outcomes and measures

    Study-measured SBP was the primary outcome, and non-HDL cholesterol level was the secondary outcome. Measurements were taken over 12 months and assessed by linear mixed models. Prespecified moderators tested were sex at birth, baseline ASCVD risk, and trial site.

    Results

    A total of 297 PWH were randomized to the EXTRA-CVD arm (n = 149) or control arm (n = 148). Participants had a median (IQR) age of 59.0 (53.0-65.0) years and included 234 males (78.8%). Baseline mean (SD) SBP was 135.0 (18.8) mm Hg and non-HDL cholesterol level was 139.9 (44.6) mg/dL. At 12 months, participants in the EXTRA-CVD arm had a clinically significant 4.2-mm Hg (95% CI, 0.3-8.2 mm Hg; P = .04) lower SBP and 16.9-mg/dL (95% CI, 8.6-25.2 mg/dL; P < .001) lower non-HDL cholesterol level compared with participants in the control arm. There was a clinically meaningful but not statistically significant difference in SBP effect in females compared with males (11.8-mm Hg greater difference at 4 months, 9.6 mm Hg at 8 months, and 5.9 mm Hg at 12 months; overall joint test P = .06).

    Conclusions and relevance

    Results of this trial indicate that the EXTRA-CVD strategy effectively reduced BP and cholesterol level over 12 months and should inform future implementation of multifaceted ASCVD prevention programs for PWH.

    Trial registration

    ClinicalTrials.gov Identifier: NCT03643705.
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    Rationale and design of a nurse-led intervention to extend the HIV treatment cascade for cardiovascular disease prevention trial (EXTRA-CVD).
    (American heart journal, 2019-10) Okeke, Nwora Lance; Webel, Allison R; Bosworth, Hayden B; Aifah, Angela; Bloomfield, Gerald S; Choi, Emily W; Gonzales, Sarah; Hale, Sarah; Hileman, Corrilynn O; Lopez-Kidwell, Virginie; Muiruri, Charles; Oakes, Megan; Schexnayder, Julie; Smith, Valerie; Vedanthan, Rajesh; Longenecker, Chris T
    Persons living with human immunodeficiency virus (PLHIV) are at increased risk of atherosclerotic cardiovascular disease (ASCVD). In spite of this, uptake of evidence-based clinical interventions for ASCVD risk reduction in the HIV clinic setting is sub-optimal. METHODS: EXTRA-CVD is a 12-month randomized clinical effectiveness trial that will assess the efficacy of a multi-component nurse-led intervention in reducing ASCVD risk among PLHIV. Three hundred high ASCVD risk PLHIV across three sites will be randomized 1:1 to usual care with generic prevention education or the study intervention. The study intervention will consist of four evidence-based components: (1) nurse-led care coordination, (2) nurse-managed medication protocols and adherence support (3) home BP monitoring, and (4) electronic health records support tools. The primary outcome will be change in systolic blood pressure and secondary outcome will be change in non-HDL cholesterol over the course of the intervention. Tertiary outcomes will include change in the proportion of participants in the following extended cascade categories: (1) appropriately diagnosed with hypertension and hyperlipidemia (2) appropriately managed; (3) at treatment goal (systolic blood pressure <130 mm Hg and non-HDL cholesterol < National Lipid Association targets). CONCLUSIONS: The EXTRA-CVD trial will provide evidence appraising the potential impact of nurse-led interventions in reducing ASCVD risk among PLHIV, an essential extension of the HIV care continuum beyond HIV viral suppression.
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    Social Disadvantage, Politics, and Severe Acute Respiratory Syndrome Coronavirus 2 Trends: A County-level Analysis of United States Data.
    (Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2021-05) Mourad, Ahmad; Turner, Nicholas A; Baker, Arthur W; Okeke, Nwora Lance; Narayanasamy, Shanti; Rolfe, Robert; Engemann, John J; Cox, Gary M; Stout, Jason E

    Background

    Understanding the epidemiology of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is essential for public health control efforts. Social, demographic, and political characteristics at the United States (US) county level might be associated with changes in SARS-CoV-2 case incidence.

    Methods

    We conducted a retrospective analysis of the relationship between the change in reported SARS-CoV-2 case counts at the US county level during 1 June-30 June 2020 and social, demographic, and political characteristics of the county.

    Results

    Of 3142 US counties, 1023 were included in the analysis: 678 (66.3%) had increasing and 345 (33.7%) nonincreasing SARS-CoV-2 case counts between 1 June and 30 June 2020. In bivariate analysis, counties with increasing case counts had a significantly higher Social Deprivation Index (median, 48 [interquartile range {IQR}, 24-72]) than counties with nonincreasing case counts (median, 40 [IQR, 19-66]; P = .009). Counties with increasing case counts were significantly more likely to be metropolitan areas of 250 000-1 million population (P < .001), to have a higher percentage of black residents (9% vs 6%; P = .013), and to have voted for the Republican presidential candidate in 2016 by a ≥10-point margin (P = .044). In the multivariable model, metropolitan areas of 250 000-1 million population, higher percentage of black residents, and a ≥10-point Republican victory were independently associated with increasing case counts.

    Conclusions

    Increasing case counts of SARS-CoV-2 in the US during June 2020 were associated with a combination of sociodemographic and political factors. Addressing social disadvantage and differential belief systems that may correspond with political alignment will play a critical role in pandemic control.
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    The influence of healthcare financing on cardiovascular disease prevention in people living with HIV.
    (BMC public health, 2020-11) Webel, Allison R; Schexnayder, Julie; Rentrope, C Robin; Bosworth, Hayden B; Hileman, Corrilynn O; Okeke, Nwora Lance; Vedanthan, Rajesh; Longenecker, Chris T

    Background

    People living with HIV are diagnosed with age-related chronic health conditions, including cardiovascular disease, at higher than expected rates. Medical management of these chronic health conditions frequently occur in HIV specialty clinics by providers trained in general internal medicine, family medicine, or infectious disease. In recent years, changes in the healthcare financing for people living with HIV in the U.S. has been dynamic due to changes in the Affordable Care Act. There is little evidence examining how healthcare financing characteristics shape primary and secondary cardiovascular disease prevention among people living with HIV. Our objective was to examine the perspectives of people living with HIV and their healthcare providers on how healthcare financing influences cardiovascular disease prevention.

    Methods

    As part of the EXTRA-CVD study, we conducted in-depth, semi-structured interviews with 51 people living with HIV and 34 multidisciplinary healthcare providers and at three U.S. HIV clinics in Ohio and North Carolina from October 2018 to March 2019. Thematic analysis using Template Analysis techniques was used to examine healthcare financing barriers and enablers of cardiovascular disease prevention in people living with HIV.

    Results

    Three themes emerged across sites and disciplines (1): healthcare payers substantially shape preventative cardiovascular care in HIV clinics (2); physician compensation tied to relative value units disincentivizes cardiovascular disease prevention efforts by HIV providers; and (3) grant-based services enable tailored cardiovascular disease prevention, but sustainability is limited by sponsor priorities.

    Conclusions

    With HIV now a chronic disease, there is a growing need for HIV-specific cardiovascular disease prevention; however, healthcare financing complicates effective delivery of this preventative care. It is important to understand the effects of evolving payer models on patient and healthcare provider behavior. Additional systematic investigation of these models will help HIV specialty clinics implement cardiovascular disease prevention within a dynamic reimbursement landscape.

    Trial registration

    Clinical Trial Registration Number: NCT03643705 .
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    Understanding constraints on integrated care for people with HIV and multimorbid cardiovascular conditions: an application of the Theoretical Domains Framework.
    (Implementation science communications, 2021-02) Schexnayder, Julie; Longenecker, Chris T; Muiruri, Charles; Bosworth, Hayden B; Gebhardt, Daniel; Gonzales, Sarah E; Hanson, Jan E; Hileman, Corrilynn O; Okeke, Nwora Lance; Sico, Isabelle P; Vedanthan, Rajesh; Webel, Allison R

    Background

    People with HIV (PWH) experience increased cardiovascular disease (CVD) risk. Many PWH in the USA receive their primary medical care from infectious disease specialists in HIV clinics. HIV care teams may not be fully prepared to provide evidence-based CVD care. We sought to describe local context for HIV clinics participating in an NIH-funded implementation trial and to identify facilitators and barriers to integrated CVD preventive care for PWH.

    Methods

    Data were collected in semi-structured interviews and focus groups with PWH and multidisciplinary healthcare providers at three academic medical centers. We used template analysis to identify barriers and facilitators of CVD preventive care in three HIV specialty clinics using the Theoretical Domains Framework (TDF).

    Results

    Six focus groups were conducted with 37 PWH. Individual interviews were conducted with 34 healthcare providers and 14 PWH. Major themes were captured in seven TDF domains. Within those themes, we identified nine facilitators and 11 barriers to CVD preventive care. Knowledge gaps contributed to inaccurate CVD risk perceptions and ineffective self-management practices in PWH. Exclusive prioritization of HIV over CVD-related conditions was common in PWH and their providers. HIV care providers assumed inconsistent roles in CVD prevention, including for PWH with primary care providers. HIV providers were knowledgeable of HIV-related CVD risks and co-located health resources were consistently available to support PWH with limited resources in health behavior change. However, infrequent medical visits, perceptions of CVD prevention as a primary care service, and multiple co-location of support programs introduced local challenges to engaging in CVD preventive care.

    Conclusions

    Barriers to screening and treatment of cardiovascular conditions are common in HIV care settings and highlight a need for greater primary care integration. Improving long-term cardiovascular outcomes of PWH will likely require multi-level interventions supporting HIV providers to expand their scope of practice, addressing patient preferences for co-located CVD preventive care, changing clinic cultures that focus only on HIV to the exclusion of non-AIDS multimorbidity, and managing constraints associated with multiple services co-location.

    Trial registration

    ClinicalTrials.gov , NCT03643705.
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    Use of a human-centered design approach to adapt a nurse-led cardiovascular disease prevention intervention in HIV clinics.
    (Progress in cardiovascular diseases, 2020-03) Aifah, Angela; Okeke, Nwora Lance; Rentrope, Cynthia R; Schexnayder, Julie; Bloomfield, Gerald S; Bosworth, Hayden; Grover, Kiran; Hileman, Corrilynn O; Muiruri, Charles; Oakes, Megan; Webel, Allison R; Longenecker, Chris T; Vedanthan, Rajesh
    Stakeholder-informed strategies addressing cardiovascular disease (CVD) burden among people living with HIV (PWH) are needed within healthcare settings. This study provides an assessment of how human-centered design (HCD) guided the adaptation of a nurse-led intervention to reduce CVD risk among PWH. Using a HCD approach, research staff guided two multidisciplinary "design teams" in Ohio and North Carolina, with each having five HCD meetings. We conducted acceptability and feasibility testing. Six core recommendations were produced by two design teams of key stakeholders and further developed after the acceptability and feasibility testing to produce a final list of 14 actionable areas of adaptation. Acceptability and feasibility testing revealed areas for adaptation, e.g. patient preferences for communication and the benefit of additional staff to support patient follow-up. In conclusion, along with acceptability and feasibility testing, HCD led to the production of 14 key recommendations to enhance the effectiveness and scalability of an integrated HIV/CVD intervention.
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    Why Do People Living with HIV Adhere to Antiretroviral Therapy and Not Comorbid Cardiovascular Disease Medications? A Qualitative Inquiry.
    (Patient preference and adherence, 2020-01) Muiruri, Charles; Sico, Isabelle P; Schexnayder, Julie; Webel, Allison R; Okeke, Nwora Lance; Longenecker, Christopher T; Gonzalez, Juan Marcos; Jones, Kelley A; Gonzales, Sarah E; Bosworth, Hayden B

    Background

    After achieving viral suppression, it is critical for persons living with HIV (PLWH) to focus on prevention of non-AIDS comorbidities such as cardiovascular disease (CVD) in order to enhance their quality of life and longevity of life. Despite PLWH elevated risk of developing CVD compared to individuals without HIV, PLWH do not often meet evidence-based treatment goals for CVD prevention; the reasons for PLWH not meeting guideline recommendations are poorly understood. The objective of this study was to identify the factors associated with adherence to CVD medications for PLWH who have achieved viral suppression.

    Methods

    Qualitative data were obtained from formative research conducted to inform the adaptation of a nurse-led intervention trial to improve cardiovascular health at three large academic medical centers in the United States. Transcripts were analyzed using content analysis guided by principles drawn from grounded theory.

    Results

    Fifty-one individuals who had achieved viral suppression (<200 copies/mL) participated: 37 in 6 focus groups and 14 in individual semi-structured interviews. Mean age was 57 years (SD: 7.8); most were African Americans (n=31) and majority were male (n=34). Three main themes were observed. First, participants reported discordance between their healthcare providers' recommendations and their own preferred strategies to reduce CVD risk. Second, participants intentionally modified frequency of CVD medication taking which appeared to be related to low CVD risk perception and perceived or experienced side effects with treatment. Finally, participants discussed the impact of long-term experience with HIV care on adherence to CVD medication and motivational factors that enhanced adherence to heart healthy behaviors.

    Conclusion

    Findings suggest that future research should focus on developing interventions to enhance patient-provider communication in order to elicit beliefs, concerns and preferences for CVD prevention strategies. Future research should seek to leverage and adapt established evidence-based practices in HIV care to support CVD medication adherence.