Publications by authors named "Catherine R Lesko"

72 Publications

Alcohol Use Disorder and Recent Alcohol Use and HIV Viral Non-Suppression Among People Engaged in HIV Care in an Urban Clinic, 2014-2018.

AIDS Behav 2021 Oct 9. Epub 2021 Oct 9.

Division of General Internal Medicine, Johns Hopkins School of Medicine, Baltimore, MD, USA.

We estimated joint associations between having history of alcohol use disorder (AUD) (based on prior ICD-9/ICD-10 codes) and recent self-reported alcohol use and viral non-suppression (≥ 1 viral load measurement > 20 copies/mL in the same calendar year as alcohol consumption was reported) among patients on ART enrolled in routine care, 2014-2018, in an urban specialty clinic. Among 1690 patients, 26% had an AUD, 21% reported high-risk alcohol use, and 39% had viral non-suppression. Relative to person-years in which people without AUD reported not drinking, prevalence of viral non-suppression was higher in person-years when people with AUD reported drinking at any level; prevalence of viral non-suppression was not significantly higher in person-years when people with AUD reported not drinking or person-years when people without AUD reported drinking at any level. No level of alcohol use may be "safe" for people with a prior AUD with regard to maintaining viral suppression.
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http://dx.doi.org/10.1007/s10461-021-03487-3DOI Listing
October 2021

Depression and HIV viral nonsuppression among people engaged in HIV care in an urban clinic, 2014-2019.

AIDS 2021 10;35(12):2017-2024

Department of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.

Objective: The aim of this study was to describe the risk of viral nonsuppression across the depression care cascade.

Design: A clinical cohort study.

Methods: We used depressive symptoms (PHQ-8 ≥ 10) self-reported on computer-assisted surveys, clinical diagnoses of depression in the medical record in the prior year and pharmacologic (any prescription for an antidepressant) and psychologic treatments for depression (attendance at at least two mental health visits in the prior year) to classify patients into groups: no history of depression; prior depression diagnosis; current indication for depression treatment (symptoms or clinical diagnosis); and treated depression (stratified by presence of persistent symptoms). We associated position in the depression care cascade with viral nonsuppression (>200 copies/ml) 7 days before to 6 months after the index self-report of depressive symptoms.

Results: History of depression [adjusted risk difference (aRD) relative to no history = 5.9%, 95% confidence interval (95% CI): 1.5-10.3] and current depression (symptoms or diagnosis) in the absence of treatment (aRD relative to no current depression or depression treatment = 4.8%, 95% CI: 1.8-7.8) were associated with a higher risk of viral nonsuppression than no history of depression. Depression treatment mitigated this association (aRD = -0.4%, 95% CI: -2.5 to 1.7).

Conclusion: The relationship between depression care cascade and viral suppression is complex. Untreated depression and clinically unrecognized depressive symptoms were both related to viral nonsuppression. Treated depression was not associated with viral nonsuppression; however, a high proportion of treated patients still had depressive symptoms. Depression treatment should be titrated if patients' symptoms are not responsive and patients with a history of depression should be monitored for ART adherence.
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http://dx.doi.org/10.1097/QAD.0000000000003005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8416789PMC
October 2021

The Effect Of Buprenorphine On HIV Viral Suppression.

Clin Infect Dis 2021 Jun 25. Epub 2021 Jun 25.

Department of Epidemiology, Johns Hopkins Bloomberg School of Public health, Baltimore, MD, USA.

Background: Opioid use is prevalent among people with HIV and adversely affects HIV outcomes. We assessed the effect of buprenorphine (BUP) initiation on subsequent HIV viral loads.

Methods: We identified people with HIV (PWH) from the Johns Hopkins HIV Clinical Cohort who initiated BUP between 2002-2017. Poisson regression with robust variance was used to estimate the prevalence of viral suppression (<200 copies/mL) before and after BUP initiation. We then matched individuals who initiated BUP with controls based upon viral load measurement dates and used prior event rate ratio (PERR) methods to estimate the effect of initiation of BUP on viral suppression. PERR methods account for unmeasured confounders.

Results: We identified 279 PWH who initiated BUP. After BUP initiation, PWH were more likely to be virally suppressed (prevalence ratio [PR]: 1.19, 95% CI [1.03, 1.37],). After matching PWH initiating BUP to 2422 PWH controls and accounting for measured and unmeasured confounders, BUP initiation increased viral suppression for both those on ART at baseline (PERR PR: 1.08 [1.00, 1.18]) and those not on ART at baseline (PR: 1.31 [1.10, 1.61]).

Conclusions: Our results indicate that the initiation of BUP results in an increase in the probability of being virally suppressed after accounting for both measured and unmeasured confounders. Persons with opioid use disorder should initiate buprenorphine to not only treat substance use but also increase the chances of ART use for treatment as prevention.
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http://dx.doi.org/10.1093/cid/ciab578DOI Listing
June 2021

Decreased Alcohol Consumption in an Implementation Study of Computerized Brief Intervention among HIV Patients in Clinical Care.

AIDS Behav 2021 May 16. Epub 2021 May 16.

Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.

This prospective, nonrandomized implementation study evaluated a computerized brief intervention (CBI) for persons with HIV (PWH) and heavy/hazardous alcohol use. CBI was integrated into two HIV primary care clinics. Eligible patients were engaged in care, ≥ 18 years old, English speaking, endorsed heavy/hazardous alcohol use on the Alcohol Use Disorders Identification Test-C (AUDIT-C). Two 20-min computerized sessions using cognitive behavioral techniques were delivered by a 3-D avatar on touch screen tablets. Of 816 eligible AUDIT-C scores, 537 (66%) resulted in CBI invitation, 226 (42%) of invited patients enrolled, and 176 (78%) of enrolled patients watched at least one session. CBI enrollment was associated with a significant average reduction of 9.1 drinks/week (95% CI - 14.5, - 3.6) 4-12 months post-enrollment. Among those who participated in one or both sessions, average reduction in drinks/week was 11.7 drinks/week (95% CI - 18.8, - 4.6). There was corresponding improvement in AUDIT-C scores. Overall patients reported high levels of intervention satisfaction, particularly among older and Black patients. These promising results point to a practical intervention for alcohol reduction in this vulnerable patient population with elevated rates of heavy/hazardous drinking. Future research should examine strategies to increase initial engagement, strengthen intervention effects to increase the number of patients who achieve non-hazardous drinking, and examine the duration of therapeutic effects.
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http://dx.doi.org/10.1007/s10461-021-03295-9DOI Listing
May 2021

Editorial: Robust Sensitivities.

Am J Epidemiol 2021 08;190(8):1437-1448

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http://dx.doi.org/10.1093/aje/kwab071DOI Listing
August 2021

Causal inference in the face of competing events.

Curr Epidemiol Rep 2020 Sep 12;7(3):125-131. Epub 2020 Jul 12.

Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh.

Purpose Of Review: Epidemiologists frequently must handle competing events, which prevent the event of interest from occurring. We review considerations for handling competing events when interpreting results causally.

Recent Findings: When interpreting statistical associations as causal effects, we recommend following a causal inference "roadmap" as one would in an analysis without competing events. There are, however, special considerations to be made for competing events when choosing the causal estimand that best answers the question of interest, selecting the statistical estimand (e.g. the cause-specific or subdistribution) that will target that causal estimand, and assessing whether causal identification conditions (e.g., conditional exchangeability, positivity, and consistency) have been sufficiently met.

Summary: When doing causal inference in the competing events setting, it is critical to first ascertain the relevant question and the causal estimand that best answers it, with the choice often being between estimands that do and do not eliminate competing events.
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http://dx.doi.org/10.1007/s40471-020-00240-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7968079PMC
September 2020

Combining Effect Estimates Across Cohorts and Sufficient Adjustment Sets for Collaborative Research: A Simulation Study.

Epidemiology 2021 05;32(3):421-424

Division of Environmental and Occupational Health, University of California, Davis School of Medicine, Davis, CA.

Background: Collaborative research often combines findings across multiple, independent studies via meta-analysis. Ideally, all study estimates that contribute to the meta-analysis will be equally unbiased. Many meta-analyses require all studies to measure the same covariates. We explored whether differing minimally sufficient sets of confounders identified by a directed acyclic graph (DAG) ensures comparability of individual study estimates. Our analysis applied four statistical estimators to multiple minimally sufficient adjustment sets identified in a single DAG.

Methods: We compared estimates obtained via linear, log-binomial, and logistic regression and inverse probability weighting, and data were simulated based on a previously published DAG.

Results: Our results show that linear, log-binomial, and inverse probability weighting estimators generally provide the same estimate of effect for different estimands that are equally sufficient to adjust confounding bias, with modest differences in random error. In contrast, logistic regression often performed poorly, with notable differences in effect estimates obtained from unique minimally sufficient adjustment sets, and larger standard errors than other estimators.

Conclusions: Our findings do not support the reliance of collaborative research on logistic regression results for meta-analyses. Use of DAGs to identify potentially differing minimally sufficient adjustment sets can allow meta-analyses without requiring the exact same covariates.
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http://dx.doi.org/10.1097/EDE.0000000000001336DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8012230PMC
May 2021

Target validity: Bringing treatment of external validity in line with internal validity.

Curr Epidemiol Rep 2020 Sep 30;7(3):117-124. Epub 2020 Jun 30.

Department of Epidemiology, University of North Carolina, Chapel Hill, NC.

Purpose Of Review: "Target bias" is the difference between an estimate of association from a study sample and the causal effect in the target population of interest. It is the sum of internal and external bias. Given the extensive literature on internal validity, here, we review threats and methods to improve external validity.

Recent Findings: External bias may arise when the distribution of modifiers of the effect of treatment differs between the study sample and the target population. Methods including those based on modeling the outcome, modeling sample membership, and doubly robust methods are available, assuming data on the target population is available.

Summary: The relevance of information for making policy decisions is dependent on both the actions that were studied and the sample in which they were evaluated. Combining methods for addressing internal and external validity can improve the policy relevance of study results.
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http://dx.doi.org/10.1007/s40471-020-00239-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7879946PMC
September 2020

A learning algorithm for predicting mental health symptoms and substance use.

J Psychiatr Res 2021 02 19;134:22-29. Epub 2020 Dec 19.

Johns Hopkins Bloomberg School of Public Health, Department of Biostatistics, Baltimore, MD, USA. Electronic address:

Learning health systems use data to generate knowledge that informs clinical care, but few studies have evaluated how to leverage patient-reported mental health symptoms and substance use data to make patient-specific predictions. We developed a general Bayesian prediction algorithm that uses self-reported psychiatric symptoms and substance use within a population to predict future symptoms and substance use for individuals in that population. We validated our approach in 2444 participants from two clinical cohorts - the National Network of Depression Centers and the Johns Hopkins HIV Clinical Cohort - by predicting symptoms of depression, anxiety, and mania as well as alcohol, heroin, and cocaine use and comparing our predictions to observed symptoms and substance use. When we dichotomized mental health symptoms as moderate-severe vs. none-mild, individual predictions yielded areas under the ROC curve (AUCs) of 0.84 [95% confidence interval 0.80-0.88] and 0.85 [0.82-0.88] for symptoms of depression in the two cohorts, AUCs of 0.84 [0.79-0.88] and 0.85 [0.82-0.88] for symptoms of anxiety, and an AUC of 0.77 [0.72-0.82] for manic symptoms. Predictions of substance use yielded an AUC of 0.92 [0.88-0.97] for heroin use, 0.90 [0.82-0.97] for cocaine use, and 0.90 [0.88-092] for alcohol misuse. This rigorous, mathematically grounded approach could provide patient-specific predictions at the point of care. It can be applied to other psychiatric symptoms and substance use indicators, and is customizable to specific health systems. Such approaches can realize the potential of a learning health system to transform ever-increasing quantities of data into tangible guidance for patient care.
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http://dx.doi.org/10.1016/j.jpsychires.2020.12.049DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8323478PMC
February 2021

Teaching Epidemiology Online (Pandemic Edition).

Am J Epidemiol 2021 07;190(7):1183-1189

In response to the threat posed by the coronavirus disease 2019 (COVID-19) pandemic, many universities are encouraging or requiring online instruction. Teaching an epidemiology course online is different in many respects from teaching in person. In this article, we review specific approaches and strategies related to teaching epidemiology online during the pandemic and beyond, including a discussion of options for course format, grading and assessment approaches, pandemic-related contingencies, and the use of technology. Throughout this article we present practical, epidemiology-specific teaching examples. Moreover, we also examine 1) how the lessons learned about the practice of epidemiology during the pandemic can be integrated into the didactic content of epidemiology training programs and 2) whether epidemiologic pedagogy and teaching strategies should change in the long term, beyond the COVID-19 pandemic. The pandemic has served to heighten our awareness of concerns related to student health and safety, as well as issues of accessibility, equity, and inclusion. Our goal is to present a practical overview connecting pandemic-era online teaching with thoughts about the future of epidemiologic instruction.
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http://dx.doi.org/10.1093/aje/kwaa285DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7799241PMC
July 2021

Generalizing randomized trial findings to a target population using complex survey population data.

Stat Med 2021 02 26;40(5):1101-1120. Epub 2020 Nov 26.

Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.

Randomized trials are considered the gold standard for estimating causal effects. Trial findings are often used to inform policy and programming efforts, yet their results may not generalize well to a relevant target population due to potential differences in effect moderators between the trial and population. Statistical methods have been developed to improve generalizability by combining trials and population data, and weighting the trial to resemble the population on baseline covariates. Large-scale surveys in fields such as health and education with complex survey designs are a logical source for population data; however, there is currently no best practice for incorporating survey weights when generalizing trial findings to a complex survey. We propose and investigate ways to incorporate survey weights in this context. We examine the performance of our proposed estimator through simulations in comparison to estimators that ignore the complex survey design. We then apply the methods to generalize findings from two trials-a lifestyle intervention for blood pressure reduction and a web-based intervention to treat substance use disorders-to their respective target populations using population data from complex surveys. The work highlights the importance in properly accounting for the complex survey design when generalizing trial findings to a population represented by a complex survey sample.
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http://dx.doi.org/10.1002/sim.8822DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8034867PMC
February 2021

Changing Patterns of Alcohol Use and Probability of Unsuppressed Viral Load Among Treated Patients with HIV Engaged in Routine Care in the United States.

AIDS Behav 2021 Apr 16;25(4):1072-1082. Epub 2020 Oct 16.

Division of General Internal Medicine, Johns Hopkins School of Medicine, Baltimore, MD, USA.

We examined HIV viral load non-suppression ([Formula: see text] 200 copies/mL) subsequent to person-periods (3-18 months) bookended by two self-reports of alcohol use on a standardized patient reported outcome assessment among adults in routine HIV care. We examined the relative risk (RR) of non-suppression associated with increases and decreases in alcohol use (relative to stable use), stratified by use at the start of the person-period. Increases in drinking from abstinence were associated with higher risk of viral non-suppression (low-risk without binge: RR 1.16, 95% CI 1.03, 1.32; low-risk with binge: RR 1.35, 95% CI 1.11, 1.63; high-risk: RR 1.89, 95% CI 1.16, 3.08). Decreases in drinking from high-risk drinking were weakly, and not statistically significantly associated with lower risk of viral non-suppression. Other changes in alcohol use were not associated with viral load non-suppression. Most changes in alcohol consumption among people using alcohol at baseline were not strongly associated with viral non-suppression.
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http://dx.doi.org/10.1007/s10461-020-03065-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7979457PMC
April 2021

HIV and COVID-19: Intersecting Epidemics With Many Unknowns.

Am J Epidemiol 2021 01;190(1):10-16

As of July 2020, approximately 6 months into the pandemic of novel coronavirus disease 2019 (COVID-19), whether people living with human immunodeficiency virus (HIV; PLWH) are disproportionately affected remains an unanswered question. Thus far, risk of COVID-19 in people with and without HIV appears similar, but data are sometimes contradictory. Some uncertainty is due to the recency of the emergence of COVID-19 and sparsity of data; some is due to imprecision about what it means for HIV to be a "risk factor" for COVID-19. Forthcoming studies on the risk of COVID-19 to PLWH should differentiate between 1) the unadjusted, excess burden of disease among PLWH to inform surveillance efforts and 2) any excess risk of COVID-19 among PLWH due to biological effects of HIV, independent of comorbidities that confound rather than mediate this effect. PLWH bear a disproportionate burden of alcohol, other drug use, and mental health disorders, as well as other structural vulnerabilities, which might increase their risk of COVID-19. In addition to any direct effects of COVID-19 on the health of PLWH, we need to understand how physical distancing restrictions affect secondary health outcomes and the need for, accessibility of, and impact of alternative modalities of providing ongoing medical, mental health, and substance use treatment that comply with physical distancing restrictions (e.g., telemedicine).
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http://dx.doi.org/10.1093/aje/kwaa158DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7454306PMC
January 2021

The Promise, and Challenges, of Methods to Enhance the External Validity of Randomized Trial Results.

Clin Pharmacol Ther 2020 12 8;108(6):1132-1134. Epub 2020 Aug 8.

Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.

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http://dx.doi.org/10.1002/cpt.1992DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7669659PMC
December 2020

Cardiovascular disease risk among transgender women living with HIV in the United States.

PLoS One 2020 20;15(7):e0236177. Epub 2020 Jul 20.

Department of Social Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, United States of America.

Background: Transgender women (TW) are disproportionately affected by both HIV and cardiovascular disease (CVD).

Objectives: We aim to quantify prevalence of elevated predicted CVD risk for TW compared to cisgender women (CW) and cisgender men (CM) in HIV care and describe the impact of multiple operationalizations of CVD risk score calculations for TW.

Design: We conducted a cross-sectional analysis of patients engaged in HIV care between October 2014 and February 2018.

Setting: The Centers for AIDS Research Network of Integrated Clinical Systems, a collaboration of 8 HIV clinical sites in the United States contributed data for this analysis.

Patients: 221 TW, 2983 CW, and 13467 CM.

Measurements: The measure of interest is prevalence of elevated 10-year cardiovascular disease risk based on ACC/AHA Pooled Cohort Risk Assessment equations (PCE) and the Framingham Risk Score (FRS), calculated for TW by: birth-assigned sex (male); history of exogenous sex hormone use (female/male); and current gender (female).

Results: Using birth-assigned sex, the adjusted prevalence ratio (aPR) was 2.52 (95% CI: 1.08,5.86) and 2.58 (95% CI: 1.71,3.89) comparing TW to CW, by PCE and FRS, respectively. It was 1.25 (95% CI: 0.54,2.87) and 1.25 (95% CI: 0.84,1.86) comparing TW to CM, by PCE and FRS, respectively. If TW were classified according to current gender versus birth-assigned sex, their predicted CVD risk scores were lower.

Limitations: PCE and FRS have not been validated in TW with HIV. Few adjudicated CVD events in the data set precluded analyses based on clinical outcomes.

Conclusions: After adjustment for demographics and history of HIV care, prevalence of elevated CVD risk in TW was similar to CM and equal to or higher than in CW, depending operationalization of the sex variable. Future studies with CVD outcomes are needed to help clinicians accurately estimate CVD risk among TW with HIV.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0236177PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7371206PMC
September 2020

Variation in estimated viral suppression associated with the definition of viral suppression used.

AIDS 2020 08;34(10):1519-1526

Department of Epidemiology.

Objective: The proportion of people living with HIV with suppressed viral load is a key indicator of the HIV care continuum. We explored how this proportion varied depending on how it was calculated.

Design: Observational cohort study.

Methods: We calculated the proportion of the Johns Hopkins HIV Clinical Cohort who were virally suppressed each year, 2010-2018, based on different denominators; thresholds for suppression (≤20, ≤50, ≤200, or ≤400 copies/ml); and strategies for summarizing multiple viral load measurements (we classified persons as suppressed if they had any lab, ≥50% of labs, last lab, or all labs below the threshold). We also calculated 5-year risk of all-cause mortality associated with each classification of viral suppression.

Results: Three thousand eleven persons contributed 60 858 viral load values to this analysis. Proportion classified as virally suppressed ranged from 51.8 to 92.5%, depending on the definition used and persons included in the calculation. Requiring more labs below the threshold; using a lower threshold; and assuming persons lost to follow-up were not suppressed (stricter definitions) resulted in a lower proportion estimated to be suppressed. Suppression by stricter definitions were associated with better 5-year survival.

Discussion: The proportion suppressed varied greatly as a function of the subset of persons in whom it was calculated, the threshold used for suppression, and the way multiple viral loads per person per year were summarized. Measures of durable viral suppression, and low-level viremia (20-400 copies/ml), should be considered in describing the health of people with HIV, in addition to the standard estimates of suppression.
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http://dx.doi.org/10.1097/QAD.0000000000002579DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8327702PMC
August 2020

Gone But Not Lost: Implications for Estimating HIV Care Outcomes When Loss to Clinic Is Not Loss to Care.

Epidemiology 2020 07;31(4):570-577

From the Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, NC.

Background: In some time-to-event analyses, it is unclear whether loss to follow up should be treated as a censoring event or competing event. Such ambiguity is particularly common in HIV research that uses routinely collected clinical data to report the timing of key milestones along the HIV care continuum. In this setting, loss to follow up may be viewed as a censoring event, under the assumption that patients who are "lost" from a study clinic immediately enroll in care elsewhere, or a competing event, under the assumption that people "lost" are out of care all together.

Methods: We illustrate an approach to address this ambiguity when estimating the 2-year risk of antiretroviral treatment initiation among 19,506 people living with HIV who enrolled in the IeDEA Central Africa cohort between 2006 and 2017, along with published estimates from tracing studies in Africa. We also assessed the finite sample properties of the proposed approach using simulation experiments.

Results: The estimated 2-year risk of treatment initiation was 69% if patients were censored at loss to follow up or 59% if losses to follow up were treated as competing events. Using the proposed approach, we estimated that the 2-year risk of antiretroviral therapy initiation was 62% (95% confidence interval: 61, 62). The proposed approach had little bias and appropriate confidence interval coverage under scenarios examined in the simulation experiments.

Conclusions: The proposed approach relaxes the assumptions inherent in treating loss to follow up as a censoring or competing event in clinical HIV cohort studies.
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http://dx.doi.org/10.1097/EDE.0000000000001201DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8344105PMC
July 2020

Biopsychosocial Mechanisms Linking Gender Minority Stress to HIV Comorbidities Among Black and Latina Transgender Women (LITE Plus): Protocol for a Mixed Methods Longitudinal Study.

JMIR Res Protoc 2020 Apr 13;9(4):e17076. Epub 2020 Apr 13.

Department of Social Medicine, University of North Carolina, Chapel Hill, Chapel Hill, NC, United States.

Background: Black and Latina transgender women (TW) experience a disparate burden of HIV and related comorbidities, including poor mental health and cardiovascular disease (CVD) risks. Pervasive multilevel stigma and discrimination operate as psychosocial stressors for TW living with HIV and shape health disparities for this population. Gender-affirming hormone therapy (GAHT) is commonly used by TW to facilitate alignment of the body with gender identity; in the context of stigma, GAHT may both improve mental health and increase CVD risks.

Objective: This study aims to quantify the longitudinal relationship between stigma and chronic stress among black and Latina TW living with HIV. Secondary objectives include identifying pathways linking chronic stress to HIV comorbidities and exploring chronic stress as a mediator in the pathway linking stigma and GAHT to CVD comorbidities.

Methods: This US-based mixed methods longitudinal study will enroll a prospective cohort of 200 black and Latina TW living with HIV, collecting quantitative survey data, qualitative interviews, and biomarkers of chronic stress. Interviewer-administered surveys will include validated psychosocial measures of self-reported stigma and discrimination, perceived stress, CVD risk factors, mental health, access to gender-affirming care, coping, and social support. Medical record abstraction will collect data on GAHT use, CD4 count, HIV viral load, antiretroviral therapy, treatment, and comorbid conditions. Clinical measures will include physiological biomarkers as well as salivary and blood-based biomarkers of chronic stress. Survey data will be collected every 6 months (baseline, and 6, 12, 18, and 24 months), and biospecimens will be collected at baseline and at 12 and 24 months. A purposive subsample (stratified by use of GAHT and presence of depressive symptoms) of 20 to 30 TW living with HIV will be invited to participate in in-depth interviews at 6 and 18 months to explore experiences of intersectional stigma, chronic stress, and the role of GAHT in their lives.

Results: This study was funded by the National Institute on Minority Health and Health Disparities in December 2018. The study community advisory board and scientific advisors provided critical input on study design. Recruitment began in October 2019 (n=29 participants as of submission) and data collection will continue through 2022, with publication of baseline results anticipated summer 2021.

Conclusions: This study will focus on black and Latina TW living with HIV, an understudied health disparities population, advance both stigma and intersectionality research, and move chronic stress physiology research toward a more nuanced understanding of sex and gender. The comprehensive methodology will support the exploration of the role of exogenous estrogen in the pathways between stress and HIV comorbidities, elucidating the role of GAHT in the stress-health relationship. Finally, this study will provide longitudinal evidence of the impact of stigma-related chronic stress on the lives of black and Latina TW living with HIV integrating qualitative and quantitative data with psychosocial, clinical, and biological measures.

International Registered Report Identifier (irrid): DERR1-10.2196/17076.
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http://dx.doi.org/10.2196/17076DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7186865PMC
April 2020

The Epidemiologic Toolbox: Identifying, Honing, and Using the Right Tools for the Job.

Am J Epidemiol 2020 06;189(6):511-517

There has been much debate about the relative emphasis of the field of epidemiology on causal inference. We believe this debate does short shrift to the breadth of the field. Epidemiologists answer myriad questions that are not causal and hypothesize about and investigate causal relationships without estimating causal effects. Descriptive studies face significant and often overlooked inferential and interpretational challenges; we briefly articulate some of them and argue that a more detailed treatment of biases that affect single-sample estimation problems would benefit all types of epidemiologic studies. Lumping all questions about causality creates ambiguity about the utility of different conceptual models and causal frameworks; 2 distinct types of causal questions include 1) hypothesis generation and theorization about causal structures and 2) hypothesis-driven causal effect estimation. The potential outcomes framework and causal graph theory help efficiently and reliably guide epidemiologic studies designed to estimate a causal effect to best leverage prior data, avoid cognitive fallacies, minimize biases, and understand heterogeneity in treatment effects. Appropriate matching of theoretical frameworks to research questions can increase the rigor of epidemiologic research and increase the utility of such research to improve public health.
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http://dx.doi.org/10.1093/aje/kwaa030DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7368131PMC
June 2020

A comparison of cancer stage at diagnosis and treatment initiation between enrollees in an urban HIV clinic and SEER.

Cancer Causes Control 2020 May 6;31(5):511-516. Epub 2020 Mar 6.

Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.

Purpose: A comparison of stage at cancer diagnosis and cancer treatment rates between people with HIV (PWH) and the general US population is needed to identify any disparities by HIV status.

Methods: We compared 236 PWH in clinical care diagnosed with cancer from 1997 to 2014 to a sample from NCI's Surveillance, Epidemiology and End Results (SEER) Program, presumed to be HIV negative. We performed G-computation using random forest methods to estimate stage and treatment percent differences (PD) by HIV. We conducted sensitivity analyses among non-AIDS-defining cancers (NADC), by sex and by CD4 ≤ 200 or > 200 cells/mm.

Results: PWH were less likely to be diagnosed at localized stage (PD = - 16%; 95% CI - 21, - 11) and more likely to be diagnosed at regional stage (PD = 14%; 95% CI 8, 19) than those in SEER. Cancer treatment rates were 13% lower among PWH as compared to SEER (95% CI - 18, - 8). The difference in percent receiving cancer treatment was more pronounced for those with lower CD4 at cancer diagnosis (PD -15%; 95% CI - 27, - 6). Lower treatment rates were observed among NADC, males, and women with CD4 ≤ 200.

Conclusion: Cancer care for PWH could be improved by diagnosis at earlier stages and increasing rates of cancer treatment.
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http://dx.doi.org/10.1007/s10552-020-01289-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7416538PMC
May 2020

Reducing the Population Burden of Coronary Heart Disease by Modifying Adiposity: Estimates From the ARIC Study.

J Am Heart Assoc 2020 02 6;9(4):e012214. Epub 2020 Feb 6.

Department of Epidemiology Gillings School of Global Public Health University of North Carolina at Chapel Hill NC.

Background Excess adiposity, which affects 69% of US adults, increases coronary heart disease (CHD) risk in an association that manifests below conventional obesity cut points. The population-level impact on CHD risk that is attainable through modest adiposity reductions in populations is not well characterized. We estimated the effect of hypothetical reductions in both body mass index (BMI) and waist circumference (WC) on CHD incidence. Methods and Results The study population included 13 610 ARIC (Atherosclerosis Risk in Communities) participants. Our hypothetical reduction in BMI or WC was applied relative to the temporal trend, with no hypothetical reduction among those with BMI >24 or WC >88 cm, respectively. This threshold for hypothetical reduction is near the clinical guidelines for excess adiposity. CHD risk differences compared the hypothetical reduction with no reduction. Sensitivity analysis was conducted to estimate the effect of applying the hypothetical BMI reduction at the established overweight cut point of 25. Cumulative 12-year CHD incidence with no intervention was 6.3% (95% CI, 5.9-6.8%). Risk differences following the hypothetical BMI and WC reductions were -0.6% (95% CI, -1.0% to -0.1%) and -1.0% (95% CI, -1.4% to -0.5%), respectively. These results were robust for the sensitivity analyses. Consequently, we estimated that this hypothetical reduction of 5% in BMI and WC, respectively, could have prevented 9% and 16%, respectively, of the CHD events occurring in this study population over 12 years, after adjustment for established CHD risk factors. Conclusions Meaningful CHD risk reductions could derive from modest reductions in adiposity attainable through lifestyle modification.
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http://dx.doi.org/10.1161/JAHA.119.012214DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7070207PMC
February 2020

Limitations of the UNAIDS 90-90-90 metrics: a simulation-based comparison of cross-sectional and longitudinal metrics for the HIV care continuum.

AIDS 2020 06;34(7):1047-1055

Carolina Population Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.

Objectives: The Joint United Nations Programme on HIV/AIDS (UNAIDS) 90-90-90 and other cross-sectional metrics can lead to potentially counterintuitive conclusions when used to evaluate health systems' performance. This study demonstrates how time and population dynamics impact UNAIDS 90-90-90 metrics in comparison with a longitudinal analogue.

Design: A simplified simulation representing a hypothetical population was used to estimate and compare inference from UNAIDS 90-90-90 metrics and longitudinal metrics based on Kaplan-Meier-estimated 2-year probability of transition between stages.

Methods: We simulated a large cohort over 15 years. Everyone started out at risk for HIV, and then transitioned through the HIV care continuum based on fixed daily probabilities of acquiring HIV, learning status, entering care, initiating antiretroviral therapy (ART), and becoming virally suppressed, or dying. We varied the probability of ART initiation over three five-year periods (low, high, and low). We repeated the simulation with an increased probability of death.

Results: The cross-sectional probability of being on ART among persons who were diagnosed responded relatively slowly to changes in the rate of ART initiation. Increases in ART initiation rates caused apparent declines in the cross-sectional probability of being virally suppressed among persons who had initiated ART, despite no changes in the rate of viral suppression. In some cases, higher mortality resulted in the cross-sectional metrics implying improved healthcare system performance. The longitudinal continuum was robust to these issues.

Conclusion: The UNAIDS 90-90-90 care continuum may lead to incorrect inference when used to evaluate health systems performance. We recommend that evaluation of HIV care delivery include longitudinal care continuum metrics wherever possible.
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http://dx.doi.org/10.1097/QAD.0000000000002502DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7253182PMC
June 2020

Immune Status and Associated Mortality After Cancer Treatment Among Individuals With HIV in the Antiretroviral Therapy Era.

JAMA Oncol 2020 02;6(2):227-235

Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.

Importance: Immunologic decline associated with cancer treatment in people with HIV is not well characterized. Quantifying excess mortality associated with cancer treatment-related immunosuppression may help inform cancer treatment guidelines for persons with HIV.

Objective: To estimate the association between cancer treatment and CD4 count and HIV RNA level in persons with HIV and between posttreatment CD4 count and HIV RNA trajectories and all-cause mortality.

Design, Setting, And Participants: This observational cohort study included 196 adults with HIV who had an incident first cancer and available cancer treatment data while in the care of The Johns Hopkins HIV Clinic from January 1, 1997, through March 1, 2016. The study hypothesized that chemotherapy and/or radiotherapy in people with HIV would increase HIV RNA levels owing to treatment tolerability issues and would be associated with a larger initial decline in CD4 count and slower CD4 recovery compared with surgery or other treatment. An additional hypothesis was that these CD4 count declines would be associated with higher mortality independent of baseline CD4 count, antiretroviral therapy use, and risk due to the underlying cancer. Data were analyzed from December 1, 2017, through April 1, 2018.

Exposures: Initial cancer treatment category (chemotherapy and/or radiotherapy vs surgery or other treatment).

Main Outcomes And Measures: Post-cancer treatment longitudinal CD4 count, longitudinal HIV RNA level, and all-cause mortality.

Results: Among the 196 participants (135 [68.9%] male; median age, 50 [interquartile range, 43-55] years), chemotherapy and/or radiotherapy decreased initial CD4 count by 203 cells/μL (95% CI, 92-306 cells/μL) among those with a baseline CD4 count of greater than 500 cells/μL. The decline for those with a baseline CD4 count of no greater than 350 cells/μL was 45 cells/μL (interaction estimate, 158 cells/μL; 95% CI, 31-276 cells/μL). Chemotherapy and/or radiotherapy had no detrimental association with HIV RNA levels. After initial cancer treatment, every 100 cells/μL decrease in CD4 count resulted in a 27% increase in mortality (hazard ratio, 1.27; 95% CI, 1.08-1.53), adjusting for HIV RNA level. No significant increase in mortality was associated with a unit increase in log10 HIV RNA after adjusting for CD4 count (hazard ratio, 1.24; 95% CI, 0.94-1.65).

Conclusions And Relevance: In this study, chemotherapy and/or radiotherapy was associated with significantly reduced initial CD4 count in adults with HIV compared with surgery or other treatment. Lower CD4 count after cancer treatment was associated with an increased hazard of mortality. Further research is necessary on the immunosuppressive effects of cancer treatment in adults with HIV and whether health care professionals must consider the balance of cancer treatment efficacy against the potential cost of further immunosuppression. Monitoring of immune status may also be helpful given the decrease in CD4 count after treatment and the already immunocompromised state of patients with HIV.
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http://dx.doi.org/10.1001/jamaoncol.2019.4648DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6902188PMC
February 2020

Short Communication: Differences in 5-Year Survival After Cancer Diagnosis Between HIV Clinic Enrollees and the General U.S. Population.

AIDS Res Hum Retroviruses 2020 02 17;36(2):116-118. Epub 2019 Dec 17.

Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.

A total of 236 people with HIV (PWH) with cancer diagnosed between 1997 and 2014 in the Johns Hopkins HIV Clinical Cohort (JHHCC) were compared with a sample from NCI's Surveillance, Epidemiology, and End Results (SEER) Program, presumed to be HIV negative. Using G-computation with random survival forest methods, we estimated 5-year restricted mean survival time (RMST) differences by HIV status. Sensitivity analyses were performed among non-AIDS defining cancers, males, females, and stratifying PWH by CD4 ≤ 200 or >200 cells/mm at cancer diagnosis. PWH with CD4 ≤ 200 cells/mm had decreased survival compared with those in SEER (-7 months; 95% CI = -13 to -2). Women with HIV and CD4 ≤ 200 cells/mm at cancer diagnosis had lower survival than SEER women (-10 months; 95% CI = -18 to -2). In the total population, there was no significant difference in 5-year RMST; however, women with HIV and low CD4 had higher mortality despite accounting for stage at diagnosis and first course of cancer treatment.
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http://dx.doi.org/10.1089/AID.2019.0145DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7044775PMC
February 2020

Tobacco Smoking, Substance Use, and Mental Health Symptoms in People with HIV in an Urban HIV Clinic.

J Health Care Poor Underserved 2019 ;30(3):1083-1102

The prevalence of tobacco smoking among people with HIV (PWH) ranges from 40% to 70%. Additionally, tobacco smoking is higher among low-income individuals, yet few studies have examined tobacco smoking in low socioeconomic status PWH. Using data from a cohort of PWH receiving care in an urban HIV clinic, we characterized factors associated with current and former smoking and with initiation/re-initiation and cessation of tobacco use. Among a study sample of 1,607 PWH, the prevalence of current smoking was 46.6% among men and 46.0% among women. Current smoking in men and women was associated with Medicaid insurance status, substance use, and panic symptoms. In women, but not men, hazardous alcohol use decreased the likelihood of quitting smoking and increased the risk of initiation/re-initiation. Smoking interventions for low-income, urban PWH may need to be tailored to address mental health and substance use comorbidities.
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http://dx.doi.org/10.1353/hpu.2019.0075DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7304241PMC
April 2020

Censoring for Loss to Follow-up in Time-to-event Analyses of Composite Outcomes or in the Presence of Competing Risks.

Epidemiology 2019 11;30(6):817-824

From the Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.

Background: In time-to-event analyses, there is limited guidance on when persons who are lost to follow-up (LTFU) should be censored.

Methods: We simulated bias in risk estimates for: (1) a composite event of measured (outcome only observable in a patient encounter) and captured events (outcome observable outside a patient encounter); and a (2) measured or (3) captured event in the presence of a competing event of the other type, under three censoring strategies: (i) censor at the last study encounter; (ii) censor when LTFU definition is met; and (iii) a new, hybrid censoring strategy. We demonstrate the real-world impact of this decision by estimating: (1) time to acquired immune deficiency syndrome (AIDS) diagnosis or death, (2) time to initiation of antiretroviral therapy (ART), and (3) time to death before ART initiation among adults engaged in HIV care.

Results: For (1) our hybrid censoring strategy was least biased. In our example, 5-year risk of AIDS or death was overestimated using last-encounter censoring (25%) and under-estimated using LTFU-definition censoring (21%), compared with results from our hybrid approach (24%). Last-encounter censoring was least biased for (2). When estimating 5-year risk of ART initiation, LTFU-definition censoring underestimated risk (80% vs. 85% using last-encounter censoring). LTFU-definition censoring was least biased for (3). When estimating 5-year risk of death before ART initiation, last-encounter censoring overestimated risk (5.2% vs. 4.7% using LTFU-definition censoring).

Conclusions: The least biased censoring strategy for time-to-event analyses in the presence of LTFU depends on the event and estimand of interest.
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http://dx.doi.org/10.1097/EDE.0000000000001073DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6768756PMC
November 2019

Recent Substance Use and Probability of Unsuppressed HIV Viral Load Among Persons on Antiretroviral Therapy in Continuity Care.

Am J Epidemiol 2019 10;188(10):1830-1837

Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland.

Among persons with human immunodeficiency virus (HIV) infection, illegal drug use and hazardous alcohol use are hypothesized to be strong risk factors for failure to achieve or maintain a suppressed HIV viral load, but accurate quantification of this association is difficult because of challenges involved in measuring substance use as part of routine clinical care. We estimated the associations of recent cocaine use, opioid/heroin use, and hazardous alcohol use with unsuppressed viral load among 1,554 persons receiving care at the John G. Bartlett Specialty Practice (Baltimore, Maryland) between 2013 and 2017. We accounted for measurement error in substance use using Bayesian models and prior estimates of the sensitivity and specificity of 2 imperfect measures of substance use derived from a previous analysis in this cohort. The prevalence difference for unsuppressed viral load associated with recent cocaine use was 11.3% (95% credible interval (CrI): 6.4, 17.0); that associated with recent opioid/heroin use was 13.2% (95% CrI: 6.6, 20.7); and that associated with recent hazardous alcohol use was 8.5% (95% CrI: 3.2, 14.4). Failure to account for measurement error resulted in clinically meaningful underestimates of the prevalence difference. Time-varying substance use is prevalent and difficult to measure in routine care; here we demonstrate a method that improves the utility of imperfect data by accounting for measurement error.
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http://dx.doi.org/10.1093/aje/kwz159DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6768806PMC
October 2019

Association of History of Injection Drug Use with External Cause-Related Mortality Among Persons Linked to HIV Care in an Urban Clinic, 2001-2015.

AIDS Behav 2019 Dec;23(12):3286-3293

Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 N Wolfe St, Baltimore, MD, 21205, USA.

High mortality rates among persons with HIV with a history of injection drug use (PWID) are thought to be driven in part by higher rates of external cause-related mortality. We followed 4796 persons aged 18-70 engaged in continuity HIV care from 2001 to 2015 until death or administrative censoring. We compared cause-specific (csHR) and subdistribution hazards (sdHR) of death due to external causes among PWID and persons who acquired their HIV infection through other routes (non-IDU). We standardized estimates on age, sex, race, and HIV-related health status. The standardized csHR for external cause-related death was 3.57 (95% CI 2.39, 5.33), and the sdHR was 3.14 (95% CI 2.16, 4.55). The majority of external cause-related deaths were overdose-related and standardized sdHR was 4.02 (95% CI 2.40, 6.72). Absolute rate of suicide was low but the csHR for PWID compared to non-IDU was most elevated for suicide (6.50, 95% CI 1.51, 28.03). HIV-infected PWID are at a disproportionately increased risk of death due to external causes, particularly overdose and suicide.
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http://dx.doi.org/10.1007/s10461-019-02497-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6778696PMC
December 2019
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