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Longitudinal association between e-cigarette use and respiratory symptoms among US adults: Findings from the Population Assessment of Tobacco and Health Study Waves 4-5

Karey, Emma; Xu, Shu; He, Pan; Niaura, Raymond S; Cleland, Charles M; Stevens, Elizabeth R; Sherman, Scott E; El-Shahawy, Omar; Cantrell, Jennifer; Jiang, Nan
BACKGROUND:We assessed longitudinal effects of e-cigarette use on respiratory symptoms in a nationally representative sample of US adults by combustible tobacco smoking status. METHODS:We analyzed Waves 4-5 public-use data from the Population Assessment of Tobacco and Health Study. Study sample included adult respondents who reported no diagnosis of respiratory diseases at Wave 4, and completed Waves 4-5 surveys with no missing data on analytic variables (N = 15,291). Outcome was a validated index of functionally important respiratory symptoms based on 7 wheezing/cough questions (range 0-9). An index score of ≥2 was defined as having important respiratory symptoms. Weighted lagged logistic regression models were performed to examine the association between e-cigarette use status at Wave 4 (former/current vs. never use) and important respiratory symptoms at Wave 5 by combustible tobacco smoking status (i.e., never/former/current smokers), adjusting for Wave 4 respiratory symptom index, sociodemographic characteristics, secondhand smoke exposure, body mass index, and chronic disease. RESULTS:Among current combustible tobacco smokers, e-cigarette use was associated with increased odds of reporting important respiratory symptoms (former e-cigarette use: adjusted odds ratio [AOR] = 1.39, 95% confidence interval [CI]: 1.07-1.81; current e-cigarette use: AOR = 1.55, 95% CI: 1.17-2.06). Among former combustible tobacco smokers, former e-cigarette use (AOR = 1.51, 95% CI: 1.06-2.15)-but not current e-cigarette use (AOR = 1.59, 95% CI: 0.91-2.78)-was associated with increased odds of important respiratory symptoms. Among never combustible tobacco smokers, no significant association was detected between e-cigarette use and important respiratory symptoms (former e-cigarette use: AOR = 1.62, 95% CI: 0.76-3.46; current e-cigarette use: AOR = 0.82, 95% CI: 0.27-2.56). CONCLUSIONS:The association between e-cigarette use and respiratory symptoms varied by combustible tobacco smoking status. Current combustible tobacco smokers who use e-cigarettes have an elevated risk of respiratory impairments.
PMCID:10903800
PMID: 38421978
ISSN: 1932-6203
CID: 5644112

Trends in reported and biologically confirmed drug use among people who use ecstasy in the nightclub/festival-attending population, 2016-2022

Palamar, Joseph J; Salomone, Alberto; Massano, Marta; Cleland, Charles M
BACKGROUND/UNASSIGNED:Nightclub/festival attendees are a population with high rates of party drug use, but research is needed to determine whether there have been shifts in unintended drug exposure in this population (e.g., via adulterants) to inform prevention and harm reduction efforts. METHODS/UNASSIGNED:Adults entering nightclubs and festivals in New York City were asked about past-year drug use in 2016 through 2022, with a subset providing a hair sample for testing. We focused on the 1943 who reported ecstasy use (of which 247 had a hair sample analyzed) and compared trends in self-reported drug use, drug positivity, and adjusted prevalence (adjusting for unreported use). RESULTS/UNASSIGNED:MDMA positivity decreased from 74.4 % to 42.3 %, and decreases occurred regarding detection of synthetic cathinones ("bath salts"; a 100.0 % decrease), MDA (a 76.9 % decrease), amphetamine (an 81.3 % decrease), methamphetamine (a 64.2 % decrease), and ketamine (a 33.4 % decrease) (ps < .05). Although prevalence of MDA and synthetic cathinone use was comparable between self-report and adjusted report in 2022, gaps in prevalence were wider in 2016 (ps < .01). Adjusted prevalence of synthetic cathinone use decreased more across time than prevalence based on self-report (a 79.4 % vs. 69.1 % decrease) and adjusted report for MDA use decreased more than prevalence based on self-report (a 50.6 % vs. 38.9 % decrease). CONCLUSIONS/UNASSIGNED:Combining self-report and toxicology tests helped us determine that decreases in drug use/exposure were steeper regarding adjusted prevalence. Underreported drug exposure-possibly due to exposure to adulterants-appears to have had less of an effect on prevalence in 2022 than it did in 2016.
PMCID:10665664
PMID: 38023341
ISSN: 2772-7246
CID: 5617202

Subthreshold opioid use disorder prevention (STOP) trial: a cluster randomized clinical trial: study design and methods

Liebschutz, Jane M; Subramaniam, Geetha A; Stone, Rebecca; Appleton, Noa; Gelberg, Lillian; Lovejoy, Travis I; Bunting, Amanda M; Cleland, Charles M; Lasser, Karen E; Beers, Donna; Abrams, Catherine; McCormack, Jennifer; Potter, Gail E; Case, Ashley; Revoredo, Leslie; Jelstrom, Eve M; Kline, Margaret M; Wu, Li-Tzy; McNeely, Jennifer
BACKGROUND:Preventing progression to moderate or severe opioid use disorder (OUD) among people who exhibit risky opioid use behavior that does not meet criteria for treatment with opioid agonists or antagonists (subthreshold OUD) is poorly understood. The Subthreshold Opioid Use Disorder Prevention (STOP) Trial is designed to study the efficacy of a collaborative care intervention to reduce risky opioid use and to prevent progression to moderate or severe OUD in adult primary care patients with subthreshold OUD. METHODS:The STOP trial is a cluster randomized controlled trial, randomized at the PCP level, conducted in 5 distinct geographic sites. STOP tests the efficacy of the STOP intervention in comparison to enhanced usual care (EUC) in adult primary care patients with risky opioid use that does not meet criteria for moderate-severe OUD. The STOP intervention consists of (1) a practice-embedded nurse care manager (NCM) who provides patient participant education and supports primary care providers (PCPs) in engaging and monitoring patient-participants; (2) brief advice, delivered to patient participants by their PCP and/or prerecorded video message, about health risks of opioid misuse; and (3) up to 6 sessions of telephone health coaching to motivate and support behavior change. EUC consists of primary care treatment as usual, plus printed overdose prevention educational materials and an educational video on cancer screening. The primary outcome measure is self-reported number of days of risky (illicit or nonmedical) opioid use over 180 days, assessed monthly via text message using items from the Addiction Severity Index and the Current Opioid Misuse Measure. Secondary outcomes assess other substance use, mental health, quality of life, and healthcare utilization as well as PCP prescribing and monitoring behaviors. A mixed effects negative binomial model with a log link will be fit to estimate the difference in means between treatment and control groups using an intent-to-treat population. DISCUSSION:Given a growing interest in interventions for the management of patients with risky opioid use, and the need for primary care-based interventions, this study potentially offers a blueprint for a feasible and effective approach to improving outcomes in this population. TRIAL REGISTRATION:Clinicaltrials.gov, identifier NCT04218201, January 6, 2020.
PMCID:10657560
PMID: 37980494
ISSN: 1940-0640
CID: 5608242

Utility of self-report antiretroviral adherence for predicting HIV viral load among persons who inject drugs in Hai Phong Vietnam: assessing differences by methamphetamine use

Feelemyer, Jonathan; Des Jarlais, Don C; Nagot, Nicolas; Huong, Duong Thi; Oanh, Khuat Thi Hai; Khue, Pham Minh; Thi Giang, Hoang; Tuyet Thanh, Nham Thi; Cleland, Charles M; Arasteh, Kamyar; Caniglia, Ellen; Chen, Yu; Bart, Gavin; Moles, Jean Pierre; Vinh, Vu Hai; Vallo, Roselyne; Quillet, Catherine; Rapoud, Delphine; Le, Sao M; Michel, Laurent; Laureillard, Didier; Khan, Maria R
PMID: 37909053
ISSN: 1360-0451
CID: 5614452

"As safe as possible": a qualitative study of opioid withdrawal and risk behavior among people who use illegal opioids

Frank, David; Elliott, Luther; Cleland, Charles M; Walters, Suzan M; Joudrey, Paul J; Russell, Danielle M; Meyerson, Beth E; Bennett, Alex S
BACKGROUND:Opioid withdrawal is a regular occurrence among many people who use illicit opioids (PWUIO) that has also been shown to increase their willingness to engage in risk-involved behavior. The proliferation of fentanyl in the illicit opioid market may have amplified this relationship, potentially putting PWUIO at greater risk of negative health outcomes. Understanding the relationship between withdrawal and risk-involved behavior may also have important implications for the ways that problematic drug use is conceptualized, particularly in disease models of addiction, which position risk behavior as evidence of pathology that helps to justify ontological distinctions between addicts and non-addicts. Examining withdrawal, and its role in PWUIO's willingness to engage in risk, may aid in the development of alternative theories of risk involvement and create discursive spaces for de-medicalizing and de-othering people who use illegal drugs. METHODS:This article is based on 32 semi-structured interviews with PWUIO in the New York City area who also reported recent withdrawal experience. Interviews were conducted remotely between April and August 2022 and recorded for later transcription. Data were then coded and analyzed based on a combination of inductive and deductive coding strategies and informed by the literature. RESULTS:Participants described a strong relationship between withdrawal and their willingness to engage in risk-involved behavior that was exacerbated by the proliferation of fentanyl. Yet, their descriptions did not align with narratives of risk as a product of bad decisions made by individuals. Rather, data demonstrated the substantial role of social and structural context, particularly drug policies like prohibition and criminalization, in the kinds of risks that PWUIO faced and their ability to respond to them. CONCLUSIONS:Withdrawal should be taken more seriously both from an ethical perspective and as an important catalyst of risk behavior. However, theories that position activities taken to avoid withdrawal as irrational and as evidence of pathology are poorly aligned with the complexity of PWUIO's actual lives. We recommend the use of less deterministic and less medicalized theories of risk that better account for differences between how people view the world, and for the role of socio-structural forces in the production of risk.
PMCID:10605476
PMID: 37891630
ISSN: 1477-7517
CID: 5609632

Understanding why racial/ethnic inequities along the HIV care continuum persist in the United States: a qualitative exploration of systemic barriers from the perspectives of African American/Black and Latino persons living with HIV

Filippone, Prema; Serrano, Samantha; Campos, Stephanie; Freeman, Robin; Cluesman, Sabrina R; Israel, Khadija; Amos, Brianna; Cleland, Charles M; Gwadz, Marya
BACKGROUND:Racial/ethnic inequities along the HIV care continuum persist in the United States despite substantial federal investment. Numerous studies highlight individual and social-level impediments in HIV, but fewer foreground systemic barriers. The present qualitative study sought to uncover and describe systemic barriers to the HIV care continuum from the perspectives of African American/Black and Latino persons living with HIV (PLWH) with unsuppressed HIV viral load, including how barriers operated and their effects. METHODS:Participants were African American/Black and Latino PLWH with unsuppressed HIV viral load (N = 41). They were purposively sampled for maximum variability on key indices from a larger study. They engaged in semi-structured in-depth interviews that were audio-recorded and professionally transcribed. Data were analyzed using directed content analysis. RESULTS:Participants were 49 years old, on average (SD = 9), 76% were assigned male sex at birth, 83% were African American/Black and 17% Latino, 34% were sexual minorities (i.e., non-heterosexual), and 22% were transgender/gender-nonbinary. All had indications of chronic poverty. Participants had been diagnosed with HIV 19 years prior to the study, on average (SD = 9). The majority (76%) had taken HIV medication in the six weeks before enrollment, but at levels insufficient to reach HIV viral suppression. Findings underscored a primary theme describing chronic poverty as a fundamental cause of poor engagement. Related subthemes were: negative aspects of congregate versus private housing settings (e.g., triggering substance use and social isolation); generally positive experiences with health care providers, although structural and cultural competency appeared insufficient and managing health care systems was difficult; pharmacies illegally purchased HIV medication from PLWH; and COVID-19 exacerbated barriers. Participants described mitigation strategies and evidenced resilience. CONCLUSIONS:To reduce racial/ethnic inequities and end the HIV epidemic, it is necessary to understand African American/Black and Latino PLWH's perspectives on the systemic impediments they experience throughout the HIV care continuum. This study uncovers and describes a number of salient barriers and how they operate, including unexpected findings regarding drug diversion and negative aspects of congregate housing. There is growing awareness that systemic racism is a core determinant of systemic barriers to HIV care continuum engagement. Findings are interpreted in this context.
PMCID:10466874
PMID: 37649049
ISSN: 1475-9276
CID: 5607032

Mediation of the Effect of Incarceration on Selling Sex Among Black Sexual Minority Men and Black Transgender Women in the HPTN 061 Study

Remch, Molly; Scheidell, Joy D; Cleland, Charles M; Turpin, Rodman; Duncan, Dustin T; Dyer, Typhanye T; Kaufman, Jay S; Mazumdar, Medha; Brewer, Russell; Feelemyer, Jonathan; Mayer, Kenneth H; Khan, Maria R
Incarceration among Black sexual minority men and Black transgender women (BSMM/BTW) is disproportionately high in the United States. Limited research has documented the disruptive effect of incarceration on sexual networks and sexual partnership exchange among BSMM/BTW. We estimate the influence of incarceration on selling sex and mediating pathways among 1169 BSMM/BTW enrolled in the HIV Prevention Trials Network (HPTN) 061 cohort to assess this relationship. Mediators investigated were social support, violence, illicit drug use, and distress due to experienced racism and homophobia. During the 6 months following baseline, 14% of the cohort was incarcerated, including 24% of BTW. After adjustment, recent incarceration was associated with 1.57 (95% CI 1.02, 2.42) times the risk of subsequently selling sex. The hypothesized mediators together explained 25% of the relationship, with an indirect effect risk ratio of 1.09 (95% CI 0.97, 1.24). Our results document an association and call for more research investigating mechanisms.
PMID: 36746876
ISSN: 1573-3254
CID: 5536312

The POP (Permanent Supportive Housing Overdose Prevention) Study: protocol for a hybrid type 3 stepped-wedge cluster randomized controlled trial

Doran, Kelly M; Torsiglieri, Allison; Blaufarb, Stephanie; Hernandez, Patricia; Melnick, Emily; Velez, Lauren; Cleland, Charles M; Neighbors, Charles; O'Grady, Megan A; Shelley, Donna
BACKGROUND:Permanent supportive housing (PSH)-subsidized housing paired with support services such as case management-is a key part of national strategic plans to end homelessness. PSH tenants face high overdose risk due to a confluence of individual and environmental risk factors, yet little research has examined overdose prevention in PSH. METHODS:We describe the protocol for a hybrid type 3 stepped-wedge cluster randomized controlled trial (RCT) of overdose prevention practice implementation in PSH. We adapted evidence-based overdose prevention practices and implementation strategies for PSH using input from stakeholder focus groups. The trial will include 20 PSH buildings (with building size ranging from 20 to over 150 tenants) across New York City and New York's Capital Region. Buildings will be randomized to one of four 6-month intervention waves during which they will receive a package of implementation support including training in using a PSH Overdose Prevention (POP) Toolkit, time-limited practice facilitation, and learning collaboratives delivered to staff and tenant implementation champions appointed by each building. The primary outcome is building-level fidelity to a defined list of overdose prevention practices. Secondary and exploratory implementation and effectiveness outcomes will be examined using PSH staff and tenant survey questionnaires, and analysis of tenant Medicaid data. We will explore factors related to implementation success, including barriers and facilitators, using qualitative interviews with key stakeholders. The project is being conducted through an academic-community partnership, and an Advisory Board including PSH tenants and other key stakeholders will be engaged in all stages of the project. DISCUSSION:We describe the protocol for a hybrid type 3 stepped-wedge cluster RCT of overdose prevention practice implementation in PSH. This study will be the first controlled trial of overdose prevention implementation in PSH settings. The research will make a significant impact by testing and informing future implementation strategies to prevent overdose for a population at particularly high risk for overdose mortality. Findings from this PSH-focused research are expected to be broadly applicable to other housing settings and settings serving people experiencing homelessness. TRIAL REGISTRATION:ClinicalTrials.gov, NCT05786222 , registered 27 March 2023.
PMCID:10246871
PMID: 37287026
ISSN: 1748-5908
CID: 5541642

Facilitation of team-based care to improve HTN management and outcomes: a protocol for a randomized stepped wedge trial

Shelley, Donna R; Brown, Dominique; Cleland, Charles M; Pham-Singer, Hang; Zein, Dina; Chang, Ji Eun; Wu, Winfred Y
BACKGROUND:There are well-established guidelines for treating hypertension (HTN), yet only half of patients with HTN meet the defined target of < 140/90. Team-based care (TBC) is an evidence-based strategy for improving blood pressure (BP) management and control. TBC is defined as the provision of health services by at least two health professionals "who work collaboratively with patients and their caregivers to accomplish shared goals to achieve coordinated, high-quality care". However, primary care practices experience challenges to implementing TBC principles and care processes; these are more pronounced in small independent practice settings (SIPs). Practice facilitation (PF) is an implementation strategy that may overcome barriers to adopting evidence-based TBC to improve HTN management in SIPs. METHODS:Using a stepped wedge randomized controlled trial design, we will test the effect of PF on the adoption of TBC to improve HTN management in small practices (< 5 FTE clinicians) in New York City, and the impact on BP control compared with usual care. We will enroll 90 SIPs and randomize them into one of three 12-month intervention waves. Practice facilitators will support SIPs to adopt TBC principles to improve implementation of five HTN management strategies (i.e., panel management, population health, measuring BP, supporting medication adherence, self-management). The primary outcome is the adoption of TBC for HTN management measured at baseline and 12 months. Secondary outcomes include the rate of BP control and sustainability of TBC and BP outcomes at 18 months. Aggregated data on BP measures are collected every 6 months in all clusters so that each cluster provides data points in both the control and intervention conditions. Using a mixed methods approach, we will also explore factors that influence the effectiveness of PF at the organization and team level. DISCUSSION/CONCLUSIONS:This study will provide much-needed guidance on how to optimize adoption and sustainability of TBC in independent primary care settings to reduce the burden of disease related to suboptimal BP control and advance understanding of how facilitation works to improve implementation of evidence-based interventions. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov; NCT05413252 .
PMCID:10230682
PMID: 37259081
ISSN: 1472-6963
CID: 5538272

Effects of Behavioral Intervention Components for African American/Black and Latino Persons Living with HIV with Non-suppressed Viral Load Levels: Results of an Optimization Trial

Cleland, Charles M; Gwadz, Marya; Collins, Linda M; Wilton, Leo; Leonard, Noelle R; Ritchie, Amanda S; Martinez, Belkis Y; Silverman, Elizabeth; Sherpa, Dawa; Dorsen, Caroline
There is an urgent need for efficient behavioral interventions to increase rates of HIV viral suppression for populations with serious barriers to engagement along the HIV care continuum. We carried out an optimization trial to test the effects of five behavioral intervention components designed to address barriers to HIV care continuum engagement for African American/Black and Latino persons living with HIV (PLWH) with non-suppressed HIV viral load levels: motivational interviewing sessions (MI), focused support groups (SG), peer mentorship (PM), pre-adherence skill building (SB), and navigation with two levels, short (NS) and long (NL). The primary outcome was HIV viral suppression (VS) and absolute viral load (VL) and health-related quality of life were secondary outcomes. Participants were 512 African American/Black and Latino PLWH poorly engaged in HIV care and with detectable HIV viral load levels in New York City, recruited mainly through peer referral. Overall, VS increased to 37%, or 45% in a sensitivity analysis. MI and SG seemed to have antagonistic effects on VS (z = - 1.90; p = 0.057); the probability of VS was highest when either MI or SG was assigned, but not both. MI (Mean Difference = 0.030; 95% CI 0.007-0.053; t(440) = 2.60; p = 0.010) and SB (Mean Difference = 0.030; 95% CI 0.007-0.053; t(439) = 2.54; p = 0.012) improved health-related quality of life. This is the first optimization trial in the field of HIV treatment. The study yields a number of insights into approaches to improve HIV viral suppression in PLWH with serious barriers to engagement along the HIV care continuum, including chronic poverty, and underscores challenges inherent in doing so.
PMCID:10211286
PMID: 37227621
ISSN: 1573-3254
CID: 5504752