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Empirical Development of a Behavioral Intervention for African American/Black and Latino Persons with Unsuppressed HIV Viral Load Levels: An Application of the Multiphase Optimization Strategy (MOST) Using Cost-Effectiveness as an Optimization Objective
Feelemyer, Jonathan; Braithwaite, R Scott; Zhou, Qinlian; Cleland, Charles M; Manandhar-Sasaki, Prima; Wilton, Leo; Ritchie, Amanda; Collins, Linda M; Gwadz, Marya V
We used results from an optimization randomized controlled trial which tested five behavioral intervention components to support HIV antiretroviral adherence/HIV viral suppression, grounded in the multiphase optimization strategy and using a fractional factorial design to identify intervention components with cost-effectiveness sufficiently favorable for scalability. Results were incorporated into a validated HIV computer simulation to simulate longer-term effects of combinations of components on health and costs. We simulated the 32 corresponding long-term trajectories for viral load suppression, health related quality of life (HRQoL), and costs. The components were designed to be culturally and structurally salient. They were: motivational interviewing counseling sessions (MI), pre-adherence skill building (SB), peer mentorship (PM), focused support groups (SG), and patient navigation (short version [NS], long version [NL]. All participants also received health education on HIV treatment. We examined four scenarios: one-time intervention with and without discounting and continuous interventions with and without discounting. In all four scenarios, interventions that comprise or include SB and NL (and including health education) were cost effective (< $100,000/quality-adjusted life year). Further, with consideration of HRQoL impact, maximal intervention became cost-effective enough to be scalable. Thus, a fractional factorial experiment coupled with cost-effectiveness analysis is a promising approach to optimize multi-component interventions for scalability. The present study can guide service planning efforts for HIV care settings and health departments.
PMCID:11415978
PMID: 38662280
ISSN: 1573-3254
CID: 5732902
Race and Ethnicity Are Related to Undesirable Home Health Care Outcomes in Seriously Ill Older Adults
Jones, Tessa; Luth, Elizabeth A; Cleland, Charles M; Brody, Abraham A
OBJECTIVES/OBJECTIVE:Medicare Home Health Care (HHC) services are integral to the care of homebound seriously ill older adults requiring ongoing specialized medical care. Although disparities in health outcomes are well documented in inpatient and primary care, disparities experienced by historically marginalized racial and ethnic groups underrepresented in HHC are understudied. This study aimed to examine the relationship between individual characteristics and differences in HHC health outcomes for seriously ill older adults. DESIGN/METHODS:Secondary data analysis, repeated measure. SETTING AND PARTICIPANTS/METHODS:Seriously ill older adults who received HHC in 2016 in the HHC Outcome and Assessment Information Set (OASIS). METHODS:Start of care and discharge data from the 2016 HCC OASIS were used to examine the relationship between individual characteristics and differences in HHC health outcomes identified by the Centers for Medicare and Medicaid Services as key indicators of quality in HHC, including dyspnea, pain frequency, cognitive functioning, and presence of unhealed pressure ulcer stage II or higher. A generalized ordered logit model with partial proportional odds was used for the ordinal categorical outcomes and a logistic regression was used for the binary dependent variable. RESULTS:Findings indicated that of 227,402 seriously ill individuals with an HHC episode in 2016, those from underrepresented racial and ethnic groups had between 14% and 57% higher odds of worse health outcomes compared with non-Hispanic white patients with the exception of pain frequency. CONCLUSIONS AND IMPLICATIONS/CONCLUSIONS:For people living with serious illness, there are significant differences in Medicare HHC health outcomes when comparing underrepresented racial or ethnic beneficiaries with white counterparts. More research is needed to understand how health care processes such as referral patterns or time to care initiation, and structural factors such as HHC agency quality and neighborhood social deprivation are related to health differences observed in the population.
PMCID:11139601
PMID: 38604244
ISSN: 1538-9375
CID: 5657342
Impact of decarceration plus alcohol, substance use, and mental health screening on life expectancies of Black sexual minority men and Black transgender women (BSMM/BTW) living with HIV in the United States: A Simulation Study based on HPTN 061
Feelemyer, Jonathan; Bershteyn, Anna; Scheidell, Joy D; Brewer, Russell; Dyer, Typhanye V; Cleland, Charles M; Hucks-Ortiz, Christopher; Justice, Amy; Mayer, Ken; Grawert, Ames; Kaufman, Jay S; Braithwaite, Scott; Khan, Maria R
Background Given the disproportionate rates of incarceration and lower life expectancy (LE) among Black sexual minority men (BSMM) and Black transgender women (BTW) with HIV, we modeled the impact of decarceration and screening for psychiatric conditions and substance use on LE of US BSMM/BTW with HIV. Methods We augmented a microsimulation model previously validated to predict LE and leading causes of death in the US with estimates from the HPTN 061 cohort and the Veteran's Aging Cohort Studies. We estimated independent associations among psychiatric and substance use disorders, to simulate the influence of treatment of one condition on improvement on others. We used this augmented simulation to estimate LE for BSMM/BTW with HIV with a history of incarceration under alternative policies of decarceration (i.e., reducing the fraction exposed to incarceration), screening for psychiatric conditions and substance use, or both. Results Baseline LE was 61.3 years. Reducing incarceration by 25%, 33%, 50%, and 100% increased LE by 0.29 years, 0.31 years, 0.53 years, and 1.08 years, respectively, versus no reductions in incarceration. When reducing incarceration by 33% and implementing screening for alcohol, tobacco, substance use, and depression, in which a positive screen triggers diagnostic assessment for all psychiatric and substance use conditions and linkage to treatment, LE increased by 1.52 years compared to no screening or decarceration. Discussion LE among BSMM/BTW with HIV is short compared with other people with HIV. Reducing incarceration and improving screening and treatment of psychiatric conditions and substance use could substantially increase LE in this population.
PMID: 38032748
ISSN: 1944-7884
CID: 5616952
Using decision analysis for intervention value efficiency to select optimized interventions in the multiphase optimization strategy
Strayhorn, Jillian C; Cleland, Charles M; Vanness, David J; Wilton, Leo; Gwadz, Marya; Collins, Linda M
OBJECTIVE:Optimizing multicomponent behavioral and biobehavioral interventions presents a complex decision problem. To arrive at an intervention that is both effective and readily implementable, it may be necessary to weigh effectiveness against implementability when deciding which components to select for inclusion. Different components may have differential effectiveness on an array of outcome variables. Moreover, different decision-makers will approach this problem with different objectives and preferences. Recent advances in decision-making methodology in the multiphase optimization strategy (MOST) have opened new possibilities for intervention scientists to optimize interventions based on a wide variety of decision-maker preferences, including those that involve multiple outcome variables. In this study, we introduce decision analysis for intervention value efficiency (DAIVE), a decision-making framework for use in MOST that incorporates these new decision-making methods. We apply DAIVE to select optimized interventions based on empirical data from a factorial optimization trial. METHOD/METHODS:We define various sets of hypothetical decision-maker preferences, and we apply DAIVE to identify optimized interventions appropriate to each case. RESULTS:We demonstrate how DAIVE can be used to make decisions about the composition of optimized interventions and how the choice of optimized intervention can differ according to decision-maker preferences and objectives. CONCLUSIONS:We offer recommendations for intervention scientists who want to apply DAIVE to select optimized interventions based on data from their own factorial optimization trials. (PsycInfo Database Record (c) 2024 APA, all rights reserved).
PMID: 37535575
ISSN: 1930-7810
CID: 5626332
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
Factors associated with retention in Quitline counseling for smoking cessation among HIV-positive smokers receiving care at HIV outpatient clinics in Vietnam
Nguyen, Nam Truong; Nguyen, Trang; Vu, Giap Van; Cleland, Charles M; Pham, Yen; Truong, Nga; Kapur, Reet; Alvarez, Gloria Guevara; Phan, Phuong Thu; Armstrong-Hough, Mari; Shelley, Donna
BACKGROUND:Quitline counseling is an effective method for supporting smoking cessation, offering personalized and accessible assistance. Tobacco use is a significant public health issue among people living with HIV. In Vietnam, over 50% of men living with HIV use tobacco. However, there is limited research on Quitline use and retention rates in this population and a lack of research on factors associated with retention in Quitline counseling. The study aims to evaluate the factors associated with retention in Quitline counseling for smoking cessation among HIV-positive smokers receiving care at HIV outpatient clinics in Vietnam. METHOD/METHODS:The study analyzed data from a randomized controlled trial (RCT) that compared the effectiveness of three smoking cessation interventions for smokers living with HIV at 13 Outpatient Clinics in Ha Noi. A total of 221 smokers aged 18 and above living with HIV participated in Arm 1 of the RCT, which included screening for tobacco use (Ask), health worker-delivered brief counseling (Assist), and proactive referral to Vietnam's national Quitline (AAR), in which the Quitline reached out to the patient to engage them in up to 10 sessions of smoking cessation counseling. Retention in Quitline counseling was defined as participating in more than five counseling calls. The study used bivariate and logistic regression analyses to explore the associations between retention and other factors. RESULTS:Fifty-one percent of HIV-positive smokers completed more than five counseling sessions. Smokers living with HIV aged 35 or older (OR = 5.53, 95% CI 1.42-21.52), who had a very low/low tobacco dependence level (OR = 2.26, 95% CI 1.14-4.51), had a lower score of perceived importance of quitting cigarettes (OR = 0.87, 95% CI 0.76-0.99), had a household ban or partial ban on cigarettes smoking (OR = 2.58, 95% CI 1.39-4.80), and had chosen a quit date during the Quitline counseling (OR = 3.0, 95% CI 1.63-5.53) were more likely to retain in the Quitline counseling than those smokers living with HIV whose ages were less than 35, who had a high/very high tobacco dependence level, had a higher score of perception of the importance of quitting cigarettes, did not have a household ban on cigarettes smoking, and did not choose a quit date during counseling. CONCLUSION/CONCLUSIONS:There is a high retention rate in Quitline counseling services among PLWHs receiving care at HIV outpatient clinics. Tailoring interventions to the associated factors such as age, tobacco dependence, perceived importance of quitting, household smoking bans, and setting a quit date during counseling may improve engagement and outcomes, aiding in the reduction of smoking prevalence among HIV-positive individuals.
PMCID:11687760
PMID: 39739725
ISSN: 1932-6203
CID: 5779232
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