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Selecting optimized behavioral interventions from an optimization randomized controlled trial on increasing COVID-19 testing for African American/Black and Latino frontline essential workers not up-to-date on COVID-19 vaccination

Heng, Siyu; Ye, Xuancheng; Strayhorn, Jillian C; Cleland, Charles M; Parameswaran, Lalitha; Gwadz, Marya
BACKGROUND:African American/Black and Latino (AABL) persons suffer higher COVID-19 infection rates and adverse consequences (hospitalization, death) compared to White persons, especially among frontline essential workers who are not up-to-date on COVID-19 vaccination. Regular COVID-19 testing plays an essential role in mitigating such disparities. PURPOSE/OBJECTIVE:The New York Community Action Project (NCAP), conducted in New York City between July 2022 and February 2024, was motivated by the goal of developing an effective and implementable behavioral intervention to promote COVID-19 testing among AABL frontline essential workers. In the present study, we selected an optimized intervention, based on data from the NCAP optimization randomized controlled trial ("optimization RCT"), which was guided by the multiphase optimization strategy (MOST) framework. METHODS:The NCAP optimization RCT (N = 438) used a full 24 factorial design, testing the following candidate intervention components: motivational interviewing counseling (MIC; off vs. on); text messaging grounded in behavioral economics (behavioral economics intervention [BEI; off vs. on]); peer education (PE; off vs. on); and access to COVID-19 testing via either a navigation meeting [NM] or self-test kits [SK]). We applied Decision Analysis for Intervention Value Efficiency (DAIVE) to identify the optimized intervention (ie, the optimized combination of the four intervention components) that is effective at promoting the COVID-19 testing rate while remaining implementable. To estimate expected outcomes on the primary outcome (binary; self-reported COVID-19 testing at two follow-up assessments), we applied three alternative strategies for handling missing data and investigated decision-making robustness. RESULTS:The three missing data strategies did not differ in ways that would shape optimization decision-making, suggesting robustness across strategies. The optimized intervention that strategically balances effectiveness and implementability contained motivational interviewing counseling (MIC), the behavioral economics intervention (BEI), and self-test kits (SK). CONCLUSIONS:The optimized intervention we identified based on empirical data from the NCAP optimization RCT shows potential to effectively increase the COVID-19 testing rate among AABL frontline essential workers who are not up to date on COVID-19 vaccination. Our demonstration of missing data strategies under the DAIVE framework offers meaningful practical guidance for behavioral medicine researchers.
PMID: 42847356
ISSN: 1532-4796
CID: 6073997

Selecting optimized behavioral interventions from an optimization randomized controlled trial on increasing COVID-19 testing for African American/Black and Latino frontline essential workers not up-to-date on COVID-19 vaccination

Heng, Siyu; Ye, Xuancheng; Strayhorn, Jillian C; Cleland, Charles M; Parameswaran, Lalitha; Gwadz, Marya
BACKGROUND:African American/Black and Latino (AABL) persons suffer higher COVID-19 infection rates and adverse consequences (hospitalization, death) compared to White persons, especially among frontline essential workers who are not up-to-date on COVID-19 vaccination. Regular COVID-19 testing plays an essential role in mitigating such disparities. PURPOSE/OBJECTIVE:The New York Community Action Project (NCAP), conducted in New York City between July 2022 and February 2024, was motivated by the goal of developing an effective and implementable behavioral intervention to promote COVID-19 testing among AABL frontline essential workers. In the present study, we selected an optimized intervention, based on data from the NCAP optimization randomized controlled trial ("optimization RCT"), which was guided by the multiphase optimization strategy (MOST) framework. METHODS:The NCAP optimization RCT (N = 438) used a full 24 factorial design, testing the following candidate intervention components: motivational interviewing counseling (MIC; off vs. on); text messaging grounded in behavioral economics (behavioral economics intervention [BEI; off vs. on]); peer education (PE; off vs. on); and access to COVID-19 testing via either a navigation meeting [NM] or self-test kits [SK]). We applied Decision Analysis for Intervention Value Efficiency (DAIVE) to identify the optimized intervention (ie, the optimized combination of the four intervention components) that is effective at promoting the COVID-19 testing rate while remaining implementable. To estimate expected outcomes on the primary outcome (binary; self-reported COVID-19 testing at two follow-up assessments), we applied three alternative strategies for handling missing data and investigated decision-making robustness. RESULTS:The three missing data strategies did not differ in ways that would shape optimization decision-making, suggesting robustness across strategies. The optimized intervention that strategically balances effectiveness and implementability contained motivational interviewing counseling (MIC), the behavioral economics intervention (BEI), and self-test kits (SK). CONCLUSIONS:The optimized intervention we identified based on empirical data from the NCAP optimization RCT shows potential to effectively increase the COVID-19 testing rate among AABL frontline essential workers who are not up to date on COVID-19 vaccination. Our demonstration of missing data strategies under the DAIVE framework offers meaningful practical guidance for behavioral medicine researchers.
PMID: 42847356
ISSN: 1532-4796
CID: 6073998

The permanent supportive housing overdose prevention project

Doran, Kelly M; Velez, Lauren; Spiers, Andrew; Hernandez, Patricia; Blaufarb, Stephanie; Pyle, Bailey; Cleland, Charles M; Shelley, Donna; O'Grady, Megan A
BACKGROUND:Overdose is a large concern in permanent supportive housing (PSH), yet has been sparsely addressed in research or practice. We previously developed a technical assistance intervention to empower PSH buildings to implement evidence-based overdose prevention practices. We now describe delivery of and participation in this novel intervention. METHODS:Intervention delivery occurred over four six-month periods from November 2023-January 2026. The six-month intervention included a written implementation Toolkit, individually-tailored practice facilitation sessions, and monthly learning collaboratives. Tenant implementation champions participated alongside staff champions and other key building leaders. Trained practice facilitators recorded the attendance and content of all intervention sessions in REDCap logs. Analysis used quantitative descriptive methods. RESULTS:Twenty buildings received the intervention; they were located in New York City and upstate New York and served over 1200 PSH tenants. One building discontinued the intervention due to lack of staff time. The remaining 19 buildings participated in 95% of planned practice facilitation sessions. Additionally, 17 buildings attended over half of the monthly learning collaboratives. Most practice facilitation sessions and learning collaboratives (94%; 211 of 225 sessions) included the full content as planned in the intervention guide. CONCLUSION/CONCLUSIONS:We implemented a novel, place-based intervention to address the leading cause of death among PSH tenants, a population that faces outsized overdose risks. The intervention was feasible to deliver, designed to be sustainable and scalable, and may be a model for other communities seeking to reduce overdose risk in PSH and similar housing settings.
PMID: 42641573
ISSN: 1879-0046
CID: 6071774

Nudging provider adoption of clinical decision support: study protocol for a stepped-wedge cluster randomized, hybrid type III trial of an electronic health record-agnostic pulmonary embolism risk tool

Khan, Sundas; Thomas, Ynhi; Garg, Nidhi; Genes, Nicholas; Simon, Gregory W; Cleland, Charles M; Mir, Usman; Dauber-Decker, Katherine L; Solomon, Jeffrey N; Shunk, Amelia; Xu, Lynn; Mastrianni, Angela; Cui, Yuhan; Henning, Natalie; Diefenbach, Michael A; McGinn, Thomas; Richardson, Safiya
BACKGROUND:About one-third of the computed tomography (CT) scans ordered yearly to evaluate for pulmonary embolism (PE) in emergency departments (ED) in the U.S. are avoidable. Clinical guidelines recommend the use of validated PE prediction rules which reduce CT scan ordering without an increase in missed PEs, but there is low provider adoption. Clinical decision support (CDS) that incorporates these rules along with nudges (subtle, non-coercive influences on decision-making) may improve provider adoption. In our pilot trial of a PE risk CDS tool with a nudge at order entry, adoption was significantly higher (39.1%) than for the tool without nudges (20.7%). The tool was developed on an EHR-agnostic web-based platform, designed for dissemination to work with any EHR. The objective of this study is to evaluate the tool with a nudge in a multi-site, randomized trial. METHODS:A hybrid type III, stepped-wedge, ED-level, cluster randomized trial will be conducted. Study settings include 12 EDs in three geographically diverse health care systems. The EDs will be randomized over 9 steps over 30 months, ensuring at least 3 months of intervention exposure for all EDs. We will randomize matched pairs of EDs based on patient volume in each stratum to early intervention or late intervention. All providers ordering CTs for the evaluation of PE in adult patients at the site EDs will be included. Our study will be guided by two complementary frameworks: Behavioral Change Wheel Framework and Proctor's Implementation Outcomes Framework. Nudge implementation strategies in the CDS user interface will be a peer comparison of providers' hit rates for CTs ordered for PE and salient messaging. We will use an EHR-agnostic, web-based platform to implement the tool. The primary outcome will be guideline-concordant CT ordering for PE. DISCUSSION/CONCLUSIONS:This trial will advance our understanding of the impact of behavioral strategies on improving provider adoption of CDS. Additionally, the trial will confirm the impact of guideline-concordant CT ordering on CT yield rates across a diverse patient population. The use of an EHR-agnostic platform helps maximize the dissemination potential of the core evidence-based practices it facilitates. TRIAL REGISTRATION/BACKGROUND:NCT07249385; Registered 11/18/2025.
PMCID:13390430
PMID: 42186073
ISSN: 1748-5908
CID: 6070513

Considering unintentional exposure when testing for cocaine use via oral fluid testing

Palamar, Joseph J; Krotulski, Alex J; Abukahok, Nina; Acosta, Patricia; Walton, Sara E; Stang, Brianna; Cleland, Charles M
Research is needed to establish optimal cutoffs to determine cocaine use via oral fluid testing while considering the possibility of unintentional exposure. We compared detection of cocaine and its metabolites to self-reported use while considering other drug use to determine optimal cutoffs to determine intentional use. In this study, 1819 adults entering randomly selected nightclubs were surveyed about cocaine and other drug use and had their oral fluid analyzed using liquid chromatography quadrupole time-of-flight mass spectrometry. We compared self-reported use to detected exposure. 13.6% of participants reported past 24-hour cocaine use, 43.7% tested positive for cocaine exposure (≥1 ng/mL), and 11.8% tested positive for at least one metabolite. 28.6% either tested positive for or reported past 24-hour use of other drugs, primarily ketamine. Among those testing positive for cocaine exposure (n = 794), only 29.1% reported past 24-hour use. Among positive cases, the optimal cocaine concentration cut-point for predicting self-report was ≥ 26 ng/mL. When focusing on the full sample and a subsample with data on past 48-hour reported use, optimal cut-points were ≥ 6 ng/mL and ≥ 5 ng/mL, respectively. However, detection of metabolites was the strongest predictor of self-reported use. Using self-report as the gold standard, metabolite detection most accurately classified reported use, over and above detection of cocaine or other drugs; however, relying solely on detection of metabolites or higher cocaine concentration thresholds often led to under-detection. In conclusion, relying on detection of metabolites or higher concentrations most accurately detects intentional use, but these lack sensitivity to detect a portion of use.
PMCID:13307504
PMID: 42330734
ISSN: 1872-6283
CID: 6055362

Differentiating intentional ketamine use from unintentional exposure as an adulterant using oral fluid testing

Palamar, Joseph J; Krotulski, Alex J; Abukahok, Nina; Acosta, Patricia; Walton, Sara E; Stang, Brianna; Cleland, Charles M
Recreational ketamine use and related adverse outcomes have been increasing; however, correct diagnostic classification of quantitative oral fluid test results remains challenging, considering the potential for unintentional exposure to ketamine as an adulterant in other drugs. We surveyed and collected oral fluid from 1819 adults entering nightclubs and compared detection results with past 24-h self-reported ketamine use. Other drug use (based on detection and on self-reported past 24-h use) was considered a risk factor for unintentional ketamine exposure as an adulterant. Oral fluid specimens were analyzed via liquid chromatography quadrupole time-of-flight mass spectrometry. 10.8% of participants reported past 24-h ketamine use, 23.7% tested positive for ketamine (≥ 1 ng/mL), and 10.9% tested positive for norketamine (≥ 1 ng/mL). 46.0% tested positive for drugs other than ketamine, primarily cocaine. Among those testing positive for ketamine (n = 431), 41.5% reported past 24-h use. Among these cases, the optimal ketamine concentration cut-point for predicting self-report was ≥ 18 ng/mL. In analyses using the full sample (n = 1819) and a subsample with data on past 48-h use (n = 795), optimal cut-points were ≥ 2 ng/mL and ≥ 5 ng/mL, respectively. However, norketamine detection was the strongest predictor of self-reported use across the full sample and subsamples examined. Using self-report as the comparison, norketamine detection most accurately classified reported use; however, relying solely on higher concentration thresholds of ketamine or norketamine detection alone may lead to underdetection in some cases. Findings indicate the importance of carefully selected biological markers and thresholds when interpreting oral fluid results in settings where adulterant exposure is common.
PMID: 42321998
ISSN: 1556-4029
CID: 6050492

Detection of Party Drugs on Mobile Phones in Relation to Self-Reported Use and Oral Fluid Detection Among NYC Nightclub Attendees

Palamar, Joseph J; Abukahok, Nina; Denn, Max T; Acosta, Patricia; Cleland, Charles M; Walton, Sara E; Stang, Brianna; Krotulski, Alex J
OBJECTIVES/OBJECTIVE:Self-report and biospecimen testing to assess drug exposure have limitations. Surface testing of personal objects (e.g., mobile phones) may provide complementary information about drug exposure, particularly when there is discordance between biospecimen results and self-report. We examined whether mobile phone swab testing, alongside self-report and oral fluid data, could provide information regarding drug exposure among nightlife attendees-a population with high prevalence of party drug use. We also examined whether detection could inform situations in which a drug is detected in oral fluid but not reportedly used. METHODS:In 2025, we assessed self-reported drug use and analyzed oral fluid and swabs of mobile phones from 127 adults attending nightclubs in New York City. We compared the prevalence of detection of cocaine, ketamine, 3,4-methylenedioxymethamphetamine (MDMA), and 4-methylmethcathinone (4-MMC) across the three modes of collection. RESULTS:Cocaine was detected on 26.8% of phones, followed by ketamine (22.0%), 4-MMC (3.1%), and MDMA (2.4%). When classifying phone detection, reported past-48-hour use and oral fluid detection of cocaine and ketamine demonstrated high specificity (0.85-0.91), but lower sensitivity (0.37-0.73). Among participants with oral fluid positivity after not reporting use, 33.3% and 17.1% of these discordant cases had ketamine and cocaine detected on their phones, respectively. CONCLUSIONS:Phone swab results often align with self-reported use and, less consistently with biologically confirmed exposure. However, drugs detected on phones may reflect less recent use or unintentional environmental sources contributing to oral fluid detection, supporting the role of phone swabbing as a complementary tool for detecting possible drug exposure.
PMCID:13012264
PMID: 41854109
ISSN: 1938-4114
CID: 6016912

Development and Validation of a Provider-Specific Anticipated Stigma Scale for People Who Inject Drugs

Ivasiy, Roman; Earnshaw, Valerie A; Huh, Jimi; Cleland, Charles M; Friedman, Samuel R; Schneider, John A; Ompad, Danielle; Bluthenthal, Ricky N; Walters, Suzan M
Stigma in healthcare settings is a critical barrier to HIV prevention and treatment among people who inject drugs (PWID). While previous tools have measured anticipated stigma, few account for the intersectional and provider-specific experiences of PWID-particularly from syringe service programs (SSPs). We developed and validated the Substance Use Anticipated Provider Stigma Scale (SU-APSS), a multidimensional instrument assessing anticipated stigma from four provider types: healthcare workers, substance use treatment staff, pharmacists, and SSP personnel. Data were drawn from a cross-sectional survey of 264 PWID who were 18 or older, HIV-negative, had injected drugs and used opioids within the past 30 days, and showed visible signs of recent injection. We conducted confirmatory factor analysis (CFA) on responses from 218 participants to evaluate structural validity and used Cronbach's alpha to assess internal consistency. The CFA supported a four-factor structure with strong model fit indices (CFI = 0.97, RMSEA = 0.09 [0.07, 0.11], SRMR = 0.04). All items significantly loaded onto their respective factors (loadings: 0.62-1.06). Internal consistency was high across all subscales (α = 0.85-0.96) and for the overall scale (α = 0.87). Attribution analysis revealed drug use, physical appearance, and income level as the most common perceived reasons for anticipated stigma. The SU-APSS offers a practical tool for identifying provider-specific stigma, informing stigma-reduction interventions, and evaluating implementation strategies to improve HIV prevention and care engagement among PWID.
PMID: 41831112
ISSN: 1573-3254
CID: 6016252

Effectiveness of behavioural tobacco cessation interventions with and without pharmacotherapy among people living with HIV in Viet Nam: a three-arm pragmatic randomised controlled trial

Shelley, Donna; Armstrong-Hough, Mari; Nguyen, Trang; Alvarez, Gloria Guevara; Kapur, Reet; Shuter, Jonathan; Goldsamt, Lloyd; Tozan, Yesim; Van Minh, Hoang; Van Vu, Giap; Phan, Phuong Thu; Cleland, Charles M; Nguyen, Nam
BACKGROUND:People living with HIV are two to three times more likely to smoke than the general population, resulting in higher risk for tobacco-related morbidity and mortality. Despite this growing burden of disease, there is little evidence for the long-term effectiveness of tobacco cessation interventions among people living with HIV, particularly in low-income and middle-income countries. We aimed to compare the effectiveness of three tobacco cessation interventions among people living with HIV. METHODS:We conducted an open-label, three-arm pragmatic randomised controlled trial in 13 outpatient HIV clinics (OPCs) in Hanoi, Viet Nam. Adults who smoked at least one cigarette a day, lived in Hanoi, had a clinic visit in the past 12 months, and had daily access to a mobile telephone that could receive text messages were allocated (1:1:1) to either: proactive referral to Viet Nam's national smokers' Quitline counselling programme (Quitline group); six-session tailored counselling delivered by trained OPC nurses plus text messages (Counselling + SMS group); or Counselling + SMS plus 6 weeks of nicotine replacement therapy (ie, 2 mg nicotine gum; Counselling + SMS+ gum group). Randomisation was by stratified permuted block randomisation with block sizes of three and six. Neither study participants, OPC health-care workers, nor study staff were masked to group assignment. All patients received advice to quit and brief cessation counselling during their physician visit. The primary outcome was 7-day point-prevalence smoking abstinence confirmed at 6 months by exhaled carbon monoxide concentration of less than 8 ppm, assessed with an intention-to-treat analysis. The trial was registered on Dec 17, 2021, at ClinicalTrials.gov (NCT05162911). FINDINGS/RESULTS:Between Nov 30, 2021 and Sept 27, 2023, 672 patients were randomly allocated to the three test groups (221 to the Quitline group, 225 to the Counselling + SMS group, and 226 to the Counselling + SMS + gum group). 338 (50%) patients reported dual waterpipe and cigarette use. At 6 months, 109 (16%) patients had confirmed abstinence (28 [13%] for Quitline, 40 [18%] for Counselling + SMS, and 41 [18%] for Counselling + SMS + gum). There were no significant differences between intervention groups: Counselling + SMS versus Quitline (odds ratio 1·48, 95% CI 0·78-2·81; p=0·33), Counselling + SMS+ gum versus Quitline (1·64, 0·86-3·11; p=0·17), and Counselling + SMS + gum versus Counselling +SMS (1·11, 0·61-2·00; p=0·91). There were no serious adverse events linked to the study interventions throughout the trial duration. INTERPRETATION/CONCLUSIONS:Integrating nurse-delivered cessation treatment and proactive referral to a national Quitline was feasible within the context of HIV care. In the absence of evidence that tailored interventions provide additional benefit, our findings suggest that national Quitlines, available in 42 low-income and middle-income countries, might serve as a resource for integrating tobacco treatment into HIV care systems. FUNDING/BACKGROUND:US National Cancer Institute.
PMID: 41713442
ISSN: 2214-109x
CID: 6005092

Refining a Novel Measure of Polysubstance Use: Applying the Cognitive Interview Method with People Who Use Drugs

Bunting, Amanda M; Griffin, Brittany; Rubens, Adam; Lima, Daniel; Lam, Victoria; Bender, Matheus; Fawole, Adetayo; McNeely, Jennifer; Cleland, Charles M
BACKGROUND:Cognitive interviewing is a methodological technique to elicit feedback on item comprehension and response categories by the target population. This method can be particularly relevant when working with vulnerable populations, such as people who use drugs, and for complex behaviors, including the use of multiple drugs (i.e., polysubstance use). While cognitive interviewing is recognized as an important technique, few case studies of the method have been published. OBJECTIVE:The current manuscript details the cognitive interview method employed as part of the development of a novel polysubstance assessment tool. RESULTS:Participants (n=28) with recent polysubstance use provided qualitative feedback using an iterative study design. Results detail the decision-making process of the study team to improve comprehension of complex behaviors, specifically simultaneous and same-day polysubstance use. Notably, the administration modality changed from self to interviewer-administered to facilitate participant understanding. CONCLUSIONS:Findings highlight the utility of the cognitive interview method in improving assessments of substance use.
PMID: 41718537
ISSN: 1532-2491
CID: 6005292