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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

The Polysubstance Assessment Tool: Reliability, acceptability and feasibility of a novel measure of polysubstance use

Bunting, Amanda M; Cleland, Charles M; Barratt, S Michaela; Griffin, Brittany; Williams, Jaimee; Oser, Carrie B; Lee, Joshua D; McNeely, Jennifer
BACKGROUND AND AIMS/OBJECTIVE:There are currently no brief quantitative assessments that capture the drug patterns of people who engage in use of more than one drug on the same day or simultaneously. The current study examined the retest reliability, acceptability and feasibility of a new quantitative assessment to measure polysubstance use. DESIGN/METHODS:A tool for assessing simultaneous and same-day polysubstance behaviors, the polysubstance assessment tool (PAT) was developed in interviewer-administered and electronic self-administered formats. Participants were allocated 1:1 to receive either version of the PAT and returned one to three days later to repeat the assessment. SETTING/METHODS:New York City, New York, USA. PARTICIPANTS/METHODS:Adults (18 + years, n = 115) who reported use of more than one drug per day in the last 30 days. MEASUREMENTS/METHODS:Test-retest reliability estimates for dichotomous items were assessed using Cohen's kappa, Gwet's Agreement Coefficient 1 (AC1) and percent agreement. Continuous items were assessed with two-way mixed effects intraclass correlations. Bivariate analyses examined acceptability using nine Likert-type survey questions. Feasibility was examined via time to completion. FINDINGS/RESULTS:Overall reliability was moderate to excellent [Gwet's AC1 range 0.70-0.96; intraclass correlation (ICC) range 0.62-0.88]. Reliability was higher for simultaneous polysubstance use (Gwet's AC1 = 0.90) as compared with same-day (Gwet's AC1 = 0.70). Acceptability was high, with no statistically significant difference between the self- and interviewer-administered versions of the tool. Median time to completion was 7 minutes, and was statistically significantly lower for the self-administered tool (median = 5 minutes) compared with the interviewer-administered version (median = 8 minutes) (P < 0.001). CONCLUSIONS:A new polysubstance assessment tool appears to have good reliability and can be considered by researchers seeking a quantitative measure of polysubstance use behaviors given its simplicity, high acceptability and quick completion time.
PMID: 41677773
ISSN: 1360-0443
CID: 6002392

Peer Navigator Intervention and Opioid-Related Adverse Events for Emergency Department Patients: A Randomized Clinical Trial

Doran, Kelly M; Welch, Alice E; Kepler, Kelsey L; Jeffers, Angela; Chambless, Dominique; Cowan, Ethan; Wittman, Ian; Regina, Angela; Siu, Katherine; Bailey, Veronika S; Rostam-Abadi, Yasna; Kennedy, Joseph; Kunins, Hillary V; Gwadz, Marya; Shelley, Donna; Cleland, Charles M; McNeely, Jennifer
IMPORTANCE/UNASSIGNED:Emergency departments (EDs) serve patients at high risk for overdose. There is increasing interest in peer-delivered ED interventions for substance use but little rigorous research on their effectiveness. OBJECTIVE/UNASSIGNED:To examine the effectiveness of an initiative (Relay) operated by the New York City Health Department that dispatches trained peer wellness advocates (WAs) to support ED patients after a nonfatal opioid overdose. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:This randomized clinical trial compared Relay and site-directed care (SDC) at 4 EDs in New York, New York. Adult patients presenting after opioid-involved overdose were enrolled from October 6, 2020, to June 30, 2022, with 12 months of outcome follow-up. Statistical analysis was performed from November 4, 2024, to May 6, 2025. INTERVENTION/UNASSIGNED:ED workers (generally physicians) called the Relay hotline for patients presenting after a suspected opioid-involved overdose. WAs met patients in the ED to provide peer support and brief overdose risk reduction education. WAs attempted to contact patients for 90 days to provide ongoing support, education, and referrals using a harm reduction framework. MAIN OUTCOMES AND MEASURES/UNASSIGNED:Opioid-related adverse events (any opioid-involved overdose [fatal or nonfatal] or any other substance use-related ED visit) in the 12 months after enrollment were identified using health care administrative data plus self-report. RESULTS/UNASSIGNED:Among a total of 253 participants randomized, 127 were randomized to the Relay arm and 126 to the SDC arm. A total of 247 participants, 125 in the Relay arm and 122 in the SDC arm (190 [76.9%] men; 80 [32.4%] Black, 126 [51.0%] Hispanic or Latinx, 76 [30.8%] White, and 91 other race [36.8%]), were included in the intention-to-treat analyses. No statistically significant differences between arms were observed for the primary outcome (mean [SD] opioid-related adverse events, 3.29 [4.52] in the Relay arm and 4.10 [9.36] in the SDC arm; rate ratio, 1.02; 95% CI, 0.72-1.45; P = .90). By 12 months after enrollment, 24 participants (9.7%) had died (17 [70.8%] due to overdose). Relay participants reported high satisfaction with the ED intervention. CONCLUSIONS AND RELEVANCE/UNASSIGNED:This randomized clinical trial examining the impact of an ED peer navigator intervention on subsequent opioid-related adverse events did not find significant outcome differences for Relay vs SDC participants. These findings highlight the importance of intervening to save lives in this high-risk population and suggest potential refinements to future ED peer intervention research. TRIAL REGISTRATION/UNASSIGNED:ClinicalTrials.gov Identifier: NCT04317053.
PMID: 41649817
ISSN: 2574-3805
CID: 6000622

An Examination of How People Who Use Drugs Conceptualize the Benefits and Drawbacks of Using Overdose Prevention Centers

Frank, David; Bennett, Alex S; Elliott, Luther; Scheidell, Joy D; Walters, Suzan M; Cleland, Charles M
BACKGROUND/UNASSIGNED:In 2021, NYC implemented overdose prevention center (OPC) services at two existing syringe exchange programs, allowing people to use pre-obtained drugs on-site. Although OPCs in Canada, Western Europe, and Australia have demonstrated their feasibility and benefits towards reducing overdose risk and drug-related harm, there is less data on how people who use drugs (PWUD) conceptualize the benefits and any potential drawbacks of using OPCs. METHODS/UNASSIGNED:In June-August 2022, we conducted 26 semistructured interviews with people in New York City who used unprescribed opioids. Interviews lasted 30-60 min and were conducted remotely using Zoom and later transcribed by a professional service. Data were then coded, using AtlasTi, into meaningful categories using a thematic approach based on the aims of the study and existing literature. RESULTS/UNASSIGNED:Most participants had heard of OnPoint and reported a willingness to use it. They described the ability of OnPoint staff to reverse an overdose quickly and the presence of naloxone, oxygen, and other supplies as the primary benefits. Yet, many also noted that OPCs provide PWUD with a place to escape from the weather and/or avoid law enforcement. Participants also reported concerns about how far PWUD would be willing to travel or wait to use an OPC and for the autonomy of PWUD in the context of formal, sanctioned OPCs. CONCLUSIONS/UNASSIGNED:Results suggest that many PWUD in NYC are well-informed about OnPoint and are willing to use OPCs. Yet, to fulfil their potential, OPCs must be located near to where PWUD live, and should be made as low-threshold as possible. However, since it is unlikely that OPCs will be expanded enough to meet the need and because some PWUD will never choose to use in sanctioned OPCs, expanding the reach of alternative strategies, such as Mobile Overdose Response Services, is recommended.
PMCID:12851624
PMID: 41613410
ISSN: 0091-4509
CID: 6003732

People Who Use Illegal Opioids Use of Methadone over Time, and What Characteristics Are Correlated with Staying in Methadone Maintenance Treatment

Frank, David; Elliott, Luther; Bennett, Alex; Cleland, Charles; Patel, Dev; Scheidell, Joy
INTRODUCTION/UNASSIGNED:Methadone maintenance treatment (MMT) is among the best strategies for reducing harms associated with illegal opioid use, yet it is hindered by low rates of treatment initiation and retention that limit its impact. There has been a lack of studies that describe how people who use illegal opioids use methadone-both from opioid treatment programs, and bought illegally-over time, or what factors correlate with long-term participation in MMT. METHODS/UNASSIGNED: = 412 people who use illicit opioids in New York City from April 2019-2022. We used bivariate analyses to estimate the distribution of baseline sociodemographic and background characteristics. Multinomial logistic regression was then used to estimate the association between those characteristics and methadone use over time. RESULTS/UNASSIGNED:Findings show that people who are older, who used heroin for longer amounts of time, and who had multiple episodes of substance use disorder treatment other than medication for opioid use disorder are more likely to use MMT consistently over time. DISCUSSION/UNASSIGNED:Our findings may be related to the many barriers to long-term participation in MMT, such as travel distance, the need for regular attendance, and patients' dissatisfaction with opioid treatment programs. Consistent participation in MMT may become acceptable only when the difficulties and burdens of criminalized drug use begin to outweigh those of MMT participation, and after non-medication-using treatments have already been tried. Efforts to make MMT less burdensome could reduce the tendency to avoid MMT until later in life and improve people's consistency of participation over time.
PMID: 41320869
ISSN: 1532-2491
CID: 5974492

Understanding overdose risk and response in permanent supportive housing: results of focus groups with tenants, staff, and leaders

Gaeta Gazzola, Marina; Torsiglieri, Allison; Blaufarb, Stephanie; Velez, Lauren; Hernandez, Patricia; O'Grady, Megan A; Shelley, Donna; Frank, David; Cleland, Charles M; Doran, Kelly M
BACKGROUND:Permanent supportive housing (PSH) is an evidence-based intervention for people experiencing homelessness which integrates permanent housing with voluntary support services. PSH tenants are at high risk for overdose death, yet little research to date has examined overdose in PSH. We sought to examine overdose risk and existing responses in PSH, which can shed light on opportunities for future overdose prevention efforts. METHODS:We conducted focus groups with PSH tenants, staff, and leaders in New York City and New York's Capital Region. Focus groups were recorded and professionally transcribed. Two investigators independently completed rapid turnaround qualitative analysis, completing templated summaries of each focus group and compiling key content in an analysis matrix, which a third investigator reviewed; discrepancies were resolved by consensus. RESULTS:From October to December 2022, we held 8 focus group sessions with PSH tenants (3 focus groups, n = 10 total participants), staff (3 focus groups, n = 13), and leaders (2 focus groups, n = 11) grouped by role and region. Participants were diverse in age (26-67 years), gender (18 women, 16 men), race (3 Asian, 12 Black, 11 White, 5 multiracial, 3 other), and ethnicity (5 Latinx, 29 not Latinx). Analysis revealed four main themes: (1) Overdose was a large concern in PSH and created significant trauma for tenants and staff; (2) Environmental factors in PSH contributed to overdose risk; (3) There was heterogeneity in PSH buildings' current overdose prevention efforts and adoption of harm reduction principles; and (4) Multifactorial barriers resulted in limited tenant use of opioid agonist treatment. CONCLUSIONS:Overdose is a major concern for PSH tenants, staff, and leaders. Our findings shed new light on overdose in PSH settings, providing insight into risk factors, existing responses, and barriers and facilitators to future overdose prevention efforts. These findings can inform future overdose prevention interventions within PSH. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov, NCT05786222, registered 27 March 2023.
PMCID:12664209
PMID: 41316389
ISSN: 1940-0640
CID: 5968912

Social processes and engagement along the HIV care continuum: a mixed methods exploratory study with diverse African American/Black and Latine emerging adults living with HIV

Wilton, Leo; Gwadz, Marya; Cleland, Charles M; Munson, Michelle R; Campos, Stephanie; Israel, Khadija; Medvedchikova, Maria; Beharie, Nisha; Rosmarin-DeStefano, Corey; Sherpa, Dawa; Serrano, Samantha
BACKGROUND:Racial/ethnic and age-related disparities in HIV care continuum engagement are serious in the US. American/Black and Latine (AABL) young/emerging adults living with HIV have the lowest rates of engagement, but aspects of their experiences and some subpopulations are understudied. The present study is grounded in social action theory and uses a sequential explanatory mixed methods design to explore social interaction processes (e.g., social networks, trust), and their relationships to HIV management, in a diverse cohort including those with non-suppressed HIV viral load. METHODS: = 62) was purposively sampled for maximum variability for qualitative interviews. Quantitative data were analyzed with descriptive statistics and logistic regression. The primary outcomes were engagement in HIV care and viral suppression. Quantitative results were used to develop qualitative research questions, and qualitative data were analyzed with directed content analysis. Joint display methods were used to integrate results. RESULTS: = 0.045) increased the odds of viral suppression. In qualitative results we found social networks were vital to well-being, but, like participants, located in strained socioeconomic circumstances. In this context, we organized results into five themes: (1) social losses were disruptive to HIV management; (2) service settings and care providers were important network members; (3) family disapproval of sexual/gender minority status had negative effects; (4) immigrant participants were highly reliant on service settings; and (5) networks influenced participants’ drug use and their drug use also reduced the size and changed the composition of networks. CONCLUSIONS:The present study advances knowledge on social interaction processes among diverse AABL young/emerging adults living with HIV, and highlights points of intervention. SUPPLEMENTARY INFORMATION:The online version contains supplementary material available at 10.1186/s12939-025-02662-5.
PMCID:12560509
PMID: 41152903
ISSN: 1475-9276
CID: 5961232

PrEP Intentions, Heavy Substance Use, and Gender Affirmation among Black and Latine Transgender and Gender-Expansive Youth: A Structural Equation Modeling Analysis

Cluesman, Sabrina R; Gwadz, Marya; Cleland, Charles M
Black and Latine transgender/gender-expansive youth/emerging adults ages 13-24 years, experience disproportionate HIV risk, yet have the lowest PrEP uptake rates in the U.S. (< 8%). This study examines the effects of gender-minority stressors, gender affirmation, and heavy substance use on their PrEP outcomes using data from the CDC's 2018 START study (N = 423). We used structural equation modeling (Mplus v. 8.10) to examine factors related to their PrEP intentions using our newly developed conceptual model. The majority of participants were 18-24 (77.3%), transfemale (69.7%), Latine (63.1%), and reported heavy substance use behaviors (50.6%). Family rejection increased perceived stigma (b = 0.209, SE = 0.050, p < 0.001) and heavy substance use behaviors (b = 0.356, SE = 0.072, p < 0.001). Perceived stigma also increased heavy substance use behaviors (b = 0.084, SE = 0.041, p 0.041). Additionaly, heavy substance use decreased PrEP intentions (b = -0.160, SE = 0.049, p < 0.001), while gender affirmation increased PrEP intentions (b = 0.087, SE = 0.030, p < 0.004). When family rejection was present, for each 1-point increase in gender affirmation, the risk of heavy substance use was reduced by -0.197 (SE = 0.038; p < 0.001). This study identifies heavy substance use as a potential barrier to PrEP uptake among Black and Latine transgender and gender-expansive youth, given its significant negative association with PrEP intentions. Findings highlight the need for strategies to improve PrEP outcomes, underscoring the importance of operationalizing gender affirmation across settings, particularly amid family rejection and heavy substance use.
PMID: 41071502
ISSN: 1573-3254
CID: 5952372

Perspectives on COVID-19 Vaccination Among Unvaccinated and Under-Vaccinated African American/Black and Latine Frontline Essential Workers: A Qualitative Exploration

Gwadz, Marya; Robinson, Jennifer A; Serrano, Fernanda Gonzalez Blanco; Campos, Stephanie; Freeman, Robin M; Chero, Rauly; Cleland, Charles M; Parameswaran, Lalitha; Hawkins, Robert L; Filippone, Prema; Lizardo, Maria; Bangser, Greg; Ramirez, Paola G; Negret, Andrea; Kagzi, Mehreen; Lissinna, Hanna
Racial/ethnic disparities in COVID-19 morbidity and mortality are serious in the United States, particularly among African American/Black and Latine (AABL) populations. Staying up-to-date on COVID-19 vaccination is essential for mitigating risk, but AABL vaccination rates are low. The present qualitative study explores perspectives on COVID-19 among AABL persons at high-risk for exposure to the SARS-CoV- 2 virus: frontline essential workers engaged in public-facing professions (e.g., retail). From a larger study of AABL frontline essential workers not up-to-date on COVID-19 vaccination, N = 50 participants were purposively sampled for maximum variability. Participants engaged in semi-structured qualitative interviews in English or Spanish that were audio-recorded, professionally transcribed, and translated into English as needed. Data were analyzed using a directed content analysis approach that was both inductive and theory-driven. Participants were 37 years old, on average, and most (65%) were men. Approximately half (56%) were Latine/Hispanic and 44% were African American/Black. Occupations included food preparation (40%), retail (28%), construction (12%), in-home health care (8%), and building maintenance and personal services (12%). Approximately a third (38%) had received ≥ 1 COVID-19 vaccine dose. We found COVID-19 vaccination perspectives were grounded in a larger context of medical and institutional distrust and past/ongoing systemic racism. In this context, results were organized into the following themes: general perspectives on COVID-19; barriers/facilitators related to race/ethnicity, social class, and community; specific aspects of the COVID-19 vaccine as barriers; mandates, incentives, and pressures to be vaccinated; and mixed effects of public health initiatives. Overall, participants were knowledgeable about COVID-19. Social norms reduced vaccine intentions but altruism and community/family concern could motivate it. Aspects of the public health response (e.g., advertisement campaigns targeting AABL populations) increased distrust and reduced vaccination willingness. However, at least some ambivalence about vaccination was common (participants would consider it). Yet there was a large gap between considering and receiving vaccination. Thus, barriers to COVID-19 vaccination for AABL frontline essential workers operate at multiple levels of influence, but are addressable. The present study yields recommendations to improve vaccination, including increasing the trustworthiness of systems and institutions, reducing systemic/structural barriers, harnessing social forces, and engaging AABL communities in program planning.
PMID: 40205313
ISSN: 1573-3254
CID: 5824012