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Electronic cigarettes as a harm reduction strategy among patients with COPD: protocol for an open-label two arm randomized controlled pilot trial

Stevens, Elizabeth R; Lei, Lei; Cleland, Charles M; Vojjala, Mahathi; El-Shahawy, Omar; Berger, Kenneth I; Kirchner, Thomas R; Sherman, Scott E
BACKGROUND:Smoking cessation is the most effective means of slowing the decline of lung function associated with chronic obstructive pulmonary disease (COPD). While effective smoking cessation treatments are available, they are underutilized and nearly half of people with COPD continue to smoke. By addressing both nicotine and behavioral dependence, electronic cigarettes (EC) could help people with COPD reduce the harm of combustible cigarettes (CC) through reductions in number of Cigarettes per Day (CPD) or quitting CC completely. The purpose of this pilot study is to identify barriers and facilitators to the use of and assess the preliminary effectiveness of EC as a harm reduction strategy among people with COPD. METHODS:In an open-label two-arm randomized controlled trial pilot study, 60 patients identified as smokers with a COPD diagnosis via electronic health records from a large urban health center are randomized in a 1:1 ratio to either standard care [counseling + nicotine replacement therapy (NRT)] or counseling + EC. The NRT arm will receive nicotine patches and nicotine lozenges for 12 weeks. The EC arm will receive EC for 12 weeks. Both cohorts will receive counseling from a licensed mental health counselor. Using ecological momentary assessment, participants will report their use of CC in both arms and EC use in the EC arm daily via text message. Primary outcomes will be feasibility and acceptability of intervention, and secondary outcomes will be reduction in CPD and change in COPD symptoms as measured by COPD Assessment Tool (CAT) score at 12-weeks. EC displacement of CC. To explore attitudes towards the use of EC as a harm-reduction strategy for patients with COPD, interviews will be performed with a sample of participants from both study arms. DISCUSSION/CONCLUSIONS:Despite decades of availability of smoking cessation medications, nearly half of people with COPD still smoke. This study aims to address the unmet need for feasible and effective strategies for reducing CC use among those with COPD, which has the potential to significantly improve the health of people with COPD who smoke. Trial Registration ClinicalTrials.gov Identifier: NCT04465318.
PMCID:8734340
PMID: 34991693
ISSN: 1940-0640
CID: 5107362

What is the prevalence of drug use in the general population? Simulating underreported and unknown use for more accurate national estimates

Levy, Natalie S; Palamar, Joseph J; Mooney, Stephen J; Cleland, Charles M; Keyes, Katherine M
PURPOSE/OBJECTIVE:To outline a method for obtaining more accurate estimates of drug use in the United States (US) general population by correcting survey data for underreported and unknown drug use. METHODS:We simulated a population (n=100,000) reflecting the demographics of the US adult population per the 2018 American Community Survey. Within this population, we simulated the "true" and self-reported prevalence of past-month cannabis and cocaine use by using available estimates of underreporting. We applied our algorithm to samples of the simulated population to correct self-reported estimates and recover the "true" population prevalence, validating our approach. We applied this same method to 2018 National Survey on Drug Use and Health data to produce a range of underreporting-corrected estimates. RESULTS:Simulated self-report sensitivities varied by drug and sampling method (cannabis: 77.6-78.5%, cocaine: 14.3-22.1%). Across repeated samples, mean corrected prevalences (calculated by dividing self-reported prevalence by estimated sensitivity) closely approximated simulated "true" prevalences. Applying our algorithm substantially increased 2018 NSDUH estimates (self-report: cannabis=10.5%, cocaine=0.8%; corrected: cannabis=15.6-16.6%, cocaine=2.7-5.5%). CONCLUSION/CONCLUSIONS:National drug use prevalence estimates can be corrected for underreporting using a simple method. However, valid application of this method requires accurate data on the extent and correlates of misclassification in the general US population.
PMID: 34990827
ISSN: 1873-2585
CID: 5107312

Recurrent Injecting Drug Use as a Mediator between Psychiatric Disorder and Non-Fatal Overdose

Barnes, David M; Xu, Shu; Cleland, Charles M; McKnight, Courtney; Des Jarlais, Don
BACKGROUND/UNASSIGNED:Unintentional drug overdose has increased markedly in the United States. Studies document an association between psychiatric disorder and unintentional overdose; we extend this research through a preliminary test of a causal model of recurrent injection drug use mediating this relationship. METHODS/UNASSIGNED:In a cross-sectional study of 241 adults in New York City with a possible current substance use disorder, we conducted conventional and Imai's mediation analyses to examine if psychiatric disorder is associated with increased prevalence of ever overdosing and if recurrent injection drug use mediates this association. Our cross-sectional data permit the first step of assessing causal models: testing if statistical associations are consistent with the model. RESULTS/UNASSIGNED: = 0.02) of the association between psychiatric diagnosis and ever overdosing. Conventional mediation analysis produced similar results. CONCLUSIONS/UNASSIGNED:Our results provide a warrant for taking the necessary next step for assessing a causal model using longitudinal data, potentially providing a strong rationale for intervening on psychiatric disorders to stem overdose.
PMID: 35611936
ISSN: 1532-2491
CID: 5283362

Concerts, bars, parties, and raves: Differential risk for drug use among high school seniors according to venue attendance

Palamar, Joseph J; Rutherford, Caroline; Cleland, Charles M; Keyes, Katherine M
PMID: 35113010
ISSN: 1547-0164
CID: 5153762

Behavioral intervention grounded in motivational interviewing and behavioral economics shows promise with Black and English-speaking Latino persons living with HIV with unsuppressed HIV viral load in New York City: A mixed methods pilot study

Gwadz, Marya; Serrano, Samantha; Linnemayr, Sebastian; Cleland, Charles M; Cluesman, Sabrina R; Freeman, Robin M; Kellam, Kinsey; De Stefano, Corey; Israel, Khadija; Pan, Emily
Introduction/UNASSIGNED:Sustained HIV viral suppression is the ultimate goal of HIV treatment. African American/Black and Latino persons with HIV (PWH) in the United States are less likely than their White peers to achieve and sustain viral suppression. To address these disparities, we developed a "low-touch" behavioral intervention drawing on motivational interviewing and behavioral economics. The intervention had three main components: (1) a motivational interviewing counseling session, (2) 16 weeks of automated text messages and quiz questions about HIV management, where participants earned points by answering quiz questions, and 3) a lottery prize, based on viral suppression status, number of points earned, and chance (max. $275). Materials and methods/UNASSIGNED:The intervention was tested in a pre-test/post-test design. The present pilot study used mixed methods to explore the intervention's feasibility, acceptability, impact, and ways it could be improved. Participants engaged in a baseline assessment, qualitative interview, and two structured follow-up assessments over an 8-month period, and provided laboratory reports to document HIV viral load. We carried out descriptive quantitative analyses. Qualitative data were analyzed using a directed content analysis approach. Data integration was carried out using the joint display method. Findings/UNASSIGNED:= 40) were 50 years old, on average (SD = 11), and approximately half (58%) were male. Close to two-thirds (68%) were African American/Black and 32% were Latino. Participants were diagnosed with HIV 22 years ago on average (SD = 8). The intervention was feasible (e.g., mean number of quiz questions answered = 13/16) and highly acceptable. While not powered to assess efficacy, the proportion with suppressed HIV viral load increased from baseline to follow-up (46% participants at the first, 52% participants at the second follow-up evidenced HIV viral suppression). In qualitative analyses, perspectives included that overall, the intervention was acceptable and useful, it was distinct from other programs, lottery prizes were interesting and appreciated but not sufficient to motivate behavior change, and the structure of lottery prizes was not sufficiently clear. Regarding data integration, qualitative data shed light on and extended quantitative results, and added richness and context. Conclusion/UNASSIGNED:This low-touch intervention approach is sufficiently promising to warrant refinement and study in future research.
PMCID:9522600
PMID: 36187648
ISSN: 2296-2565
CID: 5351302

HIV Diagnosis and the Clinical Course of COVID-19 Among Patients Seeking Care Within the New York City Public Hospital System During the Initial Pandemic Peak

Kaplan-Lewis, Emma; Banga, Jaspreet; Khan, Maria; Casey, Eunice; Mazumdar, Medha; Bratu, Simona; Abdallah, Marie; Pitts, Robert; Leider, Jason; Hennessey, Karen; Cohen, Gabriel M; Cleland, Charles M; Salama, Carlos
Reports conflict on how HIV infection influences the clinical course of COVID-19. The New York City (NYC) public hospital system provides care for over 14,000 people with HIV, was central in responding to the COVID-19 pandemic, and is therefore in a unique position to evaluate the intersection of these concurrent infections. Retrospective chart review of patients presenting to NYC Health and Hospitals (NYC H+H) diagnosed with COVID-19 infection from March 1, 2020, through April 28, 2020, compared people living with HIV (PLWH) and a propensity-matched (PM) control group of patients without HIV to evaluate associations between HIV status and COVID-19 outcomes. Two hundred thirty-four PLWH presented for COVID-19 testing and 110 (47%) were diagnosed with COVID-19. Among 17,413 patients with COVID-19 and without HIV, 1:n nearest neighbor propensity score matching identified 194 patients matched on age, sex, race, and any comorbidity. In the sample with COVID-19 (N = 304), PLWH (9.1%) had lower rates of mortality than controls [19.1%; PM odds ratio (PM-OR): 0.41, 95% confidence interval (CI): 0.19-0.86]. Among hospitalized COVID-19 patients (N = 179), HIV infection was associated with lower rates of mechanical ventilation (PM-OR: 0.31, 95% CI: 0.11-0.84) and mortality (PM-OR: 0.40, 95% CI: 0. 17-0.95). In the extended pandemic period through April 2021, aggregate data by HIV status suggested elevated hospitalization and mortality rates in PLWH versus people without HIV. These results suggest that the direct biological impacts of the HIV virus do not negatively influence COVID-19-related outcomes when controlling for comorbidity and demographic variables.
PMID: 34780305
ISSN: 1557-7449
CID: 5046482

Individual and poly-substance use and condomless sex among HIV-uninfected adults reporting heterosexual sex in a multi-site cohort

Fredericksen, R J; Whitney, B M; Trejo, E; Nance, R M; Fitzsimmons, E; Altice, F L; Carrico, A W; Cleland, C M; Del Rio, C; Duerr, A; El-Sadr, W M; Kahana, S; Kuo, I; Mayer, K; Mehta, S; Ouellet, L J; Quan, V M; Rich, J; Seal, D W; Springer, S; Taxman, F; Wechsberg, W; Crane, H M; Delaney, J A C
BACKGROUND:We analyzed the association between substance use (SU) and condomless sex (CS) among HIV-negative adults reporting heterosexual sex in the Seek, Test, Treat, and Retain (STTR) consortium. We describe the impact of SU as well as person/partner and context-related factors on CS, identifying combinations of factors that indicate the highest likelihood of CS. METHODS:We analyzed data from four US-based STTR studies to examine the effect of SU on CS using two SU exposures: 1) recent SU (within 3 months) and 2) SU before/during sex. Behavioral data were collected via 1:1 or self-administered computerized interviews. Adjusted individual-study, multivariable relative risk regression was used to examine the relationship between CS and SU. We also examined interactions with type of sex and partner HIV status. Pooled effect estimates were calculated using traditional fixed-effects meta-analysis. We analyzed data for recent SU (n = 6781; 82% men, median age = 33 years) and SU before/during sex (n = 2915; 69% men, median age = 40 years). RESULTS:For both exposure classifications, any SU other than cannabis increased the likelihood of CS relative to non-SU (8-16%, p-values< 0.001). In the recent SU group, however, polysubstance use did not increase the likelihood of CS compared to single-substance use. Cannabis use did not increase the likelihood of CS, regardless of frequency of use. Type of sex was associated with CS; those reporting vaginal and anal sex had a higher likelihood of CS compared to vaginal sex only for both exposure classifications (18-21%, p < 0.001). Recent SU increased likelihood of CS among those reporting vaginal sex only (9-10%, p < 0.001); results were similar for those reporting vaginal and anal sex (5-8%, p < 0.01). SU before/during sex increased the likelihood of CS among those reporting vaginal sex only (20%; p < 0.001) and among those reporting vaginal and anal sex (7%; p = 0.002). Single- and poly-SU before/during sex increased the likelihood of CS for those with exclusively HIV-negative partners (7-8%, p ≤ 0.02), and for those reporting HIV-negative and HIV-status unknown partners (9-13%, p ≤ 0.03). CONCLUSION:Except for cannabis, any SU increased the likelihood of CS. CS was associated with having perceived HIV-negative partners and with having had both anal/vaginal sex.
PMCID:8567631
PMID: 34736425
ISSN: 1471-2458
CID: 5068332

Adaptation and Assessment of a Text Messaging Smoking Cessation Intervention in Vietnam: Pilot Randomized Controlled Trial

Jiang, Nan; Nguyen, Nam; Siman, Nina; Cleland, Charles M; Nguyen, Trang; Doan, Hue Thi; Abroms, Lorien C; Shelley, Donna R
BACKGROUND:Text message (ie, short message service, SMS) smoking cessation interventions have demonstrated efficacy in high-income countries but are less well studied in low- and middle-income countries, including Vietnam. OBJECTIVE:The goal of the research is to assess the feasibility, acceptability, and preliminary efficacy of a fully automated bidirectional SMS cessation intervention adapted for Vietnamese smokers. METHODS:The study was conducted in 3 phases. In phase 1, we adapted the SMS library from US-based SMS cessation programs (ie, SmokefreeTXT and Text2Quit). The adaptation process consisted of 7 focus groups with 58 smokers to provide data on culturally relevant patterns of tobacco use and assess message preferences. In phase 2, we conducted a single-arm pilot test of the SMS intervention with 40 smokers followed by in-depth interviews with 10 participants to inform additional changes to the SMS library. In phase 3, we conducted a 2-arm pilot randomized controlled trial (RCT) with 100 smokers. Participants received either the SMS program (intervention; n=50) or weekly text assessment on smoking status (control; n=50). The 6-week SMS program consisted of a 2-week prequit period and a 4-week postquit period. Participants received 2 to 4 automated messages per day. The main outcomes were engagement and acceptability which were assessed at 6 weeks (end of intervention). We assessed biochemically confirmed smoking abstinence at 6 weeks and 12 weeks. Postintervention in-depth interviews explored user experiences among a random sample of 16 participants in the intervention arm. RESULTS:Participants in both arms reported high levels of engagement and acceptability. Participants reported using the program for an average of 36.4 (SD 3.4) days for the intervention arm and 36.0 (SD 3.9) days for the control arm. Four of the 50 participants in the intervention arm (8%) reset the quit date and 19 (38%) texted the keyword TIPS. The majority of participants in both arms reported that they always or usually read the text messages. Compared to the control arm, a higher proportion of participants in the intervention arm reported being satisfied with the program (98% [49/50] vs 82% [41/50]). Biochemically verified abstinence was higher in the intervention arm at 6 weeks (20% [10/50] vs 2% [1/50]; P=.01), but the effect was not significant at 12 weeks (12% [6/50] vs 6% [3/50]; P=.49). In-depth interviews conducted after the RCT suggested additional modifications to enhance the program including tailoring the timing of messages, adding more opportunities to interact with the program, and placing a greater emphasis on messages that described the harms of smoking. CONCLUSIONS:The study supported the feasibility and acceptability of an SMS program adapted for Vietnamese smokers. Future studies need to assess whether, with additional modifications, the program is associated with prolonged abstinence. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov NCT03219541; https://clinicaltrials.gov/ct2/show/NCT03219541.
PMID: 34623318
ISSN: 2291-5222
CID: 5031592

Pre-Exposure Prophylaxis (PrEP) Awareness Among Black Men Who Have Sex with Men with a History of Criminal Justice Involvement in Six U.S. Cities: Findings from the HPTN 061 Study

Feelemyer, Jonathan P; Khan, Maria R; Dyer, Typhanye V; Turpin, Rodman E; Hucks-Ortiz, Christopher; Cleland, Charles M; Scheidell, Joy D; Hoff, Lee; Mayer, Kenneth H; Brewer, Russell A
Transition from detention to the community for Black men who have sex with men with criminal justice involvement (BMSM-CJI) represents a particularly vulnerable period for HIV acquisition and transmission. We examined levels of HIV PrEP awareness among BMSM-CJI. PrEP awareness among BMSM-CJI was low (7.9%) with evidence of lower awareness levels among those with STI. There was evidence that HIV testing history was associated with higher PrEP awareness. Study findings highlight needs for further assessment of PrEP knowledge among BMSM-CJI. The strong association between HIV testing and PrEP awareness underscores an opportunity to integrate PrEP education within HIV/STI testing services.
PMCID:8568669
PMID: 34427848
ISSN: 1573-2800
CID: 5048662

Characterisation of social support following incarceration among black sexual minority men and transgender women in the HPTN 061 cohort study

Scheidell, Joy D; Dyer, Typhanye V; Hucks-Ortiz, Christopher; Abrams, Jasmyn; Mazumdar, Medha; Cleland, Charles; Irvine, Natalia; Turpin, Rodman E; Severe, MacRegga; Mayer, Kenneth; Khan, Maria
OBJECTIVE:To examine longitudinal associations between recent incarceration and subsequent social support among black sexual minority men and transgender women, and whether associations differed between those who did and did not have support prior to incarceration. DESIGN:A secondary analysis in 2020 of data from the HIV Prevention Trials Network 061, a cohort study of black sexual minority men and transgender women recruited in 2009-2010 and followed for 12 months. SETTING:Six US cities (Atlanta, Boston, Los Angeles, New York City, San Francisco and Washington DC). PARTICIPANTS:Individuals ≥18 years of age who identified as black, reported being male or assigned male at birth, reported ≥1 unprotected anal intercourse event with a male partner in the past 6 months, and reported on incarceration at the 6-month follow-up visit. EXPOSURE:Having spent ≥1 night in jail/prison in the past 6 months reported at the 6-month follow-up visit. OUTCOME:Social support measured using a six-item scale assessing frequency of emotional/informational, affectionate and tangible support (range 6-30); and dichotomous indicators of low support for each item (ie, receiving that form of support none/little of the time). RESULTS:Among participants who returned for the 6-month visit (N=1169), 14% had experienced incarceration in the past 6 months. Mean support score was 20.9; 18.9 among those with recent incarceration versus 21.2 among those without. Recent incarceration predicted lower support (adjusted β -2.40, 95% CI -3.94 to -0.85). Those recently incarcerated had increased risk of lacking emotional/informational (eg, no one to talk to adjusted risk ratio (aRR) 1.55, 95% CI 1.13 to 2.13) and affectionate (aRR 1.51, 95% CI 1.11 to 2.04) but not tangible support. Effects appeared somewhat stronger among those who had support at baseline. CONCLUSIONS:Incarceration may reduce support on re-entry among black sexual minority men and transgender women, populations unequally targeted for incarceration and at risk for low support.
PMCID:8483031
PMID: 34588263
ISSN: 2044-6055
CID: 5037642