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Effectiveness of a multicomponent strategy for implementing guidelines for treating tobacco use in Vietnam Commune Health Centers

Shelley, D; Cleland, C M; Nguyen, T; Van Devanter, N; Siman, N; Van M, Hoang; Nguyen, N T
INTRODUCTION/BACKGROUND:Strategies are needed to increase implementation of evidence-based tobacco dependence treatment (TDT) in health care systems in low-and middle-income countries (LMICs). METHODS:We conducted a two-arm cluster randomized controlled trial to compare the effectiveness of two strategies for implementing TDT guidelines in community health centers (n=26) in Vietnam. Arm 1 included training and a tool kit (e.g., reminder system) to promote and support delivery of the 4As (Ask about tobacco use, Advise to quit, Assess readiness, Assist with brief counseling) (Arm 1). Arm 2 included Arm 1 components plus a system to refer smokers to a community health worker (CHW) for more intensive counseling (4As+R). Provider surveys were conducted at baseline, six- and 12-months to assess the hypothesized effect of the strategies on provider and organizational-level factors. The primary outcome was provider adoption of the 4As. RESULTS:Adoption of the 4As increased significantly across both study arms (all p<.001). Perceived organizational priority for TDT, compatibility with current workflow, and provider attitudes, norms and self-efficacy related to TDT also improved significantly across both arms. In Arm 2 sites, 41% of smokers were referred to a CHW for additional counseling. CONCLUSION/CONCLUSIONS:The study demonstrated the effectiveness of a multicomponent and multilevel strategy (i.e., provider and system) for implementing evidence-based TDT in the Vietnam public health system. Combining provider-delivered brief counseling with opportunities for more in-depth counseling offered by a trained CHW may optimize outcomes and offers a potentially scalable model for increasing access to TDT in health care systems like Vietnam. IMPLICATIONS/CONCLUSIONS:Improving implementation of evidence-based tobacco dependence treatment (TDT) guidelines is a necessary step towards reducing the growing burden of non-communicable disease (NCDs) and premature death in LMICs. The findings provide new evidence on the effectiveness of multilevel strategies for adapting and implementing TDT into routine care in Vietnam, and offers a potentially scalable model for meeting FCTC Article 14 goals in other LMICs with comparable public health systems. The study also demonstrates that combining provider-delivered brief counseling with referral to a community health worker for more in-depth counseling and support can optimize access to evidence-based treatment for tobacco use.
PMID: 34543422
ISSN: 1469-994x
CID: 5088102

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

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

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

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