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Youth E-Cigarette Use and Functionally Important Respiratory Symptoms: The Population Assessment of Tobacco and Health (PATH) Study Waves 3 and 4
Stevens, Elizabeth R; Xu, Shu; Niaura, Raymond; Cleland, Charles M; Sherman, Scott E; Mai, Andi; Karey, Emma; Jiang, Nan
Respiratory effects of e-cigarette use among youth are not fully understood. This study investigated the longitudinal association between e-cigarette use and a validated index of functionally important respiratory symptoms among US youth. Data from Waves 3-4 of the Population Assessment of Tobacco and Health Study were analyzed. The sample included youth (aged 12-17) without asthma at baseline (Wave 3), who completed a follow-up survey (Wave 4), and were not missing data for analytic variables (n = 3899). Exposure was e-cigarette use status (never, former, or current) at baseline. The outcome was a respiratory symptom index based on responses for seven wheezing items at Wave 4. An index of ≥2 was defined as having functionally important respiratory symptoms. Lagged logistic regression models examined the association between baseline e-cigarette use and functionally important respiratory symptoms at follow-up by combustible tobacco use status (never or ever), and controlling for baseline covariates. At baseline, 13.7% of participants reported former e-cigarette use, and 4.3% reported current use. Baseline e-cigarette use did not increase the odds of having functionally important respiratory symptoms at follow-up regardless of combustible tobacco use status. Future research on larger populations of e-cigarette users with longer follow-up periods will improve our understanding of the respiratory risks associated with e-cigarette use among youth.
PMCID:9690418
PMID: 36430043
ISSN: 1660-4601
CID: 5382882
Modelling the impact of HIV and hepatitis C virus prevention and treatment interventions among people who inject drugs in Kenya
Stone, Jack; Fraser, Hannah; Walker, Josephine G; Mafirakureva, Nyashadzaishe; Mundia, Bernard; Cleland, Charles; Bartilol, Kigen; Musyoki, Helgar; Waruiru, Wanjiru; Ragi, Allan; Bhattacharjee, Parinita; Chhun, Nok; Lizcano, John; Akiyama, Matthew J; Cherutich, Peter; Wisse, Ernst; Kurth, Ann; Luhmann, Niklas; Vickerman, Peter
OBJECTIVES:People who inject drugs (PWID) in Kenya have high HIV (range across settings: 14-26%) and hepatitis C virus (HCV; 11-36%) prevalence. We evaluated the impact of existing and scaled-up interventions on HIV and HCV incidence among PWID in Kenya. DESIGN:HIV and HCV transmission model among PWID, calibrated to Nairobi and Kenya's Coastal region. METHODS:For each setting, we projected the impact (percent of HIV/HCV infections averted in 2020) of existing coverages of antiretroviral therapy (ART; 63-79%), opioid agonist therapy (OAT; 8-13%) and needle and syringe programmes (NSP; 45-61%). We then projected the impact (reduction in HIV/HCV incidence over 2021-2030), of scaling-up harm reduction [Full harm reduction ('Full HR'): 50% OAT, 75% NSP] and/or HIV (UNAIDS 90-90-90) and HCV treatment (1000 PWID over 2021-2025) and reducing sexual risk (by 25/50/75%). We estimated HCV treatment levels needed to reduce HCV incidence by 90% by 2030. RESULTS:In 2020, OAT and NSP averted 46.0-50.8% (range of medians) of HIV infections and 50.0-66.1% of HCV infections, mostly because of NSP. ART only averted 12.9-39.8% of HIV infections because of suboptimal viral suppression (28-48%). Full HR and ART could reduce HIV incidence by 51.5-64% and HCV incidence by 84.6-86.6% by 2030. Also halving sexual risk could reduce HIV incidence by 68.0-74.1%. Alongside full HR, treating 2244 PWID over 2021-2025 could reduce HCV incidence by 90% by 2030. CONCLUSION:Existing interventions are having substantial impact on HIV and HCV transmission in Kenya. However, to eliminate HIV and HCV, further scale-up is needed with reductions in sexual risk and HCV treatment.
PMCID:9671825
PMID: 36111533
ISSN: 1473-5571
CID: 5374312
Adapting a tobacco cessation treatment intervention and implementation strategies to enhance implementation effectiveness and clinical outcomes in the context of HIV care in Vietnam: a case study
Shelley, Donna; Alvarez, Gloria Guevara; Nguyen, Trang; Nguyen, Nam; Goldsamt, Lloyd; Cleland, Charles; Tozan, Yesim; Shuter, Jonathan; Armstrong-Hough, Mari
BACKGROUND:Smoking rates remain high in Vietnam, particularly among people living with HIV/AIDS (PLWH), but tobacco cessation services are not available in outpatient HIV clinics (OPCs). The research team is conducting a type II hybrid randomized controlled trial (RCT) comparing the cost-effectiveness of three tobacco cessation interventions among PLWH receiving care in HIV clinics in Vietnam. The study is simultaneously evaluating the implementation processes and outcomes of strategies aimed at increasing the implementation of tobacco dependence treatment (TDT) in the context of HIV care. This paper describes the systematic, theory-driven process of adapting intervention components and implementation strategies with demonstrated effectiveness in high-income countries, and more recently in Vietnam, to a new population (i.e., PLWH) and new clinical setting, prior to launching the trial. METHODS:Data collection and analyses were guided by two implementation science frameworks and the socio-ecological model. Qualitative interviews were conducted with 13 health care providers and 24 patients in three OPCs. Workflow analyses were conducted in each OPC. Qualitative data were analyzed using rapid qualitative analysis procedures. Based on findings, components of the intervention and implementation strategies were adapted, followed by a 3-month pilot study in one OPC with 16 patients randomized to one of two intervention arms. RESULTS:The primary adaptations included modifying the TDT intervention counseling content to address barriers to quitting among PLWH and Vietnamese sociocultural norms that support smoking cessation. Implementation strategies (i.e., training and system changes) were adapted to respond to provider- and clinic-level determinants of implementation effectiveness (e.g., knowledge gaps, OPC resource constraints, staffing structure, compatibility). CONCLUSIONS:Adaptations were facilitated through a mixed method, stakeholder (patient and health care provider, district health leader)-engaged evaluation of context-specific influences on intervention and implementation effectiveness. This data-driven approach to refining and adapting components aimed to optimize intervention effectiveness and implementation in the context of HIV care. Balancing pragmatism with rigor through the use of rapid analysis procedures and multiple methods increased the feasibility of the adaptation process. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov NCT05162911 . Registered on December 16, 2021.
PMCID:9574833
PMID: 36253834
ISSN: 2662-2211
CID: 5360302
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
Incarceration, Social Support Networks, and Health among Black Sexual Minority Men and Transgender Women: Evidence from the HPTN 061 Study
Scheidell, Joy D; Kapadia, Farzana; Turpin, Rodman E; Mazumdar, Medha; Dyer, Typhanye V; Feelemyer, Jonathan; Cleland, Charles M; Brewer, Russell; Parker, Sharon D; Irvine, Natalia M; Remch, Molly; Mayer, Kenneth H; Khan, Maria R
Support from social networks buffers against negative effects of stress but is disrupted by incarceration. Few studies examine incarceration, social support networks, and health among Black sexual minority men (BSMM) and Black transgender women (BTW). We conducted a secondary analysis using HIV Prevention Trials Network 061 (HPTN 061), a sample of BSMM/BTW recruited from six US cities. We measured associations between recent incarceration reported at six months follow-up and social support networks at twelve months follow-up, and cross-sectional associations between support networks and twelve-month health outcomes (e.g., sexual partnerships, substance use, healthcare access and depressive symptoms). Among the analytic sample (N = 1169), recent incarceration was associated with small medical support networks (adjusted risk ratio [aRR] 1.16, 95% CI 1.01, 1.34) and small financial support networks (aRR 1.18, 95% CI 1.04, 1.35). Support networks were associated with multiple partnerships (adjusted prevalence ratio [aPR] 0.77, 95% CI 0.65, 0.90), unhealthy alcohol use (aPR 1.20, 95% CI 0.96, 1.51), and depressive symptoms (aPR 1.16, 95% CI 0.99, 1.36). Incarceration adversely impacts social support networks of BSMM/BTW, and support networks were associated with a range of important health outcomes.
PMCID:9564690
PMID: 36231367
ISSN: 1660-4601
CID: 5352172
Correction: Advancing behavioral interventions for African American/Black and Latino persons living with HIV using a new conceptual model that integrates critical race theory, harm reduction, and self-determination theory: a qualitative exploratory study
Gwadz, Marya; Cluesman, Sabrina R; Freeman, Robert; Collins, Linda M; Dorsen, Caroline; Hawkins, Robert L; Cleland, Charles M; Wilton, Leo; Ritchie, Amanda S; Torbjornsen, Karen; Leonard, Noelle R; Martinez, Belkis Y; Silverman, Elizabeth; Israel, Khadija; Kutnick, Alexandra
PMID: 35978365
ISSN: 1475-9276
CID: 5300032
Using the multiphase optimization strategy (MOST) framework to optimize an intervention to increase COVID-19 testing for Black and Latino/Hispanic frontline essential workers: A study protocol
Gwadz, Marya; Cleland, Charles M; Lizardo, Maria; Hawkins, Robert L; Bangser, Greg; Parameswaran, Lalitha; Stanhope, Victoria; Robinson, Jennifer A; Karim, Shristi; Hollaway, Tierra; Ramirez, Paola G; Filippone, Prema L; Ritchie, Amanda S; Banfield, Angela; Silverman, Elizabeth
BACKGROUND:Among those at highest risk for COVID-19 exposure is the large population of frontline essential workers in occupations such food service, retail, personal care, and in-home health services, among whom Black and Latino/Hispanic persons are over-represented. For those not vaccinated and at risk for exposure to COVID-19, including frontline essential workers, regular (approximately weekly) COVID-19 testing is recommended. However, Black and Latino/Hispanic frontline essential workers in these occupations experience serious impediments to COVID-19 testing at individual/attitudinal- (e.g., lack of knowledge of guidelines), social- (e.g., social norms), and structural-levels of influence (e.g., poor access), and rates of testing for COVID-19 are insufficient. METHODS/DESIGN:The proposed community-engaged study uses the multiphase optimization strategy (MOST) framework and an efficient factorial design to test four candidate behavioral intervention components informed by an integrated conceptual model that combines critical race theory, harm reduction, and self-determination theory. They are A) motivational interview counseling, B) text messaging grounded in behavioral economics, C) peer education, and D) access to testing (via navigation to an appointment vs. a self-test kit). All participants receive health education on COVID-19. The specific aims are to: identify which components contribute meaningfully to improvement in the primary outcome, COVID-19 testing confirmed with documentary evidence, with the most effective combination of components comprising an "optimized" intervention that strategically balances effectiveness against affordability, scalability, and efficiency (Aim 1); identify mediators and moderators of the effects of components (Aim 2); and use a mixed-methods approach to explore relationships among COVID-19 testing and vaccination (Aim 3). Participants will be N = 448 Black and Latino/Hispanic frontline essential workers not tested for COVID-19 in the past six months and not fully vaccinated for COVID-19, randomly assigned to one of 16 intervention conditions, and assessed at 6- and 12-weeks post-baseline. Last, N = 50 participants will engage in qualitative in-depth interviews. DISCUSSION:This optimization trial is designed to yield an effective, affordable, and efficient behavioral intervention that can be rapidly scaled in community settings. Further, it will advance the literature on intervention approaches for social inequities such as those evident in the COVID-19 pandemic. TRIAL REGISTRATION:ClinicalTrials.gov: NCT05139927 ; Registered on 11/29/2021. Protocol version 1.0. May 2, 2022, Version 1.0.
PMCID:9210062
PMID: 35729622
ISSN: 1471-2458
CID: 5278012
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
Advancing behavioral interventions for African American/Black and Latino persons living with HIV using a new conceptual model that integrates critical race theory, harm reduction, and self-determination theory: a qualitative exploratory study
Gwadz, Marya; Cluesman, Sabrina R; Freeman, Robert; Collins, Linda M; Dorsen, Caroline; Hawkins, Robert L; Cleland, Charles M; Wilton, Leo; Ritchie, Amanda S; Torbjornsen, Karen; Leonard, Noelle R; Martinez, Belkis Y; Silverman, Elizabeth; Israel, Khadija; Kutnick, Alexandra
BACKGROUND:Rates of participation in HIV care, medication uptake, and viral suppression are improving among persons living with HIV (PLWH) in the United States. Yet, disparities among African American/Black and Latino PLWH are persistent, signaling the need for new conceptual approaches. To address gaps in services and research (e.g., insufficient attention to structural/systemic factors, inadequate harm reduction services and autonomy support) and improve behavioral interventions, we integrated critical race theory, harm reduction, and self-determination theory into a new conceptual model, then used the model to develop a set of six intervention components which were tested in a larger study. The present qualitative study explores participants' perspectives on the study's acceptability, feasibility, and impact, and the conceptual model's contribution to these experiences. METHODS:Participants in the larger study were African American/Black and Latino PLWH poorly engaged in HIV care and with non-suppressed HIV viral load in New York City (N = 512). We randomly selected N = 46 for in-depth semi-structured interviews on their experiences with and perspectives on the study. Interviews were audio-recorded and professionally transcribed verbatim, and data were analyzed using directed qualitative content analysis. RESULTS:On average, participants were 49 years old (SD = 9) and had lived with HIV for 19 years (SD = 7). Most were male (78%) and African American/Black (76%). All had taken HIV medication previously. Challenging life contexts were the norm, including poverty, poor quality/unstable housing, trauma histories exacerbated by current trauma, health comorbidities, and substance use. Participants found the study highly acceptable. We organized results into four themes focused on participants' experiences of: 1) being understood as a whole person and in their structural/systemic context; 2) trustworthiness and trust; 3) opportunities for self-reflection; and 4) support of personal autonomy. The salience of nonjudgment was prominent in each theme. Themes reflected grounding in the conceptual model. Participants reported these characteristics were lacking in HIV care settings. CONCLUSIONS:The new conceptual model emphasizes the salience of systemic/structural and social factors that drive health behavior and the resultant interventions foster trust, self-reflection, engagement, and behavior change. The model has potential to enhance intervention acceptability, feasibility, and effectiveness with African American/Black and Latino PLWH.
PMCID:9286957
PMID: 35840962
ISSN: 1475-9276
CID: 5269602
Considerations Before Selecting a Stepped-Wedge Cluster Randomized Trial Design for a Practice Improvement Study
Nguyen, Ann M; Cleland, Charles M; Dickinson, L Miriam; Barry, Michael P; Cykert, Samuel; Duffy, F Daniel; Kuzel, Anton J; Lindner, Stephan R; Parchman, Michael L; Shelley, Donna R; Walunas, Theresa L
PURPOSE:Despite the growing popularity of stepped-wedge cluster randomized trials (SW-CRTs) for practice-based research, the design's advantages and challenges are not well documented. The objective of this study was to identify the advantages and challenges of the SW-CRT design for large-scale intervention implementations in primary care settings. METHODS:The EvidenceNOW: Advancing Heart Health initiative, funded by the Agency for Healthcare Research and Quality, included a large collection of SW-CRTs. We conducted qualitative interviews with 17 key informants from EvidenceNOW grantees to identify the advantages and challenges of using SW-CRT design. RESULTS:All interviewees reported that SW-CRT can be an effective study design for large-scale intervention implementations. Advantages included (1) incentivized recruitment, (2) staggered resource allocation, and (3) statistical power. Challenges included (1) time-sensitive recruitment, (2) retention, (3) randomization requirements and practice preferences, (4) achieving treatment schedule fidelity, (5) intensive data collection, (6) the Hawthorne effect, and (7) temporal trends. CONCLUSIONS:.
PMID: 35606135
ISSN: 1544-1717
CID: 5247862