There is a critical need for objective data to guide effective health promotion and care for homeless populations. However, many investigators exclude homeless populations from clinical trials due to practical concerns about conducting research with this population. This report is based on our experience and lessons learned while conducting two large NIH-funded randomized controlled trials targeting smoking cessation among persons who are homeless. The current report also addresses challenges when conducting clinical trials among homeless populations and offers potential solutions. Homeless individuals face several challenges including the need to negotiate daily access to food, clothing, and shelter. Some of the critical issues investigators encounter include recruitment and retention obstacles; cognitive impairment, mental health and substance abuse disorders; transportation and scheduling challenges; issues pertaining to adequate study compensation; the need for safety protocols for study staff; and issues related to protecting the wellbeing of these potentially vulnerable adults. Anticipating realistic conditions in which to conduct studies with participants who are homeless will help investigators to design efficient protocols and may improve the feasibility of conducting clinical trials involving homeless populations and the quality of the data collected by the researchers.Trial registrationClinicalTrials.gov, ID: NCT00786149. Registered on 5 November 2008;ClinicalTrials.gov, ID: NCT01932996. Registered on 20 November 2014.
BackgroundDespite progress in reducing cigarette smoking in the general U.S. population, smoking rates, cancer morbidity and related heart disease remain strikingly high among the poor and underserved. Homeless individuals’ cigarette smoking rate remains an alarming 70 % or greater, and this population is generally untreated with smoking cessation interventions. Furthermore, the majority of homeless smokers also abuse alcohol and other drugs, which makes quitting more difficult and magnifies the health consequences of tobacco use.Methods/DesignParticipants will be randomized to one of three groups, including (1) an integrated intensive smoking plus alcohol intervention using cognitive behavioral therapy (CBT), (2) intensive smoking intervention using CBT or (3) usual care (i.e., brief smoking cessation and brief alcohol counseling). All participants will receive 12-week treatment with a nicotine patch plus nicotine gum or lozenge. Counseling will include weekly individual sessions for 3 months, followed by monthly booster group sessions for 3 months. The primary smoking outcome is cotinine-verified 7-day smoking abstinence at follow-up week 52, and the primary alcohol outcome will be breathalyzer-verified 90-day alcohol abstinence at week 52.DiscussionThis study protocol describes the design of the first community-based controlled trial (n = 645) designed to examine the efficacy of integrating alcohol abuse treatment with smoking cessation among homeless smokers. To further address the gap in effectiveness of evidence-based smoking cessation interventions in the homeless population, we are conducting a renewed smoking cessation clinical trial called Power to Quit among smokers experiencing homelessness.Trial registrationClinicalTrials.gov Identifier: NCT01932996. Date of registration: 20 November 2014.
Introduction Somali Muslim male immigrants in Minnesota have a high prevalence of smoking, estimated at 44%, compared with the average smoking rate for adults in the United States (14%). However, the literature has reported spontaneous reductions of smoking during Ramadan. This study sought to gather the views of Somali Muslim men on how faith impacts their smoking, and determine what messaging to incorporate into a tailored text messages intervention that draws on the Muslim faith beliefs and practices during Ramadan to promote smoking cessation. Methods Thirty-seven Somali adult male smokers were recruited from community settings to participate in one of five focus groups in Minneapolis and Saint Paul, Minnesota. The research study team developed a semi-structured focus group guide that explored: (1) the experience of Muslim immigrants quitting smoking during Ramadan, (2) views on text messaging interventions to reduce smoking focusing on health and faith, and (3) views on the relationship between faith and smoking. A thematic analysis was conducted. Results Participants reported reductions in smoking during Ramadan, which was mostly achieved without formal treatment (ie, willpower). There was interest in text messaging interventions that incorporated faith and health-related messages, and that would be delivered around the time of Ramadan. Participants described concerns about the adverse health effects of smoking, including the risk of chronic health issues, cancer, and death. Conclusion Combining faith and health-related text-based messaging, and tailoring interventions around and beyond Ramadan, maybe a valuable approach to help address smoking disparities in the Somali immigrant community. Implications Ramadan offers a unique window of opportunity to intervene upon smoking for Somali Muslim immigrant men, for whom rates of smoking are high. Combining faith and health-related text-based messaging, and tailoring interventions around and beyond Ramadan, maybe a valuable approach to help address these serious smoking disparities.
Background Adults experiencing homelessness have higher rates of disease and premature morbidity compared to the general population. Tobacco use is a primary contributing factor to these disparities; however, less is known regarding e-cigarette use patterns among adults experiencing homelessness and whether e-cigarettes are used in a manner that is narrowing or widening health disparities. This study aimed to describe the 1) prevalence and trends in e-cigarette use, 2) correlates of e-cigarettes use, and 3) rates of chronic health conditions by product use pattern in a community-based sample of adults experiencing homelessness. Methods Adults experiencing homelessness in Minnesota were surveyed by self-report in 2015 (n = 3672) and 2018 (n = 4181) regarding e-cigarette and combustible cigarette use, potential correlates of e-cigarette use, and self-reported chronic health conditions (i.e., asthma, hypertension, diabetes, and cancer). Results Frequency of use increased from 2015 to 2018 for combustible cigarettes (66.9% vs. 72.3%), e-cigarettes (11.4% vs. 14.5%), and dual combustible/e-cigarette use (10.2% vs. 12.9%). The strongest bivariate correlates of past 30-day e-cigarette use were younger age, non-binary gender identification, non-heterosexual orientation, identification as White/Caucasian, greater frequency of lifetime homelessness, substance use, lack of regular place for medical care, mental health diagnosis, criminal justice involvement, and combustible cigarette smoking. Dual users had significantly higher rates of asthma and cancer than both those using combustible cigarettes and those using neither combustible nor e-cigarettes. Conclusions During a time when cigarette smoking, e-cigarette use, and dual use were decreasing in the general population in Minnesota, rates increased in the homeless population. We observed that the rates of dual use were more than five times greater among homeless adults compared to the general population in 2018. Correlates of e-cigarette use were identified and should be used to identify subpopulations for intervention targeting. Mechanisms of the relationship between dual use and increased risks of health conditions deserve further study.
Introduction The objective of this clinical trial was to compare the effects of e-cigarettes with and without nicotine on patterns of combustible cigarette use and biomarkers of exposure to tobacco toxicants among African American smokers. Methods African American smokers (n = 234) were enrolled in a 12-week, single blind, randomized controlled trial and assigned to ad lib use of nicotine e-cigarettes with or without menthol (2.4% nicotine [equivalent to combustible cigarettes], n = 118), or no-nicotine e-cigarettes (n = 116) for 6 weeks. Surveys were administered at baseline, 2, 6, and 12 weeks, and urinary biomarkers 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) and total nicotine equivalents (TNE) were assessed at baseline and 6 weeks. Results Participants smoked an average of 11.4 cigarettes per day (CPD) and 88% used menthol cigarettes at baseline. At Week 6, the nicotine group reported using e-cigarettes 9.1 times per day compared to 11.4 times in the no-nicotine group (p = 0.42). Combustible cigarette smoking decreased 3.0 CPD in the nicotine group compared to 2.7 CPD in the no-nicotine group (p = 0.74). Neither TNE nor NNAL changed significantly between baseline and Week 6. There were no differences in nicotine withdrawal symptoms between treatment groups. Smoking reduction persisted in both groups at Week 12. Conclusions Contrary to our hypotheses, nicotine e-cigarettes did not significantly reduce the use of combustible cigarettes compared to no-nicotine e-cigarettes in this cohort of African American smokers. Findings suggest e-cigarettes are modestly associated with the decreased use of combustible cigarettes among non-treatment seeking smokers, regardless of nicotine content, but without a reduction in tobacco toxicants. Implications Although e-cigarettes have the potential to reduce harm if substituted for combusted cigarettes (or if they promoted cessation) because of lower levels of tobacco toxicants, this study suggests ad lib use of e-cigarettes among African American smokers, with or without nicotine, results in modest smoking reduction but does not change toxicant exposure in a cohort where smoking cessation or reduction is not the goal. These data suggest that testing future harm reduction interventions using e-cigarettes should include more specific behavioral change coaching, including substituting for or completely stopping combusted cigarettes. Clinical Trial Registration ClinicalTrials.gov – NCT03084315
Introduction The prevalence of smoking among Somali Muslim male immigrants residing in Minnesota is estimated at 44%, however smoking reduction is common during the month of Ramadan. This study evaluated the feasibility and impact of a religiously-tailored text message intervention delivered during Ramadan to encourage smoking reduction among Somali Muslim men who smoke. Methods 50 Somali men were recruited. Participants received two text messages per day starting one week prior to and throughout the month of Ramadan. Approximately half were religiously-tailored and half were about the risks of smoking and benefits of quitting. Smoking behavior was assessed at baseline, and at weeks 4 (end of Ramadan), 8, and 16. Outcomes included feasibility, acceptability, and preliminary impact of the text message intervention on smoking reduction and bio-verified abstinence. Results The average age was 41 years. Average time to first cigarette was 1.8 hours at baseline, and 46% of participants smoked menthol cigarettes. Eighteen of 50 participants selected English and 32 selected Somali text messages. Subjects significantly reduced self-reported cigarettes per day (CPD) from 12.4 CPD at baseline to 5.8 CPD at Week 16 (p<0.001). Seven subjects reported quitting at week 16, five completed CO testing, confirming self-reported abstinence. The majority of participants found the cultural and religious references encouraging at the end of the week 16 survey. Conclusions Religiously-tailored text messages to decrease smoking are feasible and acceptable to Somali Muslim men who smoke during Ramadan. This intervention for addressing smoking disparities is worthy of further study. Implications Recruitment of Somali Muslim men who smoke is feasible and supports the idea that further studies targeting smoking during Ramadan are practical. Ramadan presents a window of opportunity upon which to build smoking cessation interventions for smokers who identify as Muslim. These preliminary findings suggest that text messaging is a feasible and acceptable intervention strategy, and that religious tailoring was well received. Such an approach may offer potential for addressing smoking disparities among Somali Muslim male smokers.
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