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.