Clinical Research Directory

Health Warnings and Counseling for Smoking Cessation

Tobacco use remains persistently high across South Asia, despite numerous public health efforts, and continues to significantly contribute to the burden of non-communicable diseases (NCDs) such as cardiovascular disease, hypertension, diabetes, and stroke. Community pharmacists-widely accessible and trusted within their communities-are an underutilized resource for delivering public health interventions. Graphic health warnings (GHWs), recommended by the World Health Organization (WHO), have been shown to promote smoking cessation, but are rarely paired with personalized counseling by healthcare providers. This study aims to evaluate both the effectiveness and cost-effectiveness of integrating GHWs with pharmacist-led personalized counseling at primary healthcare pharmacies in Bangladesh and Pakistan. A cluster randomized controlled trial (RCT) will be conducted, enrolling 3,240 adult participants in Bangladesh and \~160 participants in Pakistan (for feasibility study) from community pharmacies. Participants will be randomly assigned to one of three groups: (1) GHW only (distribution of printed booklets); (2) GHW + counseling (pharmacist-led counselling sessions based on booklets at baseline and six months, with monthly SMS reminders); or (3) standard care (usual pharmacy services with no additional materials). The intervention includes twice-yearly counseling sessions-delivered both in-person and digitally-supported by educational booklets and leaflets. The primary outcome is self-reported 7-day point prevalence abstinence at 12 months (validated where feasible). Secondary outcomes include reduction in cigarettes per day, quit attempts, readiness to quit, awareness of tobacco harms, diet and physical activity scores, quality of life, blood pressure control among hypertensive participants, and cost-effectiveness. Feasibility outcomes in Pakistan include recruitment rate, participant retention, intervention fidelity and acceptability. Bayesian statistical models will be used to assess efficacy, and economic evaluations will determine the cost-effectiveness of the interventions. The findings aim to inform scalable public health strategies for tobacco control and NCD prevention in resource-limited settings.

A Web-Based Text Messaging for Tobacco Cessation in Rural Mississippi

Cigarette smoking prevalence has decreased to \~12% in 2022; however, over 40 million U.S. adults were current cigarette smokers in the same year. Rural-urban disparities in tobacco use are persistent, with higher tobacco use and lower cessation in rural areas. Less research has been dedicated to addressing rural-urban tobacco use disparities, perhaps due to logistics, difficulty recruiting and following participants from rural areas, and challenges with conducting clinic-based interventions. Mississippi is one of the states with higher rurality, as 79% of Mississippi counties are classified as rural. Additionally, Mississippi has a higher prevalence of tobacco use and lower cessation rates compared with the national average. Moreover, Mississippi is one of the few states that did not expand Medicaid, which covers comprehensive tobacco cessation services. This may add to the persistent disparity in tobacco use and cessation between rural and urban Mississippians. To overcome these challenges, the investigators propose a randomized clinical trial to test the effectiveness of theory-driven text messaging for tobacco cessation in rural Mississippi among users of cigarettes, smokeless tobacco (SLT), and dual users of cigarettes and SLT. Specifically, this proposal has the following specific aims: (1) To conduct a two-arm, randomized, clinical trial (RCT) of a web-based, text messaging approach for tobacco cessation among cigarette smokers, SLT users and dual users from rural Mississippi; (2) To assess the effectiveness of a web-based, text messaging intervention on tobacco cessation among cigarette smokers, SLT users and dual users; and (3) To identify barriers to and facilitators of tobacco cessation using ecological momentary assessment (EMA). To achieve these aims, a sample of 150 tobacco users (50 cigarette smokers, 50 SLT users, 50 dual users) who intend to quit and have made ≥1 quit attempt in the past 6 months will be recruited via a web-based, crowdsourcing platform (ResearchMatch.org). ResearchMatch.org is a large crowdsourcing platform that facilitates recruitment of a desired research sample from an online panel. Eligible participants will be randomized to intervention and control arms and will be asked to set up a quit date within the first 4 weeks post-intervention. Participants in the intervention arm will receive up to 3 motivational text messages daily during the first 4 weeks, and up to 2 daily during the last 2 weeks. The same frequency will be followed for the control group, but they will receive non-specific text messages. Participants will also receive a daily, midday text message during weeks 1-10 post-intervention to document the barriers and facilitators of tobacco cessation using EMA approach. After week 10 and to the end of 6 months post-intervention, the frequency of EMA texts will be reduced to once per week. Two-way text messaging will be facilitated via a web-based service called Mosio. The investigators will assess prolonged and 7-day point prevalence abstinence at 6 weeks, 3 months, and 6 months post-intervention. This project represents an attempt to test a simple and innovative approach to reducing rural-urban tobacco use disparities and overall tobacco-related morbidity and mortality. The findings can facilitate applying for extramural funding for a larger trial.

Extended Intervention for Tobacco Use (EXIT) for People Experiencing Homelessness

This study is investigating tobacco use and providing tobacco treatment among people experiencing homelessness in California, in San Francisco and Los Angeles.

FRESH Delivers: An Innovative Approach to Reducing Tobacco Use Among Rural Smokers

The long-term goal of FRESH Delivers is to fill a critical gap in knowledge on the role of a home-based food delivery social intervention in the elimination of tobacco-caused cancer health burdens. The central hypothesis is that smokers who receive real-time video-based motivational counseling and home-based food deliveries will have greater cotinine-verified 7-day point prevalence abstinence than those who receive real-time video-based motivational counseling alone or home food delivery alone. The rationale for this approach is that studies show increased odds of smoking cessation with increasing food security.

Tobacco Cessation Texting Intervention for People Living With HIV Who Smoke in Vietnam

The intersection of smoking and HIV/AIDS poses a serious public health threat in Vietnam. Vietnam is dealing with these two challenges with parallel rather than integrated plans. Using a computer-tailored texting intervention, study investigators seek to promote the use of an underused, available, government-funded resource (the Quitline) and Nicotine Replacement Therapy (NRT) that the quitline provides, thus, promoting cessation among PLWH.

Adaptation and Evaluation of a Culturally and Gender Relevant Tobacco Cessation Among Women in Brazil: An Integrated mHealth Approach

We developed and established the efficacy of a theory-based, culturally- and gender-relevant Community Health Worker (CHW) intervention for low-income Brazilian women that augments the tobacco cessation program offered through the public health system. This study represents the continuation of our gender-relevant tobacco control efforts in Brazil by proposing the adaptation of this CHW-delivered tobacco cessation program to be integrated with mHealth support through mobile devices (App). We are proposing an integrated CHW-mHealth application that (a) is culturally- and gender-relevant, (b) is theory-based (Social Cognitive Theory), (c) considers the existing structure of the Brazilian health care system, and (d) will be adapted based on an efficacious intervention as well as salient features of other mHealth applications that have been shown to be successful in engaging users. During phase I we will make the adaptations and determine feasibility of a CHW-delivered intervention that is integrated with a mHealth tobacco cessation application (interactive App for participants and tracking system for CHWs) through formative assessments among all involved stakeholders, pretesting, and pilot testing of the intervention. In phase II we will assess the effectiveness of the integrated CHW-mHealth tobacco cessation intervention through a group randomized trial with towns as the unit of randomization (8 towns, N=344). The comparison group will be the same as the previous intervention (consisting of a home visit by a CHW during which the participant is scheduled to attend the tobacco cessation program at the neighborhood public health clinic) to allow for comparisons. We hypothesize that at 6-months, women smokers who receive the integrated CHW-mHealth intervention will have significantly higher 7-day point prevalence abstinence (defined as no cigarettes in the past 7 days) than women smokers in the control condition. Self-report will be verified through measurement of exhaled carbon monoxide levels among 30% of participants. If shown to be effective, this approach could be utilized as a model for a population-based intervention in low-resource settings, including rural and disadvantaged women in the U.S.

Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse

The study aims to investigate whether behavioral interventions promote cessation in adult smokers by ameliorating negative emotions and improving self-control and identify the neural markers of these effects.

Persistent Poverty Counties Pregnant Women With Medicaid

Although many women initially quit smoking during pregnancy, most will return to smoking by the end of pregnancy or during the first 6 months postpartum. The proposed pilot project is designed to evaluate the feasibility and potential efficacy of offering small financial incentives for the completion of smoking cessation coaching and biochemically-verified smoking abstinence at follow-up among pregnant women with Medicaid insurance who contact the Oklahoma Tobacco Helpline (OTH). The study will enroll 100 pregnant women who will be randomly assigned to OTH care or OTH plus escalating incentives (OTH+I) for completing up to 5 coaching calls over the first 8 weeks after enrolling (prepartum) and for biochemically-verified smoking abstinence at 9 weeks post-enrollment (assessed remotely via smartphone). In addition, participants will be incentivized for completing a postpartum coaching call by 8 weeks postpartum. Feasibility outcomes for the incentives based intervention will focus on coaching call completion, rates of prepartum and postpartum follow-up, biochemically-verified smoking cessation, and perceptions of the intervention. Potential effectiveness will be evaluated by comparing biochemically-verified smoking abstinence rates in OTH+I relative to OTH alone at 12 weeks post-enrollment (prepartum) and 12 weeks postpartum.

A Stepped Care Approach to Treating Tobacco Use in Rural Veterans

Tobacco use remains prevalent among Veterans. Although effective smoking cessation interventions exist, long-term term quit rates remain sub-optimal. The project will investigate the feasibility of a stepped care approach to treating tobacco use that includes enhancements based on initial response to treatment to augment the investigators' existing tailored tobacco treatment intervention.