In-Clinic vs. Online Recruitment of Women with a History of Cervical Intraepithelial Neoplasia or Cervical Cancer to a Smoking Cessation Trial: A Post-hoc Comparison of Participant Characteristics, Study Retention, and Cessation Outcomes.

INTRODUCTION: Recruiting special populations to smoking cessation trials is challenging and approaches beyond in-clinic recruitment may be beneficial. This secondary analysis of data from a smoking cessation RCT for individuals with a history of cervical cancer or cervical intraepithelial neoplasia (CIN) explored differences associated with in-clinic vs. online recruitment. METHODS: Participants were recruited from clinics within a university-based NCI-designated cancer center (n=87) and online nationally via Facebook (n=115). Baseline measures included sociodemographics, smoking history, and cancer or CIN history. Study retention and smoking abstinence were assessed 12 months post-baseline. Group differences in baseline characteristics were evaluated. Retention and abstinence were evaluated while controlling for group differences and predictors. RESULTS: Participants recruited online (vs. in-clinic) had higher educational attainment (p=.01) and health literacy (p=.003). They were more likely to have CIN vs. cancer, to be further from the time of diagnosis, and to have completed active treatment (p values<.001). While controlling for these group differences and independent predictors, retention was higher among participants recruited online (log-likelihood χ2(1)=11.41, p<.001). There were no recruitment differences in self-reported (p=.90) or biochemically confirmed smoking abstinence (p=.18). CONCLUSIONS: Compared to individuals recruited in-person, individuals recruited online were more educated, had higher health literacy, and presented with a different clinical profile (i.e., more likely to have CIN vs. cancer and to have completed active treatment). There were few differences in participant characteristics between recruitment approaches, and no differences on any smoking-related variables. Online recruitment has the potential to improve enrollment of cancer survivors to smoking cessation trials. IMPLICATIONS: People with a history of CIN or cervical cancer recruited to a smoking cessation RCT online (vs. in-clinic) were more likely to have a diagnosis of CIN vs. cancer and were more educated and health literate. Participants recruited online were more likely to be retained in the study and there were no differences in smoking abstinence rates at 12-months. Incorporating online recruitment increased the reach of tobacco treatment efforts to a larger and more diverse sample. This could reduce the burden of tobacco-related disease, improve CIN and cancer treatment outcomes, and reduce secondary malignancies and morbidity among this underserved group.

Smoking Cessation by Cancer Treatment Status Among Cervical Cancer Survivors.

INTRODUCTION: Continued smoking following a cancer diagnosis is associated with poorer cancer treatment outcomes and survival times. Little is known about how cancer treatment status at the time of tobacco treatment enrollment impacts long-term smoking cessation outcomes. Using data from a smoking cessation RCT, this study compared long-term cessation outcomes of women undergoing active treatment for cervical cancer at trial enrollment (n=40) to outcomes of women with a history of cervical cancer or cervical intraepithelial neoplasia (CIN) who were not undergoing active cancer treatment at enrollment (n=154). METHODS: Participants (n=194) were randomized to Standard Treatment (ST) or ST plus a 6-session Motivation And Problem Solving (MAPS) telephone counseling protocol (data collected: 2017-2021; analyzed: 2023). Sociodemographic differences between participants undergoing (versus not undergoing) active cancer treatment at enrollment were examined. Significant covariates were included in a logistic regression analysis comparing the 2 groups' smoking cessation outcomes at 12 months, the end of the tobacco treatment period. RESULTS: Participants in active cancer treatment at enrollment were significantly younger and less educated than those not in active cancer treatment. Race/ethnicity, relationship status, household income, nicotine dependence, and tobacco treatment condition did not vary by cancer treatment status. After adjusting for tobacco treatment condition, age, and education, being in active cancer treatment at the time of enrollment was associated with lower odds of abstinence at 12 months (5% vs 20%, aOR=0.22, 95% CI [0.05-0.998]). CONCLUSIONS: Further research is necessary to identify and overcome barriers to abstinence among cancer survivors undergoing active treatment.

Enhancing long-term smoking abstinence among individuals with a history of cervical intraepithelial neoplasia or cervical cancer (Project ACCESS): protocol for a randomized clinical trial.

BACKGROUND: The prevalence of smoking among cervical cancer survivors is high and evidence-based smoking cessation interventions are critically needed. This paper describes the study design, methods, and data analysis plans for a randomized clinical trial (RCT) designed to evaluate the efficacy of a novel, personally tailored SMS-delivered text-based digital treatment adjuvant designed to enhance the long-term efficacy of a "Motivation And Problem-Solving" (MAPS) approach for smoking cessation among individuals with a history of cervical intraepithelial neoplasia (CIN) or cervical cancer. MAPS is a phone counseling approach designed to facilitate long-term abstinence that comprises 6 counseling calls over 12 months. The current trial is evaluating the efficacy of MAPS+, which comprises all MAPS components plus a 24-month digital treatment adjuvant. This trial represents a logical extension of our previous RCT, which compared the efficacy of MAPS to a quitline control condition and found that MAPS resulted in greater than a 2-fold increase in smoking abstinence at 12 months (i.e., 26.4% vs. 11.9%). This treatment effect was no longer significant at 18 months, suggesting that efficacy dissipated as time from the end of treatment increased. The primary aim of the current trial is to compare the efficacy of MAPS + and ST in facilitating long-term abstinence. METHODS: Individuals who smoke and have a history of cervical cancer or CIN (N = 340) are recruited throughout Florida and randomly assigned to Standard Treatment [ST] or MAPS+. ST participants are electronically connected with the Florida Quitline. MAPS + consists of 6 proactive MAPS-based counseling calls over 12 months plus the novel, personally tailored, text message-based treatment adjuvant delivered over 24 months. All participants receive 12 weeks of combination nicotine replacement therapy (patch and lozenge) and are followed for 24 months. Participant recruitment commenced in December 2022 and is ongoing. DISCUSSION: This study builds on promising results from our recent trial which found that MAPS was associated with substantially higher abstinence from smoking at the end of the 12-month treatment period. Finding that this low-burden, personally tailored digital treatment adjuvant improves the long-term efficacy of MAPS would have important clinical and public health implications. TRIAL REGISTRATION: Clinical Trials Registry NCT05645146; https://clinicaltrials.gov/ct2/show/NCT05645146 ; Registered on December 9, 2022.

Ending Tobacco Use Through Interactive Tailored Messaging for Cambodian People With HIV (Project EndIT): Protocol for a Randomized Controlled Trial.

BACKGROUND: The prevalence of smoking remains high in many low- and middle-income countries (LMICs), including the Southeast Asian nation of Cambodia. Smoking is especially hazardous for people with HIV. In Cambodia, approximately 43%-65% of men with HIV and 3%-5% of women with HIV smoke cigarettes. Thus, there is a critical need for cost-effective smoking cessation interventions for Cambodian people with HIV. This paper describes the design, methods, and data analysis plans for a randomized controlled trial assessing the efficacy of a theory-based mobile health smoking cessation intervention in Cambodian people with HIV. OBJECTIVE: This 2-group randomized controlled trial compares the efficacy of a mobile health-based automated messaging (AM) intervention versus standard care (SC) in facilitating smoking cessation among Cambodian people with HIV. METHODS: Cambodian people with HIV who currently smoke and are receiving antiretroviral treatment (target, N=800) will be randomized to (1) SC or (2) the AM intervention. SC participants will receive brief advice to quit smoking, written self-help materials, nicotine patches, and will complete weekly app-delivered dietary assessments for 26 weeks. AM participants will receive all SC components (but will complete smoking-related weekly assessments instead of dietary assessments), in addition to a fully automated tailored messaging program driven by the weekly assessments to facilitate smoking cessation. In the Phase-Based Model of smoking cessation, the cessation process is partitioned into 4 phases: motivation, preparation (precessation), cessation (quit date to 2 weeks post quit), and maintenance (up to 6 months post quit). Our AM program targets processes within these phases, including increasing motivation to quit, enhancing self-efficacy, obtaining social support, skills to cope with nicotine withdrawal symptoms and stress, and skills to maintain abstinence. All participants will complete baseline and 3-, 6-, and 12-month in-person follow-up assessments. The primary outcome is biochemically confirmed abstinence at 12 months, with 3- and 6-month abstinence as secondary outcomes. Potential mediators and moderators underlying treatment effects will be explored, and cost-effectiveness will be assessed. RESULTS: This study was approved by all relevant domestic and international institutional and ethical review boards. Participant recruitment commenced in January 2023. Data collection is expected to conclude by the end of 2025. CONCLUSIONS: By demonstrating the greater efficacy and cost-effectiveness of AM relative to SC, this study has the potential to transform HIV care in Cambodia and prevent tobacco-related diseases. Furthermore, it may be adapted for use in other Cambodian populations and in other low- and middle-income countries. Ultimately, the AM approach to smoking cessation could greatly improve public health in the developing world and beyond. TRIAL REGISTRATION: ClinicalTrials.gov NCT05746442; https://clinicaltrials.gov/ct2/show/NCT05746442. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/48923.

Feasibility, Acceptability, and Preliminary Effects of a Video-Based Intervention for Smoking Cessation Among People with HIV in Kathmandu, Nepal: A Single-Armed Pilot Study.

Despite the evidence of the disproportionate burden of tobacco use among people with HIV (PWH), little effort has been made to design and test smoking cessation interventions for PWH in resource-limited countries. We assessed the feasibility, acceptability, and preliminary effects of a video-based smoking cessation intervention consisting of eleven 3-8-minute sessions among PWH in Nepal, a lower-middle-income country. Guided by the phased-based model, our 3-month intervention focused on setting the quit date, smoking cessation, and abstinence maintenance. We screened 103 PWH over three weeks for our single-arm trial, with 53 considered eligible and 48 recruited (91%). Forty-six participants watched all video clips, while two watched 7-9. All participants were retained at a 3-month follow-up. The 1-week point prevalence abstinence (self-report supported with expired carbon monoxide levels < 5ppm) at 3-month follow-up was 39.6%. Most (90%) participants reported "very much" or "much" comfort with watching the videos on their smartphones, and all would recommend the intervention to other PWH who smoke. Overall, our pilot trial demonstrated the feasibility, acceptability, and high-level efficacy of the video-based smoking cessation intervention highlighting its potential for scaling up in Nepal and other resource-limited countries.

Efficacy of a Smoking Cessation Intervention for Survivors of Cervical Intraepithelial Neoplasia or Cervical Cancer: A Randomized Controlled Trial.

PURPOSE: Women who smoke and have a history of cervical intraepithelial neoplasia (CIN) or cervical cancer represent a vulnerable subgroup at elevated risk for recurrence, poorer cancer treatment outcomes, and decreased quality of life. The purpose of this study was to evaluate the long-term efficacy of Motivation And Problem Solving (MAPS), a novel treatment well-suited to meeting the smoking cessation needs of this population. METHODS: Women who were with a history of CIN or cervical cancer, age 18 years and older, spoke English or Spanish, and reported current smoking (≥100 lifetime cigarettes plus any smoking in the past 30 days) were eligible. Participants (N = 202) were recruited in clinic in Oklahoma City and online nationally and randomly assigned to (1) standard treatment (ST) or (2) MAPS. ST consisted of repeated referrals to a tobacco cessation quitline, self-help materials, and combination nicotine replacement therapy (patch plus lozenge). MAPS comprised all ST components plus up to six proactive telephone counseling sessions over 12 months. Logistic regression and generalized estimating equations evaluated the intervention. The primary outcome was self-reported 7-day point prevalence abstinence from tobacco at 18 months, with abstinence at 3, 6, and 12 months and biochemically confirmed abstinence as secondary outcomes. RESULTS: There was no significant effect for MAPS over ST at 18 months (14.2% v 12.9%, P = .79). However, there was a significant condition × assessment interaction (P = .015). Follow-up analyses found that MAPS (v ST) abstinence rates were significantly greater at 12 months (26.4% v 11.9%, P = .017; estimated OR, 2.60; 95% CI, 1.19 to 5.89). CONCLUSION: MAPS led to a greater than two-fold increase in smoking abstinence among survivors of CIN and cervical cancer at 12 months. At 18 months, abstinence in MAPS declined to match the control condition and the treatment effect was no longer significant.

The implementation of ask-advise-connect in a federally qualified health center: a mixed methods evaluation using the re-aim framework.

Ask-Advise-Connect (AAC) efficiently links smokers in healthcare settings with evidence-based Quitline-delivered tobacco treatment through training clinic staff to systematically ask patients about smoking status, advise smokers to quit, and connect patients with state Quitlines using the electronic health record. This study utilized a mixed-methods approach, guided by the RE-AIM framework, to evaluate the implementation of AAC in a Federally Qualified Health Center (FQHC). AAC was implemented for 18 months at a FQHC serving primarily low-socioeconomic status (SES) Latinos and Latinas. Results are presented within the RE-AIM conceptual framework which includes dimensions of reach, effectiveness, adoption, implementation, and maintenance. Quantitative patient-level outcomes of reach, effectiveness, and Impact were calculated. Post-implementation, in-depth interviews were conducted with clinic leadership and staff (N = 9) to gather perceptions and inform future implementation efforts. During the implementation period, 12.0% of GNHC patients who reported current smoking both agreed to have their information sent to the Quitline and were successfully contacted by the Quitline (Reach), 94.8% of patients who spoke with the Quitline enrolled in treatment (Effectiveness), and 11.4% of all identified smokers enrolled in Quitline treatment (Impact). In post-implementation interviews assessing RE-AIM dimensions, clinic staff and leadership identified facilitators and advantages of AAC and reported that AAC was easy to learn and implement, streamlined existing procedures, and had a positive impact on patients. Staff and leadership reported enthusiasm about AAC implementation and believed AAC fit well in the clinic. Staff were interested in AAC becoming the standard of care and made suggestions for future implementation. Clinic staff at a FQHC serving primarily low-SES Latinos and Latinas viewed the ACC implementation process positively. Findings have implications for streamlining clinical smoking cessation procedures and the potential to reduce tobacco-related disparities.

Ask-Advise-Connect (AAC) simplifies and streamlines the process of asking patients about their smoking status, advising smokers to quit, and connecting patients through the electronic health record with free, evidence-based tobacco cessation treatment offered by state Quitlines. This study is the first to evaluate perceptions of AAC among clinic leadership and staff. After an 18-month implementation of AAC at a clinic serving mostly low-income Latinos and Latinas, clinic staff (e.g., medical assistants) and leaders were interviewed. Respondents reported that AAC streamlined their efforts to get patients to quit smoking, was easy to carry out, and fit well into the clinic flow. Staff wanted to keep AAC as the standard of care and made suggestions to improve how AAC works. They reported positive feedback from patients. In addition, a similar proportion of smokers enrolled in Quitline treatment as in other AAC trials. Thus, AAC worked well for patients and clinic staff. Having AAC in other clinics could improve enrollment in evidence-based smoking cessation treatment, facilitate successful smoking cessation among low-income primary care patients, and reduce burden on healthcare providers.

Ask-Advise-Connect: Differential Enrollment and Smoking Cessation Outcomes Between Primary Care Patients Who Received Quitline-Delivered Treatment in Spanish vs English.

PURPOSE: This study examined differences in Quitline treatment enrollment, engagement, and smoking cessation outcomes among primary care patients preferring Spanish and English using the evidence-based tobacco treatment Ask-Advise-Connect. METHODS: Ask-Advise-Connect was implemented April 2013 through February 2016 in a large safety-net health system to connect smokers with treatment via a link in the electronic health record. Rates of treatment enrollment, engagement, acceptance of nicotine replacement therapy, and smoking abstinence (self-reported and biochemically confirmed) were compared at 6 months among patients who received treatment in Spanish and English using χ 2 tests. Logistic regression examined language and nicotine replacement therapy and their interaction as predictors of abstinence. RESULTS: The smoking status of 218,915 patients was assessed and recorded in the electronic health record. Smoking prevalence was 8.4% among patients preferring Spanish and 27.0% among those preferring English. Spanish-preferring patients were less likely to enroll in treatment (10.7% vs 12.0%, χ 2 = 12.06, P = .001) yet completed more counseling calls when enrolled (median = 2 vs 1, P <.001). Patients who received treatment in Spanish (vs English) were twice as likely to be abstinent at 6 months (self-reported: 25.1% vs 14.5%, odds ratio [OR] = 1.98, 95% CI, 1.62-2.40; biochemically confirmed: 7.6% vs 3.7%, OR = 2.13, 95% CI, 1.52-2.97). Receipt of nicotine replacement therapy increased abstinence for all patients and language did not interact with nicotine replacement therapy to predict abstinence. CONCLUSIONS: Automated point-of-care approaches such as Ask-Advise-Connect have great potential to reach Spanish-preferring smokers. Those who received tobacco treatment in Spanish (vs English) demonstrated better engagement and cessation outcomes.

Comparison of an automated smartphone-based smoking cessation intervention versus standard quitline-delivered treatment among underserved smokers: protocol for a randomized controlled trial.

BACKGROUND: Smoking is the leading cause of preventable morbidity and mortality in the United States. Individuals with low socioeconomic status have disproportionately high smoking rates and greater difficulty quitting smoking. Efficiently connecting underserved smokers to effective tobacco cessation programs is crucial for disease prevention and the elimination of health disparities. Smartphone-based interventions have the potential to enhance the reach and efficacy of smoking cessation treatments targeting underserved smokers, but there is little efficacy data for these interventions. In this study, we will partner with a large, local hunger-relief organization to evaluate the efficacy and economic impact of a theoretically-based, fully-automated, and interactive smartphone-based smoking cessation intervention. METHODS: This study will consist of a 2-group randomized controlled trial. Participants (N = 500) will be recruited from a network of food distribution centers in West Central Florida and randomized to receive either Standard Treatment (ST, n = 250) or Automated Treatment (AT, n = 250). ST participants will be connected to the Florida Quitline for telephone-based treatment and will receive a 10-week supply of nicotine replacement therapy (NRT; transdermal patches and lozenges). AT participants will receive 10 weeks of NRT and a fully-automated smartphone-based intervention consisting of interactive messaging, images, and audiovisual clips. The AT intervention period will span 26 weeks, with 12 weeks of proactive content and 26 weeks of on-demand access. ST and AT participants will complete weekly 4-item assessments for 26 weeks and 3-, 6-, and 12-month follow-up assessments. Our primary aim is to evaluate the efficacy of AT in facilitating smoking abstinence. As secondary aims, we will explore potential mediators and conduct economic evaluations to assess the cost and/or cost-effectiveness of ST vs. AT. DISCUSSION: The overall goal of this project is to determine if AT is better at facilitating long-term smoking abstinence than ST, the more resource-intensive approach. If efficacy is established, the AT approach will be relatively easy to disseminate and for community-based organizations to scale and implement, thus helping to reduce tobacco-related health disparities. TRIAL REGISTRATION: Clinical Trials Registry NCT05004662 . Registered August 13, 2021.

Mobile contingency management for smoking cessation among socioeconomically disadvantaged adults: Protocol for a randomized trial.

BACKGROUND: Smoking rates remain high among socioeconomically disadvantaged adults. Offering small escalating financial incentives for abstinence (i.e., contingency management [CM]), alongside clinic-based treatment dramatically increases cessation rates in this vulnerable population. However, innovative approaches are needed for those who are less able to attend office visits. The current study will evaluate an automated mobile phone-based CM approach that will allow socioeconomically disadvantaged individuals to remotely earn financial incentives for smoking cessation. METHODS: The investigators have previously combined technologies, including 1) carbon monoxide monitors that connect with mobile phones to remotely verify abstinence, 2) facial recognition software to confirm identity during breath sample submissions, and 3) automated delivery of incentives triggered by biochemical abstinence confirmation. This automated CM approach will be evaluated in a randomized controlled trial of 532 low-income adults seeking cessation treatment. Participants will be randomly assigned to telephone counseling and nicotine replacement therapy (standard care [SC]) or SC plus mobile financial incentives (CM) for abstinence. RESULTS: Biochemically-verified 7-day point prevalence abstinence at 26 weeks post-quit is the primary outcome. The cost-effectiveness of the interventions will be evaluated. Potential treatment mechanisms, including self-efficacy, motivation, and treatment engagement, will be explored to optimize future interventions. DISCUSSION: Automated mobile CM may offer a low-cost approach to smoking cessation that can be combined with telephone counseling and pharmacological interventions. This approach represents a critical step toward the widespread dissemination of CM treatment to real-world settings, to reduce tobacco-related disease and disparities.

Sustained reduction of attentional bias to smoking cues by smartphone-delivered attentional bias modification training for smokers.

OBJECTIVE: Cigarette smoking is thought to be at least partially maintained by the attentional bias (AB) toward smoking cues that develops as a consequence of drug dependence. This study evaluated the impact of smartphone-delivered, in-home attentional bias modification (ABM) to reduce AB to smoking cues and to reduce smoking behavior and withdrawal-related symptoms when used as an adjunct to conventional smoking cessation treatment. METHOD: Participants (N = 246) were treatment-seeking smokers who completed up to 13 days of either ABM designed to train attention away from smoking cues, using a modified dot-probe task, or sham training, followed by 8 weeks of nicotine replacement therapy and counseling. Outcomes measured at baseline, 1-day post-ABM training, and 8 weeks post-ABM training included AB to smoking images and words using the dot-probe and smoking Stroop tasks, respectively, along with cigarettes per day, craving, and smoking abstinence. RESULTS: We found that ABM training reduced AB to smoking stimuli on both the dot-probe task, ηp² = 0.056, 90% CI [0.024, 0.097], and the smoking Stroop task, ηp² = 0.017, 90% CI [0.002, 0.044], up to 8 weeks after ABM training when covarying for baseline response, but did not concurrently decrease smoking behavior or craving. CONCLUSIONS: Thirteen days of smartphone-delivered ABM training, as an adjunct to smoking cessation treatment, reduced AB to both modality-specific and cross-modality smoking cues but did not impact smoking-related behavior. While ABM can reduce AB to smoking cues across modalities, it is unclear whether it has therapeutic potential as an adjunct to conventional smoking cessation therapy. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Mobile-health intervention for smoking cessation among Cambodian people living with HIV: A mixed-methods pilot study.

This mixed methods study aimed to evaluate the feasibility and preliminary efficacy of a fully automated, interactive smartphone-delivered intervention for smoking cessation among people living with HIV in Cambodia. We used the explanatory sequential design, with a pilot two-group single-blind randomized controlled trial (N = 50) followed by in-depth interviews with all trial participants. In the trial, participants were randomized to Standard Care (SC) or Automated Messaging (AM) group. SC comprised brief advice to quit and self-help materials. AM consisted of the SC components plus a fully automated smartphone-based treatment program that involved interactive and tailored proactive messaging for 2 months. Results showed that the AM approach was highly feasible and efficacious. Feasibility was supported by high rates of treatment engagement (e.g., 81% of delivered messages and assessments were read or completed) and high retention (96%) through the 2-month follow-up. Biochemically verified point prevalence abstinence at follow-up was 40% for the AM group and 8% for the SC group (relative risk: 5.0, 95% confidence interval: 1.2, 20.5). Being able to avoid other smokers, having coping skills, and having social/familial support contributed to successful abstinence. The AM program has the potential for wide-scale implementation in Cambodia and other low-income countries.

Evaluation of the Efficacy of a Smoking Cessation Intervention for Cervical Cancer Survivors and Women With High-Grade Cervical Dysplasia: Protocol for a Randomized Controlled Trial.

BACKGROUND: The prevalence of smoking among cervical cancer survivors is strikingly high, yet no smoking cessation interventions to date have specifically targeted this population. This paper describes the study design, methods, and data analysis plans for a randomized clinical trial designed to evaluate the efficacy of a theoretically and empirically based Motivation And Problem Solving (MAPS) approach for promoting and facilitating smoking cessation among cervical cancer survivors. MAPS is a comprehensive, dynamic, and holistic intervention that incorporates empirically supported cognitive behavioral and social cognitive theory-based treatment strategies within an overarching motivational framework. MAPS is designed to be appropriate for all smokers regardless of their motivation to change and views motivation as dynamically fluctuating from moment to moment throughout the behavior change process. OBJECTIVE: This 2-group randomized controlled trial compares the efficacy of standard treatment to MAPS in facilitating smoking cessation among women with a history of high-grade cervical dysplasia or cervical cancer. METHODS: Participants (N=202) are current smokers with a history of high-grade cervical dysplasia or cervical cancer recruited nationally and randomly assigned to one of two treatment conditions: (1) standard treatment (ST) or (2) MAPS. ST consists of repeated letters referring participants to their state's tobacco cessation quitline, standard self-help materials, and free nicotine replacement therapy when ready to quit. MAPS has all ST components along with 6 proactive telephone counseling sessions delivered over 12 months. The primary outcome is abstinence from tobacco at 18 months. Secondary outcomes include abstinence over time across all assessment points, abstinence at other individual assessment time points, quit attempts, cigarettes per day, and use of state quitlines. Hypothesized treatment mechanisms and cost-effectiveness will also be evaluated. RESULTS: This study was approved by the institutional review boards at the University of Texas MD Anderson Cancer Center, the University of Oklahoma Health Sciences Center, and Moffitt Cancer Center. Participant enrollment concluded at Moffitt Cancer Center in January 2020, and follow-up data collection was completed in July 2021. Data analysis is ongoing. CONCLUSIONS: This study will yield crucial information regarding the efficacy and cost-effectiveness of a MAPS approach for smoking cessation tailored to the specific needs of women with a history of high-grade cervical dysplasia or cervical cancer. Findings indicating that MAPS has substantially greater efficacy than existing evidence-based tobacco cessation treatments would have tremendous public health significance. TRIAL REGISTRATION: ClinicalTrials.gov NCT02157610; https://clinicaltrials.gov/ct2/show/NCT02157610. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/34502.

Mobile Text Messaging for Tobacco Risk Communication Among Young Adult Community College Students: Randomized Trial of Project Debunk.

BACKGROUND: The use of new and emerging tobacco products (NETPs) and conventional tobacco products (CTPs) has been linked to several alarming medical conditions among young adults (YAs). Considering that 96% of YAs own mobile phones, SMS text messaging may be an effective strategy for tobacco risk communication. OBJECTIVE: Project Debunk is a community-based randomized trial aiming to identify specific types of messages that effectively improve perceived NETP and CTP risk among YAs in community colleges. METHODS: With YAs recruited offline from 3 campuses at the Houston Community College (September 2016 to July 2017), we conducted a 6-month randomized trial with 8 arms based on the combination of 3 message categories: framing (gain-framed vs loss-framed), depth (simple vs complex), and appeal (emotional vs rational). Participants received fully automated web-based SMS text messages in two 30-day campaigns (2 messages per day). We conducted repeated-measures mixed-effect models stratified by message type received, predicting perceived CTP and NETP risks. Owing to multiple testing with 7 models, an association was deemed significant for P<.007 (.05 divided by 7). RESULTS: A total of 636 participants completed the baseline survey, were randomized to 1 of 8 conditions (between 73 and 86 participants per condition), and received messages from both campaigns. By the 2-month post campaign 2 assessment point, 70.1% (446/636) completed all outcome measures. By the end of both campaigns, participants had a significant increase in perceived NETP risk over time (P<.001); however, participants had a marginal increase in perceived CTP risk (P=.008). Separately for each group, there was a significant increase in perceived NETP risk among participants who received rational messages (P=.005), those who received emotional messages (P=.006), those who received simple messages (P=.003), and those who received gain-framed messages (P=.003). CONCLUSIONS: In this trial, YAs had an increase in perceived NETP risk. However, with stratification, we observed a significant increase in perceived NETP risk upon exposure to rational, emotional, simple, and gain-framed messages. In addition, YAs generally had an increase in perceived CTP risk and presented nonsignificant but observable improvement upon exposure to emotional, complex, and loss-framed messages. With the results of this study, researchers and practitioners implementing mobile health programs may take advantage of our tailored messages through larger technology-based programs such as smartphone apps and social media campaigns. TRIAL REGISTRATION: ClinicalTrials.gov NCT03457480; https://clinicaltrials.gov/ct2/show/NCT03457480. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/10977.

Evaluating the Efficacy of Automated Smoking Treatment for People With HIV: Protocol for a Randomized Controlled Trial.

BACKGROUND: Smoking prevalence rates among people with HIV are nearly 3 times higher than those in the general population. Nevertheless, few smoking cessation trials targeting smokers with HIV have been reported in the literature. Efforts to develop and evaluate sustainable, low-cost, and evidence-based cessation interventions for people with HIV are needed. Given the widespread proliferation of mobile phones, the potential of using mobile health apps to improve the reach and efficacy of cessation interventions is promising, but evidence of efficacy is lacking, particularly among people with HIV. OBJECTIVE: This study will consist of a 2-group randomized controlled trial to evaluate a fully automated smartphone intervention for people with HIV seeking cessation treatment. METHODS: Participants (N=500) will be randomized to receive either standard treatment (ST; 250/500, 50%) or automated treatment (AT; 250/500, 50%). ST participants will be connected to the Florida Quitline and will receive nicotine replacement therapy in the form of transdermal patches and lozenges. This approach, referred to as Ask Advise Connect, was developed by our team and has been implemented in numerous health systems. ST will be compared with AT, a fully automated behavioral treatment approach. AT participants will receive nicotine replacement therapy and an interactive smartphone-based intervention that comprises individually tailored audiovisual and text content. The major goal is to determine whether AT performs better in terms of facilitating long-term smoking abstinence than the more resource-intensive ST approach. Our primary aim is to evaluate the efficacy of AT in facilitating smoking cessation among people with HIV. As a secondary aim, we will explore potential mediators and moderators and conduct economic evaluations to assess the cost and cost-effectiveness of AT compared with ST. RESULTS: The intervention content has been developed and finalized. Recruitment and enrollment will begin in the fall of 2021. CONCLUSIONS: There is a critical need for efficacious, cost-effective, and sustainable cessation treatments for people with HIV who smoke. The AT intervention was designed to help fill this need. If efficacy is established, the AT approach will be readily adoptable by HIV clinics and community-based organizations, and it will offer an efficient way to allocate limited public health resources to tobacco control interventions. TRIAL REGISTRATION: ClinicalTrials.gov NCT05014282; https://clinicaltrials.gov/ct2/show/NCT05014282. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/33183.

The United States National Cancer Institute's Coordinated Research Effort on Tobacco Use as a Major Cause of Morbidity and Mortality among People with HIV.

The use of antiretroviral therapy for people with HIV (PWH) has improved life expectancy. However, PWH now lose more life-years to tobacco use than to HIV infection. Unfortunately, PWH smoke at higher rates and have more difficulty maintaining abstinence than the general population, compounding their risk for chronic disease. In this Commentary, we describe a United States National Cancer Institute-led initiative to address the relative lack of research focused on developing, testing, and implementing smoking cessation interventions for PWH. This initiative supports seven clinical trials designed to systematically test and/or develop and test adaptations of evidence-based smoking cessation interventions for PWH (eg, combination of behavioral and pharmacological). We summarize each project, including setting/recruitment sites, inclusion/exclusion criteria, interventions being tested, and outcomes. This initiative provides critical opportunities for collaboration and data harmonization across projects. The knowledge gained will inform strategies to assist PWH to promote and maintain abstinence, and ensure that these efforts are adaptable and scalable, thereby addressing one of the major threats to the health of PWH. Reducing smoking behavior may be particularly important during the COVID-19 pandemic given that smokers who become infected with SARS-CoV-2 may be at risk for more severe disease. IMPLICATIONS: This Commentary describes a National Cancer Institute-led initiative to advance the science and practice of treating tobacco use among PWH, which is now responsible for more life years lost than HIV. We describe the scope of the problem, the objectives of the initiative, and a summary of the seven funded studies. Harmonization of data across projects will provide information related to treatment mediators and moderators that was not previously possible. Stakeholders interested in tobacco cessation, including researchers, clinicians and public health officials, should be aware of this initiative and the evidence-base it will generate to advance tobacco treatment among this high-risk population.

Predicting the first smoking lapse during a quit attempt: A machine learning approach.

BACKGROUND: Just-in-time adaptive interventions (JITAI) aim to prevent smoking lapse using tailored support delivered via mobile technology in the moments when it is most needed. Effective smoking cessation JITAI rely on the development of accurate decision rules that determine when someone is most likely to lapse. The primary goal of the present study was to identify the strongest predictors of first lapse among smokers undergoing a quit attempt. METHODS: Smokers attending a clinic-based smoking cessation program (n = 74) were asked to complete ecological momentary assessments five times daily on study-provided smartphones for 4 weeks post-quit. A three-stage modeling process utilized Cox proportional hazards regression to examine time to lapse a function of 31 predictors. First, univariate models evaluated the relationship between each predictor and time to lapse. Second, the elastic net machine learning algorithm was used to select the best predictors. Third, backwards elimination further reduced the set of predictors to optimize parsimony. RESULTS: Univariate models identified seven predictors significantly related to time to lapse. The elastic net algorithm retained five: perceived odds of smoking today, confidence in ability to avoid smoking, motivation to avoid smoking, urge to smoke, and cigarette availability. The reduced model demonstrated inadequate approximation to the non-penalized baseline model. CONCLUSIONS: Accurate estimation of moments of high risk for smoking lapse remains an important goal in the development of JITAI. These results demonstrate the utility of exploratory data-driven approaches to variable selection. The results of this study can inform future JITAI by highlighting targets for intervention.

Inflammation in Relation to Intensity and Duration of Cigarette Smoking Among People Living with HIV.

Both inflammation and smoking are independent predictors of morbidity and mortality among people living with HIV (PLHIV). As smoking burden is likely to exacerbate inflammation, we tested the hypothesis that higher intensity and longer duration of smoking are positively associated with C-reactive protein (CRP, an inflammatory marker) among 284 PLHIV in Kathmandu, Nepal. We measured smoking status, intensity of smoking, smoking duration, and CRP concentrations. In total, 22.9% of never smokers, 24.3% former smokers, and 34.1% current smokers had high CRP (> 3 mg/l). The median intensity and duration of smoking were 12 (cigarettes/day) and 19 years, respectively. Intensity of smoking (beta for increase in number of cigarettes/day: ß = 0.245; p = 0.017), smoking duration (beta for 1-year increase in smoking: ß = 0.341; p = 0.013), and pack-years of smoking (beta for 1-pack-years of smoking increase: ß = 0.351; p = 0.002) were each positively associated with CRP concentrations. While quitting is important, reducing the intensity and duration of smoking until quitting might be helpful in reducing the levels of inflammation, thereby in mitigating HIV-related harms.