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.

Qualitative evaluation of the implementation and future sustainability of an e-referral system for smoking cessation at a US NCI-designated comprehensive cancer center: lessons learned.

BACKGROUND: Promoting smoking cessation is recognized as an essential part of cancer care. Moffitt Cancer Center, supported by the National Cancer Institute Cancer Moonshot Cancer Center Cessation Initiative, developed and implemented an opt-out-based automatic electronic health record (EHR)-mediated referral (e-referral) system for Tobacco Quitline services along with options for local group cessation support and an in-house tobacco treatment specialist. This study evaluated barriers and facilitators for implementation of the e-referral system. METHOD: Steering committee members (N=12) responsible for developing and implementing the new clinical workflow and nurses (N=12) who were expected to use the new e-referral system completed semi-structured interviews. Qualitative thematic content analyses were conducted. RESULTS: Interviewees perceived the e-referral system as an effective strategy for identifying and referring smokers to cessation services. However, barriers were noted including competing demands and perceptions that smoking cessation was a low priority and that some patients were likely to have low motivation to quit smoking. Suggestions to improve future implementation and sustainability included providing regular trainings and e-referral outcome reports and increasing the visibility of the e-referral system within the EHR. CONCLUSION: Initial implementation of the e-referral system was perceived as successful; however, additional implementation strategies are needed to ensure sustainability at both the clinician and system levels. Recommendations for future modifications include providing regular clinician trainings and developing a fully closed-loop system. Implications for cancer survivors Initial implementation of an e-referral system for smoking cessation for cancer patients revealed opportunities to improve the smoking cessation referral process at cancer centers.

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.

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.

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.

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.

Quitline Treatment Enrollment and Cessation Outcomes Among Smokers Linked With Treatment via Ask-Advise-Connect: Comparisons Among Smokers With and Without HIV.

INTRODUCTION: Given that people living with HIV (PLWH) are disproportionately burdened by tobacco-related morbidity and mortality, it is critically important to understand the degree to which evidence-based cessation interventions are utilized by and are effective among PLWH. AIMS AND METHODS: This secondary data analysis aimed to examine differences in Quitline treatment enrollment and 6-month cessation outcomes among smokers seeking care at 1 HIV clinic and 12 non-HIV clinics that were part of a large healthcare system in the greater Houston, Texas metropolitan area, United States. Data were from a 34-month (April 2013-February 2016) one-group implementation trial that evaluated the Ask-Advise-Connect (AAC) approach to linking smokers with Quitline treatment. Primary outcomes included (1) treatment enrollment and (2) 6-month self-reported and biochemically confirmed abstinence. RESULTS: The smoking status of 218 915 unique patients was recorded in the electronic health record; 5285 (2.7%) of these patients were seen at the HIV clinic where the smoking prevalence was 45.9%; smoking prevalence at the non-HIV clinics was 17.9%. The proportion of identified smokers who enrolled in treatment was 10.8% at the HIV clinic and 11.8% at the non-HIV clinics. The self-reported abstinence rate was 18.7% among HIV clinic patients and 16.5% among non-HIV clinic patients. Biochemically confirmed abstinence was lower at 4.2% and 4.5%, respectively (all ps > .05). CONCLUSIONS: AAC resulted in rates of Quitline treatment enrollment and abstinence rates that were comparable among patients seen at an HIV clinic and non-HIV clinics. Findings suggest that AAC should be considered for widespread implementation in HIV clinics. IMPLICATIONS: PLWH were as likely as other patients to enroll in evidence-based tobacco cessation treatment when it was offered in the context of a primary care visit. Cessation outcomes were also comparable. Therefore, standard care for PLWH should include routine screening for smoking status and referrals to cessation treatment.

Enhancing Smoking Risk Communications: The Influence of Health Literacy and Message Content.

Background: Efforts are needed to ensure that smokers with lower health literacy are provided with understandable and impactful information about the health consequences of smoking and benefits of quitting. Purpose: To test the influence of health literacy on smokers' responses to health risk messages manipulated on framing (gain vs. loss) and emotionality (factual vs. emotional). Methods: Participants (N = 402) were randomized to evaluate one of four sets of smoking risk messages (factual gain-framed, factual loss-framed, emotional gain-framed, or emotional loss-framed). Multiple linear regressions examined main effects of health literacy, message emotionality, and message framing on: (a) risk perceptions, (b) behavioral expectations (i.e. cut down, limit, quit), and (c) risk knowledge. Two-way interactions of health literacy with emotionality and framing were examined for these outcomes. Analyses were based on theory-driven, a priori hypotheses. Results: As hypothesized, main effects emerged such that smokers with higher health literacy reported stronger risk perceptions and knowledge retention regardless of message type. Additionally, emotional (vs. factual) and gain- (vs. loss-) framed messages were associated with certain lower risk perceptions regardless of health literacy level. Consistent with hypotheses, two-way crossover interactions emerged between health literacy and emotionality. Among smokers with higher health literacy, factual messages produced higher perceived risk and stronger expectations for quitting. Among smokers with lower health literacy, emotional messages produced higher perceived risk and stronger expectations for quitting. Conclusions: Health literacy plays an important role in influencing how smokers respond to different risk messages. One's health literacy should be considered when determining whether risk communications emphasize factual or emotional content.

Effects of cigarette smoking and nicotine dependence on adherence to antiretroviral therapy among HIV-positive patients in Vietnam.

Cigarette smoking is increasingly recognized as an indicator for inferior adherence to antiretroviral therapy (ART) among HIV-positive patients. Given the limited body of work on this issue, we aimed to explore the relations between cigarette smoking, nicotine dependence, and ART adherence in Vietnam. A cross-sectional study of 1050 HIV-positive people was conducted from January to September 2013 in Hanoi (the capital) and Nam Dinh (a rural city). Adherence to ART during the last 30 days was measured by the 100-point visual analog scale (VAS). Smoking history and nicotine dependence (Fagerstrom Test of Nicotine Dependence) were self-reported by participants. Multiple logistic regression was performed to examine the association of current smoking and nicotine dependence with ART nonadherence. Using the established VAS cut point of 95 to indicate adequate adherence, the prevalence of ART nonadherence was 30.9%. Approximately 35.5% of the sample reported current smoking. No association between smoking status and ART nonadherence was found. However, participants with greater nicotine dependence (OR = 1.1, 95%CI = 1.0-1.2 per unit increase) were more likely to be nonadherent. Also, individuals who were female (OR = 1.70, 95%CI = 1.19-2.42), receiving ART in Nam Dinh (OR = 1.6, 95%CI = 1.1-2.4), and currently feeling anxiety (OR = 1.6, 95% CI = 1.2-2.1) had a higher likelihood of ART nonadherence. Additionally, current smokers reporting current pain (OR = 1.9, 95%CI = 1.2-3.1) were more likely to be nonadherent. Conversely, protective factors included living with a spouse/partner (OR = 0.5, 95%CI = 0.3-0.7) and having more than a high school education (OR = 0.4, 95%CI = 0.1-1.0). Given the high prevalence of suboptimal adherence and current smoking among HIV-positive patients, screening for smoking status and nicotine dependence during ART treatment may help to improve patients' adherence to medication. More efforts should be targeted to women, patients with mental health problems, and ART clinics in rural areas.

Motivation to quit smoking among HIV-positive smokers in Vietnam.

BACKGROUND: Smoking cessation is emerging as an important component in current HIV care to reduce smoking-related adverse health outcomes. This study aimed to examine motivation to quit and its associated factors in a sample of 409 HIV-positive smokers in Vietnam. METHODS: A cross-sectional survey was conducted from January to September 2013 in Hanoi (the capital) and Nam Dinh (a rural city). Motivation to quit was measured by a 4-point single item, and was dichotomized as having any motivation versus no motivation. Smoking history, nicotine dependence (Fagerstrom Test of Nicotine Dependence), and other covariates were self-reported by participants. Multivariate logistic regression was performed to identify correlates of motivation to quit. RESULTS: The sample was mostly male (97%). Mean age was 36 years (SD = 5.8). Approximately 37% and 69% of the sample were hazardous drinkers and ever drug users, respectively. The mean duration of HIV infection and ART treatment were 6 years (SD = 3.6) and 5 years (SD = 2.2), respectively. Overall, 59% of the sample was motivated to quit. Factors significantly associated with motivation to quit were income, pain, currently taking Methadone, and the interaction between binge drinking and lifetime drug use. Individuals with the highest income level (OR = 2.2, 95% CI = 1.3-3.6), moderate income level (OR = 1.8, 95% CI = 1.1-3.1), and currently feeling pain (OR = 1.6, 95% CI = 1.0-2.5) were more likely to be motivated to quit. Conversely, taking Methadone was associated with a lower likelihood of motivation to quit (OR = 0.4, 95% CI = 0.2-0.9). Also, those who reported binge drinking only (OR = 0.5, 95% CI = 0.3-0.9), lifetime drug use only (OR = 0.3, 95% CI = 0.1, 0.7), or both substance uses (OR = 0.4, 95% CI = 0.2, 0.8) were less motivated to quit smoking. CONCLUSION: Smoking cessation treatment should be integrated into HIV care in Vietnam, and should be tailored to meet specific needs for individuals with different attitudes on smoking, low income, and polysubstance use.

Health Literacy, Smoking, and Health Indicators in African American Adults.

We examined cross-sectional associations of health literacy (HL) with smoking and other established health indicators among 1,467 African American adults. Data emanated from a longitudinal cohort study designed to investigate cancer risk factors among church-going African American adults. We conducted linear and logistic regression analyses to assess associations between HL and health indicators. HL was assessed using an established single-item screening question. Outcomes included indicators of poor physical health (cigarette smoking, self-rated general and physical health) and mental health (self-rated mental health, depressive symptoms, perceived stress). Nearly 19% of participants had low HL. Low HL was significantly associated with current smoking, poorer self-rated general and physical health, and higher perceived stress (ps < .05) even after we controlled for demographic variables (i.e., age, gender, relationship status) and indicators of socioeconomic status (i.e., education, income, insurance status). Low HL appears to be an independent risk factor for smoking and other indicators of poor physical and mental health in a large sample of African American adults. Future directions and clinical implications are discussed.

Failure to replicate the structure of a Spanish-language brief Wisconsin Inventory of Smoking Dependence Motives across three samples of Latino smokers.

BACKGROUND: Research in smoking is hindered by a lack of validated measures available in languages other than English. Availability of measures in languages other than English is vital to the inclusion of diverse groups in smoking research. To help address this gap, this study attempted to validate a Spanish-language version of the brief Wisconsin Inventory of Smoking Dependence Motives (Brief WISDM). METHODS: Data from 3 independent, diverse samples of Spanish-speaking Latino smokers seeking cessation counseling were utilized. Confirmatory factor analyses of 3 known structures of the Brief WISDM were examined for fit within each sample. A separate analysis was also conducted with the 3 samples combined. A post-hoc exploratory factor analyses with the combined sample was also conducted. RESULTS: Across 12 confirmatory factor analyses, none of the 3 structures demonstrated good fit in any of the samples independently or in the combined sample. Across the 3 samples, high intercorrelations (>.90) were found among the Loss of Control, Craving, Tolerance, and Cue Exposure scales, suggesting great redundancy among these scales. An exploratory factor analyses (EFAs) further supported these high intercorrelations. Some subscales remained intact in the EFA but accounted for little variance. CONCLUSIONS: Overall, this study was unable to replicate the structure of a Spanish-language Brief WISDM in 3 independent samples of smokers. Possible explanations include inadequate translation of the measure and/or true and meaningful differences in the construct of dependence among Spanish-speaking Latino smokers. Both possibilities merit further research.

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.

Race moderates the effect of menthol cigarette use on short-term smoking abstinence.

INTRODUCTION: The Food and Drug Administration is in the process of reviewing evidence of the impact of mentholated cigarettes on smoking behaviors and smoking cessation in order to determine if these products should be removed from the market. More empirical research is needed to inform those decisions. The goal of this study was to examine associations of menthol cigarette use with biochemically verified continuous short-term smoking abstinence, and potential moderation by race, among adult current smokers enrolled in a cohort study (N = 183; 57.4% female; 48.1% non-Hispanic Black, 51.9% non-Hispanic White). METHODS: Continuation ratio logit models, adjusted for age, race, gender, total annual household income, educational level, employment status, and partner status, were used to examine associations of menthol use with smoking abstinence with and without an interaction term for race. RESULTS: Menthol cigarette use was not significantly associated with smoking abstinence in the sample as a whole; however, there was a significant interaction of menthol use with race (p = .03). Follow-up analyses stratified by race indicated that among White participants, menthol users had significantly lower odds of maintaining continuous abstinence than nonmenthol users (p = .05). Exploratory analyses suggested that tobacco dependence may lie along the causal pathway and partially explain this effect. CONCLUSIONS: White menthol smokers in this sample were at increased risk of smoking relapse relative to White nonmenthol smokers, at least partially due to greater tobacco dependence. Results should be replicated among other treatment-seeking samples with a greater representation of White menthol and Black nonmenthol smokers.

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.

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.

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.

Neighborhood perceptions are associated with tobacco dependence among African American smokers.

INTRODUCTION: The animal and human research literatures suggest that deprived environmental conditions may be associated with drug dependence, but the relation of neighborhood perceptions with a multidimensional measure of tobacco dependence has not been previously studied. The purpose of this study was to examine the associations between neighborhood perceptions (neighborhood problems and neighborhood vigilance) and tobacco dependence among smokers as measured by the Wisconsin Inventory of Smoking Dependence Motives-68 (WISDM). METHODS: Participants were 384 African American smokers (49% men, 80% < $30,000 annual household income) enrolled in a randomized clinical trial of a smoking cessation intervention. A series of regression models were conducted to examine the associations between neighborhood perceptions and tobacco dependence using a generalized estimating equation approach, which accounted for potential correlation in tobacco dependence between participants from the same neighborhood. RESULTS: Results indicated that more self-reported neighborhood problems and greater neighborhood vigilance were significantly associated with tobacco dependence as measured by the WISDM total score in analyses adjusted for age, gender, income, education, employment status, and partner status (p ≤ .002). Neighborhood perceptions were related to both primary and secondary dependence motives (p ≤ .005). CONCLUSIONS: Results suggest that the neighborhood context is associated with dependence on tobacco among African American smokers but longitudinal studies are needed to assess causation. Future research should also explore the mechanisms that account for the associations between neighborhood perceptions and tobacco dependence to better inform intervention development.

Increasing treatment enrollment among smokers who are not motivated to quit: a randomized clinical trial.

There is a significant research-to-practice gap with respect to reaching underserved populations with evidence-based tobacco cessation treatments. Increasing enrollment in evidence-based treatments is necessary to reduce tobacco use and tobacco-related health inequities. The purpose of the current study was to evaluate whether Motivation And Problem Solving (MAPS), a flexible, holistic counseling/navigation approach delivered via phone, and proactive provision of Nicotine Replacement Therapy (NRT) would improve Quitline enrollment among a sample of low SES smokers who were not motivated to quit. In a 3×2 factorial design, cigarette smokers (N = 603) were randomized to one of six treatment conditions (Standard Treatment, MAPS-6, or MAPS-12 by NRT or no NRT). Results indicated that both MAPS-6 and MAPS-12 increased Quitline enrollment compared to Standard Treatment (ps < .03). There were no differences between MAPS conditions. NRT did not increase Quitline enrollment. MAPS is an effective intervention with the potential to be disseminated and implemented in healthcare and community settings to increase the reach of evidence-based interventions for tobacco cessation.

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.