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BackgroundMore people who smoke and are living with HIV now die from tobacco-related diseases than HIV itself. Most people are ambivalent about quitting smoking and want to quit someday but not yet. Scalable, effective interventions are needed to motivate and support smoking cessation among people ambivalent about quitting smoking (PAQS) who are living with HIV. ObjectiveThis study aims to develop an app-based intervention for PAQS who are living with HIV and assess its feasibility, acceptability, and potential impact. Results of this study will inform plans for future research and development. MethodsIn phase 1, PAQS living with HIV (n=8) participated in user-centered design interviews to inform the final intervention app design and recruitment plan for a subsequent randomized pilot study. In phase 2, PAQS living with HIV were randomized to either a standard care control app or a similar experimental app with additional content tailored for PAQS and those with HIV. Participants were followed for 3 months. Feasibility focused on recruitment, retention, and participants’ willingness to install the app. The study was not powered for statistical significance. Indices of acceptability (satisfaction and use) and impact (smoking behavior change and treatment uptake) were assessed via automated data and self-report among those who installed and used the app (n=19). ResultsRecruitment for both study phases was a challenge, particularly via web-based and social media platforms. Enrollment success was greater among people living with HIV recruited from a health care provider and research registry. Once enrolled, retention for the phase 2 randomized study was good; 74% (14/19) of the participants completed the 3-month follow-up. Phase 1 findings suggested that PAQS living with HIV were receptive to using an app-based intervention to help them decide whether, when, and how to stop smoking, despite not being ready to quit smoking. Phase 2 findings further supported this conclusion based on feedback from people who agreed to use an app, but group differences were observed. Indices of acceptability favored the experimental arm, including a descriptively higher mean number of sessions and utilization badges. Similarly, indices of potential impact were descriptively higher in the experimental arm (proportion reducing smoking, making a quit attempt, or calling free tobacco quitline). No participants in either arm quit smoking at the 3-month follow-up. ConclusionsOn the basis of this formative work, PAQS living with HIV may be receptive to using a mobile health–based app intervention to help them decide whether, when, or how to stop using tobacco. Indices of acceptability and impact indicate that additional research and development are warranted. Trial RegistrationClinicalTrials.gov NCT05339659; https://clinicaltrials.gov/study/NCT05339659

BackgroundMost smokers are ambivalent about quitting—they want to quit someday, but not now. Interventions are needed that can engage ambivalent smokers, build their motivation for quitting, and support future quit attempts. Mobile health (mHealth) apps offer a cost-effective platform for such interventions, but research is needed to inform their optimal design and assess their acceptability, feasibility, and potential effectiveness. ObjectiveThis study aims to assess the feasibility, acceptability, and potential impact of a novel mHealth app for smokers who want to quit smoking someday but are ambivalent about quitting in the near term. MethodsWe enrolled adults across the United States who smoked more than 10 cigarettes a day and were ambivalent about quitting (n=60). Participants were randomly assigned to 1 of 2 versions of the GEMS app: standard care (SC) versus enhanced care (EC). Both had a similar design and identical evidence-based, best-practice smoking cessation advice and resources, including the ability to earn free nicotine patches. EC also included a series of exercises called experiments designed to help ambivalent smokers clarify their goals, strengthen their motivation, and learn important behavioral skills for changing smoking behavior without making a commitment to quit. Outcomes were analyzed using automated app data and self-reported surveys at 1 and 3 months post enrollment. ResultsParticipants who installed the app (57/60, 95%) were largely female, White, socioeconomically disadvantaged, and highly nicotine dependent. As expected, key outcomes trended in favor of the EC group. Compared to SC users, EC participants had greater engagement (mean sessions 19.9 for EC vs 7.3 for SC). An intentional quit attempt was reported by 39.3% (11/28) of EC users and 37.9% (11/29) of SC users. Seven-day point prevalence smoking abstinence at the 3-month follow-up was reported by 14.7% (4/28) of EC users and 6.9% (2/29) of SC users. Among participants who earned a free trial of nicotine replacement therapy based on their app usage, 36.4% (8/22) of EC participants and 11.1% (2/18) of SC participants requested the treatment. A total of 17.9% (5/28) of EC and 3.4% (1/29) of SC participants used an in-app feature to access a free tobacco quitline. Other metrics were also promising. EC participants completed an average of 6.9 (SD 3.1) out of 9 experiments. Median helpfulness ratings for completed experiments ranged from 3 to 4 on a 5-point scale. Finally, satisfaction with both app versions was very good (mean 4.1 on a 5-point Likert scale) and 95.3% (41/43) of all respondents would recommend their app version to others. ConclusionsAmbivalent smokers were receptive to the app-based intervention, but the EC version, which combined best-practice cessation advice with self-paced, experiential exercises, was associated with greater use and evidence of behavior change. Further development and evaluation of the EC program is warranted. Trial RegistrationClinicalTrials.gov NCT04560868; https://clinicaltrials.gov/ct2/show/NCT04560868

Background Testosterone treatment is common in men, although risks for major cardiovascular events are unclear. Methods and Results A study was conducted in US male veterans, aged ≥40 years, with low serum testosterone and multiple medical comorbidities and without history of myocardial infarction, stroke, venous thromboembolism, prostate cancer, or testosterone treatment in the prior year. For the primary outcome, we examined if testosterone treatment was associated with a composite cardiovascular outcome (incident myocardial infarction, ischemic stroke, or venous thromboembolism). Testosterone use was modeled as intramuscular or transdermal and as current use, former use, and no use. Current testosterone users were compared with former users to reduce confounding by indication. The cohort consisted of 204 857 men with a mean (SD) age of 60.9 (9.9) years and 4.7 (3.5) chronic medical conditions. During follow‐up of 4.3 (2.8) years, 12 645 composite cardiovascular events occurred. In adjusted Cox regression analyses, current use of transdermal testosterone was not associated with risk for the composite cardiovascular outcome (hazard ratio [HR], 0.89; 95% CI, 0.76–1.05) in those without prevalent cardiovascular disease, and in those with prevalent cardiovascular disease was associated with lower risk (HR, 0.80; 95% CI, 0.70–0.91). In similar analyses, current use of intramuscular testosterone was not associated with risk for the composite cardiovascular outcome in men without or with prevalent cardiovascular disease (HR, 0.91; 95% CI, 0.80–1.04; HR, 0.98; 95% CI, 0.89–1.09, respectively). Conclusions In a large cohort of men without a history of myocardial infarction, stroke, or venous thromboembolism, testosterone treatment was not associated with increased risk for incident composite cardiovascular events.

Abstract Background Smokers are at increased risk of oral disease. While routine dental care can help prevent and treat oral health problems, smokers have far lower rates of dental care utilization compared with non-smokers. We sought to better understand which factors may facilitate or hinder dental care utilization among low-income smokers participating in a randomized intervention trial in order to inform future intervention planning. Methods This is a secondary analysis of data collected between 2015 and 2017 as part of the OralHealth4Life trial. Participants were eligible callers to the Louisiana, Nebraska, and Oregon state tobacco quitlines who had no dental appointment in the prior or upcoming six months. We examined the association between participants’ baseline characteristics and their receiving professional dental care between baseline and the 6-month follow-up survey. Results Participants were racially diverse (42% non-White) and two-thirds had an annual household income under $20,000. Most (86.7%) had not had a dental cleaning in more than one year. Commonly cited barriers to dental care included cost (83.7%) and no dental insurance (78.1%). Those with dental insurance were more likely to see a dentist at follow-up (RR 1.66). Similarly, those reporting a dental insurance barrier to care were less likely to see a dentist at follow-up (RR 0.69); however, there was no significant utilization difference between those reporting a cost barrier vs. those who did not. After controlling for these financial factors, the following baseline characteristics were significantly associated with a higher likelihood of dental care utilization at 6 months: higher motivation (RR 2.16) and self-efficacy (RR 1.80) to visit the dentist, having a disability (RR 1.63), having a higher education level (RR 1.52), and having perceived gum disease (RR 1.49). Factors significantly associated with a lower likelihood of dental care utilization included being married (RR 0.68) and not having a last dental cleaning within the past year (RR 0.47). Conclusions Our findings provide important insight into factors that may facilitate or deter use of professional dental care among low-income smokers. This information could inform the development of future interventions to promote dental care utilization. Trial registration ClinicalTrials.gov: NCT02347124; registered 27 January 2015.