A Novel mHealth App for Smokers Living With HIV Who Are Ambivalent About Quitting Smoking: Formative Research and Randomized Feasibility Study.

BACKGROUND: More 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. OBJECTIVE: This 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. METHODS: In 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). RESULTS: Recruitment 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. CONCLUSIONS: On 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 REGISTRATION: ClinicalTrials.gov NCT05339659; https://clinicaltrials.gov/study/NCT05339659.

Eye Adult Changes in Thought (Eye ACT) Study: Design and Report on the Inaugural Cohort.

Background: Conflicting research on retinal biomarkers of Alzheimer's disease and related dementias (AD/ADRD) is likely related to limited sample sizes, study design, and protocol differences. Objective: The prospective Eye Adult Changes in Thought (Eye ACT) seeks to address these gaps. Methods: Eye ACT participants are recruited from ACT, an ongoing cohort of dementia-free, older adults followed biennially until AD/ADRD, and undergo visual function and retinal imaging assessment either in clinic or at home. Results: 330 participants were recruited as of 03/2023. Compared to ACT participants not in Eye ACT (N = 1868), Eye ACT participants (N = 330) are younger (mean age: 70.3 versus 71.2, p = 0.014), newer to ACT (median ACT visits since baseline: 3 versus 4, p < 0.001), have more years of education (17.7 versus 16.2, p < 0.001) and had lower rates of visual impairment (12% versus 22%, p < 0.001). Compared to those seen in clinic (N = 300), Eye ACT participants seen at home (N = 30) are older (77.2 versus 74.9, p = 0.015), more frequently female (60% versus 49%, p = 0.026), and have significantly worse visual acuity (71.1 versus 78.9 Early Treatment Diabetic Retinopathy Study letters, p < 0.001) and contrast sensitivity (-1.9 versus -2.1 mean log units at 3 cycles per degree, p = 0.002). Cognitive scores and retinal imaging measurements are similar between the two groups. Conclusions: Participants assessed at home had significantly worse visual function than those seen in clinic. By including these participants, Eye ACT provides a unique longitudinal cohort for evaluating potential retinal biomarkers of dementia.

Comparison of brain imaging and physical health between research and clinical neuroimaging cohorts of ageing.

OBJECTIVES: To compare brain MRI measures between Adult Changes in Thought (ACT) participants who underwent research, clinical, or both MRI scans, and clinical health measures across the groups and non-MRI subjects. METHODS: Retrospective cohort study leveraging MRI, clinical, demographic, and medication data from ACT. Three neuroradiologists reviewed MRI scans using NIH Neuroimaging Common Data Elements (CDEs). Total brain and white matter hyperintensity (WMH) volumes, clinical characteristics, and outcome measures of brain and overall health were compared between groups. 1166 MRIs were included (77 research, 1043 clinical, and 46 both) and an additional 3146 participants with no MRI were compared. RESULTS: Compared to the group with research MRI only, the clinical MRI group had higher prevalence of the following: acute infarcts, chronic haematoma, subarachnoid haemorrhage, subdural haemorrhage, haemorrhagic transformation, and hydrocephalus (each P < .001). Quantitative WMH burden was significantly lower (P < .001) and total brain volume significantly higher (P < .001) in research MRI participants compared to other MRI groups. Prevalence of hypertension, self-reported cerebrovascular disease, congestive heart failure, dementia, and recent hospitalization (all P < .001) and diabetes (P = .002) differed significantly across groups, with smaller proportions in the research MRI group. CONCLUSION: In ageing populations, significant differences were observed in MRI metrics between research MRI and clinical MRI groups, and clinical health metric differences between research MRI, clinical MRI, and no-MRI groups. ADVANCES IN KNOWLEDGE: This questions whether research cohorts can adequately represent the greater ageing population undergoing imaging. These findings may also be useful to radiologists when interpreting neuroimaging of ageing.

STRategies to Improve Pain and Enjoy life (STRIPE): results of a pragmatic randomized trial of pain coping skills training and opioid medication taper guidance for patients on long-term opioid therapy.

ABSTRACT: Because long-term opioid therapy (LtOT) for chronic pain has uncertain benefits and dose-dependent harms, safe and effective strategies for opioid tapering are needed. Adapting a promising pilot study intervention, we conducted the STRategies to Improve Pain and Enjoy life (STRIPE) pragmatic clinical trial. Patients in integrated health system on moderate-to-high dose of LtOT for chronic noncancer pain were randomized individually to usual care plus intervention (n = 79) or usual care only (n = 74). The intervention included pain coping skills training and optional support for opioid taper, delivered in 18 telephone sessions over a year, with pharmacologic guidance provided to participants' primary care providers by a pain physician. Coprimary outcomes were daily opioid dose (morphine milligram equivalent [MME]), calculated using pharmacy dispensing data, and the self-reported Pain, Enjoyment of Life and General Activity scale at 12 months (primary time point) and 6 months. Secondary outcomes included opioid misuse, opioid difficulties, opioid craving, pain self-efficacy, and global impression of change, depression, and anxiety. Only 41% randomized to the intervention completed all sessions. We did not observe significant differences between intervention and usual care for MME (adjusted mean difference: -2.3 MME; 95% confidence interval: -10.6, 5.9; P = 0.578), the Pain, Enjoyment of Life, General Activity scale (0.0 [95% confidence interval: -0.5, 0.5], P = 0.985), or most secondary outcomes. The intervention did not lower opioid dose or improve pain or functioning. Other strategies are needed to reduce opioid doses while improving pain and function for patients who have been on LtOT for years with high levels of medical, mental health, and substance use comorbidity.

Feasibility, Acceptability, and Potential Impact of a Novel mHealth App for Smokers Ambivalent About Quitting: Randomized Pilot Study.

BACKGROUND: Most 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. OBJECTIVE: This 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. METHODS: We 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. RESULTS: Participants 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. CONCLUSIONS: Ambivalent 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 REGISTRATION: ClinicalTrials.gov NCT04560868; https://clinicaltrials.gov/ct2/show/NCT04560868.

Diabetic Retinopathy and Dementia Association, Beyond Diabetes Severity.

PURPOSE: To investigate whether associations between diabetic retinopathy (DR) and dementia and Alzheimer's disease (AD) remain significant after controlling for several measures of diabetes severity. DESIGN: Retrospective cohort study. METHODS: Adult Changes in Thought (ACT) is a prospective cohort study of adults aged ≥65 years, randomly selected and recruited from the membership rolls of Kaiser Permanente Washington, who are dementia free at enrollment and followed biennially until incident dementia. The ACT participants were included in this study if they had type 2 diabetes mellitus at enrollment or developed it during follow-up, and data were collected through September, 2018 (3516 person-years of follow-up). Diabetes was defined by ≥ 2 diabetes medication fills in 1 year. Diagnosis of DR was based on International Classification of Diseases Ninth and Tenth Revision codes. Estimates of microalbuminuria, long-term glycemia, and renal function from longitudinal laboratory records were used as indicators of diabetes severity. Alzheimer's disease and dementia were diagnosed using research criteria at expert consensus meetings. RESULTS: A total of 536 participants (median baseline age 75 [interquartile range 71-80], 54% women) met inclusion criteria. Significant associations between DR >5 years duration with dementia (hazard ratio 1.81 [95% CI 1.23, 2.65]) and AD (1.80 [1.15, 2.82]) were not altered by adjustment for estimates of microalbuminuria, long-term glycemia, and renal function (dementia: 1.69 [1.14, 2.50]; AD: 1.73 [1.10, 2.74]). CONCLUSIONS: Among people with type 2 diabetes, DR itself appears to be an important biomarker of dementia risk in addition to glycemia and renal complications.

Combining information to estimate adherence in studies of pre-exposure prophylaxis for HIV prevention: Application to HPTN 067.

In trials of oral HIV pre-exposure prophylaxis (PrEP), multiple approaches have been used to measure adherence, including self-report, pill counts, electronic dose monitoring devices, and biological measures such as drug levels in plasma, peripheral blood mononuclear cells, hair, and/or dried blood spots. No one of these measures is ideal and each has strengths and weaknesses. However, accurate estimates of adherence to oral PrEP are important as drug efficacy is closely tied to adherence, and secondary analyses of trial data within identified adherent/non-adherent subgroups may yield important insights into real-world drug effectiveness. We develop a statistical approach to combining multiple measures of adherence and show in simulated data that the proposed method provides a more accurate measure of true adherence than self-report. We then apply the method to estimate adherence in the ADAPT study (HPTN 067) in South African women.

Improving Quality Improvement Capacity and Clinical Performance in Small Primary Care Practices.

PURPOSE: We undertook a study to assess whether implementing 7 evidence-based strategies to build improvement capacity within smaller primary care practices was associated with changes in performance on clinical quality measures (CQMs) for cardiovascular disease. METHODS: A total of 209 practices across Washington, Oregon, and Idaho participated in a pragmatic clinical trial that focused on building quality improvement capacity as measured by a validated questionnaire, the 12-point Quality Improvement Capacity Assessment (QICA). Clinics reported performance on 3 cardiovascular CQMs-appropriate aspirin use, blood pressure (BP) control (<140/90 mm Hg), and smoking screening/cessation counseling-at baseline (2015) and follow-up (2017). Regression analyses with change in CQM as the dependent variable allowed for clustering by practice facilitator and adjusted for baseline CQM performance. RESULTS: Practices improved QICA scores by 1.44 points (95% CI, 1.20-1.68; P <.001) from an average baseline of 6.45. All 3 CQMs also improved: aspirin use by 3.98% (average baseline = 66.8%; 95% CI for change, 1.17%-6.79%; P = .006); BP control by 3.36% (average baseline = 61.5%; 95% CI for change, 1.44%-5.27%; P = .001); and tobacco screening/cessation counseling by 7.49% (average baseline = 73.8%; 95% CI for change, 4.21%-10.77%; P <.001). Each 1-point increase in QICA score was associated with a 1.25% (95% CI, 0.41%-2.09%, P = .003) improvement in BP control; the estimated likelihood of reaching a 70% BP control performance goal was 1.24 times higher (95% CI, 1.09-1.40; P <.001) for each 1-point increase in QICA. CONCLUSION: Improvements in clinic-level performance on BP control may be attributed to implementation of 7 evidence-based strategies to build quality improvement capacity. These strategies were feasible to implement in small practices over 15 months.

Association Between Testosterone Treatment and Risk of Incident Cardiovascular Events Among US Male Veterans With Low Testosterone Levels and Multiple Medical Comorbidities.

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.

Impact of a novel oral health promotion program on routine oral hygiene among socioeconomically disadvantaged smokers: results from a randomized semi-pragmatic trial.

Smokers are at high risk of oral disease and report sub-optimal oral hygiene. Improving smokers' oral hygiene could reduce their future disease risk. The purpose of this study is to assess the effects of a novel, multi-modal oral health promotion program (Oral Health 4 Life; OH4L) targeted to socioeconomically disadvantaged smokers and delivered through state-funded tobacco quitlines. Smokers (n = 718) were randomized to standard quitline care or standard care plus OH4L. OH4L recipients received a comprehensive behavioral intervention and were advised of the benefits of routine oral hygiene, encouraged to brush and floss daily (for better oral health and to manage cigarette cravings), and provided a toothbrush and floss. Participants were followed for 6 months to assess the intervention effects on routine oral hygiene (brushing and flossing) and changes in motivation and self-efficacy. Data were collected between 2015 and 2017. At 2-month follow-up, OH4L participants were more likely to meet the American Dental Association (ADA) recommendations for brushing twice daily (adjusted RR = 1.15 [1.04, 1.27], p = .006), flossing daily (adjusted RR = 1.20 [1.03, 1.39], p = .02), and for both brushing and flossing (adjusted RR = 1.33 [1.10, 1.61], p = .003). Daily flossing was more likely at 6-month follow-up (adjusted RR = 1.21 [1.04, 1.42], p = .02) among OH4L participants. The change in self-efficacy and motivation for daily flossing from baseline to 2 months was significantly greater among OH4L participants and mediated the intervention effect on flossing at 6 months. Integrating oral hygiene promotion with standard tobacco quitline services improved oral health self-care.

Factors associated with future dental care utilization among low-income smokers overdue for dental visits.

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.

Testosterone treatment and the risk of aggressive prostate cancer in men with low testosterone levels.

PURPOSE: Testosterone treatment of men with low testosterone is common and, although relatively short-term, has raised concern regarding an increased risk of prostate cancer (CaP). We investigated the association between modest-duration testosterone treatment and incident aggressive CaP. MATERIALS AND METHODS: Retrospective inception cohort study of male Veterans aged 40 to 89 years with a laboratory-defined low testosterone measurement from 2002 to 2011 and recent prostate specific antigen (PSA) testing; excluding those with recent testosterone treatment, prostate or breast cancer, high PSA or prior prostate biopsy. Histologically-confirmed incident aggressive prostate cancer or any prostate cancer were the primary and secondary outcomes, respectively. RESULTS: Of the 147,593 men included, 58,617 were treated with testosterone. 313 aggressive CaPs were diagnosed, 190 among untreated men (incidence rate (IR) 0.57 per 1000 person years, 95% CI 0.49-0.65) and 123 among treated men (IR 0.58 per 1000 person years; 95% CI 0.48-0.69). After adjusting for age, race, hospitalization during year prior to cohort entry, geography, BMI, medical comorbidities, repeated testosterone and PSA testing, testosterone treatment was not associated with incident aggressive CaP (HR 0.89; 95% CI 0.70-1.13) or any CaP (HR 0.90; 95% CI 0.81-1.01). No association between cumulative testosterone dose or formulation and CaP was observed. CONCLUSIONS: Among men with low testosterone levels and normal PSA, testosterone treatment was not associated with an increased risk of aggressive or any CaP. The clinical risks and benefits of testosterone treatment can only be fully addressed by large, longer-term randomized controlled trials.

Sexual Risk Behaviors Among Black Men Who Have Sex With Men Who Also Report Having Sex With Transgender Partners: Analysis of HIV Prevention Trials Network (HPTN) 061 Study.

HIV Prevention Trials Network (HPTN 061) study data of Black MSM were analyzed to determine characteristics associated with having transgender sexual partners (TGP) and the association of having TGP with sexual risk. Of 1,449 cisgender MSM, 343(24%) reported also having TGP. MSM with TGP were more likely to be older, have a sexual orientation other than homosexual, have a history of incarceration, or have insufficient funds for necessities, but less likely to be HIV positive or report sex with men to health care providers. MSM with TGP were 3.67 times more likely to recently have 5+ new partners and 2.02 times more likely to report 6+ condomless sexual acts. Since MSM with TGP reported not disclosing sex with men to health care providers, these men may need tailored HIV prevention and care. Future studies should examine differing sexual risks MSM take with sexual partners with different gender identities.