Implementing text-messaging to support and enhance delivery of health behavior change interventions in low- to middle-income countries: case study of the Lifestyle Africa intervention.

The prevalence of non-communicable diseases, such as diabetes and cardiovascular disease, is rising in low- and middle-income countries (LMICs). Health behavior change (HBC) interventions such as the widely used Diabetes Prevention Program (DPP) are effective at reducing chronic disease risk, but have not been adapted for LMICs. Leveraging mobile health (mHealth) technology such as text messaging (SMS) to enhance reach and participant engagement with these interventions has great promise, yet we lack evidence-informed approaches to guide the integration of SMS specifically to support HBC interventions in LMIC contexts. To address this gap, we integrated guidance from the mHealth literature with expertise and first-hand experience to establish specific development steps for building and implementing SMS systems to support HBC programming in LMICs. Specifically, we provide real-world examples of each development step by describing our experience in designing and delivering an SMS system to support a culturally-adapted DPP designed for delivery in South Africa. We outline eight key SMS development steps, including: 1) determining if SMS is appropriate; 2) developing system architecture and programming; 3) developing theory-based messages; 4) developing SMS technology; 5) addressing international SMS delivery; 6) testing; 7) system training and technical support; and 8) cost considerations. We discuss lessons learned and extractable principles that may be of use to other mHealth and HBC researchers working in similar LMIC contexts.Trial registration Clinicaltrials.gov, NCT03342274 . Registered 10 November 2017.

Evaluation of an adapted version of the Diabetes Prevention Program for low- and middle-income countries: A cluster randomized trial to evaluate "Lifestyle Africa" in South Africa.

BACKGROUND: Low- and middle-income countries (LMICs) are experiencing major increases in diabetes and cardiovascular conditions linked to overweight and obesity. Lifestyle interventions such as the United States National Diabetes Prevention Program (DPP) developed in high-income countries require adaptation and cultural tailoring for LMICs. The objective of this study was to evaluate the efficacy of "Lifestyle Africa," an adapted version of the DPP tailored for an underresourced community in South Africa compared to usual care. METHODS AND FINDINGS: Participants were residents of a predominantly Xhosa-speaking urban township of Cape Town, South Africa characterized by high rates of poverty. Participants with body mass index (BMI) ≥ 25 kg/m2 who were members of existing social support groups or "clubs" receiving health services from local nongovernmental organizations (NGOs) were enrolled in a cluster randomized controlled trial that compared Lifestyle Africa (the intervention condition) to usual care (the control condition). The Lifestyle Africa intervention consisted of 17 video-based group sessions delivered by trained community health workers (CHWs). Clusters were randomized using a numbered list of the CHWs and their assigned clubs based on a computer-based random allocation scheme. CHWs, participants, and research team members could not be blinded to condition. Percentage weight loss (primary outcome), hemoglobin A1c (HbA1c), blood pressure, triglycerides, and low-density lipoprotein (LDL) cholesterol were assessed 7 to 9 months after enrollment. An individual-level intention-to-treat analysis was conducted adjusting for clustering within clubs and baseline values. Trial registration is at ClinicalTrials.gov (NCT03342274). Between February 2018 and May 2019, 782 individuals were screened, and 494 were enrolled. Participants were predominantly retired (57% were receiving a pension) and female (89%) with a mean age of 68 years. Participants from 28 clusters were allocated to Lifestyle Africa (15, n = 240) or usual care (13, n = 254). Fidelity assessments indicated that the intervention was generally delivered as intended. The modal number of sessions held across all clubs was 17, and the mean attendance of participants across all sessions was 61%. Outcome assessment was completed by 215 (90%) intervention and 223 (88%) control participants. Intent-to-treat analyses utilizing multilevel modeling included all randomized participants. Mean weight change (primary outcome) was -0.61% (95% confidence interval (CI) = -1.22, -0.01) in Lifestyle Africa and -0.44% (95% CI = -1.06, 0.18) in control with no significant difference (group difference = -0.17%; 95% CI = -1.04, 0.71; p = 0.71). However, HbA1c was significantly lower at follow-up in Lifestyle Africa compared to the usual care group (mean difference = -0.24, 95% CI = -0.39, -0.09, p = 0.001). None of the other secondary outcomes differed at follow-up: systolic blood pressure (group difference = -1.36; 95% CI = -6.92, 4.21; p = 0.63), diastolic blood pressure (group difference = -0.39; 95% CI = -3.25, 2.30; p = 0.78), LDL (group difference = -0.07; 95% CI = -0.19, 0.05; p = 0.26), triglycerides (group difference = -0.02; 95% CI = -0.20, 0.16; p = 0.80). There were no unanticipated problems and serious adverse events were rare, unrelated to the intervention, and similar across groups (11 in Lifestyle Africa versus 13 in usual care). Limitations of the study include the lack of a rigorous dietary intake measure and the high representation of older women. CONCLUSIONS: In this study, we found that Lifestyle Africa was feasible for CHWs to deliver and, although it had no effect on the primary outcome of weight loss or secondary outcomes of blood pressure or triglycerides, it had an apparent small significant effect on HbA1c. The study demonstrates the potential feasibility of CHWs to deliver a program without expert involvement by utilizing video-based sessions. The intervention may hold promise for addressing cardiovascular disease (CVD) and diabetes at scale in LMICs. TRIAL REGISTRATION: ClinicalTrials.gov NCT03342274.

COVID-19 Testing in African American Churches Using a Faith-Health- Academic Partnership.

Increasing access to COVID-19 testing in influential, accessible community settings is needed to address COVID-19 disparities among African Americans. We describe COVID-19 testing intervention approaches conducted in Kansas City, Missouri, African American churches via a faith-health-academic partnership. Trained faith leaders promoted COVID-19 testing with church and community members by implementing multilevel interventions using a tailored toolkit and standard education information. The local health department conducted more than 300 COVID-19 tests during or after Sunday church services and outreach ministry activities. (Am J Public Health. 2022;112(S9):S887-S891. https://doi.org/10.2105/AJPH.2022.306981).

Effectiveness of Recruitment Strategies of Latino Smokers: Secondary Analysis of a Mobile Health Smoking Cessation Randomized Clinical Trial.

BACKGROUND: Latinos remain disproportionately underrepresented in clinical trials, comprising only 2%-3% of research participants. In order to address health disparities, it is critically important to increase enrollment of Latino smokers in smoking cessation trials. There is limited research examining effective recruitment strategies for this population. OBJECTIVE: The purpose of this study was to compare the effectiveness of direct versus mass and high- versus low-effort recruitment strategies on recruitment and retention of Latino smokers to a randomized smoking cessation trial. We also examine how the type of recruitment might have influenced the characteristics of enrolled participants. METHODS: Latino smokers were enrolled into Decídetexto from 4 states-New Jersey, Kansas, Missouri, and New York. Participants were recruited from August 2018 until March 2021. Mass recruitment strategies included English and Spanish advertisements to the Latino community via flyers, Facebook ads, newspapers, television, radio, church bulletins, and our Decídetexto website. Direct, high-effort strategies included referrals from clinics or community-based organizations with whom we partnered, in-person community outreach, and patient registry calls. Direct, low-effort strategies included texting or emailing pre-existing lists of patients who smoked. A team of trained bilingual (English and Spanish) recruiters from 9 different Spanish-speaking countries of origin conducted recruitment, assessed eligibility, and enrolled participants into the trial. RESULTS: Of 1112 individuals who were screened, 895 (80.5%) met eligibility criteria, and 457 (457/895, 51.1%) enrolled in the trial. Within the pool of screened individuals, those recruited by low-effort recruitment strategies (both mass and direct) were significantly more likely to be eligible (odds ratio [OR] 1.67, 95% CI 1.01-2.76 and OR 1.70, 95% CI 0.98-2.96, respectively) and enrolled in the trial (OR 2.60, 95% CI 1.81-3.73 and OR 3.02, 95% CI 2.03-4.51, respectively) compared with those enrolled by direct, high-effort strategies. Among participants enrolled, the retention rates at 3 months and 6 months among participants recruited via low-effort strategies (both mass and direct) were similar to participants recruited via direct, high-effort methods. Compared with enrolled participants recruited via direct (high- and low-effort) strategies, participants recruited via mass strategies were less likely to have health insurance (44.0% vs 71.2% and 71.7%, respectively; P<.001), lived fewer years in the United States (22.4 years vs 32.4 years and 30.3 years, respectively; P<.001), more likely to be 1st generation (92.7% vs 76.5% and 77.5%, respectively; P=.007), more likely to primarily speak Spanish (89.3% vs 65.8% and 66.3%, respectively), and more likely to be at high risk for alcohol abuse (5.8 mean score vs 3.8 mean score and 3.9 mean score, respectively; P<.001). CONCLUSIONS: Although most participants were recruited via direct, high-effort strategies, direct low-effort recruitment strategies yielded a screening pool more likely to be eligible for the trial. Mass recruitment strategies were associated with fewer acculturated enrollees with lower access to health services-groups who might benefit a great deal from the intervention. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03586596; https://clinicaltrials.gov/ct2/show/NCT03586596. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-DOI: 10.1016/j.cct.2020.106188.

Use of pre-enrollment randomization and delayed consent to maximize participation in a clinical trial of opt-in versus opt-out tobacco treatment.

Background: Enrollment in smoking cessation trials remain sub-optimal. The aim of this analysis was to determine the effectiveness of a modified Zelen's design in engaging hospitalized patients who smoke in a pragmatic OPT-IN versus OPT-OUT tobacco treatment trial. Methods: At bedside, clinical staff screened smokers for eligibility, randomized eligible into study arms, and delivered the appropriate treatment approach. Study staff called randomized patients at one-month post-discharge, debriefed patients on the study design, and collected consent to participate. We used frequencies and percentages for categorical variables and means and standard deviations for quantitative variables to describe the characteristics of those who consented and were enrolled versus those who did not enroll. We also compared the characteristics of participants who consented and those who were reached and explicitly refused consent at one-month follow-up. We used the Cohen's d measure of effect size to evaluate differences. Results: Of the 1,000 randomized, 741 (74.1%) consented to continue in the study at one-month follow-up. One hundred and twenty-seven (12.7%) refused consent and 132 (13.2%) were unreachable. Cohen's d effect size differences between those who consented/enrolled (n = 741) and those who were not enrolled (n = 259) were negligible (<0.2) for age, gender, race/ethnicity, and most forms of insurance. The effect size was small for Medicaid (0.36), and other public insurance (0.48). After excluding those unreached at 1 month (12.7%), there were medium Cohen's d effect size differences between those who consented to participate (n = 741) and those who explicitly refused (n = 127) with respect to age (0.55) and self-pay or no insurance (0.51). There were small to negligible effect size differences with respect to sex, race/ethnicity, and other forms of health insurance. Conclusions: The modified Zelen's design resulted in successful enrollment of most participants who were initially randomized into the trial, including those not motivated to quit.

Brief Motivational Intervention to Improve Adolescent Sexual Health Service Uptake: A Pilot Randomized Controlled Trial in the Emergency Department.

OBJECTIVE: To test the hypothesis that our motivational sexual health intervention (SexHealth) would increase health service uptake when compared with control. STUDY DESIGN: In a randomized controlled trial at a pediatric emergency department, sexually active adolescents received either the SexHealth intervention or printed materials (control). SexHealth, delivered by a health educator, was a tablet-based, interactive intervention that included motivational techniques to promote sexual health, condom skills training, and tailored service recommendations. We assessed feasibility (eg, intervention completion, recommendations discussed, intervention duration), acceptability (ie, proportion enrolled and rating intervention as satisfactory), and efficacy; secondary outcomes were sexual and care-seeking behaviors at 6 months. The efficacy outcome was completion of ≥1 service at the index visit (ie, counseling, condoms, emergency contraception for immediate or future use, pregnancy/sexually transmitted infection/HIV testing, sexually transmitted infection treatment, and clinic referral). RESULTS: We enrolled 91 participants (intervention = 44; control = 47). The intervention demonstrated high feasibility: 98% completed the intervention; 98% of recommendations were discussed; duration was 24.6 minutes, and acceptability: 87% of eligible adolescents enrolled and 93% rated the intervention as fairly to very satisfactory. Compared with controls, intervention participants were more likely to complete ≥1 service (98% vs 70%, P < .001) including HIV testing (33% vs 6%, P = .02) and emergency contraception (80% vs 0%, P = .01). There were no meaningful differences between arms in behaviors at follow-up. CONCLUSIONS: SexHealth was feasible to implement, acceptable to youth, and resulted in increased uptake of health services during the emergency department visit. Additional strategies may be needed to extend intervention effects over time. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov; NCT03341975.

Youth Knowledge of Tobacco 21 and its Association With Intention to Use Tobacco.

BACKGROUND: Raising the minimum legal age (MLA) of tobacco sales from 18 to 21 (Tobacco 21 [T21]) has recently been implemented nationwide as a method to reduce tobacco use, but empirical data on youth knowledge of T21 policies and related pathways to tobacco use are limited. METHODS: Data were collected from the 2018 Kansas Communities That Care Student Survey. Knowledge of the MLA was compared between T21 and non-T21 regions using a quasi-experimental design. Logistic regression and mediation analysis were conducted to assess the association between knowledge of the MLA, influencing factors, and intention to use tobacco. RESULTS: Of 16 949 students (aged between 11 and 18) completing the T21 survey, fewer students responded correctly about the MLA in T21 than in non-T21 regions (37.4% vs. 46.3% responded correctly, 27.6% vs. 24.2% responded incorrectly, respectively). In T21 regions, Hispanics and students who support T21 were more likely to respond correctly about the MLA. Among current non-tobacco users in T21 regions, students who responded correctly about the MLA were less likely to report intention to use tobacco (adjusted odds ratio [AOR] = 0.7, 95% confidence interval [CI]: [0.6-0.8]) than those who responded incorrectly. The pathway from knowledge of the MLA to intention to use tobacco was significantly mediated by increased support for T21 (p = .002), perceived difficulty in accessing cigarettes (p = .042), and reduced susceptibility to peer influence (p = .027). CONCLUSIONS: Knowledge of the MLA was inversely associated with intention to use tobacco among youth. Educational campaigns to raise awareness and support for T21 among youth may improve the impact of T21 policies. IMPLICATIONS: This study examined youth knowledge of the MLA to purchase tobacco products, and whether knowledge of the MLA was associated with reduced intention to use tobacco. It also examined other influencing factors (eg, perceived support for T21) and potential mediation pathways linking knowledge of the MLA with intention to use tobacco. Given the nationwide adoption of T21, educational campaigns to promote knowledge of the policy may improve its impact.

Stress, Depression and Quit Attempt Outcomes among Unmotivated Smokers.

INTRODUCTION: Stress and depressive symptoms have been linked to a reduced likelihood of sustaining smoking cessation. Because stress and depressive symptoms may negatively affect motivation to quit, stress and depression may also be important for whether or not smokers make a quit attempt. OBJECTIVE: To examine the relationship between perceived stress and depressive symptoms and initiating a quit attempt in a smoking cessation induction trial. METHODS: We conducted a secondary analysis of existing data from a randomized clinical trial (N = 255) comparing motivational interviewing to health education and brief advice for smoking cessation induction in smokers with low motivation to quit. RESULTS: We observed positive associations between baseline predictors and quit attempts at week 12 (r = 0.192, p < 0.01 for depressive symptoms and r = 0.136, p < 0.05 for perceived stress). Logistic regression models revealed similar significant positive associations between baseline perceived stress and baseline depressive symptoms and making a quit attempt by week 12 (OR = 1.5, CI:1.03, 2.19 and OR = 1.03, 95% CI: 1.01, 1.06; respectively). CONCLUSION: Unexpectedly, this study found generally small but consistently positive associations between baseline depressive symptoms and baseline perceived stress and making a quit attempt by week 12. The results can be viewed as encouraging in that interventions to encourage quit attempts do not appear counter-productive for individuals higher in stress and depressive symptoms, but these patients very likely will need additional supports to sustain abstinence.

Mechanisms of Motivational Interviewing for Antiretroviral Medication Adherence in People with HIV.

Antiretroviral therapy (ART) for HIV requires strict regimen adherence. Motivational interviewing (MI) can improve ART adherence. MI process studies have rarely focussed on ART adherence. Such studies may facilitate MI modifications to improve outcomes. This study employed a single group pre and post-test design with 62 adults with HIV (16 female; mean age 40 years). Therapist use of MI-consistent (MICO) methods, MI spirit, and client change and sustain talk were coded from an MI session. Relationships were assessed with ART schedule adherence. MICO methods positively correlated with change and sustain talk and were negatively associated with proportion of change talk. No variables were associated with ART adherence change. Mediation analysis did not support the MI model of change. This may be due to the fact that ART adherence is determined by both motivational and non-motivational factors. It may also be that bidirectional relationships exist between therapist and client speech.

Motivational Interviewing to Encourage Quit Attempts Among Smokers Not Ready to Quit: A Trial-Based Economic Analysis.

INTRODUCTION: This study used data from a randomized controlled trial evaluating the efficacy of motivational interviewing (MI) relative to health education (HE) and brief advice (BA) to encourage quit attempts and cessation in order to determine their relative cost-effectiveness. AIMS AND METHODS: Urban community residents (n = 255) with low desire to quit smoking were randomized to MI, HE, or BA which differed in communication style and/or number of treatment sessions. Incremental cost-effectiveness ratios were used to compare the intensive interventions (MI and HE) to BA for facilitating quit attempts and smoking cessation. Costs were calculated from the perspective of an agency that might engage in program delivery. Sensitivity analysis examined different assumptions for MI training and pharmacotherapy costs. RESULTS: Total intervention delivery time costs per participant for MI, HE, and BA were $46.63, $42.87, and $2.4, respectively. Cost-effectiveness ratios per quit attempt at 24 weeks were $380 for MI, $272 for HE, and $209 for BA. The cost per additional quit attempt for MI and HE relative to BA was $508 and $301, respectively. The cost per additional quit for MI and HE relative to BA was $2030 and $752, respectively. Four separate sensitivity analyses conducted in our study did not change the conclusion the HE had a lower Incremental Cost-Effectiveness Ratio for both quit attempts and cessation. CONCLUSIONS: HE was the most cost-effective of the three types of smoking cessation induction therapies and therefore may be preferable for smokers who are less motivated to quit. Providing valuable cost information in choosing different clinical methods for motivating smokers to quit. IMPLICATIONS: All direct costs and activity-based time costs associated with delivering the intervention were analyzed from the perspective of an agency that may wish to replicate these strategies. A randomized controlled trial evaluating the efficacy of MI relative to HE and BA to encourage quit attempts and cessation determined their relative cost-effectiveness. HE was the most cost-effective of the three types of smoking cessation induction therapies and therefore may be preferable. Despite guideline recommendations, MI may not be the best approach to encourage quit attempts in diverse populations. Rather, a structured, intensive HE intervention might be the most cost-effective alternative.

Retail violations of sales to minors on e-cigarettes and cigars.

OBJECTIVES: The finalized 'Deeming Rule' extended the Food and Drug Administration (FDA) authority to regulate e-cigarettes, cigars, and other newly deemed tobacco products. We seek to assess the neighborhood characteristics associated with retail violations of sales to minors (RVSM) by tobacco product. STUDY DESIGN: We collected national inspection data on tobacco retailers during August 8, 2016, and May 31, 2018, from the FDA compliance check database. METHODS: A web scraping tool was applied to text mine the FDA decision letters and extract information on the tobacco product involved in RVSM. Separate logistic regression models with random effects were performed to examine the association between zip code-level neighborhood characteristics and RVSM by tobacco product. RESULTS: Of 268,317 minor-involved compliance inspections, 35,403 (13.2%) were identified as RVSM. Among 23,352 warning letters included in the final analysis, e-cigarettes, cigars, cigarettes, and smokeless tobacco accounted for 20.0% (n = 4673), 40.4% (9439), 35.6% (8303), and 4.0% (937) of RVSM, respectively. Flavored tobacco products were abundant among underage sales. For e-cigarettes, RVSM were more likely to occur in zip codes with a larger proportion of youth population aged 10-17 years (adjusted odds ratio [AOR] = 1.17 [1.02-1.34]). A larger proportion of African Americans was associated with a higher risk of RVSM for cigars (AOR = 1.09 [1.07-1.11]) but a lower risk of RVSM for e-cigarettes (AOR = 0.90 [0.87-0.93]). CONCLUSIONS: Retail violations of underage sales for cigars and e-cigarettes are prevalent and neighborhood characteristics associated with violations differ by tobacco product. Continued inspections with tailored strategies to reduce RVSM of all tobacco products are needed.

Discontinuing Treatment Against Medical Advice: The Role of Perceived Autonomy Support From Providers in Relapsing-Remitting Multiple Sclerosis.

BACKGROUND: Long-term medication adherence is problematic among patients with chronic medical conditions. To our knowledge, this was the first study to examine factors associated with nonadherence among patients with relapsing-remitting multiple sclerosis who discontinue disease-modifying treatments against medical advice. PURPOSE: To examine differences in perceived provider autonomy support between disease-modifying treatment-adherent relapsing-remitting multiple sclerosis patients and relapsing-remitting multiple sclerosis patients who discontinued disease-modifying treatments against medical advice. METHODS: Self-report questionnaires and a neurologic exam were administered to demographically matched adherent (n = 50) and nonadherent (n = 79) relapsing- remitting multiple sclerosis patients from the Midwest and Northeast USA. RESULTS: Adherent patients reported greater perceived autonomy support from their treatment providers, F(1, 124) = 28.170, p < .001, partial η2 = .185. This difference persisted after controlling for current multiple sclerosis healthcare provider, education, disease duration, Expanded Disability Status Scale, perceived barriers to adherence, and prevalence of side effects, F(1, 121) = 9.61, p = .002, partial η2 = .074. Neither depressive symptoms, F(1, 124) = 1.001, p > .05, partial η2 = .009, nor the occurrence of a major depressive episode, χ2(1, N = 129) = .288, p > .05, differed between adherent and nonadherent patients. CONCLUSIONS: Greater perceived autonomy support from treatment providers may increase adherence to disease-modifying treatments among patients who discontinue treatment against medical advice. Results may inform interventions for patients who discontinue treatment against medical advice.

Feasibility and Outcomes of an HIV Testing Intervention in African American Churches.

The updated National HIV/AIDS Strategy recommends widespread HIV education and testing and calls the faith community to assist in these efforts. Yet, limited information exist on church-based HIV testing interventions. This study examined feasibility and assessed HIV testing outcomes of Taking It to the Pews (TIPS), a multilevel HIV education and testing intervention. Four African American churches were matched and randomized to TIPS or a standard-information control arm. Intervention churches delivered the religiously-tailored TIPS Tool Kit, which included educational materials to individuals and ministry groups; pastoral activities (e.g., sermons preached, receipt of HIV testing role-modeled), responsive readings, and church bulletin inserts in church services; and HIV testing during church services and church outreach events. All churches delivered 2-3 tools/month and coordinated 3 HIV testing events. At 12 months, significant increases in receipt of HIV testing (59% vs. 42%, p = 0.008), and particularly church-based testing (54% vs. 15%, p < 0.001), relative to controls were found. TIPS has great potential to increase reach, feasibility, and impact of HIV testing in African American churches.

Coding Client Language in Motivational Interviewing for HIV Medication Adherence Using Self-Determination Theory.

BACKGROUND: Both motivational interviewing (MI) and self-determination theory (SDT) emphasise the importance of an individual's autonomy. SDT proposes that motivation is on a continuum with autonomous motivation (AM) at the self-determined end of the spectrum. Whether client speech reflects AM is not coded in MI process studies, however, as it is subsumed under the broader category of change talk (CT). We aimed to code naturalistic speech within MI sessions for HIV medication (antiretroviral) adherence according to whether expressed motivation was autonomous or controlled. We then assessed relationships between adherence and both autonomous/controlled motivational speech (AM/CM) and CT. METHODS: We developed a new coding tool (the SDT coding system: SDTCS) to measure naturally occurring AM speech and CM speech expressed during an MI session targeting antiretroviral (ART) adherence with 62 adults living with HIV (16 female; mean age 40 years). We coded the same sessions using the motivational interviewing skills code (MISC) 2.5 and then examined relationships with on-time ART adherence. RESULTS: The SDTCS was developed using a combined inductive and deductive approach. Adequate reliability estimates were achieved and the measure possessed good content validity. Naturally occurring AM speech had a stronger relationship to ART adherence in the week after the MI session than CM speech. There was also some evidence that the relationship between AM speech and adherence was stronger than between CT and adherence. CONCLUSION: Future refinement and extension of the SDTCS could allow for a more nuanced understanding of client motivational speech that is currently provided by existing coding tools.

Reasons for nonadherence and response to treatment in an adherence intervention trial for relapsing-remitting multiple sclerosis patients.

OBJECTIVES: To explore whether patients in an adherence trial who appeared not to take disease modifying therapy (DMT) for avoidance reasons could be reliably identified, by observational coding, for their main reason of not taking DMT. To determine whether reason groups could be distinguished by clinical and self-report psychological characteristics and intervention outcomes. METHOD: Participants were multiple sclerosis patients (N = 78, 88.5% female, mean age 45.64) demotivated to take DMT. Audio recordings of the sessions were coded for the main reason of not taking DMT. Reason groups were compared based on patient characteristics and intervention outcomes. RESULTS: Avoidance and three other reasons for not taking DMT (side effects, cost, and mild course) were reliably identified (κ = 0.88). Patient characteristics failed to distinguish participants in the Avoidance group, which also had poorer outcomes (X2 [2, n = 73] = 6.35, p = 0.036). CONCLUSIONS: Patients not taking DMT for avoidance reasons may need novel methods to identify them and encourage (re-)initiation.

The effects of assurances of voluntary compliance on retail sales to minors in the United States: 2015-2016.

Multiple state attorneys generals have entered assurances of voluntary compliance (AVCs) with numerous national retail chains as an application of consumer protection laws to help prevent tobacco sales to minors. Little is known about the effectiveness of AVCs in reducing the violations of tobacco retailers for underage sales. We collected inspection data involving minors (n=53,832) on tobacco retailers in 2015 and 2016 from the Food and Drug Administration (FDA) compliance check database. Inspections on 13 national retail chains were classified into four categories: gas stations from oil companies, convenience stores, pharmacy stores, and supermarkets. Multilevel logistic regression models were performed to examine the effectiveness of AVCs, adjusted for state tobacco control policies, state youth smoking rates, and socio-economic status (SES) at census tracts. Overall the Retail Violation Rate for sales to minors (RVRm) significantly varied by retail category from 7.7% in pharmacy stores to 18.9% in gas stations from oil companies. Retailers that entered an AVC had lower odds of underage sales violations in convenience stores (aOR=0.75, 95% CI [0.61-0.93]) and supermarkets (aOR=0.74, 95% CI [0.59-0.93]). For gas stations from oil companies and pharmacy stores, there were no significant differences in RVRm between stores with an AVC and stores without an AVC. We found that entering into AVCs is associated with fewer retail violations of underage sales for convenience stores and pharmacy stores. Continued efforts to strengthen the enforcement of AVCs and to expand AVCs to more states and other retail chains may improve youth tobacco control.

Effectiveness of motivational interviewing, health education and brief advice in a population of smokers who are not ready to quit.

BACKGROUND: Motivational Interviewing (MI), Brief Advice (BA) and Health Education (HE) are established smoking cessation induction methods for smokers with low desire to quit. Although randomized controlled trials (RCT's) have been frequently used to assess these interventions the temporal efficacy and effectiveness of these interventions have been poorly elaborated. The present work endeavors to fill the gap by considering the full range of possible motivational outcomes for all of the participants. METHODS: As a two-step process, Markov Chain (MC) and Ordinary Differential Equation (ODE) models were successively employed to examine the temporal efficacy and effectiveness of these interventions by computing the gradual movements of participants from an initial stage of unmotivated smoker to stages of increased motivation to quit and cessation. Specifically, in our re-analysis of data from the RCT we examined the proportion of participants in 4 stages of readiness to quit (unmotivated, undecided, motivated, former smokers) over 6 months, across treatment groups [MI (n = 87), BA (n = 43) and HE (n = 91)]. RESULTS: Although HE had greater efficacy compared to MI and BA (i.e., the highest smoking cessation rates), it had lower effectiveness at certain time points. This was due to the fact that HE had the greatest proportion of motivated smokers who quit smoking but simultaneously a large proportion of the motivated smokers became unmotivated to quit. The effectiveness of HE dropped substantially in weeks 3-12 and remained below the effectiveness of BA from week 12 onward. The 2-year ODE model projections show that the prevalence of motivated smokers in HE group may fall below 5%. The prevalence of HE former smokers can reach an equilibrium of 26%, where the prevalence of both BA and MI former smokers exceeds this equilibrium. CONCLUSIONS: The methodology proposed in this paper strongly benefits from the capabilities of both MC and ODE modeling approaches, in the event of low observations over the time. Particularly, the temporal population sizes are first estimated by the MC model. Then they are used to parametrize the ODE model and predict future values. The methodology enabes us to determine and compare the temporal efficacy and effectiveness of smoking cessation interventions, yielding predictive and analytic insights related to temporal characteristics and capabilities of these interventions during the study period and beyond. TRIAL REGISTRATION: Testing Counseling Styles to Motivate Smokers to Quit, NCT01188018 , (July 4, 2012). This study is registered at www.clinicaltrials.gov NCT01188018.

Baseline predictors of DMT reinitiation among patients with multiple sclerosis following an MI-CBT intervention.

Patients with multiple sclerosis (MS) are often nonadherent to their disease modifying therapy (DMT). While recent studies demonstrate enhanced DMT adherence following intervention grounded in motivational interviewing (MI), little is known about how to address DMT reinitiation among MS patients who have prematurely discontinued DMT against medical advice and do not intend to reinitiate. We examined baseline predictors of DMT reinitiation among patients with MS who discontinued medications against medical advice following a telephone-based MI and Cognitive Behavioral Therapy (MI-CBT) intervention. Following MI-CBT intervention, 66 patients reported whether or not they opted to reinitiate DMT. Rate of disease progression (ß = 0.295) and perceived personal control (ß = - 0.131) emerged as unique significant predictors of DMT reinitiation following intervention. Clinical characteristics and health-related beliefs may be used to prospectively identify patients most likely to reinitiate DMT following MI-CBT intervention, furthering the goal of preserving brain health and preventing neurologic decline in MS via appropriate DMT utilization. Further study is warranted to delineate potential mediators and moderators of DMT reinitiation outcomes.

Vape Shop Density and Socio-Demographic Disparities: A US Census Tract Analysis.

INTRODUCTION: Vape shops are an emerging business specializing in the sales and promotion of e-cigarette, e-juice, and other vaping products. This study sought to evaluate the associations between vape shop density and socio-demographic characteristics at the US census tract level. METHODS: Vape shop data (n = 9943) were collected from three online directories: Yelp.com, Yellowpages.com, and Guidetovaping.com. Addresses of vape shops were geocoded and the density per 10 000 people was estimated at each US census tract. Zero inflated negative binomial regression model was performed to examine the socio-demographic factors associated with vape shop density. RESULTS: Overall, there was a higher vape shop density in urban versus nonurban census tracts. In urban areas, higher vape shop density was associated with larger proportions of Hispanics and Asians, adults aged 18-44 years old and higher poverty, while the decrease in vape shop density was associated with larger proportions of population under 18 years old, higher education, larger household size, and a higher percentage of owner occupied housing units. In nonurban areas, higher vape shop density was associated larger proportions of African Americans and Hispanics, smaller household size and a lower percentage of owner occupied housing units. CONCLUSION: At the national level, there are inequalities of vape shop density by some socio-demographic characteristics and heterogeneity between urban and nonurban areas. IMPLICATIONS: Vape shops are more likely to be concentrated in areas where people with a higher risk for vaping and smoking reside. Our findings could inform initiatives aimed at a stronger licensing requirement for vape shops and federal and state-level regulations of this industry to prevent vape shop from targeting minority and other socially disadvantaged groups.