Intervention fidelity and factors affecting the process of implementing a mobile phone text messaging intervention among adolescents living with HIV: a convergent mixed-methods study in southern Ethiopia.

OBJECTIVE: To assess the intervention fidelity and explore contextual factors affecting the process of implementing a mobile phone text messaging intervention in improving adherence to and retention in care among adolescents living with HIV, their families and their healthcare providers in southern Ethiopia. DESIGN: A convergent mixed-methods design guided by the process evaluation theoretical framework and the Reach, Effectiveness, Adoption, Implementation and Maintenance framework was used alongside a randomised controlled trial to examine the fidelity and explore the experiences of participants in the intervention. SETTING: Six hospitals and five health centres provide HIV treatment and care to adolescents in five zones in southern Ethiopia. PARTICIPANTS: Adolescents (aged 10-19), their families and their healthcare providers. INTERVENTION: Mobile phone text messages daily for 6 months or standard care (control). RESULTS: 153 participants were enrolled in the process evaluation. Among the 153 enrolled in the intervention arm, 78 (49.02%) were male and 75 (43.8%) were female, respectively. The mean and SD age of the participants is 15 (0.21). The overall experiences of implementing the text messages reminder intervention were described as helpful in terms of treatment support for adherence but had room for improvement. During the study, 30 700 text messages were sent, and fidelity was high, with 99.4% successfully delivered text messages during the intervention. Barriers such as failed text messages delivery, limitations in phone ownership and technical limitations affected fidelity. Technical challenges can hinder maintenance, but a belief in the future of digital communication permeates the experiences of the text message reminders. CONCLUSIONS: Overall fidelity was high, and participants' overall experiences of mobile phone text messages were expressed as helpful. Contextual factors, such as local telecommunications networks and local electric power, as well as technical and individual factors must be considered when planning future interventions. TRIAL REGISTRATION NUMBER: PACTR202107638293593.

The effect of adding physician recommendation in digitally-enabled outreach for COVID-19 vaccination in socially/economically disadvantaged populations.

INTRODUCTION: People from backgrounds that are economically/socially disadvantaged experienced disproportionately high COVID-19 death rates and had lower vaccination rates. Effective outreach strategies for increasing vaccine uptake during the pandemic are not fully known. Among patients receiving care at a Federally Qualified Health Center, we tested whether community engaged digitally-enabled outreach from a trusted clinician messenger increased COVID vaccine uptake. STUDY DESIGN, SETTING, AND PARTICIPANTS: A 3-parallel-arm randomized controlled trial with a hybrid effectiveness-implementation design was conducted among patients ≥ 18 years old on study enrollment during 2021 with 1,650 assigned in 3:10:20 ratio; 2,328 were later selected for two subsequent implementation rounds. INTERVENTIONS: From April 13 to June 10, 2021, patients were proactively sent a text-messaging invitation to make an appointment for vaccination as part of the routine practice with a link to frequently asked questions (Arm 1, n = 150) with added personalized clinician recommendation alone (Arm 2, n = 500) or with enabled 2-way SMS messaging feature (Arm 3, n = 1,000). Further implementation used messaging addressing vaccine hesitancy (n = 1,323) or adverse reactions to vaccines (n = 1,005). MAIN OUTCOMES AND MEASURES: The primary outcome was the completion of the first SARS-Cov-2 vaccine dose determined at 14, 30 and 90 days after outreach. RESULTS: Of 1,650 patients in effectiveness Arms, 61% was female. Vaccination rates for Arms 1, 2, and 3, were 6% (n = 9), 5.4% (n = 27) and 3.3% (n = 33) at 14 days, and 11.5% (n = 17), 11.6% (n = 58), and 8.5% (n = 85) at 90 days, respectively, which were similar in pairwise comparisons. At 90 days, vaccination rates were similar across the two implementation rounds (3.9% vs. 3.6%) and were similar to the rate (3.3%) among patients who were not selected for intervention arms or implementation rounds (n = 8,671). CONCLUSIONS: Digitally-enabled outreach that included SMS messaging outreach augmented with clinician recommendations did not improve COVID-19 vaccination rates. TRIAL REGISTRATION: This study is registered at ClinicalTrails.gov Identifier: NC-T04952376.

Experimenting to increase the effectiveness of a national campaign on hygiene behavior in Tanzania.

Through Tanzania's National Sanitation Campaign, we study the effectiveness of two common elements of behavior change campaigns: endorsements from celebrities and testimonials. Using four experiments in Tanzania in early 2021 as part of the national campaign, we find that including endorsements and testimonials in text messages sent to individuals significantly increases self-reported hygiene behavior. These results mask important heterogeneity based on the source of endorsement or framing of the testimonial and provide insights into cost-effective approaches for changing behavior at scale.

Individualized treatment effects of a digital alcohol intervention and their associations with participant characteristics and engagement.

AIMS: Conditional average treatment effects are often reported in intervention studies, in which assumptions are made regarding how effects are similar across a heterogeneous sample. Nonetheless, differing factors, such as genetics, age, and sex, can impact an intervention's effect on outcomes. The study aimed to estimate the individualized effects of a digital alcohol intervention among individuals looking online to reduce their drinking. METHODS: We used data from a randomized controlled trial (RCT), including 2129 adults from the Swedish general population. The RCT concerned a text message-based alcohol intervention that sought to engender change through increasing knowledge on how to change and instilling confidence in changing behaviour. Outcomes were total weekly alcohol consumption and monthly heavy episodic drinking. Individualized treatment effects were modelled using baseline characteristics (age, gender, alcohol consumption, and psychosocial variables) and engagement with the intervention content. RESULTS: We found evidence that the effects of the digital alcohol intervention were heterogeneous concerning participants' age, baseline alcohol consumption, confidence, and importance. For heavy episodic drinking, there was evidence that effects were heterogeneous concerning age, sex, and baseline alcohol consumption. Overall, women, older individuals, and heavier drinkers benefitted more from the intervention in terms of effect size. In addition, participants who engaged more with the goal-setting and screening content reported better outcomes. CONCLUSIONS: The results highlight how different individuals respond differently to a digital alcohol intervention. This allows insight into who benefits the most and least from the intervention and highlights the potential merit of designing interventions adapted to different individuals' needs.

Feasibility and Preliminary Effects of a Social Media-Based Peer-Group Mobile Messaging Smoking Cessation Intervention Among Chinese Immigrants who Smoke: Pilot Randomized Controlled Trial.

BACKGROUND: Chinese immigrants experience significant disparities in tobacco use. Culturally adapted tobacco treatments targeting this population are sparse and the use is low. The low use of these treatment programs is attributed to their exclusive focus on individuals who are ready to quit and the wide range of barriers that Chinese immigrants face to access these programs. To support Chinese immigrant smokers at all levels of readiness to quit and address their access barriers, we developed the WeChat Quit Coach, a culturally and linguistically appropriate WeChat (Tencent Holdings Limited)-based peer group mobile messaging smoking cessation intervention. OBJECTIVE: This study aims to assess the feasibility, acceptability, and preliminary effects of WeChat Quit Coach. METHODS: We enrolled a total of 60 Chinese immigrant smokers in 2022 in New York City for a pilot randomized controlled trial (RCT) and a single-arm pilot test. The first 40 participants were randomized to either the intervention arm (WeChat Quit Coach) or the control arm (self-help print material) using 1:1 block randomization stratified by sex. WeChat Quit Coach lasted 6 weeks, featuring small peer groups moderated by a coach, daily text messages with text questions, and chat-based instant messaging support from the coach in response to peer questions. The next 20 participants were enrolled in the single-arm pilot test to further assess intervention feasibility and acceptability. All 60 participants were offered a 4-week supply of complimentary nicotine replacement therapy. Surveys were administered at baseline and 6 weeks, with participants in the pilot RCT completing an additional survey at 6 months and biochemical verification of abstinence at both follow-ups. RESULTS: Of 74 individuals screened, 68 (92%) were eligible and 60 (88%) were enrolled. The majority of participants, with a mean age of 42.5 (SD 13.8) years, were male (49/60, 82%) and not ready to quit, with 70% (42/60) in the precontemplation or contemplation stage at the time of enrollment. The pilot RCT had follow-up rates of 98% (39/40) at 6 weeks and 93% (37/40) at 6 months, while the single-arm test achieved 100% follow-up at 6 weeks. On average, participants responded to daily text questions for 25.1 days over the 42-day intervention period and 23% (9/40) used the chat-based instant messaging support. Most participants were satisfied with WeChat Quit Coach (36/39, 92%) and would recommend it to others (32/39, 82%). At 6 months, self-reported 7-day point prevalence abstinence rates were 25% (5/20) in the intervention arm and 15% (3/20) in the control arm, with biochemically verified abstinence rates of 25% (5/20) and 5% (1/20), respectively. CONCLUSIONS: WeChat Quit Coach was feasible and well-received by Chinese immigrants who smoke and produced promising effects on abstinence. Large trials are warranted to assess its efficacy in promoting abstinence in this underserved population. TRIAL REGISTRATION: ClinicalTrials.gov NCT05130788; https://clinicaltrials.gov/study/NCT05130788.

Effectiveness of a Mobile Phone Messaging-Based Message Framing Intervention for Improving Maternal Health Service Uptake and Newborn Care Practice in Rural Jimma Zone, Ethiopia: Protocol for a Cluster Randomized Controlled Trial.

BACKGROUND: Ethiopia has high rates of maternal and neonatal mortality. In 2019 and 2020, the maternal and newborn mortality rates were estimated at 412 per 1,000,000 births and 30 per 10,000 births, respectively. While mobile health interventions to improve maternal and neonatal health management have shown promising results, there are still insufficient scientific studies to assess the effectiveness of mobile phone messaging-based message framing for maternal and newborn health. OBJECTIVE: This research aims to examine the effectiveness of mobile phone messaging-based message framing for improving the use of maternal and newborn health services in the Jimma Zone, Ethiopia. METHODS: A 3-arm cluster-randomized trial design was used to evaluate the effects of mobile phone-based intervention on maternal and newborn health service usage. The trial arms were (1) gain-framed messages (2) loss-framed messages, and (3) usual care. A total of 21 health posts were randomized, and 588 pregnant women who had a gestational age of 16-20 weeks, irrespective of their antenatal care status, were randomly assigned to the trial arms. The intervention consisted of a series of messages dispatched from the date of enrolment until 6-8 months. The control group received existing care without messages. The primary outcomes were maternal health service usage and newborn care practice, while knowledge, attitude, self-efficacy, iron supplementation, and neonatal and maternal morbidity were secondary outcomes. The outcomes will be analyzed using a generalized linear mixed model and the findings will be reported according to the CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth) statement for randomized controlled trials. RESULTS: Recruitment of participants was conducted and the baseline survey was administered in March 2023. The intervention was rolled out from May 2023 till December 2023. The end-line assessment was conducted in February 2024. CONCLUSIONS: This trial was carried out to understand how mobile phone-based messaging can improve maternal and newborn health service usage. It provides evidence for policy guidelines around mobile health strategies to improve maternal and newborn health. TRIAL REGISTRATION: Pan African Clinical Trials Registry PACTR202201753436676; https://tinyurl.com/ykhnpc49. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52395.

Reducing the Gap in Knowledge and Expectations between Clinicians and People with Polycystic Ovary Syndrome or Adrenal Conditions: Simulation via Instant Messaging-Birmingham Advance: Patient and Public Involvement (SIMBA-PPI) Study.

BACKGROUND: To evaluate the efficacy of SIMBA as an educational intervention for both HCPs and people with either PCOS or adrenal conditions and to study the change in knowledge of people with PCOS or adrenal conditions about the conditions and expectations from the HCPs involved in their care following SIMBA-PPI sessions. METHODS: Two SIMBA-PPI sessions (SIMBA-PPI Polycystic ovary syndrome (SIMBA-PCOS) and SIMBA-PPI Adrenal conditions (SIMBA-Adrenal conditions)) were conducted in September 2021 and March 2022. In both sessions, HCPs interacted with moderators on patient management through WhatsApp. Patients with respective conditions underwent workshop-style learning in the same cases. SIMBA-PCOS transcripts were also translated into Brazilian Portuguese and workshops were held in both Brazilian Portuguese and English. The two groups (HCPs and patients) were then brought together to discuss exploring gaps in knowledge and expectations. The Wilcoxon Signed-Rank test compared differences in pre- and post-SIMBA self-reported confidence levels in HCPs and patients. Qualitative data from the online recordings were transcribed and analysed with inductive thematic analysis to identify gaps in knowledge and expectations from managing the cases. RESULTS: 48 HCPs and 25 patients participated in our study. When compared to pre-SIMBA confidence levels, SIMBA-PPI sessions effectively improved clinicians' confidence in managing PCOS (40.5%, p < .001) and adrenal conditions (23.0%, p < .001) post-SIMBA. Patient participants' confidence in HCPs significantly increased in the PCOS session (SIMBA-PCOS: 6.25%, p = 0.01). CONCLUSIONS: Integration of PPI into SIMBA improved HCPs' confidence in managing PCOS and adrenal conditions. SIMBA-PPI also improved patients' confidence in HCPs. Our findings suggest that participating in SIMBA-PPI sessions can reduce the gap in knowledge and expectations between patients and HCPs involved in their care.

SMS-based interventions for improving child and adolescent vaccine coverage and timeliness: a systematic review.

BACKGROUND: The aim of this review was to investigate the impact of short message service (SMS)-based interventions on childhood and adolescent vaccine coverage and timeliness. METHODS: A pre-defined search strategy was used to identify all relevant publications up until July 2022 from electronic databases. Reports of randomised trials written in English and involving children and adolescents less than 18 years old were included. The review was conducted in accordance with PRISMA guidelines. RESULTS: Thirty randomised trials were identified. Most trials were conducted in high-income countries. There was marked heterogeneity between studies. SMS-based interventions were associated with small to moderate improvements in vaccine coverage and timeliness compared to no SMS reminder. Reminders with embedded education or which were combined with monetary incentives performed better than simple reminders in some settings. CONCLUSION: Some SMS-based interventions appear effective for improving child vaccine coverage and timeliness in some settings. Future studies should focus on identifying which features of SMS-based strategies, including the message content and timing, are determinants of effectiveness.

A qualitative study of stakeholders' experiences with and acceptability of a technology-supported health coaching intervention (SHARE-S) delivered in coordination with cancer survivorship care.

PURPOSE: Healthy cancer survivorship involves patients' active engagement with preventative health behaviors and follow-up care. While clinicians and patients have typically held dual responsibility for activating these behaviors, transitioning some clinician effort to technology and health coaches may enhance guideline implementation. This paper reports on the acceptability of the Shared Healthcare Actions & Reflections Electronic systems in survivorship (SHARE-S) program, an entirely virtual multicomponent intervention incorporating e-referrals, remotely-delivered health coaching, and automated text messages to enhance patient self-management and promote healthy survivorship. METHODS: SHARE-S was evaluated in single group hybrid implementation-effectiveness pilot study. Patients were e-referred from the clinical team to health coaches for three health self-management coaching calls and received text messages to enhance coaching. Semi-structured qualitative interviews were conducted with 21 patient participants, 2 referring clinicians, and 2 health coaches to determine intervention acceptability (attitudes, appropriateness, suitability, convenience, and perceived effectiveness) and to identify important elements of the program and potential mechanisms of action to guide future implementation. RESULTS: SHARE-S was described as impactful and convenient. The nondirective, patient-centered health coaching and mindfulness exercises were deemed most acceptable; text messages were less acceptable. Stakeholders suggested increased flexibility in format, frequency, timing, and length of participation, and additional tailored educational materials. Patients reported tangible health behavior changes, improved mood, and increased accountability and self-efficacy. CONCLUSIONS: SHARE-S is overall an acceptable and potentially effective intervention that may enhance survivors' self-management and well-being. Alterations to tailored content, timing, and dose should be tested to determine impact on acceptability and outcomes.

Mediated effects of a randomised control trial for a text messaging smoking cessation intervention for online help-seekers and primary care visitors.

BACKGROUND AND AIMS: Digital smoking cessation interventions have been shown to be effective in helping individuals achieve prolonged smoking abstinence. Nonetheless, the mechanisms that drive such effects are unclear. The current study aimed to estimate a digital smoking cessation intervention's natural direct and indirect effects. METHODS: This secondary analysis of mediated effects uses data from a randomised controlled trial which included participants who smoked at least one cigarette a week, had access to a mobile phone, and were 18 years or older. The comparator was existing smoking cessation support available to all members of the Swedish public. Primary outcomes were prolonged smoking abstinence and point prevalence of smoking abstinence, measured at 3- and 6-months post-randomisation. A counterfactual framework was used to estimate three hypothesised mediators of the intervention's effects: importance, knowledge of how to change (know-how), and confidence. RESULTS: Between 18/09/20 and 16/06/22, 1012 participants were randomised. The intervention led to improved confidence and know-how, which both partially mediated the effects of the digital intervention on smoking abstinence at 3- and 6 months post-randomisation. CONCLUSIONS: A digital smoking cessation intervention was found to partially affect smoking abstinence by improving individuals' confidence in their ability to quit smoking and developing knowledge on how to quit. Face-value single-item mediator measures, lack of blinding, and attrition limit the study. Future studies should address these limitations and assess additional mechanisms mediating intervention effects. TRIAL REGISTRATION: ISRCTN13455271.

Enhancing COVID-19 booster vaccination among the elderly through text message reminders.

The BOOST (Booster promotion for older outpatients using SMS text reminders) program at Taipei Veterans General Hospital assessed the effectiveness of text message reminders in enhancing COVID-19 booster vaccination rates among the elderly, guided by the Health Belief Model (HBM). Targeting patients aged 65 and above, eligible yet unvaccinated for a COVID-19 booster, this cohort study sent personalized reminders a week prior to their scheduled appointments between April 18, 2022, and May 12, 2022, acting as cues to action to enhance vaccination uptake by overcoming perceived barriers and raising awareness of benefits. Over 5 weeks, the study observed a 38% increase in vaccination rate among 3,500 eligible patients, markedly surpassing the concurrent national rate increase of 4% for the same demographic. The majority of vaccinations occurred within two weeks after the reminder, illustrating the effectiveness of the strategy. Cox regression analysis identified age and time since last vaccination as significant predictors of responsiveness, with those aged 65-74 and 75-84 showing higher uptake, particularly when reminders were sent within 4 months after the last dose. A single reminder proved to be effective. The findings of this study demonstrate the potential of SMS reminders to promote COVID-19 vaccination among the elderly through the strategic use of HBM principles, suggesting a feasible and effective approach to public health communication.

Maternal health service utilization in the Jimma Zone, Ethiopia: results from a baseline study for mobile phone messaging interventions.

BACKGROUND: Over the last 20 years, global healthcare has placed a major focus on improving the survival rates of mothers and children, recognizing the potential to prevent a significant number of deaths resulting from pregnancy and childbirth. Nevertheless, there remains an ongoing obstacle to the insufficient utilization of critical obstetric services to achieve optimal health outcomes for pregnant women. This study aimed to assess the magnitude and determinants of maternal healthcare use in the Jimma Zone, Ethiopia. METHODS: Data were obtained from a household survey as part of the baseline assessment of a cluster randomized controlled trial. The study participants comprised 588 women in early pregnancy, specifically those with a gestational age of less than 20 weeks. Logistic regression analysis was employed to identify factors associated with the use of maternal health services. Adjusted odds ratios (AORs) were used to assess the strength of the associations, with significance level set at a p-value ≤ 0.05. RESULTS: The overall prevalence of maternal health service utilization was 87.9% (CI: 85.1, 90.4) for antenatal care, 74.7% (CI: 73.2, 79.9) for health facility delivery, and 60.4% (CI: 56.4, 64.3) for postnatal care. Multivariable logistic analysis revealed that maternal health service use was significantly influenced by access to health facilities (AOR: 6.6; 95% CI: 2.39, 18.16), financial hardship (AOR: 3; 95% CI: 1.97, 4.61), perceived respectful care (AOR: 2.3; 95% CI: 1.07, 5.11), perceived privacy of service provisions (AOR: 2.4; 95% CI: 1.47, 4.06), and attitudes toward maternal service use (AOR: 2.2; 95% CI: 1.48, 3.24). CONCLUSIONS: The study revealed slightly higher rates of antenatal care, facility delivery, and postpartum care utilization. However, there was a low proportion of early antenatal care initiation, and high rates of antenatal care dropout. Mobile phone-based messaging intervention may enhance maternal health service use by addressing factors such as lack of access, economic challenges, disrespectful care, no privacy of procedures, and unfavorable attitudes.

Remote Monitoring App for Endocrine Therapy Adherence Among Patients With Early-Stage Breast Cancer: A Randomized Clinical Trial.

Importance: Adjuvant endocrine therapy (AET) use among women with early-stage, hormone receptor-positive breast cancer reduces the risk of cancer recurrence, but its adverse symptoms contribute to lower adherence. Objective: To test whether remote monitoring of symptoms and treatment adherence with or without tailored text messages improves outcomes among women with breast cancer who are prescribed AET. Design, Setting, and Participants: This nonblinded, randomized clinical trial (RCT) following intention-to-treat principles included English-speaking women with early-stage breast cancer prescribed AET at a large cancer center with 14 clinics across 3 states from November 15, 2018, to June 11, 2021. All participants had a mobile device with a data plan and an email address and were asked to use an electronic pillbox to monitor AET adherence and to complete surveys at enrollment and 1 year. Interventions: Participants were randomized into 3 groups: (1) an app group, in which participants received instructions for and access to the study adherence and symptom monitoring app for 6 months; (2) an app plus feedback group, in which participants received additional weekly text messages about managing symptoms, adherence, and communication; or (3) an enhanced usual care (EUC) group. App-reported missed doses, increases in symptoms, and occurrence of severe symptoms triggered follow-ups from the oncology team. Main Outcomes and Measures: The primary outcome was 1-year, electronic pillbox-captured AET adherence. Secondary outcomes included symptom management abstracted from the medical record, as well as patient-reported health care utilization, symptom burden, quality of life, physician communication, and self-efficacy for managing symptoms. Results: Among 304 female participants randomized (app group, 98; app plus feedback group, 102; EUC group, 104), the mean (SD) age was 58.6 (10.8) years (median, 60 years; range, 31-83 years), and 60 (19.7%) had an educational level of high school diploma or less. The study completion rate was 87.5% (266 participants). There were no statistically significant differences by treatment group in AET adherence (primary outcome): 76.6% for EUC, 73.4% for the app group (difference vs EUC, -3.3%; 95% CI, -11.4% to 4.9%; P = .43), and 70.9% for the app plus feedback group (difference vs EUC, -5.7%; 95% CI, -13.8% to 2.4%; P = .17). At the 1-year follow-up, app plus feedback participants had fewer total health care encounters (adjusted difference, -1.23; 95% CI, -2.03 to -0.43; P = .003), including high-cost encounters (adjusted difference, -0.40; 95% CI, -0.67 to -0.14; P = .003), and office visits (adjusted difference, -0.82; 95% CI, -1.54 to -0.09; P = .03) over the previous 6 months compared with EUC participants. Conclusions and Relevance: This RCT found that a remote monitoring app with alerts to the patient's care team and tailored text messages to patients did not improve AET adherence among women with early-stage breast cancer; however, it reduced overall and high-cost health care encounters and office visits without affecting quality of life. Trial Registration: ClinicalTrials.gov Identifier: NCT03592771.

INcentives and ReMINDers to Improve Long-Term Medication Adherence (INMIND): impact of a pilot randomized controlled trial in a large HIV clinic in Uganda.

INTRODUCTION: Habits are a common strategy for successfully countering medication non-adherence, yet existing interventions do not support participants during the long habit formation period, resulting in high attrition. We test a novel intervention combining text messages and incentives with anchoring to support antiretroviral therapy (ART) pill-taking habits. METHODS: In a randomized, parallel controlled trial, a sample of 155 participants 18 years and older who initiated ART within 3 months were recruited at Mildmay Uganda between October 2021 and April 2022. All participants were educated on the anchoring strategy and chose an anchor, that is existing routines, to pair with pill-taking. Participants were randomized to either usual care (C = 49), daily text message reminders to follow their anchoring plan (Messages group; T1 = 49) or messages and incentives conditional on pill-taking in line with their anchor (Incentives group; T2 = 57). Assessments occurred at baseline, month 3 (end of intervention) and month 9 (end of observation period). The primary outcomes are electronically measured mean adherence and pill-taking consistent with participants' anchor time. RESULTS: The primary outcome of pill-taking in line with the anchoring plan was higher in the Incentives group during the 3-month intervention (12.2 p.p. [95% CI: 2.2 22.2; p = .02]), and remained significantly higher after the incentives were withdrawn (months 4-6 (14.2 p.p. [95% CI 1.1 27.2; p = .03]); months 7-9 (14.1 p.p. [95% CI -0.2 28.5; p = .05])). Mean adherence was higher in both treatment groups relative to the control group during the intervention (T1 vs. C, p = .06; T2 vs. C, p = .06) but not post-intervention. CONCLUSIONS: The promising approach of using incentives to support habit formation among ART treatment initiators needs to be evaluated in a fully powered study to further our understanding of the habit formation process and to evaluate its cost-effectiveness.

An SMS chatbot digital educational program to increase healthy eating behaviors in adolescence: A multifactorial randomized controlled trial among 7,890 participants in the Danish National Birth Cohort.

BACKGROUND: Few cost-effective strategies to shift dietary habits of populations in a healthier direction have been identified. We examined if participating in a chatbot health education program transmitted by Short Messages Service ("SMS-program") could improve adolescent dietary behaviors and body weight trajectories. We also explored possible added effects of maternal or peer involvement. METHODS AND FINDINGS: We conducted a randomized controlled trial (RCT) among adolescents from the Danish National Birth Cohort (DNBC). Eligible were adolescents who during 2015 to 2016 at age 14 years had completed a questionnaire assessing height, weight, and dietary habits. Two thirds were offered participation in an SMS-program, whereas 1/3 ("non-SMS group") received no offer. The SMS program aimed to improve 3 key dietary intake behaviors: sugar-sweetened beverages (SSBs), fruit and vegetables (FV), and fish. The offered programs had 3 factorially randomized schemes; the aims of these were to test effect of asking the mother or a friend to also participate in the health promotion program, and to test the effect of a 4-week individually tailored SMS program against the full 12-week SMS program targeting all 3 dietary factors. Height and weight and intakes of SSB, FV, and fish were assessed twice by a smartphone-based abbreviated dietary questionnaire completed at 6 months (m) and 18 m follow-up. Main outcome measures were (1) body mass index (BMI) z-score; and (2) an abbreviated Healthy Eating Index (mini-HEI, 1 m window, as mean of z-scores for SSB, FV, and fish). Among the 7,890 randomized adolescents, 5,260 were assigned to any SMS program; 63% (3,338) joined the offered program. Among the 7,890 randomized, 74% (5,853) and 68% (5,370) responded to follow-ups at 6 m and 18 m, respectively. Effects were estimated by intention-to-treat (ITT) analyses and inverse probability weighted per-protocol (IPW-PP) analyses excluding adolescents who did not join the program. Mean (standard deviation (SD)) mini-HEI at baseline, 6 m and 18 m was -0.01 (0.64), 0.01 (0.59), and -0.01 (0.59), respectively. In ITT-analyses, no effects were observed, at any time point, in those who had received any SMS program compared to the non-SMS group, on BMI z-score (6 m: -0.010 [95% confidence interval (CI) -0.035, 0.015]; p = 0.442, 18 m: 0.002 [95% CI -0.029, 0.033]; p = 0.901) or mini-HEI (6 m: 0.016 [95% CI -0.011, 0.043]; p = 0.253, 18m: -0.016 [95% CI -0.045, 0.013]; p = 0.286). In IPW-PP analyses, at 6 m, a small decrease in BMI z-score (-0.030 [95% CI -0.057, -0.003]; p = 0.032) was observed, whereas no significant effect was observed in mini-HEI (0.027 [95% CI -0.002, 0.056]; p = 0.072), among those who had received any SMS program compared to the non-SMS group. At 18 m, no associations were observed (BMI z-score: -0.006 [95% CI -0.039, 0.027]; p = 0.724, and mini-HEI: -0.005 [95% CI -0.036, 0.026]; p = 0.755). The main limitations of the study were that DNBC participants, though derived from the general population, tend to have higher socioeconomic status than average, and that outcome measures were self-reported. CONCLUSIONS: In this study, a chatbot health education program delivered through an SMS program had no effect on dietary habits or weight trajectories in ITT analyses. However, IPW-PP-analyses, based on those 63% who had joined the offered SMS program, suggested modest improvements in weight development at 6 m, which had faded at 18 m. Future research should focus on developing gender-specific messaging programs including "booster" messages to obtain sustained engagement. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02809196 https://clinicaltrials.gov/study/NCT02809196.

Smartband-based smoking detection and real-time brief mindfulness intervention: findings from a feasibility clinical trial.

BACKGROUND: Smartbands can be used to detect cigarette smoking and deliver real time smoking interventions. Brief mindfulness interventions have been found to reduce smoking. OBJECTIVE: This single arm feasibility trial used a smartband to detect smoking and deliver brief mindfulness exercises. METHODS: Daily smokers who were motivated to reduce their smoking wore a smartband for 60 days. For 21 days, the smartband monitored, detected and notified the user of smoking in real time. After 21 days, a 'mindful smoking' exercise was triggered by detected smoking. After 28 days, a 'RAIN' (recognize, allow, investigate, nonidentify) exercise was delivered to predicted smoking. Participants received mindfulness exercises by text message and online mindfulness training. Feasibility measures included treatment fidelity, adherence and acceptability. RESULTS: Participants (N=155) were 54% female, 76% white non-Hispanic, and treatment starters (n=115) were analyzed. Treatment fidelity cutoffs were met, including for detecting smoking and delivering mindfulness exercises. Adherence was mixed, including moderate smartband use and low completion of mindfulness exercises. Acceptability was mixed, including high helpfulness ratings and mixed user experiences data. Retention of treatment starters was high (81.9%). CONCLUSIONS: Findings demonstrate the feasibility of using a smartband to track smoking and deliver quit smoking interventions contingent on smoking.

Remote Blood Pressure Monitoring With Social Support for Patients With Hypertension: A Randomized Clinical Trial.

Importance: Hypertension management has traditionally been based on office visits. Integrating remote monitoring into routine clinical practices and leveraging social support might improve blood pressure (BP) control. Objective: To evaluate the effectiveness of a bidirectional text monitoring program focused on BP control and medication adherence with and without social support in adults with hypertension. Design, Setting, and Participants: This randomized clinical trial included adults aged 18 to 75 treated at an academic family medicine practice in Philadelphia in 2018 and 2019. Patients had been seen at least twice in the prior 24 months and had at least 2 elevated BP measurements (>150/90 mm Hg or >140/90 mm Hg for patients aged 18-59 years or with diabetes or chronic kidney disease) during visits. All participants had a cell phone with text messaging, offered at least 1 support partner, and were taking maintenance medications to treat hypertension. Patients were randomized 2:2:1 to remote monitoring of BP and medication adherence (RM), remote monitoring of BP and medication adherence with feedback provided to a social support partner (SS), or usual care (UC). Data were analyzed on an intention-to-treat basis between October 14, 2019, and May 30, 2020, and were revisited from May 23 through June 2, 2023. Interventions: The RM and SS groups received an automatic home BP monitor, 3 weekly texts requesting BP measurements, 1 weekly text inquiring about medication adherence, and a weekly text with feedback. In the SS arm, support partners received a weekly progress report. The UC group received UC through their primary care practice. Clinicians caring for the patients in the intervention groups received nudges via electronic health records to adjust medications when 3 of 10 reported BP measurements were elevated. Patients were followed up for 4 months. Main Outcomes and Measures: The primary outcome was systolic BP at 4 months measured during the final follow-up visit. Secondary outcomes included achievement of normotension and diastolic BP. Results: In all, 246 patients (mean [SD] age, 50.9 [11.4] years; 175 females [71.1%]; 223 Black individuals [90.7%] and 13 White individuals [5.3%]) were included in the intention-to-treat analysis: 100 patients in the RM arm, 97 in the SS arm, and 49 in the UC arm. Compared with the UC arm, there was no significant difference in systolic or diastolic BP at the 4-month follow-up visit in the RM arm (systolic BP adjusted mean difference, -5.25 [95% CI, -10.65 to 0.15] mm Hg; diastolic BP adjusted mean difference, -1.94 [95% CI, -5.14 to 1.27] mm Hg) or the SS arm (systolic BP adjusted mean difference, -0.91 [95% CI, -6.37 to 4.55] mm Hg; diastolic BP adjusted mean difference, -0.63 [95% CI, -3.77 to 2.51] mm Hg). Of the 206 patients with a final BP measurement at 4 months, BP was controlled in 49% (41 of 84) of patients in the RM arm, 31% (27 of 87) of patients in the SS arm, and 40% (14 of 35) of patients in the UC arm; these rates did not differ significantly between the intervention arms and the UC group. Conclusions and Relevance: In this randomized clinical trial, neither remote BP monitoring nor remote BP monitoring with social support improved BP control compared with UC in adults with hypertension. Additional efforts are needed to examine whether interventions directed at helping patients remember to take their BP medications can lead to improved BP control. Trial Registration: ClinicalTrials.gov Identifier: NCT03416283.

Engagement With a Mobile Chat-Based Intervention for Smoking Cessation: A Secondary Analysis of a Randomized Clinical Trial.

Importance: Determining how individuals engage with digital health interventions over time is crucial to understand and optimize intervention outcomes. Objective: To identify the engagement trajectories with a mobile chat-based smoking cessation intervention and examine its association with biochemically validated abstinence. Design, Setting, and Participants: A secondary analysis of a pragmatic, cluster randomized clinical trial conducted in Hong Kong with 6-month follow-up. From June 18 to September 30, 2017, 624 adult daily smokers were recruited from 34 community sites randomized to the intervention group. Data were analyzed from March 6 to October 30, 2023. Intervention: Chat-based cessation support delivered by a live counselor via a mobile instant messaging app for 3 months from baseline. Main Outcomes and Measures: Group-based trajectory modeling was used to identify engagement trajectories using the participants' weekly responses to the messages from the counselor over the 3-month intervention period. The outcome measures were biochemically validated tobacco abstinence at 3-month (end of treatment) and 6-month follow-ups. Covariates included sex, age, educational level, nicotine dependence, past quit attempt, and intention to quit at baseline. Results: Of 624 participants included in the analysis, 479 were male (76.8%), and the mean (SD) age was 42.1 (16.2) years. Four distinct engagement trajectories were identified: low engagement group (447 [71.6%]), where participants maintained very low engagement throughout; rapid-declining group (86 [13.8%]), where participants began with moderate engagement and rapidly decreased to a low level; gradual-declining group (58 [9.3%]), where participants had high initial engagement and gradually decreased to a moderate level; and high engagement group (58 [5.3%]), where participants maintained high engagement throughout. Compared with the low engagement group, the 6-month validated abstinence rates were significantly higher in the rapid-declining group (adjusted relative risk [ARR], 3.30; 95% CI, 1.39-7.81), gradual-declining group (ARR, 5.17; 95% CI, 2.21-12.11), and high engagement group (ARR, 4.98; 95% CI, 1.82-13.60). The corresponding ARRs (95% CI) of 3-month validated abstinence were 4.03 (95% CI, 1.53-10.59), 5.25 (95% CI, 1.98-13.88), and 9.23 (95% CI, 3.29-25.86). Conclusions and Relevance: The findings of this study suggest that higher levels of engagement with the chat-based smoking cessation intervention were associated with greater biochemically validated tobacco abstinence. Improving engagement with digital interventions may increase intervention benefits. Trial Registration: ClinicalTrials.gov Identifier: NCT03182790.

Comparing the effectiveness and cost-effectiveness of text-message reminders and telephone patient navigation to improve the uptake of faecal immunochemical test screening among non-responders in London: a randomised controlled trial protocol.

INTRODUCTION: Participation in bowel cancer screening is lower in regions where there is high ethnic diversity and/or socioeconomic deprivation. Interventions, such as text message reminders and patient navigation (PN), have the potential to increase participation in these areas. As such, there is interest in the comparative effectiveness of these interventions to increase bowel cancer screening participation, as well as their relative cost-effectiveness. METHODS AND ANALYSIS: This study will use a three-arm randomised controlled trial design to compare the effectiveness and cost-effectiveness of text message reminders and PN to increase the uptake of bowel cancer screening in London. Participants will be individuals who have not returned a completed faecal immunochemical test kit within 13 weeks of receiving a routine invitation from the London bowel cancer screening hub. Participants will be randomised (in a 1:1:1 ratio) to receive either (1) usual care (ie, 'no intervention'), (2) a text message reminder at 13 weeks, followed by repeated text message reminders at 15, 17 and 19 weeks (in the event of non-response) or (3) a text message reminder at 13 weeks, followed by PN telephone calls at 15, 17 and 19 weeks in the event of non-response. The primary endpoint will be participation in bowel cancer screening, defined as 'the return of a completed kit by week 24'. Statistical analysis will use multivariate logistic regression and will incorporate pairwise comparisons of all three groups, adjusted for multiple testing. ETHICS AND DISSEMINATION: Approvals to conduct the research have been obtained from University College London's Joint Research Office (Ref: 150666), the Screening Research, Innovation and Development Advisory Committee ('RIDAC', Ref: 2223 014 BCSP Kerrison), the Health Research Authority (Ref: 22/WM/0212) and the Confidentiality Advisory Group (Ref: 22/CAG/0140). Results will be conveyed to stakeholders, notably those managing the screening programme and published in peer-reviewed journals/presented at academic conferences. TRIAL REGISTRATION NUMBER: ISRCTN17245519.

Engagement in mHealth-Prompted Self-Measured Blood Pressure Monitoring Among Participants Recruited From a Safety-Net Emergency Department: Secondary Analysis of the Reach Out Trial.

Background: Hypertension, a key modifiable risk factor for cardiovascular disease, is more prevalent among Black and low-income individuals. To address this health disparity, leveraging safety-net emergency departments for scalable mobile health (mHealth) interventions, specifically using text messaging for self-measured blood pressure (SMBP) monitoring, presents a promising strategy. This study investigates patterns of engagement, associated factors, and the impact of engagement on lowering blood pressure (BP) in an underserved population. Objective: We aimed to identify patterns of engagement with prompted SMBP monitoring with feedback, factors associated with engagement, and the association of engagement with lowered BP. Methods: This is a secondary analysis of data from Reach Out, an mHealth, factorial trial among 488 hypertensive patients recruited from a safety-net emergency department in Flint, Michigan. Reach Out participants were randomized to weekly or daily text message prompts to measure their BP and text in their responses. Engagement was defined as a BP response to the prompt. The k-means clustering algorithm and visualization were used to determine the pattern of SMBP engagement by SMBP prompt frequency-weekly or daily. BP was remotely measured at 12 months. For each prompt frequency group, logistic regression models were used to assess the univariate association of demographics, access to care, and comorbidities with high engagement. We then used linear mixed-effects models to explore the association between engagement and systolic BP at 12 months, estimated using average marginal effects. Results: For both SMBP prompt groups, the optimal number of engagement clusters was 2, which we defined as high and low engagement. Of the 241 weekly participants, 189 (78.4%) were low (response rate: mean 20%, SD 23.4) engagers, and 52 (21.6%) were high (response rate: mean 86%, SD 14.7) engagers. Of the 247 daily participants, 221 (89.5%) were low engagers (response rate: mean 9%, SD 12.2), and 26 (10.5%) were high (response rate: mean 67%, SD 8.7) engagers. Among weekly participants, those who were older (>65 years of age), attended some college (vs no college), married or lived with someone, had Medicare (vs Medicaid), were under the care of a primary care doctor, and took antihypertensive medication in the last 6 months had higher odds of high engagement. Participants who lacked transportation to appointments had lower odds of high engagement. In both prompt frequency groups, participants who were high engagers had a greater decline in BP compared to low engagers. Conclusions: Participants randomized to weekly SMBP monitoring prompts responded more frequently overall and were more likely to be classed as high engagers compared to participants who received daily prompts. High engagement was associated with a larger decrease in BP. New strategies to encourage engagement are needed for participants with lower access to care.