Megastudy shows that reminders boost vaccination but adding free rides does not.

Encouraging routine COVID-19 vaccinations is likely to be a crucial policy challenge for decades to come. To avert hundreds of thousands of unnecessary hospitalizations and deaths, adoption will need to be higher than it was in the autumn of 2022 or 2023, when less than one-fifth of Americans received booster vaccines1,2. One approach to encouraging vaccination is to eliminate the friction of transportation hurdles. Previous research has shown that friction can hinder follow-through3 and that individuals who live farther from COVID-19 vaccination sites are less likely to get vaccinated4. However, the value of providing free round-trip transportation to vaccination sites is unknown. Here we show that offering people free round-trip Lyft rides to pharmacies has no benefit over and above sending them behaviourally informed text messages reminding them to get vaccinated. We determined this by running a megastudy with millions of CVS Pharmacy patients in the United States testing the effects of (1) free round-trip Lyft rides to CVS Pharmacies for vaccination appointments and (2) seven different sets of behaviourally informed vaccine reminder messages. Our results suggest that offering previously vaccinated individuals free rides to vaccination sites is not a good investment in the United States, contrary to the high expectations of both expert and lay forecasters. Instead, people in the United States should be sent behaviourally informed COVID-19 vaccination reminders, which increased the 30-day COVID-19 booster uptake by 21% (1.05 percentage points) and spilled over to increase 30-day influenza vaccinations by 8% (0.34 percentage points) in our megastudy. More rigorous testing of interventions to promote vaccination is needed to ensure that evidence-based solutions are deployed widely and that ineffective but intuitively appealing tools are discontinued.

Acute Effects of Coffee Consumption on Health among Ambulatory Adults.

BACKGROUND: Coffee is one of the most commonly consumed beverages in the world, but the acute health effects of coffee consumption remain uncertain. METHODS: We conducted a prospective, randomized, case-crossover trial to examine the effects of caffeinated coffee on cardiac ectopy and arrhythmias, daily step counts, sleep minutes, and serum glucose levels. A total of 100 adults were fitted with a continuously recording electrocardiogram device, a wrist-worn accelerometer, and a continuous glucose monitor. Participants downloaded a smartphone application to collect geolocation data. We used daily text messages, sent over a period of 14 days, to randomly instruct participants to consume caffeinated coffee or avoid caffeine. The primary outcome was the mean number of daily premature atrial contractions. Adherence to the randomization assignment was assessed with the use of real-time indicators recorded by the participants, daily surveys, reimbursements for date-stamped receipts for coffee purchases, and virtual monitoring (geofencing) of coffee-shop visits. RESULTS: The mean (±SD) age of the participants was 39±13 years; 51% were women, and 51% were non-Hispanic White. Adherence to the random assignments was assessed to be high. The consumption of caffeinated coffee was associated with 58 daily premature atrial contractions as compared with 53 daily events on days when caffeine was avoided (rate ratio, 1.09; 95% confidence interval [CI], 0.98 to 1.20; P = 0.10). The consumption of caffeinated coffee as compared with no caffeine consumption was associated with 154 and 102 daily premature ventricular contractions, respectively (rate ratio, 1.51; 95% CI, 1.18 to 1.94); 10,646 and 9665 daily steps (mean difference, 1058; 95% CI, 441 to 1675); 397 and 432 minutes of nightly sleep (mean difference, 36; 95% CI, 25 to 47); and serum glucose levels of 95 mg per deciliter and 96 mg per deciliter (mean difference, -0.41; 95% CI, -5.42 to 4.60). CONCLUSIONS: In this randomized trial, the consumption of caffeinated coffee did not result in significantly more daily premature atrial contractions than the avoidance of caffeine. (Funded by the University of California, San Francisco, and the National Institutes of Health; CRAVE ClinicalTrials.gov number, NCT03671759.).

Detecting fake-review buyers using network structure: Direct evidence from Amazon.

Online reviews significantly impact consumers' decision-making process and firms' economic outcomes and are widely seen as crucial to the success of online markets. Firms, therefore, have a strong incentive to manipulate ratings using fake reviews. This presents a problem that academic researchers have tried to solve for over two decades and on which platforms expend a large amount of resources. Nevertheless, the prevalence of fake reviews is arguably higher than ever. To combat this, we collect a dataset of reviews for thousands of Amazon products and develop a general and highly accurate method for detecting fake reviews. A unique difference between previous datasets and ours is that we directly observe which sellers buy fake reviews. Thus, while prior research has trained models using laboratory-generated reviews or proxies for fake reviews, we are able to train a model using actual fake reviews. We show that products that buy fake reviews are highly clustered in the product reviewer network. Therefore, features constructed from this network are highly predictive of which products buy fake reviews. We show that our network-based approach is also successful at detecting fake review buyers even without ground truth data, as unsupervised clustering methods can accurately identify fake review buyers by identifying clusters of products that are closely connected in the network. While text or metadata can be manipulated to evade detection, network-based features are more costly to manipulate because these features result directly from the inherent limitations of buying reviews from online review marketplaces, making our detection approach more robust to manipulation.

A 680,000-person megastudy of nudges to encourage vaccination in pharmacies.

Encouraging vaccination is a pressing policy problem. To assess whether text-based reminders can encourage pharmacy vaccination and what kinds of messages work best, we conducted a megastudy. We randomly assigned 689,693 Walmart pharmacy patients to receive one of 22 different text reminders using a variety of different behavioral science principles to nudge flu vaccination or to a business-as-usual control condition that received no messages. We found that the reminder texts that we tested increased pharmacy vaccination rates by an average of 2.0 percentage points, or 6.8%, over a 3-mo follow-up period. The most-effective messages reminded patients that a flu shot was waiting for them and delivered reminders on multiple days. The top-performing intervention included two texts delivered 3 d apart and communicated to patients that a vaccine was "waiting for you." Neither experts nor lay people anticipated that this would be the best-performing treatment, underscoring the value of simultaneously testing many different nudges in a highly powered megastudy.

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.

A randomized controlled trial of an app-based intervention on physical activity and glycemic control in people with type 2 diabetes.

BACKGROUND: We investigated the effects of a physical activity encouragement intervention based on a smartphone personal health record (PHR) application (app) on step count increases, glycemic control, and body weight in patients with type 2 diabetes (T2D). METHODS: In this 12-week, single-center, randomized controlled, 12-week extension study, patients with T2D who were overweight or obese were randomized using ratio 1:2 to a group using a smartphone PHR app (control group) or group using the app and received individualized motivational text messages (intervention group) for 12 weeks. During the extension period, the sending of the encouraging text messages to the intervention group was discontinued. The primary outcome was a change in daily step count after 12 weeks and analyzed by independent t-test. The secondary outcomes included HbA1c, fasting glucose, and body weight analyzed by paired or independent t-test. RESULTS: Of 200 participants, 62 (93.9%) and 118 (88.1%) in the control and intervention group, respectively, completed the 12-week main study. The change in daily step count from baseline to week 12 was not significantly different between the two groups (P = 0.365). Among participants with baseline step counts < 7,500 steps per day, the change in the mean daily step count at week 12 in the intervention group (1,319 ± 3,020) was significantly larger than that in control group (-139 ± 2,309) (P = 0.009). At week 12, HbA1c in the intervention group (6.7 ± 0.5%) was significantly lower than that in control group (6.9 ± 0.6%, P = 0.041) and at week 24, changes in HbA1c from baseline were significant in both groups but, comparable between groups. Decrease in HbA1c from baseline to week 12 of intervention group was greater in participants with baseline HbA1c ≥ 7.5% (-0.81 ± 0.84%) compared with those with baseline HbA1c < 7.5% (-0.22 ± 0.39%) (P for interaction = 0.014). A significant reduction in body weight from baseline to week 24 was observed in both groups without significant between-group differences (P = 0.370). CONCLUSIONS: App-based individualized motivational intervention for physical activity did not increase daily step count from baseline to week 12, and the changes in HbA1c levels from baseline to week 12 were comparable. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03407222).

Rationale, Design and Baseline Characteristics of a Randomized Controlled Trial of a Cardiovascular Quality Improvement Strategy in India: The C-QIP Trial.

BACKGROUND: Quality of chronic care for cardiovascular disease (CVD) remains suboptimal worldwide. The Collaborative Quality ImProvement (C-QIP) trial aims to develop and test the feasibility and clinical effect of a multicomponent strategy among patients with prevalent CVD in India. METHODS: The C-QIP is a clinic-based, open randomized trial of a multicomponent intervention vs usual care that was locally developed and adapted for use in Indian settings through rigorous formative research guided by Consolidated Framework for Implementation Research (CFIR). The C-QIP intervention consisted of 5 components: 1) electronic health records and decision support system for clinicians, 2) trained nonphysician health workers (NPHW), 3) text-message based lifestyle reminders, 4) patient education materials, 5) quarterly audit and feedback reports. Patients with CVD (ischemic heart disease, ischemic stroke, or heart failure) attending outpatient CVD clinics were recruited from September 2022 to September 2023 and were randomized to the intervention or usual care arm for at least 12 months follow-up. The co-primary outcomes are implementation feasibility, fidelity (ie, dose delivered and dose received), acceptability, adoption and appropriateness, measured at multiple levels: patient, provider and clinic site-level, The secondary outcomes include prescription of guideline directed medical therapy (GDMT) (provider-level), and adherence to prescribed therapy, change in mean blood pressure (BP) and LDL-cholesterol between the intervention and control groups (patient-level). In addition, a trial-based process and economic evaluations will be performed using standard guidelines. RESULTS: We recruited 410 socio-demographically diverse patients with CVD from 4 hospitals in India. Mean (SD) age was 57.5 (11.7) years, and 73.0% were males. Self-reported history of hypertension (48.5%) and diabetes (41.5%) was common. At baseline, mean (SD) BP was 127.9 (18.2) /76.2 (11.6) mm Hg, mean (SD) LDLc: 80.3 (37.3) mg/dl and mean (SD) HbA1c: 6.8% (1.6%). At baseline, the GDMT varied from 62.4% for patients with ischemic heart disease, 48.6% for ischemic stroke and 36.1% for heart failure. CONCLUSION: This study will establish the feasibility of delivering contextually relevant, and evidence-based C-QIP strategy and assess whether it is acceptable to the target populations. The study results will inform a larger scale confirmatory trial of a comprehensive CVD care model in low-resource settings. TRIAL REGISTRATION: Clinical Trials Registry India: CTRI/2022/04/041847; Clinicaltrials.gov number: NCT05196659.

Remote monitoring of patients with rheumatoid arthritis in a low disease activity state: a mixed methods evaluation across six hospitals in London, UK.

OBJECTIVES: This study evaluated the scale-up of a remote monitoring service, capturing monthly Rheumatoid Arthritis Impact of Disease scores and patient-generated text messages, for patients with rheumatoid arthritis (RA; in remission or with low disease activity) attending routine outpatient clinics across six hospitals. We explored patients and staff experiences and implementation outcomes. METHODS: A pragmatic, mixed methods approach was used, with active patient involvement throughout. We undertook a rapid review, analysed service-level data, and conducted a patient survey and patient and staff interviews, informed by the Capability, Opportunity, Motivation, Behaviour (COM-B) and Exploration, Preparation, Implementation, Sustainment (EPIS) theoretical frameworks. RESULTS: The review included 37 articles, covering themes of patient and clinician acceptability, engagement, feasibility and clinical impact. Service-level data (n = 202) showed high levels of patient engagement with the service. The patient survey (n = 155) showed patients felt the service was easy to use, had confidence in it and felt it improved access to care. Patient interview (n = 22) findings mirrored those of the survey. Motivating factors included increased responsiveness and ease of contact with clinical teams. Views from staff interviews (n = 16) were more mixed. Some implementation barriers were specific to roll-out sites. Prioritization of staff needs was emphasized. CONCLUSION: Patients were positive about the service and engagement was high. Staff views and engagement were more mixed. Results suggest that equal levels of patient and staff engagement are required for sustainability. These findings further our understanding of the implementation challenges to scaling remote monitoring interventions for patients with rheumatoid arthritis in routine care settings.

Automated Reminders Enhance Mailed Fecal Immunochemical Test Completion Among Veterans: a Randomized Controlled Trial.

BACKGROUND: The Veterans Affairs (VHA) is working to establish a population-based colorectal cancer screening program for average-risk patients using mailed fecal immunochemical testing (FIT). However, low response rates to mailed FIT may hinder success. Key features of mailed FIT programs, including the use of reminders, differ among various national programs, with limited evidence among veterans. OBJECTIVE: We sought to test whether using reminders, either via telephone call or text message, was effective in improving mailed FIT response rates. DESIGN: We conducted a prospective, randomized quality improvement trial ( ClinicalTrials.gov NCT05012007). Veterans who had not returned a FIT within 2 weeks of receiving the kit were randomized to one of three groups: (1) control (no reminder); (2) an automated telephone call reminder; or (3) an automated text message reminder. PARTICIPANTS: A total of 2658 veterans enrolled at VA Puget Sound Health Care System who were aged 45-75 and had an average risk of colorectal cancer. INTERVENTIONS: A single automated telephone call or text message reminder prompting veterans to return the FIT kit. MAIN MEASURES: Our primary outcome was FIT return at 90 days and our secondary outcome was FIT return at 180 days. KEY RESULTS: Participant average age was 62 years, 88% were men, and 66% White. At 90 days, both the phone and text reminder interventions had higher FIT return rates compared to control (intention-to-treat results (ITT): control 28%, phone 39%, text 38%; p<0.001). At 180 days, FIT kit return remained higher in the reminder interventions (ITT: control 32%, phone 42%, text 40%; p<0.001). CONCLUSIONS: Automated reminders increased colorectal cancer screening completion among average-risk veterans. An automated phone call or text message was equally effective. VHA facilities seeking to implement a mailed FIT program should consider using phone or text reminders, depending on available resources.

Impact of Text-Based Monthly Check-Ins on Pre-Exposure Prophylaxis Retention at a Sexual Health Clinic.

ABSTRACT: We conducted a retrospective cohort study of preexposure prophylaxis patients at the municipal Sexual Health Clinic in Seattle-King County, Washington from 2019 to 2021 to determine whether monthly check-in text messages impacted 4- and 6-month pre-exposure prophylaxis retention. Monthly check-ins did not appear to improve retention above and beyond open-ended texting and appointment reminders.

JYNNEOS Vaccine Safety Surveillance During the 2022 Mpox Outbreak Using the Vaccine Adverse Event Reporting System and V-safe, United States, 2022 to 2023.

BACKGROUND: In response to the 2022 mpox outbreak in the United States, people with higher potential for exposure to mpox were recommended to receive 2 doses of the JYNNEOS vaccine. Vaccine safety was monitored using 2 complementary systems. METHODS: The Vaccine Adverse Event Reporting System (VAERS) is a passive surveillance system that accepts reports of adverse events after vaccination. VAERS is capable of rapidly identifying rare adverse events and unusual reporting patterns. Medical records were requested and reviewed for adverse events of special interest, including myocarditis. Adverse event reporting rates were calculated as the number of verified adverse event cases divided by the number of JYNNEOS doses administered. V-safe for mpox was a voluntary smartphone-based vaccine safety surveillance system that sent enrolled persons text messages linked to health surveys asking about reactions and health impact events occurring after vaccination. RESULTS: There were 1,207,056 JYNNEOS doses administered in the United States. VAERS received 1927 reports for JYNNEOS. The myocarditis reporting rate per million doses was 2.69 after dose 1 and 8.64 after dose 2. V-safe had 213 participants complete at least one health survey. Rates of injection site and systemic reactions were similar in the first week after dose 1 and dose 2. CONCLUSIONS: JYNNEOS vaccine safety surveillance findings from VAERS and v-safe did not identify any unexpected safety concerns. The VAERS reporting rate for myocarditis was similar to previously published population background rates.

Impact of mobile health technologies on human papillomavirus vaccination uptake among mothers of unvaccinated girls aged 9-14 years in Lagos, Nigeria (mHealth-HPVac): study protocol of a randomised controlled trial.

BACKGROUND: Despite the availability of effective vaccines, human papillomavirus (HPV) vaccine uptake remains low in most resource-limited settings including Nigeria. Mobile health technology (mHealth) has the potential to empower patients to manage their health, reduce health disparities, and enhance the uptake of HPV vaccination. AIM: The "mHealth-HPVac" study will assess the effects of mHealth using short text messages on the uptake of HPV vaccination among mothers of unvaccinated girls aged 9-14 years and also determine the factors influencing the uptake of HPV vaccination among these mothers. METHODS: This protocol highlights a randomised controlled trial involving women aged 25-65 years who will be enrolled on attendance for routine care at the General Outpatient clinics of Lagos University Teaching Hospital, Lagos, Nigeria between July and December 2024. At baseline, n = 123 women will be randomised to either a short text message or usual care (control) arm. The primary outcome is vaccination of the participant's school-age girl(s) at any time during the 6 months of follow-up. The associations between any two groups of continuous variables will be assessed using the independent sample t-test for normally distributed data, or the Mann-Whitney U test for skewed data. For two groups of categorical variables, the Chi-square (X2) test or Fisher's exact test will be used, as appropriate. Using the multivariable binary logistic regression model, we will examine the effects of all relevant sociodemographic and clinical variables on HPV vaccination uptake among mothers of unvaccinated but vaccine-eligible school-age girls. Statistical significance will be reported as P < 0.05. DISCUSSION: The mHealth-Cervix study will evaluate the impact of mobile technologies on HPV vaccination uptake among mothers of unvaccinated but vaccine-eligible school-age girls in Lagos, Nigeria as a way of contributing to the reduction in the wide disparities in cervical cancer incidence through primary prevention facilitated using health promotion to improve HPV vaccination uptake. REGISTRATION: PACTR202406727470443 (6th June 2024).

Efficacy of a short message service brief contact intervention (SMS-SOS) in reducing repetition of hospital-treated self-harm: randomised controlled trial.

BACKGROUND: Hospital-treated self-harm is common and costly, and is associated with repeated self-harm and suicide. AIMS: To investigate the effectiveness of a brief contact intervention delivered via short message service (SMS) text messages in reducing hospital-treated self-harm re-presentations in three hospitals in Sydney (2017-2019), Australia. Trial registration number: ACTRN12617000607370. METHOD: A randomised controlled trial with parallel arms allocated 804 participants presenting with self-harm, stratified by previous self-harm, to a control condition of treatment as usual (TAU) (n = 431) or an intervention condition of nine automated SMS contacts (plus TAU) (n = 373), over 12 months following the index self-harm episode. The primary outcomes were (a) repeat self-harm event rate (number of self-harm events per person per year) at 6-, 12- and 24-month follow-up and (b) the time to first repeat at 24-month follow-up. RESULTS: The event rate for self-harm repetition was lower for the SMS compared with TAU group at 6 months (IRR = 0.79, 95% CI 0.61-1.01), 12 months (IRR = 0.78, 95% CI 0.64-0.95) and 24 months (IRR = 0.78, 95% CI 0.66-0.91). There was no difference between the SMS and TAU groups in the time to first repeat self-harm event over 24 months (HR = 0.96, 95% CI 0.72-1.26). There were four suicides in the TAU group and none in the SMS group. CONCLUSIONS: The 22% reduction in repetition of hospital-treated self-harm was clinically meaningful. SMS text messages are an inexpensive, scalable and universal intervention that can be used in hospital-treated self-harm populations but further work is needed to establish efficacy and cost-effectiveness across settings.

Reach and Engagement With Population Health Management Interventions to Address COVID-19 Among Safety-Net Health Care Systems.

Interventions designed to address COVID-19 needed to be rapidly scaled up to the population level, and to address health equity by reaching historically marginalized populations most affected by the pandemic (e.g., racial/ethnic minorities and rural and low socioeconomic status populations). From February 2021 to June 2022, SCALE-UP Utah used text messaging interventions to reach 107 846 patients from 28 clinics within seven safety-net health care systems. Interventions provided informational and motivational messaging regarding COVID-19 testing and vaccination, and were developed using extensive community partner input. (Am J Public Health. 2024;114(11):1207-1211. https://doi.org/10.2105/AJPH.2024.307770).

The PICOTS-ComTeC Framework for Defining Digital Health Interventions: An ISPOR Special Interest Group Report.

OBJECTIVES: Digital health definitions are abundant, but often lack clarity and precision. We aimed to develop a minimum information framework to define patient-facing digital health interventions (DHIs) for outcomes research. METHODS: Definitions of digital-health-related terms (DHTs) were systematically reviewed, followed by a content analysis using frameworks, including PICOTS (population, intervention, comparator, outcome, timing, and setting), Shannon-Weaver Model of Communication, Agency for Healthcare Research and Quality Measures, and the World Health Organization's Classification of Digital Health Interventions. Subsequently, we conducted an online Delphi study to establish a minimum information framework, which was pilot tested by 5 experts using hypothetical examples. RESULTS: After screening 2610 records and 545 full-text articles, we identified 101 unique definitions of 67 secondary DHTs in 76 articles, resulting in 95 different patterns of concepts among the definitions. World Health Organization system (84.5%), message (75.7%), intervention (58.3%), and technology (52.4%) were the most frequently covered concepts. For the Delphi survey, we invited 47 members of the ISPOR Digital Health Special Interest Group, 18 of whom became the Delphi panel. The first, second, and third survey rounds were completed by 18, 11, and 10 respondents, respectively. After consolidating results, the PICOTS-ComTeC acronym emerged, involving 9 domains (population, intervention, comparator, outcome, timing, setting, communication, technology, and context) and 32 optional subcategories. CONCLUSIONS: Patient-facing DHIs can be specified using PICOTS-ComTeC that facilitates identification of appropriate interventions and comparators for a given decision. PICOTS-ComTeC is a flexible and versatile tool, intended to assist authors in designing and reporting primary studies and evidence syntheses, yielding actionable results for clinicians and other decision makers.

Pilot Randomized Controlled Trial of Game Plan for PrEP: A Brief, Web and Text Message Intervention to Help Sexual Minority Men Adhere to PrEP and Reduce Their Alcohol Use.

Suboptimal adherence to oral PrEP medications, particularly among younger sexual minority men (SMM), continues to be a key barrier to achieving more substantial declines in new HIV infections. Although variety of interventions, including web and text-message-based applications, have successfully addressed PrEP adherence, very few have addressed the potential influence of alcohol. This pilot study explored whether the Game Plan for PrEP, a brief, web-based and text messaging intervention, helped promote PrEP persistence and adherence and reduced condomless sex and alcohol use. Seventy-three heavy-drinking SMM on PrEP were recruited online from states with Ending the HIV Epidemic jurisdictions and randomly assigned 1:1 to receive either the Game Plan for PrEP intervention or an attention-matched control. We collected online surveys assessing primary outcomes at one, three, and six months post-enrollment. As secondary outcomes, we also collected dried blood spot samples at baseline, three, and six months to analyze for biomarkers of PrEP and alcohol use. Our results showed that the odds of stopping PrEP or experiencing a clinically meaningful lapse in PrEP adherence (≥ 4 consecutive missed doses) were not different across the two conditions. We also did not find evidence of any differences in condomless sex or drinking outcomes across conditions, although participants in both conditions reported drinking less often over time. These findings were consistent across both self-reported outcomes and biomarkers. Overall, we did not find evidence that our brief, web and text messaging intervention encouraged more optimal PrEP coverage or moderate their alcohol use.

Implementation of free-draft text messaging to enhance care retention and satisfaction for persons living with HIV infection.

Eligible persons with HIV infection can receive client-centered case management to coordinate medical and social services. Novel mobile health interventions could improve effective case management and retention in care, an important goal to help end the HIV epidemic. Using a hybrid type I effectiveness-implementation design, we assessed whether access to bidirectional, free-draft secure text messaging with a case manager and clinic pharmacist could improve client satisfaction and care retention in a Southern academic HIV clinic. Sixty-four clients enrolled between November 2019 and March 2020, had a median age of 39 years, and were mostly male, single, and African-American. Heavy app users texted over 100 times (n = 6) over the course of the 12-month intervention while others never texted (n = 12). App usage peaked during months of clinic closure due to COVID-19. Most participants reported high satisfaction with the app and planned continued usage after study completion. Changes in clinic retention and virologic suppression rates were not observed, a result confounded by practice changes due to COVID-19. High usage and satisfaction of free-draft text messaging in case-managed HIV clients supports inclusion of this communication option in routine HIV clinical care.

Evaluation of Feasibility and Acceptability of a Text-Messaging Intervention for Tobacco Cessation in India.

INTRODUCTION: The aim of our study was to assess the feasibility and acceptability of a brief behavioral intervention for tobacco cessation delivered via mobile phone text messaging in India. AIMS AND METHODS: We conducted an uncontrolled intervention cohort study in adult current users of tobacco. The participants received intervention messages on their mobile phones for eight weeks. We collected qualitative data about participants' perceptions of intervention delivery and receipt, acceptability, and feasibility of the intervention. The outcomes measured at 3 months post-recruitment were self-reported 7- and 28-day point-prevalence abstinence, and Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) risk categories for tobacco-low (0-3), moderate (4-26), and high (≥27). RESULTS: We recruited 26 eligible participants, and 22 completed the outcome assessments. The participants generally perceived the intervention content to be simple to access and useful in facilitating a change in tobacco use. None of the participants indicated that they wanted to discontinue receiving the intervention messages. Some suggestions for enhancing acceptability included supplementing text messaging with more intensive counseling and the use of multimedia content. Eighteen percent of participants reported abstinence in the past 7 and 28 days. A greater proportion of those who used smokeless tobacco were abstinent at follow-up compared to those who smoked (42.9% vs. 6.7%; p = .04). CONCLUSIONS: If effective, simple and low-cost mobile phone text messaging can be used to deliver interventions for tobacco use, and has the potential to be scaled up so it can be delivered to populations of smokers interested in receiving cessation support. IMPLICATIONS: Our study is an important step towards the development of a contextually relevant intervention suited for low- and middle-income countries and which is responsive to the needs of both those who use smoked and smokeless tobacco. If found to be effective, our intervention would be a scalable solution to overcome the human resource related barrier to accessing tobacco cessation services in low resource settings.

Feasibility Randomized Controlled Trial of Face-to-Face Counseling and Mobile Phone Messages Compared to Usual Care for Smokeless Tobacco Cessation in Indian Primary Care: Project CERTAIN.

INTRODUCTION: Smokeless tobacco (SLT) use in low- and middle-income countries has adverse health consequences. We hypothesize that it is feasible to test an intervention of mobile phone messages and face-to-face counseling sessions for SLT cessation in India. AIMS AND METHODS: We conducted an exploratory, individual parallel two group, randomized controlled trial (RCT), with baseline and end-point (3 months from randomization) assessments in urban primary health centers in Odisha, India. A total of 250 current (i.e., users in the last 3 months) SLT users or dual users (ie, smokers and SLT users) were recruited to the trial (125 in each group). Participants were randomized to either routine care, face-to-face counseling, and reminder mobile messages or routine care only. The primary outcomes were to assess the feasibility of running a full RCT including recruitment, compliance, and retention. RESULTS: A total of seven (77.8%) out of nine primary care centers took part in the trial. Out of the 315 SLT users invited to participate, 250 provided consent and were randomized [79.4% (95% CI: 74.5, 83.7)]. Out of the 250 randomized SLT users, 238 [95% (95% CI: 91.8, 97.5)] were followed up at 3 months (117 in the intervention group and 121 in the control group). Of the participants in the intervention group, 74 (63.8%) reported that they received the mobile messages. CONCLUSIONS: This exploratory trial demonstrated the feasibility of delivering and evaluating an intervention of mobile phone messages and face-to-face counseling for SLT users in Indian primary care in a full randomized trial. IMPLICATIONS: This study found that combining mobile messages with face-to-face counseling for smokeless tobacco users visiting primary health care settings in India is feasible in terms of recruitment of users, compliance with the intervention, and retention of study participants within the trial. The biochemically verified smokeless tobacco abstinence rate was higher in the intervention group compared with the control group. There was poor agreement between self-reported tobacco cessation and the measured salivary cotinine in smokeless tobacco users. The findings support the feasibility and acceptability of the intervention signaling the need for a larger clinical trial to test the effectiveness of the intervention.