Dataset Information

The Mobile Solutions for Immunization (M-SIMU) Trial: A Protocol for a Cluster Randomized Controlled Trial That Assesses the Impact of Mobile Phone Delivered Reminders and Travel Subsidies to Improve Childhood Immunization Coverage Rates and Timeliness in Western Kenya.

ABSTRACT: BACKGROUND:Text message (short message service, SMS) reminders and incentives are two demand-side interventions that have been shown to improve health care-seeking behaviors by targeting participant characteristics such as forgetfulness, lack of knowledge, and transport costs. Applying these interventions to routine pediatric immunizations may improve vaccination coverage and timeliness. OBJECTIVE:The Mobile Solutions for Immunization (M-SIMU) trial aims to determine if text message reminders, either with or without mobile phone-based incentives, sent to infant's parents can improve immunization coverage and timeliness of routine pediatric vaccines in rural western Kenya. METHODS:This is a four-arm, cluster, randomized controlled trial. Villages are randomized to one of four study arms prior to enrollment of participants. The study arms are: (1) no intervention (a general health-related text message will be texted to this group at the time of enrollment), (2) text message reminders only, (3) text message reminders and a 75 Kenyan Shilling (KES) incentive, or (4) text message reminders and a KES200 incentive. Participants assigned to study arms 2-4 will receive two text message reminders; sent 3 days before and one day before the scheduled immunization visit at 6, 10, and 14 weeks for polio and pentavalent (containing diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenza type b antigens) type b antigens) vaccines, and at 9 months for measles vaccine. Participants in incentive arms will, in addition to text message reminders as above, receive mobile phone-based incentives after each timely vaccination, where timely is defined as vaccination within 2 weeks of the scheduled date for each of the four routine expanded program immunization (EPI) vaccination visits. Mother-infant pairs will be followed to 12 months of age where the primary outcome, a fully immunized child, will be ascertained. A fully immunized child is defined as a child receiving vaccines for bacille Calmette-Guerin, three doses of pentavalent and polio, and measles by 12 months of age. General estimating equation (GEE) models that account for clustering will be employed for primary outcome analyses. RESULTS:Enrollment was completed in October 2014. Twelve month follow-up visits to ascertain immunization status from the maternal and child health booklet were completed in February 2016. CONCLUSIONS:This is one of the first studies to examine the effect of text message reminders on immunization coverage and timeliness in a lower income country and is the first study to assess the effect of mobile money-based incentives to improve immunization coverage. TRIAL REGISTRATION:Clinicaltrials.gov NCT01878435; https://clinicaltrials.gov/ct2/show/NCT01878435 (Archived by WebCite at http://www.webcitation.org/6hQlwGYJR).

SUBMITTER: Gibson DG

PROVIDER: S-EPMC4887657 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature

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The Mobile Solutions for Immunization (M-SIMU) Trial: A Protocol for a Cluster Randomized Controlled Trial That Assesses the Impact of Mobile Phone Delivered Reminders and Travel Subsidies to Improve Childhood Immunization Coverage Rates and Timeliness in Western Kenya.

Gibson Dustin G DG Kagucia E Wangeci EW Ochieng Benard B Hariharan Nisha N Obor David D Moulton Lawrence H LH Winch Peter J PJ Levine Orin S OS Odhiambo Frank F O'Brien Katherine L KL Feikin Daniel R DR

JMIR research protocols 20160517 2

<h4>Background</h4>Text message (short message service, SMS) reminders and incentives are two demand-side interventions that have been shown to improve health care-seeking behaviors by targeting participant characteristics such as forgetfulness, lack of knowledge, and transport costs. Applying these interventions to routine pediatric immunizations may improve vaccination coverage and timeliness.<h4>Objective</h4>The Mobile Solutions for Immunization (M-SIMU) trial aims to determine if text messa ...[more]

PMID: 27189422

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Project description:BackgroundAs mobile phone access continues to expand globally, opportunities exist to leverage these technologies to support demand for immunisation services and improve vaccine coverage. We aimed to assess whether short message service (SMS) reminders and monetary incentives can improve immunisation uptake in Kenya.MethodsIn this cluster-randomised controlled trial, villages were randomly and evenly allocated to four groups: control, SMS only, SMS plus a 75 Kenya Shilling (KES) incentive, and SMS plus 200 KES (85 KES = USD$1). Caregivers were eligible if they had a child younger than 5 weeks who had not yet received a first dose of pentavalent vaccine. Participants in the intervention groups received SMS reminders before scheduled pentavalent and measles immunisation visits. Participants in incentive groups, additionally, received money if their child was timely immunised (immunisation within 2 weeks of the due date). Caregivers and interviewers were not masked. The proportion of fully immunised children (receiving BCG, three doses of polio vaccine, three doses of pentavalent vaccine, and measles vaccine) by 12 months of age constituted the primary outcome and was analysed with log-binomial regression and General Estimating Equations to account for correlation within clusters. This trial is registered with ClinicalTrials.gov, number NCT01878435.FindingsBetween Oct 14, 2013, and Oct 17, 2014, we enrolled 2018 caregivers and their infants from 152 villages into the following four groups: control (n=489), SMS only (n=476), SMS plus 75 KES (n=562), and SMS plus 200 KES (n=491). Overall, 1375 (86%) of 1600 children who were successfully followed up achieved the primary outcome, full immunisation by 12 months of age (296 [82%] of 360 control participants, 332 [86%] of 388 SMS only participants, 383 [86%] of 446 SMS plus 75 KES participants, and 364 [90%] of 406 SMS plus 200 KES participants). Children in the SMS plus 200 KES group were significantly more likely to achieve full immunisation at 12 months of age (relative risk 1·09, 95% CI 1·02-1·16, p=0·014) than children in the control group.InterpretationIn a setting with high baseline immunisation coverage levels, SMS reminders coupled with incentives significantly improved immunisation coverage and timeliness. Given that global immunisation coverage levels have stagnated around 85%, the use of incentives might be one option to reach the remaining 15%.FundingBill & Melinda Gates Foundation.

Project description:BackgroundImproved routine immunization (RI) coverage is recommended as the priority public health strategy to decrease vaccine-preventable diseases and eradicate polio in Pakistan and worldwide.ObjectiveThe objective of this study was to ascertain whether customized, automated, one-way text messaging (short message service, SMS) reminders delivered to caregivers via mobile phones when a child is due for an RI visit can improve vaccination uptake and timelines in Pakistan.MethodsThis was a randomized controlled trial, conducted in an urban squatter settlement area of Karachi, Pakistan. Infants less than 2 weeks of age with at least one family member who had a valid mobile phone connection and was comfortable receiving and reading SMS text messages were included. Participants were randomized to the intervention (standard care + one-way SMS reminder) or control (standard care) groups. The primary outcome was to compare the proportion of children immunized up to date at 18 weeks of age. Vaccine given at 6, 10, and 14 weeks schedule includes DPT-Hep-B-Hib vaccine (ie, diphtheria, pertussis, and tetanus; hepatitis B; and Haemophilus influenza type b) and oral poliovirus vaccine (OPV). Data were analyzed using chi-square tests of independence and tested for both per protocol (PP) and intention-to-treat (ITT) analyses.ResultsOut of those approached, 84.3% (300/356) of the participants were eligible for enrollment and 94.1% (318/338) of the participants had a working mobile phone. Only children in the PP analyses, who received an SMS reminder for vaccine uptake at 6 weeks visit, showed a statistically significant difference (96.0%, 86/90 vs 86.4%, 102/118; P=.03).The immunization coverage was consistently higher in the intervention group according to ITT analyses at the 6 weeks scheduled visit (76.0% vs 71.3%, P=.36). The 10 weeks scheduled visit (58.7% vs 52.7%, P=.30) and the 14 weeks scheduled visit (31.3% vs 26.0%, P=.31), however, were not statistically significant.ConclusionsAutomated simple one-way SMS reminders in local languages might be feasible for improving routine vaccination coverage. Whether one-way SMS reminders alone can have a strong impact on parental attitudes and behavior for improvement of RI coverage and timeliness needs to be further evaluated by better-powered studies and by comparing different types and content of text messages in low-and middle-income countries (LMICs).Trial registrationClinicalTrials.gov NCT01859546; https://clinicaltrials.gov/ct2/show/NCT01859546 (Archived by WebCite at http://www.webcitation.org/6xFr57AOc).

Project description:BACKGROUND:Vaccination is a cost-effective strategy for reducing morbidity and mortality among children under 5 years old. To be fully protected from diseases such as tuberculosis, diphtheria, pertussis, and polio, children must receive all recommended vaccinations in a timely manner. In many countries, including Tanzania, high overall vaccination rates mask substantial regional variation in vaccination coverage and low rates of vaccination timeliness. This study evaluates the efficacy of mobile phone-based (mHealth) reminders and incentives for improving vaccination timeliness in the first year of life. METHODS:The study, conducted in Mtwara Region in Tanzania, includes 400 late-stage pregnant women enrolled from rural and urban health facilities and surrounding communities. The primary outcome is timeliness of vaccinations among their children at 6, 10, and 14 weeks after birth. Timeliness is defined as vaccination receipt within 28 days after the vaccination due date. The quasi-randomized controlled trial includes three arms: (1) standard of care (no reminders or incentives), (2) mobile phone-based reminders, and (3) mobile phone-based reminders and incentives in the form of conditional financial transfers. Assignment into study arms is based on scheduled vaccination dates. Reminder messages are sent to arms 2 and 3 participants via mobile phones 1 week and 1 day prior to each scheduled vaccination. For arm 3 participants, reminder messages offer an incentive that is provided in the form of a mobile phone airtime recharge voucher code for each timely vaccination. Vaccination dates are recorded via participant contact with an mHealth system, phone calls with mothers, and a review of government-issued vaccination cards during an end-line survey. Random effects logistic regression models will be used to estimate the effects of reminders and incentives on the timeliness of vaccinations. DISCUSSION:The results will inform implementation science research on the effectiveness of reminders and incentives as a means of improving vaccination timeliness. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03252288 . Registered on 17 August 2017 (retrospectively registered).

Project description:BackgroundThis study is one of the first randomized controlled trials investigating cognitive behavioral therapy for insomnia (CBT-I) delivered by a fully automated mobile phone app. Such an app can potentially increase the accessibility of insomnia treatment for the 10% of people who have insomnia.ObjectiveThe objective of our study was to investigate the efficacy of CBT-I delivered via the Sleepcare mobile phone app, compared with a waitlist control group, in a randomized controlled trial.MethodsWe recruited participants in the Netherlands with relatively mild insomnia disorder. After answering an online pretest questionnaire, they were randomly assigned to the app (n=74) or the waitlist condition (n=77). The app packaged a sleep diary, a relaxation exercise, sleep restriction exercise, and sleep hygiene and education. The app was fully automated and adjusted itself to a participant's progress. Program duration was 6 to 7 weeks, after which participants received posttest measurements and a 3-month follow-up. The participants in the waitlist condition received the app after they completed the posttest questionnaire. The measurements consisted of questionnaires and 7-day online diaries. The questionnaires measured insomnia severity, dysfunctional beliefs about sleep, and anxiety and depression symptoms. The diary measured sleep variables such as sleep efficiency. We performed multilevel analyses to study the interaction effects between time and condition.ResultsThe results showed significant interaction effects (P<.01) favoring the app condition on the primary outcome measures of insomnia severity (d=-0.66) and sleep efficiency (d=0.71). Overall, these improvements were also retained in a 3-month follow-up.ConclusionsThis study demonstrated the efficacy of a fully automated mobile phone app in the treatment of relatively mild insomnia. The effects were in the range of what is found for Web-based treatment in general. This supports the applicability of such technical tools in the treatment of insomnia. Future work should examine the generalizability to a more diverse population. Furthermore, the separate components of such an app should be investigated. It remains to be seen how this app can best be integrated into the current health regimens.Trial registrationNetherlands Trial Register: NTR5560; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5560 (Archived by WebCite at http://www.webcitation.org/6noLaUdJ4).

Project description:Importance:Limited evidence supports mobile phone-delivered cessation interventions for socioeconomically disadvantaged individuals. Objective:To assess the efficacy of mobile phone-delivered cessation interventions targeted to smokers at neighborhood sites serving racial/ethnic minority and socioeconomically disadvantaged individuals. Design, Setting, and Participants:This group-randomized clinical trial with neighborhood site serving as the sampling unit compared smoking cessation interventions that included (1) nicotine replacement therapy (NRT), (2) NRT plus text messaging, and (3) NRT plus text messaging plus proactive counseling via mobile phone. Recruitment took place at churches, public housing complexes, and community centers located throughout the Houston, Texas, area. A total of 624 current cigarette smokers 18 years or older were enrolled at neighborhood sites from August 13, 2011, through December 12, 2014. Final follow-up was completed on June 12, 2015, and data were analyzed from August 17, 2017, through May 10, 2018, based on intention to treat. Interventions:Nicotine replacement therapy consisted of transdermal nicotine patches; NRT plus text messages, transdermal nicotine patches and individually tailored mobile phone text messages; and NRT plus text plus call, transdermal patches, individually tailored mobile phone text messages, and proactive counseling via mobile phone. Main Outcomes and Measures:The primary outcome was smoking abstinence at 6 months, defined as (1) biochemically verified smoking abstinence (calculated among a subgroup of 377 participants) as determined by saliva cotinine level; and (2) self-reported 30-day abstinence (calculated among all 624 participants). Results:The study sample included 624 current cigarette smokers (50.6% female; mean [SD] age, 45.8 [12.8] years). Among the 377 participants eligible for biochemical verification, 127 self-reported 30-day abstinence and were asked to provide saliva samples. Of these, 98 samples were returned (participants who did not return samples were coded as smoking). Biochemically verified abstinence rates were 12.0% for NRT, 12.0% for NRT plus text, and 25.5% for NRT plus text plus call. Participants in the NRT plus text plus call group were 2.11 (95% CI, 1.00-4.48) times more likely to be biochemically verified as abstinent compared with the NRT group. No differences in biochemically verified abstinence between the NRT plus text group and the NRT group were observed. Similar associations were observed with the self-report cessation outcomes. Conclusions and Relevance:Findings indicate that assignment to an intervention consisting of text messaging alone may not increase cessation rates for socioeconomically disadvantaged smokers. However, text messaging plus proactive counseling may be an efficacious option. Trial Registration:ClinicalTrials.gov identifier: NCT00948129.

Project description:BackgroundAdherence to treatment remains the cornerstone of long term viral suppression and successful treatment outcomes among patients receiving Antiretroviral Therapy (ART).Objective(s)Evaluate the effectiveness of mobile phone reminders and peer counseling in improving adherence and treatment outcomes among HIV positive patients on ART in Malaysia.MethodsA single-blind, parallel group RCT conducted in Hospital Sungai Buloh, Malaysia in which 242 adult Malaysian patients were randomized to intervention or control groups. Intervention consisted of a reminder module delivered through SMS and telephone call reminders by trained research assistants for 24 consecutive weeks (starting from date of ART initiation), in addition to adherence counseling at every clinic visit. The length of intended follow up for each patient was 6 months. Data on adherence behavior of patients was collected using specialized, pre-validated Adult AIDS Clinical Trial Group (AACTG) adherence questionnaires. Data on weight, clinical symptoms, CD4 count and viral load tests were also collected. Data was analyzed using SPSS version 22 and R software. Repeated measures ANOVA, Friedman's ANOVA and Multivariate regression models were used to evaluate efficacy of the intervention.ResultsThe response rate after 6 months follow up was 93%. There were no significant differences at baseline in gender, employment status, income distribution and residential location of respondents between the intervention and control group. After 6 months follow up, the mean adherence was significantly higher in the intervention group (95.7; 95% CI: 94.39-96.97) as compared to the control group (87.5; 95% CI: 86.14-88.81). The proportion of respondents who had Good (>95%) adherence was significantly higher in the intervention group (92.2%) compared to the control group (54.6%). A significantly lower frequency in missed appointments (14.0% vs 35.5%) (p = 0.001), lower viral load (p = 0.001), higher rise in CD4 count (p = 0.017), lower incidence of tuberculosis (p = 0.001) and OIs (p = 0.001) at 6 months follow up, was observed among patients in the intervention group.ConclusionMobile phone reminders (SMS and telephone call reminders) and peer counseling are effective in improving adherence and treatment outcomes among HIV positive patients on ART in Malaysia. These findings may be of potential benefit for collaborative adherence planning between patients and health care providers at ART commencement.

Project description:BackgroundGrowing evidence shows that fixed, nonpersonalized daily step goals can discourage individuals, resulting in unchanged or even reduced physical activity.ObjectiveThe aim of this randomized controlled trial (RCT) was to evaluate the efficacy of an automated mobile phone-based personalized and adaptive goal-setting intervention using machine learning as compared with an active control with steady daily step goals of 10,000.MethodsIn this 10-week RCT, 64 participants were recruited via email announcements and were required to attend an initial in-person session. The participants were randomized into either the intervention or active control group with a one-to-one ratio after a run-in period for data collection. A study-developed mobile phone app (which delivers daily step goals using push notifications and allows real-time physical activity monitoring) was installed on each participant's mobile phone, and participants were asked to keep their phone in a pocket throughout the entire day. Through the app, the intervention group received fully automated adaptively personalized daily step goals, and the control group received constant step goals of 10,000 steps per day. Daily step count was objectively measured by the study-developed mobile phone app.ResultsThe mean (SD) age of participants was 41.1 (11.3) years, and 83% (53/64) of participants were female. The baseline demographics between the 2 groups were similar (P>.05). Participants in the intervention group (n=34) had a decrease in mean (SD) daily step count of 390 (490) steps between run-in and 10 weeks, compared with a decrease of 1350 (420) steps among control participants (n=30; P=.03). The net difference in daily steps between the groups was 960 steps (95% CI 90-1830 steps). Both groups had a decrease in daily step count between run-in and 10 weeks because interventions were also provided during run-in and no natural baseline was collected.ConclusionsThe results showed the short-term efficacy of this intervention, which should be formally evaluated in a full-scale RCT with a longer follow-up period.Trial registrationClinicalTrials.gov: NCT02886871; https://clinicaltrials.gov/ct2/show/NCT02886871 (Archived by WebCite at http://www.webcitation.org/6wM1Be1Ng).

Dataset Information

The Mobile Solutions for Immunization (M-SIMU) Trial: A Protocol for a Cluster Randomized Controlled Trial That Assesses the Impact of Mobile Phone Delivered Reminders and Travel Subsidies to Improve Childhood Immunization Coverage Rates and Timeliness in Western Kenya.

Publications

The Mobile Solutions for Immunization (M-SIMU) Trial: A Protocol for a Cluster Randomized Controlled Trial That Assesses the Impact of Mobile Phone Delivered Reminders and Travel Subsidies to Improve Childhood Immunization Coverage Rates and Timeliness in Western Kenya.

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