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 Inability to track children’s vaccination history coupled with parents’ lack of awareness of vaccination due dates compounds the problem of low immunization coverage and timeliness in developing countries. Traditional Reminder/Recall (RR) interventions such as paper-based immunization cards or mHealth based platforms do not yield optimal results in resource-constrained settings. There is thus a need for a low-cost intervention that can simultaneously stimulate demand and track immunization history to help reduce drop-outs and improve immunization coverage and timeliness. The objective of this study is to evaluate the impact of low-cost vaccine reminder and tracker bracelets for improving routine childhood immunization coverage and timeliness in Pakistani children under 2 years of age. Methods The study is an individually randomized, three-arm parallel Randomized Controlled Trial with two intervention groups and one control group. Infants in the two intervention groups will be given two different types of silicone bracelets at the time of recruitment, while infants in the control group will not receive any intervention. The two types of bracelets consist of symbols and/or numbers to denote the EPI vaccination schedule and each time the child will come for vaccination, the study staff will perforate a hole in the appropriate symbol to denote vaccine administration. Therefore, by looking at the bracelet, caregivers will be able to see how many vaccines have been received. Our primary outcome measure is the increase in coverage and timeliness of Pentavalent-3/PCV-3/Polio-3 and Measles-1 vaccine in the intervention versus control groups. A total of 1446 participants will be recruited from 4 Expanded Program on Immunization (EPI) centers in Landhi Town, Karachi. Each enrolled child will be followed up till the Measles-1 vaccine is administered, or till eleven months have elapsed since enrolment. Discussion Participant recruitment commenced on July 19, 2017, and was completed on October 10, 2017. Proposed duration of the study is 18 months and expected end date is December 1, 2018. This study constitutes one of the first attempts to rigorously evaluate an innovative, low-cost vaccine reminder bracelet. Trial registration ClinicalTrials.gov NCT03310762. Retrospectively Registered on October 16, 2017.

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Impact evaluation of a community engagement intervention in improving childhood immunization coverage: a cluster randomized controlled trial in Assam, India

BMC Public Health ◽

10.1186/s12889-018-5458-x ◽

2018 ◽

Vol 18 (1) ◽

Cited By ~ 2

Author(s):

Santanu Pramanik ◽

Arpita Ghosh ◽

Rituu B. Nanda ◽

Marlou de Rouw ◽

Philip Forth ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Community Engagement ◽

Impact Evaluation ◽

Controlled Trial ◽

Immunization Coverage ◽

Cluster Randomized Controlled Trial ◽

Childhood Immunization ◽

Randomized Controlled ◽

Cluster Randomized ◽

Engagement Intervention

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Text Message Reminders and Unconditional Monetary Incentives to Improve Measles Vaccination in Western Kenya: Study Protocol for the Mobile and Scalable Innovations for Measles Immunization Randomized Controlled Trial (Preprint)

10.2196/preprints.13221 ◽

2018 ◽

Author(s):

Dustin G Gibson ◽

E Wangeci Kagucia ◽

Joyce Were ◽

David Obor ◽

Kyla Hayford ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Mobile Phone ◽

Controlled Trial ◽

Text Message ◽

Immunization Coverage ◽

Western Kenya ◽

Mobile Money ◽

Randomized Controlled ◽

Sms Reminders ◽

Measles Vaccination

BACKGROUND Globally, 21 million children do not receive the measles vaccine each year. With high levels of mobile phone access and ownership, opportunities exist to leverage mobile health technologies to generate demand for immunization. OBJECTIVE The aim of the Mobile and Scalable Innovations for Measles Immunization trial is to determine if text message (short message service, SMS) reminders, either with or without mobile phone–based incentives, can improve measles immunization coverage and timeliness in rural western Kenya. METHODS This is a 3-arm, parallel, randomized controlled trial (RCT). Using simple randomization, caregivers in Siaya County, Kenya, will be randomized and evenly allocated to 1 of 3 study arms: (1) control, (2) SMS reminders only, and (3) SMS reminders plus a 150 Kenyan Shilling (KES) incentive. Participants assigned to the SMS group will be sent SMS reminders 3 days before and on the day before the measles immunization visit scheduled for when the child is 9 months of age. Participants in the incentive arm will, in addition to SMS reminders as above, be sent an unconditional 150 KES mobile-money incentive to their mobile phone 3 days before the child becomes 9 months of age. Children will be followed up to the age of 12 months to assess the primary outcome, a measles vaccination by 10 months of age. Log-binomial regressions will be used to calculate relative risks. RESULTS Enrollment was completed in March 2017. We enrolled 537 caregivers and their infants into the following groups: control (n=179), SMS reminders only (n=179), and SMS reminders plus 150 KES (n=179). Results will be made publicly available in 2020. CONCLUSIONS Few RCTs have examined the effect of text message reminders to improve measles immunization coverage. This is the first study to assess the effect of SMS reminders with and without unconditionally provided mobile-money incentives to improve measles immunization coverage. CLINICALTRIAL ClinicalTrials.gov NCT02904642; https://clinicaltrials.gov/ct2/show/NCT02904642 (Archived by WebCite® at http://www.webcitation.org/78r7AzD2X). INTERNATIONAL REGISTERED REPOR RR1-10.2196/13221

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Frequency of repositioning for preventing pressure ulcers in patients hospitalized in ICU: protocol of a cluster randomized controlled trial

BMC Nursing ◽

10.1186/s12912-021-00616-0 ◽

2021 ◽

Vol 20 (1) ◽

Author(s):

Olga L. Cortés ◽

Mauricio Herrera-Galindo ◽

Juan Carlos Villar ◽

Yudi A. Rojas ◽

María del Pilar Paipa ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Critical Care ◽

Pressure Ulcers ◽

Controlled Trial ◽

Cluster Randomized Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Link Type ◽

Cluster Randomized ◽

The Impact

Abstract Background Despite being considered preventable, ulcers due to pressure affect between 30 and 50% of patients at high and very high risk and susceptibility, especially those hospitalized under critical care. Despite a lack of evidence over the efficacy in prevention against ulcers due to pressure, hourly repositioning in critical care as an intervention is used with more or less frequency to alleviate pressure on patients’ tissues. This brings up the objective of our study, which is to evaluate the efficacy in prevention of ulcers due to pressure acquired during hospitalization, specifically regarding two frequency levels of repositioning or manual posture switching in adults hospitalized in different intensive care units in different Colombian hospitals. Methods A nurse-applied cluster randomized controlled trial of parallel groups (two branches), in which 22 eligible ICUs (each consisting of 150 patients), will be randomized to a high-frequency level repositioning intervention or to a conventional care (control group). Patients will be followed until their exit from each cluster. The primary result of this study is originated by regarding pressure ulcers using clusters (number of first ulcers per patient, at the early stage of progression, first one acquired after admission for 1000 days). The secondary results include evaluating the risk index on the patients’ level (Hazard ratio, 95% IC) and a description of repositioning complications. Two interim analyses will be performed through the course of this study. A statistical difference between the groups < 0.05 in the main outcome, the progression of ulcers due to pressure (best or worst outcome in the experimental group), will determine whether the study should be put to a halt/determine the termination of the study. Conclusion This study is innovative in its use of clusters to advance knowledge of the impact of repositioning as a prevention strategy against the appearance of ulcers caused by pressure in critical care patients. The resulting recommendations of this study can be used for future clinical practice guidelines in prevention and safety for patients at risk. Trial registration PENFUP phase-2 was Registered in Clinicaltrials.gov (NCT04604665) in October 2020.

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Seeing is believing: the impact of body-worn cameras on court outcomes, a cluster-randomized controlled trial in Miami Beach

Journal of Experimental Criminology ◽

10.1007/s11292-021-09479-6 ◽

2021 ◽

Author(s):

Kevin Petersen ◽

Alejandro Mouro ◽

Donald Papy ◽

Noel Castillo ◽

Barak Ariel

Keyword(s):

Domestic Violence ◽

Randomized Controlled Trial ◽

Police Officers ◽

Negative Binomial ◽

Controlled Trial ◽

Cluster Randomized Controlled Trial ◽

Randomized Controlled ◽

Early Results ◽

Cluster Randomized ◽

The Impact

Abstract Objectives To assess the effects of BWCs on prosecutorial and court-related charge outcomes across multiple crime types, including domestic violence charges, crimes committed against police officers, and drug/alcohol charges. Methods A cluster-randomized controlled trial with 22 spatiotemporal police units assigned to BWCs and 17 assigned to control conditions. Data from the State Attorney’s Office were used to track convictions, adjudication withheld dispositions, and declined prosecutions for both experimental and control charges. A series of multilevel logistic and negative binomial regression models were used to estimate the effect of BWC footage on charge outcomes. Outcomes BWCs led to a significantly higher proportion of crimes against police officers resulting in convictions or adjudication withheld outcomes, and a significantly higher proportion of domestic violence charges resulting in convictions alone, compared to control charges. However, after the clustering effect was taken into account, only the effect of BWCs on crimes against police officers remained statistically significant. Conclusion These early results suggest that BWCs have significant evidentiary value that varies by crime type. BWCs may be best suited to capture evidence of crimes committed against police officers and potentially in domestic violence offenses as well.

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