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Enhancing vaccine uptake is a critical public health challenge 1 . Overcoming vaccine hesitancy 2 , 3 and failure to follow through on vaccination intentions 3 requires effective communication strategies 3 , 4 . Here we present two sequential randomized controlled trials to test the effect of behavioural interventions on the uptake of COVID-19 vaccines. We designed text-based reminders that make vaccination salient and easy, and delivered them to participants drawn from a healthcare system one day (first randomized controlled trial) ( n  = 93,354 participants; clinicaltrials number NCT04800965) and eight days (second randomized controlled trial) ( n  = 67,092 individuals; clinicaltrials number NCT04801524) after they received a notification of vaccine eligibility. The first reminder boosted appointment and vaccination rates within the healthcare system by 6.07 (84%) and 3.57 (26%) percentage points, respectively; the second reminder increased those outcomes by 1.65 and 1.06 percentage points, respectively. The first reminder had a greater effect when it was designed to make participants feel ownership of the vaccine dose. However, we found no evidence that combining the first reminder with a video-based information intervention designed to address vaccine hesitancy heightened its effect. We performed online studies ( n  = 3,181 participants) to examine vaccination intentions, which revealed patterns that diverged from those of the first randomized controlled trial; this underscores the importance of pilot-testing interventions in the field. Our findings inform the design of behavioural nudges for promoting health decisions 5 , and highlight the value of making vaccination easy and inducing feelings of ownership over vaccines. Two randomized controlled trials demonstrate the ability of text-based behavioural ‘nudges’ to improve the uptake of COVID-19 vaccines, especially when designed to make participants feel ownership over their vaccine dose.

Five hundred thousand children under the age of 5 die from vaccine preventable diseases in India every year. More than just improving coverage, increasing timeliness of immunizations is critical to ensuring infant health in the first year of life. Novel, culturally appropriate community engagement strategies are worth exploring to close the immunization gap. In our study, a digital NFC (Near Field Communication) pendant worn on black thread and voice call reminder system was tested for the effectiveness in improving DTP3 adherence within 2 monthly camps from DTP1 administration. A cluster randomized controlled trial was conducted in which 96 village health camps were randomized to 3 arms: NFC sticker, NFC pendant, and NFC pendant with voice call reminder in local dialect. Randomization was done across 5 blocks in the Udaipur District serviced by Seva Mandir from August 2015 to April 2016. In terms of our three primary outcomes related to DTP3 adherence, point estimates show conflicting results. Two outcomes presented adherence in the control. DTP3 completion within two camps after DTP1 showed higher adherence in the Control (Sticker) (74.2%) arm compared to the Pendant (67.2%) and Pendant and Voice arms (69.3%). Likewise, the estimate for DTP3 completion within 180 days of birth in the Control (Sticker) (69.4%) arm was higher than estimates in the Pendant (57.4%) and Pendant and Voice arms (58.7%). However, one outcome displayed higher adherence in the intervention. DTP3 completion within two months from the time of registration was higher in the Pendant (37.7%) and Pendant and Voice arms (38.7%) compared to the Control (Sticker) arm (27.4%). In all primary outcomes, differences in adherence were statistically insignificant both before and after controlling for confounding factors. In terms of secondary outcomes, our results suggest that providing a necklace generated significant community discussion (H = 8.8796, df = 2, p = .0118), had strong satisfaction among users (χ2=26.039, df = 4, p < .0001), and resulted in increased visibility within families (grandmothers:χ2=34.023, df = 2, p < .0001, fathers: χ2=34.588, df = 2, p < .0001). Neither the NFC necklace nor the necklace with additional voice call reminders in the local dialect directly resulted in an increase in infant immunization timeliness through DTP3, the primary outcome. Still our process outcomes suggest that our culturally symbolic necklace has potential to be an assistive tool in immunization campaigns. Follow-on work will seek to examine whether positive behavior change towards vaccines can be fostered with earlier engagement of this platform beginning in the prenatal stage, under a continuum of care framework.

•In Cambodia, we assessed vaccine wastage-related vaccinator knowledge and practices.•Mean vaccine wastage rates were between 4 and 81%, varying substantially by vaccine type.•17% of providers administered measles-containing vaccine less frequently than other vaccines.•Vaccinators wait for at least 2 children before opening measles-containing vaccine.•Too much focus on reducing wastage leads to missed opportunities for vaccination. Missed opportunities for vaccination (MOV) can result in inadequate protection against disease. Although healthcare provider reluctance to open multi-dose, lyophilized vaccine vials (particularly the measles-containing vaccine [MCV]) for every eligible child due to concerns about wasting vaccine is a known reason for MOV, little is known about providers’ related attitudes and practices. In 100 randomly selected health facilities and 24 districts of Cambodia, we surveyed healthcare providers and their district supervisors regarding routine vaccine administration and wastage knowledge and practices, and child caregivers (five per facility) regarding MOV. Vaccine stock management data covering six months were reviewed to calculate facility and district level wastage rates and vaccine usage patterns for six vaccines, including a recently introduced second dose of MCV (MCV2). Response rates were 100/100 (100%) among facility staff, 48/48 (100%) among district staff, and 436/500 (87%) among caregivers. Mean facility-level wastage rates varied from 4% for single-dose diphtheria-tetanus-pertussis-hepatitis B-Haemophilus influenzae type b vaccine to 60% for 10-dose MCV; district-level wastage rates for all vaccines were 0%. Some vaccines had lower wastage rates in large facilities compared to small facilities. The mean MCV wastage rate was the same before and immediately after MCV2 introduction. Providers reported waiting for a mean of two children prior to opening an MCV vial, and 71% of providers reported offering MCV vaccination less frequently during scheduled vaccination sessions than other vaccines. Less than 5% of caregivers reported that their child had been turned away for vaccination, most frequently (65%) for MCV. Although the MCV wastage rate in our study was in line with national targets, providers reported waiting for more than one child before opening an MCV vial, contrary to vaccine management guidelines. Future research should explore the causal links between provider practices related to vaccine wastage and their impact on vaccination coverage.

Background The aim of this study was to assess the effectiveness of an EPI smartphone application (EPI app) on improving vaccination coverage in rural Sichuan Province, China. Methods This matched-pair cluster randomized controlled study included 32 village doctors, matched in 16 pairs, and took place from 2013 to 2015. Village doctors in the intervention group used the EPI app and reminder text messages while village doctors in the control group used their usual procedures and text messages. The primary outcome was full vaccination coverage with all five vaccines (1 dose of BCG, 3 doses of hepatitis B, 3 doses of OPV, 3 doses of DPT and 1 dose of measles vaccine), and the secondary outcome was coverage with each dose of the five individual vaccines. We also conducted qualitative interviews with village doctors to understand perceptions on using the EPI app and how this changed their vaccination work. Results The full vaccination coverage increased statistically significant from baseline to end-line in both the intervention (67 % [95 % CI:58-75 %] to 84 % [95 % CI:76-90 %], P  = 0.028) and control group (71 % [95 % CI:62-79 %] to 82 % [95 % CI:74-88 %], P  = 0.014). The intervention group had higher increase in full vaccination coverage from baseline to end-line compared to the control group (17 % vs 10 %), but this was not statistically significant ( P  = 0.164). Village doctors found it more convenient to use the EPI app to manage child vaccination and also reported saving time by looking up information of caregivers and contacting caregivers for overdue vaccinations quicker. However, village doctors found it hard to manage children who migrated out of the counties. Conclusions This study showed that an app and text messages can be used by village doctors to improve full vaccination coverage, though no significant increase in vaccination coverage was found when assessing the effect of the app on its own. Village doctors using EPI app reported having improved their working efficiency of managing childhood vaccination. Future studies should be conducted to evaluate the impact of more integrated approach of mHealth intervention on child immunization. Trial registration Chinese Clinical Trials Registry (ChiCTR): ChiCTR-TRC- 13003960 , registered on December 6, 2013.

Demographic and health surveys, immunization coverage surveys and administrative data often divergently estimate vaccination coverage, which hinders pinpointing districts where immunization services require strengthening. We assayed vaccination coverage in three regions in Ethiopia by coverage surveys and linked serosurveys. Households with children aged 12-23 (N = 300) or 6-8 months (N = 100) in each of three districts (woredas) were randomly selected for immunization coverage surveys (inspection of vaccination cards and immunization clinic records and maternal recall) and linked serosurveys. IgG-ELISA serologic biomarkers included tetanus antitoxin ≥ 0.15 IU/ml in toddlers (receipt of tetanus toxoid) and Haemophilus influenzae type b (Hib) anti-capsular titers ≥ 1.0 mcg/ml in infants (timely receipt of Hib vaccine). Coverage surveys enrolled 1,181 children across three woredas; 1,023 (87%) also enrolled in linked serosurveys. Administrative data over-estimated coverage compared to surveys, while maternal recall was unreliable. Serologic biomarkers documented a hierarchy among the districts. Biomarker measurement in infants provided insight on timeliness of vaccination not deducible from toddler results. Neither administrative projections, vaccination card or EPI register inspections, nor parental recall, substitute for objective serological biomarker measurement. Including infants in serosurveys informs on vaccination timeliness.

Background High retention (follow-up) rates improve the validity and statistical power of outcomes in longitudinal studies and the effectiveness of programs with prolonged administration of interventions. We assessed participant retention in a potential HIV vaccine trials population of fishing communities along Lake Victoria, Uganda. Methods In a community-based individual randomized trial, 662 participants aged 15–49 years were randomized to either mobile phone or physical contact tracing reminders and followed up at months 1, 2, 3, 6, 12 and 18 post-enrolment. The visit schedules aimed at mimicking a vaccine efficacy trial representing an early interval (months 1–6) where most vaccinations would be administered and a later period of post-vaccination follow-up. The primary outcome was retention measured as the proportion of post-baseline follow up visits completed by a participant. Retention was estimated in early and later follow-up intervals, and overall for all the six follow-up visits. Adjusted differences in retention between the study arms were determined by multivariable logistic regression using Stata® 14. One participant was later dropped from the analysis because of age ineligibility discovered after enrolment. Results Of the expected total follow up visits of 3966 among 661 participants, 84.1% (3334) were attained; 82.1% (1626/1980) in the phone arm and 86% (1708/1986) in the physical tracing arm ( p  = 0.001). No statistically significant differences in retention were observed between the study arms in the first 6 months but thereafter, retention was significantly higher for physical contact reminders than mobile phones; 91.5% versus 82.1% ( p  < 0.0001) at month 12 and 82.8% versus 75.4%, ( p  = 0.021) at month 18. Controlling for sex, age, education, occupation, community location, length of stay and marital status, the odds of good retention (completing 5 out of 6 follow-up visits) were 1.56 (95% CI;1.08–2.26, p  = 0.018) for physical contact tracing compared to mobile phone tracing. Other statistically significant predictors of good retention were residing on islands and having stayed in the fishing communities for 5 or more years. Conclusions Among fishing communities of Lake Victoria, Uganda, 84% of follow-up visits can be attained and participant retention is higher using physical contact reminders than mobile phones. Trial registration number PACTR201311000696101 ( http://www.pactr.org/ ). retrospectively registered on 05 November, 2013.

Administration of 1/5th dose of Inactivated poliovirus vaccine intradermally (fIPV) provides similar immune response as full-dose intramuscular IPV, however, fIPV administration with BCG needle and syringe (BCG NS) is technically difficult. We compared immune response after one fIPV dose administered with BCG NS to administration with intradermal devices, referred to as Device A and B; and assessed feasibility of conducting a door-to-door vaccination campaign with fIPV. In Phase I, 452 children 6–12months old from Karachi were randomized to receive one fIPV dose either with BCG NS, Device A or Device B in a health facility. Immune response was defined as seroconversion or fourfold rise in polio neutralizing antibody titer 28days after fIPV among children whose baseline titer ≤362. In Phase II, fIPV was administered during one-day door-to-door campaign to assess programmatic feasibility by evaluating vaccinators’ experience. For all three poliovirus (PV) serotypes, the immune response after BCG NS and Device A was similar, however it was lower with Device B (34/44 (77%), 31/45 (69%), 16/30 (53%) respectively for PV1; 53/78 (68%), 61/83 (74%), 42/80 (53%) for PV2; and; 58/76 (76%), 56/80 (70%), 43/77 (56%) for PV3; p<0.05 for all three serotypes). Vaccinators reported problems filling Device B in both Phases; no other operational challenges were reported during Phase II. Use of fIPV offers a dose-saving alternative to full-dose IPV.

Objectives(1) To develop methods for conducting cluster randomised trials of text messaging interventions utilising routine electronic health records at low cost; (2) to assess the effectiveness of text messaging influenza vaccine reminders in increasing vaccine uptake in patients with chronic conditions.DesignCluster randomised trial with general practices as clusters.SettingEnglish primary care.Participants156 general practices, who used text messaging software, who had not previously used text message influenza vaccination reminders. Eligible patients were aged 18–64 in ‘at-risk’ groups.InterventionsPractices were randomly allocated to either an intervention or standard care arm in the 2013 influenza season (September to December). Practices in the intervention arm were asked to send a text message influenza vaccination reminder to their at-risk patients under 65. Practices in the standard care arm were asked to continue their influenza campaign as planned.BlindingPractices were not blinded. Analysis was performed blinded to practice allocation.Main outcome measuresPractice-level influenza vaccine uptake among at-risk patients aged 18–64 years.Results77 practices were randomised to the intervention group (76 analysed, n at-risk patients=51 121), 79 to the standard care group (79 analysed, n at-risk patients=51 136). The text message increased absolute vaccine uptake by 2.62% (95% CI −0.09% to 5.33%), p=0.058, though this could have been due to chance. Within intervention clusters, a median 21.0% (IQR 10.2% to 47.0%) of eligible patients were sent a text message. The number needed to treat was 7.0 (95% CI −0.29 to 14.3).ConclusionsPatient follow-up using routine electronic health records is a low cost method of conducting cluster randomised trials. Text messaging reminders are likely to result in modest improvements in influenza vaccine uptake, but levels of patients being texted need to markedly increase if text messaging reminders are to have much effect.Trial registration numberISRCTN48840025.

Background Although good progress has been achieved in expanding immunization of children in China, disparities exist across different provinces. Information gaps both from the service supply and demand sides hinder timely vaccination of children in rural areas. The rapid development of mobile health technology (mHealth) provides unprecedented opportunities for improving health services and reaching underserved populations. However, there is a lack of literature that rigorously evaluates the impact of mHealth interventions on immunization coverage as well as the usability and feasibility of smart phone applications (apps). This study aims to assess the effectiveness of a smart phone-based app (Expanded Program on Immunization app, or EPI app) on improving the coverage of children’s immunization. Methods/Design This cluster randomized trial will take place in Xuanhan County, Sichuan Province, China. Functionalities of the app include the following: to make appointments automatically, record and update children’s immunization information, generate a list of children who missed their vaccination appointments, and send health education information to village doctors. After pairing, 36 villages will be randomly allocated to the intervention arm (n = 18) and control arm (n = 18). The village doctors in the intervention arm will use the app while the village doctors in the control arm will record and manage immunization in the usual way in their catchment areas. A household survey will be used at baseline and at endline (8 months of implementation). The primary outcome is full-dose coverage and the secondary outcome is immunization coverage of the five vaccines that are included in the national Expanded Program on Immunization program as well as Hib vaccine, Rotavirus vaccine and Pneumococcal conjugate vaccine. Multidimensional evaluation of the app will also be conducted to assess usability and feasibility. Discussion This study is the first to evaluate the effectiveness of a smart phone app for child immunization in rural China. This study will contribute to the knowledge about the usability and feasibility of a smart phone app for managing immunization in rural China and to similar populations in different settings. Trial registration Chinese Clinical Trials Registry (ChiCTR): ChiCTR-TRC-13003960

Background After childbirth, most women do not lose the extra weight gained during pregnancy. This is important because postnatal weight retention contributes to the development of obesity in later life. Research shows that postnatal women living with overweight would prefer to weigh less, are interested in implementing weight loss strategies, and would like support. Without evidence for the benefit of weight management interventions during pregnancy, postnatal interventions are increasingly important. Research has focused on intensive weight loss programmes, which cannot be offered to all postnatal women. Instead, we investigated the feasibility of a brief intervention delivered to postnatal women at child immunisation appointments. This qualitative study explored the views of women who received the intervention and healthcare professionals who delivered it. Methods The intervention was delivered within the context of the national child immunisation programme. The intervention group were offered brief support encouraging self-management of weight when attending general practices to have their child immunised at two, three and four months of age. The intervention involved motivation and support from practice nurses to encourage women to make healthier lifestyle choices through self-monitoring of weight and signposting to an online weight management programme. Nurses provided external accountability for weight loss. Women were asked to weigh themselves weekly and record this on a weight record card. Nested within this trial, semi-structured interviews explored the experiences of postnatal women who received the intervention and nurses who delivered it. Results The intervention was generally acceptable to participants and child immunisation appointments considered a suitable intervention setting. Nurses were hesitant to discuss maternal weight, viewing the postnatal period as a vulnerable time. Whilst some caveats to implementation were discussed by nurses, they felt the intervention was easy to deliver and would motivate postnatal women to lose weight. Conclusions Participants were keen to lose weight after childbirth. Overall, they reported that the intervention was acceptable, convenient, and, appreciated support to lose weight after childbirth. Although nurses, expressed concerns about raising the topic of weight in the early postnatal period, they felt the intervention was easy to deliver and would help to motivate women to lose weight.