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Vaccination is a cost-effective public health intervention, yet evidence abounds that vaccination uptake is still poor in many low- and middle-income countries. Traditional and Religious Leaders play a substantial role in improving the uptake of health services such as immunization. However, there is paucity of evidence on the cost-effectiveness of using such strategies. This study aimed to assess the cost-effectiveness of using a multi-faceted intervention that included traditional and religious leaders for community engagement to improve uptake of routine immunisation services in communities in Cross River State, Southern Nigeria. The target population for the intervention was traditional and religious leaders in randomly selected communities in Cross River State. The impact of the intervention on the uptake of routine vaccination among children 0 to 23 months was assessed using a cluster randomized trials. Outcome assessments were performed at the end of the project (36 months).The cost of the intervention was obtained from the accounting records for expenditures incurred in the course of implementing the intervention. Costs were assessed from the health provider perspective. The cost-effectiveness analysis showed that the incremental cost of the initial implementation of the intervention was US $19,357and that the incremental effect was 323 measles cases averted, resulting in an incremental cost-effectiveness ratio (ICER) of US$ 60/measles case averted. However, for subsequent scale-up of the interventions to new areas not requiring a repeat expenditure of some of the initial capital expenditure the ICER was estimated to be US$34 per measles case averted. Involving the traditional and religious leaders in vaccination is a cost-effective strategy for improving the uptake of childhood routine vaccinations.

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.

Background Monitoring of the expanded program on immunization’s performance is not only limited to routine periodic reports but equally includes surveys. Based on unpublished national EPI surveillance data from the past 5 years in Cameroon, the Foumban health district has reported a high number of vaccine preventable disease suspected cases. Contradictory information on the immunization coverage in this district exists from both administrative data and published literature. As a result, the objective of this study was to estimate the immunization coverage and dropout rate in age group 12–23 months and timeliness in age group 0–59 months among children in Foumban Health District (Cameroon), in 2018. Method This was a descriptive cross-sectional study targeting randomly selected children aged 0–59 months from Foumban health district. Data were collected by trained and supervised surveyors using a pretested questionnaire to describe the immunization coverage, timeliness and dropout rate in eighty clusters of about thirty buildings selected by stratified random sampling in July 2018. Results In total, 80 clusters covering 2121 buildings were selected and all were reached (100%). A total of 1549 (81.2%) households accepted to participate in the survey and 1430 children aged 0–59 months including 294 (20.6%) aged 12–23 months were enrolled into the study. Of these 1430 children, 427 [29.9 (27.4–32.2)%] aged 0–59 months were vaccinated with evidence. In the age group 12–23 months, the immunization coverage with evidence of BCG, DPT-Hi + Hb 3 and measles/rubella were 28.6(23.4–33.9)%, 22.8 (18.1–27.6)% and 14.3 (10.3–18.1)% respectively. Within age group 0–59 months; the proportion of children who missed their vaccination appointments increased from 23.3 to 31.7% for the vaccine planned at birth (BCG) and last vaccine planned (Measles/Rubella) for the EPI program respectively. In age group 12–23 months; the specific (DPT-Hi + Hb1–3) and general (BCG-Measles/Rubella) dropout rates of vaccination with evidence were 14.1 and 50.0% respectively. Conclusion Documented immunization coverage, dropout rate and timeliness in Foumban Health district are lower than that targeted by the Cameroon EPI. Competent health authorities have to take necessary actions to ensure the implementation of national guidelines with regards to children access to immunization. Also, studies have to be conducted to identify determinants of low immunization coverage and delays in immunization schedules as well as high dropout rates.

State health departments commonly use quality improvement coaching as an implementation strategy for improving low human papillomavirus (HPV) vaccination coverage, but such coaching can be resource intensive. To explore opportunities for improving efficiency, we compared in-person and webinar delivery of coaching sessions on implementation outcomes, including reach, acceptability, and delivery cost. In 2015, we randomly assigned 148 high-volume primary care clinics in Illinois, Michigan, and Washington State to receive either in-person or webinar coaching. Coaching sessions lasted about 1 hr and used our Immunization Report Card to facilitate assessment and feedback. Clinics served over 213,000 patients ages 11-17. We used provider surveys and delivery cost assessment to collect implementation data. This report is focused exclusively on the implementation aspects of the intervention. More providers attended in-person than webinar coaching sessions (mean 9 vs. 5 providers per clinic, respectively, p = .004). More providers shared the Immunization Report Card at clinic staff meetings in the in-person than webinar arm (49% vs. 20%; p = .029). In both arms, providers' belief that their clinics' HPV vaccination coverage was too low increased, as did their self-efficacy to help their clinics improve (p < .05). Providers rated coaching sessions in the two arms equally highly on acceptability. Delivery cost per clinic was$733 for in-person coaching versus $ 461 for webinar coaching. In-person and webinar coaching were well received and yielded improvements in provider beliefs and self-efficacy regarding HPV vaccine quality improvement. In summary, in-person coaching cost more than webinar coaching per clinic reached, but reached more providers. Further implementation research is needed to understand how and for whom webinar coaching may be appropriate. Keywords HPV vaccine, Immunization programs, Quality improvement coaching, Primary care, State health departments, Assessment and feedback

Background To improve immunization coverage, most interventions that are part of the national immunization program in India address supply-side challenges. But, there is growing evidence that addressing demand-side factors can potentially contribute to improvement in childhood vaccination coverage in low- and middle-income countries. Participatory engagement of communities can address demand-side barriers while also mobilizing the community to advocate for better service delivery. The objective of this study is to evaluate the impact of a novel community engagement approach in improving immunization coverage. In our proposed intervention, we go a step beyond merely engaging the community and strive towards increasing ‘ownership’ by the communities. Methods/Design We adopt a cluster randomized design with two groups to evaluate the intervention in Assam, a state in the northeast region of India. To recruit villages and participants at baseline, we used a two-stage stratified random sampling method. We stratified villages; our unit of randomization, based on census data and randomly selected villages from each of the four strata. At the second-stage, we selected random sub-sample of eligible households (having children in the age group of 6–23 months) from each selected village. The study uses a repeated cross sectional design where we track the same sampled villages but draw independent random samples of households at baseline and endline. Total number of villages required for the study is 180 with 15 eligible HHs from each village. Post-baseline survey, we adopt a stratified randomization strategy to achieve better balance in intervention and control groups, leveraging information from the extensive baseline survey. Discussion The proposed intervention can help identify barriers to vaccination at the local level and potentially lead to more sustainable solutions over the long term. Our sampling design, sample size calculation, and randomization strategy address internal validity of our evaluation design. We believe that it would allow us to causally relate any observed changes in immunization coverage to the intervention. Trial registration The trial has been registered on 7th February, 2017 under the Clinical Trials Registry- India (CTRI), hosted at the ICMR’s National Institute of Medical Statistics, having registration number CTRI/2017/02/007792 . This is the original study protocol.

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.

Background Measles and oral polio vaccinations may reduce child mortality to an extent that cannot be explained by prevention of measles and polio infections; these vaccines seem to have beneficial non-specific effects. In the last decades, billions of children worldwide have received measles vaccine (MV) and oral polio vaccine (OPV) through campaigns. Meanwhile the under-five child mortality has declined. Past MV and OPV campaigns may have contributed to this decline, even in the absence of measles and polio infections. However, cessation of these campaigns, once their targeted infections are eradicated, may reverse the decline in the under-five child mortality. No randomized trial has assessed the real-life effect of either campaign on child mortality and morbidity. We present the research protocol of two concurrent trials: RECAMP-MV and RECAMP-OPV. Methods Both trials are cluster-randomized trials among children registered in Bandim Health Project’s rural health and demographic surveillance system throughout Guinea-Bissau. RECAMP-MV is conducted among children aged 9–59 months and RECAMP-OPV is conducted among children aged 0–8 months. We randomized 222 geographical clusters to intervention or control clusters. In intervention clusters, children are offered MV or OPV (according to age at enrolment) and a health check-up. In control clusters, children are offered only a health check-up. Enrolments began in November 2016 (RECAMP-MV) and March 2017 (RECAMP-OPV). We plan 18,000 enrolments for RECAMP-MV with an average follow-up period of 18 months and 10,000 enrolments for RECAMP-OPV with an average follow-up period of 10 months. Data collection is ongoing. The primary outcome in both trials is non-accidental death or non-accidental first non-fatal hospitalization with overnight stay (composite outcome). Secondary outcomes are: non-accidental death, repeated non-fatal hospitalizations with overnight stay, cause-specific primary outcome, outpatient visit, and illness. We obtained ethical approval from Guinea-Bissau and consultative approval from Denmark. Discussion Cluster randomization and minimum risk of loss to follow-up are strengths, and no placebo a limitation. Our trials challenge the understanding that MV and OPV only prevent measles and polio, and that once both infections are eradicated, campaigns with MV and OPV can be phased out without negative implications on child health and survival. Trial registration NCT03460002 .

Background Immunization quality improvement programs are often limited by the cost and inconvenience associated with delivering face-to-face consultations to primary care providers. To investigate a more efficient mode of intervention delivery, we conducted a process evaluation that compared in-person consultations to those delivered via interactive webinar. Methods The Centers for Disease Control and Prevention’s Assessment, Feedback, Incentives, and eXchange (AFIX) Program is an immunization quality improvement program implemented in all 50 states. In 2011, we randomly assigned 61 high-volume primary care clinics in North Carolina to receive an in-person or webinar AFIX consultation focused on adolescent immunization. We used surveys of participating vaccine providers and expense tracking logs to evaluate delivery modes on participation, satisfaction, and cost. Clinics served 71,874 patients, ages 11 to 18. Results Clinics that received in-person and webinar consultations reported similar levels of participation on key programmatic activities with one exception: more webinar clinics reported improving documentation of previously administered, ‘historical’ vaccine doses. Both in-person and webinar clinics showed sustained improvement in confidence to use reminder/recall systems (both p  < 0.05). Participants rated delivery modes equally highly on satisfaction measures such as convenience (mean = 4.6 of 5.0). Delivery cost per clinic was $152 for in-person consultations versus $100 for webinar consultations. Conclusions In-person and webinar delivery modes were both well received, but webinar AFIX consultations cost substantially less. Interactive webinar delivery shows promise for considerably extending the reach of immunization quality improvement programs. Trial registration Clinicaltrials.gov, NCT01544764

Objective To determine whether integrating family planning (FP) messages and referrals into facility-based, child immunization services increase contraceptive uptake in the 9- to 12-month post-partum period. MethodsꈸA cluster-randomized trial was used to test an intervention where vaccinators were trained to provide individualized FP messages and referrals to women presenting their child for immunization services. In each of 2 countries, Ghana and Zambia, 10 public sector health facilities were randomized to control or intervention groups. Shortly after the introduction of the intervention, exit interviews were conducted with women 9-12 months postpartum to assess contraceptive use and related factors before and after the introduction of the intervention. In total, there were 8892 participants (Control Group Ghana, 1634; Intervention Group Ghana, 1129; Control Group Zambia, 3751; Intervention Group Zambia, 2468). Intervention effects were evaluated using logistic mixed models that accounted for clustering in data. In addition, in-depth interviews were conducted with vaccinators, and a process assessment was completed mid-way through the implementation of the intervention. Results In both countries, there was no significant effect on non-condom FP method use (Zambia, P = 0.56 and Ghana, P = 0.86). Reported referrals to FP services did not improve nor did women's knowledge of factors related to return of fecundity. Some providers reported having made modifications to the intervention; they generally provided FP information in group talks and not individually as they had been trained to do. Conclusion Rigorous evidence of the success of integrated immunization services in resource poor settings remains weak.

•A cluster randomized trial improved influenza vaccine uptake over secular trends.•Early receipt of vaccine enabled practices to lengthen the vaccination season.•Preseason in-service is an easy strategy for improving influenza vaccination uptake.•Immunization champions help practices maintain motivation to increase vaccination. To increase childhood influenza vaccination rates using a toolkit and early vaccine delivery in a randomized cluster trial. Twenty primary care practices treating children (range for n=536–8183) were randomly assigned to Intervention and Control arms to test the effectiveness of an evidence-based practice improvement toolkit (4 Pillars Toolkit) and early vaccine supplies for use among disadvantaged children on influenza vaccination rates among children 6 months–18 years. Follow-up staff meetings and surveys were used to assess use and acceptability of the intervention strategies in the Intervention arm. Rates for the 2010–2011 and 2011–2012 influenza seasons were compared. Two-level generalized linear mixed modeling was used to evaluate outcomes. Overall increases in influenza vaccination rates were significantly greater in the Intervention arm (7.9 percentage points) compared with the Control arm (4.4 percentage points; P<0.034). These rate changes represent 4522 additional doses in the Intervention arm vs. 1390 additional doses in the Control arm. This effect of the intervention was observed despite the fact that rates increased significantly in both arms – 8/10 Intervention (all P<0.001) and 7/10 Control sites (P-values=0.04 to <0.001). Rates in two Intervention sites with pre-intervention vaccination rates >58% did not significantly increase. In regression analyses, a child's likelihood of being vaccinated was significantly higher with: younger age, white race (Odds ratio [OR]=1.29; 95% confidence interval [CI]=1.23–1.34), having commercial insurance (OR=1.30; 95%CI=1.25–1.35), higher pre-intervention practice vaccination rate (OR=1.25; 95%CI=1.16–1.34), and being in the Intervention arm (OR=1.23; 95%CI=1.01–1.50). Early delivery of influenza vaccine was rated by Intervention practices as an effective strategy for raising rates. Implementation of a multi-strategy toolkit and early vaccine supplies can significantly improve influenza vaccination rates among children in primary care practices but the effect may be less pronounced in practices with moderate to high existing vaccination rates. Clinical trial registry name/number: From Innovation to Solutions: Childhood Influenza/NCT01664793.