ASSURed awareness campaign to address parental hesitancy and encourage childhood vaccine uptakE in Nigeria: a pilot randomised controlled trial

Background Parental vaccine hesitancy is a prevalent global challenge, particularly in Nigeria, where many children remain zero-dose. Yet, a gap remains in testing the feasibility and acceptability of a co-produced ASSURed awareness campaign to encourage childhood vaccine uptakE (ASSURE) among parents who are not or partially up-to-date with their child’s vaccinations – representing the study’s primary aims. Method A mixed-methods randomised controlled trial (RCT) compared ASSURE with usual intervention alone among 74 parents recruited from Delta State, Nigeria, whose children were not or partially up to date with their vaccines. At baseline, 74 participants were recruited and randomised; however, four participants dropped out after the intervention, leaving 70 who completed the assessment at the end of the intervention. The ASSURE intervention is a 3-min media campaign designed to increase awareness of the risks of vaccine hesitancy, highlight the benefits of childhood vaccination, reduce vaccine-related anxiety, and provide information on accessing immunisation services. The primary outcome was feasibility, measured by participant recruitment and retention rates, while the intervention’s acceptability was measured by the Service Satisfaction Scale (SSS). For secondary outcomes, the study evaluated the intervention’s potential efficacy in addressing vaccine-related anxiety, measured using the Generalised Anxiety Disorder (GAD-7) scale and conspiracy beliefs about vaccines limiting uptake, measured using the World Health Organization-Childhood Vaccine Hesitancy Scale (WHO-CVHS). Outcomes were assessed at baseline and the End of the Intervention (EOI) using a survey-questionnaire. Results The Experimental Group (EG) ( n = 36) reported a high participant recruitment and retention rate of 97% at the end of the intervention, compared with 92% in the control group ( n = 34). In addition, EG reported higher satisfaction with SSS (75%) than the control group, where 26% reported satisfaction and 15% were unsure. Regarding the secondary outcomes, for GAD-7 scores, EG showed a potential reduction in anxiety from baseline to EOI compared to the control group, with differences at the end of intervention indicating −9.16 (−11.99 to −6.32) ( p < 0.001) compared to the baseline showing −1.675 (−4.09 to 0.748) ( p > 0.172). Regarding WHO-CVHS, the experimental group demonstrated some reductions in hesitancy from baseline to EOI compared with the control group, with reductions of −18.70 (−23.39 to −14.00) ( p < 0.001) at the end of intervention compared to −2.675 (−5.38 to 0.033) ( p > 0.053) at baseline. Conclusion The ASSURE intervention is feasible, acceptable and appropriate for addressing childhood vaccine hesitancy in Nigeria. Further adequately powered RCTs evaluating the intervention’s effectiveness and cost-effectiveness are recommended. Clinical trial registration https://clinicaltrials.gov/study/NCT07510230?term=NCT07510230&viewType=Card&rank=1 .