Media Orientation to Improve Childhood Vaccine Uptake and Address Parent and Caregivers Vaccine-related Anxiety: A Pilot Study

Официальное название

Media Campaign Intervention to Increase Childhood Immunisation Vaccine Uptake, Access and Reduce Vaccine Hesitancy for Parents/Caregivers With Children: A Pilot Randomised Controlled Trial

Обзор

Vaccine hesitancy-defined as delayed acceptance or refusal of vaccines despite availability-remains a significant barrier to childhood immunisation uptake in Nigeria, a country with high zero-dose unvaccinated children. Several factors limit vaccine uptake, including poor awareness, misinformation, fear, anxiety and a perceived sense of conspiracy. Yet, a gap exists to address this urgent problem. The proposed study seeks to pilot the feasibility and acceptability of a novel co-produced media campaign intervention called ASSURed awareness campaign to encourage childhood vaccine uptakE (ASSURE) with parent-caregivers who are not or partially up to date with their child's vaccination. The ASSURE intervention is designed to encourage vaccine uptake and access, reduce vaccine hesitancy whilst addressing vaccine-related anxiety. The ASSURE intervention is low-intensity, lasting approximately 3-5-minute designed to raise awareness of the need for vaccination uptake and its implications for children, including their development and well-being whist addressing vaccine related anxiety and fears. The proposed study is also to pilot and test the instrument to determine effectiveness and cost effectiveness including the mechanism on why the intervention might potentially work.

Вмешательства

• Поведенческое ASSURed awareness campaign to encourage childhood vaccine uptakE (ASSURE) intervention
  The media intervention is a low-intensity intervention lasting 3-5 minutes. The intervention is designed to promote awareness on the risk of vaccine hesitancy, its implication on the child wellbeing and health outcomes, the benefits of vaccination and immunisation and avenues or mediums for accessing childhood immunisation. The media intervention will also address anxiety associated with childhood vaccination and avenues for support. The recorded message introduction will commence with a welcome
• Поведенческое Intervention as usual
  Existing information provided by primary health care centre around childhood vaccination.

Первичные конечные точки

• Service Satisfaction Scale [Срок оценки: At the end of intervention (day 2)]

Вторичные конечные точки (7)

• Generalised Anxiety Disorder (GAD-7) [Срок оценки: Baseline (day 1) and at the end of intervention (day 2)]]
• Oxford Vaccine Hesitancy Scale [Срок оценки: Baseline (day 1) and at the end of intervention (day 2)]
• Oslo Social Support Scale (OSSS-3) [Срок оценки: Baseline (day 1) and at the end of intervention (day 2)]
• Vaccine Conspiracy Belief Scale [Срок оценки: Baseline (day 1) and at the end of intervention (day 2)]
• European Quality of Life Scale EQ-5D-5L [Срок оценки: (day 1) and at the end of intervention (day 2)]
• World Health Organization (WHO) Childhood Vaccine Hesitancy Scale [Срок оценки: (day 1) and at the end of intervention (day 2)]
• Cultural and religious belief scale about attitude towards childhood vaccine hesitancy [Срок оценки: Baseline (day 1) and at the end of intervention (day 2)]

Критерии участия

Критерии включения

• Parent or primary caregivers aged 18 years and above
• Whose child(ren) are not or partially up-to-date with childhood immunisation vaccination
• Able to provide full consent for their participation.
• Able to speak the English Language.
• Able to take part in the intervention and are available for the intervention assessment at baseline and end of intervention.

Критерии исключения

• Less than 18 years
• Parent or Career whose child(ren) are up-to-date with childhood immunisation vaccination
• Unable to consent.
• Currently undergoing severe mental health treatment.
• Unable to speak the English language .

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Kazungu JS, Adetifa IMO. Crude childhood vaccination coverage in West Africa: Trends and predictors of completeness. Wellcome Open Res. 2017 Feb 15;2:12. doi: 10.12688/wellcomeopenres.10690.1. PMID 28459105
• Gulumbe BH, Danlami MB, Yusuf AB, Shehu A, Chidiebere O. Vaccine hesitancy under the lens: Nigeria's struggle against the worst diphtheria outbreak in decades. Ther Adv Infect Dis. 2024 Mar 27;11:20499361241242218. doi: 10.1177/20499361241242218. eCollection 2024 Jan-Dec. PMID 38550914

Идентификаторы

NCT: NCT07510230 · 0000-0003-0516-0313I

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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