Improving uptake of pediatric vaccines through religious conferences and mobile vaccine clinics in Aceh, Indonesia (TABRIE): study protocol for a stepped wedge cluster randomized controlled trial.
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| Název: | Improving uptake of pediatric vaccines through religious conferences and mobile vaccine clinics in Aceh, Indonesia (TABRIE): study protocol for a stepped wedge cluster randomized controlled trial. |
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| Autoři: | Ladhania R; Department of Health Management and Policy, School of Public Health, University of Michigan, Ann Arbor, MI, 48109, USA.; Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, MI, 48109, USA.; Center for Global Health Equity, Ann Arbor, MI, 48109, USA., Ichsan I; Department of Family Medicine, School of Medicine, Universitas Syiah Kuala, Banda Aceh, 23111, Indonesia.; Medical Research Unit, School of Medicine, Universitas Syiah Kuala, Banda Aceh, 23111, Indonesia.; Department of Microbiology, School of Medicine, Universitas Syiah Kuala, Banda Aceh, 23111, Indonesia.; Tsunami & Disaster Mitigation Research Center (TDMRC), Universitas Syiah Kuala, Banda Aceh, 23111, Indonesia., Koumpias AM; Department of Economics, University of Michigan, Dearborn, MI, 48128, USA., Yufika A; Department of Family Medicine, School of Medicine, Universitas Syiah Kuala, Banda Aceh, 23111, Indonesia., Indah R; Medical Education Unit, School of Medicine, Universitas Syiah Kuala, Banda Aceh, 23111, Indonesia., Liansyah TM; Department of Family Medicine, School of Medicine, Universitas Syiah Kuala, Banda Aceh, 23111, Indonesia.; Department of Pediatrics, School of Medicine, Universitas Syiah Kuala, Banda Aceh, 23111, Indonesia., Wagner AL; Center for Global Health Equity, Ann Arbor, MI, 48109, USA. awag@umich.edu.; Department of Epidemiology, School of Public Health, University of Michigan, Ann Arbor, MI, 48109, USA. awag@umich.edu., Harapan H; Center for Global Health Equity, Ann Arbor, MI, 48109, USA.; Medical Research Unit, School of Medicine, Universitas Syiah Kuala, Banda Aceh, 23111, Indonesia.; Department of Microbiology, School of Medicine, Universitas Syiah Kuala, Banda Aceh, 23111, Indonesia.; Tsunami & Disaster Mitigation Research Center (TDMRC), Universitas Syiah Kuala, Banda Aceh, 23111, Indonesia.; Tropical Disease Centre, Universitas Syiah Kuala, Banda Aceh, 23111, Indonesia. |
| Zdroj: | Trials [Trials] 2025 Nov 21; Vol. 26 (1), pp. 528. Date of Electronic Publication: 2025 Nov 21. |
| Způsob vydávání: | Journal Article; Clinical Trial Protocol |
| Jazyk: | English |
| Informace o časopise: | Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: [London] : BioMed Central, 2006- |
| Výrazy ze slovníku MeSH: | Parents*/psychology , Vaccination*/psychology , Vaccination*/statistics & numerical data , Vaccination Hesitancy*/psychology, Humans ; Indonesia ; Randomized Controlled Trials as Topic ; Health Knowledge, Attitudes, Practice ; Infant ; Child, Preschool ; Cross-Sectional Studies |
| Abstrakt: | Competing Interests: Ethics approval and consent to participate: The study has been approved by the University of Michigan Health Sciences and Behavioral Sciences Institutional Review Board (application HUM00235620) and the Komite Etik Penelitian Kesehatan at the Universitas Syiah Kuala (application 098/EA/FK/2023). Written, informed consent to participate will be obtained from all participants. Consent for publication: Not applicable. Competing interests: The authors declare that they have no competing interests. Background: Despite advancements in child immunization, inadequate immunization rates in low- and middle-income countries persist due to inadequate health infrastructure, challenges in vaccine supply and distribution, insufficient healthcare provider training, and low levels of community trust in vaccines. Aceh, a religiously conservative province in Indonesia, has low pediatric vaccination coverage and exemplifies the need for innovative vaccine delivery models. Evidence suggests interventions should target both logistical barriers (e.g., distance or clinic wait times) and societal factors, including misinformation, that contribute towards vaccine hesitancy. Methods: The trial "TABRIE" will measure the impact of two strategies on children's vaccination rates and parental attitudes towards vaccines in Banda Aceh and Aceh Besar, Indonesia, compared to current outreach strategies. The two strategies being tested are (a) an informational conference with religious leaders who work in specific clinics and (b) a mobile vaccine clinic staffed with community health workers conducting a variety of outreach events. We will execute a stepped wedge cluster randomized design with baseline measures and a cross-sectional sampling structure. Twelve districts (Kecamatan) will be randomized into one of the two strategies. In year 1, three districts from each strategy will implement the intervention, with the other three districts implementing the strategy in the second year. We will conduct cross-sectional surveys in September 2023 (baseline), September 2024 (year 1), and September 2025 (year 2). The primary outcome is the proportion of fully vaccinated children aged 1-5 years for bacillus Calmette-Guérin (BCG), diphtheria-tetanus-pertussis (DTP), polio, and measles. Secondary outcomes include the proportion of children aged 1-5 years with at least one dose of DTP and measles vaccines, the proportion of vaccine-hesitant parents, social norms surrounding vaccination, parental trust in community health workers to administer vaccines, the proportion of parents experiencing distance barriers to vaccination, the proportion of parents reporting that their religious leader encourages vaccination, and the proportion of parents receiving vaccination information from their religious leader. Discussion: This study will conduct a stepped wedge cluster randomized trial to separately estimate the effects of religious conferences and mobile vaccine clinics on pediatric vaccination rates and parental attitudes towards vaccination. It will offer a novel paradigm in vaccination delivery by inserting vaccination from clinics into social spaces that provide alternative, community-centered policy solutions to vaccine hesitancy. Trial Registration: ClinicalTrials.gov NCT06160999. Registered on December 14, 2023. (© 2025. The Author(s).) |
| References: | J Am Pharm Assoc (2003). 2019 Mar - Apr;59(2):228-231.e1. (PMID: 30578128) Am J Prev Med. 2021 Jan;60(1 Suppl 1):S44-S52. (PMID: 33189503) Vaccine. 2015 Aug 14;33(34):4161-4. (PMID: 25896383) BMC Health Serv Res. 2017 Sep 26;17(1):681. (PMID: 28950899) Stat Med. 2015 Jan 30;34(2):181-96. (PMID: 25346484) Prog Community Health Partnersh. 2016 Spring;10(1):19-30. (PMID: 27018351) Prev Sci. 2010 Jun;11(2):219-27. (PMID: 20049541) CMAJ. 2020 Aug 10;192(32):E901-E906. (PMID: 32778601) Prev Med Rep. 2021 Dec;24:101551. (PMID: 34522575) Vaccine. 2016 Feb 17;34(8):1018-24. (PMID: 26672676) Confl Health. 2020 Jan 30;14:4. (PMID: 32021649) |
| Contributed Indexing: | Keywords: Community health workers; Indonesia; Low- and middle-income countries; Mobile vaccine clinics; Public health intervention; Religious leader conferences; Religious leaders; Routine pediatric vaccination; Stepped wedge cluster randomized controlled trial; Vaccine hesitancy |
| Molecular Sequence: | ClinicalTrials.gov NCT06160999 |
| Entry Date(s): | Date Created: 20251122 Date Completed: 20251122 Latest Revision: 20251124 |
| Update Code: | 20251124 |
| PubMed Central ID: | PMC12639800 |
| DOI: | 10.1186/s13063-025-09170-5 |
| PMID: | 41272880 |
| Databáze: | MEDLINE |
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Nájsť tento článok vo Web of Science | Abstrakt: | Competing Interests: Ethics approval and consent to participate: The study has been approved by the University of Michigan Health Sciences and Behavioral Sciences Institutional Review Board (application HUM00235620) and the Komite Etik Penelitian Kesehatan at the Universitas Syiah Kuala (application 098/EA/FK/2023). Written, informed consent to participate will be obtained from all participants. Consent for publication: Not applicable. Competing interests: The authors declare that they have no competing interests.<br />Background: Despite advancements in child immunization, inadequate immunization rates in low- and middle-income countries persist due to inadequate health infrastructure, challenges in vaccine supply and distribution, insufficient healthcare provider training, and low levels of community trust in vaccines. Aceh, a religiously conservative province in Indonesia, has low pediatric vaccination coverage and exemplifies the need for innovative vaccine delivery models. Evidence suggests interventions should target both logistical barriers (e.g., distance or clinic wait times) and societal factors, including misinformation, that contribute towards vaccine hesitancy.<br />Methods: The trial "TABRIE" will measure the impact of two strategies on children's vaccination rates and parental attitudes towards vaccines in Banda Aceh and Aceh Besar, Indonesia, compared to current outreach strategies. The two strategies being tested are (a) an informational conference with religious leaders who work in specific clinics and (b) a mobile vaccine clinic staffed with community health workers conducting a variety of outreach events. We will execute a stepped wedge cluster randomized design with baseline measures and a cross-sectional sampling structure. Twelve districts (Kecamatan) will be randomized into one of the two strategies. In year 1, three districts from each strategy will implement the intervention, with the other three districts implementing the strategy in the second year. We will conduct cross-sectional surveys in September 2023 (baseline), September 2024 (year 1), and September 2025 (year 2). The primary outcome is the proportion of fully vaccinated children aged 1-5 years for bacillus Calmette-Guérin (BCG), diphtheria-tetanus-pertussis (DTP), polio, and measles. Secondary outcomes include the proportion of children aged 1-5 years with at least one dose of DTP and measles vaccines, the proportion of vaccine-hesitant parents, social norms surrounding vaccination, parental trust in community health workers to administer vaccines, the proportion of parents experiencing distance barriers to vaccination, the proportion of parents reporting that their religious leader encourages vaccination, and the proportion of parents receiving vaccination information from their religious leader.<br />Discussion: This study will conduct a stepped wedge cluster randomized trial to separately estimate the effects of religious conferences and mobile vaccine clinics on pediatric vaccination rates and parental attitudes towards vaccination. It will offer a novel paradigm in vaccination delivery by inserting vaccination from clinics into social spaces that provide alternative, community-centered policy solutions to vaccine hesitancy.<br />Trial Registration: ClinicalTrials.gov NCT06160999. Registered on December 14, 2023.<br /> (© 2025. The Author(s).) |
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| ISSN: | 1745-6215 |
| DOI: | 10.1186/s13063-025-09170-5 |