NCT04042246

Brief Summary

Child immunization is not a one-time behavior; rather, it is a repeated behavior within a specific timeframe. Not only the low immunization, but also the dropout of immunization and the delayed immunization from the recommended immunization schedule are prevalent and high in Africa. The most common reason for the incomplete vaccination is that caregivers thought the children had already been fully immunized (44.8%), according to Nigeria Multiple Indicator Cluster Survey (MICS) conducted in 2016/2017. Caregivers' misconception of the complete immunization can be attributed to the complicated immunization schedule. In Nigeria, infants are supposed to receive 9 different types of vaccines at 5 different times within the first year since the births. To make things more complicated, the vaccine schedule changes over time; for example in Nigeria, the new vaccine, inactivated polio vaccine (IPV) was introduced in 2015 to be received at 14 weeks after births, and rotavirus vaccine and meningococcal A vaccine are scheduled for the introduction in 2019. In this complicated and rapidly-changing environment regarding vaccination schedule, the goal of the study is to improve the understanding of vaccination completion and children's vaccination status among caregivers, which can then lead to the improved rate of full vaccination among children. Objectives The main objectives of this study are to understand the impact of providing the general and tailored information on the vaccination schedule and vaccination status of women's children on the vaccine take-up. In this study, the investigators focus on women who has a child who is 12 months old or younger. Hypothesis The main hypothesis of this proposed study are as follows:

  1. 1.Information on vaccination among caregivers: the general and tailored information on vaccination schedule and child's vaccination status, improves the knowledge on benefit and understanding of vaccination completion, vaccination schedule and the vaccination status of the children among caregivers
  2. 2.Full immunization rate: through the improved knowledge level on the concept of vaccination completion and their children's vaccination status, the proposed study increases the full immunization rate among children

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

September 15, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2020

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

5 months

First QC Date

July 29, 2019

Last Update Submit

July 11, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Number of participants who have the accurate knowledge level of vaccination, as assessed by survey questionnaire

    The investigators will collect the information on respondents' knowledge on vaccination through surveys. The knowledge level is calculated from 5 questions: 1) the number of type of vaccines a child needs to receive before 12 months old, 2) the number of times a child needs to receive Pentavalent vaccine, 3) the last month when a child needs to receive Pentavalent vaccine, 4) the timing when a child needs to receive BCG vaccine, and 5) the number of clinic visits (at minimum) a child needs to make for complete vaccination. For each question, the score is 0 if wrong, or 1 if correct. The knowledge level scale ranges from 0 to 5, which is the total number of correct answers.

    2 weeks

  • Number of participants who bring their children for the full vaccination, as assessed by the follow-up tracking survey at health clinics

    The investigators will collect the information on the actual vaccination status among respondents' children

    9 months

Study Arms (2)

Control

NO INTERVENTION

No intervention is implemented among Control

Treatment (Educational Information on Vaccination)

EXPERIMENTAL

Provide general and tailored information on vaccination and vaccination schedule at the end of the baseline survey

Behavioral: Information Provision

Interventions

Provide the information on the importance of the vaccination and tailored vaccination schedule

Treatment (Educational Information on Vaccination)

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • women with a child 12 months old or younger

You may not qualify if:

  • exclude women who do not have a child 12 months or younger

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jada Local Government Primary Health Care Development Agency

Jada, Adamawa, Nigeria

Location

Related Publications (12)

  • Bolu O, Nnadi C, Damisa E, Braka F, Siddique A, Archer WR, Bammeke P, Banda R, Higgins J, Edukugo A, Nganda GW, Forbi JC, Liu H, Gidado S, Soghaier M, Franka R, Waziri N, Burns CC, Vertefeuille J, Wiesen E, Adamu U. Progress Toward Poliomyelitis Eradication - Nigeria, January-December 2017. MMWR Morb Mortal Wkly Rep. 2018 Mar 2;67(8):253-256. doi: 10.15585/mmwr.mm6708a5.

    PMID: 29494568BACKGROUND
  • Feldstein LR, Mariat S, Gacic-Dobo M, Diallo MS, Conklin LM, Wallace AS. Global Routine Vaccination Coverage, 2016. MMWR Morb Mortal Wkly Rep. 2017 Nov 17;66(45):1252-1255. doi: 10.15585/mmwr.mm6645a3.

    PMID: 29145357BACKGROUND
  • 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: 28459105BACKGROUND
  • Kim-Farley RJ, Rutherford G, Lichfield P, Hsu ST, Orenstein WA, Schonberger LB, Bart KJ, Lui KJ, Lin CC. Outbreak of paralytic poliomyelitis, Taiwan. Lancet. 1984 Dec 8;2(8415):1322-4. doi: 10.1016/s0140-6736(84)90831-6.

    PMID: 6150332BACKGROUND
  • Lukusa LA, Ndze VN, Mbeye NM, Wiysonge CS. A systematic review and meta-analysis of the effects of educating parents on the benefits and schedules of childhood vaccinations in low and middle-income countries. Hum Vaccin Immunother. 2018;14(8):2058-2068. doi: 10.1080/21645515.2018.1457931. Epub 2018 May 14.

    PMID: 29580159BACKGROUND
  • Manakongtreecheep K. SMS-reminder for vaccination in Africa: research from published, unpublished and grey literature. Pan Afr Med J. 2017 Jun 22;27(Suppl 3):23. doi: 10.11604/pamj.supp.2017.27.3.12115. eCollection 2017.

    PMID: 29296158BACKGROUND
  • Mbengue MAS, Mboup A, Ly ID, Faye A, Camara FBN, Thiam M, Ndiaye BP, Dieye TN, Mboup S. Vaccination coverage and immunization timeliness among children aged 12-23 months in Senegal: a Kaplan-Meier and Cox regression analysis approach. Pan Afr Med J. 2017 Jun 21;27(Suppl 3):8. doi: 10.11604/pamj.supp.2017.27.3.11534. eCollection 2017.

    PMID: 29296143BACKGROUND
  • Mutua MK, Kimani-Murage E, Ngomi N, Ravn H, Mwaniki P, Echoka E. Fully immunized child: coverage, timing and sequencing of routine immunization in an urban poor settlement in Nairobi, Kenya. Trop Med Health. 2016 May 16;44:13. doi: 10.1186/s41182-016-0013-x. eCollection 2016.

    PMID: 27433132BACKGROUND
  • Powell-Jackson T, Fabbri C, Dutt V, Tougher S, Singh K. Effect and cost-effectiveness of educating mothers about childhood DPT vaccination on immunisation uptake, knowledge, and perceptions in Uttar Pradesh, India: A randomised controlled trial. PLoS Med. 2018 Mar 6;15(3):e1002519. doi: 10.1371/journal.pmed.1002519. eCollection 2018 Mar.

    PMID: 29509769BACKGROUND
  • Tannenbaum MB, Hepler J, Zimmerman RS, Saul L, Jacobs S, Wilson K, Albarracin D. Appealing to fear: A meta-analysis of fear appeal effectiveness and theories. Psychol Bull. 2015 Nov;141(6):1178-204. doi: 10.1037/a0039729.

    PMID: 26501228BACKGROUND
  • VanderEnde K, Gacic-Dobo M, Diallo MS, Conklin LM, Wallace AS. Global Routine Vaccination Coverage - 2017. MMWR Morb Mortal Wkly Rep. 2018 Nov 16;67(45):1261-1264. doi: 10.15585/mmwr.mm6745a2.

    PMID: 30439873BACKGROUND
  • Jacobson Vann JC, Jacobson RM, Coyne-Beasley T, Asafu-Adjei JK, Szilagyi PG. Patient reminder and recall interventions to improve immunization rates. Cochrane Database Syst Rev. 2018 Jan 18;1(1):CD003941. doi: 10.1002/14651858.CD003941.pub3.

    PMID: 29342498BACKGROUND

MeSH Terms

Conditions

InfectionsInformation Seeking Behavior

Condition Hierarchy (Ancestors)

CommunicationBehavior

Study Officials

  • Ryoko Sato, Ph.D.

    Harvard School of Public Health (HSPH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 29, 2019

First Posted

August 1, 2019

Study Start

September 15, 2019

Primary Completion

February 9, 2020

Study Completion

February 9, 2020

Last Updated

July 14, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations