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Effect of Knowledge on Vaccine Take-up in Adamawa State, Northeastern Nigeria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04042246
Recruitment Status : Completed
First Posted : August 1, 2019
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
Ryoko Sato, Harvard School of Public Health

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. 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. 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

Condition or disease Intervention/treatment Phase
Immunization; Infection Educational Problems Information Seeking Behavior Behavioral: Information Provision Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Health Services Research
Official Title: Knowledge on Vaccination Schedule and Full Immunization, and Its Effect on Vaccine Take-up in Jada Local Government Area in Adamawa State, Northeastern Nigeria
Actual Study Start Date : September 15, 2019
Actual Primary Completion Date : February 9, 2020
Actual Study Completion Date : February 9, 2020

Arm Intervention/treatment
No Intervention: Control
No intervention is implemented among Control
Experimental: Treatment (Educational Information on Vaccination)
Provide general and tailored information on vaccination and vaccination schedule at the end of the baseline survey
Behavioral: Information Provision
Provide the information on the importance of the vaccination and tailored vaccination schedule




Primary Outcome Measures :
  1. Number of participants who have the accurate knowledge level of vaccination, as assessed by survey questionnaire [ Time Frame: 2 weeks ]

    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. Number of participants who bring their children for the full vaccination, as assessed by the follow-up tracking survey at health clinics [ Time Frame: 9 months ]
    The investigators will collect the information on the actual vaccination status among respondents' children



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • women with a child 12 months old or younger

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04042246


Locations
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Nigeria
Jada Local Government Primary Health Care Development Agency
Jada, Adamawa, Nigeria
Sponsors and Collaborators
Harvard School of Public Health
Investigators
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Principal Investigator: Ryoko Sato, Ph.D. Harvard School of Public Health
Publications:

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Responsible Party: Ryoko Sato, Principal Investigator, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT04042246    
Other Study ID Numbers: TBDNA
First Posted: August 1, 2019    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No