Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202006722055635 Date of Approval: 09/06/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Theory-Based Immunisation Health Education Intervention in Improving Child Immunisation Uptake Among Antenatal Mothers Attending Federal Medical Centre in Nigeria: A Study Protocol for a Randomized Controlled Trial
Official scientific title Theory-Based Immunisation Health Education Intervention in Improving Child Immunisation Uptake Among Antenatal Mothers Attending Federal Medical Centre in Nigeria: A Study Protocol for a Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Vaccine Preventable Diseases are still the most common cause of childhood mortality with an estimated of approximately 3 million death every year mainly in Africa and Asia and about 29% of deaths among children aged 1–59 months were as a result of vaccine preventable. Despite the benefit of childhood immunization uptake, routine vaccination coverage for all recommended Expand Program on Immunization vaccines has remained poor in Nigeria (31%) with Zamfara state been among the state with poorest coverage (<10%). Despite this, no study has been conducted guided by any health theory in improving the knowledge, attitude, outcome expectations and self-efficacy of antenatal mothers towards childhood immunization which may increase childhood immunization uptake and finally decrease childhood mortality and morbidity. The general objective of this study is to develop, implement and evaluate the effects of an immunization health educational intervention with application of Social Cognitive Theory on pregnant women to improve childhood immunization uptake among children in Federal Medical Center Gusau, Zamfara State Nigeria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 18/04/2021
Actual trial start date 04/10/2021
Anticipated date of last follow up 17/04/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 392
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Immunization health education intervention Childhood immunization uptake for pentavalent vaccine1, pentavalent vaccine2 and pentavalent vaccine3. Minimum of three months and maximum of six months. The immunization health education intervention will be based on social cognitive theory using knowledge, attitude, outcome expectation and self-efficacy constructs. 196
Control Group Usual care Childhood immunization uptake for pentavalent vaccine1, pentavalent vaccine2 and pentavalent vaccine3 Minimum of three months and maximum of six months. The participants in the control group will recieve the usual care (standard care) given to pregnant women at the federal medical center Gusau Zamfara state Nigeria. 196 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
i. Antenatal mothers of age above 18 who are in third trimesters (28-37 gestational weeks). ii. Mothers with single pregnancy. iii. Must be mothers who planned to deliver and intended to attend the clinic to immunized their children at Federal Medical Center Gusau. iv. Citizens of Nigeria. v. Those resident in Gusau. i. Mothers without good understanding of Hausa language as the intervention will be delivered in Hausa language. ii. Mothers who attended previous health education intervention on immunization will be excluded to minimize confounding, as previous study revealed high immunization uptake among children whose mothers attended previous health education intervention on immunization. iii. Mothers of family with nomadic lifestyle will also be excluded as previous study reported revealed low immunization uptake among children whose mothers’ practice nomadic lifestyle. Adult: 19 Year-44 Year 18 Year(s) 44 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/11/2020 Ethics Committee for Research Involving Human Subjects JKEUPM University Putra Malaysia
Ethics Committee Address
Street address City Postal code Country
University Putra Malaysia 43400, UPM Serdang Selangor Darul Ehsan Malaysia Serdang 43400 Malaysia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome childhood immunization uptake At three time points
Secondary Outcome Increase in knowledge scores, attitude scores, outcome expectation scores, self-efficacy scores, cultural beliefs scores and assumptions on religious regulations scores. At three points time
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal medical center Gusau Zamfara state Nigeria Gusau bye pass road Gusau 860271 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Mr Abubaker Galadima Jalan Universiti 1 Serdang 43400 Malaysia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor parents Gangaren yarima tudun wada Gusau Gusau 860271 Nigeria parents
COLLABORATORS
Name Street address City Postal code Country
Prof Nor Afiah Mohd Zulkifil Jalan Universiti 1, Faculty of medicine and health sciences, University Putra Malaysia Serdang 43400 Malaysia
Prof Salmiah MD Said Jalan Universiti 1, Faculty of medicine and health sciences, University Putra Malaysia Serdang 43400 Malaysia
Dr Norliza Ahmad Jalan Universiti 1, Faculty of medicine and health sciences, University Putra Malaysia Serdang 43400 Malaysia
Dr Saleh Ngaski Garba community market zaria 810211 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abubakar Galadima galadimamafara@gmail.com +60164565102 JALAN UNIVERSITI 1
City Postal code Country Position/Affiliation
Serdang 43400 Malaysia PhD student
Role Name Email Phone Street address
Scientific Enquiries Nor Afiah Zulkifil norafiah@upm.edu.my +60125289553 JALAN UNIVERSITI 1
City Postal code Country Position/Affiliation
Serdang 43400 Malaysia Main Supervisor
Role Name Email Phone Street address
Public Enquiries Abubakar Galadima galadimamafara@gmail.com +60164565102 JALAN UNIVERSITI 1
City Postal code Country Position/Affiliation
Serdang 43400 Malaysia PhD Student main researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Question 1. sociodemographic 10, question 2. obstetric history 3, question 3. health care of respondent 4, question 4 social cognitive constructs: knowledge 42, attitude 15, out expectation 12, self efficacy 3 and finally childhood immunization uptake. Informed Consent Form 12 months after study completion Prof Nor Afiah Mohd Zulkefli norafiah@upm.edu.my
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information