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.: PACTR201702002043415 Date of Approval: 15/02/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effects of Nursing Intervention on Routine Childhood Immunization Completion in Ibadan Oyo State, Nigeria
Official scientific title EFFECTS OF COMMUNITY-BASED NURSING INTERVENTION ON ROUTINE CHILDHOOD IMMUNIZATION COMPLETION IN IBADAN OYO STATE, NIGERIA
Brief summary describing the background and objectives of the trial Vaccine- Preventable Diseases (VPDs) account for high morbidity and mortality among under - five children in low-income countries. Infant immunization is considered essential for the prevention of VPDs to improve child survival. In Nigeria, despite the different immunization strategies adopted, compliance with immunization schedule and completion is still low, hence many children die of VPDs. The use of Reminder/Recall (R/R) system has been proven as one of the effective ways of improving immunization rates in developed countries. However, there is dearth of information on its use in Nigeria. This study was designed to evaluate the individual and combined effects of cell phone R/R and Primary Health Care Immunization Providers¿ Training (PHCIPT) intervention on routine childhood immunization completion among children aged 0-12 months in Ibadan, Oyo state, Nigeria
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics,Routine childhood immunization completion
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 09/07/2012
Actual trial start date 09/07/2012
Anticipated date of last follow up 20/09/2013
Actual Last follow-up date 20/09/2013
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants) 605
Recruitment status Completed
Publication URL http://link.springer.com/article/10.1007/s10900-015-0092-3
Secondary Ids Issuing authority/Trial register
AD 13/479/209) Oyo State Research Ethical Review Committee
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 Stratified allocation Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Cell phone immunization reminder/recall of parents of children 9-12 months cellphone calls for immunization reminder/recall intervention 153 Active-Treatment of Control Group
Experimental Group Immunization providers' training Two days Training of immunization providers on theory and practice of immunization 151 Active-Treatment of Control Group
Experimental Group Combination of immunization reminder/recall and training of immunization providers 9-12 months Cellphone calls Immunization reminder/recall of parents of children and immunization providers¿ training 149
Control Group Control 9-12 months 152 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
For Children (i) Being brought for first immunization visit. (ii) Aged 0-12 weeks. (iii) Any of the child¿s parents possessing at least a cell phone with valid phone number. (iv) Child¿s family living within the community of the study site. For Immunization providers (i) Being a Primary Health Care (PHC) worker that vaccinate children (that is a nurse, a midwife, a Community Health Officer (CHO) or a Community Health Extension Workers (CHEWs.) (ii) Having worked for at least three months in the selected study health facility and (iii) Non-participation in any form of immunization training in the last six months. For Children (i) A child who has previously been brought for immunization visit (ii) A child who is older than 12 weeks (iii) A child whose parents do not possess at least a valid phone and phone number (iv) A child whose mother is a temporary residence in the community of the study site For Immunization Providers (i) PHC health workers like doctors, health assistants, laboratory assistants, record assistants and pharmacy technicians. (ii) Newly transferred immunization providers who have not spent up to three months in the study health facilities will be trained but will not be evaluated. (iii) Immunization providers that have undergone training on immunization less than six months. 0 Day(s) 12 Week(s) Both
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 07/02/2012 Oyo State Research Ethical Review Committee
Ethics Committee Address
Street address City Postal code Country
Oyo State Ministry of Health Secretariat, Ibadan Ibadan 200214 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Immunization completed or immunization not completed (that is the receipt or non-receipt of all scheduled routine childhood immunization in Nigeria 12 months
Secondary Outcome To isolate the effect of each intervention independently and also to evaluate whether combination of both interventions is superior to only one intervention (that is to determine which of the three intervention strategies is most effective in increasing the percentage of routine childhood immunization completion 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ibadan North-east local government area Iwo road Ibadan 200223 Nigeria
Egbeda local government area Alakia Ibadan 200224 Nigeria
Ibadan South-west local government area Ringroad Ibadan 200253 Nigeria
Akinyele local government area Moniya Ibadan 200285 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
The African Population and Health Research Centre (APHRC) in partnership with the International Development Research Centre (IDRC) APHRC Campus, Manga Close off Kirawa Road Nairobi 020 324 2000 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor The African Population and Health Research Centre (APHRC) in partnership with the International Development Research Centre (IDRC) APHRC Campus, Manga Close off Kirawa Road Nairobi 020 324 2000 Kenya Funding Agency
COLLABORATORS
Name Street address City Postal code Country
The African Population and Health Research Centre (APHRC) in partnership with the International Development Research Centre (IDRC) APHRC Campus, Manga Close off Kirawa Road Nairobi 020 324 2000 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Victoria Bolanle Brown vicbrown2010@gmail.com +2348037272857 School of Nursing, University College Hospital
City Postal code Country Position/Affiliation
Ibadan 200212 Nigeria Chief Nurse Tutor
Role Name Email Phone Street address
Public Enquiries Victoria Bolanle Brown vicbrown2010@gmail.com +2348037272857 School of Nursing, University College Hospital
City Postal code Country Position/Affiliation
Ibadan 200212 Nigeria Chief Nurse Tutor
Role Name Email Phone Street address
Scientific Enquiries Oyeninhun Abimbola Oluwatosin aoluwatosin@yahoo.com +2348057070510 Department of Nursing, Faculty of Clinical Sciences, College of Medicine, University of Ibadan
City Postal code Country Position/Affiliation
Ibadan 200213 Nigeria
Role Name Email Phone Street address
Scientific Enquiries Oyeninhun Abimbola Oluwatosin aoluwatosin@yahoo.com +2348057070510 Department of Nursing, Faculty of Clinical Sciences, College of Medicine, University of Ibadan
City Postal code Country Position/Affiliation
Ibadan 200213 Nigeria Senior Lecturer
REPORTING
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