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.: PACTR202312664285367 Date of Approval: 14/12/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of health education intervention on the use of insecticide treated nets and its practices among pregnant women attending antenatal clinic
Official scientific title Effects of health education intervention on the use of insecticide treated nets and its practices among pregnant women attending antenatal clinic in university of Nigeria teaching hospital (UNTH) Enugu, Nigeria.
Brief summary describing the background and objectives of the trial Malaria poses a public health challenge in endemic African countries (WHO, 2014). Global estimates of malaria indicate at least 3.3 billion people are at risk of being infected with malaria and developing disease, and 1.2 billion are at high risk. According to the latest World Malaria Report, released in November 2017, there were 216 million cases of malaria in 2017, up from 211 million cases in 2016. The objective is to develop, implement and evaluate the effects of health education intervention on the practice of insecticide treated nets among pregnant women attending antenatal clinic in UNTH Enugu, Nigeria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Early detection /Screening
Anticipated trial start date 13/11/2023
Actual trial start date 14/01/2024
Anticipated date of last follow up 13/06/2024
Actual Last follow-up date 13/06/2024
Anticipated target sample size (number of participants) 283
Actual target sample size (number of participants) 283
Recruitment status Not yet recruiting
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Health Education Intervention 1 hour six months Respondents of the intervention group will receive health education in addition to their usual clinic care. A total of 6 sessions and thirty minutes in each session. The duration of the intervention is six months and the total duration is 1 hour 142
Control Group Clinical care 1hour six Months Respondents of the control group will receive their usual clinic care and placebo. The duration is six months during intervention and post. 141 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All pregnant women age 18 years and above. All pregnant women who are in their 1st and 2nd trimesters. All pregnant women who has had past history of malaria. Pregnant women who are in their 3rd trimester. All pregnant women who are already diagnosed with malaria Adult: 19 Year-44 Year 18 Year(s) 40 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 01/09/2023 Ethics Committee for Research involving Human Subjects of Univerisit Putra Malaysia
Ethics Committee Address
Street address City Postal code Country
Jalan Universiti 1,Serdang, Selangor Serdang 43400 Malaysia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 02/10/2023 University of Nigeria Teaching Hospital Enugu Nigeria
Ethics Committee Address
Street address City Postal code Country
University of Nigerian Teaching Hospital Ituku-Ozalla Enugu Port- Harcourt Express Way Enugu Eungu 400001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Health Education at baseline, at 3 months during intervention and 6 months post intervention
Secondary Outcome Knowledge & Attitude on ITNs use & Health Belief Model (HBM) construct. At baseline, 3 months during intervention and 6 months post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Nigeria Teaching Hospital Ituku, Ozalla, Nigeria Enugu 400001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Monica Opara Onyinyechi Univ360 Place, Jalan jaya2. Malaysia Serdang 43300 Malaysia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Ijeoma Unazi Department of Public Health Federal University Of Technology Owerri, Imo State Nigeria. Owerri 460114 Nigeria Individual
Secondary Sponsor Dr Jessica Lekwa Department of Public Health Federal University Of Techonology Owerri Imo State, Nigeria Owerri 460114 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Idenyi Elias Ndubuisi eliasndubuisi7@gmail.com 2348033889157 University Of Calabar Nigeria
City Postal code Country Position/Affiliation
Calabar 540271 Nigeria Professor
Role Name Email Phone Street address
Public Enquiries Nelson Lilian Ujunwa ujunwalilib@yahoo.com 2348056299692 Federal University Of Technology Owerri
City Postal code Country Position/Affiliation
Owerri 460114 Nigeria Professor
Role Name Email Phone Street address
Scientific Enquiries Idenyi Elias Ndubuisi Omaba eliasndubuisi7@gmail.com 2348033889157 University Of Calabar Nigeria
City Postal code Country Position/Affiliation
Calabar 540271 Nigeria Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participant data will be available and all the individual participant data collected during the data collection will be shared. Data will be stored in SPSS and results generated will be published in Scopus Index journal for public use. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol All data will be available for public use starting August 2024 and there is no end date. Anyone who wishes to access the data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Data will be available at https://submission.springernature.com/submission-details/b9a3abfc-3d3f-4abe-a5fb-f84deb677634 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