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.: PACTR202105554130782 Date of Approval: 24/05/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECTIVENESS OF SOCIAL COGNITIVE THEORY-BASED INTERVENTION TO IMPROVE BCG UPTAKE AND PRACTICE OF CHILDHOOD TUBERCULOSIS AMONG PREGNANT WOMEN.
Official scientific title EFFECTIVENESS OF SOCIAL COGNITIVE THEORY-BASED INTERVENTION TO IMPROVE BCG UPTAKE AND PRACTICE OF CHILDHOOD TUBERCULOSIS AMONG PREGNANT WOMEN.
Brief summary describing the background and objectives of the trial The general objective of this study is to evaluate the effectiveness of SCT-based-intervention module to improve BCG uptake, practice, knowledge, attitude, outcome expectation, and self-efficacy of childhood TB among pregnant women in a Hospital, Mogadishu, Somalia. The specific objectives of this study include i) to describe and compare socio-demographic and obstetric characteristic between the intervention and control groups at the baseline; ii) to describe and compare the knowledge, attitude, practices, outcome expectation, and self-efficacy of childhood TB, between the intervention and control groups at the baseline; iii) to evaluate the effectiveness of an SCT-based-intervention module on BCG uptake between (intervention and control) and within groups (at 2-months to 4-months after birth); vii) to evaluate the effectiveness of a SCT-based-intervention module to improve the knowledge, attitude, practices, outcome expectation and self-efficacy of childhood TB between (intervention and control) and within groups (at 2-months to 4-months after birth) among pregnant women in a Hospital, Mogadishu, Somalia.
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 Tuberculosis
Purpose of the trial Prevention
Anticipated trial start date 01/06/2021
Actual trial start date 01/07/2021
Anticipated date of last follow up 01/11/2021
Actual Last follow-up date 01/11/2021
Anticipated target sample size (number of participants) 540
Actual target sample size (number of participants) 370
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Safety is the priority waitlist 4 month No intervention 185 Uncontrolled
Experimental Group safety is the priority single dose 4 month The intervention constitutes five sessions delivered in 3 weeks. each session of these modules will cover a specific area relating to the main characteristics and problems of childhood TB to generate the strategies to improve their knowledge, attitude, and self-efficacy towards BCG Vaccine and practices of the TB. The supervisory committee will be assessed the validity of module contents. Appropriate reading level and language in the print materials will be prepared. The program will be delivered to all the participants in the intervention group. The contents of the program will be delivered using PowerPoint software, a video projector, and self-help materials covering each session. The method of delivery will be brainstorming, Questions and answers, use peer leader in the discussion, Group discussion, Situational role play Information, give verbal reinforcement, Experience sharing, Demonstration skills were used in this intervention 185
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
 Those between 24 to 30 weeks of their pregnancy will be selected, as their gestational ages will more likely to allow them to complete the study.  Those Plan to follow up their post-natal visit in the Banadir Maternal and Child Hospital, Mogadishu.  Those coming for other health conditions  Those coming other purposes like family planning  Those non-Somalian women Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 49 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 14/02/2021 Ministry of health and human services of somalia
Ethics Committee Address
Street address City Postal code Country
Shangani, Mogadishu, Somalia Mogadishu none Somalia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome BCG uptake, Practices of childhood TB 4 month
Secondary Outcome Self-efficacy, Knowledge, and Attitude 4 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Banadir Maternal and Child Hospital Hodan, near kilometer 5 Mogadishu Somalia
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Mohamed Dirie Hodan, near Ollow tower Mogadishu Somalia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Daahir Mohamed Dirie howlwadaag, near ekis control Mogadishu Somalia brother
COLLABORATORS
Name Street address City Postal code Country
Jamhuriya University Benadir Street, Hodon District, Banadir Region Mogadishu Somalia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Mohamed Dirie diiriyenih@gmail.com +252614169097 Hodan, near ollow Tower
City Postal code Country Position/Affiliation
Mogadishu Somalia Research
Role Name Email Phone Street address
Public Enquiries Osman Fiidow Wilow@gmail.com +252615969793 madina, near daljirka
City Postal code Country Position/Affiliation
Mogadishu Somalia Researcher
Role Name Email Phone Street address
Scientific Enquiries Salmiah bint Md Said Salmiahms@upm.edu.my +60136362574 Department of Community Health, Faculty of Medicine and Health Sciences, UPM
City Postal code Country Position/Affiliation
kaululumpur Malaysia Expert
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes according to WHO requirement for all trials being registered after 1 January 2019 to include an IPD Sharing Statement prior to registration, I'm here to state that, I'm ready to share those documents with 12 months of the study completion date. Informed Consent Form,Statistical Analysis Plan,Study Protocol after a year it will be open
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