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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Dec 29, 2024
Date Accepted: Sep 15, 2025

The final, peer-reviewed published version of this preprint can be found here:

Effectiveness of a Theory-Based Intervention in Improving Bacillus Calmette-Guérin Uptake and Preventive Practices of Childhood Tuberculosis Among Pregnant Women: Protocol for a Randomized Control Trial

Mohd Zulkefli NA, Dirie AM, Md. Said S, azman AZF, Jimale KA, Aboukar H.M.Fiidow O

Effectiveness of a Theory-Based Intervention in Improving Bacillus Calmette-Guérin Uptake and Preventive Practices of Childhood Tuberculosis Among Pregnant Women: Protocol for a Randomized Control Trial

JMIR Res Protoc 2026;15:e68088

DOI: 10.2196/68088

PMID: 41662504

PMCID: 12887941

EFFECTIVENESS OF THEORY-BASED INTERVENTION IN IMPROVING BCG UPTAKE AND PREVENTIVE PRACTICES OF CHILDHOOD TUBERCULOSIS AMONG PREGNANT WOMEN: A STUDY PROTOCOL FOR A RANDOMIZED CONTROL TRIAL

  • Nor Afiah Mohd Zulkefli; 
  • Ahmed Mohamed Dirie; 
  • Salmiah Md. Said; 
  • Ahmed Zaid Fatah azman; 
  • Kassim Abdi Jimale; 
  • Osman Aboukar H.M.Fiidow

ABSTRACT

Background:

Tuberculosis (TB) in children is one of the significant public health crises in Somalia. This issue is aggravated by the fact that only 37% of children in the country receive the Bacillus Calmette–Guérin (BCG) vaccine, which helps prevent TB-disseminated diseases. Among the major factors that contribute to the poor BCG uptake and TB prevention practices include the lack of maternal knowledge, negative attitude, and self-efficacy towards BCG vaccine and TB prevention practices. As such, pregnant women play a vital role in ensuring that their children receive routine BCG vaccine and accurate TB prevention practices.

Objective:

The objective of our study was to develop, implement, and evaluate the impact of health education intervention using the Information-Motivation-Behaviour Skills (IMB) model to improve knowledge, attitude, and self-efficacy regarding BCG uptake and TB prevention among pregnant women in Banadir Hospital.

Methods:

This health education intervention will be carried out based on the IMB model. A total of 370 pregnant women in their second and third trimesters who attended the antenatal care clinic at Banadir Hospital, Mogadishu, Somalia, will be recruited in this study. The evaluation of the intervention will be conducted using a single-blinded randomised controlled trial design, where the participants are randomly assigned into two groups: the intervention group undergoes the IMB-based health education sessions on BCG vaccine and TB preventive practices, while the control group is placed on a waiting list. The proposed intervention module consists of four main modules and is reviewed by a panel of experts before being trained and implemented to ensure effective delivery of the module's content to the participants. The effects of the intervention will be assessed by handing out the same self-administered questionnaires at baseline, 2-month post-intervention, and 4-month post-intervention. The Generalized Estimating Equation (GEE) will be employed to analyse the collected data, with adjustments made for relevant covariates. The intention to treat analysis will also be conducted. Furthermore, the BCG vaccine uptake and TB prevention practices are considered as the primary outcome, while the secondary outcomes include the knowledge, attitude, and self-efficacy scores.

Results:

Overall, 370 pregnant women were recruited between November 25, 2021, and December 21, 2021. At four-month follow-up, of these 370 pregnant women, 329 (88.9%) was completed the intervention program. Findings will be reported in the first half of 2025.

Conclusions:

The developed health education intervention module in this study has the potential to be adopted and included as part of the routine antenatal care service. Its implementation could effectively raise awareness among pregnant women in Somalia regarding the importance of BCG vaccination and TB prevention practices, ultimately mitigating childhood mortality rates associated with TB-disseminated diseases in the country. Clinical Trial: Trial registration :The unique identification number for the registry PACTR202105554130782, Registered on May 24th 2021.


 Citation

Please cite as:

Mohd Zulkefli NA, Dirie AM, Md. Said S, azman AZF, Jimale KA, Aboukar H.M.Fiidow O

Effectiveness of a Theory-Based Intervention in Improving Bacillus Calmette-Guérin Uptake and Preventive Practices of Childhood Tuberculosis Among Pregnant Women: Protocol for a Randomized Control Trial

JMIR Res Protoc 2026;15:e68088

DOI: 10.2196/68088

PMID: 41662504

PMCID: 12887941

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