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

Background: Tuberculosis (TB) in children is one of the most significant public health crises in Somalia. This issue is aggravated by the fact that only 36.7% of children aged 12 to 23 months receive the Bacillus Calmette-Guérin (BCG) vaccine in Somalia, which helps prevent TB-disseminated diseases. Among the major factors that contribute to poor BCG uptake and TB prevention practices are the lack of maternal knowledge, negative attitude, and poor self-efficacy toward the BCG vaccine and TB prevention practices. As such, pregnant women play a vital role in ensuring timely, routine BCG vaccination for their newborns and adherence to TB prevention practices. Objective: This study aims to develop, implement, and evaluate the impact of health education intervention using the information-motivation-behavioral (IMB) skills model to improve knowledge, attitudes, and self-efficacy regarding BCG uptake and TB prevention among pregnant women in Banadir Hospital. Methods: This single-blind randomized controlled trial enrolled a sample of 370 pregnant women recruited at Banadir Hospital in Mogadishu, Somalia. Eligible participants will be randomized to an intervention group receiving an IMB-based health education and to a waiting list control group, in a 1:1 ratio. Outcome assessments will be conducted at baseline, 2-month follow-up, and 4-month follow-up. The primary outcomes are BCG vaccine uptake and TB prevention practices. Secondary outcomes include knowledge, attitudes, and self-efficacy related to the BCG vaccine and TB prevention practices. The IMB-based health education intervention program consists of 6 sessions, with 1 group per session, and with each session containing 30 participants. The effects of the intervention will be assessed by handing out the same self-administered questionnaires at baseline, 2-month postintervention, and 4-month postintervention. Results: A total of 370 pregnant women were recruited at baseline in November 2021, with 185 assigned to the intervention group and 185 assigned to the control group. In January 2022, the 185 pregnant women enrolled in the intervention program and completed the sessions by February 2022. Data collection for the 2-month and 4-month postintervention assessments was completed in June 2022. The findings of this study will be reported by the beginning of 2026. Conclusions: The developed health education intervention module in this study has the potential to be adopted and included as part of routine antenatal care services. 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.